Professional Documents
Culture Documents
Through providing the right information, The result is better, healthier lives for
diagnostics enable healthcare professionals patients, and healthcare systems poised for
to work more knowledgeably so that the long term.
they can make better treatment decisions.
Driving this change are the new biomarkers That’s the power of knowing.
and testing technologies, which give That’s Roche Diagnostics.
laboratories an expanded role in delivering
improved patient outcomes.
IVD accounts for ~ 2 % of worldwide IVD influences > 60 % of clinical Diagnostics Pharmaceuticals
Increased value of Diagnostics patients can now benefit from targeted With our leading Pharmaceuticals and In pursuit of this vision, we are developing
In vitro diagnostics (IVDs) have long been treatments based on the presence of Diagnostics businesses under one roof, we our capabilities and building strategic
considered as the “silent champion” of specific genetic defects or biomarkers in are positioned to deliver Personalised partnerships so new information and
healthcare, influencing over 60 % of clinical their blood or tissue. Targeted therapies Healthcare. Roche’s vision is to unlock the insights lead to the right treatment for the
decision-making, while accounting for only and diagnostic tests that help to improve full potential of personalised healthcare for right patient at the right time.
about 2 % of total healthcare spending. medical decision-making not only offer patients through the development of break-
clinical benefits for patients but are also through medicines and leading diagnostics. With a proven track record in delivering
The role of IVDs is set to grow with today’s attractive through health economic breakthrough medicines and diagnostics
changes in healthcare. With the develop- benefits to regulatory authorities and payers. and deep expertise in molecular biology
ment of Personalized Healthcare (PHC), and data science, Roche is a unique part-
ner to drive this next step in the evolution
of healthcare.
*Roche Annual Report 2015/Roche HY 2016 sales report: “Today 27 % of Roche Pharma’s sales are generated
by products with a companion test on the label (Roche half-year sales 2016)”
2|3
Our business strategy Roche Diagnostics commitment
Differentiation with testing efficiency and Providing innovation and excellence today
medical value throughout the entire healthcare and tomorrow
value chain
In modern healthcare, in vitro diagnostics decision-making along the entire continuum We offer a pioneering partnership Global and local expertise and dedicated
go far beyond simply telling a doctor of a patient’s health or disease, enabling to make the maximum contribution service and support teams in over 130
whether a patient has a certain disease physicians to make full use of IVDs along to patient care countries are there to support you every
or not. Today, they are an integral part of the healthcare value chain. As a leader in IVD solutions*, we are your step of the way. Our commitment and rich
dedicated partner supporting you through pipeline of differentiated solutions and
our technologies for centralized and technologies are there all the way to sup-
Healthy Asymptomatic/Symptomatic disease Chronic disease decentralized settings, in molecular and port you in providing improved patient care
tissue testing as well as automation – today and also tomorrow.
Diagnostics and IT solutions.
Today, IVDs are an integral part of decision-making along the entire continuum of a patient’s health or disease,
enabling physicians to make full use of IVDs along the healthcare value chain. cy M
Total solution en Pioneer in
provider Personalized
ed
i
ic
ica
eff
Healthcare
l val
Testing
ue
Personalized Comprehensive
solutions for different and differentiated
throughput needs testing menu
Pa r t
n ership
4|5
Roche Diagnostics’ areas of expertise “We are committed to delivering the best possible
diagnostic solutions to improve people’s lives.
Covering all in vitro diagnostic segments Sustainable healthcare depends on diagnostics,
in all major healthcare areas and as the leader in the industry, we have the
opportunity to shape healthcare delivery and to opti-
mize resources in order to ultimately benefit society
as a whole.”
Roche Diagnostics serves customers Roche Diagnostics offers the industry’s Roland Diggelmann, COO Roche Diagnostics
spanning the entire healthcare spectrum – broadest range of diagnostic tests*. Our
from research institutions, hospitals and pioneering technologies and solutions not
commercial laboratories to physicians and only help ensure an accurate diagnosis,
patients. Performed on blood, tissue or they can detect the risk of disease, predict
other patient samples, in vitro diagnostics how a disease may progress, and enable
are a critical source of objective information the right treatment decision at the outset.
for improved disease management and
patient care. We help patients gain control over chronic
conditions by enabling both physicians
and patients to monitor treatment progress.
And, through our successful collaboration
with laboratories, we provide the fast and
reliable results needed for life-changing We focus on all major healthcare areas
Research
Research
Research Clinical Clinical
Clinical applications
applications
applications
Research Research
Research Clinical applications
decisions.Clinical
Clinical
applications
applications Oncology Cardiology & metabolism Infectious diseases
6|7
Contents
Serum Work Area solutions...................... 13 Elecsys® TORCH panel..........................................68 Hematology............................................ 107 COBAS® AmpliPrep/
cobas® modular platform....................................14 Elecsys® Troponin T – high sensitive................ 70 NEW cobas m 511..................................... 108 COBAS® TaqMan® HIV-1 Test, v2.0.......... 141
cobas® 8000 modular analyzer series.............16 Elecsys® NT-proBNP..............................................72 COBAS® AmpliPrep/
cobas 6000 analyzer series..............................20
®
Elecsys® IL-6, PCT and Tina-quant® CRP....... 74 COBAS® TaqMan® HBV Test, v2.0..............142
cobas 4000 analyzer series..............................24
®
Elecsys® tumor marker portfolio........................ 76 NEW cobas® HBV....................................... 144
cobas c 111 analyzer............................................26 Elecsys® HE4............................................................. 78 Urinalysis................................................111 COBAS® AmpliPrep/
COBAS INTEGRA 400 plus................................28
®
Elecsys® ProGRP.....................................................80 Urinalysis from Roche....................................112 COBAS® TaqMan® CMV Test...................... 146
cobas c 513 analyzer............................................30 Elecsys® SCC............................................................82 Micral-Test® strip for albumin in urine......113 NEW cobas® CMV...................................... 148
Automation & IT solutions....................................32 NEW The Roche lung cancer Combur-Test® strip..........................................114 COBAS® AmpliPrep/
cobas middleware solutions............................34
®
diagnostics portfolio..............................................84 Urisys 1100® analyzer.....................................115 COBAS® TaqMan® System........................... 149
cobas® infinity IT solutions................................36 Elecsys® Calcitonin.................................................86 cobas u 411 urine analyzer.........................116 cobas® 6800/8800 Systems........................ 150
Standalone and connected automation..........40 Elecsys® Tg II............................................................88 cobas® 6500 urine analyzer series............118 cobas® 4800 System......................................152
cobas p 512 and cobas p 612 Elecsys® Anti-TSHR................................................90 cobas® Liat® System..................................... 156
pre-analytical systems...........................................42 Elecsys® Vitamin D total II...................................92 cobas s 201 System...................................... 158
cobas p 312 pre-analytical system..................44 Fully automated Elecsys® FLOW Solution................................................. 160
cobas p 501 and cobas p 701 Anti-Müllerian Hormone (AMH) assay...........94 Molecular diagnostics.........................121 LightCycler® Systems..................................... 162
post-analytical units...............................................45 Elecsys® sFlt-1/PlGF...............................................96 Molecular diagnostics solutions.................122 LightCycler® 2.0 Instrument......................... 164
cobas® 8100 automated workflow series......46 The full SWA immunosuppressive Test Overview.....................................................124 MagNA Pure Systems.................................... 166
cobas® connection modules (CCM)................48 drug assay panel.....................................................98 cobas® HPV Test.............................................126 cobas p 480 instrument............................... 168
Overview of Serum Work Area tests.................50 cobas® Oncology Portfolio...........................128 cobas p 680 instrument................................170
Elecsys® ECL – unique immunoassay NEW cobas® CT/NG.................................. 130
technology.................................................................56 cobas® HSV 1 and 2 Test............................ 131
Turbidimetry – highly developed Hemostasis testing................................... 101 COBAS® TaqMan® MTB Test........................132
detection technology.............................................58 cobas t 411 coagulation analyzer...................102 cobas® Cdiff Test.............................................133 Roche Blood Safety Solutions............ 173
Diagnostics excellence in Multiplate® analyzer.............................................104 cobas® MRSA/SA Test................................. 134 Roche Blood Safety Solutions......................174
Infectious Diseases................................................60 cobas® HCV test..............................................135
The Roche Hepatitis diagnostic portfolio........62 cobas® HCV Genotyping test......................137
Elecsys® HIV combi PT COBAS® AmpliPrep/
4th Generation (Ag+Ab test)................................64 COBAS® TaqMan® HCV qualitative
The Syphilis test panel...........................................66 and quantitative Tests, v2.0.......................... 138
Elecsys® Syphilis immunoassay.......................... 67 cobas® HIV-1................................................... 139
8|9
Point-of-care testing............................ 177 Tissue diagnostics................................213 Roche Sequencing Solutions: Consultancy services........................... 273
Overview of point-of-care Tissue diagnostics............................................214 a Unifying Force in NGS......................245 Consultancy services......................................274
diagnostic tests.................................................178 VENTANA HE 600 system.............................216 NEW HEAT-Seq Target Enrichment
cobas® POC IT solution............................... 181 BenchMark Special Stains............................218 Systems............................................................... 246
cobas® infinity POC tablet......................... 184 VENTANA BenchMark systems..................220 SeqCap Target Enrichment.......................... 248
cobas® infinity POC mobile....................... 186 IHC and ISH detection...................................222 NEW Harmony Prenatal Test.................... 250 Digital Services..................................... 277
cobas® bge link software........................... 188 Primary antibodies...........................................224 NEW AVENIO Millisect Instrument.........252 Roche DiaLog....................................................278
cobas b 221 system...................................... 190 Breast cancer diagnostics.............................227 NEW Cell-Free DNA Collection Tube.....253 Roche Inventory Solutions............................279
cobas b 123 POC system.............................192 Cervical disease diagnostics........................228 NEW KAPA DNA Library Preparation
Accu-Chek® Inform II solution................... 194 Colorectal diagnostics................................... 230 Kits for Illumina................................................ 254 Trademarks............................................280
cobas h 232 POC system............................ 196 Hematopathology diagnostics.....................232 NEW KAPA HyperPrep Kits...................... 256
Roche CARDIAC® Trop T Lung cancer diagnostic solutions............. 234 NEW KAPA HyperPlus Kits....................... 258
Sensitive test..................................................... 198 Prostate cancer diagnostics........................ 236 NEW KAPA Stranded mRNA-Seq Kits..... 260
CoaguChek® XS system.................................200 Connectivity solutions.....................................237 NEW KAPA Stranded RNA-Seq
CoaguChek® Pro II system............................202 VANTAGE workflow solution....................... 238 with RiboErase................................................. 261
Accutrend® Plus system............................... 204 Companion diagnostics................................ 240 NEW KAPA Library Quantification Kits.... 262
Reflotron® Plus system and Digital pathology..............................................242 KAPA Library Amplification Kits................ 264
Reflotron® Sprint systems............................ 206 NEW KAPA hgDNA Quantification
cobas b 101 system...................................... 208 and QC Kits....................................................... 266
NEW CoaguChek® INRange system......210 NEW KAPA Accessories............................ 268
NEW KAPA RNA HyperPrep Kits.............270
10 | 11
Serum Work Area solutions
Immunochemistry Laboratories have to manage critical work-
flow processes and provide uninterrupted
Roche’s flexible cobas IT systems include
middleware applications, laboratory infor-
Laboratories
everything from sample entry to result resources more effectively, while monitoring
reporting and archiving. With their scalable laboratory performance and increasing
modular design, they can be customized quality and confidence.
Instruments Automation
• Designed to
work together
• Easy onsite
upgradability
Reagents • Maximum IT Solutions
consolidation
• Future proof
12 | 13
cobas® modular platform
www.cobas.com
Flexible family concept for tailor-made solutions
14 | 15
cobas® 8000 modular analyzer series
www.cobas.com
Intelligent LabPower
The cobas 8000 modular analyzer series is Your benefit • Easy and fast on-site expandability for
the newest member of the Roche cobas Maximize productivity and efficiency highly efficient change management
modular platform family. • Maximizes throughput and consolidation • Connectivity to pre- and post-analytics al-
power without compromising workflow lows integration and further automation
One cobas 8000 modular analyzer series • Manages peak times efficiently for less variability and more predictability
configuration consists of up to 4 analytical • Improves sample turn around time and in the process, providing confidence in
modules and is built with a core unit, an availability results
optional ISE unit (cobas ISE module),
a high volume throughput clinical chemis- Support best patient care Product characteristics
try module (cobas c 702 module, cobas c • Broad reagent menu and the high number • High speed: From 170 to 1,200 immuno
701 module), a mid volume throughput of reagent channels onboard maximizes assay tests/hour and 2,000 to 9,800 Some examples from possible
clinical chemistry module (cobas c 502 the testing consolidation power clinical chemistry tests/hour depending configurations
module) a high throughput immunoassay • Patient single tube with low sample volume on configurations Throughput (tests/hour with ISE)
module (cobas e 801 module) and a mid • High quality reagents and reliable H
itachi • Up to 280 reagent channels 10,000
volume throughput immunoassay module systems create confidence in results • Multidimensional modularity: more than 9,000
(cobas e 602 module). • Seamless STAT integration for short 450 configurations for tailored solutions
8,000
2,000
1,000
0
0 50 100 150 200 250 300
Reagent channels
16 | 17
cobas® 8000 modular analyzer series
At a glance
Immunoassay Modules
The cobas 6000 analyzer series is a Your benefit Product characteristics Delivers customized solutions for
member of the cobas modular platform. Increased efficiency High system reliability various work and testing requirements
It offers medium workload laboratories • Perfect fit of throughput and reagent • More than 12,000 systems in operation Throughput (tests/hour with ISE)
tailor made solutions for clinical chemis- channels achieved across the seven worldwide
2,200
try and immunochemistry testing. different configurations • Proactive automated maintenance for
2,000
• Consolidation of 98 % of the Serum over 99 % uptime on a 24/7 base
The more than 20,000 active modules Work Area testing 1,800
are the best testimonial for the success- • Simplified lab processes and reduced costs Unique reagent concept 1,600
20 | 21
cobas® 6000 analyzer series
www.cobas.com
The success story continues
22 | 23
cobas® 4000 analyzer series
www.cobas.com
Freedom to realize your lab’s potential
The cobas 4000 analyzer series is a Your benefit Product characteristics cobas c 311 analyzer
member of the cobas modular platform Increased efficiency First class performance
family and designed for laboratories • Consolidation of 98 % or more of Serum • More than 120 assays and applications
processing 25,000 to 500,000 tests per Work Area workloads available including DATs, TDMs, specific
year or 50 to 400 samples per day. proteins and whole blood HbA1c
It consists of the c obas c 311 analyzer Maximum uptime • Throughput: up to 300 tests/h; ISE: 150
for clinical chemistry and the cobas • Highly reliable system based on more samples/h (corresponding to 450 tests/h)
e 411 analyzer for immunochemistry than 35 years of experience
testing. Together with cobas infinity • Excellent support by Roche organizations Intelligent sample workflow
standardized 3R (Request, Result, Reporting) worldwide • 108 sample positions with continuous • 9 min. STAT applications including Troponin,
solution and the ability to integrate the random access and flexible STAT priority CK-MB, Myoglobin, ß-hCG and PTH
cobas p 312 pre-analytical system, the Quality of results settings • Disposable tips and cups for carryover-
c obas 4000 analyzer series provides a • Integrated safety features for results free sample pipetting
comprehensive Serum Work Area solution you can trust Unique reagent concept
that brings workflow efficiency to the • Predictable turn-around time • Convenient handling of c obas c packs Intelligent sample workflow
next level. • Economic usage with high stabilities • 75 sample positions (rack system)
and convenient kit sizes • 30 sample positions (disk system)
• Continuous random access and flexible
Multiple LIS High system reliability STAT priority settings
• Programmable automated maintenance
functionalities Unique reagent concept
cobas infinity 3R virtual automation
• Convenient and error-free handling
Product characteristics cobas e 411 analyzer of cobas e packs
First class performance • Economic usage with high stabilities
• More than 100 assays available and convenient kit sizes
• Throughput: up to 86 tests/h
• Superior immunoassay testing using High system reliability
ECL technology • More than 15,000 analyzers installed
worldwide
cobas p 312 cobas c 311 clinical cobas e 411 immunochemistry • High uptime of 99.8 %
pre-analytical system chemistry analyzer analyzer (rack system) Source: Roche data on file.
24 | 25
cobas c 111 analyzer
www.cobas.com
Small box. Big performance.
The cobas c 111 analyzer is the smallest Your benefit Product characteristics
member of the cobas® serum work area High quality of results World-class performance
platform family and the ideal solution for • Comprehensive testing capabilities • More than 40 assays and applications
clinical chemistry testing in laboratories • Results you can trust available including whole blood HbA1c,
running ten to 50 samples per day. With a hsCRP, and D-dimer
comprehensive test menu and easy inte- Increased efficiency • Externally rated world-class performance2
gration of STAT samples, it can support • Essential routine testing on a small
testing of both routine clinical chemistry footprint Good fit for labs <50 samples/day
panels and rapid turnaround critical care • Simplified system operation • Throughput of up to 100 tests/hour
markers. In addition, the cobas c 111 • Compact benchtop system for labs with
analyzer uses the same reagent formula- Maximum uptime limited floor space
tions as the larger cobas clinical chemistry • Highly reliable system delivering • Easy, intuitive software handling
analyzers. This standardizes patient results, > 99 % uptime1
which is vital to integrated laboratory net- • Excellent support provided by Roche High system reliability
works serving outpatient services, emer- organizations worldwide • Robust system design
gency departments and clinics, as well as • Wizard-guided maintenance procedures
private laboratories serving primary care Optimized workflow • More than 5,500 analyzers installed
physicians. • Reducing complexity for a range of labo- worldwide
ratories, both networked or standalone
• Consistent results across the cobas Network compatibility
platform • Ability to connect to local IT environment
• Common reagent chemistry across the
cobas® platform
26 | 27
COBAS INTEGRA® 400 plus
www.cobas.com
The specialist in the routine laboratory
The COBAS INTEGRA 400 plus analyzer is Your benefit Product characteristics
the perfect solution for laboratories running High quality of results First class performance
50 to 400 samples per day. Its broad test • Results you can trust • More than 110 assays and applications
menu comprises over 120 assays and appli- available including clinical chemistry,
cations that consolidate clinical chemistry Increased efficiency specific proteins, TDMs, DATs and whole
with specific proteins, therapeutic drug • Comprehensive testing capabilities on a blood HbA1c
monitoring and drug abuse testing. This compact footprint
compact tabletop analyzer offers maximum • Simplified processes and reduced costs Good fit for labs processing
versatility to improve efficiency and reduce 50 to 400 samples/day
costs. It uses the convenient cobas c pack Optimized workflow • Throughput of up to 400 tests/hour
reagent f ormat, which standardizes patient • Consistent results across the cobas® • Compact benchtop system for labs with
results across integrated laboratory networks. platform limited floor space
28 | 29
cobas c 513 analyzer
www.cobas.com
Setting a new precedent in HbA1c lab efficiency
30 | 31
Automation & IT solutions
www.cobas.com
Personalized Lab Automation
32 | 33
cobas® middleware solutions
Intelligent workflow management
for your laboratory
cobas middleware solutions are the Your benefit Easily accessible management information
workflow manager for your laboratory, Effective use of your resources • Task-oriented for proactive exception
consolidating Roche instruments, • Manage your laboratory instruments management
third-party instruments and host systems and the people that use them from a • Sample archive management for automated
to enable e fficient sample workflows. single application or manual post-analytical phase
Different IT solutions are available to meet • Expert system allows you to focus on
regional customer needs (cobas IT critical information Save time and reduce duplication
middleware & cobas® infinity IT solutions). * of effort
Improve quality performance • Configurable automated validation
The intuitive automated validation and • High level of traceability and transparency with multiple levels of expertise ensuring
quality control tools reduce operator through audit trail for each sample reproducible outcome
intervention, while allowing laboratory • Support to achieve compliance with • Task-oriented and easy-to-use
production to be monitored through regulations user interface
real-time dashboards.
Efficient workflows for today and
the future
Intelligent workflow management for your laboratory • Connects multiple instruments and soft-
wares, multiple LIS from multiple sites
• Scalable to follow the growth of your
organization
• Automated or manual pre-analytics and
Pre-analytical Analytical Post-analytical
post-analytics with complete traceability
Sample ID and Result generation Add-on test
tracking management
Helping to improve your quality processes
Sample preparation Quality control Archiving and retrieval • Quality control management including
multi-rules and drift control
34 | 35
cobas® infinity IT solutions
www.cobas.com
One expert package to empower all
of your expertise
cobas infinity IT solutions is a web- cobas infinity IT solutions enables a Your benefit
based application with scalable modules paperless workflow, and is structured around Right solution for every environment
that are designed to manage complex work areas that focus on the tasks in hand. • Specialized modules designed for different
lab processes and give sample testing and The unique workflow engine removes the test disciplines – matching the structure
result data an efficient and transparent need to write complex rules to manage the and processes of different areas of the
flow. It automates the three main areas of sample automation. Autovalidation enables laboratory. It helps automate many manual
lab operations: pre-analytics, analytics efficient result management, and integrated tasks and optimizes productivity
and post-analytics; but also extends beyond quality management tools organize the • Scalable and expandable for every kind
the lab to ordering, blood collection quality process to support accreditation. of laboratory, now and in the future
validation and reporting.
Makes work flow • A comprehensive Integrated Quality
• The unique workflow engine drives Management tool that not only manages
Hospital network sample and data flow, streamlining job assay performance but also enables
tasks and optimizing all process your organization to improve overall quality
Hemato Urinalysis Micro
logy biology steps in the different levels of automation processes supporting accreditation
• Consistent look and feel across all
user interfaces help staff learn quickly and
POC SWA
Standalone Extended lab enables better communication in and
systems IT functionality
across disciplines including Point of Care
• Designed for easy of use on PC’s, tablets
Blood Pre/Post Specimen
safety analytics reception and mobile phones to see whats important
Standalone lab and act fast- from wherever you are
Flexile intelligence across lab disciplines and POC One decision for all choices – scalable to your needs
and work areas. again and again. Dynamic production monitoring
• Real time information for timely Designed to be easy to use, everywhere.
decision-making with the live view tool
• The Insights module retrieves retro
spective accessible data from all process
steps and turns the unsorted data
into meaningful statistical reports to
demonstrate lab performance
36 | 37
cobas® infinity IT solutions
www.cobas.com
One expert package to empower all
of your expertise
cobas infinity central lab cobas infinity microbiology cobas infinity live view cobas infinity POC tablet
• Empowering lab experts to manage • Turns testing complexity into efficient • See what’s important • Move and work
complex processes workflow • Shares real time information for lab • A tablet app designed to help POC
• Designed for labs to manage complex • Designed for work area and technicians and lab managers on Coordinators (POCCs) manage their
sample testing and result data flows in processes specific for microbiology. PC, tablets and mobile devices. While complete POC testing program whilst
an efficient and transparent way It offers management of cultures, out of the office, laboratory users moving around
related biochemical testing and anti- can access valuable real-time information • The app enables POC Coordinators to
cobas infinity central lab – 3R biotic susceptibility on turnaround time, sample load realise the full potential of working with
• Standardized for request, result, and and delayed samples in a core lab a tablet, allowing them to become really
reporting in small labs cobas infinity total quality management efficient
• Pre-configured central lab module • Empowering management of a high level cobas infinity insights
for smaller labs for simple set-up with quality culture • Demonstrate your value as a trusted cobas infinity POC mobile
basic functionalities • Designed for proactive documentation-, partner • Always with you
issues-, indicators- and audits • Designed to turn objective lab statistics • A mobile application designed for POC
management to achieve and maintain into meaningful information to improve coordinators in hospitals to keep
accreditation process performance and understand the control and act on what is important
value of the lab while away from their PCs
38 | 39
Standalone and connected automation
Personalized solutions for every lab
www.cobas.com
Your benefit
Quality comes first
At an early pre-analytical stage, the
automation solutions from Roche perform
a comprehensive inspection of sample
quality and volume, maximizing an overall
optimization of lab workflow through:
• Early error detection
• Reduced workload and reagents waste
• Shortest time to consistent results
40 | 41
cobas p 512 and cobas p 612
pre-analytical systems www.cobas.com
Evolution of cobas p 512/612 pre-analytical • Tube type identification Product characteristics • Spin status detection:
systems – new and innovative standalone • Sample volume check • Freely definable input and output Detects if blood samples have been
solutions for high throughput laboratories. • Spin status detection sorting areas already centrifuged or not
cobas p 612 differs from cobas p 512 • Sample quality check • Input with capacity of 600 samples and • Early detection and sorting of tubes
system due to the aliquot functionality. output of 1,200 samples with errors and issues
Flexibility • Connection to a bulk loader • Selective decapping of sample tubes
These standalone automation solutions Adapts to the lab’s sample handling needs. • Connection to single or double centrifuge • cobas p 612 system includes an
are validated for cross-contamination • A solution compatible with all lab disciplines • Handling of Roche and non-Roche racks aliquoting section with barcode labelling
compliance and therefore may be used to • Adapted sorting areas to your workflow and centrifuge buckets of secondary tubes
automate and simplify processes in to stay flexible • Throughput up to 1,400 samples/hour • Sorting of tubes directly into analyzers
clinical laboratories and blood banks. • Single point of entry and bulk loading • Registration of primary samples target racks
of tubes for convenient sample loading • Orientation of barcode in a • Archiving of processed samples with
Your benefit • Long walk-away time “good-to-read” position optional recapping
Innovation • Tube type identification • Upgradeability to connected automation
The best answer to face emerging c hallenges • Sample volume and quality check Source: Specifications sheet cobas p 512/612.
in laboratory operations.
• Upgradable to connected automation
• Easy to add functionalities
• Comprehensive inspection of sample
quality
• Increased productivity in the same
footprint
42 | 43
cobas p 312 pre-analytical system cobas p 501 and cobas p 701
Compact automation for maximum efficiency post-analytical units
The automated archive
www.cobas.com
44 | 45
cobas® 8100 automated workflow series
www.cobas.com
3-D intelligence in lab automation
cobas 8100 intelligent tube transport • Primary sample workflow – if the focus
provides a short predictable time to results, is on cost efficiency
including prioritization for emergency • Aliquot workflow – if the focus is on
samples. With flexible workflows, early error sample integrity and parallel testing
detection and fully automated add-on • Mixed workflow – to optimize the benefits
handling, cobas 8100 allows for personal- of both
ized solutions to suit individual laboratory
needs, guaranteeing that quality comes first. Short and predictable time to results
• 3D intelligent tube transport improves Solution with cobas 8100 automated workflow series
cobas 8100 covers the needs of high- patient care by offering reliable results
throughput laboratories achieving 1,100 within predictably short turnaround times, Product characteristics
samples/hour. Designed with options for even during peak workflows cobas® 8100 is made up of three stations: needs in order to optimize the required
connectivity to Serum Work Area analyzers, • Multi-level and bidirectional tube transport: output, input and aliquot stations. Each workflow now. In the future, it can easily
hematology, coagulation, selective third- empty tube holders and holders with tubes station can be configured according to the grow as needed.
party analyzers and archiving, cobas 8100 run separately to avoid traffic jams number of samples and individual laboratory
fully automates the laboratory process • Tubes always have a clear destination and
from beginning to end. do not circle the track, guaranteeing first-
in first-out sample processing Output station Input station Aliquot station
Your benefit • Tubes can bypass modules if processing
Quality comes first is not required
At an early pre-analytical stage, Roche • Prioritized STAT workflow
automation solutions check the sample
quality and volume, maximizing workflow Flexible tube storage
efficiency. A solution with cobas 8100 offers 3 storage 1 2 3 4 5 6 7 8 9
• Early error detection concepts, ensuring fast access as soon as
• Reduced workload a tube is needed.
• No reagent waste • Short-term storage for an immediate re-run 1 Restopper flex-cap/screw cap 6 Sample check module
• Mid-term storage in the Add-on Buffer 2 Add-on/output buffer 7 Destopper
Workflow your way Module – for optimized add-on request 3 Output buffer/sorter 8 Barcode labeler/tube feeder
Personalized workflows enable you to choose processing within the same day 4 Input buffer 9 Aliquot module
from primary, aliquot or mixed workflow. • Long-term storage 5 Automatic centrifuge unit
46 | 47
cobas® connection modules (CCM)
www.cobas.com
Everything designed to work together as one
cobas connection modules allow the Quality comes first • Adapted sorting areas to your workflow
connection of the standalone automation CCM performs a comprehensive inspection to stay flexible. Automates sorting areas
systems, cobas p 512 and cobas p 612, of samples at an early stage, optimizing also for non-connected work areas
to analytics and post-analytics through the lab workflow and ensuring the best use • Long walk-away time
a fast track. of time and resources. • Flexibility of layouts with the possibility
• Tube type identification to easily adapt for future changes
You can still take advantage of the huge • Sample volume check
flexibility of the standalone automation • Spin status detection Possible solutions
concept, while adding predictability of • Sample quality check The fast track to sample flow efficiency
time to results by getting connected cobas connection modules connects
through cobas® connection modules. Workflow your way pre-analytical system to multidisciplinary
Personalized workflows enable you to targets streamlining and optimizing labo-
Your benefit choose from primary, aliquot or mixed ratory processes.
Multidisciplinary connectivity workflow.
• Serum Work Area – cobas® 6000/8000 • Primary sample workflow – if the focus cobas connection modules is a connected
analyzer series, MODULAR ANALYTICS is on cost efficiency automation solution validated for cross-
• Hematology – Sysmex HST/XN-9000 • Aliquot workflow – if the focus is on contamination compliance and therefore
hematology analyzers sample integrity and parallel testing may be used to automate and simplify
• Coagulation – Stago STA-R Evolution® • Mixed workflow – to optimize the benefits processes in clinical laboratories and blood
Expert Series System and Stago STA-R of both workflows banks.
Max® System
• Urinalysis – cobas® 6500 urine analyzer Flexibility
series Adapts to the lab’s sample handling needs.
• Molecular Diagnostics – cobas® 6800/ • A solution compatible with all lab
8800 system disciplines
• Post-analytics – cobas p 501/701 post- • Single point of entry and bulk loading of
analytical unit tubes for convenient sample loading
Please note that not all versions are distributed in all countries. For further details contact your local affiliate.
48 | 49
Overview of Serum Work Area tests
www.cobas.com
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
platform: e module
platform: e module
platform: e module
platform: e module
platform: c module
platform: c module
platform: c module
platform: c module
cobas® modular
cobas® modular
cobas® modular
cobas® modular
cobas modular
cobas modular
cobas modular
cobas modular
cobas c 111
cobas c 111
cobas c 111
cobas c 111
400 plus
400 plus
400 plus
400 plus
analyzer
analyzer
analyzer
analyzer
Anemia CK-MB • • • Drugs of Abuse Testing Cortisol •
Ferritin • • • CK-MB (mass) • Amphetamines (Ecstasy) • • C-Peptide •
Folate • CK-MB (mass) STAT • Barbiturates • • FT3 •
Folate RBC • CRP hs • • • Barbiturates (Serum) • FT4 •
Iron • • • Cystatin C • • Benzodiazepines • • hGH •
Iron binding capacity D-Dimer • • • Benzodiazepines (Serum) • Hydroxybutyrate • •
– Unsaturated • • Digitoxin • • • Cannabinoids • • Dehydrogenase
Soluble transferrin receptor • • Digoxin • • • Cocaine • • IGF-17 •
Transferrin • • GDF-15 • Ethanol • • Insulin •
Vitamin B12 • HDL Cholesterol direct • • • LSD • 2
• Lipase • • •
Active B12 7
• Homocysteine • • Methadone • • PTH STAT •
Lactate Dehydrogenase • • • Hydroxybutyrate • • Methadone metabolites • • T3 •
Dehydrogenase
Bone (EDDP) T4 • •
Calcium • • • LDL Cholesterol direct • • • Methaqualone • • Thyreoglobulin (TG II) •
N-MID Osteocalcin • Lipoprotein (a) • • Opiates • • Thyreoglobulin confirmatory •
P1NP • Myoglobin • • • Oxycodone • 3
• TSH •
Phosphorus • • • Myoglobin STAT • Phencyclidine • • T-uptake • •
PTH • NT-proBNP • Propoxyphene • • Fertility
PTH (1-84) • NT-proBNP STAT • 1
Endocrinology Anti-Müllerian Hormone •
b-CrossLaps • Troponin I • 1
Amylase – pancreatic • • • DHEA-S •
Vitamin D total • Troponin I STAT • Amylase – total • • • Estradiol •
Cardiac Troponin T hs • ACTH • FSH •
Apolipoprotein A1 • • Troponin T hs STAT • Anti-Tg • hCG •
Apolipoprotein B • • Coagulation Anti-TPO • hCG plus beta •
Cholesterol • • • AT III • • Anti-TSH-R • LH •
CK • • • D-Dimer • • • Calcitonin • Progesterone •
1
Not on cobas e 411 4
Not on cobas e 801 7
In development
2 Not on cobas c 311 5 Only on cobas e 801 Please check with your local Roche representative for
3 Not on cobas c 701 or 702 6 Only on cobas c 501 or 502 availability of the assays and tests in your country.
50 | 51
www.cobas.com
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
platform: e module
platform: e module
platform: e module
platform: e module
platform: c module
platform: c module
platform: c module
platform: c module
cobas® modular
cobas® modular
cobas® modular
cobas® modular
cobas modular
cobas modular
cobas modular
cobas modular
cobas c 111
cobas c 111
cobas c 111
cobas c 111
400 plus
400 plus
400 plus
400 plus
analyzer
analyzer
analyzer
analyzer
Prolactin • Anti-HBs • C3c • • Glucose • • •
SHBG • HBsAg • C4 • • HbA1c (hemolysate) • • 3
•
Testosterone • HBsAg confirmatory • Ceruloplasmin • • HbA1c (whole blood) • • 3
•
Hepatology HBsAg quantitative • CRP (Latex) • • • Insulin •
Alkaline phosphatase (IFCC) • • • Anti-HCV • Haptoglobin • • Lactate • • •
ALT/GPT with Pyp • • • Chagas • IgA • • Magnesium • • •
ALT/GPT without Pyp • • • CMV IgG • IgE • Potassium • • •
Ammonia • • • CMV IgG Avidity • IgG • • Sodium • • •
AST/GOT with Pyp • • • CMV IgM • IgM • • Total Protein • • •
AST/GOT without Pyp • • • HIV DUO7 • 5
Immunglobulin A CSF • Triglycerides • • •
Bilirubin – direct • • • HIV combi PT • 4
Immunglobulin M CSF • Triglycerides Glycerol blanked •
Bilirubin – total • • • HIV-Ag • 4
Interleukin 6 • Vitamin D total •
Cholinesterase Acetyl • 3
HIV-Ag confirmatory • 4
Kappa light chains • • Oncology
Cholinesterase Butyryl • • HSV-1 IgG • Kappa light chains free • 6
• Acid phosphatase • •
Gamma Glutamyl Transferase • • • HSV-2 IgG • Lambda light chains • • AFP •
Glutamate Dehydrogenase • • HTLV-I/II • Lambda light chains free • 6
• CA 125 •
HBeAg • Rubella IgG • Prealbumin • • CA 15-3 •
HBsAg • Rubella IgM • Procalcitonin • CA 19-9 •
Lactate Dehydrogenase • • • Syphilis • Rheumatoid factor • • CA 72-4 •
Infectious diseases Toxo IgG • a1-Acid Glycoprotein • • Calcitonin •
Anti-HAV • Toxo IgG Avidity • a1-Antitrypsin • • CEA •
Anti-HAV IgM • Toxo IgM • Metabolic Cyfra 21-1 •
Anti-HBc • TPLA (Syphilis) • 6
Bicarbonate (CO2) • • • hCG plus beta •
Anti-HBc IgM • Inflammation Calcium • • • HE4 •
Anti-HBe • Anti-CCP • Chloride • • • Kappa light chains free • 6
•
HBeAg • ASLO • • Fructosamine • • Lambda light chains free • 6
•
1
Not on cobas e 411 4
Not on cobas e 801 7
In development
2 Not on cobas c 311 5 Only on cobas e 801 Please check with your local Roche representative on
3 Not on cobas c 701 or 702 6 Only on cobas c 501 or 502 availability of the assays and tests in your country.
52 | 53
www.cobas.com
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
COBAS INTEGRA®
platform: e module
platform: e module
platform: e module
platform: e module
platform: c module
platform: c module
platform: c module
platform: c module
cobas® modular
cobas® modular
cobas® modular
cobas® modular
cobas modular
cobas modular
cobas modular
cobas modular
cobas c 111
cobas c 111
cobas c 111
cobas c 111
400 plus
400 plus
400 plus
400 plus
analyzer
analyzer
analyzer
analyzer
NSE • Therapeutic drug monitoring Tobramycin • • Testosterone •
proGRP • Acetaminophen (Paracetamol) • • Valproic acid • • CMV IgG •
PSA free • Amikacin • • Valproic acid free • CMV IgG Avidity •
PSA total • Carbamazepine • • Vancomycin • • CMV IgM •
SCC • Cyclosporine • • Women's health Rubella IgG •
S-100 • Digitoxin • • • Anti-Müllerian Hormone • Rubella IgM •
Thyreoglobulin (TG II) • Digoxin • • • AFP • Toxo IgG •
Thyreoglobulin confirmatory • Everolimus • b-Crosslaps • Toxo IgG Avidity •
b2-Microglobulin • Gabapentin6 • DHEAS • Toxo IgM •
Renal Gentamicin • • Estradiol •
Albumin (BCG) • • • Lidocaine • FSH •
Albumin (BCP) • • Lithium • ISE free ßhCG •
Albumin immunologic • • • Methotrexate6 • hCG •
Creatinine (enzymatic) • • • Mycophenolic acid • • hCG plus beta •
Creatinine (Jaffe) • • • NAPA • • hCG STAT •
Cystatin C • • Phenobarbital • • HE4 •
Potassium • • • Phenytoin • • LH •
PTH • Phenytoin free • N-MID Osteocalcin •
PTH (1-84) • Primidone • PAPP-A •
Total Protein • • • Procainamide • • PlGF •
Total Protein, Urine/CSF • • Quinidine • • sFIt-1 •
Urea/BUN • • • Salicylate • • P1NP •
Uric acid • • • Sirolimus • Progesterone •
a1-Microglobulin • • Tacrolimus • Prolactin •
b2-Microglobulin • Theophylline • • SHBG •
1
Not on cobas e 411 4
Not on cobas e 801 7
In development
2 Not on cobas c 311 5 Only on cobas e 801 Please check with your local Roche representative on
3 Not on cobas c 701 or 702 6 Only on cobas c 501 or 502 availability of the assays and tests in your country.
54 | 55
Elecsys® ECL – unique immunoassay
technology www.cobas.com
ECL (ElectroChemiLuminescence) is Roche’s Your benefit Elecsys® – 20 years of innovation and experience
technology for immunoassay detection. Rapid response times With the past in mind and the future in focus we are celebrating 20 years of continuous
Based on this technology and combined • 93 % of assays with 18 min. assay time evolution of Elecsys assays.
with well-designed, specific and sensitive or less
immunoassays, our Elecsys® tests deliver • 9 min. STAT applications for emergency Product success
reliable results. The development of ECL samples
immunoassays is based on the use of a
ruthenium complex and tripropylamine. Wide measuring range
35,000 105 60 24
cobas e module Elecsys tests/second Elecsys assay launches
The chemiluminescence reaction for detec- • Linear signal response over six orders placements parameters used and updates
tion of the reaction complex is initiated by of magnitude available in the last 5 years
Controlled reaction
1996 105 assays
• High on-board stability and long shelf-life 16 assays 2016 NT-proBNP AMH
measuring range
Source: Roche data on file
56 | 57
Turbidimetry – highly developed
detection technology
Integrate specific protein testing into
your routine
DuREL technology
Δ Absorbance
Radius I
Radius II
S D P S D P
Elecsys immunoassays Molecular assays
Anti-HAV total • • HBV DNA quantitative •
Roche Diagnostics offers a comprehensive • The CMV tests allow for a reliable Anti-HAV IgM • HCV RNA qualitative •
Viral hepatitis
portfolio of infectious diseases assays discrimination between an acute and a HBsAg • • HCV RNA quantitative •
along the continuum of care, thereby en- remote infection, therefore preventing
HBsAg confirmatory • HCV genotyping •
Viral hepatitis
abling laboratories to provide the right unnecessary repeat testing 8
HBsAg quantitative • • HEV RNA qualitative •
Anti-HBs • • MPX (HIV/HCV/HBV) •
information, from screening and diagnosis Anti-HBc • • DPX (B19V/HAV) •
to patient management and treatment Our extensive infectious diseases portfolio Anti-HBc IgM • CT DNA • •
monitoring. is expanding every year. We are not only Anti-HBe • • CT/NG DNA • •
focusing on launching new parameters HBeAg • • HSV1 and HSV2 DNA •
Our complete Infectious Diseases offer but we are also continuously updating Anti-HCV • • HIV RNA quantitative •
STDs
includes serology and also molecular our existing portfolio seeking continuous HIV combi PT • • HIV RNA qualitative • •
testing (please refer to chapter «Molecular improvement, as well as keeping pace
HIV Antigen • HPV DNA •
Diagnostics» for more information) which, with the evolution of pathogens.
HIV Antigen confirmatory • HPV genotyping •
Syphilis • • MPX (HIV/HCV/HBV) •
thanks to our Personalized Lab Automation
STDs
Syphilis TPLA • • CMV DNA quantitative • •
TORCH
solutions can be configured, connected Syphilis RPR • • •
and integrated to suit the requirements of HSV-1 IgG • •
any laboratory. HSV-2 IgG • • C. Difficile DNA •
HTLV-I/II • • MRSA DNA •
Each Roche Diagnostics infectious diseases CMV IgG • • MRSA/SA DNA •
•
Others
test is designed with a clinical benefit
CMV IgM • • MTB DNA
CMV IgG Avidity • MAI DNA •
in mind. A few examples that have been •
HSV-1 IgG • • Sepsis
described in scientific publications are: •
HSV-2 IgG • • VRE 1
• The Anti-HCV II and HIV Combi PT tests Rubella IgG • • West Nile Virus •
TORCH
excel in seroconversion sensitivity allowing 1 Combined data from “Study report: Performance Rubella IgM • • Part of the Roche Blood Safety Solutions panel
earlier intervention1-3 evaluation CE: Elecsys Anti-HCV II; 20 Feb.; Version2;
Study Number: CIM RD 001230/B10P010”
Toxo IgG • • 1 For research use only
• Studies have confirmed the superior Penzberg, Germany. Toxo IgM • •
capability of the HBsAg and HIV Combi 2 Esteban, et al. (2013). J Med Virol. Toxo IgG Avidity • Please check with your local Roche representative on
3 Mühlbacher, et al. (2012). Med Microbiol Immunol.
PT tests to detect mutants and rare Miller et al. (2010). (HIV).
Syphilis • • the availability of the assays and tests in your country.
variants, therefore driving screening 4 Ly et al. (2012). J Clin Virol. Syphilis TPLA • •
5 Mühlbacher, et al. (2008). Med Microbiol Immunol. 6. Syphilis RPR • • •
effectiveness 4-7 Jia, et al. (2009). Med Microbiol Immunol.
Chagas • •
Others
60 | 61
The Roche Hepatitis diagnostic portfolio
A clear direction ahead
Anti-HAV w v
HAV
Anti-HAV IgM
Viral hepatitis is a global burden. In par Roche provides integrated and comprehen-
ticular, infection with HBV or HCV leads sive solutions consisting of the cobas® HBsAg II HBsAg II quant II
to chronic liver disease including fibrosis, family of diagnostic platforms combined
cirrhosis and eventually hepatocellular with workflow and IT solutions for stream- Anti-HBc IgM Anti-HBs II
carcinoma in hundreds of millions of p eople.1 lined lab operations, and diagnostic assays
HBsAg Anti-HBe
According to WHO, HBV and HCV infec- that cover the complete hepatitis health- confirmatory
tions cause approximately 80 % of all liver care continuum.
Anti-HBc II HBeAg
HBV
cancer related deaths and kill approximately
1.4 million people every year.2 Most of Roche offers a broad portfolio of serology- HBeAg HBV DNA
those infected are undiagnosed, thereby based and molecular tests required for quantitative
increasing the risk of developing severe screening, diagnosis and management of Anti-HBe
liver disease and transmitting the virus to viral hepatitis. With more than 30 years of
others. experience in the area of Infectious Diseases, Anti-HBs II
HCV
leverage our experience as the provider Anti-HCV II
General Hepatitis
in hepatitis From screening to patient management,
Trichrome
Roche’s diagnostic excellence and efficiency
provides answers today for a healthier AFP
tomorrow.
ALTLP GGT-2 AFP
Bilirubin
1 Mauss S et al. Hepatology – A Clinical Textbook; 7th Edition, 2016. Medizin Fokus Verlag. Roche Serum Work Area Roche Tissue Diagnostics
2 http://www.who.int/mediacentre/news/releases/2015/world-hepatitis-day/en Roche Molecular Diagnostics
62 | 63
Elecsys® HIV combi PT
4th Generation (Ag+Ab test) www.cobas.com
64 | 65
The Syphilis test panel Elecsys® Syphilis immunoassay
Fully automated for complete a ssessment Confidence in all stages of treponemal
of the disease syphilis infection
www.cobas.com
Syphilis is caused by the intracellular gram- Your benefit The Syphilis immunoassay has been
negative spirochete bacterium Treponema • Reliable and complete solution using your designed using the latest recombinant
pallidum subspecies pallidum. It is mainly algorithm of choice thermostable-antigen technology, to
transmitted sexually, but can also be • Integrated with other tests in the TORCH achieve unprecedented high sensitivity
transmitted from mother to fetus during and blood safety solutions portfolios and specificity performance across all
pregnancy or at birth, resulting in • Treponemal test suitable for screening in stages of infection.
congenital syphilis. Syphilis facilitates the the general population, pregnant women
acquisition of HIV. and blood donations Your benefit
Designed for high sensitivity
Roche offers an automated panel of • High sensitivity minimizes the probability
three assays for efficient and reliable of missing new infections Product characteristics
assessment of syphilis patients. • Serum, standard or separating gel tubes
Cost efficiency
• Plasma types: Li-heparin, Na-heparin,
• High specificity reduces the need
K2-EDTA, K3-EDTA, Na-citrate, ACD, CPD,
Treatment for re-testing1
Screening Diagnosis CP2D, CPDA and K2-EDTA plasma tubes
monitoring
Clear results interpretation containing separating gel
• Syphilis • Syphilis • RPR • Clear cut-off separation of positive • Sample volume: 10 μL
• TPLA • TPLA
• RPR • RPR and negative results • Assay time: 18 min.
Efficient use of sample volume • Test format: IgM/IgG (three antigens:
Panel for the complete assessment of the syphilis patient.
Screening, diagnosis, confirmation and activity monitoring of the disease. • Maximizes the chance to order all the TpN15, TpN17, TpN47)
TPLA and RPR are SEKISUI, Japan products distributed by Roche. tests required from the same sample • Clinical sensitivity: 100 % (n = 924)
TPLA = T. pallidum Latex Agglutination • Clinical specificity: 99.88 % (n = 8,079)
RPR = Rapid Plasma Reagin – Blood donors: 99.93 % (n = 4,579)
– Routine samples: 99.80 % (n = 3,500)
66 | 67
Elecsys® TORCH panel
www.cobas.com
Reliable screening for early diagnosis
Infections with Toxoplasma gondii, Rubella Your benefit Product characteristics The combination of these assays provides
virus, Cytomegalovirus (CMV) and Herpes High efficiency Roche has been continuously developing an excellent tool for identifying and charac-
simplex virus (HSV), collectively designated • Consolidation of TORCH panel on cobas® innovative TORCH assays. Based on recom- terizing Rubella infections.
as TORCH, pose a particular risk during immunology analyzers binant antigens and specific assay formats
pregnancy. Prenatal diagnosis of such in- such as μ-capture and DAGS (double Elecsys® CMV IgM, IgG and IgG Avidity
fections is important and demands assays Early detection antigen sandwich), these assays combine • Designed to detect all suspected primary
of outstanding quality and reliability. • Allows early management of acute high clinical sensitivity and specificity. infections
congenital infections • Less sensitive to persistent IgM antibodies1
Opportunistic infections with Toxo and CMV Elecsys® Toxo IgM, IgG and IgG Avidity • Prevents cross reactivity with other
can also have severe consequences for Fewer confirmation tests and • The Elecsys® Toxo IgM assay design and herpes viruses
immunodeficient patients. A combination fewer reruns1-3 respective cut-off minimize the probability • CMV IgG avidity testing is the most
of high clinical sensitivity and specificity is • Due to highly specific assays of missing any new infection reliable procedure to identify primary
therefore essential. • The Toxo IgG assay accurately detects infection or confirm past infection
Efficient use of sample volume past infections
Sample volume* in µL • Maximizes the chance to order all the • The Elecsys® Toxo IgG Avidity assay is a Elecsys® HSV-1 IgG and HSV-2 IgG
tests required from the same sample reliable method to rule out infection • Identification of silent carriers of Herpes
occurring within the last 4 months simplex virus infection
130
120
CMV IgG & IgM Fast reporting • Combined use of the three assays allows • Type-specific assays for reliable
• Results in less than 20 min. accurate determination of primary infec- differentiation between HSV-1 and HSV-2
70 Rubella IgG & IgM tions and rules out non relevant cases (two Elecsys HSV IgG assays available)
Toxo IgG & IgM Increased efficiency by time to first according to the recommendation from
result Elecsys® Rubella IgM and IgG CDC or European guidelines*
Time to First Result for TORCH panel Clearly discriminates between an acute
cobas® Liaison® Architect®
cobas®
and a remote infection * Workowski et al. Sexually Transmitted Diseases
Treatment Guidelines 2015. MMWR Recomm Rep
*Sample volume without dead volumes; Serum/Plasma
Architect®
• The ultrasensitive Rubella IgG test detects
2015;64:27-32.
samples (for all values); information from respective pack
Liaison®
remote infections Patel et al. (2011) European guideline for the manage-
inserts.
• Complemented with early detection of ment of genital herpes 2010 Int J STD AIDS 22(1):1-10.
Source: Product inserts assessed September 2016. For 0 10 20 30 40
Roche products: current Package Insert.
acute infections by the Rubella IgM test
min. 18
In a clinical setting consistent with myocar- Your benefit Product characteristics 1 hour
TRAPID-AMI
dial ischemia, detection of a rise and/or fall Early diagnosis of AMI with cTnT-hs • STAT test: 9 min. with Roche
in troponin is the cornerstone of myocardial using the T0/1-hour or 3-hour algorithm • 99th percentile upper reference limit: Troponin T-hs
infarction diagnosis. • The accelerated algorithm to rule-in/out 14 ng/L (pg/mL) Observation
AMI within 1- or 3-hour using cTnT-hs is • 10 % CV precision: 13 ng/L (pg/mL) time for heart
The joint ESC/ACCF/AHA/WHF task force endorsed by the 2015 European Society of attack 3 hours
diagnosis High sensitivity
for the Universal definition of myocardial Cardiology (ESC) guidelines for Acute Troponin test
infarction and the IFCC recommend using Coronary Syndrome (ACS) without ST- Introduction of cTnT-hs in routine
6 hours
a troponin test that can measure the 99th elevation6 practice helps to: Conventional
percentile upper reference limit (URL) with • The performance of cTnT-hs 0h/1-h • Reduce time to diagnosis and test
an analytical precision ≤10% (% CV; coeffi- algorithm is validated by three multicenter improve patient care 9,11
cient of variation)1,2. The Elecsys Troponin trials in over 3,038 patients and results • Lower the need for cardiac stress
T–hs assay achieves less than 10 % CV at
the 99th percentile URL defined at 14 ng/L
demonstrate that >75 % of patients are
triaged within 1 hour 7,8,9
testing by more than 30 %11
• Shorten the length of stay in the
?
and complies with this recommendation. • The high negative predictive value and emergency department by nearly
Diagnosis >1 hour
the low 30-day-mortality rate confirmed 80 minutes and has the potential to within 1 hour
In addition the IFCC defines a high-sensi- the safety of this approach for early dis- contribute to cost savings11
75%
of patients are already
tivity troponin test as one that can measure charge7,8,9 diagnosed within 1 hour
cTn above the Limit of Detection (LoD) in of observation time 6,7,8
≥50 % of healthy subjects2. For example a Improved risk stratification and clinical
multicenter trial reports that 57 % of healthy management of patients with suspected 1 Thygesen, K. et al. (2012). J. Am. Coll Cardiol; 60:1581-98.
2 Apple, F.S. et al. (2015). Clin, Biochem.; 48(4-5):201-3.
subjects were measured with cTnT-hs levels ACS compared with conventional cTn
3 Saenger, A.K. et al. (2011). Clin Chim Acta; 412(9-10):748-54.
above 3 ng/L3. Studies report LoD of assays 4 Elecsys Troponin T-high sensitive package insert, 2016.
2.05 – 2.85 ng/L with the cobas e 601/ • More at-risk patients are identified 5 Eggers, K.M. et al. (2016). Eur Heart J 2016 Aug
7;37(30):2417-24.
e 602/MODULAR ANALYTICS E170)4. without inappropriate increase in hospital 6 Roffi, M. et al. (2015). Eur Heart J 2016; 37(3):267-315.
resource utilisation5 7 Reichlin, T. et al. (2012). Arch Intern Med; 172(16):1211-8.
8 Reichlin, T. et al. (2015). CMAJ; 187(8):E243-52.
This analytical performance results in 9 Mueller, C. et al. (2016). Annal Emerg Med.;68(1):76-87.
significant clinical advantages for the diag- Consistent correlation 10 Roche CARDIAC POC Tropoin T Package insert, 2015.
nosis of acute coronary syndrome (ACS).5 • Between POC devices for emergency 11 Twerenbold, R. et al. (2016). Eur Heart J. 2016 Nov 21;
37(44):3324-3332.
testing and all cobas® immunoassay
analyzers10
70 | 71
Elecsys® NT-proBNP
www.cobas.com
The clear choice for heart failure management
Heart failure (HF) is a global health problem Product characteristics Simplified testing process and improved
associated with high morbidity and mortality • Fully automated quantitative assay efficiency of testing
affecting 26 million patients worldwide.1 • Low sample volume: 50 μL • NT-proBNP sample stability is 3 days at
• Fast results: 9 min. with STAT assay room temperature and longer at 4 °C
Early stage diagnosis of HF and appropriate • High test precision (CV 2.9 to 6.1 %) • Test tube requirements allow one tube
treatment are key objectives in improving coupled with wide dynamic measuring solution for all cardiac markers
patients’ quality of life. range (5 – 35,000 pg/mL)
• Sample material: standard serum and NT-proBNP: an objective and cost-effec-
Patients with HF – especially with mild heparin/EDTA plasma tive tool from diagnosis to monitoring
symptoms – are often not diagnosed. On
the other hand, many patients with suspect- Your benefit Diagnosis Prognosis
ed heart failure are unnecessarily referred Recommended by major Guidelines • In combination to clinical assessment, • NT-proBNP levels correlate with disease
to echocardiography. • NT-proBNP is recommended by major NT-proBNP is an essential test improving severity
international guidelines (ACC/AHA, ESC, diagnostic in acute (emergency depart-
• NT-proBNP is well-established in inter NICE) ment) and non-acute onset (outpatient Monitoring
national guidelines and primary care)4 • NT-proBNP serial measurements helps to
• NT-proBNP has shown to improve clinical Reliable results, regardless of therapy • Associated with more efficient allocation gain information about disease progres-
decision-making in HF management from • Unlike BNP, NT-proBNP is not a neprilysin of imaging and faster patient turnover in sion or improvement of patients' condition
diagnosis to monitoring substrate and is the more suitable the emergency department5,6
biomarker for patients treated with new
ARNi drugs (e.g. sacubitril-varlsartan)2,3
NT-proBNP is formed by cleavage
1 Ambrosy, P.A. et al. (2014). The Global Health and 5 Behnes, M. et al. (2009). Diagnostic performance and
of proBNP Consistent correlation between all Economic Burden of Hospitalizations for Heart Failure. cost effectiveness of measurements of plasma
pre-proBNP Lessons Learned From Hospitalized Heart Failure N-terminal pro brain natriuretic peptide in patients
cobas® immunoassay analyzers and POC
Heart muscle
Registries. J Am Coll Cardiol, 63: 1123–1133. presenting with acute dyspnea or peripheral edema.
devices 2 McKie, P.M. and Burnett, J.C. (2016). NT-proBNP: Int J Cardiol, 135(2): 165-174.
proBNP
• Ability to generalize cut-offs without the The Gold Standard Biomarker in Heart Failure. 6 Moe, G. et al. (2007). N-Terminal Pro–B-Type
JACC, Vol 68, No 22. Natriuretic Peptide Testing Improves the Management
N-terminal proBNP BNP need to rebaseline patients’ value when 3 Januzzi, J.L. Jr. (2016). B-Type Natriuretic Peptide of Patients With Suspected Acute Heart Failure.
Half life 120 min. 20 min. changing instrument Testing in the Era of Neprilysin Inhibition: Are the Circ, 115: 3103-3110.
Winds of Change Blowing? Clin Chem. May,
62(5):663-5.
Myocardial Blood 4 Ponikowski, P. et al. (2016). ESC Guidelines for the
stretch and strain
diagnosis and treatment of acute and chronic heart
failure. Eur J Heart Fail. Aug, 18(8):891-975.
72 | 73
Elecsys® IL-6, PCT and Tina-quant® CRP
www.cobas.com
For early and effective sepsis management –
because time matters
Sepsis, the systemic inflammatory response Your benefit PCT, IL-6 and CRP: a biomarker
to infection, is a leading cause of death. Rapid diagnostics panel to support early recognition
More than 1 in 1,000 people in developed • Short total assay time and management of sepsis
countries develop sepsis each year, repre- IL-6: Early warning sign of (systemic)
senting a major burden on healthcare.1 Testing efficiency inflammation and sepsis
• All parameters from one sample tube PCT: Follows IL-6 and indicates high
Early recognition is critically important probability of bacterial sepsis
for patient survival, but clinical signs and Economical sample handling CRP: Released from the liver as a later
symptoms are often ambiguous. • Low sample volumes, especially important marker of inflammation
for pediatrics
Elecsys IL-6, Elecsys BRAHMS PCT, in Product characteristics
combination with CRP, deliver rapid, reliable Assay Elecsys BRAHMS PCT Elecsys IL-6 CRP on
information about the patient’s immediate cobas c analyzers
inflammatory status and likelihood of Sample material Serum, Li-heparin and Serum, Li-heparin Serum, Li-heparin and
K 3-EDTA plasma and K 2- and K 3-EDTA K 2- and K 3-EDTA plasma
bacterial sepsis, which is important for plasma
antimicrobial therapy management. Sample volume 30 µL 30 µL 2 μL
Assay time 18 min. 18 min. 10 min.
Acute inflammatory Clinical indication Differential Severe sepsis/shock Measuring range 0.02 – 100 ng/mL 1.5 – 5,000 pg/mL 0.3 – 350 mg/L
episode of sepsis diagnosis
Analytical sensitivity <0.02 ng/mL 1.5 pg/mL 0.3 mg/L
Suspicion/treatment characterization Therapy stewardship
of infection* Functional sensitivity <0.06 ng/mL 5 pg/mL 0.6 mg/L
Traceability Standardized against WHO Standard NIBSC IRMM reference prepa-
• IL-6 • Temperature • Blood culture • PCT
– PCT BRAHMS PCT LIA 1st IS 89/548 ration CRM470 (RPPHS)
• Heart rate
• Breathing rate – IL-6
• Leukocytes – CRP
• CRP
* R apid identification of sepsis pathogens is possible with LightCycler® SeptiFast Test.
74 | 75
Elecsys® tumor marker portfolio
Supporting improvements in cancer diagnosis
and monitoring
In the last decade, the sensible use of Reliable results Roche reagent and application portfolio for consolidated tumor marker testing
tumor markers and the careful interpretation • Robustness against interference Test Cancer indications Roche/ COBAS cobas e MODULAR cobas c
of their results have led to the continuous (e.g. HAMA) by blocking proteins, Hitachi INTEGRA systems ANALYTICS systems
systems EVO
enhancement of their clinical significance. fragmented catcher or tracer antibodies
AFP Liver, testicles
The inclusion of tumor markers in clinical or chimeric antibodies1
Calcitonin Medullary, thyroid carcinoma
management can help to provide more • Standardized to international standards CA 125 Ovary
information for improved clinical decision- or, if no standard available, traceable to HE4 Ovary
making and therefore maximize the quality a commonly accepted methodology CA 15-3 Breast
cancer patients is guided by tumor marker Operational efficiency CA 72-4 Gastric, colorectal,
mucinous ovarian
measurements based on the individual • High degree of system automation
CEA Colorectal- and lung
base line levels before and after primary • Less retesting due to high precision and adenocarcinoma
treatment. An excellent long-term assay wide measuring ranges CYFRA 21-1 Non small cell lung
accuracy, lot-to-lot stability and precision is • Broad tumor marker menu with specialties Ferritin Tumor related anemia
crucial for the reliable evaluation of signifi- such as CA72-4, S100, NSE, CYFRA 21-1, HCG Chorion
Longitudinal accuracy for reliable Complete diagnostic picture with Total PSA Prostate
76 | 77
Elecsys® HE4
www.cobas.com
An oncological biomarker improving ovarian
cancer care
Worldwide, ovarian cancer is a gynecolog- dicting recurrence within 12 months after Product characteristics 1 Moore, R.G., Brown, A.K., Miller, M.C., Skates, S.,
Allard, W.J., Verch, T., Steinhoff, M., Messerlian, G.,
ical disease with one of the highest mor- first-line chemotherapy.2 • Assay time: 18 min. DiSilvestro, P., Granai, C.O., Bast, R.C. Jr. (2008). The
tality rates. As survival rate and stage at • Sample material: Serum collected using use of multiple novel tumor biomarkers for the detec-
tion of ovarian carcinoma in patients with a pelvic
diagnosis are correlated, it is important to Reliable results with efficiency standard sampling tubes or tubes con- mass. Gynecologic Oncology, Volume 108, Issue 2,
detect this cancer early. Especially in early • Excellent precision and lot-to-lot taining separating gel Li-heparin plasma, February, 402-408, ISSN 0090-8258, http://dx.doi.
org/10.1016/j.ygyno.2007.10.017. (http://www.science-
stages symptoms are unspecific and consistency K2-EDTA and K3-EDTA plasma direct.com/science/article/pii/S0090825807008542).
cause little, if any, discomfort. For detect- • Comprehensive tumor marker menu • Sample volume: 10 μL 2 Nassir, M., Guan, J., Luketina, H. et al. (2016). Tumor
Biol. 37: 3009. doi:10.1007/s13277-015-4031-9.
ing the disease earlier, the biomarkers HE4 available on all cobas® platforms • Limit of detection: 15 pmol/L 3 Moore, R.G. et al. (2009). A novel multiple marker
(human epididymal protein 4) and CA125 • Measuring range: 15 – 1,500 pmol/L bioassay utilizing HE4 and CA125 for the prediction of
ovarian cancer in patients with a pelvic mass.
can play a very important role here. ROMA increases the diagnostic value • Intermediate imprecision cobas e 411 Gynecologic Oncology, 112, 40-46.
of the dual marker combination HE4 analyzer, Elecsys 2010 analyzer: 2.7 – 4.3 % 4 Dayyani, F., et al. (2006). Diagnostic performance of
Risk of Ovarian Malignancy Algorithm against CA 125
Your benefits and CA 125 cobas e 601/e 602 modules, E170: 2.6 – 3.4 % and HE4 in connection with ovarian cancer. Int J
Early marker with increased sensitivity Measured values of HE4 and CA 125 can • Repeatability cobas e 411 analyzer, Gynecol Cancer, 26, 1586–93.
5 Ortiz-Munoz, B., et al. (2014). HE4, Ca125 and ROMA
for supporting the diagnosis of epithelial be combined in an algorithm called ROMA Elecsys 2010 analyzer: 1.3 – 1.8 % algorithm for differential diagnosis between benign
ovarian cancer (EOC) — which takes into account the menopausal cobas e 601/e 602 modules, E170: 1.5 – 1.9 % gynaecological diseases and ovarian cancer. Tumour
Biol, 35, 7249–58.
• As a single tumor marker, HE4 had the status of the woman. Several published
highest sensitivity (specificity 95 %) in studies show that ROMA helps in the triage
detecting of EOC, especially in the early of pre- and postmenopausal women sus- Pelvic mass evaluation: Risk of Ovarian Malignancy Algorithm (ROMA)
78 | 79
Elecsys® ProGRP
www.cobas.com
Crucial information for differential d iagnosis
in lung cancer and monitoring of small-cell lung
cancer patients
Progastrin-releasing peptide (ProGRP) In future, lung cancer biomarkers such as • Lung cancer biomarkers available on a
is a tumor marker with benefits for the ProGRP can also play an important role in single automated platform – CEA, CYFRA
management of small-cell lung cancer assessing therapy resistance of patients 21-1, NSE, ProGRP and SCC
patients. receiving targeted EGFR-tyrosine kinase • Equivalent performance between plasma
inhibitor (TKI) therapies. It has been de and serum for flexibility and convenience,
Lung cancer is one of the most common
monstrated that a subset of NSCLCs with thus offering advantages over existing
cancers in the world with 1.35 million new
mutated EGFR return as SCLC when resis- assays3
cases diagnosed every year. The two main
tance to EGFR-TKIs develops and that this
histological types of the disease are small
is caused by a transformation from NSCLC Product characteristics
cell lung cancer (SCLC) and non-small cell
to SCLC.2 • Assay time: 18 min.
lung cancer (NSCLC). It is important to
• Sample material: • Sample volume: 30 μL
distinguish between these two subtypes
Your benefit – Serum collected using standard • Limit of detection (LoD): 3 pg/mL
as they have different treatments and prog-
• High sensitivity and discrimination aiding s ampling tubes or tubes containing • Measuring range (lower end defined
noses. NSCLC (approx. 80 % of cases),
the accurate differential d
iagnosis of SCLC separating gel by LoD): 3 – 5,000 pg/mL
when in the early stages, is curable with
• Excellent precision across the entire – Li-heparin plasma, K2-EDTA and
surgery. SCLC, however, is an aggressively
measuring range for reliable results K3-EDTA plasma
spreading neoplasm of rapid growth that
is usually only treatable with chemo and
radiotherapy.1 N=105 N=748 N=37 N=169
Lung cancer 120,000
SCLC
ProGRP is the tumor marker of choice for differential
>80.1 pg/mL 20,000
diagnosis
ProGRP (pg/mL)
SCLC as it aids in quick and decisive 5,000
discrimination between SCLC and NSCLC ProGRP 1,000
NSCLC
for faster decisions on patient treatment. serum/plasma 200
<80.1 pg/mL 100
ProGRP is also a tumor marker that can be level 50
20
used to assess response to therapy as well The 80.1 pg/mL cut-off value is based on the 95 % 10
as to monitor recurrence of the disease.2 s pecificity of the NSCLC collective. 3
NSCLC NSCLC SCLC SCLC
1 Ferlay, J., Soerjomataram, I., Ervik, M., Dikshit, R., Eser, S., Mathers, C., Rebelo, M., Parkin, D.M., Forman, D., Bray, F. China EU China EU
GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France:
International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on day/month/year. Use of ProGRP for the primary differential diagnosis in lung cancer. The ability of ProGRP to distinguish
2 Oser, M.G. et al. (2015). Transformation from non-small cell lung cancer to small-cell lung cancer: molecular drivers and SCLC from NSCLC was investigated in a study on 1059 patients in 5 centers in Europe and China
cells of origin. Lancet Oncol.; 16: e165-172.
(206 SCLCs and 853 NSCLCs), and ProGRP levels were correlated with biopsy proven histology.
3 Korse, C. et al (2015). Multicenter evaluation of a new progastrin-releasing peptide (ProGRP) immunoassay across Europe
and China. Clinica Chimica Acta 438, 388-395. (Source: Elecsys ProGRP Method Sheet)
80 | 81
Elecsys ® SCC
An important part of Roche’s portfolio
in tumor markers for managing patients
with squamous cell cancers
The SCC assay is used as an aid in types of lung cancer.8 Based on literature, Your benefit • One blood sample for all lung cancer
the management of patients with squamous SCCA elevated serum levels were • Combining SCC antigen with other lung biomarkers for time and cost efficiency
cell carcinoma in conjunction with found to be indicative of NSCLC if renal cancer biomarkers (ProGRP, CYFRA 21-1, • High reagent on-board stability
other methods that align to the standard failure and dermatological diseases NSE and CEA) gives a clearer picture on • Short turn around time for fast results
clinical management guidelines. were excluded.9 Utility of SCCA in lung the patient’s status
cancer has been also reported to • SCC antigen as biomarker for cervical Product characteristics
SCC antigen (SCCA) has been studied in its indicate disease recurrence and residual cancer is another tool in patient • Assay time: 18 min.
involvement in squamous cell malignancies disease following treatment and management together with other markers • Sample material: Serum, plasma
including lung, uterine cervix, esophagus, response to therapy.10 for gynecological malignancies (i.e. CA • Sample volume: 15 μL
head & neck, anal canal and skin for many • The most common histology in cervical 125, HE4, CA 15-3, HPV, CINtec® PLUS • Measuring range: 0.1– 70 ng/mL
years.1-3 SCCA levels can be elevated in cancer is SCC, with SCCA being the Cytology) • LoQ: 0.24 ng/mL
squamous cell cancers and it has been biomarker of choice for this histology. • High assay precision for accurate and • Precision: 5 % CV
reported that more advanced cancer stages Serum levels of SCCA have been found sustainable results for patient monitoring • Detection of SCC antigen 1 and 2
are associated with higher SCCA levels to correlate with tumor stage, tumor size • Standardization: Abbott Architect
e specially in lung and cervical cancer.4,5 It and residual tumor after treatment,
1 Kato, H., Torigoe, T. (1977). Radioimmunoassay for Tumor 9 Molina, R., Auge, J.A., Escudero, J.M., et al. (2008). Mucins
was reported that measurement of the recurrent or progressive disease, and Antigen of Human Cervical Squamous Cell Carcinoma. CA 125, CA 19.9, CA 15.3 and TAG-72.4 as Tumor Markers
Cancer; 40: 1621-1628. in Patients with Lung Cancer: Comparison with CYFRA
antigen, in serial determinations, aids in survival in patients with squamous 2 Cataltepe, S., Gornstein, E.R., Schick, C., et al. (2000). 21-1, CEA, SCC and NSE. Tumor. Biol.; 29: 371-380.
the assessment of disease recurrence, cell cervical c ancer.11,12 Co-expression of the Squamous Cell Carcinoma Vntigens 10 Ebert, W., Muley, T., Drings, P. (1996). Does the assess-
1 and 1 in Normal Adult Human Tissues and Squamous ment of serum markers in patients with lung cancer aid
residual disease following treatment, and • 90 % of head & neck cancers are Cell Carcinomas. J Histochem Cytochem; 48(1): 113-122. in the clinical decision making process? Anticancer Res.;
response to therapy.6,7 SCCs, in patients with primary tumors, 3 Torre, G.C. (1998). SCC antigen in malignant and nonma- 16: 2161-2168.
lignant squamous lesions. Tumor Biol 1998;19: 517-526. 11 Lozza, L., Merola, M., Fontanelli, R., et al. (1997). Cancer
SCCA serum levels were related to 4 Einarsson, R. (2005). Squamous Cell Carcinoma Antigen of the uterine cervix: clinical value of squamous cell
(SCCA) Isomers- Markers for squamous cell carcinoma. c arcinoma antigen (SCC) measurements. Anticancer
SCC antigen in different types of nodal involvement with significantly higher Adv. Clin. Exp. Med.; 14: 643-648. Research; 17: 525-530.
squamous cell cancers: levels in node-positive patients. Multi 5 Henry, R.J., Dodd, J.K., Tyler, J.P., and Houghton, C.R. 12 Kato, H. et al. (1983). Prognostic significance of the
(1987). SCC Tumor Marker and Its Relationship to tumor antigen T4-A in squamous cell carcinoma of the
• SCCA has been reported as a biomarker variate analyses showed that SCCA is a Clinical Stage in Squamous Cervical Cancer. Aust. NZl. uterine cervix. Am. J. Obstet. Gynecol.; 145: 350-354.
Obstet. Gynaecol.; 27: 338-340. 13 Molina, R., Torres, M.D., Moragas, M., Perez-Villa, J.,
for non-small cell lung cancer significant independent predictor of 6 Kenter, G., Bonfrer, J.M.G. and Heintz, A.P.M. (1987). Filella, X., Jo, J., Farrus, B., Giménez, N., Traserra, J.,
(NSCLC), mainly of the squamous disease-free survival and pretreatment Pretreatment Tumor-Antigen TA-4 in Serum of Patients Ballesta, A.M. (1996). Prognostic significance of SCC
With Squamous Cell Carcinoma of the Uterine Cervix. Br. antigen in the serum of patients with head and neck
cell carcinoma type. SCC in lung levels are an independent prognostic J. Cancer; 56: 157-158. cancer. Tumor Biol.; 17: 81-90.
7 Barak, V., Holdenrieder, S., Nisman, B., et al. (2009/2010).
is closely correlated with a history of indicator in patients with head and neck Relevance of circulating biomarkers for the therapy mon-
tobacco smoking, more than other malignancies.13 itoring and follow-up investigations in patients with non-
small cell lung cancer. Cancer Biomarkers; 6: 191-196.
8 Kenfield, S.A., Wei, E.K., Stampfer, M.J., Rosner, B.A.,
Colditz, G.A. (2008). Comparison of aspects of smoking
among the four histological types of lung cancer.
Tobacco Control; 17: 198–204.
82 | 83
The Roche lung cancer diagnostics Initial Assessment
NEW
Imaging
portfolio CEA, CYFRA21-1, SCC, ProGRP Cancer Center
Diagnostic aid in addition to imaging
and histology CT Biopsy
H&E IHC
Histological classification Sub-typing
About 70 % of NSCLC cases can be About 30 % of cases require IHC
diagnosed based on morphological to subclassify poorly differentiated
evaluation alone non-small cell lung carcinomas
Strengthen our diagnostics position in Background
Oncology using the potential of Roche’s full • Enhanced medical value with a compre- ProGRP for differential diagnosis in case of histological discrepancies
lung cancer portfolio for patient manage- hensive tumor marker panel
ment across all business areas utilizing all • This requires a common vision and NSCLC SCLC
available technologies. strategy for oncology, a coordinated
TTF-1 + p40 +
portfolio view across technologies and a Napsin A + CK 5/6 +
consolidated commercialization focus
Adenocarcinoma Squamous Cell
Carcinoma
Prediction
Stage I/II Stage III/IV Stage I/II Stage III/IV All Stages
EGFR +
Hematoxylin & Eosin Stain (H&E)/Immunohistochemistry (IHC)
ALK +
SP142
Therapy Decision
Imaging
84 | 85
Elecsys® Calcitonin
www.cobas.com
A powerful tool for the diagnosis and monitoring
of medullary thyroid carcinoma (MTC)
86 | 87
Elecsys® Tg II
The power to offer more for differentiated
thyroid cancer (DTC) management
The main application for Thyroglobulin (Tg) Your benefit High quality patient results and
testing is the post‑operative follow‑up of Excellent functional sensitivity accurate long-term monitoring
patients with differentiated thyroid carcinoma and precision • Excellent precision across the entire
(DTC). Detectable levels of serum Tg after • Improved sensitivity comes with better measuring range supports accurate
total thyroidectomy are indicative of persis- precision in the range around the clinical results
tent or recurrent DTC.1 cut-off and improved negative predictive • Lot-to-lot consistency across all cobas®
value platforms allows a reliable long-term
• Sensitive Tg assays can avoid TSH- patient monitoring
stimulated Tg testing during follow-up • Elecsys Tg II shows lower TgAb interfer-
in low-risk patients1 ence compared to other assays
• Patients with a basal Tg below the
functional sensitivity of a sensitive Tg Higher sensitivity allows for potentially Product characteristics
assay have a high chance of being free earlier detection of persistence or • Assay time: 18 min.
of disease2 recurrence • Sample material: Serum, K2-EDTA plasma,
• Increasing concentrations of Tg (even K3-EDTA plasma
at low concentrations) are an early and • Sample volume: 35 μL
Analytical sensitivity/LoD Functional sensitivity
reliable indicator of recurrent disease • LoB, LoD, LoQ*: 0.02 ng/mL, 0.04 ng/mL,
2nd gen. 0.05 –0.1 ng/mL 1st gen. 0.5–1 ng/mL
• Treatment is usually more successful 0.1 ng/mL
Roche (Elecsys Tg II) 0.04 0.09
with early detection as the tumor burden • Measuring range: 0.04 – 500 ng/mL
Siemens (Immulite®) 0.2 0.9
is lower • Traceability: BCR-CRM 457
Danaher (Access) 0.1
• Total imprecision:
DiaSorin (LIAISON®) 0.2
– cobas e 411 analyzer, E2010: 2.6 – 9.2 %
BRAHMS (Kryptor) 0.17 0.5
– cobas e 601/cobas e 602 modules:
BRAHMS (K. compact plus) 0.09 0.15
4.0 – 5.9 %
0.01 0.1 1
Tg concentration (ng/mL)
88 | 89
Elecsys® Anti-TSHR
www.cobas.com
Complex testing simplified and automated
Sensitivity
(figure 13) Area under curve (AUC): Using a cutoff of 1.75 IU/L a clinical
0.5
0.98 (95 % CI: 0.97– 0.99)
35 0.4 sensitivity of 97 % and a specificity of 99 %
30 0.3 was obtained.
25 0.2
FS (CV 20 %): 0.73 IU/L
CV [%]
90 | 91
Elecsys® Vitamin D total II
www.cobas.com
Allowing better patient care with results
you can trust
Vitamin D has a proven impact on bone Your benefit Product characteristics Proven accuracy with CDC reference
mineral density and bone quality. Desirable • Direct traceability to the official reference • Assay time: 27 min. samples
levels of 30 ng/mL have been shown to measurement procedure (Ghent University • Sample material: Serum and plasma 100
Passing/Bablok Linear regression
20 20
Reference method
0 0
ID-LC-MS/MS Ghent 0 20 40 60 80 100 0 20 40 60 80 100
Calibration: Rererence Method Procedure Vitamin D total II MP lot (ng/mL) Vitamin D total II MP lot (ng/mL)
(RMP) calibrated with NIST standards
92 | 93
Fully automated Elecsys®
Anti-Müllerian Hormone (AMH) assay www.cobas.com
CV %
5.50
assessing ovarian reserve levels and • Clinical agreement with Antral-Follicle- L H
2.75 H
therefore the capacity to provide eggs Count (AFC)
0
for fertilization. • Age specific reference ranges and PCOS Elecsys® AMH Automated AMH Manual AMH A Manual AMH B
(polycystic ovary syndrome) information Results of an independent study demonstrates Elecsys AMH provides superior precision at clinically relevant levels
Serum AMH levels have been shown to L: low level control; M: medium level control; H: high level control
remain relatively stable during the men-
strual cycle and may be measured on any Age specific reference ranges and Polycystic ovary syndrome (PCOS) information
day of the cycle. Median percentile 5th percentile 95th percentile
140
n=150 n=150 n=138 n=138 n=142 n=169 n=149 14 Elecsys ® AMH values of apparently healthy
94 | 95
Elecsys® sFlt-1/PlGF
www.cobas.com
Short term prediction and diagnosis
of preeclampsia
Preeclampsia is defined as new-onset of enabling clinicians to exclude preeclampsia Measuring range 10– 85,000 pg/mL 3 – 10,000 pg/mL
hypertension and proteinuria after 20 weeks for 1 week with very high confidence,
of gestation. The clinical presentation of reassuring women suspected of having the The PROGNOSIS study collected samples and clinical data from 1,273 pregnant
preeclampsia and subsequent clinical course disease that is safe to go home. women with clinical suspicion of PE, between 24 + 0 and 36 + 6 weeks of gestation,
of the disease can vary tremendously, making at 30 study sites in different global locations.
prediction, diagnosis and assessment of • Elecsys sFlt-1 and PlGF immunoassays
disease progression difficult. for preeclampsia are the first available A cut-off of <38 for the sFlt-1/PlGF ratio was identified for the rule out of preeclampsia
and approved automated diagnostic and is approved by NICE for use in clinical practice. In addition cut-offs that aid in
Angiogenic factors (sFlt-1 and PlGF) are tests for fast and easy assessment in a diagnosis (i.e. rule-in of PE) have also been validated, though these are not currently
proven to play an important role in the clinical context recommended by NICE.
pathogenesis of preeclampsia and their • The measurement of the Elecsys sFlt-1/
concentrations in maternal serum are PlGF ratio is a reliable tool to identify the Elecsys® sFlt-1/PlGF ratio cut-offs
altered even before the onset of the disease patients that are at high risk to develop Early onset preeclampsia – gestational week 20 – 33 + 6 days
making them a tool for prediction and preeclampsia requiring a closer monitoring sFIt-1/PIGF Diagnosis 99.4 % specificity
diagnosis of preeclampsia. and to confidently send home patients that ≥ 85 the woman has preeclampsia
Sensitivity: 88.0 %
are not going to develop the disease
sFIt-1/PIGF Prediction 36.7 % PPV
• Early and precise diagnosis of < 85 rule-in in the next 4 weeks the woman is at high risk to develop
preeclampsia can lead to to effective > 38 preeclampsia within the next 4 weeks
clinical management and improved sFIt-1/PIGF Prediction 99.3 % NPV
outcome for both mother and child ≤ 38 rule-out for the next 1 week the woman will not develop
preeclampsia for the next 1 week
Verlohren, S., Herraiz, I., Lapaire, O., Schlembach, D., Zeisler, H., et al. (2014). Hypertension; 63(2),346–352.
Verlohren, S., Galindo, A., Schlembach, D., et al. (2010). Am J Obstet Gynecol; 202(161).e1-11
Zeisler, H., Llurba, E., Chantraine, F., et al (2016). N Engl J Med; 374:13-22
National Institute for Health and Care Excellence (2016). NICE guideline DG23.
96 | 97
The full SWA immunosuppressive
drug assay panel www.cobas.com
• Outstanding possibilities for consolidation Sensitivity LoB * 0.3 ng/ml 20 ng/mL 0.4 ng/mL 0.4 ng/mL
20 with >230 parameters on one cobas® LoD * 0.5 ng/mL 30 ng/mL 0.5 ng/mL 0.5 ng/mL
LoQ * 1.0 ng/mL 50 ng/mL 1.5 ng/mL 1.0 ng/mL
platform
Measuring range 0.5 – 40 ng/mL 30 – 2,000 ng/mL 0.5 – 30 ng/mL 0.5 – 30 ng/mL
10
Total imprecision
High precision for confidence cobas e 411 analyzer 2.1–14.2 % 4.2 – 9.2 % 2.8 – 10.9 % 2.7 – 8.1 %
0 in results cobas e 601/e 602 modules 2.4 –10.4 % 3.1– 6.4 % 3.4 – 9.5 % 3.9 – 6.7 %
0 10 20 30 40
LC-MS/MS (ng/mL)
• High precision at low drug concentrations * LoB = Limit of Blank; LoD = Limit of Detection; LoQ = Limit of Quantitation
Hemostasis
number of industry firsts and innovative portfolio. It serves low- to medium-volume
applications for early disease detection central coagulation laboratories. Featuring
and monitoring. From easy-to-use, low- innovative sample and reagent management
Multiplate
results, offering outstanding productivity by instruments that will serve the medium-
while reducing complexity. to high-volume laboratories and for which
connectivity to Roche’s automation line will
Like Roche’s current instruments, the new be available.
generation of testing solutions is driven by
a commitment to deliver high-quality, cost- The new coagulation analyzers, combined
effective solutions capable of addressing with the point-of-care meters, the
the current and future testing needs of a Multiplate® analyzer and the LightCycler®
wide range of customers. for genetic hemostasis testing will allow
Roche to provide a full portfolio of solutions
for primary and secondary hemostasis
testing.
100 | 101
cobas t 411 coagulation analyzer
www.cobas.com
For maximum efficiency
Reagents
• Continuous rack-based loading
• Up to 70 vials on-board capacity
• Extended Routine Menu inlcuding PT,
APTT, FIB, TT, AT and DD
102 | 103
Multiplate® analyzer
www.roche-multiplate.com
Platelet function testing with excellent
predictivity
Blood platelets play a pivotal role in physi- patients have a 5 – 10 fold increased risk of Your benefit Consistent results
ological hemostasis, but also in the devel- stent thrombosis, stroke and myocardial in- Cost-effective therapies • using standardized reagents and
opment of arterial thrombosis (myocardial farction1-4 following percutaneous coronary • in cardiac surgery10,11 procedures
infarction and stroke). Platelet function interventions. Multiplate analyzer delivers • in coronary interventions12
testing is utilized in the analysis of inherited excellent predictivity5 and evidence is avail- Medical momentum
and acquired platelet function disorders able demonstrating that Multiplate guided Fast and easy assessment • More than 600 Medline publications,
that may cause a transient or permanent anti-platelet therapy has the potential to • of platelet function from small volumes consensus papers with Multiplate and
bleeding tendency. The Multiplate analyzer improve patient outcome.6-8 of whole blood published guidelines for PFT
can detect platelet dysfunction and thus
aid in the therapeutic management of such The Multiplate analyzer also plays a role in Excellent predictivity Product characteristics
patients. the analysis of platelet function in anesthesia • for stratification of bleeding risk in • High throughput: 30 tests/hour
and intensive care, where platelet dysfunc- surgical procedures • Sample volume: only 300 μL per analysis
It can also be used for monitoring of anti- tion can lead to severe bleeding complica- • for tailored anti-platelet therapy • Fast turn-around time: 10 min./test
platelet drugs where both compliance and tions. The detection or exclusion of platelet
drug effectiveness are key issues. It was dysfunction before invasive procedures Comprehensive reagent menu of CE marked tests and controls
shown with Multiplate analyzer results1 that or in bleeding patients can aid the risk
Products Description
up to 20 % of patients do not respond stratification and management in these
ADPtest ADP induced platelet activation sensitive to clopidogrel, prasugrel and other ADP
adequately to clopidogrel treatment. These situations.9-11 receptor antagonists
1 Sibbing, D. et al. (2009). J Am Coll Cardiol. Mar 10; ASPItest Cyclooxygenase dependent aggregation (using arachidonic acid) sensitive to
53(10):849-56. Aspirin®, NSAIDs and other inhibitors of platelet cyclooxygenase
2 Sibbing, D. et al. (2010). Thromb Haemost. Jan; COLtest Collagen induced aggregation
103(1):151-9. RISTOtest vWF and GpIb dependent aggregation (using ristocetin)
3 Schulz, S. et al. (2010). Am Heart J. Aug; 160(2):355-61.
4 Siller-Matula, J.M. et al. (2010). J Thromb Haemost. Feb; TRAPtest Platelet stimulation via the thrombin receptor (using TRAP-6), sensitive to IIbIIIa
8(2):351-9. receptor antagonists
5 Tantry, U. et al. (2013). J Am Coll Cardiol. 62:2261–73. Prostaglandin E1 reagent For the assessment of ADPtest HS (high sensitivity). For the assessment of positive
6 Siller-Matula, J.M. et al. (2013). Int J Cardiol. Sep 1; 167(5): (i.e. abnormal) controls of the ADPtest
2018-2023. ASA reagent Inhibitor of cyclooxygenase. Addition of ASA reagent to the blood sample leads to
7 Sibbing, D. et al. (2012). J Am Coll Cardiol. 59; E265. reduced aggregation responses in ASPItest and COLtest
8 Aradi et al. (2013). J Am Coll Cardiol. 61(10): E1922. GpIIb/IIIa antagonist reagent Inhibitor of the platelet GpIIb/IIIa receptor. Addition to a blood sample leads to
9 Ranucci, M. et al. (2011). Ann Thorac Surg. Jan; 91(1):123-9. strongly reduced aggregation in the TRAPtest
10 Weber, C.F. et al. (2012). Anesthesiology, Sep; 117(3):531-47. Hirudin blood tubes Anticoagulant for platelet function analysis with physiological calcium
11 Rafiq, S. et al. (2016). J Card Surg. 31(9):565-71. concentrations
12 Straub, N. et al. (2013). Thromb Haemost, 111(2):290-299.
Liquid control set Quality control for electrical signal in impedance aggregometry based on the
Not for use in the US. analysis of an artificial liquid control material
104 | 105
Hematology
Hematology Reinvented Hematology is the study of blood including
the blood forming organs, their pathologies
CBC is used in conjunction with the WBC
Differential which provides more detailed
and the study of the diseases. Hematology information about the WBC distribution in
Bloodhound® technology testing is used in a variety of settings, from
initial screening up to most complicated
peripheral blood. When it comes to diagno-
sis, cell morphology is a key contributor, as
Innovation – maturation status of blood cells. (such as sickle cell anemia, Chronic Lym-
phatic Leukemia, assessment of anemia
106 | 107
cobas m 511
NEW
Hematology Reinvented
108 | 109
Urinalysis
Laboratories
urine is still a key health barometer for needs. Drawing on our 50 years of experi-
many diseases, mainly urinary tract infec- ence in urinalysis, starting with the launch
Sediment
tions, kidney disease and diabetes. The of the first Combur-Test ® strip, we have
analysis of urine can reveal serious diseases continuously improved strip technology for
that show no symptoms in their early stages clinical and general practice. In response
Urine work area solution but are treatable. These diseases can cause
severe damage if they remain undetected.
to customer needs for increased efficiency
and safety, we have developed a range
110 | 111
Urinalysis from Roche Micral-Test ® strip for albumin in urine
Expertise coming from a long tradition Quick and secure results of albumin
of more than 50 years in urine
www.cobas.com
Zone 2:
Capture
Sample level Matrix Fleece Carrier foil
112 | 113
Combur-Test ® strip Urisys 1100 ® analyzer
Established quality – proven to perform Small and easy
Urine reagent strips are a useful tool for Safety The Urisys 1100 analyzer is a small semi- Your benefit
investigating, diagnosing and screening • Independence interference from of automated benchtop instrument for a Compact
diseases immediately. Reliable and precise glued components as a result of a unique workload of 10 to 50 samples per day. It is • Semi-automated urine analyzer for the
results are important, since adulterated sealing technology optimal for small labs, doctor’s offices or small lab, ward or doctor’s office
results can lead to false negative results • Test area colors prevented from flowing in decentralized settings.
or re-testing of patients. Roche’s unique with an absorbent paper Easy handling
test strip technology is used for visual test • Reduction of the risk of false results The high quality Combur-Test ® strips • Automatic printing of results
strips and for all instrument test strips. through compensation of strong intrinsic provide accurate results in one minute
urine coloration with the availability of a which can be optionally printed out for Simplify your life
Your benefit color compensation pad* your convenient documentation. • Eliminate manual documentation through
Accuracy the export of data via host connection
• Combur-Test ® strip * detects even low Easy strip handling
concentrations of glucose and erythro- • Facilitation of analysis with a consistent Safety
cytes/hemoglobin (5 – 10 Ery/mL) in the reading time of 60 seconds for all • Prevent unauthorized access and comply
presence of vitamin C1 parameters with accreditation requirements via an
• Advanced and hygienic strip handling operator lock-out feature
Efficiency with possibility of reading tip down
• Avoidance of retesting and false-negative Product characteristics
ERY/Hb
results in glucose and blood even • Workloads: 10 – 50 samples per day1
COMP
UBG
GLU
PRO
LEU
KET
NIT
BIL
SG
pH
with high levels of ascorbic acid (up to • Throughput: approx. 50 test strips/hour
400 mg/L) with the application of an • Combur-Test ® is resistant to ascorbic
iodate impregnated mesh layer1 acid interference
Diazonium • Control-Test M for weekly calibration
salt Iodate
Nylon impregnated impregnated • Test strips *: Combur 10 Test ® UX
mesh mesh mesh
• Memory capacity: 100 results
Plastic Absorbent
• Printer: Thermal printer
carrier foil paper • Connectivity to the cobas POC IT solution
Combur-Test urine test strips from Roche have * Combur 7 Test ® , Combur5Test ® are not available in
1 Combur10 Test M, M. S., 2017. eLabDoc. iodate impregnated mesh layers and are uninfluenced 1 Urisys 1100, O. M., 2016. eLabDoc. all countries.
[Online] Available at: https://dialog1.roche.com by ascorbic acid.1 [Online] Available at: https://dialog1.roche.com
[Accessed 4 January 2017]. * For instrument tests only. [Accessed 13 February 2017].
114 | 115
cobas u 411 urine analyzer
www.cobas.com
Consolidated result management
2. Result download
1 Combur10 Test M, M. S., 2017. eLabDoc. [Online] Available at: https://dialog1.roche.com Display of sample
ID + test strip
[Accessed 4 January 2017].
2 cobas u 411 system, O. M., 2014. eLabDoc. [Online] Available at: https://dialog1.roche.com
[Accessed 13 February 2017]. Semi-automated urine work area solution.
116 | 117
cobas ® 6500 urine analyzer series
www.cobas.com
One tube, one touch – fully automated
urine workflow
The cobas 6500 urine analyzer series is a Precise and safe strip results Product characteristics1
fully automated urine work area solution for • High quality results by proven unique strip cobas u 601 urine analyzer
laboratories processing 100 – 1,000 urine construction based on 50 years experience • Fully automated urine strip new generation
samples per day. • Accurate, safe results by new technology • 12 on-board parameters
• Throughput: 240 samples/hour
Due to its modular design cobas 6500 Consolidation of urine work area • cobas u pack;
urine a nalyzer series can be installed as a • Convenient validation – – cassette with 400 test strips
stand-alone urine analyzer or as a stand- all results on one screen – Combur-Test ® strips technology cobas u 601 urine analyzer
alone m icroscopy analyzer or together as a • Full menu covers urine strip testing – two weeks on-board stability
fully automated urine work area. and urine sedimentation (humidity protected)
• New photometer technology for the strip
Your benefit Workflow optimization result reading
Automation of the gold standard • Full integration into lab automation • Detecting the intact and lysed erythrocytes
• Taking real microscopy images – elimi
nating operator variability and the need cobas u 701 microscopy analyzer
for manual review, improving TAT • Fully automated urine microscopy system cobas u 701 microscopy analyzer
• 11 on-board parameters
• Reagent-free system
• Throughput: 116 samples/hour
• 400 cuvettes in one package
(cobas u cuvette)
• Excellent counting performance
• Storage of real images
cobas 6500 urine analyzer series
cobas® connection module (CCM) connected to 2 cobas 8000, 1 cobas 6500 urine analyzer series, O. M., 2016. eLabDoc. [Online]
cobas p 501 post-analytical unit, cobas 6500 and cobas u 601 Not for use in the US. Available at: https://dialog1.roche.com [Accessed 13 February 2017].
118 | 119
Molecular diagnostics
Virology
innovative tests based on the Nobel diseases. In addition we offer a range of
Prize-winning polymerase chain reaction products to identify the molecular charac-
(PCR) technology. teristics of patients and diseases, thus
Full automation
and laboratories worldwide. by using Roche Molecular Diagnostics
approved systems to screen donations.
Roche provides solutions for indication
Companion diagnostics within the lab for after hours and STAT
testing, and in the primary care segment
For more information please
visit www.molecular.roche.com
120 | 121
Molecular diagnostics solutions
www.molecular.roche.com
Innovative, reliable and efficient
Meeting the requirements for confidence in for unrivalled efficiency, integrated IVD and Your benefit
PCR results and comprehensive high- LDT processing for greater consolidation, • Flexible, efficient workflow • Confidence in results due to integrated
quality solutions, Roche offers a wide range and connectivity to pre- and post-analytics. • Innovative real-time PCR technology meets quality controls and physical and
of systems including full lab automation international guidelines for sensitivity and biochemical contamination control
linear measurement range
Workflow solutions for molecular diagnostics
• Mid-high throughput cobas® 6800 System • High throughput cobas s 201 System
• Absolute automation
• Unmatched flexibility
•M id to low throughput cobas® 4800 System
• Full automation LDT Solutions
cobas z 480 Analyzer • High throughput FLOW Solution
available as standalone cobas x 480 cobas z 480 • Complete Workflow
solution with manual
Instrument Analyzer
sample prep for oncology
• Medium throughput Manual or COBAS® AmpliPrep Instrument COBAS® TaqMan® 48 Analyzer • Medium and low MagNA Pure 24 System or High Pure Kits LightCycler ® 96 or 480 Systems
Manual low throughput throughput
solution available with
COBAS® TaqMan® 48
Analyzer
• Very low throughput cobas® Liat® System
On-demand testing for
the Point of Care as well
as out-of-hours & STAT
testing.
122 | 123
Test Overview
cobas® 6800/8800
COBAS® TaqMan®
COBAS® TaqMan®
LightCycler ® 2.0
LightCycler ® 2.0
cobas® 4800,
cobas® 4800,
cobas s 201
cobas s 201
Liat® System
Liat® System
AMPLICOR
AMPLICOR
Detection
Detection
Instrument
Instrument
COBAS®
COBAS®
cobas®
cobas®
Viruses Sepsis pathogens
Cytomegalovirus Quant. • • * • Bacteria/Fungi Qual., Diff. •
Hepatitis B Quant. • • • Bacteria/Fungi Qual., Ident. •
Hepatitis C quant Quant. • • • Blood screening
Hepatitis C qual Qual. • MPX: HIV-1 **, HIV-2, HCV, HBV Qual., Diff. • •
Hepatitis C GT Genot. • • DPX: B19V/HAV Qual., Diff. • •
Herpes Qual., Diff. • • West Nile virus Qual. • •
Human Immunodeficiency Quant. • • • Hepatitis E Qual. •
Human Immunodeficiency Qual. • * • Bacteria
Human Immunodeficiency RUO Qual. • Strep A Qual. •
Human Papillomavirus Qual., Genot. • * • Oncology
Influenza A/B Qual., Diff. • BRAF Qual., Mut. Detect. •
Influenza A/B+RSV Qual., Diff. • BRAF/NRAS (LSR) Qual., Mut. Detect. •
Parvo B 19 (RUO) Quant. • KRAS Qual., Mut. Detect. •
Varicella-Zoster Qual. • KRAS V2 (LSR) Qual., Mut. Detect. •
Other pathogens EGFR V2 Qual., Mut. Detect. •
Chlamydia trachomatis/Neisseria gonorrhoeae Qual. • • • PIK3CA (RUO) Qual., Ident. •
Chlamydia trachomatis Qual. • Genetics
Clostridium difficile Qual. • • * Factor V Leiden Qual., Mut. Detect. • * •
Methicillin-resistant Staphylococcus aureus Qual., Diff. • • * • Factor II Qual., Mut. Detect. • * •
Mycobacteria Tuberculosis Qual. • * •
Trichonomas vaginalis/Mycoplasma genitalis Qual. • *
Vancomycin resistant enterococcus Qual. • Qual. = Qualitative; Quant. = Quantitative; Genot. = Genotyping;
Diff. = Differentiation; Ident. = identification; Mut. Detect. = Mutation Detection
* In development. ** Groups M and O.
RUO = For research use only. Not for use in diagnostic procedures.
Please check with your local Roche representative on availability of the assays and tests in your country. LSR = Life Science Research. Not for use in diagnostic procedures.
124 | 125
cobas® HPV Test
www.hpv16and18.com
Know the risk
The cobas ® Oncology Portfolio exemplifies Key features and shared benefits Portfolio menu* cobas ® DNA Sample Preparation Kit
Roche’s commitment to Personalized • Complete and controlled IVD system cobas EGFR Mutation Test v2
® • Validated with FFPET samples
Healthcare. The tests detect mutations in optimized for use with the cobas® DNA • Identifies patients with non-small • Isolation time: 3 – 4 hours only
key biomarkers which helps identify patients Sample Preparation Kit, the cobas® cell lung cancer who benefit from
who are most likely to respond to certain cfDNA Sample Preparation Kit (only for anti-EGFR TKI therapy, e. g. Tarceva ® cobas ® cfDNA Sample Preparation Kit
drug treatments. These extensively validated cobas® EGFR Mutation Test v2), the in first-line therapy or TAGRISSO ™ • Validated with plasma samples
diagnostic tests can help our physicians cobas® BRAF, KRAS, EGFR v2 and in subsequent-lines of therapy • Isolation time: ~2 hours
make important treatment decisions and PIK3CA (RUO) Mutation Tests, as well as • Detects 42 mutations in exons 18, 19, 20
allow investigators to assess clinical rele- the cobas® 4800 System, v2.1 or higher and 21 of the EGFR gene cobas® PIK3CA Mutation Test (RUO)
vance. When every day counts, the cobas® • Automated result interpretation and • One test, two sample types (tissue and • Broad detection of 17 PIK3CA mutations
Oncology Portfolio provides answers in hours test reporting provide from laboratory plasma) in exons 1, 4, 7, 9 and 20
instead of days or weeks. to laboratory
• Delivering patient results in one work cobas® 4800 BRAF V600 Mutation Test BRAF/NRAS Mutation Test (LSR)
shift • Identifies which metastatic melanoma • Broad detection of 11 BRAF mutations in
• 24 reportable results from a single test kit patients can be considered for BRAF exons 11 and 15 plus 25 NRAS mutations
• Only requires one 5 µm tissue section inhibitor therapy, e. g. Zelboraf® in exons 2, 3 and 4
• Detects V600E mutations of the BRAF
gene; also sensitive to V600K and V600D KRAS Mutation Test v2 (LSR)
• Broad detection of 28 KRAS mutations in
cobas ® KRAS Mutation Test exons 2, 3 and 4
• Identifies which metastatic colorectal
c ancer patients can be considered for
anti-EGFR mAb therapies e.g. Vectibix®,
Erbitux®
• Detects all of the reported mutations in
exons 2 and 3** of the KRAS gene
* Data on file
** Not available in all markets.
RUO = For research use only. Not for use in diagnostic procedures.
See page 84 for additional information on the Roche lung cancer diagnostics portfolio. LSR = Life Science Research. Not for use in diagnostic procedures.
128 | 129
cobas® CT/NG cobas® HSV 1 and 2 Test
NEW
Proven efficiency, giving you the freedom Bring more to your sexually transmitted
to do more infections menu
Chlamydia trachomatis (CT) and/or Neisseria Your benefit Due to extremely different outcomes Your benefit
gonorrhoeae (NG) are among the most Exceptional Assay Performance regarding recurrence, it is essential to Amplified reliability
common sexually transmitted infections • Validated for CE-IVD use with extragenital determine whether a patient has type 1 or • Robust, dual-target detection amplifies
(STIs). cobas® CT/NG for use on the samples type 2 herpes simplex virus. The cobas two separate regions on each of the
cobas® 6800/8800 Systems is an automated, • Extensive contamination control solution HSV 1 and 2 Test, which runs on the cobas HSV-1 and HSV-2 genomes
qualitative in vitro nucleic diagnostic test, • Proven, performance in u
rogenital samples 4800 System, offers exceptional sensitivity • Optimizes sensitivity and specificity
that utilizes real-time polymerase chain while delivering reliable answers that • Ensures reliable results as new HSV
reaction (PCR), for the direct detection of Most Efficient Workflow result in optimal patient treatment and strains emerge
CT and NG, simultaneously from the same • Highest volume molecular test for CT/NG management decisions.
sample. cobas® CT/NG is intended as an • Onboard capacity of up to 5,670 tests with Reduced hands-on time
aid in the diagnosis of chlamydial and onboard stability of 90 days • Just load your primary sample vials
gonococcal disease in both symptomatic • Continuous loading with no pre-sorting on the cobas® 4800 System and you’re
and asymptomatic individuals. required for mixed test request ready to go
130 | 131
COBAS® TaqMan® MTB Test cobas® Cdiff Test
Rapid MTB detection The right result the first time
Tuberculosis is the world’s most common Product characteristics* Clostridum difficile (C. difficile) infection Your benefit*
infectious disease, with two million deaths • Detects pathogens of the Mycobacterium is a major cause of diarrhea in healthcare Exceptional performance
annually. Due to the risk and severity of tuberculosis complex (M. tuberculosis, facilities. By rapidly detecting Cdiff in • Selectively detects a specific Cdiff toxin
the disease, rapid diagnosis of the M. tuber M. bovis, M. africanum, M. microti) patient stool samples, the cobas® Cdiff Test, gene directly from unformed stool s amples
culosis-complex is extremely important. • Test is performed on the IVD CE-marked which is performed on the cobas 4800 using real-time PCR
Routine cultures are time-consuming and COBAS TaqMan 48 Analyzer that allows System, provides accurate information for • Generates robust results automatically,
can take up to eight weeks. Microscopic variable batch sizes – between 1 and timely treatment and prevention. using patented, state-of-the art algorithms
examination of acid-fast smears is insensi- 48 tests per run • Detects the presence of 31 Cdiff toxino-
tive and nonspecific. The COBAS TaqMan • Internal controls included in the same types and 20 ribotypes
MTB test has further improved the rapid reaction batch
diagnosis of tuberculosis by allowing • Specificity: 99 % Confidence in results
direct detection of mycobacteria in clinical • Sensitivity: 0.46 CFU/PCR, corresponding • Lower inhibition rate minimizes invalids
specimens. to a calculated concentration of and need for repeat testing resulting in
18 CFU/mL sputum cost efficiency
Your benefit* • Reduces possibilities for errors
• Fast results in only 3.5 hours including
sample preparation Unmatched flexibility
• Reliability of test results • Run as few as 6 or as many as 94 samples
– high sensitivity and specificity • Process different tests and sample types
– clear differentiation of the pathogen simultaneously
from atypical mycobacteria (MOTT)
– contamination protection through
AmpErase System
• Efficient workflow, no manual steps
required after sample preparation
• Proven and safe sample preparation with
the COBAS® AMPLICOR® respiratory
specimen preparation kit
132 | 133
cobas® MRSA/SA Test cobas® HCV test
Faster than a spreading infection Own the future
Staphylococcus aureus (SA) and methicillin- Your benefit The cobas® HCV test quantitative nucleic cobas® HCV test performance summary*
resistant Staphylococcus aureus (MRSA) Exceptional performance acid test for use on the cobas® 6800/8800
Parameter Performance
infections represent a critical threat to • Quickly identify colonized patients and Systems delivers robust, clinically relevant
Sample type EDTA plasma, serum
public health. The cobas MRSA/SA Test, take decisive action assay performance based on Roche’s
Minimum amount 650 µL or 350 µL
performed on the cobas® 4800 System, • Get the sensitivity and specificity that only proprietary dual-probe assay design. cobas® of sample required
provides innovative solutions for detecting PCR technology can deliver HCV test provides built-in redundancy with Sample processing 500 µL or 200 µL
both organism variances from a single broad genotype coverage and incorporates volume
Analytical sensitivity 15 IU/mL (500 µL)
nasal swab specimen, providing timesaving Greater workflow efficiencies mismatch tolerance to ensure confidence (LoD by hit rate of 40 IU/mL (200 µL)
efficiencies and lifesaving answers. • Save time with first-of-its-kind primary in viral load monitoring. cobas® HCV test ≥ 95%)
sample vial loading is designed to deliver high sensitivity to Linear range 500 µL: 15 IU/mL – 1×10 8 IU/mL
200 µL: 40 IU/mL – 1×10 8 IU/mL
• Run MRSA/SA, Cdiff, and HSV 1 and meet the requirements of current and future Specificity 100 % (one-sided 95 %
2 samples at the same time, on the same chronic hepatitis C therapies. confidence interval: 99.5 %)
system Genotypes detected HCV genotypes 1– 6
5’
NT
R
COR
E E1 E2 P7 NS2
HCV RNA
NS
3 TR
NS
3’N
4A
NS
Two 4B
Forward Primer Reverse Primers N S 5A N S5 B
134 | 135
cobas® HCV test cobas® HCV Genotyping test
See what truly matters See what truly matters
cobas® HCV test quantitative nucleic acid • Accurate detection and quantification Identification of the infecting genotype is Automated assay providing
test for use on the cobas® 4800 System, of HCV genotypes 1 through 6 required before a patient is prescribed workflow efficiencies
delivers robust, clinically relevant assay • High sensitivity suitable for use with antiviral therapy as response to treatment • Time to first result: <4 hrs
performance based on the proprietary new HCV therapies correlates to the HCV genotype. • Generates up to 90 reportable results
dual-probe assay design from Roche with • Excellent correlation with the COBAS ® Determination of HCV genotype prior in 8 hours
built-in redundancy for broad genotype AmpliPrep/COBAS ® TaqMan ® HCV to treatment initiation has been • Mixed testing capability with HIV-1
coverage and improved mismatch tolerance Quantitative Test, v2.0 implemented in international HCV and HCV viral load tests on the
to ensure confidence in viral load treatment guidelines. cobas® 4800 System
monitoring. cobas® HCV test performance • Small sample processing volume: 400 μL
cobas® HCV GT test for use on the cobas®
Parameter Performance
cobas HCV test accurately detects
® 4800 System is a highly sensitive real-time Sensitivity to meet clinical needs
Sample types Serum, plasma
and quantifies all HCV genotypes PCR based test for the qualitative identifi-
Sample processing 400 µL and 200 µL Limit of detection (LoD)*
1 through 6 volume
cation of HCV genotypes 1 to 6 and geno-
Genotype Serum (IU/mL) Plasma (IU/mL)
• Two non-overlapping detection Sensitivity plasma: 9.2 IU/mL (400 µL); type 1 subtypes a and b in human plasma
(LoD by PROBIT 15.2 IU/mL (200 µL) 1a 125 125
probes, when combined with or serum from individuals with chronic HCV
at ≥95 % hit rate) serum: 7.6 IU/mL (400 µL); 1b 125 250
two staggered primers, ensure assay 15.3 IU/mL (200 µL) infection.
2 50 125
performance Linear range 400 µL: 15 – 1×10 IU/mL
8
p7 NS4A
136 | 137
COBAS ® AmpliPrep/ cobas® HIV-1
COBAS ® TaqMan ® HCV qualitative Stay one step ahead
and quantitative Tests, v2.0
Empowering change in HCV
COBAS ® AmpliPrep/COBAS ® TaqMan ® Your benefit It takes more than just a single target. cobas® HIV-1 performance summary
HCV quantitative Test, v2.0 • Precisely distinguish true signals from As the challenges you face evolve,
Parameter Performance
assess the probability of a sustained viral background noise for more accurate viral stay one step ahead with the cobas®
Sample type EDTA plasma, serum
response early in a course of antiviral load results HIV-1 quantitative test with a dual
Sample process 500 µL or 200 µL
therapy and viral response to antiviral • Perfect tool to aid in response-guided ther- target approach. volume
treatment. apy with excellent sensitivity and specificity Analytical sensitivity 13.2 cp/mL (500 µL)
• Economic sample provides laboratory Rapidly mutating HIV-1 virus can evade 35.5 cp/mL (200 µL)
COBAS ® AmpliPrep/COBAS ® Linear range 500 µL: 20 cp/mL – 1.0E+07 cp/mL
TaqMan ® HCV qualitative Test, v2.0 with enough left over sample for other quantification with a single target viral load 200 µL: 50 cp/mL – 1.0E+07 cp/mL
and quantitative Test, v2.0 laboratory testing assay. cobas® HIV-1 quantitative nucleic Specificity 100 % (one-sided 95 %
acid test for use on the cobas® 6800/8800 confidence intervat: 99.5 %)
developed with a lower input volume, and Product characteristics Genotypes detected HIV-1M (A-D, F-H, CRF01_AE,
innovative dual-probe design to provide Systems targets two unique regions of
• Kit configuration 72 tests/kit CRF02_AG), HIV-1O, HIV-1N
improved sensitivity and precise detection the HIV-1 genome, gag and LTR, which are
• Sample types EDTA plasma and serum
across all genotypes for the new era of not subject to selective drug pressure. Drive better decisions for a positive
• Sample input volume 650 µL
direct acting antiviral agents (DAAs). This a
pproach improves test sensitivity, impact on patients’ lives
• Limit of detection 15 IU/mL
coverage and security in the event of • Targeting two regions improves genotype
• Genotype inclusivity genotypes 1 through 6
The COBAS ® AmpliPrep/COBAS ® mutation in one primer/probe region. inclusivity, detects HIV-1 variants and
TaqMan ® HCV qualitative Test, v2.0 Workflow potentially avoids under quantification
a qualitative molecular diagnostic tool in • Flexible batch size with continuous loading • Accurate quantification of HIV-1 RNA
HCV diagnosis patients who have evidence • Interleave with other COBAS ® TaqMan ® with a dual target assay contributes to
of liver disease and antibody e vidence of Tests (HIV, HBV, HCV, CMV) optimal treatment decisions for patient
HCV infection. Not commercially available in all countries. Data on file. management
138 | 139
cobas® HIV-1 COBAS ® AmpliPrep/
Stay one step ahead COBAS ® TaqMan® HIV-1 Test, v2.0
A dual-target approach for greater security
against the unexpected
It takes more than just a single target. Drive better decisions for a positive An in vitro nucleic acid amplification Product characteristics
As the challenges you face evolve, impact on patients’ lives test for the quantitation of HIV-1 RNA in • Offers primers and probes that are
stay one step ahead with the cobas® • Targeting two regions improves genotype human plasma. used to amplify the gag and LTR regions
HIV-1 quantitative test with a dual inclusivity, detects HIV-1 variants and • Provides LTR primers that have
target approach. potentially avoids under quantification This test enhances the reliability of test broad genotype inclusivity and are
• Accurate quantification of HIV-1 RNA results and provides great confidence well conserved phylogenetically
Rapidly mutating HIV-1 virus can evade with a dual target assay contributes to in assessing viral loads. It also increases • Quantifies the clinically significant
quantification with a single target viral load optimal treatment decisions for patient the probability of detection and expands HIV-1 groups and subtypes with full
assay. cobas® HIV-1 quantitative nucleic management coverage by targeting two highly conserved subtype coverage and quantification
acid test for use on the cobas® 4800 regions of the HIV-1 genome to compensate of HIV-1 groups O and M
System targets two unique regions of the cobas® HIV-1 performance summary for the possibility of mutations or mis- • Quantitates HIV-1 RNA from
HIV-1 genome, gag and LTR, which are not matches. 20 – 10,000,000 copies/mL
Parameter Performance
subject to selective drug pressure. This • Has a lower limit of detection (LOD)
Sample types EDTA plasma
approach improves test sensitivity, coverage and 100 % specificity at 20 copies/mL than
Sample process 400 µL or 200 µL
and security in the event of mutation volume
previously available HIV-1 tests
in one primer/probe region. Analytical sensitivity 14.2 cp/mL (400 µL) • Is fully traceable to WHO international
43.9 cp/mL (200 µL) standards
Linear range 400 µL: 20 cp/mL – 1.0E+07 cp/mL
200 µL: 60 cp/mL – 1.0E+07 cp/mL
Not commercially available in all countries. Data on file.
Specificity 100 % (one-sided 95 %
confidence interval: 99.5 %)
Genotypes detected HIV-1M (A-D, F-H, CRF01_AE,
CRF02_AG), HIV-1O, HIV-1N
140 | 141
COBAS® AmpliPrep/
COBAS® TaqMan® HBV Test, v2.0
The trusted choice for Hepatitis B
viral load testing
Improve patient management and treatment Your benefit Roche HBV Tests in clinical trials for approved HBV drugs on the market
success. • Confidence in assay design with opti-
Generic Name Trade Name Date FDA Approved
mized primer-probe selection targeting
Interferon alfa-2b INTRON® A 1991
Fully automated viral load quantitative highly conserved pre-core and core
Lamivudine EPIVIR-HBV ®
1998
hepatitis B test used in the management of regions. The amplified region of the
Adefovir dipivoxil HEPSERA™ 2002
patients with chronic hepatitis B infection genome will not be affected by mutations
Entecavir BARACLUDE™ 2005
undergoing antiviral therapy. that arise due to drug resistance
Peginterferon alfa-2a PEGASYS® 2005
Telbivudine TYZEKA™ 2006
The test provides clinically relevant assay • Confidence in detection with multiple
Tenofovir VIREAD (HIV) 2008
performance, and high sensitivity to layers of contamination control including
deliver optimal results throughout critical built-in AmpErase enzyme, optimized
Not commercially available in all countries.
medical decision points and across all pipetting and workflow settings and
genotypes, all combined with fully automated verified low rates of cross contamination
sample extraction and real-time PCR
amplification and detection for a highly • Confidence in measuring HBV DNA with
efficient laboratory workflow. high precision at medical decisions points
translates into confidence in each result
regardless of HBV DNA level
142 | 143
cobas® HBV
NEW
NEW
Better information for patient management
The cobas® HBV Test for use on the The cobas® HBV Test offers The cobas® HBV Test for use on the cobas® HBV performance summary
cobas® 6800 and 8800 Systems provides • Broad coverage of all known HBV geno- cobas® 4800 Systems provides robust, Parameter Performance
robust, clinically relevant assay perfor- types (A – H) including pre-core mutations clinically relevant assay performance, and Sample types EDTA plasma, serum
mance, and high sensitivity to deliver • Tight precision at medically relevant high sensitivity. cobas® HBV delivers Minimum amount Please refer to the cobas®
optimal results throughout critical medical decision points optimal results throughout critical medical of sample required 4800 Systems Opterator’s
Manual for cobas® HBV
decision points and across all genotypes, • Excellent performance and flexibility with decision points and across all genotypes
Sample process 400 µL or 200 µL
for an improved patient care, all combined serum and plasma specimens combined with a highly efficient laboratory volume
with a highly efficient laboratory workflow. • Built-in contamination control with workflow. Analytical sensitivity 400 µL 200 µL
AmpErase enzyme to prevent carryover EDTA plasma (IU/mL) 4.4 7.6
Roche primers and probes target the highly contamination Roche primers and probes target the highly Serum (IU/mL) 2.8 5.5
conserved pre-core and core regions of the • Excellent correlation to Roche COBAS® conserved pre-core and core regions of the Linear range 400 µL: 10 – 1.0E+09 IU/mL
(IU/mL) 200 µL: 25 – 1.0E+09 IU/mL
HBV genome. AmpliPrep/COBAS® TaqMan® HBV Test, v2.0 HBV genome.
Specificity 100 % (one-sided 95 %
confidence interval: 99.5 %)
The amplified region of the genome will not cobas® HBV performance summary The amplified region of the genome will not Genotypes detected HBV Genotype A – H, precore
mutant
be affected by mutations that arise due to Parameter Performance
be affected by mutations that arise due to
Cross Contamination 0.0 % (one-sided 95 %
drug resistance.1 Sample types EDTA plasma, serum
drug resistance.1 confidence interval of 1.3 %)
Minimum amount 650 µL or 350 µL
of sample required
Sample process 500 µL or 200 µL
volume
Analytical sensitivity 400 µL 200 µL
(LoD by hit rate of
≥95 %)
EDTA plasma (IU/mL) 2.7 15.5
Serum (IU/mL) 1.45 12.5
Linear range 500 µL: 10 – 1.0E+09 IU/mL
(IU/mL) 200 µL: 25 – 1.0E+09 IU/mL
Specificity 100 % (one-sided 95 %
confidence interval: 99.5 %)
Genotypes detected HBV Genotype A – H, and
predominant precore mutant Data on file.
144 | 145
COBAS® AmpliPrep/
COBAS® TaqMan® CMV Test
Setting the standard in assessing virological
response in CMV infection
Improve disease management and patient Your benefit CMV viral load test standardization enables improvement in CMV infection
care with a Roche real-time, fully automated With the COBAS® AmpliPrep/COBAS® management4,5
PCR test. TaqMan® CMV Test, you can be reassured
that you are requesting: Comparability of the Roche CMV Test results Comparability of LTD results across five
Cytomegalovirus (CMV) is a leading cause across five laboratory testing sites laboratory testing sites
of morbidity and mortality in transplant • A test that fulfils international guideline
recipients. Severe CMV infection in recommendations – demonstrating
high risk patients may develop soon after co-linearity to the WHO international
transplantation and without effective standard and reports results in IU/mL,
treatment, may lead to CMV syndrome, as recommended by the international
tissue invasive disease, and potential consensus guidelines for CMV manage-
rejection or loss of the graft. Roche’s CMV ment in solid organ transplant patients 1,8
Test reliably monitors Cytomegalovirus
(CMV) infection in patients receiving anti- • A test that is clinically validated – Used in
viral therapy. key clinical studies, demonstrating clinical
utility of CMV viral load monitoring 3,9
146 | 147
cobas® CMV COBAS ® AmpliPrep/
NEW
Consistency in test results is vital for Your benefit The COBAS ® AmpliPrep/COBAS ® Your benefit
successful CMV management, helping • Traceability to the first WHO Standard TaqMan ® System, a real-time PCR system, Safety and reliability
transplant patients enjoy long, healthy lives. (NIBSC 09/162) providing consistent, unites primary tube handling with fully • Closed tubes for samples and purified
The cobas® CMV quantitative nucleic reliable results across the dynamic range automated sample preparation, amplification nucleic acids minimize contamination
acid test for use on the cobas® 6800/8800 of the assay and across institutions and detection of RNA or DNA. The • Sample tracking with barcoded tubes
Systems reliably monitors infection in • Proven advantages over Lab Developed system provides high throughput pro- prevents sample mix-ups
patients receiving antiviral therapy. Tests1-5 – providing quality control and cessing for a menu includes HIV, HCV,
quality assurance of reagents and valid HBV, and CMV. Efficiency
ated results • Handles up to four tests simultaneously;
• Reassurance in clinical decision making – The system improves workflow efficiencies continuous reloading during the run
cobas® CMV standardized viral load test- with the COBAS® AmpliPrep Instrument for • Ready to use reagents – no aliquotting or
ing enables a common strategy to be automated extraction of DNA and RNA mixing required
developed in the management of CMV using magnetic bead technology • Overnight runs
infection in transplant patients and the COBAS® TaqMan® or COBAS®
TaqMan® 48 Anayzers for automated Reliability for routine PCR
cobas® HBV performance summary real-time amplification and detection of • Reliable results within two to three hours
Parameter Performance DNA or RNA for up to 96 samples • Sensitive, highly linear tests can
Sample types EDTA plasma and four assays at the same time. handle both low titer and high titer
Minimum amount 500 µL samples in the same run
of sample required • Greater safety due to AmpErase enzyme
Sample process 350 µL
volume contamination prevention and
Analytical sensitivity 34.5 IU/mL internal controls for detecting possible
1 Kotton, C.N. et al. (2013). Updated international consensus
guidelines on the management of cytomegalovirus in solidor- Linear range 34.5 IU/mL – 1E+07 IU/mL PCR inhibitors
gan transplantation. Transplantation; 96:333–360.
2 Razonable, R.R., Hayden, R.T. (2013). Clinical utility of viral load Specificity 100 %
in management of cytomegalovirus infection after solid organ
transplantation. Clin Microbiol Rev; 26:703–727.
Genotypes detected CMV Glycoprotein B Geno-
3 Wolff, D.J. et al. (2009). Multisite PCRbased CMV viral load type 1– 4
assessmentassays demonstrate linearity and precision, but Drug resistant CMV CMV specimens resistant
lack numeric standardization. A report of the Association for specimens detected against Ganciclovir,
Molecular Pathology. J Mol Diagn; 11:87–92.
4 Pang, X.L., Fox, J.D., Fenton, J.M., Miller, G.G., Caliendo, A.M.,
Valganciclovir, Cidofovir and
Preiksaitis, J.K. (2009). Interlaboratory comparison of cytomeg- Foscamet
alovirus viral load assays. Am J Transplant; 9:258–268.
5 Hirsch, H.H. et al. (2013). An international multicenter perfor-
mance analysis of cytomegalovirus load tests. Clin Infect Dis;
56:367–373. Data on file.
148 | 149
cobas® 6800/8800 Systems
www.cobas68008800.com
Own the future
The cobas 6800/8800 Systems are new Your benefit Product characteristics
molecular testing platforms, available in Unparalleled Performance eady-to-use reagents do not
R Uni- and bi-directional LIS
medium and high throughput models, Rapidly complete daily testing requirements require thawing, mixing or pouring interface
designed for donor screening, viral load with trusted and reproducible results.
monitoring, women’s health, and utomated onboard storage and
A ystem connectivity: up to six
S
micro-biology testing. Absolute Automation refrigeration of consumables and systems managed by a single
Allows you to focus on more complex testing reagents instrument gateway
The cobas 6800 System and the higher demands while increasing productivity within
throughput cobas 8800 System are the lab. FID and barcodes ensure
R Consolidate LDTs with routine IVD
designed to be readily integrated into full traceability from sample in tests with the cobas omni Utility
laboratory workflow from pre-analytic Unmatched Flexibility to results out Channel
to post-analytic solutions. Run the tests you want when you want
For more information visit www.cobas68008800.com with minimal user interactions. Consolidated menu
Offers a broad and expanding menu to meet your needs today and in the future.
Automated pre-analytic sample handling
Blood Screening Infectious Diseases Women’s Health * Currently in development
** Dual-target for HIV-1 and
cobas® connection modules MPX** HIV-1 † MTB* HPV* dual-probe for HCV
† Dual-target
WNV HBV MAI* CT/NG* †† Dual-probe
te
te
workflows
sts
sts
*
*
Centrifu- Bulk 8 hours 4 hours
work-away work-away
gation loading time* time*
150 | 151
cobas® 4800 System
Works the way you do
The cobas® 4800 System offers state-of-the- Your benefit Test menu
art, fully automated sample preparation, Workflow efficiency
Virology Microbiology & G&O
real-time PCR amplification/detection and • Flexible and efficient sample loading of Women’s Health
easy-to-use software for multiple sample primary and secondary vials
HIV-1† HPV BRAF * Currently in development
types and an expanding menu of assays. • Run up to 3 tests simultaneously for †
Dual-target
HBV CT/NG KRAS †† Dual-probe
faster turnaround of results
HCV†† HSV 1/2 KRAS v2* (LSR) RUO Research Use Only
It consists of the cobas x 480 Instrument • Scalability on each and every test through LSR Life Science Research
HCV GT Cdiff EGFR v2
for the nucleic acid extraction sample flexible run sizes
Virus
preparation and PCR pipetting and the CMV* MRSA/SA PIK3CA (RUO) Bacteria
Variant
obas z 480 real-time PCR analyzer.
c Consolidated menu BRAF/NRAS (LSR)
For Lab Developed Tests
• Broad and expanding assay menu for IVD Factor II/V*
The cobas z 480 analyzer is also available and LDT testing on a single instrument
cobas® assays are not available
as single system and can be used for USER DEFINED FUNCTIONALITY
in all markets.
parameters in the oncology field like BRAF, Confidence in results
KRAS and EGFR. • Physical and chemical measures ensure
confidence in results
• Certainty of results through validation of
every test run
• Automated interpretation of PCR results
eliminates subjectivity
Data on file.
152 | 153
cobas® 4800 System
Works the way you do
Product characteristics cobas p 480 Instrument Mixed testing on cobas® 4800 System
• Processes up to 376 samples in 10 h
• Bidirectional connectivity to LIS Primary & secondary automated
pre-analytical sample handling
• Easy to use software or
• Automated result interpretation Decapping Recapping
HIV-1 HCV HCV-GT MRSA/SA C. difficile HSV 1 and
samples samples 2 samples
Aliquoting Reagent addition
& heating
HCV Cdiff
HIV-1 HSV 1 and 2
HCV-GT MRSA/SA Parallel sample processing offers
the flexibility to run different tests
and sample types, including:
• cobas® Cdiff: Stool
• cobas® MRSA/SA: Nasal
• cobas® HSV1/2: Anogenital lesions
•c obas® HIV-1: Plasma
•c obas® HCV: Plasma & Serum
cobas p 480 Instrument •c obas® HCV-GT: Plasma & Serum
Amplification and detection
with cobas z 480 Analyzer
Data on file.
154 | 155
cobas® Liat® System
www.cobasliat.com
We put a lab in a tube, because they put their
trust in you
Closed-system design and multiple process Ease-of-use Analyzer dimensions and weight
controls make it ideal for adoption by satel- • No technical training required 24.1 × 11.4 cm × 19.0 cm, 3.76 kg
lite labs, physician offices and pharmacies. • Touchscreen-guided operation,
minimizes potential for human error cobas® Liat® Assay Menu
156 | 157
cobas s 201 System
The first multi-dye nucleic acid testing (NAT)
screening system
The cobas s 201 system is a complete Your benefit Product characteristics cobas® TaqScreen DPX Test
NAT solution able to meet both current and • Full automation including optional pooling Scalable, modular system • Simultaneous quantitative detection
future needs of blood screening labs. and archiving with minimal hands-on time • Flexible, mix-and-match scalability helps of parvovirus B19V DNA and qualitative
for the entire testing process NAT labs work more efficiently detection of HAV
This system provides the efficiency • Confidence in the test results through full • Supports simultaneous multiple assay • B19V target values are traceable to the
and reliability of real-time polymerase process control processing WHO B19V International standard
chain reaction (RT-PCR) technology, • Comprehensive assay menu with ready- • Accommodates integrated backup to
modular automation, convenient ready- to-use reagents maximize lab productivity cobas ® TaqScreen WNV Test
to-use r eagents and a robust menu • Built-in viral target resolution through • Qualitative in vitro test for the direct
selection. New assays utilize multi- multi-dye technology makes confirmation Pooling and data management server detection of West Nile virus (WNV) RNA
channel capabilities to provide real-time testing obsolete • Single server, accommodating multiple in human plasma
discrimination of major v iruses. instrument configurations and providing • Screening test for donations of whole
the added security of built-in redundancy blood and blood components
The system is backed by world-class • Capable of detecting other members
service and strong local support in over Test menu of flavivirus that have been implicated in
140 countries. • Reagents are ready-to-use with built-in fusion transmitted infectious disease
contamination control
• No freezers required, reagents are stored
at 2 – 8° C
• Stabilized reagents obsoletes calibrations
Pooling and data management server cobas ® TaqScreen MPX Test, v2.0
• Cover 5 critical viral targets (HIV-1
Group M, HIV-1 group O, HIV-2, HCV
and HBV) in one easy-to-use assay
• Immediate virus discrimination in a single
assay, no need for virus discriminatory
testing
Hamilton MICROLAB STAR COBAS® AmpliPrep Instrument and
Pipettor instrument for automated pooling COBAS® TaqMan® Analyzer combined
with a docking station Data on file.
158 | 159
FLOW Solution
ldtsolutions.roche.com/flow
Unleash your potential
160 | 161
LightCycler® Systems
www.lightcycler.com
Excellence in real-time PCR
LightCycler ® 2.0 LightCycler ® 96 System LightCycler ® 480 System The LightCycler® 2.0 System (IVD) is not available in all countries.
System (IVD) Information about the high-throughput LightCycler® 1536 System is available on request.
For life science research only.
Not for use in diagnostic procedures unless otherwise noted.
162 | 163
LightCycler® 2.0 Instrument
www.lightcycler.com
For medical research
164 | 165
MagNA Pure Systems
starthere.roche.com
Breakthroughs have a beginning
Product characteristics
MagNA Pure 24 and MagNA Pure 96 Systems are for in vitro diagnostic use.
MagNA Pure 24 System MagNA Pure 96 System *only on MagNA Pure 96 Systems
(Currently in development,
available March 2017)
Data on file.
166 | 167
cobas p 480 instrument
Automating your primary vial
preprocessing steps
The cobas p 480 instrument improves Product characteristics Reduces hands on time and repetitive motions with four unique workflows
laboratory efficiency by allowing valuable Improves sample reproducibility and
technician time to be used more productively, process reliability
eliminating repetitive, manual sample • Sample chain of custody is assured
handling, improving workflow and reducing with primary and secondary vial barcode
risk of contamination, human error and matching
workplace injury. • All vials are spun prior to opening to
remove potentially contaminating droplets 1 2
Your benefit from sample caps
Decapping Recapping
Improving laboratory efficiency • Precision pipetting using CO-RE tip, Total
Removes caps from primary tubes for testing Recaps sample vials with new caps to avoid
• Accepts PreservCyt®, SurePath™ liquid Aspirate and Dispense Monitoring and on the cobas® 4800/6800/8800 Systems. contamination.
based cytology vials as well as Anti-Droplet Control technologies reduce
cobas® PCR Media and cobas® PCR Cell opportunities for contamination and
Collection Media primary vials ensure sample integrity
• Processes four vials simultaneously • No LIS or data connection required
• Intuitive interface requires minimal training • Printable reports capture all sample
• High throughput automation ID’s, sample error and reagent lot and
expiration information 3 4
Workflow Volumes
Aliquoting Reagent addition and heating *
Aliquots configurable volumes from PreservCyt®, Addition of cobas® Sample Prep Buffer and
1,536* Decapping/Recapping SurePath™ and cobas® PCR Cell Collection incubation of specimens collected in SurePath™
Media primary vials into barcode matched medium to reverse cross-linking and free
secondary tubes Compatible with SurePath™ nucleic acids for testing1.
vials with plastic inserts.
672* Aliquoting
1 Kiernan, J.A. Preservation and retrieval of antigens
for immunohistochemistry – methods and
mechanisms Part 2. Retrieving masked antigens
Department of Anatomy and Cell Biology.
The Cutting Edge, 5-11.
288* Reagent Addition & Heating
168 | 169
cobas p 680 instrument
Supports the creation of sample pools for use
with the cobas® 6800/8800 Systems
170 | 171
Roche Blood Safety Solutions
Reliable results
testing, pre-analytics and IT solutions.
Roche is the first company to offer a
connectivity of serology and nucleic acid
172 | 173
Roche Blood Safety Solutions
Striving for continual improvement to meet
blood banks’ evolving needs
cobas® CHIKV/DENV
HSV-2 IgG Toxo IgG av.
Technologies that support timely and reliable release of safe blood products
cobas 6000 cobas 8000 cobas 6800/8800, cobas p 680 cobas cobas cobas CCM
p 312 p 512 p 612
cobas IT solutions
cobas infinity blood safety
cobas IT middleware
cobas e 411 cobas s 201 cobas Synergy
174 | 175
Point-of-care testing
Point of Care The goal of Point of Care from Roche is to
help both healthcare professionals and
While the responsibility for providing the
service is in the hands of professionals, we
Anticoagulation
robust, connected, easy to use point-of- patient care:
care solutions outside the central lab, pro- • Provide accurate and timely analyses and
viding immediate results and thus allowing match them to the right patient
Critical care
176 | 177
Overview of point-of-care
diagnostic tests www.cobas.com
CoaguChek® Pro II
TROP T sensitive
TROP T sensitive
Reflotron® sprint
Reflotron® sprint
Accutrend® Plus
Accutrend® Plus
CoaguChek® XS
CoaguChek® XS
cobas b 123*
cobas b 221*
cobas b 123*
cobas b 221*
(visual strips)
(visual strips)
cobas b 101
cobas b 101
cobas h 232
cobas h 232
CoaguChek®
CoaguChek®
Urisys 1100®
Urisys 1100®
Accu-Chek®
Accu-Chek®
(visual strip)
(visual strip)
INRange
INRange
Inform II
Inform II
Combur
Combur
Anemia Myoglobin •
Bilirubin • • • • D-dimer •
Bilirubin neonatal • • HDL cholesterol (or HDL-C) • •
Hemoglobin total • • • • • LDL cholesterol (or LDL-C) • •
Hematocrit • • NT-proBNP •
Oxygen saturation (sO2) • • Coagulation
Blood gas D-dimer •
pH • • PT (INR/% Quick/sec.) • • •
pCO2 • • aPTT •
pO2 • • Metabolic
Electrolytes Ca2+ • •
Ca2+ • • Cl- • •
Cl- • • Glucose • • • • • •
K+ • • HbA1c •
Na+ • • HDL cholesterol (or HDL-C) • •
CO-oximetry Ketone • •
tHb-COOX • • LDL cholesterol (or LDL-C) •
O2Hb • • Lactate • • • •
HHb • • Potassium • • •
COHb • • Sodium • •
MetHb • • Total cholesterol (or CHOL) • • •
sO2 COOX • • Triglycerides (or TG) • • •
Bilirubin neonatal • • Hepatology
Barmetric pressure (Baro) • • Alkaline phosphatase •
Cardiac Bilirubin •
Troponin T • • Creatine kinase •
CK-MB • GGT •
178 | 179
cobas® POC IT solution
Bringing it all together
CoaguChek® Pro II
TROP T sensitive
Reflotron® sprint
Accutrend® Plus
CoaguChek® XS
results from POC analyzers that are
cobas b 123*
cobas b 221*
(visual strips)
cobas b 101
cobas h 232
CoaguChek®
Urisys 1100®
Accu-Chek®
(visual strip)
distributed across hospitals and primary
INRange
Inform II
Combur
care centres.
* In addition several calculated parameters are available. Open connectivity at its best
180 | 181
www.cobas.com
such as true wireless communication and • Connects the full Roche POC portfolio cobas® POC IT solution
observed competency on-board POC including Accu-Chek Inform II, CoaguChek
Laboratory
devices, as well as positive patient ID – XS Plus and Pro, CoaguChek Pro II, information system
ensuring p
atient safety obas® Liat®, c
c obas h 232, cobas b 101,
Urysis 1100, cobas b 121 system, cobas b
Local service and support 123 POC system and cobas b 221 system.
• Quick and easy access to Roche service
personnel in your time zone and language Roche POC e-learning Roche hotline cobas IT 1000 cobas cobas b 123
cobas e-support bge link POC system
provides efficient turnaround time for • Efficient user training, integrated into your
your questions and ensures maximum existing hospital platforms and customiz-
uptime for the systems able to your needs. Roche offer SCORM
compliant e-learning modules can be
Proven commitment hosted on your existing hospital learning
• The cobas® POC IT solutions are proven management system (LMS). cobas® IT
to perform in over 1,450 systems in > 50 1000 can be seamlessly linked to your
countries with 70,000 connected devices. hospital LMS enabling the automatic up-
Emergency Outpatient General Operating
• Including over > 50 Roche and non-Roche date of operator elearning exam results. department department wards room
POC devices – with a long-term commit- Simple for nurses and POC coordinators.
ment to enhancing value for patients and
POC coordinators missing period cobas bge link
• The cobas bge link software gives you
Product characteristics complete and easy remote management
cobas IT 1000 application of POC blood gas analyzers, allowing you
• cobas IT 1000 application gives you com- to view and control device operations
plete management of POC testing, includ- simply and efficiently.
cobas academy e-learning
ing remote configuration and control of
devices, user management and LIS/HIS cobas® e-services
interfacing from a single point of control • Gives your local Roche experts remote
access, enabling them to quickly and
efficiently answer your questions in your
time zone and language.
182 | 183
cobas® infinity POC tablet
NEW
cobas® infinity POC tablet is an app for Your benefit The QC review concept has been designed • Quality control management
iOS and Android tablet devices. It is de- Automate Operator & Device specifically for POC coordinators to utilize • Documentation of QC corrective and pre-
signed to help POC Coordinators (POCCs) Management the full potential of the tablet experience. ventative actions
manage their complete POC testing With cobas® infinity POC tablet, a POC With one click on the interactive QC chart • Device replacement and relocation
program whilst moving around. The app Coordinator can easily monitor operator all result-related information is presented • Check device status
enables POC Coordinators to realise the and device status. Enabling them to quickly for review, and troubleshooting becomes • Adding and updating operators
full potential of working with a tablet, identify where they are needed for prob- much easier. • Check and update operator training status
allowing them to become really efficient by; lem-solving. • Export list of operators requiring training
automating the coordination of compe- Product characteristics
tence and performance and supporting cobas® infinity POC tablet enables the Technical requirements:
them to better manage complex job tasks. POCC to efficiently manage their complete • cobas® IT1000 v2.07 or higher
The POCC can take their work with them POC testing program by supporting the fol- • Tablet device on hospital network
into meetings, review quality control (QC) lowing workflows: • iOS 9 or higher
performance with nurses directly on the • Android 4.3 or higher
ward, record corrective and preventative • (VPN for remote connection)
actions or discuss the training status of
users with the hospital’s education manager.
184 | 185
cobas® infinity POC mobile
www.cobas.com
Always with you
cobas® infinity POC mobile is a mobile Automate Operator Management Product characteristics
app for iOS and Android devices, which The POCC or Nurse Educator can easily Usability has been at the core of the design
works in conjunction with cobas IT 1000. review and update operator training status, process and cobas® infinity POC mobile
It is designed to help POC Coordinators quickly identifying those operators has been independently rated for usability,
(POCCs) complete key tasks whilst on the go. with expired or soon to expire certificates. scoring extremely highly. The product has
been designed from the bottom up to be
Due to the nature of the testing that they Act on What’s Important easy to use from a mobile device.
support, a POCC does a lot of their work With cobas® infinity POC mobile, a POC
while “out and about” around hospital Coordinator can monitor overall performance cobas® infinity POC mobile enables the
locations. Some of their time is spent at of POC testing and spot any issues that need POCC to easily carryout key workflows
their desk, some walking around and to be dealt with quickly and easily. whilst on the move:
for many tasks, they need to find a PC in • Device replacement
order to access a desktop. • Device relocation
• Checking device status
This dictates how POC Coordinators work, • Adding a new operator
and limits productivity. cobas® infinity • Editing existing operator details
POC mobile empowers the POCC, freeing • Checking operator training status
them from their office and enabling them to: • Export a list of operators requiring training
save time managing devices, automate • Update operator training status
operator management and act on what’s
important. Technical requirements
• cobas® IT 1000 v2.04.01 or higher and
Your benefit networked mobile device
Save Time Managing Devices • iOS 7 or higher
The POCC can easily monitor device con- • Android 4.1 or higher
nectivity and QC status. Enabling them • Mobile device on hospital network
to quickly identify where they are needed • (VPN for remote connection)
for problem solving.
186 | 187
cobas® bge link software
www.cobas.com
Central control of your Roche blood gas
and electrolyte analyzers
The cobas bge link software provides Your benefit Product characteristics
complete remote management and control Save time • Information on analyzer status, parameters,
of blood gas instruments from one work- • By not having to walk to each analyzer, reagents and reports in a clearly arranged
station. with continuous remote status monitoring layout
of your blood gas and electrolyte systems, • Management of quality controls and
This valuable tool allows the complete from the laboratory c alibration cycles
management of all cobas blood gas • Clear presentation of patient results
analyzers that are connected to a h ospital Improve analyzer uptime measured with the blood gas and
network. The cobas bge link software • With effective remote troubleshooting electrolyte systems from Roche
can improve workflow efficiency, freeing and remote control of analyzer functions • Remote control of calibrations, cleaning
up valuable staff time and improving (e.g. calibrations, QC, cleaning cycles, cycles and test functions
service to clinicians in critical care settings. test functions) • Initiation of quality control on the blood
gas and electrolyte systems from Roche
Increase confidence and security (AutoQC®), can be initiated from the
• With remote monitoring of analyzer laboratory
performance and quality while offering • Levy-Jennings overview of QC history
a clear and comprehensive audit trail and trends
• Extensive data management possible
through integration into cobas® POC IT
solution
Roche
Service Center
188 | 189
cobas b 221 system
www.cobas.com
Convenience for your critical care testing
Metabolites Glu/Lac
Bilirubin
190 | 191
cobas b 123 POC system
www.cobas.com
Allowing you to focus on patient critical care
The cobas b 123 POC system is a mobile, Your benefit Product characteristics
cartridge-based, critical care analyzer Easy to use • Throughput: 30 samples/hour
designed for POC testing. With flexible • Intuitive graphical user interface, touch- • Integration of clot prevention features to
configurations and a throughput of up to screen and graphically guided instruc- ensure patient care without interruption
30 samples per hour, the cobas b 123 POC tions allow handling steps to be learned and cost-efficient operation
system can easily be customized to the in minutes and simplify the training of • Optional mobile cart, battery operation
clinical needs of the ICU, ER, NICU, OR*, POC users and wireless connectivity enables
dialysis units or the laboratory. instrument to be operated wherever it
Safe is needed
The operator-friendly system offers easy • Access control, clot prevention, data • Variety of sample types: whole
handling and requires no preventative management including QC, remote blood,dialysis solution, QC solutions • Trending acid-base maps to support
maintenance, reducing analyzer downtime. control to increase analyzer uptime (both aqueous and blood-based) clinical decisions
• Connection to cobas® bge link software • Fluid pack – sizes 200, 400 or 700 samples
Rapid results and cobas POC IT solution
• Near-patient, whole-blood sampling pro- • Automated user management through
vides results in only 2 minutes to support cobas e-learning
timely clinical decision making
Metabolites Glu/Lac
Bilirubin
Auto QC
192 | 193
Accu-Chek ® Inform II solution
Safe for patients. Simple for professionals.
Efficient for hospitals.
194 | 195
cobas h 232 POC system
www.cobas.com
On-the-spot care & share
196 | 197
Roche CARDIAC® Trop T Sensitive test
www.cobas.com
Visual test for the rapid diagnosis
of myocardial infarction
Many patients seek medical attention only Your benefit Product characteristics
hours or even days after the onset of chest Highly versatile • Qualitative detection of troponin in
pain, especially on weekends. With the • Suitable for use in different clinical anticoagulated (EDTA or heparin) venous
Roche CARDIAC Trop T Sensitive test you settings, e.g. emergency room, GP office whole blood2
can make a diagnosis even several days or ambulance • Reaction time: 15 min.
(up to 10 – 14 days) after m
yocardial dam- • Positive result from a threshold (cut-off)
age occurs.2 Fast results of 100 ng/L
• Reliable yes/no result in 15 – 20 min. • Storage at 2 – 8° C (refrigerator)
The Trop T Sensitive test is a visual troponin • Test can be used immediately after
T test. Since it requires no system it can be Easy handling and portability removal from the refrigerator
easily deployed in rural areas near the point • Simple application that can be used • Storage for 1 week at room temperature
of patient care, at the bedside, in triage anywhere (15 – 25° C)
bays, emergency service areas, ambulances • No sample preparation • Roche CARDIAC Trop T Sensitive test is
or a designated lab area. The Trop T Sensi- • Device independent available in 5 and 10 pack sizes
tive test is designed for qualitative deter
mination of cardiac troponin T in the blood Reliable qualitative measurements
and elevated levels indicate acute mycardial • Proven test strip technology
infarction.2
Cost-effective
Results from a large prospective clinical trial
1 • Requires no external measurement system
in Denmark indicate that implementation of • Requires no special training
qualitative pre-hospital troponin T testing
in the ambulance vehicle by paramedics is On the spot rule-in acute myocardial
feasible in most patients, including non-ST infarction
segment elevation myocardial infarction • Specific cardiac marker – A positive result
(NSTEMI) patients whose condition is not indicates myocardial damage
detected by the classical electrocardiogram. • Even if characteristic ECG changes are
missing, a positive Roche CARDIAC Trop T
1 Sørensen, J.T., Terkelsen, C.J., Steengaard, C.,… Prehospital troponin T testing
Sensitive test with a non-ST-elevation in the diagnosis and triage of patients with suspected acute myocardial infarction.
myocardial infarction (NSTEMI) can aid Am J Cardiol. 2011 May 15;107(10):1436-40.
the treatment decision2 2 TROPT Sensitive – Method Sheet – package insert
198 | 199
CoaguChek® XS system
www.CoaguChek.com
Coagulation self-testing made easy
1 Kitchen, D.P., Munroe, S., Kitchen, S., Jennings, I., Woods, T.A.L., Walker, I.D. (2008).
British Journal of Haematology, Volume 141 Supplement 1: P188.
2 Heneghan, et. al (2006). Lancet, 367; 404-411.
3 Heneghan, C., Alonso-Coello, P., Garcia-Alamino, J.M., Perera, R., Meats, E:, Glasziou, P. (2016).
Lancet; 367; 404–11.
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CoaguChek ® Pro II system
www.CoaguChek.com
Delivering life-saving information with
immediately actionable coagulation
results at ALL points of care
CoaguChek® Pro II system is the clinically vi- Your benefit Product characteristics
tal point-of-care coagulation testing device. • Greater insight into patients’ coagulation • Detection system: Electrochemical deter-
In addition to monitoring warfarin therapy, status with both aPTT and PT mination of the PT and aPTT time after
the Prothrombin Time (PT) and activated • Enhanced connectivity for a streamlined activation of coagulation cascade
Partial Prothrombin Time (aPTT) tests will workflow • User interface: large TFT color touch-
help in the determination of factor defi- • Easy implementation with minimal screen; screen icons allow intuitive
ciencies and other coagulopathies in several training operation
point-of-care locations. • Memory capacity: 2,000 test results
• Integrated 2D barcode reader for entering
The enhanced connectivity options allow user/patient ID and lot numbers of
for immediate access to patients’ data via controls
their electronic health records because • Enhanced data management capabilities:
wireless technology ensures fast, accurate WLAN and unique QR Code connectivity
transmission so that workflow will be more option
streamlined and results will be available for
immediate treatment decisions.
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Accutrend® Plus system
www.cobas.com
Screening for cardiovascular risk factors
Ease of use
• Simplicity makes device ideal for testing
in the physician office or in hospital s ettings
Test Measuring ranges Measuring Sample material Sample Operating
time volumes conditions
mg/dL mmol/L
Glucose 20 – 600 1.1 – 33.3 12 sec • Fresh capillary blood 15 – 50 µL 18° – 35° C
Cholesterol 150 – 300 3.88 – 7.76 180 sec • Fresh capillary blood 15 – 40 µL 18° – 35° C
•U se of heparin-coated
pipettes possible
Triglycerides 70 – 600 0.80–6.86 max. 174 sec • F resh capillary blood 10 – 40 µL 18° – 30° C
•U se of heparin-coated
pipettes possible
Lactate 0.8 – 22 mmol/L 60 sec • F resh capillary blood 15 – 50 µL 5° – 35° or 15° – 35° C
•U se of heparin-coated depending on concent-
pipettes possible ration of analyte
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Reflotron® Plus system and
Reflotron® Sprint systems www.cobas.com
The Reflotron Plus system is a single-test Your benefit Product characteristics • Sample volume: 30 µL
clinical chemistry system which allows the Reliability • Throughput of Reflotron® Sprint: • Time-to-result: only 2 – 3 min.
measurement of 17 parameters from whole • No storage concerns due to excellent test Up to approx. 60 tests/hour (depends on parameter)
blood, plasma or serum – including liver strip stability • Throughput of Reflotron Plus: • Integrated printer:
and pancreas enzymes, metabolites, blood • Little waste and almost no maintenance Up to approx. 25 tests/hour Immediate documentation of results
lipids, hemoglobin and potassium. • Sample material: whole blood • Barcode reader and/or keyboard
Faster clinical decision making (capillary and venous) plasma or serum for patient and sample ID input
Immediate and reliable test results ensure • Quick time to result
quick performance and verification of the • No reagent preparation Covering a wide range of daily routine and emergency testing
diagnosis without delay.
Muscle diseases Anemia
The system is suitable for primary care
settings, as a back-up system in hospitals
and private labs, at screening sites and for Lipid metabolism disorders Bone diseases
health check-ups.
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cobas b 101 system
www.cobas.com
Managing diabetes and dyslipidemia
at the point of “need”
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CoaguChek® INRange system
NEW
1 H eneghan, C., Ward, A., Perera, R., et al. (2012). Self-monitoring of oral anticoagulation: systematic
review and meta-analysis of individual patient data. Lancet 379: 322-334.
2 S harma, P., Scotland, G., Cruickshank, M., Tassie, E., Fraser, C., et al (2015). Is self-monitoring an
effective option for people receiving long-term vitamin K antagonist therapy? A systematic review
and economic evaluation. BMJ Open 5: e007758.
CoaguChek INRange
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Tissue diagnostics
VENTANA Roche Tissue Diagnostics, is one of the
world’s leading cancer diagnostic compa-
In addition, Roche Tissue Diagnostics offers
premier workflow solutions specially de-
High-value assays
ized Healthcare to cancer patients.
Recognizing the world’s increasing medical
The company known as V entana Medical needs, Roche Tissue Diagnostics focuses
Companion diagnostics
University of Arizona, established the cancer tests that help enable Personalized
concept of a single, complete report cover- Healthcare. These tests allow pathologists
ing all aspects of a patient’s case, which to analyze patient samples at the molecu-
Consultative services helps to improve survivability. lar, cellular and tissue level to help deter-
mine the best course of therapy for individ-
Roche Tissue Diagnostics is passionate ual patients.
about its mission to improve the lives of all
patients afflicted with cancer by develop- For more information please
ing and delivering medical diagnostic sys- visit www.ventana.com
tems and tissue-based cancer tests that
are shaping the future of healthcare.
VENTANA products provide healthcare
professionals with a comprehensive solu-
tion for the critical steps involved in the
analysis of tissue samples.
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Tissue diagnostics
Leading future innovation
Workflow
Sample preparation H&E staining* Special stains IHC/ISH staining Digital pathology
histology
Tissue processing Morphology Protein/DNA tests Scanner and software
(IHC/ISH)
6 6
Method
1 VANTAGE software 3 BenchMark Special Stains instrument ually controlled slide heater pads for maxi- • VIRTUOSO image and workflow
• Workflow solution from sample preparation • Fully automated special stains from mum protocol flexibility management software — designed for
to statistics monitoring baking to staining • Systems with different capacity available clinical laboratory use
• Tracking of both samples and monitoring of • Capacity up to 20 slides per run to fit small to large laboratories • Industry-leading Companion Algorithm
the lab activity to help ensure quality • Individual heater pads • Open systems for antibodies image analysis solution delivers consistent
• Workflow consulting to optimise processes • Complete ready-to-use reagent kits • Broad portfolio of 250+ ready-to-use assays and objective results, time after time
• Individual slide staining technology for H&E systems • Comprehensive digital pathology • H&E, IHC *, ISH *, SpSt *
• Fully automated H&E staining from drying • Fully automated IHC * and ISH * systems, solution — from scanning and image • More than 250 antibodies
to glass coverslipping driven by easy-to-use barcoded slides viewing to customized reporting • Ready-to-use and barcoded reagents
• Elimination of xylene and alcohol from the and reagents and ISH systems with individ- • VENTANA iScan HT and iScan Coreo
H&E process scanners — combine unprecedented
flexibility, throughput and reliability
* H &E = Hematoxylin and Eosin, ISH = In situ Hybridisation, IHC= Immunohistochemistry, SpSt = Special stains
214 | 215
VENTANA HE 600 system
Master the art and science of H&E staining
216 | 217
BenchMark Special Stains
Automated slide stainer
Achieve high quality assays that are both Your benefit Workflow
consistent and reproducible, improve Fully automated • Optimize throughput capacity with single
laboratory workflow and testing efficiency, • Standardised IHC and ISH staining piece workflow
and access companion and complementary • Improve quality, workflow and testing • Increase laboratory productivity and
diagnostics with VENTANA BenchMark efficiency reduce re-run rates
systems.
Flexibility BenchMark system features
The VENTANA BenchMark GX, BenchMark • Individually controlled slide heater pads Unique and innovative technologies
XT and BenchMark ULTRA systems … enable users to run any assay side-by- designed to deliver diagnostic confidence
These systems offer the flexibility to run side • Individual slide drawers of BenchMark
any assay side-by-side, broaden your test • Customize time and temperature proto- ULTRA BenchMark ULTRA system
menu with 250+ ready-to-use assays, and cols for each individual slide position • Protocol flexibility via individually • 30 slide positions
improve overall laboratory efficiency. controlled slide heater pads • Ability to add or remove bulk reagents
Optimal quality • Unique Slide ID and LIS compatibility and waste without interrupting cases in
• Individual slide heaters, liquid coverslip with Ventana System Software 12.5 process
and air vortex mixers provide an optimal • 35 reagent positions
puddle staining environment BenchMark GX system • Continuous and random slide processing
• Sensitive detection chemistries and a • 20 slide positions to optimize laboratory workflow
broad portfolio of ready-to-use assays • 25 reagent positions
• Low to medium throughput LIS or VANTAGE software connection
• Small footprint, proven automation • Connect multiple systems with a
single computer or add a new system
BenchMark XT system to existing ones
• 30 slide positions • Share reagents and protocols across
• 35 reagent positions instruments through Central Management
• Medium to high throughput software
• Proven automation with enhanced protocol • Download patient accession and test
flexibility information from LIS to slide staining
system to mitigate data entry errors
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IHC and ISH detection
Meet your needs, and then go beyond
222 | 223
Primary antibodies
Over 250 ready-to-use clinical reagents,
optimized for use on VENTANA BenchMark
staining platforms
Ready-to-use antibodies
C4, FITC Hematopathology CD57 (NK-1)
Roche Tissue Diagnostics antibodies, novel antibodies still in the research phase. Fibrinogen, FITC ALK1 (ALK01), CONFIRM CD61 (2f2)
including a world-class breast panel, cover Staining analysis is facilitated by advanced Kappa, FITC Annexin A1 (MRQ-3) CD68 (KP-1), CONFIRM
the pathology world’s diagnostic requests. antibody performance and multiple detection Lambda, FITC bcl-2 (SP66) CD71 (MRQ-48)
Roche Tissue Diagnostics a ntibodies technologies. HHV-8 (Human Herpes Virus Type 8) bcl-2 (124), CONFIRM CD79a (SP18), CONFIRM
(13B10) bcl-6 (GI191E/A8) CD99 (O13), CONFIRM
include IVD/CE-IVD antibodies, as well as
IgA (Immunoglobulin A) BOB.1 (SP92) CD138 (Syndecan-1) (B-A38)
IgA (Immunoglobulin A), FITC c-Myc (Y69) Cyclin D1 (SP4-R)
Breast Cervical Dermatopathology IgG (Immunoglobulin G) CD1a (EP3622) Fascin (55k-2)
Actin, Smooth Muscle (1A4) CINtec® PLUS Cytology p16/Ki-67 dual Albumin, FITC IgG (Immunoglobulin G), FITC CD2 (MRQ-11) FoxP1 (SP133)
Beta-catenin (I4) stain (Cytology) (E6H4™ and 274-11 a-1-Antichymotrypsin (ACT) IgM (Immunoglobulin M) CD3 (2GV6), CONFIRM Galectin-3 (9C4)
AC3)
Calponin-1 (EP798Y) a-1-Antitrypsin (AAT) IgM (Immunoglobulin M), FITC CD4 (SP35), CONFIRM Glycophorin A (GA-R2)
Cytokeratin 14 (SP53) CINtec® Histology (E6H4) CEA (CEA31) Macrophage (HAM-56) CD5 (SP19), CONFIRM Granzyme B
Cytokeratin 5/6 (D5/16B4) Colorectal and Gastrointestinal Carcinoembryonic Antigen (CEA) MART-1/melan A (A103), CONFIRM CD7 (SP94) Hemoglobin A (SP212)
E-cadherin (36), CONFIRM Beta-catenin (14) (TF3H8-1) Melanoma Associated Antigen CD8 (SP57) HGAL (MRQ-49)
(KBA.62) CD10 (SP67), VENTANA IgA (Immunoglobulin A)
E-cadherin (EP700Y) BRAF-V600E (VE1) CD2 (MRQ-11)
Estrogen Receptor (ER) (SP1), c-KIT (9.7), PATHWAY CD3 (2GV6), CONFIRM Melanoma Associated Antigen (PNL2) CD13 (SP187) IgD (Immunoglobulin D)
CONFIRM Cadherin 17 (SP183) CD31 (JC70) Melanoma Triple Cocktail (A103, CD14 (EPR3653) IgG (Immunoglobulin G)
HMB45, T311) CD15 (MMA), CONFIRM IgM (Immunoglobulin M)
FoxA1 (2F-83) CEA (TF3H8-1) CD34 (QBEnd/10), CONFIRM
GATA3 (L50-823) CEA (CEA31) CD63 (NKI/C3) Melanosome (HMB45), CONFIRM CD16 (SP175) Kappa, CONFIRM
GCDFP-15 (EP1582Y) CDX-2 (EPR2764Y) Cytokeratin (34bE12), CONFIRM MITF (C5/D5), CONFIRM CD20 (L26), CONFIRM Lambda, CONFIRM
HER2 Dual ISH DNA Probe Cocktail COX-2 (SP21) Cytokeratin (AE1), CONFIRM Neurofilament (2F11) CD22 (SP104) LMO2 (1A9-1), CONFIRM
assay, INFORM Cytokeratin 7 (SP52), CONFIRM Cytokeratin 8 and 18 (B22.1 and B23.1), p53 (DO-7), CONFIRM CD23 (SP23), CONFIRM LMO2 (SP51)
HER-2/neu (4B5), PATHWAY Cytokeratin 19 (A53-B/A2.26) CONFIRM p53 (Bp53-11) CD25 (4C9) Lysozyme
HER-2/neu (4B5), VENTANA Cytokeratin 20 (SP33), CONFIRM Desmin (DE-R-11), CONFIRM Podoplanin (D2-40) CD30 (Ber-H2) MUM1 (MRQ-43)
IGF-1R (G11) DOG1 (SP31) EMA (Epithelial Membrane Antigen) S100 (4C4.9), CONFIRM CD31 (JC70) Myeloperoxidase
Ki-67 (30-9), CONFIRM Glutamine Synthetase (GS-6) (E29), CONFIRM S100 (Polyclonal), CONFIRM CD34 (QBEnd/10), CONFIRM Oct-2 (MRQ-2)
p120 (98) Helicobacter pylori (SP48), VENTANA Ep-CAM (Epithelial Specific Antigen) SOX-10 (SP267) CD38 (SP149) PAX5 (SP34), CONFIRM
p53 (DO-7), CONFIRM MLH-1 (M1) (Ber-EP4) Synaptophysin (MRQ-40) CD43 (L60) PD-1 (NAT-105)
p63 (4A4) MSH2 (G219-1129) Factor VIII Related Antigen Synaptophysin (SP11), CONFIRM CD45 (LCA) (2B11 and PD7/26) SOX-11 (MRQ-58)
Progesterone Receptor (PR) MSH6 (44), CONFIRM Factor XIIIa (AC-1A1) Tryptase (G3) CD45 (LCA) (RP2/18), CONFIRM Spectrin (RBC2/3D5)
(1E2),CONFIRM MUC1 (H23) Factor XIIIa (EP3372) Tyrosinase (T311), CONFIRM CD45R (MB1) T-bet (MRQ-46)
TAG-72 (B72.3) MUC2 (MRQ-18) C1q, FITC Vimentin (V9), CONFIRM CD45RO (UCHL-1), CONFIRM TdT
Topoisomerase IIa (JS5B4), PMS2 (EPR3947) C3, FITC Vimentin (Vim 3B4), CONFIRM CD56 (123C3), CONFIRM TRAcP (9C5)
CONFIRM CD56 (MRQ-42) ZAP-70 (2F3.2)
224 | 225
Breast cancer diagnostics
Empowering clinical confidence
Breast carcinoma INFORM HER2 Dual ISH DNA Probe Breast carcinoma HER2 (4B5) positive Score: 3+;
Cocktail n on-amplified; magnification: 40X. magnification: 40X.
226 | 227
Cervical disease diagnostics
The Roche cervical cancer portfolio provides The overexpression of p16 (a cyclin-dependent The CINtec® Histology test significantly
the focus needed to make decisions for each kinase inhibitor) in cervical specimens, detected increases accuracy in diagnosing ≥CIN2
patient with confidence and conclusiveness. by CINtec® products, is highly correlated with lesions when used in conjunction with H&E,
Roche has three clinically validated tests oncogenic transformation caused by persistent identifying the most appropriate p
atients for
when used in powerful combination help high-risk HPV (hrHPV) infections. treatment and intervention.5
identify women at risk and improve detection
and confirmation of high-grade disease in CINtec® PLUS Cytology* – unique to Roche, Over 100 peer-reviewed publications, medical
the first round of screening. is the only test, that detects the s imultaneous society recommendations6,7, a major Pan-
overexpression of p16 and Ki-67 within the European clinical study5, and the largest U.S.
The Roche cervical cancer portfolio includes same cervical epithelial cell, indicating the immunohistochemistry registrational trial8 Co-expression of p16INK4a (brown cytoplasmic immu-
three clinically validated tests: likely presence of a transforming HPV infec- support the scientific and medical value of nostain) and Ki-67 (red nuclear immunostain) within
1) The cobas® HPV Test is the screening test tion.1,2,3 CINtec® Histology for use in evaluation of the same cell demonstrates a positive CINtec® PLUS
Cytology test result
to determine the presence of high-risk cervical biopsy specimens.
HPV. The CINtec® PLUS Cytology test identifies
2) The CINtec® PLUS Cytology test is the triage cervical cells where HPV has disrupted * C INtec® PLUS Cytology is a CE/IVD product, intended
test. It is used to triage primary screening cellular control (p16/Ki-67 positive), confirm- for clinical use. CINtec® PLUS Cytology is not available
results from Pap cytology and/or HPV test ing the presence of a transforming HPV infec- for this use in the United States or Japan. Check with
your local Roche representative for the availability of
results. It is the test that uses dual-bio- tion, accurately predicting which women are
products in your region and the applicable intended use.
marker technology to simultaneously most likely to have pre-cancerous cervical le-
detect p16 and Ki-67 to provide a strong sions and therefore would benefit from imme- See also the cobas HPV test.
indicator of the presence of transforming diate colposcopy.
HPV infection. 1 Wentzensen, N., et al. (2015). JNCI. 107(12):djv257.
3) The CINtec® Histology test is used for CINtec® PLUS Cytology test can be used to doi:10.1093/jnci.djv257. Diffuse p16 immunostained cervical specimen demon-
diagnostic confirmation of the presence or efficiently triage 2 Gustinucci, D., et al. (2016). AJCP. 145(1),35-45. strating positive CINtec® Histology status
absence of high-grade cervical disease. • Positive HPV primary screening results1,2 doi:10.1093/ajcp.AQV019.
• ASC-US cytology results3 3 Schmidt, D., et al. (2011). Cancer Cytopathol.
The CINtec® family of products, exclusively • LSIL cytology results3 119(3), 158-166. doi:10.1002/cncy.20140.
4 Petry, K.U., et al. (2011). Gynecol Oncol. 121 (3),
from Roche, utilise biomarker technology to • Negative cytology (NILM) in the presence of
505-509. doi: 10.1016/j.ygyno.2011.02.033. 7 Stoler, M, et al. Tumours of the Uterine Cervix. In
identify cells which have undergone high-risk HPV infection4
5 Bergeron, C., et al. (2010). Am J Clin Pathol.133 (3), Kurman, RJ, Carcangiu, ML, Herrington, CS,
HPV-mediated oncogenic transformation and 395-406.doi:10.1309/AJCPXSVCDZ3D5MZM. Young, RH (Eds.), WHO Classification of Tumours
identify women at high risk of developing CINtec® Histology – is the IVD p16 immuno- 6 Darragh, T, et al. (2012). J Low Genit Tract of Female Reproductive Organs. Lyon, France:
high-grade cervical disease. histochemistry (IHC) test to identity over Dis.16(3):205-242. Erratum in J Low Genit Tract IARC and WHO, 2014:169-206.
expression of p16 in cervical biopsies. Dis. 2013; 17(3):368. 8 Roche, data on file. 2016.
228 | 229
Colorectal diagnostics
Assist in diagnosis, risk stratification and
subtyping of colorectal cancer
The stages and subtypes of colorectal Mismatch repair IHC staining patterns in colorectal cancer
cancer vary significantly in prognosis and
MMR mutations IHC result MLH1 IHC result PMS2 IHC result MSH2 IHC result MSH6
treatment options, demonstrating a need
MLH1 mutation Loss Loss Preserved Preserved
for tools that assist pathologists in detecting
and subtyping colorectal malignancies.
the BRAF V600E (VE1) Mouse Monoclonal assays facilitate efficient and cost-effective
Primary Antibody, for use on the fully-auto- subtyping within the anatomic pathology
mated VENTANA BenchMark systems. laboratory
• Gastrointestinal IHC assays such as
The Roche Tissue Diagnostics colorectal PATHWAY c-KIT (9.7) Primary Antibody
PMS2 mutation Preserved Loss Preserved Preserved
primary antibodies assist in diagnosis, risk and VENTANA Helicobacter pylori (SP48)
stratification and subtyping while helping Rabbit Monoclonal Primary Antibody
inform clinical decisions, and are supported • Highly sensitive and specific rabbit and
by innovative automation, detection and mouse monoclonal assays
workflow solutions.
Powered by the OptiView DAB IHC detection system.
230 | 231
Hematopathology diagnostics
A comprehensive solution helping you
detect and subtype
Hematological cancers vary significantly Comprehensive menu to aid in diagnosis CD30: cornerstone biomarker that helps
in both prognosis and aggressiveness, and subtyping inform clinical decisions
demonstrating a need for tools that assist
pathologists in making confident diagnoses
and helping to inform clinical decisions. We
offer over 65 cornerstone and novel hemato-
pathology ready-to-use reagents, including
key IHC antibodies and ISH probes, that aid
in the detection of lymphomas, leukemias
and other hematopoietic malignancies. bcl-2 (SP66) Rabbit Monoclonal Primary Antibody CD30 (Ber-H2) Mouse Monoclonal Primary Antibody
The dynamic range of VENTANA OptiView Roche Tissue Diagnostics hematopathology We are excited to provide you with the refor-
DAB IHC detection delivers high sensitivity suite of ready-to-use immunohistochemistry mulated CD30 (Ber-H2) Mouse Monoclonal
and specificity so you can detect antigens (IHC) and in situ hybridization (ISH) assays Primary Antibody. A cornerstone tissue
across a wide range of expression levels. feature: marker for lymphoma, CD30 delivers clinical
Our hematopathology assays are optimized • Exclusive assays such as the BRAF V600E confidence by aiding the pathologist in:
for use on the fully-automated VENTANA (VE1) Mouse Monoclonal Primary Antibody • Diagnosis of T-cell and B-cell lymphomas
BenchMark systems, maximizing quality • New products such as SOX-11 (MRQ-58) • Identification of Reed-Sternberg cells in
and laboratory efficiency. Mouse Monoclonal Primary Antibody, Hodgkins Lymphoma (HL)
CD13 (SP187) Rabbit Monoclonal Primary • Diagnosis of Anaplastic Large Cell
Antibody and CD16 (SP175) Rabbit Lymphoma (ALCL)
Monoclonal Primary Antibody
• Choice of detection systems that This reformulation features updated proto-
allows visualization of antigens with cols for both OptiView DAB Detection and
low expression ultraView Universal DAB IHC Detection.
232 | 233
Lung cancer diagnostic solutions
Driving Personalized Healthcare with key
markers for detection and subtyping
The statistics associated with lung cancer Our portfolio of products, which includes Gain a clear view by detecting ALK and PD-L1 protein expression
clearly demonstrate the aggressive nature rabbit monoclonal antibodies, novel
of this deadly disease, Roche Tissue Diag- biomarkers and detection kits, delivers
nostics offers a robust menu of tools to aid the high sensitivity and specificity needed
in the diagnosis of patients facing this from diagnostic assays.
challenge. “With the introduction of targeted
therapies that can result in dramatically Our antibodies are ready-to-use on the
different outcomes based on subtype, the fully-automated VENTANA BenchMark
importance of accurate classification has systems, which reduces the time to com-
been amplified.”1 plete diagnosis and resources required NSCLC stained with VENTANA ALK (D5F3), NSCLC stained with VENTANA PD-L1 (SP263)
with manual or semi-automated solutions. and OptiView DAB IHC detection with AMP
Differentiating between adenocarcinoma and squamous cell carcinoma VENTANA ALK (D5F3) Rabbit VENTANA PD-L1 (SP263) Rabbit
Confidently differentiate between lung Monoclonal Primary Antibody Monoclonal Primary Antibody
adenocarcinoma (ADC) and squamous cell VENTANA ALK (D5F3) is indicated as an aid The VENTANA PD-L1 (SP263) antibody
carcinoma (SCC) with four key markers, in identifying patients eligible for treatment is produced against programmed death-
including the p40 (BC28) Mouse Monoclonal with XALKORI (crizotinib). It is, therefore, ligand 1 (PD-L1) B7 homolog 1 (B7-H1,
Primary Antibody. critical that ALK positive patients are CD274). It recognizes a transmembrane
accurately identified. Shaw et al. highlights bound glycoprotein that has a molecular
p40 (BC28) Mouse Monoclonal this importance and demonstrates that mass of 45 – 55 kDa. This antibody produces
Primary Antibody ALK testing via IHC represents a reliable membranous, and/or cytoplasmic staining.
p40 (BC28) is a sensitive and specific anti- Squamous cell carcinoma stained positive with the p40 and cost effective alternative to FISH.3
body for the detection of the p40 (Np63) (BC28) assay using OptiView DAB IHC detection It is indicated as an aid in the assessment
protein. In a panel with other key markers Clone D5F3 has been identified as “one of PD-L1 expression in non-small cell lung
1 Tacha, D., Yu, C., Bremer, R., Qi, W., Haas, T. (2012).
in our portfolio (TTF-1, CK 5/6, Napsin A), Appl Immunohistochem Mol Morphol 20, 201-207. of the most promising antibodies for the cancer (NSCLC) and other tumor types.5
p40 (BC28) can provide an accurate and 2 Wei, Z., Hui, W., Yan, P., Bo, T., Lei, P., Da-Chuan, Z. detection of ALK rearrangement in NSCLC.”
4 Minca et al. (2013). J Mol Diagn. 15(3).
reliable method for differentiating pulmonary (2014). Np63, CK5/6, TTF-1 and napsin A, a reliable In a study of 296 patients with advanced 5 Zou, W., Chen, L. (2008). Inhibitory B7-family
adenocarcinoma from squamous cell panel to subtype non-small cell lung cancer in biopsy NSCLC clinically referred for ALK testing, molecules in the tumour microenvironment.
specimens. Int J Clin Exp Pathol, 7(7), 4247-4253.
carcinoma.2 the “ultrasensitive” VENTANA ALK (D5F3) Nat Rev Immunol, 8(6), 467-77.
3 Shaw et al. (2011). J Natl. Compr. Canc. Netw.
9,1335-1341. assay showed high correlation with FISH
and 100 % sensitivity and specificity.4
234 | 235
Prostate cancer diagnostics Connectivity solutions
Diagnostic solutions and innovative tools
for emerging utility
Our prostate cancer diagnostic portfolio Work confidently with Connectivity Solutions
can give you the confidence you need to from Roche Tissue Diagnostics that help
improve patient care. you optimize lab efficiency, patient safety,
and equipment uptime through direct
Empower your lab with our portfolio of connections to your Roche Tissue Diag-
biomarkers that deliver increased value for nostics platforms. From remote support to
men’s health. Our antibodies are pre- Laboratory Information Systems (LIS)
diluted and optimized for use on the fully- connectivity, we have you covered.
automated VENTANA BenchMark systems
for quality results that are both consistent Prostate carcinoma stained with ERG (EPR3864) Rabbit CareGiver Remote Support
and reproducible. We continue to d evelop Monoclonal Primary Antibody Monitoring your lab’s Roche Tissue
novel biomarkers with promising utility — Diagnostics instruments in real-time, the
such as the EZH2 (SP129) R abbit Monoclo- • Consistently strong nuclear staining allows CareGiver remote support software delivers
nal A
ntibody and the A ndrogen Receptor for easier interpretation enhanced system performance, decreased
(SP107) Rabbit Monoclonal Antibody. • Like high molecular weight cytokeratin downtime and world-class customer
34βE12, p63 is specific and sensitive for support. Your instruments are talking;
ERG (EPR3864) Rabbit Monoclonal basal cells in the prostate gland CareGiver remote support is listening.
Primary Antibody
Developed for high sensitivity and specificity, VENTANA Basal Cell Cocktail VENTANA Connect middleware
the ERG (EPR3864) Rabbit Monoclonal 34βE12+p63 VENTANA Connect middleware provides a
Primary Antibody delivers: Our Basal Cell Cocktail combines p63 (4A4) simple, flexible and scalable point of inte-
• Specificity for prostate cancer which may with 34βE12 to aid in the differentiation of gration between the Lab Information
aid in detection and diagnosis benign and malignant prostatic lesions. System (LIS), BenchMark and VENTANA
• Ability to identify a molecular prostate • Increases the sensitivity of basal cell HE 600 instruments, and the VANTAGE
cancer subtype detection Workflow Solution and Roche Digital
• High concordance to ERG FISH • Decreases staining variability Pathology systems. VENTANA Connect
• Offers more consistent basal cell middleware helps to ensure important case
VENTANA p63 (4A4) Mouse Mono immunostaining information flows seamlessly between
clonal Primary Antibody instruments and systems through a single,
The p63 (4A4) antibody empowers you to standardized and secure connection.
make informed, confident decisions.
236 | 237
VANTAGE workflow solution
A proven system for quality to increase
patient safety
Today’s histology lab managers are under Your benefit Full and fast control
increasing pressure to improve laboratory Eliminate redundancies, reduce errors • Locate any specimen, block or slide
workflow, sample tracking, quality and • Reduce data re-entry, relabelling and immediately
patient safety. labelling errors with “one label, one time” • Ask the VANTAGE system to locate any
technology and barcode scanners at patient’s slide, on any instrument, at any
VANTAGE solutions have been designed to every workstation point in your process — and count on
enable histology laboratories to address immediate, accurate results
these challenges: Lean workflow
• Prevent bottlenecks before they happen. Full transparency
Our comprehensive solution for histology The VANTAGE workflow solution gives • Populate patient details accurately
labs — hardware, software and workflow you a clear view of your lab, so you can • Retrieve patient details with a quick
consulting — offers a commanding view of maintain optimal performance barcode scan
your complex operation from a single • Collaborate with lean histology experts to
strategic perspective. It is an end-to-end improve your workflow Product characteristics
product that automates, streamlines and • Simplify workflow steps • Includes all VENTANA Connect
integrates lab work and information flow • See a comprehensive dashboard of lab characteristics
to help provide maximum productivity performance at any time • Cassette verification/identification
and improvements to patient safety. The • Identify opportunities to improve quality, • Slide label generation and management
VANTAGE workflow s olution is designed staffing and efficiency • Harmonised unique slide identification
using Lean Six Sigma principles and in- • Centralized instrument slide/test status
cludes expert workflow consulting support Establish your chain of custody • Specimen chain of custody
to help you obtain immediate and ongoing • The VANTAGE workflow management • Block/slide tracking and locating
workflow benefits. system brings all of our automated • Workflow process report and
platforms together, creating a chain of workload statistics
custody that encompasses your entire lab • QA/QC management and reports
• Specimen archive
238 | 239
Companion diagnostics
Deliver Personalized Healthcare
to those who need it
For every ten cancer patients treated, an One of the global leaders in tissue-based Helping to deliver the promise
average of only half will benefit. For some, cancer diagnostics, we provide a premier of Personalized Healthcare
the treatment won’t have any effect; others end-to-end offering, with expertise at every •C ompanion tissue tests help determine the
may suffer from serious side effects.1 stage from discovery to commercialization. best course of treatment
Ventana Medical Systems, Inc. A Member Working together under one roof, Roche • We are committed to expanding our market-
of the Roche Group is working at our and pharma increase the efficiency and leading HER2 diagnostic franchise
industry’s forefront to change this d ynamic speed of developing patient selection bio- • T he VENTANA ALK IHC Rabbit Monoclonal
by customizing therapy to individual patients, markers. Primary Antibody aids in early detection
helping you to improve diagnostic accuracy, •B rings 180+ biomarker projects with a and treatment decisions for non-small cell
lab efficiency and patient safety. strong track record — reliably on time lung cancer patients VENTANA ALK (D5F3) Rabbit Monoclonal Antibody
and on budget • The VENTANA PD-L1 assays generate
In collaboration with leading pharmaceutical • Provides global access through the results you can trust, so you can make
companies, we identify and develop inno- Roche commercial network and install base timely diagnostic decisions and therapeu-
vative companion diagnostics to target •O ffers a differentiated, broad instrument tic choices
those patients who are likely to respond to and reagent portfolio • T he majority of the Roche oncology-focused
specific therapies. Because we recognize targeted therapies, currently in late stage
the tremendous potential for these solutions, clinical trials, have an associated VENTANA
we continue to focus on addressing unmet tissue companion diagnostic
medical needs by developing the cutting-
edge tools you need. Product portfolio:
VENTANA PD-L1 (SP142) Assay
• HER2
You can be confident that VENTANA • HER2 Dual ISH
products, from Roche, are the right solution • VENTANA ALK (D5F3)
to empower you to deliver the high-quality • VENTANA PD-L1 (SP142)
diagnostic information for patients — today • VENTANA PD-L1 (SP263)
and in the future.
240 | 241
Digital pathology
Virtual consultation, image analysis
and education
242 | 243
Roche Sequencing Solutions:
a Unifying Force in NGS
Clinical research
DNA sequencing Roche is bringing together technologies
across the workflow to make next-generation
Our sample preparation products, like Seq-
Cap EZ and KAPA HyperPrep, require fewer
Innovation
sequencing (NGS) simple and accessible. steps, improve turn-around times, and are
backed by award-winning customer care.
With a growing suite of products, including
244 | 245
HEAT-Seq Target Enrichment Systems
NEW
15
in our database, allowing you to spend R2=0.9812
10
less time worrying about optimization and
5
more time focusing on your data
0
0 5 10 15 20 25
For Research Use Only.
Data on file.
246 | 247
SeqCap Target Enrichment
Confident and efficient genetic variant detection
248 | 249
Harmony Prenatal Test
NEW
The Harmony Prenatal Test is a cell-free Harmony prenatal test as Test Send FORTE algorithm measures, incorporates, Greater efficiency at lower cost
DNA based technology or non-invasive Out service (TSO) and reports fetal fraction for every sample. The Harmony test second generation cus-
prenatal test (NIPT) that provides an Laboratories and physicians can offer the Incorporation of maternal and gestational tom microarray technology improves the
assessment for the probability of fetal triso- Harmony Prenatal Test by sending whole age provides for an individualized result as precision and throughput of DANSR/
mies 21 (Down syndrome), 18, and 13. The blood specimen directly to the CLIA and opposed to an arbitrary positive/negative FORTE3, while reducing time-to-result,
test can also screen for sex chromosome CAP accredited laboratory located in San value. overall labor, and reportable results costs.
(X, Y) aneuploidies and fetal sex. This Jose, CA USA.
screening test can be performed starting
at 10 weeks gestation. Your benefit Ariosa cell-free DNA System: Features and Benefits
The Harmony Prenatal Test is Validated for Operational efficiency Integrated user interface
The Harmony Prenatal Test is available to Pregnant Women of Any Age or Risk** and • Maximum hands-free operation • User-friendly Director interface provides
laboratories around the world via the Ario- Trusted by Clinicians Worldwide • No manual pipetting full process automation control
sa cell-free DNA System (AcfS) or as a test • Studied extensively in blinded prospective • Director ensures accurate library-to-re-
send out service (TSO). trials1 Workflow and scalability sults sample tracking for optimal control
• Harmony Test significantly outperformed • Custom microarray technology and rapid
Ariosa cell-free DNA System (AcfS)* First Trimester Combined Screening quantification streamlines workflow Security and transparency
Non-Invasive Prenatal Testing Performed in (FTS**) in both trisomy 21 detection and • Modular AcfS allows for cost-efficient • Patient data housed on local server to
your Laboratory false-positive rate in a blinded, prospec- system expansion as needed avoid exposure on the cloud
The AcfS is a modular, microarray-based, tive head-to-head comparison2 • Complete price clarity: no hidden fees or
system designed to streamline the Harmo- unexpected requirements
ny (DANSR/FORTE) prenatal test for de- Technology benefit of the directed
LIBRARY PREPARATION & DETECTION MICROARRAY QUANTIFICATION FORTE ANALYSIS PATIENT RESULTS
centralized testing at local laboratories. analysis (DANSR), individualized
AcfS is optimized for laboratories perform- assessment (FORTE) P(xj | T)P(T)
P(xj | D)P(D)
ing 400 or more NIPTs per month and can DANSR assay allows for deeper analysis
• Compact and scaleable • Proprietary FORTE analysis
easily scale to accommodate tens of thou- by focusing on the specific chromosomes • <1 min./sample and patient reporting
sands of tests per year. The Harmony re- of interest, rather than random, whole
agent kit for the AcfS system is available in genome sequencing. 28 hours continous run time
250 | 251
AVENIO Millisect Instrument* Cell-Free DNA Collection Tube
NEW
NEW
Precise, consistent and confident microdissection Stable, durable and reliable blood
of FFPE tissue samples collection tubes for cell free
DNA preservation and transport
The AVENIO Millisect Instrument Your benefit The Cell-Free DNA Collection Tube is a Your benefit
(Millisect) is an automated tissue dissec- High quality and precision direct-draw tube for the collection, stabili- Specimen stability
tion system will enable the capture of • Prevent loss of precious samples with zation and transportation of whole blood • Proprietary solution prevents cell lysis to
challenging t umor samples while providing 300 μm minimum precision level and specimens, and for preservation of nucleat- enable greater detection of cfDNA
precision, accuracy, and consistency. Users equivalent recovery comparing to manual ed cells to enable analysis of cell-free DNA. • K3EDTA prevents blood coagulation
can confidently transfer annotated reference dissection
slides to serial cut sections with greater ac- • Provide consistency across samples and Safety and durability
curacy when compared to manual methods. for operators with automated dissection • Manufactured in accordance with ISO
9001 and EN ISO 13485
Millisect will allow pathology and molecular Efficient turn-around time • Made from safe, durable polyethylene
laboratories to perform automated FFPE • Dissect up to four slides in 5 to 10 minutes terephthalate (PET), which minimizes
tissue dissection while ensuring high preci- • Free up time for other tasks by reducing costly glass breakage during transport
sion and proper chain of custody, thereby the number of hands-on operations and specimen centrifugation
helping to advance the standard of oncology
testing utilizing molecular testing techno Intuitive and integrated workflow Proven and reliable
logies. • Easy-to-use intuitive user interface, • Over 1 million tubes used in cell-free
practical and all-in one touchscreen PC DNA applications by laboratories world-
• Offer flexibility for downstream applica- wide
tions with most user-defined buffers • Supported by Roche’s large service and
large distribution network
Proper chain of custody
• Track reference and sample barcodes,
time of collection, and sample collection Product Pack Size Catalog Number
data on area of interest automatically RUO* Cell-Free DNA Collection Tube 1 box of 50 tubes 07785674001
• Provide a comprehensive PDF report for 24 boxes of 50 tubes (1,200 tubes total) 07832397001
every case
Product Pack Size Catalog Number
CE-IVD Cell-Free DNA Collection 1 box of 50 tubes 07785666001
Tube**
24 boxes of 50 tubes (1,200 tubes total) 07832389001
*Expected launch – June 2017. * For Research Use Only. Not for use in diagnostic procedures.
Data on file. ** Available for countries that accept CE-Mark
252 | 253
KAPA DNA Library Preparation Kits
NEW
for Illumina
It’s complex, but we have it covered
254 | 255
KAPA HyperPrep Kits
NEW
256 | 257
KAPA HyperPlus Kits
NEW
The KAPA HyperPlus Kit provides a stream- Your benefit …can enable superior sequencing Product characteristics
lined workflow that includes fragmentation Tunable and reproducible results • DNA fragmentation and library prep
and library preparation in a single tube. fragmentation • High conversion rates results in fewer in 2.5 hours*
Building on industry-leading library con- • Adjust library insert sizes from 150 – 800 bp amplification cycles and lower duplication • Flexible DNA sample input from
Fragmentation 10 – 45 min
struction efficiencies, this integrated solu- by varying fragmentation time rates 1 ng – 1 µg*
tion combines enzymatic fragmentation, • Reproducible insert sizes across a range • Detect low-frequency mutations with high • Reduced bias and maximize sequence
Single Tube
similar in quality to mechanical shearing, of GC content and DNA input amounts confidence dueandtoA-tailing
End Repair greater library 30
diversity
min coverage*
with the speed and convenience of tag- and more uniform sequence coverage • PCR-free workflows
mentation-based workflows. Industry leading library yields… Adapter Ligation 15 min
• Routinely achieve conversion rates >80 % Minimal sequence coverage bias
from ≥100 ng input* • Lower sequence bias when compared
Bead Cleanup 30 min
• Superior performance across a range of to tagmentation and other enzymatic
DNA input amounts* fragmentation methods*
• High library yields enable PCR-free • Equivalent performance
Library Amplification to mechanical
(optional) 30 min
workflows from as little as 50 ng starting shearing*
material* • Less bias leads to more uniform sequenc-
Bead Cleanup 30 min
ing coverage and reduced sequencing
Total time: ~2.5 h
costs*
Single Tube
Library
End Repair Bead
Fragmentation Adapter Ligation Bead Cleanup Amplification
and A-tailing Cleanup
(optional)
258 | 259
KAPA Stranded mRNA-Seq Kits KAPA Stranded RNA-Seq with RiboErase
NEW
NEW
Even difficult messages should be understood Evolved to focus
The KAPA Stranded mRNA-Seq Kits Product characteristics The KAPA Stranded RNA-Seq Kit with Product characteristics
generate libraries with greater than 99 % Uncover challenging transcripts R iboErase offers a high-quality, comprehen- Industry-leading rRNA depletion
strand specificity and superior sequence • Improved coverage of GC-rich transcripts sive solution for transcriptome sequencing. • Very good rRNA depletion from high-
quality. Kits are optimized for the improved • Enhanced identification of exonic regions By utilizing a targeted enzymatic method quality and FFPE samples
coverage of GC-rich and low-abundance for depletion, our workflow enables superior • More economical NGS sequencing due to
transcripts, resulting in the identification Detect low-abundance transcripts reduction of ribosomal RNA (rRNA) and a decreased rRNA reads, providing deeper
of more genes. The KAPA Stranded • Enables identification of transcripts more complete representation of the tran- sequencing of transcripts of interest
mRNA-Seq Kits contain KAPA HiFi for missed by competitor kits, even with high scriptome, including precursor mRNAs and
high-efficiency and low bias library ampli input non-coding RNA (ncRNA). Kits also con- Maximum coverage uniformity
fication. • High uniformity across varying amounts tain KAPA HiFi for high-efficiency and • Uniform distribution of reads over each
of sample input low-bias library amplification, and include transcript
Your benefit a streamlined, “with-bead” protocol. • Minimal 5’ – 3’ bias across transcripts
• 100 ng – 4 μg of total RNA Identify more genes
• 99 % strand specificity • Higher percentage of uniquely mapped Your benefit High-quality sequencing data
• KAPA mRNA Capture Beads reads compared to Illumina® TruSeq® • Up to 99.98 % rRNA depletion • Detection of more genes and unique
• Streamlined “with-bead” Stranded mRNA Sample Prep Kits • Flexible input of 100 ng – 1 μg total RNA transcripts
protocolptimized for1 • Lower duplication rates yield better for human, mouse, or rat species • Accurate and clear identification of splice
coverage • Robust and reproducible results across sites and alternative gene splicing
various input amounts • Improved coverage enabling better detec-
• An automation-friendly workflow tion of difficult and GC-rich transcripts
260 | 261
KAPA Library Quantification Kits
NEW
Current standard protocols for commercial • qPCR specifically quantifies only PCR- Product characteristics
next generation sequencing platforms competent DNA molecules qPCR library quantification results a mplification efficiency and unreliable
employ laborious, costly, and often unreli- • is highly sensitive allowing accurate quan- in streamlined workflows quantification of some library molecules.
able methods for quantifying DNA libraries. tification of low concentration libraries KAPA Library Quantification Kits eliminate To address the demands of quantifying
the need for time-consuming and expen- complex DNA libraries, Kapa Biosystems
Accurate quantification of PCR-competent Your benefit sive titrations and provide a conducive has engineered a DNA polymerase specifi-
sequencing templates is crucial for reliable • Reliable and sensitive quantification of all format for streamlining high-throughput cally for SYBR® Green-based qPCR, en-
clonal amplification via either emulsion sequencing-competent library molecules workflows. abling efficient amplification of targets that
PCR (emPCR) or bridge PCR (bPCR) – • Accurate and reproducible quantitation present a challenge to wild-type enzymes.
underestimation usually results in non- across a wide range of library types, con- Reliable quantification results in KAPA Library Quantification Kits contain
clonality, while overestimation can lead centrations, fragment length distributions consistent cluster density this engineered polymerase to ensure
to inefficiency via poor yields of clonally and GC content robust amplification of longer fragments,
amplified templates. • More efficient, equimolar pooling for Efficient amplification of a wide range across a broad range of GC-content, re-
multiplexed sequencing of templates during qPCR quired for accurate library quantification.
Standard methods for quantifying NGS • Flexibility to support manual and auto- Traditional qPCR reagents are optimized for
libraries have a number of important disad- mated, high-throughput pipelines; as well short amplification targets; longer targets, Reliable DNA quantification standards
vantages. Electrophoresis and spectropho- as PCR-free workflows unbalanced GC-content, and problematic with minimal variability from lot-to-lot
tometry measure total nucleic acid secondary structures may result in low
concentrations, whereas optimal cluster
density or template-to-bead ratio depend qPCR Library Quantification results in streamlined workflows
on the appropriate concentration of PCR- Standard Illumina GA workflow HTP sample workflow at the Broad Institute
amplifiable DNA molecules. These methods Starting material
(qPCR library quatiffication)
262 | 263
KAPA Library Amplification Kits
The gold standard for NGS library amplification
KAPA HiFi has become the enzyme of Your benefit Exercise precise control over library Product characteristics
choice for NGS library amplification due to Achieve the lowest amplification bias amplification Improved amplification of
its ability to amplify complex DNA popula- and duplication rates • KAPA Real-Time Amplification Kits allow GC- and AT-rich genomic regions
tions with high fidelity, high efficiency, • Lower amplification bias result in for library amplification to be observed in • Reduced enzyme bias resulting in
decreased PCR duplication rates and very improved representation of all library real time improved sequencing coverage
low bias. This results in lower duplication fragments and sequence regions • Terminate amplification at the optimal • High fidelity
rates and improved coverage of GC- and • High-efficiency amplification leads to point for individual samples
AT rich regions, promoters, low complexity fewer amplification cycles and lower PCR • Optimize library amplification parameters
and other challenging regions in all NGS duplicates for higher throughput workflows
library construction workflows requiring • Less additional next-generation or Sanger
library amplification. sequencing needed to complete genomes
In addition to the standard library amplifi- Improve coverage of GC- and AT-rich
cation formulation, KAPA HiFi is available regions
in a unique real-time formulation, for appli- • Lower amplification bias improves cover-
cations that demand precise control over age uniformity of GC- and AT-rich regions,
library amplification. A uracil-tolerant vari- promoters, low complexity and other
ant, KAPA HiFi Uracil+ is also available for challenging regions
the high-efficiency, high-fidelity, low-bias • Improved overall coverage and coverage
amplification of libraries constructed from uniformity observed on both Illumina and
bisulfite-treated DNA. Ion Torrent™ sequencing platforms
264 | 265
KAPA hgDNA Quantification and QC Kits
NEW
Quality matters
266 | 267
KAPA Accessories
NEW
KAPA Pure Beads offer a tunable and Product characteristics KAPA single-indexed adapter kits Product selection guide
highly consistent solution for reaction • High recovery of single- and double- contain high-quality, ready-to-use adapters Recommended Adapter
purification and size selection in DNA and stranded DNA (1 ng – 5 μg) in a single for Illumina® library construction. Each Concentration by Input
RNA next-generation sequencing library cleanup adapter includes a single, 6-nt index (bar- Kit 30 μM 1.5 μM
construction workflows. • Fast and efficient cleanups to remove code) for multiplexed sequencing applica- KAPA HyperPlus and ≥5 ng – 1 μg <5 ng
Hyper Prep Kits
unwanted reaction components tions. KAPA Single-Indexed Adapters are
KAPA HTP or LTP ≥100 ng* ≤100 ng*
Your benefit • Easy substitution into bead-based available in two concentrations, and are “with-bead” Library
Preparation Kits
Seamless integration into NGS workflows compatible with all KAPA library prepara-
KAPA Library Preparation all inputs not recom-
workflows • Enables adjustable size selection tion kits for DNA and RNA sequencing Kits (1 – 5 μg) mended
• Compatible with all KAPA DNA and RNA • Automation friendly applications. KAPA Stranded RNA-Seq not recom- all inputs
Kits with RiboErase mended
library preparation protocols
KAPA Stranded RNA-Seq not recom- all inputs and
• Achieve equivalent yields and size KAPA Single-Indexed Adapters undergo and mRNA-Seq Kits mended workflows
distribution in comparison to Agencourt® extensive qPCR- and sequencing-based * For 100 ng input the recommended adapter
AMPure® XP functional and QC testing to confirm: c oncentration depends on average insert size
• Readily incorporated into existing • optimal library construction efficiency
automation applications • minimal levels of adapter-dimer formation
• nominal levels of barcode cross-
Tunable and highly reproducible contamination
size selection
• Obtain consistent library size distributions
• Flexible implementation at various points
during library construction
• Adjustable size selection parameters to
achieve desired library sizes
268 | 269
KAPA RNA HyperPrep Kits
NEW
Single-Day RNA
The KAPA RNA HyperPrep Kits utilize novel Flexible workflow options Generate high-quality libraries from Product characteristics
chemistry that enables the combination of • Use the KAPA RNA HyperPrep Kit as a degraded samples • Single-day library construction, inclusive
enzymatic steps and fewer reaction purifi- standalone workflow, or combine with • Input as little as 25 ng with FFPE samples, of RNA enrichment
cations, resulting in a truly streamlined either the mRNA capture or KAPA depending on total RNA quality • High success rates with low-input and
solution for the preparation of high-quality R iboErase (HMR) ribosomal RNA deple- • Achieve low duplication rates and highly degraded samples
RNA-seq libraries. The strand-specific tion modules efficient, reproducible rRNA removal with • Robust performance across different
workflow is flexible—supporting library con- degraded samples s ample types and input amounts
struction from lower-input amounts and Enable a variety of strand-specific • Identify more unique transcripts and • KAPA Pure Beads for reaction purifica-
degraded samples—and is compatible with applications genes with equivalent sequencing tions
both mRNA capture and ribosomal deple- • Input less starting material than other
tion. Kits contain all reagents required for commercially-available workflows Achieve reliable results with degraded
RNA enrichment (if performed) and library • Generate high-quality libraries – even inputs
preparation, with the exception of KAPA with degraded samples, such as FFPE • Attain a high degree of expression
Adapters (available separately). correlation between paired FFPE and
Sequence what matters fresh frozen samples, providing increased
Your benefit • Waste fewer reads due to the combination confidence in sequence data accuracy
Single-tube, single-day library prep of rRNA carryover and PCR duplicates
• Reduce hands-on and overall time • Identify more unique transcripts and
KAPA RNA KAPA RNA HyperPrep Kits KAPA mRNA
through fewer enzymatic and reaction genes with equivalent sequencing HyperPrep Kits with RiboErase (HMR) HyperPrep Kits
cleanup steps RNA Enrichment None rRNA Depletion Poly(A) Selection
• Produce strand-specific, sequencing- Achieve increased coverage uniformity Input Amount 1– 100 ng into library prep 25 ng – 1 μg 50 ng – 1 μg
into rRNA depletion into mRNA capture
ready libraries from input RNA in approxi- • Obtain more uniform distribution of reads
Sample Type High-quality total RNA High-quality total RNA High-quality total RNA
mately 4 hours across transcripts Degraded or FFPE total RNA Degraded or FFPE total RNA
Previously enriched RNA
• Complete entire workflow – inclusive of • Improve coverage of difficult GC-rich
Species Eukaryotic (animal, plant, etc.) Human, mouse, and rat Eukaryotic (animal, plant, etc.)
mRNA capture or ribosomal depletion – regions Prokaryotic (bacterial, etc.)
in a standard workday Differentiating Whole transcriptome Non-coding RNA mRNA-Seq
• Achieve high throughput and consistency Applications Whole transcriptome
Shared Gene expression analysis; detection of gene fusions, isoforms, and other structural variants;
with an automation-friendly workflow Applications novel transcript identification; SNV discovery
A workflow to meet a variety of needs. The KAPA RNA HyperPrep workflow is available in three formats:
For Research Use Only. with mRNA capture, with KAPA RiboErase (HMR) for rRNA depletion, or with no RNA enrichment reagents.
Not for use in diagnostic procedures. Data on file. This flexibility allows users to select the workflow that best meets the needs of their specific application.
270 | 271
Consultancy services
Laboratories
other diagnostic service providers are faced global and local experts, Roche provides
not just with operational but also commer- consultancy services for all areas of testing,
cial challenges. including molecular and tissue diagnostics.
Efficiency Budget cuts, lack of personnel, limited Roche’s mission is not only to help imple-
Quality
– all of these factors have become impor- developing a service strategy that is able
tant considerations. to cope with the many demands of a
constantly changing market.
Workflow solution
cobas
Continuous improvement
272 | 273
Consultancy services
Inspiring continuous improvement
A structured approach
274 | 275
Digital Services
Transparent
Relevant information
Collaboration
276 | 277
Roche DiaLog Roche Inventory Solutions
One Roche at your Fingertips Clarity at a click
Introducing Roche DiaLog e-Delivery provides a comprehensive Roche Inventory Solutions is an application Product characteristics
A single platform designed to give you faster verview of all order-related information,
o to manage inventory, designed for the Roche Inventory Solutions can help labora-
and more convenient online access to all the including past orders, delivery notes and specific needs of laboratories, optimizing tories to optimize their inventory levels, so
information and services your need. invoices. You can also track the connec- supply chain processes and providing there’s never too much (expiring on the
tions among these. real-time management insights. shelves), nor too little (stock-outs) provid-
Your benefit ing full transparency on a key cost driver.
• Simplicity: One gateway to Roche Live support chat is an additional channel, Your benefit
• Increased transparency of your processes which provides direct access to Roche Simplicity: Hassle-free integration Roche Inventory Solutions uses an intuitive
• Receive personalized support support agents whenever needed. You can into your existing infrastructure hand-held device to track deliveries and
• Stay up-to-date exchange pictures and documents to better and a user-friendly handheld that’s consumption.
and more quickly explain challenges and easy to use
Product characteristics solutions. Transparency: Know your true Based on user-defined quantities, consump-
Single point of access: One point of entry stock levels, and the numbers tion patterns and order data, the system
to all Roche Diagnostics online services. And this is just the beginning. Roche behind them, to gain important indicates upcoming shortages, can suggest
Access with just one login and password DiaLog is always evolving, continuously insights across your entire orga- or even automatically trigger an order. It
from any device (PC, tablet, mobile). introducing improvements and new nization works for any product from any vendor and
services. Peace of mind: Confidence starts provides management insights into the
Online Services* are applications to with knowing you’re never out of supply chain.
support your core business. stock, reducing urgent shipments
and the potential for error We have taken our proven track record in
They include: Universal: Industry-standard laboratory processes to create an inventory
technology ensures an ideal fit management solution that meets the spe-
Technical Product Information provides for any lab, regardless of size, cific needs of laboratories.
instant access to all documentation to complexity, product and vendor
operate instruments and reagents. It con- portfolio
tains a powerful search engine and the
ability to subscribe and receive updates
and notifications on your most frequently
used documents.
*Not all services are available in all countries. *Roche Inventory Solutions is not available in all countries.
278 | 279
Trademarks
All mentioned trademarks are owned by or
licensed to a Member of the Roche Group
280 | 281
Notes Roche Diagnostics test portfolio
Roche Diagnostics test portfolio
Tacro- Evero-
limus Sirolimus limus
Valproic Procain- Pheno- Gaba- Lido-
Phenytoin Acid Primidone amide barbital pentin NAPA Amikacin caine
Salicylate Cyclosporine
Methadone ETOH free
free Factor V
Propoxyphene LSD Gentamicin Valproic
BENZO Phenytoin Lithium Metho-
EDDP Cocaine Digoxin Acid %Quick PT INR
Serum Fibrinogen trexate Factor II
CRP hs ADPtest
Methaqualone Theophylline Tobramycin BENZO MPA Digitoxin D-Dimer TRAPtest RISTOtest COLtest ASPItest
LP (a) HEV
Quinidine THC BARB MYO NT-proBNP Trop T Trop T-hs Trop I CK CK-MB GDF-15 aPTT PT Quick DRVVT
T-uptake TSH Serum ATIII APC-R LMWH Crystals KET confirm
Opiates
Vancomycin BARB LDL UFH DRVVT VRE
Tg Thrombin time Antithrombin screen
Oxycodone Parvo B 19 HBDH Protein S Clarity Nit
T4 Cdiff
C-Peptide Cortisol ACTH Muc
Calcitonin ACETA CARBA AMPH Na Insulin
MPX (HIV/ Anti-TSH-R Lactate AMY Protein C Yeast
HCV/HBV) CHOL Mg Color pH
Phencyclidine MTB
T3 HDL APO B APO A1 HbA1c AMY-P Sperm
HCV RNA
ACP FT4 FT3 Anti-TPO Anti-Tg anti-
HBsAg quant HBc-IgM anti-HBs HBeAg LIP BIL Prot MRSA/SA
HCV GT HBsAg Homo- FRUC PC
hGH cysteine
HIV anti-HBe anti-HBc
ERY SG WNV
HIV RNA qual B2MG
A1MG Uric acid Urea/BUN TP-U/CSF CREA Cystatin C K ALB Micro-ALB HC
IGF-1* HBV DNA CA 125 EC DPX
CEA (B19V,HAV)
AFP AMH DHEA-S E2 FSH LH Progesterone Prolactin SHBG Testosterone
IgG CMV DNA HE4 NSEC UBG PIK3CA
hCG PIGF Osteo- Vit D CA Phosphorus RPR Syphilis
CSF hCG+ß fßhCG PAPP-A sFIt-1
IgA CT/NG calcin total Gluc
CERU
CSF
IgG anti-HCV PTH (1-84) PTH ßXLaps P1NP Rubella IgG
CO2 TRIG TP TPLA KRASv2
IgA C4 LEU Syphilis
HPV DNA CRP anti- anti- HIV HIV HIV-Ag Toxo Rubella IgM CMV HSV-2 HSV-1 Cl
IgM BRAF/
IgM Iron GLDH HAV HAV IgM combi PT DUO* IgM NRAS
C3c ASLO Haptoglobin Toxo IgG Avidity Toxo IgG CMV IgG Avidity CMV IgG Influenza Strep RSV Bacteria Syphilis HTLV-I/II Chagas
IgM Ferritin A/B A
CSF Transferrin sTfR UIBC Vit Active LDH Folate CA 15-3 CA 19-9 CA 72-4 CYFRA 21-1 S100 NSE free free free PSA PSA Pro-GRP SCC EGFRv2 KRAS BRAF
B12 B12* Kappa Lambda
IgE
ALP NH3 ALT/GPT AST/GOT BIL-D BIL-T CHE GGT light light
chains chains
Anti-CCP IL6 PCT Preal- Kappa Lambda
bumin light light
chains chains RF AAGP AAT
282
Subway Map
Roche Diagnostics Products and Solutions 2017
Not for distribution in the US. Products and Solutions 2017
For additional information please contact
your local Roche representative. Roche Diagnostics
©2017 Roche