DES-01016 Rev 2 T2Resistance Panel Instructions For Use CE-IVD

T2Resistance® Panel
Instructions for Use
For use exclusively on the T2Dx® Instrument

For In Vitro Diagnostic Use (CE-IVD)
This in vitro diagnostic product conforms to the requirements

of the In Vitro Diagnostics Medical Device Directive (98/79/EC)
DES-01016 R2
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T2Resistance® Panel Instructions for Use
For use exclusively on the T2Dx® Instrument

For In Vitro Diagnostic Use (CE-IVD)
T2 Biosystems, Inc.
101 Hartwell Avenue, Lexington, MA 02421
www.t2biosystems.com
T2 Biosystems®, T2Resistance™,T2MR®, T2Candida®, T2Bacteria®, T2Dx®, and the T2 Biosystems, Inc. logo design are registered
trademarks or trademarks of T2 Biosystems, Inc.
All software and documentation is subject to T2 Biosystems, Inc. copyrights.
©2019 T2 Biosystems. All rights reserved.
The current revision of this manual is available at http://info.t2biosystems.com/instructions
DES-01016 R2 04/20
Table of Contents
Proprietary Name ..............................................................................................................................1
Intended Use.....................................................................................................................................2
Summary & Explanation of the T2Resistance Panel..........................................................................3
Background of Targeted Resistance Markers ..............................................................................3
Principle of the Procedure ..........................................................................................................5
Warnings & Precautions ...................................................................................................................6
Materials Provided ............................................................................................................................8
Reagents.....................................................................................................................................8
Reagent Storage & Stability .....................................................................................................11
Materials Required but not Provided...............................................................................................12
Sample Collection, Handling & Storage .........................................................................................13
T2Resistance Panel Instructions ......................................................................................................14
Work Area Preparation ............................................................................................................14
T2Resistance Panel Assembly ...................................................................................................16
Loading the T2Resistance Panel onto the T2Dx ......................................................................21
Unloading the T2Dx ...............................................................................................................24
Quality Control .......................................................................................................................25
T2Dx Instrument ....................................................................................................................25
Internal Control .......................................................................................................................25
Process Quality Controls..........................................................................................................25
Data Retrieval & Interpreting Results .............................................................................................27
Performance Characteristics - Summary ..........................................................................................30
Limit of Detection ...................................................................................................................30
Analytical Reactivity (Inclusivity) .............................................................................................30
Analytical Specificity (Exclusivity)............................................................................................32
Reproducibility ........................................................................................................................34
Interfering Substances ..............................................................................................................34
Clinical Performance................................................................................................................35
Limitations of the Procedure ...........................................................................................................36
Bibliography....................................................................................................................................38
Table of Abbreviations ....................................................................................................................40
Understanding the Symbols ............................................................................................................41
Notice to Purchaser .........................................................................................................................42
Technical Support & Contact Information .....................................................................................43
T2 BIOSYSTEMS, INC. | 1
Proprietary Name
T2Resistance™ Panel.
2 | T2Resistance Panel Instructions for Use
Intended Use
The T2Resistance™ Panel run on the T2Dx® Instrument is a qualitative T2 Magnetic Resonance
(T2MR®) test for the direct detection of molecular markers of antimicrobial resistance in EDTA
human whole blood specimens from patients with suspected bacteremia. The T2Resistance Panel
detects thirteen molecular markers of resistance and categorizes them into the following seven groups:
1. blaKPC
2. blaCTX-M 14/15
3. blaNDM / blaVIM / blaIMP
4. blaOXA-48 Group
5. vanA / vanB
6. mecA / mecC
7. AmpC (blaCMY / blaDHA)
The T2Resistance Panel does not distinguish individual molecular markers of antimicrobial resistance
within a given group.
The T2Resistance Panel detects molecular markers that are associated with organisms that are
recognized to cause blood stream infections. Detection of the molecular marker may be indicative of
potential infection with an antibiotic resistant organism.
Negative results for these select molecular markers of antimicrobial resistance do not indicate
susceptibility, as multiple mechanisms of resistance exist, nor do they indicate absence of an infectious
pathogen.
The T2Resistance Panel is an aid for the early indication of the presence of molecular markers of
resistance that may be due to an antibiotic resistant organism and results should be used in conjunction
with other clinical and laboratory data. Concomitant blood cultures are necessary to recover organisms
for further identification, including susceptibility testing or epidemiological typing.
Summary & Explanation of the T2Resistance

Panel
Antibiotic resistance is a rapidly evolving medical challenge that requires careful oversight in the
modern emergency department (ED) and intensive care unit (ICU), where intravenous antibiotics are
administered routinely to combat bloodstream infections and sepsis. The successful treatment of a
patient suffering from a bloodstream infection, and the long-term effectiveness of antibiotic
stewardship programs, depend on rapid and accurate diagnostic information.
Treatment of bacteremia without key diagnostic information leads to overprescribing multi-day
courses of high-dose intravenous antibiotics that may not be effective. Studies have shown that 50%
to 70% of patients suspected of a bloodstream infection are on antibiotic therapy without any
supporting evidence of infection, regardless of blood culture results. Data indicates that in this
population, only ~10% have an initial positive blood culture1-3. Overuse of antimicrobial agents results
in increasing resistant trends, ultimately limiting the number of effective antimicrobial agents available
for treatment of complex infections. Further, a meta-analysis of 70 studies found empiric antibiotic
therapy was inappropriate in 46.5% of patients4. Therefore, despite high level of empiric therapy,
accurate diagnostic information is critical to effective therapy.
Delay in generating important diagnostic information negatively impacts patient mortality, increases
hospital costs, and decreases antimicrobial effectiveness. Species identification and subsequent
antimicrobial susceptibility testing is needed for a clinician to determine the most appropriate targeted
therapy for the patient, results of which are not available until days after the initial blood draw5. Studies
have shown that for patients suffering from bacteremia, their odds of death increase by 4% for every
hour of inappropriate therapy6 and the survival rate for patients suffering from septic shock decreases
by 7.6% for every hour of inappropriate therapy7. Early and appropriate treatment increases the
chances of survival for these at-risk patients.8, 9
The T2Resistance Panel (Panel) is a nucleic acid based test that simultaneously tests a single whole-
blood sample for the qualitative detection and identification of thirteen (13) markers of antibiotic
resistance. The Panel includes several classes of resistance genes found in both gram positive and gram
negative pathogens, with results that are available in as few as 3.5 hours.
Rapid detection and identification of the resistant marker(s) in the bloodstream may aid clinicians in
making appropriate treatment decisions. Early initiation of appropriate antimicrobial treatment is
critical in decreasing morbidity and mortality among patients with bloodstream infections.8 A brief
description of the resistant markers detected by the Panel follows.
Background of Targeted Resistance Markers

Carbapenem Resistance Genes (blaKPC, blaOXA, blaNDM, blaVIM, blaIMP)
Carbapenem resistant Enterobacteriaceae (CRE) are categorized as “an immediate public
health threat that requires urgent and aggressive action”10. Patients with bacteremia caused by
CRE organisms have been shown to have mortality rates >38% when they receive appropriate
therapy within 5 days; however, delay of appropriate therapy beyond 5 days was shown to
increase the mortality rate to 60.7%11.
Extended Spectrum Beta-lactamases (blaCTX-M 14/15)
Similar to CRE, blood stream infections caused by extended spectrum beta-lactamase (ESBL)
Enterobacteriaceae were shown to have a 21-day mortality rate of 18% when patients were
placed on correct therapy within a few hours of infection onset. This rate increased to 59% for
individuals that were not treated correctly within 72 hours12. ESBL infections world-wide are
increasingly being associated with the presence of CTX-M genotype13.
Vancomycin Resistance (vanA / vanB)
Vancomycin resistant Enterococcus (VRE) infections have been increasing and the CDC
reported ~30% of Enterococcus infections were caused by vancomycin resistant organisms10. A
meta-analysis of mortality associated with VRE demonstrated that, compared to infections
caused by vancomycin sensitive Enterococcus, there was significant increase in mortality with
an odds ratio of 2.52 (95% CI 1.9-3.4)14.
Methicillin Resistance (mecA / mecC)
The National Nosocomial Infections Surveillance System found that 60 percent of hospital-
acquired S. aureus isolates were MRSA.15 In a multicenter, prospective, parallel matched-
cohort study, methicillin-resistant Staphylococcus aureus (MRSA) blood stream infections had
a higher 30-day mortality ([aOR] = 4.4) and an excess length of stay of 9.2 days when
compared to patients with susceptible S. aureus infections16.
Ampicillin C Beta-lactamases (AmpC; blaCMY / blaDHA)
Resistance to broad spectrum 3rd generation-cephalosporin drugs, such as ceftazidime and
ceftriaxone, are frequently mediated by AmpC genes. In a prospective study across 13 sites,
resistance to third-generation cephalosporins in E. coli BSIs were associated with a 2.5 times
(95%CI 0.9-6.8) increase in all-cause mortality at 30 days and an excess LOS of 5 days (95%
CI 0.4-10.2) 16.
Principle of the Procedure

The T2Resistance Panel is based on detection of molecular markers of resistance associated with
bacteria direct from whole blood on the T2Dx Instrument. A K2EDTA or K3EDTA whole blood
sample is first directly loaded onto the T2Resistance Sample Inlet, which is then placed on the
T2Resistance Cartridge that is loaded with the T2Resistance Reagent Tray. Once fully assembled for
testing, the Panel contains all of the disposables and reagents required to detect multiple molecular
markers of resistance from the whole-blood samples. The assembled Panel is loaded onto the T2Dx, a
benchtop, fully automated sample-to-result system, which performs all steps of the assay after sample
loading.
During processing on the T2Dx, pathogens are concentrated directly in whole blood, then lysed to
release the target DNA. After amplification, target amplicon is hybridized with superparamagnetic
particles and then detected by T2MR.17 The Internal Control on the Panel monitors performance for
each patient sample or control.
Warnings & Precautions

• The Panel is intended for in vitro diagnostic use only with the T2Dx.
• The Panel is intended only for use with human whole blood collected in 4 milliliter (mL)
blood collection tubes with K2EDTA or K3EDTA as the anticoagulant. Use of any other
vacutainers or incorrect collection of blood may lead to assay or instrument failure.
• Avoidance of contamination is critical for the effectiveness of the Panel. To avoid false positive
results due to detection of contaminants from the workspace or from the operator, follow good
laboratory practices including the following suggestions:
o Aseptic blood collection technique, similar to blood culture sample acquisition, is
recommended to avoid sample contamination.
o Establish a clean environment in which to perform the test as described in the Work
Area Preparation section.
o Change gloves as specified in the T2Resistance Panel Instructions section when
preparing Panel components or processing samples. Operators may elect to change
gloves more frequently at their discretion.
o Wear protective clothing and disposable gloves when handling Panel components.
Wash hands thoroughly prior to and upon completion of the Panel.
o Handle all materials containing samples and controls according to good laboratory
practices in order to prevent cross-contamination.
o Assemble the Panel in a biosafety cabinet or dead air box.
o If any Panel component is dropped during the assembly process, discard the
component and get a new component, changing gloves as needed to minimize
contamination.
o If the assembled Panel is dropped during the loading or unloading process, discard the
Panel in a biohazard bag and follow your laboratory’s established Exposure Plan.
Decontamination may be required if the drop incident occurs while unloading a Panel.
Contact T2 Biosystems Service for assistance.
• The T2Resistance Panel is an aid for the early indication of the presence of molecular markers
of resistance that may be due to an antibiotic resistant organism and results should be used in
conjunction with other clinical and laboratory data.
• The use of T2Resistance Panel results to adjust antimicrobial therapy in patients should be
done in concert with all available clinical and laboratory data.
• Biohazard: The Panel contains all waste, including human whole blood samples, generated by
the test procedure. Samples should be handled as if infectious, using Universal Precautions
and safe laboratory procedures.18, 19
• Do not smoke, eat, or drink in areas where samples or reagents are being handled.
• Do not use Panel components after their expiration date.

• When handling the Panel components, avoid contact with skin, eyes, or mucous membranes.
Wash with water if contact occurs.
• Dispose of used and unused reagents and waste in accordance with Country, Federal, State,
and Local requirements.
• Safety Data Sheets are available on request from T2 Biosystems Service.
Materials Provided
Reagents
The Panel is comprised of the T2Resistance Cartridge (Cartridge), the T2Resistance Sample Inlet
(Sample Inlet), and the T2Resistance Reagent Tray (Reagent Tray) as depicted in Table 1. The Panel
is packaged in two boxes: one box contains twelve (12) Reagent Trays, and a second box contains
twelve (12) Cartridges and twelve (12) Sample Inlets.
Table 1. Panel Components

Shipped Storage Component
Picture Description
Configuration Temperature Name
Component used to
Sample Inlets
load the sample to be
(12 per box)
Cartridge Kit run.
Catalogue #: 15-30°C
90-09879
Cartridges Component that
(12 per box) contains disposables.
Reagent Trays
Reagent Trays Component that
Catalogue #: 2-8°C
(12 per box) contains the reagents.
80-10064
Cartridges
Twelve (12) single-use Cartridges per box. Each Cartridge contains a Lysis Reagent comprised of a
detergent mix and 0.1% Proclin 950 in an aqueous buffer solution.
Sample Inlets
Twelve (12) single-use Sample Inlets per box.
Reagent Trays
Twelve (12) single-use Reagent Trays per pack. Each single use Reagent Tray is preloaded with all
necessary solutions for the Panel, including:
Internal Control
Tris-EDTA buffer containing Internal Control DNA, carrier DNA, and 0.1% Proclin 950 as a
preservative.
Reaction Buffer R
Aqueous buffered solution containing sequence-specific T2Resistance target primers, and 0.1%
ProClin™ 950 as a preservative.
Enzyme Solution
Polymerase solution containing dNTPs with 0.1% ProClin™ 950 as a preservative.
KPC particles
Probe-coupled superparamagnetic particles that hybridize to KPC amplicons in an aqueous
buffered solution containing 0.1% ProClin™ 950 as a preservative.
OXA-48 Group particles

Probe-coupled superparamagnetic particles that hybridize to OXA-48 amplicons in an aqueous
buffered solution containing 0.1% ProClin™ 950 as a preservative.
NDM/VIM/IMP particles
Probe-coupled superparamagnetic particles that hybridize to NDM, VIM, or IMP amplicons in
an aqueous buffered solution containing 0.1% ProClin™ 950 as a preservative.
mecA/C particles
Probe-coupled superparamagnetic particles that hybridize to mecA or mecC amplicons in an
aqueous buffered solution containing 0.1% ProClin™ 950 as a preservative.
vanA/B particles
Probe-coupled superparamagnetic particles that hybridize to vanA or vanB amplicons in an
AmpC particles
Probe-coupled superparamagnetic particles that hybridize to CMY-2 and DHA amplicons in an
CTX-M14/15 particles
Probe-coupled superparamagnetic particles that hybridize to CTX-M14 or CTX-M15 amplicons
in an aqueous buffered solution containing 0.1% ProClin™ 950 as a preservative.
Internal Control particles

Probe-coupled superparamagnetic particles that hybridize to an Internal Control sequence
amplicon in an aqueous buffered solution containing 0.1% ProClin™ 950 as a preservative.
Tris-EDTA buffer
Composition of each component is proprietary to T2 Biosystems. All components are contained

within the Reagent Tray and never handled individually. T2Resistance Safety Data Sheets (SDS) are
available on request from T2 Biosystems Service.
Reagent Storage & Stability

• Store Cartridges at 15-30°C. Note the expiration date present on the label.
• Store Reagent Trays upright at 2-8°C. Note the expiration date present on the label.
Materials Required but not Provided

• 4 mL plastic blood collection tube (lavender top, Vacutainer® plastic K2EDTA or K3EDTA
Venous Blood Collection Tubes 13mm, Becton-Dickinson catalog #367861, #367862,
#368860 or equivalent)
• Powderless disposable gloves
• Eye protection
• Lab coat
• Surface Decontaminant:
o Pre-diluted, stabilized bleach solution consisting of ≥ 0.5% sodium hypochlorite (10%
bleach),
OR
o Pre-diluted sodium dichloroisocyanurate (Troclosene sodium or NaDCC) solution
consisting of ≥4,306 ppm chlorine (Brulin® BruTab 6S or equivalent).
• 70% isopropyl alcohol
• Lint-free wipes
• Biohazard waste bags
• Vortex Mixer (Fisher Scientific™ Analog Vortex Mixer, catalog #02-215-414, or equivalent)
Materials Available Separately from T2 Biosystems

• T2Resistance QCheck Positive Kit, catalogue #85-10060 (stored at -20°C ± 5°C)
• T2Resistance QCheck Negative Kit, catalogue #85-10059 (stored at -20°C ± 5°C)
• See T2Resistance QCheck Kits Instructions for Use for details.
Sample Collection, Handling & Storage

Ensure that the volume of whole blood collected is at least 3 mL to achieve optimal Panel performance.
Draw at least 3 mL of blood into a 4 mL K2EDTA or K3EDTA collection tube using the same
decontamination technique used as when obtaining a blood culture sample.
• After blood collection, invert vacutainer tube 8-10 times to thoroughly mix the blood with
the anticoagulant in the blood collection tube.
• Whole blood samples in K2EDTA or K3EDTA collection tubes may be stored at 2-8°C for
up to 7 days.
• Clotted specimens may negatively impact Panel performance. Visually confirm that the
sample is clot-free prior to loading.
T2Resistance Panel Instructions

Refer to T2Dx Instrument Operator Manual (DES-00405) for detailed instructions on T2Dx
operation.
NOTE: Should gloves become soiled during any of the steps of this procedure, remove and replace with
a clean pair of gloves following standard lab procedures.
NOTE: Do not spray any liquid directly on the T2Dx. Do not allow cleaning solution to drip into
the touchscreen bezel.
Work Area Preparation

Appropriate precautions should be taken to avoid contamination of samples or cartridges with cellular
or DNA material. Gloves should be changed at a minimum as indicated in the procedure below.
Prior to the first Panel(s) loaded each day and after each unload, all work surfaces and common touch
points should be disinfected as outlined below using:
• Surface Decontaminant:
o Pre-diluted, stabilized bleach solution consisting of ≥ 0.5% sodium
hypochlorite (10% bleach or approximately 5,000 ppm sodium hypochlorite),
OR
o Pre-diluted sodium dichloroisocyanurate (Troclosene sodium or NaDCC)
solution consisting of ≥4,306 ppm chlorine.
• 70% isopropyl alcohol
• Lint-free wipes
The following procedure is required for effective disinfection of the work surfaces where the Panel(s)
will be assembled, the T2Dx touchscreen and barcode scanner, the T2Dx drawer panel, and front
cover, and the benchtop where the T2Dx is located:
Put on fresh gloves.

1. Fully saturate a lint-free wipe with surface decontaminant solution. Wipe the preparation area
benchtop in a unidirectional motion. Discard wipe.
2. Dampen a new lint-free wipe with surface decontaminant solution and wipe the following T2Dx
components in a unidirectional motion (Figure 1) and in the sequence indicated below:
• Touchscreen
• Barcode scanner
3. Fully saturate the lint-free wipe with surface decontaminant solution. Wipe the following work
areas in a unidirectional motion and in the sequence indicated below (Figure 1):
• Drawer panel and front cover of the T2Dx
• Benchtop around the T2Dx
4. Discard wipe.
5. Allow the surface decontaminant solution to sit for at least 3 minutes.
6. Repeat Steps 1-5 replacing surface decontaminant solution with 70% isopropyl alcohol. Repeat
until all surface decontaminant residue (visible as white film) is completely removed.
Figure 1. Areas to clean on the T2Dx and unidirectional wiping.

T2Resistance Panel Assembly

1. Confirm that the T2Dx is operational and that a drawer is available for each sample to be loaded.
NOTE: Up to 7 samples can be loaded onto the T2Dx.
2. Obtain sample(s). If using refrigerated sample(s), allow to equilibrate to room temperature (15-
25°C) by storing upright in a rack for 30 minutes (± 10 minutes).
3. Ensure that there is at least 3 mL of sample volume in each 4 mL K2EDTA or K3EDTA tube and
that the sample label and barcode are legible and undamaged. Ensure that the sample is clot-free.
If there is any blood or fluid present on the exterior of the tubes, clean the tubes using standard
lab practices.
NOTE: Do not proceed if sample does not meet the volume requirement. Do not combine under-
filled sample tubes to satisfy minimum volume requirements.
4. Based on the number of samples to be tested, obtain the corresponding number of individually
packaged Panel components (Table 1) from storage. Return any unused Panel components to
proper storage.
5. Open the individual packaging for all Panel components.
NOTE: the packaging of each component is considered potentially contaminated, therefore, do not
remove from the packaging at this time.

6. Remove the Cartridge(s) from individual packaging, check the label and barcode for integrity, and
place onto the Panel assembly work surface. Discard packaging.
7. Remove the Sample Inlet(s) from individual packaging, check the label for integrity, and carefully
place onto the Panel assembly work surface being careful to avoid touching the foil. Discard
packaging.
8. Remove the Reagent Tray(s) from individual packaging, check the label and barcode for integrity,
and place onto the Panel assembly work surface. Discard packaging.
9. Mix the reagents in Reagent Tray by vortexing.
• Set vortex speed to 2560-3200 RPM
• Securely hold the Reagent Tray upright with the barcode facing up.
• Place the Reagent Try onto the center of the 3 inch vortex head cover attachment.
• Press down on the Reagent Tray cover while supporting the sides of the Reagent Tray to
activate the vortexer.
• Vortex the Reagent Tray for 5 seconds and then visually check the wells for homogeneity.
If the contents do not appear homogenous, repeat vortexing up to two more times until
wells are visually homogenous (Figure 2).
NOTE: If homogeneity is not achieved after three 5 second intervals (15 seconds total of vortexing),
discard Reagent Tray and repeat with a new Reagent Tray.
10. Reagent mixing may result in reagent splashing onto the walls of the reagent tray wells and/or
bubble forming in the wells. If necessary, the tray may be flicked to remove air bubbles and collect
solutions at the bottom of the wells. Visually confirm that air bubbles are removed and volumes
appear consistent (Figure 2).
Figure 2. Proper resuspension of reagents and removal of air bubbles.

11. Prepare to insert the Reagent Tray onto the Cartridge by orienting the Reagent Tray such that the
tab on the Reagent Tray cover is on the right and the notches on the Reagent Tray and Cartridge
align (Figure 3).
Figure 3. Orient the Reagent Tray such that the tab is on the right.
12. Place the Reagent Tray onto the Cartridge such that the Reagent Tray is resting on the Cartridge
(Figure 4A). Push down on the left side of the Reagent Tray cover to engage the tab on the left
(Figure 4B). Then push down on the right side of the Reagent Tray cover to engage the tab on
the right (Figure 4C). An audible click will be heard when each tab engages.
A. B. C.
Figure 4. Place Reagent Tray onto Cartridge, push down on left side of Reagent Tray cover,
then push down on right side of Reagent Tray cover.
13. Repeat Steps 9-12 for all Cartridges and Reagent Trays to be used.
14. Obtain a sample. Ensure that the sample is at room temperature. Re-suspend by inverting the
blood collection tube 8-10 times. Do not use the sample if the mixture does not visually appear to
be homogenous after re-suspension.
WARNING: In the event of sample spillage, use standard biohazardous spill cleanup procedures.
15. Uncap the blood collection tube following standard laboratory procedures. Exercise care to not
spill or aerosolize the sample. Dispose of cap as biohazard waste according to laboratory
procedures.
16. Taking care to avoid contact with the foil seal of the Sample Inlet, invert and position the Sample
Inlet snorkel inside the blood collection tube (Figure 5). Using a push and twist motion, securely
“re-cap” the blood collection tube. It is critical to ensure that a good seal has formed between the
blood collection tube and the Sample Inlet seal (the soft portion of the inlet). Ensure that the
blood collection tube is seated firmly in the Sample Inlet before proceeding to the next step.
Figure 5. Blood collection tube loading onto the T2Resistance Sample Inlet
17. Invert the Sample Inlet and blood collection tube and place on the work surface.
18. If preparing multiple panels, repeat Steps 14-17 for each sample to be tested.
19. Ensure that the sample level in each blood collection tube drops as the blood transfers from the
collection tube(s) to the Sample Inlet wells (Figure 6). If the Sample level does not drop after one
minute, gently tap the Sample Inlet module against the bench top several times to allow the sample
to flow into the Sample Inlet wells.
Figure 6. Loaded T2Resistance Sample Inlet module
NOTE: Each Sample Inlet has two wells and the Operator should visually confirm that both wells
have filled before proceeding. If the Sample Inlet wells fail to fill, discontinue loading this Panel and
contact T2 Biosystems Service.
21. Hold the back sides of a Sample Inlet assembly taking care to avoid contact with the foil seal and
push it down onto a Cartridge until an audible snap is heard (Figure 7). The Panel set-up is
complete. Repeat for all Sample Inlet assemblies and Cartridges.
Figure 7. Snap Sample Inlet onto Cartridge

Loading the T2Resistance Panel onto the T2Dx

1. With one hand, grip the sides of the Panel securely (Figure 8) and carry the Panel from Panel
assembly work space to the T2Dx.
Figure 8. Securely hold the Panel with one hand.
2. Press “Load” on the T2Dx touchscreen.

3. When prompted by the instrument, use the handheld barcode scanner on the T2Dx to scan the
Sample barcode, the Reagent Tray barcode, and the Cartridge barcode. When dictated by
laboratory protocol, you may enter a unique sample identifier using the touchscreen keyboard
instead of scanning the blood collection tube barcode.
4. The T2Dx will open an available drawer and prompt the user to load the Panel. Place the Panel
in the drawer, ensuring that it is level, fully in contact with the metal rails and seated on the
location pins (Figure 9). Press “Next” on the touchscreen.
Figure 9. Panel should be level and seated on location pins.

5. When prompted to “Tear off Label,” hold the Panel with one hand for stability and remove the
top seal from the Cartridge by gently pulling back on the label tab (Figure 10).
Figure 10. Remove top seal.
6. Hold the Panel with one hand for stability and remove the plastic Reagent Tray cover without
touching the foil seal or any of the exposed Cartridge components (Figure 11).
Figure 11. Remove Reagent Tray cover
NOTE: Failure to remove Cartridge label or Reagent Tray cover may result in a T2Dx error.
7. Visually confirm that the Reagent Tray cover and Cartridge top seal are removed and all
components are present (Figure 12):
• Large tube with cap (1)
• Small tubes with caps (9)
• Pipette tips (14)
Figure 12. Confirm all components are present.
NOTE: If any components are missing from the Panel, remove the Panel from the drawer, cancel its
load by pressing “Cancel” on the T2Dx touchscreen, and contact T2 Biosystems Service. The sample
should be discarded and a redraw requested.
8. Press “Next” on the touchscreen.

9. Scan or enter personal user ID and ensure that the Sample ID is present and the Script is
“T2Resistance”.
10. Press “Confirm” on the touchscreen, which will close the drawer and initiate the panel.
11. Repeat Steps 1-10 for all Panels assembled.
Unloading the T2Dx

Once the Panel is finished, the “Run Complete” indicator will appear on the T2Dx touchscreen. All
the used and unused disposables along with reagents, sample, and liquid waste are contained in the
Panel.
CAUTION: The used Panel contains blood and may contain DNA amplification products. Handle
with care.

1. Obtain a biohazard bag.
2. Press “Unload” on the T2Dx touchscreen. When prompted, press “Next” which will open the
drawer. Visually confirm that all of the Panel components are present. If any components are
missing, contact T2 Biosystems Service.
3. Using the biohazard waste bag as a glove, remove the used Panel from the drawer keeping it and its
contents upright to avoid spilling. Use your other hand to invert the biohazard waste bag over the
Panel as an additional precaution to limit the risk of inadvertent cross-contamination (Figure 13).
Figure 13. Proper Technique for Unloading the T2Resistance Panel.
NOTE: Be careful when removing the used Panel to avoid spilling of reagents, samples, and
disposables. Do not tip or invert the used Panel. Ensure that the Panel remains upright while
unloading.
4. Immediately close and secure the biohazard waste bag with a twist tie, and then discard in a
biohazardous waste container in accordance with local waste disposal regulations.
5. Press “Next” twice on the T2Dx touchscreen to close the drawer.
6. Repeat Steps 1-5 for all other drawers that display a “Run Complete” indication.

7. Repeat Steps 1-6 of Work Area Preparation to decontaminate the T2Dx and workspace.
Quality Control
T2Dx Instrument
The T2Dx incorporates multiple in-line sensor checks to monitor and ensure proper Panel loading,
system operation and sub-system functionality. Messages and error codes may be generated by the
T2Dx during the performance of the Panel. The user must check Panel result printouts to verify the
test result is valid. Refer to the T2Dx Instrument Operator Manual (DES-00405) for further
instructions.
Internal Control
The Panel includes an Internal Control that monitors the amplification and detection process. The
Internal Control is designed to ensure that samples do not contain inhibitors that would interfere with
the detection of the resistance markers targeted by the Panel. The Internal Control also ensures that,
when no resistance markers are detected, the amplification and detection process has functioned
properly to ensure accurate reporting of a negative result. If the Internal Control is Invalid and no
target resistance markers are detected, the result cannot be determined and “Invalid” will be displayed
as the result.
Process Quality Controls

T2 Biosystems provides T2Resistance QCheck (QCheck) positive and negative buffer-based controls
separately, to be used for periodic quality checks with the Panel and the T2Dx. Users should follow
all laboratory procedures, local, state, and/or national requirements and accrediting organizations’
guidelines for the testing of all positive and negative controls.
It is recommended that quality check testing be run as indicated in the T2Resistance QCheck
Instructions for Use which recommends quality check testing be run as follows and at least once every
30 days:
• Run a single QCheck Positive tube and a single QCheck Negative tube at least once every 30
days in order to verify the continuing performance of the T2Dx Instrument and the
T2Resistance Panel reagents.
• Run a QCheck Positive tube and a QCheck Negative tube when either of the following events
occurs:
o A new reagent lot or shipment is received into the laboratory
o Significant maintenance (including software upgrades) is performed on the T2Dx
Each Panel result generated by the Panel reagents is an independent analysis and each result has an
internal control to ensure the integrity of the result. As such, there are no recommendations regarding
the necessity to validate patient sample results solely on the basis of the results obtained from QCheck
controls. The laboratory should follow its own established standard operating procedure for
appropriate action(s).
NOTE: In the event of two successive failed or invalid QCheck controls, or in the event that system
contamination is suspected, immediately contact T2 Biosystems Service.
Data Retrieval & Interpreting Results

Panel results are accessible via printed form (Figure 14a) or via the T2Dx touchscreen display
(Figure 14b).
Figure 14a. Panel results via printed form

Figure 14b. Panel results via the T2Dx touchscreen display
Messages and error codes may be generated by the T2Dx during the performance of the Panel. The
operator must check the results printout to verify the Panel result is valid.
To print the Panel results, press “Results” on the T2Dx touchscreen, choose the box next to the result
to print, and press “Print”.
Each valid Panel will yield seven reportable results (Positive or Target Not Detected) for:
1. mecA/C
2. vanA/B
3. KPC
4. AmpC (CMY/DHA)
5. OXA-48 Group
6. NDM/VIM/IMP
7. CTX-M14/15
In addition, an Internal Control (IC) result will be reported as Valid or Invalid. Table 2 outlines
possible results for each target resistance marker and the Internal Control as well as the interpretation
of results.
Table 2. T2Resistance Panel Results

Target
Target Result IC Result Interpretation
Species
Positive Valid1 mecA / mecC detected.

mecA/C
mecA / mecC NOT detected.
Target Not Detected Valid
The Internal Control is valid.
Positive Valid1 vanA / vanB detected.

vanA/B
vanA / vanB NOT detected.
Positive Valid1 KPC detected.

KPC
KPC NOT detected.
Positive Valid1 CMY-2 / DHA detected.

AmpC
CMY-2 / DHA NOT detected.
Positive Valid1 OXA-48 Group detected.

OXA-48
Group OXA-48 Group NOT detected.
Positive Valid1 NDM/VIM/IMP detected.

NDM/VIM/
IMP
NDM/VIM/IMP NOT detected.
Positive Valid1 CTX-M14 / CTX-M15 detected.

CTX-
M14/15
CTX-M14 / CTX-M15 NOT detected.
Target results are invalid.

All Invalid Invalid
The Internal Control is invalid.
1
Any mecA/C, vanA/B, KPC, AmpC, OXA-48 Group, NDM/VIM/IMP, or CTX-M14/15 positive results
indicate that amplification was successful. In these cases the Internal Control will always be valid.
Performance Characteristics - Summary

Limit of Detection
Limit of Detection (LoD) was defined as the minimum concentration at which a 95% positivity rate
was achieved. The T2Resistance Panel has a LoD of 3-11 CFU/mL for the seven target channels as
determined by measuring the percent positive detection at a given CFU/mL level for spiked samples
(N≥20) prepared with quantitative CFU/mL plating on an aliquot of the final spike solution. At least
one strain for each of the thirteen Panel members were tested. The data are summarized in Table 3.
Table 3. LoD of T2Resistance Panel

LoD
Target
(CFU/mL)
mecA 5
mecC 5
vanA 3
vanB 5
KPC 3
CMY-2 (AmpC) 3
DHA-1 (AmpC) 5
OXA-48 5
NDM-1 11
VIM-1 3
IMP-1 7
CTX-M 14 5
CTX-M 15 5
Analytical Reactivity (Inclusivity)

To establish the analytical reactivity of the Panel, in silico analysis was performed against the National
Center for Biotechnology (NCBI) Bacterial Antimicrobial Resistance Reference Gene Database
(AMR). The possible primer and probe combinations were evaluated for potential production of
amplicon. A total of 11,368 possible amplicons were analyzed.
Inclusivity for each detection channel is shown in Table 4.
Table 4: T2Resistance Panel in silico inclusivity
Target Inclusive Genes/Variants

KPC KPC-2, KPC-3, KPC-4, KPC-5, KPC-6, KPC-7, KPC-8, KPC-10, KPC-11, KPC-12, KPC-13, KPC-
14, KPC-15, KPC-16, KPC-17, KPC-18, KPC-19, KPC-21, KPC-22, KPC-23, KPC-24, KPC-25,
KPC-26, KPC-27, KPC-28, KPC-29, KPC-30, KPC-31, KPC-32, KPC-33, KPC-34, KPC-35, KPC-
36, KPC-37, KPC-38, KPC-39, KPC-40, KPC-41, KPC-42, KPC-43, KPC-44, KPC-45, KPC-46

OXA-48 OXA-48, OXA-162, OXA-163, OXA-181, OXA-199, OXA-204, OXA-232, OXA-244, OXA-245,
OXA-247, OXA-252, OXA-370, OXA-405, OXA-416, OXA-438, OXA-439, OXA-484, OXA-
505, OXA-514, OXA-515, OXA-517, OXA-519, OXA-538, OXA-546, OXA-547, OXA-566,
OXA-567, OXA-788, OXA-793, OXA-833
NDM/ IMP-1, IMP-2, IMP-3, IMP-4, IMP-5, IMP-6, IMP-7, IMP-8, IMP-9, IMP-10, IMP-12, IMP-13,
VIM/ IMP-15, IMP-17, IMP-19, IMP-20, IMP-23, IMP-24, IMP-25, IMP-26, IMP-27, IMP-28, IMP-30,
IMP IMP-33, IMP-34, IMP-37, IMP-38, IMP-39, IMP-40, IMP-42, IMP-43, IMP-45, IMP-51, IMP-52,
IMP-53, IMP-55, IMP-59, IMP-60, IMP-61, IMP-62, IMP-63, IMP-64, IMP-66, IMP-67, IMP-69,
IMP-70, IMP-73, IMP-76, IMP-77, IMP-78, IMP-79, IMP-80, IMP-82, IMP-84, NDM-1, NDM-2,
NDM-3, NDM-4, NDM-5, NDM-6, NDM-7, NDM-8, NDM-9, NDM-10, NDM-11, NDM-12,
NDM-13, NDM-14, NDM-15, NDM-16, NDM-17, NDM-18, NDM-19, NDM-21, NDM-20,
NDM-22, NDM-23, NDM-24, NDM-27, NDM-28, VIM-1, VIM-2, VIM-3, VIM-4, VIM-5, VIM-6,
VIM-8, VIM-9, VIM-10, VIM-11, VIM-12, VIM-13, VIM-14, VIM-15, VIM-16, VIM-17, VIM-18,
VIM-19, VIM-20, VIM-23, VIM-24, VIM-25, VIM-26, VIM-27, VIM-28, VIM-29, VIM-30, VIM-
31, VIM-32, VIM-33, VIM-34, VIM-35, VIM-36, VIM-37, VIM-38, VIM-39, VIM-40, VIM-41,
VIM-42, VIM-43, VIM-44, VIM-45, VIM-46, VIM-47, VIM-48, VIM-49, VIM-50, VIM-51, VIM-
52, VIM-53, VIM-54, VIM-55, VIM-56, VIM-57, VIM-58, VIM-59, VIM-60, VIM-62, VIM-63,
VIM-64, VIM-65, VIM-66, VIM-67, VIM-68
AmpC CMY-2, CMY-4, CMY-5, CMY-6, CMY-7, CMY-12, CMY-13, CMY-14, CMY-15, CMY-16, CMY-
17, CMY-18, CMY-20, CMY-21, CMY-22, CMY-23, CMY-24, CMY-25, CMY-26, CMY-27, CMY-
93, CMY-94, CMY-95, CMY-96, CMY-99, CMY-100, CMY-101, CMY-102, CMY-104, CMY-106,
CMY-107, CMY-108, CMY-111, CMY-119, CMY-121, CMY-122, CMY-124, CMY-125, CMY-127,
CMY-163, CMY-164, CMY-165, CMY-166, CMY-167, DHA-1, DHA-2, DHA-3, DHA-4, DHA-5,
DHA-6, DHA-7, DHA-9, DHA-10, DHA-12, DHA-13, DHA-14, DHA-15, DHA-16DHA-17,
DHA-18, DHA-19, DHA-20, DHA-21, DHA-22, DHA-23, DHA-24, DHA-25, DHA-26, DHA-27,
DHA-28, DHA-29, MOR-2, LAT-1, LAT-3, BIL-1, CFE-1
CTX-M CTX-M-1, CTX-M-3, CTX-M-9, CTX-M-10, CTX-M-12, CTX-M-13, CTX-M-14, CTX-M-15,
CTX-M-16, CTX-M-17, CTX-M-19, CTX-M-21, CTX-M-22, CTX-M-23, CTX-M-24, CTX-M-27,
CTX-M-101, CTX-M-102, CTX-M-103, CTX-M-104, CTX-M-105, CTX-M-110, CTX-M-111,
CTX-M-125,

CTX-M CTX-M-126, CTX-M-127, CTX-M-129, CTX-M-130, CTX-M-132, CTX-M-134, CTX-M-136,
CTX-M-228
mecA/C mecA, mecC
vanA/B vanA, vanB
Analytical Specificity (Exclusivity)

To establish the analytical specificity of the Panel, a database containing 5,108 gene variants of >500
different resistance genes was analyzed to determine exclusivity for each channel. Variants from the
gene targeted by the panel, other variant subgroups within the more variable genes targeted by the
panel (i.e. OXA and CTX-M), and closely related genes within the same gene family are listed in the
exclusivity list in Table 5.
Table 5: T2Resistance Panel in silico exclusivity
Target Exclusivity Within Targeted Group Related Subgroups

KPC N/A N/A
OXA-48 N/A Shewanella oneidensis chromosomal progenitor
(OXA-54 group), OXA-23 group, OXA-40
group, OXA-51 group, OXA-58 group, OXA-
134a group, OXA-143 group, OXA-211
group, OXA-213 group, OXA-214 group,
OXA-229 group, OXA-235 group,
NDM/ VIM-7, VIM-61, IMP-11, IMP-14, IMP-16, SPM, GIM, SIM, KHM
VIM/ IMP-18, IMP-21, IMP-22, IMP-29, IMP-31,
IMP IMP-32, IMP-35, IMP-41, IMP-44, IMP-46,
IMP-48, IMP-49, IMP-54, IMP-56, IMP-58,
IMP-68, IMP-71, IMP-74, IMP-75, IMP-83
AmpC CMY-40, CMY-41, CMY-47, CMY-48, CMY- CMY-1/MOX group, ACC group, ACT/MIR
50, CMY-51, CMY-65, CMY-66, CMY-67, group, FOX group
CMY-68, CMY-72, CMY-75, CMY-76, CMY-
78, CMY-79, CMY-81, CMY-84, CMY-85,
CMY-87, CMY-89, CMY-90, CMY-97, CMY-
103, CMY-105, CMY-109, CMY-110, CMY-
112, CMY-113, CMY-114, CMY-115, CMY-
116, CMY-117, CMY-118, CMY-128, CMY-
135, CMY-150, CMY-151, CMY-152, CMY-

157
CTX-M-14/15 N/A CTX-M-2 group, CTX-M-8 group, CTX-M-
25 group
mecA/C N/A mecA1, mecA2, mecB, mecC2, mecC3, mecD
vanA/B Bacillus circulans vanA variant vanA-Pa, vanA-Pt, vanA-Pt2, vanA-Ao2,
vanA-Sc, vanC, vanD, vanE, vanF, vanG,
vanI, vanJ, vanK, vanL, vanM, vanN, vanO,
vanR, vanS, vanT, vanU, vanW, vanX, vanY,
vanXY, vanZ
The T2Resistance KPC, OXA-48 group, CTX-M-14/15, and mecA/C detect all known variants of
these resistance markers. Several related subgroups are not predicted to be detected by the
T2Resistance panel. For OXA-48, these include the chromosomal progenitor gene for OXA-48 found
in the environmental species Shewanella oneidensis and lower prevalence OXA extended spectrum β-
lactamases (ESBLs) or carbapenemases, most found solely in Acinetobacter baumannii.
Several variants of VIM and IMP are not expected to be detected by the NDM/VIM/IMP particle,
while all known variants of the NDM group are. The VIM and IMP variants that are not detected are
less homologous members of the group and are not considered to be highly prevalent variants. Other
lower prevalence metallo-beta-lactamase genes are not predicted to be detected by the T2Resistance
Panel.
The AmpC channel only detects AmpC β-lactamases in the most prevalent CMY and DHA groups,
and other AmpC genes will not be detected. As such, the AmpC channel is predicted to detect all
DHA variants, but several CMY-2 group variants are not predicted to be detected. The channel was
designed to pick up highly prevalent variants CMY-2, 4, and 101, and less homologous variants are
not covered by the design.
The CTX-M-14/15 channel is predicted to detect all variants in the CTX-M-14 and CTX-M-15
groups. Other CTX-M variants in related groups are not expected to be detected by the T2Resistance
Panel; however, the majority of CTX-M infections come from the CTX-M-14 and CTX-M-15
groups.
The mecA/C channel is expected to detect all mecA and mecC variants. The closely related genes
mecA1, mecA2, mecC2, and mecC3 are not expected to be detected by this channel, but these genes
are typically found in Staphylococci that rarely cause infections including S. sciuri and S. vitulinus. The
mecB and mecD genes are not predicited to be detected by this channel, but these genes carried by
Macrococcus caseolyticus, which is associated with animal infections.
The vanA/B channel is predicted to detect all vanA and vanB variants except for a vanA variant carried
by Bacillus circulans, which rarely causes human infections. Other, less prevalent, van genes are not
expected to be detected by this channel.
Reproducibility
Results agreement was analyzed over three non-consecutive days for each sample type, two operators,
and one Reagent Tray Kit lot. All targets were prepared in whole blood at 20 CFU/mL.
Reproducibility results across days, runs, and sample type were acceptable with an overall agreement
of 100% with expected results for each resistant marker tested.
Interfering Substances
T2MR® technology utilizes nuclear magnetic resonance for assay performance. As such, MRI contrast
agents and the iron supplement Feraheme have demonstrated interference with T2MR results.
To determine and characterize the effects of other potential exogenous interfering substances on the
performance of the Panel, 16 exogenous substances were spiked into Resistance positive samples that
were tested by the Panel on the T2Dx, along with negative whole blood samples. Potentially interfering
substances were tested above clinically relevant concentrations. No interference was detectable at the
specified test concentration for all substances listed below (Table 6).
Table 6. Substances tested for interference with the T2Resistance Panel –No interference observed
Exogenous Substances & Concentrations

Ampicillin 152 µmol/L K3EDTA 9 mg/mL
Azithromycin 15.3 µmol/L Gentamicin sulfate 21 µmol/L
Cefazolin Sodium Salt 2.643 mmol/L Heparin 3,000 U/L
Cefoxitin Sodium Salt 180 µg/mL Imipenem 249 µg/mL
Ceftazidime Pentahydrate 487 µg/mL Linezolid 55.8 µg/mL
Ciprofloxacin 30.2 µmol/L Piperacillin/Pipril 117 µg/mL
Clindamycin HCl 89.1 µmol/L Tazobactam (Tazobac) 18.9 µg/mL
K2EDTA 9 mg/mL Vancomycin 103 µg/mL
Clinical Performance
The clinical sensitivity and specificity of the Panel was established by evaluating whole blood clinical
samples with suspected blood steam infection. Samples were collected from one clinical site in one
geographic region in Europe. T2Resistance Panel results were compared to blood culture and post
blood culture molecular and phenotypic testing. Table 7 outlines the overall Positive Percent
Agreement (PPA) and Negative Percent Agreement (NPA) from the prospective samples collected
during the study.
Table 7. T2Resistance Clinical Sensitivity and Clinical Specificity by Channel
PPA NPA
Channel
Sensitivity 95% CI Specificity 95% CI
mecA/C 100.0% (3/3) 43.8% - 100.0% 100.0% (23/23) 85.7% - 100.0%
vanA/B -- -- -- --
KPC 100.0% (2/2) 34.2% - 100.0% 100.0% (24/24) 86.2% - 100.0%
AmpC 100.0% (2/2) 34.2% - 100.0% 100.0% (24/24) 86.2% - 100.0%
OXA-48 Group -- -- -- --
NDM/VIM/IMP -- -- -- --
CTX-M14/15 100.0% (4/4) 51.0% - 100.0% 100.0% (22/22) 85.1% - 100.0%
The negative percent agreement (NPA) or analytical specificity of the T2Resistance Panel was also
determined using 100 healthy donor samples. Table 8 outlines the T2Resistance Panel performance.
Table 8. T2Resistance Specificity by Channel
NPA
Channel
Specificity 95% CI
mecA/C 100.0% (100/100) 96.3% - 100.0%
vanA/B 100.0% (100/100) 96.3% - 100.0%
KPC 100.0% (100/100) 96.3% - 100.0%
AmpC 100.0% (100/100) 96.3% - 100.0%
OXA-48 Group 100.0% (100/100) 96.3% - 100.0%
NDM/VIM/IMP 100.0% (100/100) 96.3% - 100.0%
CTX-M14/15 100.0% (100/100) 96.3% - 100.0%
Limitations of the Procedure

• As with any procedure, good laboratory technique is important for the proper performance of
the Panel. Results are dependent on proper sample collection, handling, and storage. Failure
to observe proper procedures in any one of these steps can lead to incorrect results.
• The Panel has been validated for use only with whole blood collected in 4 mL tubes with
K2EDTA or K3EDTA as the anticoagulant.
• Panel performance was established in adult subjects. Panel performance in neonates, infants,
and pediatric patients has not been established.
• The Panel should only be processed by technicians who have been trained on use of the Panel
and the T2Dx.
• There is a risk of false positive values resulting from cross-contamination by target organisms,
their nucleic acids, or amplified products.
• The following conditions can negatively impact the performance of the test:
o Clotted blood sample
o Sample not at room temperature
o Insufficient sample volume. A minimum of 3 mL K2EDTA or K3EDTA whole
blood is required.
o Contaminated sample or contaminated T2Dx Instrument
o Interfering substances. The effect of interfering substances has only been evaluated for
those listed in the labeling. Interference by substances other than those described in the
Interference section could lead to erroneous results.
o False negatives may occur. The Internal Control has been incorporated into the
workflow to permit identification of patient samples which contain substances that
interfere with the Panel result.
• A negative Panel result does not exclude the possibility of bloodstream infection. Negative
Panel results may occur from sequence variants in the region targeted by the assay, the presence
of inhibitors, technical error, sample mix-up, or an infection caused by an organism not
detected by the panel. Panel results may also be affected by levels of organism in the sample
that are below the limit of detection of the test. Negative results should not be used as the sole
basis for diagnosis, treatment, or other management decisions.
• The ability of the T2Resistance Panel to detect the presence of polymicrobial bloodstream
infections was not demonstrated in clinical studies.
• The Panel may only be performed on the T2Dx.
• The Panel is for prescription use only.
• A trained health care professional should interpret results together with the patient’s medical
history, clinical signs and symptoms, and the results of other diagnostic tests.
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Table of Abbreviations
Table 8. Abbreviations that appear in the T2Resistance Panel CE-IVD IFU
Abbreviations Definitions
Panel T2Resistance Panel
IFU Instructions for Use
Cartridge T2Resistance Cartridge
Reagent Tray T2Resistance Reagent Tray
Sample Inlet T2Resistance Sample Inlet
IC Internal Control
KPC Klebsiella pneumonia carbapenemase
β-lactamase active against cefotaxime (CTX), first
CTX-M
discovered in Munich (M)
NDM New Delhi metallo-β-lactamase
VIM Verona integron-encoded metallo-β-lactamase
IMP Imipenemase
OXA-48 Group Oxacillinase-48 like subgroup
vanA/B Vancomycin resistance genes
mecA/C Methicillin resistance genes
AmpC Ampicillin carbapenemase
CMY Cephamycinase
DHA Dharhan β-lactamase
K2EDTA Dipotassium ethylenediaminetetraacetic acid
K3EDTA Tripotassium ethylenediaminetetraacetic acid
NaDCC Sodium dichloroisocyanurate
Tris-EDTA or TE Tris ethylenediaminetetraacetic acid
CFU Colony-forming unit
mL Milliliter
LoD Limit of Detection
RPM Revolutions Per Minute
Understanding the Symbols

Table 9. Symbols that may appear on the packaging and labeling
Symbol Meaning Symbol Meaning
Sufficient For <N

In Vitro Diagnostic Medical Device
tests>
Consult Instructions
Use By <YYYY-MM-DD>
For Use
Reference Number or Catalog

Caution
Number
Authorized
Manufacturer Representative in the
European Community
For use by prescription

Do Not Reuse
only
Batch Code or Lot Number Control
Complies with
Temperature Limitation European Conformity
Requirements
Notice to Purchaser
The Panel is an in vitro diagnostic for prescription use only.
See http://info.t2biosystems.com/instructions to download the latest version of the T2Resistance Panel
Instructions for Use.
Vacutainer® is a registered trademark of Becton Dickinson and Co.
Technical Support & Contact Information

T2 Biosystems Service
T2 Biosystems, Inc.
101 Hartwell Avenue
Lexington, MA 02421
Phone: 781-457-1200
877-504-T2T2 (8282)
Fax: 781-357-3080
US Email: t2service@t2biosystems.com
International Email: t2serviceINTL@t2biosystems.com
Manufacturer
T2 Biosystems, Inc.
101 Hartwell Avenue
Lexington, MA 02421
Phone: 781-457-1200
Fax: 781-357-3080
Email: info@t2biosystems.com
Document History
Revision For released documents: CO # Description of Change

For unreleased documents:
person who made the change
1 PCO-000090 Initial release
2 CO-006136 Updated photos, performance data, and interfering
substances data for CE market launch
Do Not Print This Page.

DES-01016 Rev 2 T2Resistance Panel Instructions For Use CE-IVD

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DES-01016 Rev 2 T2Resistance Panel Instructions For Use CE-IVD

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T2Resistance® Panel

Instructions for Use

For use exclusively on the T2Dx® Instrument

This in vitro diagnostic product conforms to the requirements

For use exclusively on the T2Dx® Instrument

Summary & Explanation of the T2Resistance

Background of Targeted Resistance Markers

Principle of the Procedure

Warnings & Precautions

• Do not use Panel components after their expiration date.

Table 1. Panel Components

OXA-48 Group particles

Internal Control particles

Composition of each component is proprietary to T2 Biosystems. All components are contained

Reagent Storage & Stability

Materials Required but not Provided

Materials Available Separately from T2 Biosystems

Sample Collection, Handling & Storage

T2Resistance Panel Instructions

Work Area Preparation

Put on fresh gloves.

Figure 1. Areas to clean on the T2Dx and unidirectional wiping.

T2Resistance Panel Assembly

Put on fresh gloves.

NOTE: Up to 7 samples can be loaded onto the T2Dx.

Put on fresh gloves.

Figure 2. Proper resuspension of reagents and removal of air bubbles.

Figure 6. Loaded T2Resistance Sample Inlet module

Figure 7. Snap Sample Inlet onto Cartridge

Loading the T2Resistance Panel onto the T2Dx

Figure 8. Securely hold the Panel with one hand.

2. Press “Load” on the T2Dx touchscreen.

Figure 9. Panel should be level and seated on location pins.

Figure 10. Remove top seal.

Figure 11. Remove Reagent Tray cover

Figure 12. Confirm all components are present.

8. Press “Next” on the touchscreen.

Unloading the T2Dx

Put on fresh gloves.

Figure 13. Proper Technique for Unloading the T2Resistance Panel.

Put on fresh gloves.

Process Quality Controls

Data Retrieval & Interpreting Results

Figure 14a. Panel results via printed form

Figure 14b. Panel results via the T2Dx touchscreen display

Table 2. T2Resistance Panel Results

Positive Valid1 mecA / mecC detected.

Positive Valid1 vanA / vanB detected.

Positive Valid1 KPC detected.

Positive Valid1 CMY-2 / DHA detected.

Positive Valid1 OXA-48 Group detected.

Positive Valid1 NDM/VIM/IMP detected.

Positive Valid1 CTX-M14 / CTX-M15 detected.

Target results are invalid.

Performance Characteristics - Summary

Table 3. LoD of T2Resistance Panel

Analytical Reactivity (Inclusivity)

Target Inclusive Genes/Variants

Target Inclusive Genes/Variants

Target Inclusive Genes/Variants

Analytical Specificity (Exclusivity)

Table 5: T2Resistance Panel in silico exclusivity

Target Exclusivity Within Targeted Group Related Subgroups