Pointofcare Testing

30
Point-of-Care Testing
Ping Wang, Maurice O’Kane
ABSTRACT
Background refined and improved to deliver easier-to-use devices with in-
Point-of-care testing (POCT) is essentially any form of labo- cremental improvements in analytical performance. Other
ratory testing that takes place outside of the conventional or major technological developments include miniaturization
central laboratory setting and encompasses a wide variety of and co-developments in consumer electronics. The develop-
locations. Use of POCT has steadily increased over the 40 or ments have enabled what are essentially laboratory instru-
so years since its introduction, principally driven by technol- ments to be reduced in both size and complexity so that they
ogy developments and changes in health care delivery that are can be used in point-of-care locations. Thus the menu of tests
aimed at delivering less costly and more effective care closer that can be measured with POCT devices has grown to include
to the patient. many of the commonly requested analytes. Developments in
information technology and informatics are described that
Content make management of POCT devices easier and allow the gen-
This chapter describes the various POCT technologies, includ- eration of accurate and timely results. The importance of care-
ing those currently in use and those developed more than ful implementation of POCT is also discussed with various
several decades ago such as glucose strips and lateral flow tech- case histories to show the clinical and cost-effectiveness of
nologies. The succeeding years have seen these technologies POCT compared with central laboratory testing.
INTRODUCTION dedicated laboratory areas. This reflects a similar evolution in

medical care that commenced in people’s homes and then to
Point-of-care testing (POCT) can be simply defined as “med- a range of different locations that can be classified as primary,
ical testing at the site of patient care”, with the implication secondary, and tertiary care. These developments came about
that appropriate and prompt decisions are made, leading to through advances in science and technology being applied to
improved health outcomes. Many other terms have been used the understanding and practice of medicine. Further develop-
to describe POCT, including bedside,1 near patient,2 physi- ments in science and technology, as reflected in the advances
cian’s office,3 extralaboratory,4 decentralized,5 offsite, satellite, in POCT technology, have now enabled health care providers
kiosk, ancillary, and alternative site testing.6 In defining POCT, and patients to make choices about where testing is con-
some may think that true POCT is testing carried out only by ducted. Box 30.1 shows the diversity of locations involved.
nonlaboratory personnel and should not include testing car- The most prominent example of this diversity is glucose test-
ried out by laboratory staff but in locations outside of the ing, which can be measured in the home by the patient, at
central laboratory. An example of the former is activated clot- numerous locations in the community, at the bedside by care-
ting time (ACT) measurements, which are usually performed givers, or in the central laboratory. Currently, advances in a
in the operating room (OR) by nonlaboratory staff. In con- range of technologies and manufacturing processes, such as
trast, an example of the latter is intraoperative parathyroid thin-film sensors, semiconductor engineering, plastic mold-
hormone (PTH) measurements, which are often performed ing, microfluidics, nanotechnology, and consumer electronics,
in the OR by laboratory personnel. For the purposes of this make it possible to adapt most of the methods used in the
chapter, we take a broad view and define POCT as any testing laboratory to the point-of-care setting.7
done outside of the central laboratory, regardless of who Several authors have suggested that we may be seeing the
performs it. POCT also includes “self-testing” in which the beginning of a movement of testing away from the central
patient performs the tests himself or herself, and in fact, self- laboratory to the point of care.8–10 Such a trend would clearly
monitoring for blood glucose and prothrombin time (PT) or support the demand for improved access to health care that
international normalized ratio (INR) together form the larg- is closer to home and a general aim of limiting lengths of
est segment of the POCT market. stay in hospital. There are a number of reasons for these
The first diagnostic or medical tests were performed at the trends, including clinical, sociologic, and economic argu-
bedside, then in the ward side-room, and then transferred to ments.11 The need to limit the increasing cost of health care
325
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326 SECTION II Analytical Techniques
Patient
BOX 30.1 Environments Where Point-
of-Care Testing Might Be Used Interpret Request
Primary Care Doctor
Home
Transmit Phlebotomy
Community pharmacy
Health centers (general practice, primary care)
Workplace clinic
Report Transport
Physician’s office and community clinic
Diagnostic and treatment center
Paramedical support vehicle (ambulance, helicopter, aircraft)
Validate Register
Secondary and Tertiary Care
Emergency department
Quality
Admissions unit Analysis Prepare
control
Ambulatory diagnostic and treatment center
FIGURE 30.1 Schematic representation of the key steps in re-
Operating room questing, delivering, and using a diagnostic test result.
Intensive care unit
Ward
Outpatient clinic BOX 30.2 Potential Advantages and
Disadvantages of Point-of-Care Testing
Advantages
has prompted Christensen and colleagues to call for a radical Reduced turnaround time for test results
change in the way that health care is delivered, a process he Improved patient management; improved engagement between
has called disruptive innovation.12 In discussing how such patient and caregiver
changes can be brought to health care, he believes that POCT Improved patient morbidity and mortality rates
is one of the key enablers of disruptive innovation, citing as Reduction in the administrative work associated with test
an example the major changes to diabetes care that have requesting and reporting
come about through the ability of patients to monitor their Reduced risk of workflow-associated errors
own glucose concentrations. The growth of telemedicine has Reduction in clinic visits
further fueled the growth of POCT.13 Reduction in hospital admissions
Although POCT can be viewed as a means of delivering re- Decreased overall cost of care
sults rapidly to where they are needed (clinical need), it can also
be seen as a means of reducing the complexity of the process Disadvantages
associated with obtaining a test result (process need). Clinical Increase in administrative work associated with training and
needs met by POCT can include one of clinical urgency and certification of operators
one of improving the engagement between the patient and the Caregiver required to perform test
clinician or caregiver to achieve greater patient empowerment Increased risk of errors if tests performed by untrained operators
and the potential to improve the clinical outcome. Similarly, Increased cost of testing
process needs met by POCT can be improving the immediate Increased waste associated with single-use disposable tests
patient-clinician-caregiver interaction, as well as reducing the
longer process of the whole patient journey, improving the pa-
tient’s experience and decreasing health care resource use. An the long-term trend of miniaturization, including both ana-
example of the latter is INR testing, either by the patient or by lytics and electronics miniaturization. Also important have
the family doctor or general practitioner, in which the test re- been advances in information and communications tech-
sults are integrated into the consultation process. Improving nologies. Starting with instruments to measure electrolytes,
both clinical and process outcomes has the potential to reduce blood gases, and glucose, it is now possible to measure many
the errors and waste of resources while also reducing the cost of other analytes using increasingly smaller devices. Accompany-
care and increasing societal gain. This argument can be applied ing the process of miniaturization has been the development
simply to the testing process (Fig. 30.1) or to the wider aspects of dry, stable reagents that can be incorporated in disposable
of the whole patient journey. See Box 30.2 for examples of the unit-dose devices. Although the throughput of tests for these
potential advantages of POCT. devices is low, the time required to produce the results is usu-
The following sections of this chapter describe the tech- ally short.
nology available for POCT, how POCT should be managed
from a quality perspective, an overview of the evidence for Required Features of Point-of-Care Testing Devices
the effectiveness of POCT, and finally how POCT should be As with any device, it is important that designers first con-
adopted and implemented. sider the needs of users, and these depend to some extent on
the clinical setting or application. Some simply stated but
TECHNOLOGY ASPECTS critical requirements are:
1. Devices should be simple to use.
The technology used to measure analytes outside of the con- 2. Reagents and consumables must be robust over extended
ventional laboratory setting has come about partly through periods of time.
CHAPTER 30 Point-of-Care Testing 327
3. Results from POCT devices should be concordant with in modern health care systems. Although technology exists to
established laboratory methods. do this, it comes at a cost, which is often difficult to recover
4. The device together with its associated reagents and con- in the usual business model in which POCT instrumentation
sumables must be safe to use. is often supplied at no or low cost, with revenue being gener-
Design criteria become more specific for particular clinical ated through reagent or consumable sales.
settings. For example, criteria exist for devices designed for use A more recent design challenge is the need to simultane-
in the developing world for sexually transmitted diseases, a ously measure multiple analytes in the same cartridge, so-
major unmet medical need that is just beginning to be ad- called multiplexing. This is driven by the desire to measure a
dressed effectively. Provided by the World Health Organization wider range of analytes on the same sample, avoiding the use
(WHO), the so-called ASSURED criteria14 are as follows: of multiple devices. The Piccolo chemistry analyzer (Abaxis,
• Affordable: for those at risk of infection Union City, CA) and blood gas or critical care analyzers are
• Sensitive: minimal false negatives examples of such technologies.
• Specific: minimal false positives
• User friendly: minimal steps to carry out test Design
• Rapid and robust: short turnaround time (TAT) and no There is a great diversity of devices being used for POCT
need for refrigerated storage (Table 30.1), although it is interesting that by far, the majority
• Equipment free: no complex equipment of them rely on technologies devised more than 2 decades
• Delivered: to end users ago. Many of the devices use the same analytical principles as
In addition, target product profiles (TPPs) (scope, perfor- those found in conventional laboratory analyzers, but newer
mance, operational characteristics, and price) have been technologies are starting to appear, some of which will be
developed to guide and support the development of POCT described later in this chapter.
diagnostic tools for several infectious diseases such as tuber- Irrespective of the type of technology, all POCT devices
culosis and hepatitis C.15–18 should have several key components, which include (1) the
There is, of course, a challenge in meeting all of these operator interface, (2) barcode identification systems, (3) sample
needs, and the final product inevitably is a compromise. and reagent delivery mechanisms, (4) reaction cell, (5) sensors,
Hsieh and colleagues have described the importance of un- (6) control and communications systems, and (7) data man-
derstanding user needs in relation to testing for human im- agement and storage. The main objectives of the design are to
munodeficiency virus (HIV) and chlamydia to arrive at the (1) enable the required reaction to take place that facilitates
best possible compromise of sensitivity versus TAT versus recognition of the analyte of interest, (2) ensure reliable per-
price.19 Clinical needs assessment exercises such as this should formance of the device over a period of time, and (3) minimize
be conducted and revisited throughout the entire product the risk of error in the use of the device and within a wide
development process in other areas of POCT to produce de- range of environmental settings (e.g., temperature, humidity).
vices that better meet user needs.13
Some of the requirements of POCT in the developed Operator Interface
world are likely to be different than those in the ASSURED The operator or user interface for a POCT device should
criteria. For example, connectivity to information systems, (1) require minimal operator interaction, (2) guide the user
including the patient health record, is a growing requirement through the operation, (3) indicate whether any key steps
TABLE 30.1 Classification of Types of Point-of-Care Testing Instruments and Devices

Type of Technology Analytical Principle Analytes
Small handheld, single-use Reflectance Urine and blood chemistry
POCT devices Lateral-flow or flow-through immunoassays Infectious disease agents, cardiac markers, hCG
Small handheld, single-use Reflectance Glucose
POCT devices with a Electrochemistry Glucose
monitoring device Reflectance Blood chemistry
Light scattering or optical motion Coagulation
Lateral-flow, flow-through, or solid-phase Cardiac markers, drugs, CRP, allergy, and fertility
immunoassays tests
Immunoturbidimetry HbA1c, urine albumin
Spectrophotometry Blood chemistry
Electrochemistry pH, blood gases, electrolytes, metabolites,
Fluorescence, electrochemistry with PCR infectious agents
Larger cartridge-type and Electrochemistry pH, blood gases, electrolytes, metabolites
bench-top POCT devices Fluorescence pH, blood gases, electrolytes, metabolites
Multiwavelength spectrophotometry Hemoglobin species, bilirubin
Time-resolved fluorescence Cardiac markers, drugs, CRP
Electrical impedance CBC
Polymerase chain reaction Bacteria and viruses
CBC, Complete blood count; CRP, C-reactive protein; HbA1c, glycated hemoglobin; hCG, human chorionic gonadotrophin; PCR, polymerase
chain reaction; POCT, point-of-care testing.
have not been completed correctly, and (4) include identify- Pull tab
ing the (a) operator, (b) patient, (c) test to be measured, and (pull to release
buffer from tray)
(d) reagent lot number and date/time of testing.
Advances in information technology (IT) and consumer
electronics have had a major impact on this area. Other Cartridge removal
Capillary
handle
forms of user interface include keypads, barcode readers, holder
and possibly a printer. In some devices, the display is the Buffer solution
only means to show the result, but many POCT devices are tray with foil
taking advantage of developments in mobile telephone and Absorbent seal (600 L)
computing technology displays and are rapidly adding more (picks up
all liquid at
sophisticated touch screens that can be used for many differ- test end)
ent functions. Agglutinator
Antibody—
Barcode Identification Systems 1-L blood latex
Many POCT devices incorporate barcode reading systems sample
for a number of purposes. These include (1) identifying Optical read
the reagent package to the system (whether it is a single- window
Oxidant
use disposable or a multi-use reagent pack–based system),
(2) incorporating factory calibration data, and in some cases FIGURE 30.2 Schematic diagram of the Siemens DCA 2000
(3) programming the instrument to process a particular test HbA1c immunoassay cartridge. (Courtesy Siemens Healthcare.)
or group of tests. Some POCT devices use magnetic strips as
a way of storing similar information, such as lot-specific cali-
bration data. Other functions of the barcode reader include glycated hemoglobin. To simplify the user interface, it is often
the capability to identify both the operator and the patient necessary to design complexity into the reaction chamber.
sample to the system. This provides traceability to the person Advances in fluidics and fabricating techniques have been
who performed the test and links the results to the correct critical to the development of POCT devices22 (for additional
patient. The latter has assumed increasing importance as part information, refer to Chapter 27). As analytical reactions
of patient safety initiatives. All of this information can then have increased in complexity, more reaction cells or zones
be combined with the information on date and time have been added. Thus in the case of molecular tests, different
when the test was performed to give the full identity of the reaction zones may be required for DNA extraction, the am-
specimen when the results are transmitted back to the patient plification reaction, and product detection. In some situa-
record. tions, it may be necessary to remove some of the reaction
constituents downstream from each zone before reaching
Sample Types and Sample Delivery the next reaction zone. There may also be differing reaction
The vast majority of POCT devices to date have used whole temperature requirements for each reaction zone. Another
blood or urine specimens; in the case of blood, this com- consideration in the design of reaction cells is to ensure that
monly involves a capillary or fingerstick sample. In this way, the requisite mixing of sample and reagents occur, which may
the sample can be introduced to the POCT device directly. be critical when using very small volumes.
Alternatively, a venous specimen can be collected and a small
sample removed for POCT; in some cases, especially with Sensors
critical care analyzers, the blood collection tube can be in- Much of the development focus in POCT devices has been
serted directly into the POCT machine. Many POCT urinaly- concerned with the advances in sensor design of which there
sis devices can be dipped into the specimen, but this is much are various types.23 A chemosensor is one where the analyte
less common for POCT blood devices. has an intrinsic property, such as electrochemistry, that en-
Looking to the future, there are devices that are designed ables it to be detected without a recognition element. More
for use with tears and interstitial fluid specimens. Sample ac- commonly, chemosensors used in many POCT devices have
cess and delivery of the sample to the actual sensing compo- a transducing element such as a chemical indicator or bind-
nent of the strip, cassette, cartridge, or fluidic cell are also key ing molecule that recognizes the analyte to be measured and
interactions of the user—and an opportunity for errors to be produces a signal, usually electrical or optical. A biosensor is
made. Ideally, after the addition of the sample, there should distinguished from a chemosensor by having a biological or
be no further need for operator intervention,20 and devices biochemical component as the recognition element. Enzymes
are now available that minimize the degree of interaction to are the most common biological element used followed by
the point where a closed tube has simply to be placed in a antibodies and nucleotides; transduction typically is via an
holder and the instrument automatically performs all other optical or electrical signal. More detail about sensor design
functions.21 can be found in Chapter 17.
Reaction Cell Control and Communications Systems

The design of the location where the analytical reaction takes In even the smallest device, there is a control subsystem that
place varies from a simple porous pad to a microfluidic car- coordinates all the other systems and ensures that all the
tridge or surface within a cartridge. An example of a cartridge required processes for an analysis take place in the correct
type of design is shown in Fig. 30.2, which shows a cross- order. Operations that require control include (1) insertion
section through the Siemens DCA cartridge that measures or removal of the strip, cartridge, cassette, or reagent;
(2) temperature control; (3) sample injection or aspiration; the patient). Although avoiding these additional steps is con-
(4) sample detection; (5) reagent addition, especially in a venient, there is the potential for error, and procedures need
fluidic-based system (6) mixing; (7) timing of the detection to be designed to reduce the risk of such errors.
process; (8) detection of measurement signal; and (9) waste Single-pad and multipad strip tests. Strip tests are single-
removal. Fluid movement is often accomplished by mechani- pad or multipad devices that can measure up to 10 different
cal means through pumps or centrifugation and by fluidic analytes using reflectance technology. They are relatively
properties, such as surface tension; the latter is often a critical simple in construction and are composed of a pad of porous
element in the design of the simple strip tests and in micro- material, such as cellulose, that is impregnated with reagent
fabricated systems.22 and then dried.28 Samples are added to the device either by
dipping (as, typically, in the case of urine analysis) or by spot-
Data Management and Storage ting (as, typically, in the case of blood glucose analysis). In the
IT is as crucial to POCT devices as sensing technology. IT latter case, there has been a gradual transition from optical to
includes data management of calibration curve data and electrochemical detection, avoiding the need to wipe the strip
quality control (QC) limits and patient results. In some sys- to remove the red cells before measurement. A critical opera-
tems, data transfer and management take place when the tor factor when spotting the sample on to the pad is the need
meter or reader is linked to a small bench-top device called a to apply a sufficient but not superfluous amount of sample.
docking station, but more commonly these days, devices use In addition, because assay readout is sensitive to reaction
wireless technology to communicate. These and other devices timing, it is necessary to time the period between placing the
include communication protocols that allow data to be trans- sample on the pad and reading the result. The timing issues
ferred to other data management systems, to electronic med- can be overcome in some instances with internal timer in the
ical records, and to other mobile computing devices.24–26 device.
Multilayer pads. More complex pads are composed of
Manufacturing of Point-of-Care Testing Devices several layers, the uppermost of which is a semipermeable
Because many POCT devices are single use and discarded, membrane that prevents red blood cells (RBCs) from enter-
reproducibility of manufacture is a key requirement so that ing the matrix. Again, with these devices, a critical operator
consistent performance extends across a large number of factor is the need to cover the whole pad with the sample. In
strips or devices. The manufacturing process includes steps addition, because the reactions often do not proceed to
that are taken to ensure that the devices are reproducible and completion, it is necessary to time the period between placing
remain stable during transit and storage for the stated period the sample on the pad and comparing the resulting color
of time.27 with a color chart. Developments of these single-stick devices
include the inclusion of two pads. These are used for mea-
Types of Existing Point-of-Care Testing Technology surement of (1) different concentrations of the same analyte,
For the purposes of this review, POCT devices are classified such as hemoglobin and glucose,28 and (2) both albumin and
into (1) small, quantitative handheld devices that often use creatinine (semiquantitative) to provide an albumin-to-
qualitative or quantitative strips or similar technology but creatinine ratio.29 Table 30.2 lists some of the tests performed
with a reader device and (2) larger bench-top devices that are by single-pad and multipad dipsticks and the chemistry used
often variants of ones used in conventional laboratories. This for analysis.
classification is somewhat arbitrary because there is no sharp Immunostrips. These are biologic sensors in which the
demarcation between the types. There are gradations in both recognition agent is an antibody that binds to the analyte.
size and internal complexity of devices, although differentia- Detection of the binding event or signal transducer is usually
tion can sometimes be made on the need for external power. via an optical mechanism, either reflectance or fluorescence
The clear trend is for devices becoming smaller and more spectrophotometry, although visual inspection has also been
capable. All the technologies described here are established used. Immunosensors usually use solid phase technologies in
commercially, sometimes for several decades, but the con- conjunction with (1) flow-through or (2) lateral-flow (also
cluding section briefly mentions some emerging technologies often referred to as immunochromatography) processes. In
that are likely to become commercial products. the flow-through format, a heterogeneous immunoassay
takes place in a porous matrix cell that acts as the solid
Small Handheld, Single-use Point-of-Care phase, capturing the bound label as the reaction mixture
Testing Devices (sample and reagents) passes through the matrix.30 In lateral
Many POCT devices fall into this category, including flow, the separation stage takes place as the reaction mixture
(1) single-pad or multipad tests that are read visually by (sample and reagents) passes along the porous matrix.31 In
reflectance photometry or electrochemically, (2) more com- all of these different formats, uniform and predictable flow
plex pads that use light reflectance for measurement, and of the sample through or along the solid phase matrix is a
(3) fabricated cassettes or cartridges that incorporate meth- major determinant of the reproducibility of the technique.
odologies such as immunochromatography, and are used as Therefore the choice of matrix and how it interacts with the
immunosensors. All of these devices are truly portable, and sample are of particular importance, and advances in the
for that reason, the way they are used operationally, often understanding of solid phase and surface chemistry technol-
immediately by the patient, is different to larger bench-top ogy have made major contributions to the development of
devices (e.g., devices that require application of a whole immunosensors.32
blood sample such as a glucose strip often obviate the need An example of immunosensor technology is shown in
for sample containers, labeling, or transport compared with Fig. 30.3. In this device, the blood sample is added and first
larger POCT instruments, which may be some distance from flows through a glass fiber fleece, which separates the plasma
TABLE 30.2 Examples of Single-Pad or Multipad Stick Tests

Test Sample Chemistry
Acetaminophen Whole blood Aryl acylamide amidohydrolase
Alanine aminotransferase Whole blood Alanine/glutamate
Albumin Whole blood, urine Dye binding
Cholesterol Whole blood Cholesterol oxidase
Creatinine Whole blood, urine Copper complexation
Glucose Whole blood Glucose oxidase
Lactate Whole blood Lactate dehydrogenase
Uric acid Whole blood Uricase
Alcohol Urine Alcohol dehydrogenase
Bilirubin Urine 2,4-Dichloroaniline
Hemoglobin Urine Peroxidase activity
Leukocyte esterase Urine Pyrrole amino ester hydrolysis
Ketones Urine Sodium nitroprusside reaction
Nitrite Urine p-Arsanilic acid reaction
pH Urine Double-indicator principle
Protein Urine Protein error of indicators
Specific gravity Urine Polyacid pH change
Urobilinogen Urine Ehrlich’s reaction
Application zone Detection zone
150 L of blood
cTnT
Signal Control
Gold-
labeled
antibody
cTnT cTnT cTnT
Biotin-
ylated
antibody Fleece Strept- Synthetic
avidine peptide
Immunoreaction: Binding of Binding of

formation of sandwich sandwich gold-labeled
complexes complexes antibodies
FIGURE 30.3 Schematic diagram of a lateral flow immunoassay strip for cardiac troponin T (cTnT).
(Courtesy Roche Diagnostics International Limited Copyright.)
from whole blood. Simultaneously, two monoclonal antihu- shows that the sample has flowed along the test strip and the
man cardiac troponin T (cTnT) antibodies, one conjugated device has performed correctly.33,34
to biotin and one labeled with gold particles, bind to the tro- Although the majority of quantitative lateral flow immu-
ponin T in the sample. The antibody-troponin complex then noassay devices measure only a single analyte at a time, some
flows in a lateral direction along the cellulose nitrate test strip can measure a panel of analytes, such as (1) cardiac mark-
until it reaches the capture zone, which contains streptavidin ers,35 (2) fertility tests,36 and (3) drugs of abuse.37 In these
bound to a solid phase. The biotin in the antibody-troponin devices, a mixture of antibodies is immobilized at the origin,
complex binds to the streptavidin and immobilizes the com- and complementary antibodies for the various analytes are
plex. The complex is then visualized as a purple band by the immobilized at varying positions along the porous strip. In
gold particles attached to one of the antibodies. The unre- the case of drugs of abuse, devices are designed such that
acted gold-labeled antibody moves farther down the strip, positive responses are obtained only if the concentration is
where it is captured by a zone containing a synthetic peptide greater than a precalibrated cutoff value.37 Another design
consisting of the epitope of human cTnT and is visualized as variation is to take advantage of the competition between the
a separate but similar colored band. The presence of this sec- target analyte and an analyte conjugate for antibodies. In this
ond band serves as an important quality indicator because it case, the analyte conjugate is immobilized close to the origin,
and the specimen is mixed with antibodies before being ap- photometric or electrochemical signal and the concentration
plied to the strip. This design is well suited for semiquantita- of glucose. More recently, strips that do not require coding
tive applications with well-defined cutoff concentrations.38 have become more commonplace, and this advance has been
facilitated by the development of electrochemical glucose
Small Handheld, Single-use Point-of-Care Devices strips. These are composed of an Ag-AgCl reference electrode
With a Monitoring Device and a carbon-based active electrode, both manufactured us-
Glucose measurement. Clinically, POCT is most fre- ing screen printing technology with the ferrocene or its de-
quently used to measure glucose. These devices are biosen- rivatives contained in the printing ink.40 The conversion of
sors because they all use an enzyme as the recognition agent, glucose is accompanied by the reduction of ferrocene and the
which is glucose oxidase (GO), hexokinase (HK), or glucose release of electrons (Fig. 30.5). Continuing innovations such
dehydrogenase (GDH), with photometric (reflectance) or as this have also facilitated the production of smaller meters,
now increasingly electrochemical detection.39 nonwipe strips, less need to clean instrument optics, more
In general, all modern glucose strips are a form of what rapid results, and smaller sample volumes.
is called thick-film technology in that the film is composed Although electrochemical systems have enabled the design
of several layers each having a specific function. These of strips that are less subject to interferences, problems still
are shown diagrammatically for a reflectance-based strip in persist. Strips that use GO are more substrate specific but are
Fig. 30.4. When blood is added to a strip, plasma passes into affected by oxygen tension and high partial pressure of oxygen
the film or analytical layer. For some photometric systems, (PO2), leading to falsely low results.41 Blood oxygen tension
erythrocytes must be excluded, and these processes are does not affect GDH-based strips, and genetically engineered
achieved by what is called the spreading or separating layer GDH strips are free from interference by maltose, which
that contains various components, including glass fibers, plagued earlier versions. Hematocrit is another important in-
fleeces, membranes, and special latex formulations. In photo- terference, the effects of which have been reduced by some
metric systems, a spreading layer is also important for the fast newer strip designs. Many different factors can lead to inac-
homogeneous distribution of the sample; electrochemical curate glucose results from strip tests; a comprehensive review
strips use capillary fill systems. The support layer is usually a of them is provided by Tonyushkina and colleagues.42
thin plastic material that in the case of reflectance-based The ubiquitous application of glucose meters has led to
strips may also have reflective properties. Additional reflec- the publication of guidelines stipulating the required accu-
tance properties have been achieved through the inclusion of racy of meters as compared with laboratory results. This is
substances such as titanium oxide, barium sulphate, and zinc particularly important when meters are being used to guide
oxide. insulin regimens and achieve tighter glycemic control. Data
Glucose strips are produced in large batches, and, after by Karon and colleagues43 show how insulin dosing errors
extensive quality assurance procedures, each batch is given a can arise from inaccurate meters, and this has led to calls for
code that is stored in a magnetic strip on the underside of tighter accuracy standards to prevent such errors occurring.
each test strip. This code describes the performance of the Although it is possible that continuing innovation will lead to
batch, including the calibrating relationship between the meters and strips that can meet these more demanding goals,
it should also be recognized that tight glycemic control itself
remains controversial.
International normalized ratio measurement. Another com-
Sample
mon meter type device used by patients at home and by
Light source applied Reflected light
health care providers in clinics is that used to monitor warfa-
rin or Coumadin therapy and measure PT reported as INR
Spreading Glucose Glucose

Ferrocene
layer Oxidase
FAD
Electron
Analytical Glucose Ferrocene +
Glucono-
layer lactone Oxidase
Carbon
FAD+
Silver
Electron
Reflective layer
6.0
Meter
mmol/L
FIGURE 30.5 Schematic diagram of the reactions taking place
in a MediSense electrochemical glucose strip. FAD, Flavin ade-
Support layer
nine dinucleotide. (Modified from Henning TP, Cunningham TP.
Biosensors for personal diabetes management. In: Ramsay G,
FIGURE 30.4 Schematic diagram of the components which ed. Commercial Biosensors. New York: John Wiley & Sons:
make up a typical reflectance-based glucose strip. 1998:3–46.)
values. First devised some 2 decades ago, a number of differ- Handheld integrated cartridge technology. The prime ex-
ent technologies have been developed to measure INR at ample of this type of technology is the i-STAT analyzer
point of care, including optical and electrochemical detec- (Abbott Point of Care, Princeton, NJ), a handheld device
tion. Innovation has been applied both to the strip, where a originally designed to measure blood gases but now with
drop of blood is placed, and to the meter into which the strip a considerably extended menu that includes electrolytes,
is placed. Historically, early systems used magnets to detect glucose, creatinine, coagulation parameters, and cardiac
the decrease in sample flow or movement that results from markers.47 In contrast to the thick-film technology described
the clotting process, but this required careful timing and a earlier, the single-use sensors in this device are constructed
large blood sample while an alternative technology used opti- using thin-film technology. The latter involves microlitho-
cal sensors to monitor the decrease in sample speed flowing graphic processes to deposit thin layers of 1 to 10 mm thick
through a sample channel as the clot forms. Speckle detection (as opposed to 10- to 50-mm thick layers in thick film tech-
technology has also been used to measure (1) PT, (2) activated nology) similar to the construction of computer chips and
partial thromboplastin time (APTT), and (3) ACT. In this ap- other silicon-based devices. The techniques such as sputter-
proach, the instrument contains an infrared light source that ing or chemical vapor deposition that are used to make these
directs a coherent light beam onto the oscillating sample. The devices including the electrodes and sensors of the i-STAT
movement of the RBCs in the blood results in the refraction of device are highly reproducible but require sophisticated and
the light to produce an interference or “speckle” pattern that is expensive manufacturing facilities.48 Each single-use i-STAT
recorded by the photodetector. This “speckle” pattern changes cartridge contains an array of electrochemical sensors for a
when the capillary flow slows as the sample clots. The time it set of particular analytes, and it is operated in conjunction
takes for this to happen is a measure of the clotting time. with a handheld reading device. Because the sensor layer is
Newer detection technologies use electrochemical mea- very thin, blood permeates this layer quickly, and the sensor
surements. In the HemoSense device (Alere, Waltham, MA), cartridge, when it reaches room temperature if it has been
clotting is detected by change in impedance (Fig. 30.6),44 and refrigerated, can be used immediately after it is unwrapped
in a Roche device (Roche Diagnostics, Basel, Switzerland), a from its packing. This is an advantage over some thick-film
change in current is detected.45 Both devices incorporate in- sensors that require an equilibration or wet-up time before
built QC systems that are activated when a patient sample is they are used to measure blood samples. With the extended
placed on the strip. In the case of HemoSense, the strip has menu through the provision of different cartridges, this de-
three channels, one for the patient test and the other two for vice has proven popular because its operation is similar for all
different concentrations of internal QC material. All of these analytes, thus avoiding the inconvenience and potential er-
innovations have improved the reliability of these devices to rors that may occur with multiple different instruments.
the extent that a systematic review of the literature on the Furthermore, it represents a potentially economical solution
quality assessment of devices for self-monitoring indicated to the need for providing low sample numbers of critical
that they generally provide comparable results to laboratory- analytes.
generated INR values.46 A disadvantage of thin-film technology is that manufac-
turing costs are high because of the need for special clean air
facilities. Thus more recent technology to measure blood
gases and related parameters uses less costly, so-called smart
card technology. Fig. 30.7 shows two views of the Epoc test
Electrodes card, which is manufactured on a 35-mm tape on reel format;
on the right is the top view of the test card showing the
sample entry port, the sealed calibrator reservoir, and the
sensor module at the top; on the left is the bottom view of
the card with the sensor module where measurements take
Test area place, and below this are details of the test panel. The Epoc
system (Siemens Healthineers, Ottawa, Canada) is used in
conjunction with a handheld analyzer, and it also can provide
a range of critical care tests, including immunoassay measure-
ment,49 with the advantage of operators having to be familiar
only with the use of a single device.
Larger Cartridge Type and Bench-top Point-of-Care

Sample well Testing Devices
This section includes a wide range of devices that are all
quantitative and not handheld but vary considerably in size.
The smaller ones typically incorporate small, compact detec-
tors, such as a charge-coupled device (CCD) camera that is a
INR
HemoSense multichannel light detector, similar to a photomultiplier tube
in a spectrophotometer, but it detects much lower signals at
low levels of light. This type of technology enables quantita-
tive measurements of lateral-flow immunoassay strips and is
FIGURE 30.6 Schematic diagram of the HemoSense prothrom- incorporated in the many different POCT devices of this type
bin time trip. INR, International normalized ratio. (Courtesy Alere.) that are available on the market.
Sensor module Measurement region

Sensor module
Valve
Blood waste chamber

Barcode
Sealed calibrator module
Sample entry port
Test card—bottom Test card—top

FIGURE 30.7 Epoch test card for blood gas analysis. (Courtesy Alere.)
Cartridge-type devices. A number of single-use, quantita- a simple user interface that enables easy application of whole
tive POCT devices are available that use a cassette or cartridge blood to the reagent cartridge or discs. After placement into
design rather than lateral-flow strips. Several cassette-based the instrument, the analysis proceeds without further in-
systems have been developed for measurement of hemoglobin. volvement of the operator. Several evaluations have shown
In one such system, RBCs are lysed in a minicuvet, hemoglobin that all three instruments meet the required analytical perfor-
is converted to methemoglobin, and the methemoglobin is mance for both HbA1c and lipid monitoring.51–53 The most
measured at 570 nm; turbidity is corrected for by an additional recent of these instruments is also considerably smaller and
measurement at 880 nm.50 that trend is likely to continue, facilitating their use in a vari-
Another type of cartridge design uses a light-scattering ety of locations where space is often at a premium.
immunoassay to measure glycated hemoglobin (HbA1c), to- Small desktop instruments. A typical example of these is
gether with a photometric assay for total hemoglobin. The the Piccolo (Abaxis, Union City, CA), which can measure a
cartridge is a relatively complex structure that contains all the wide range of general chemistry analytes on a very small
reagents required for the immunoassay and lysing reagents sample volume. It uses a small disposable rotor that contains
and potassium ferricyanide reagent for measurement of total all the required reagents and diluents to perform a battery of
hemoglobin (see Fig. 30.2). Agglutination takes place be- common chemistry tests such as the Comprehensive Meta-
tween the latex-bound antibody and a synthetic polymer that bolic Panel.54 The rotor also serves to centrifuge and separate
contains the immunoreactive portion of HbA1c, which leads whole blood samples, which are then mixed with reagent
to increased scattering of light. Addition of HbA1c in the pa- beads. The instrument monitors reaction products spectro-
tient sample reduces the agglutination by competing for the photometrically to calculate and print the results.
latex bound antibody, and the reduction in light scattering is The Radiometer AQT 90 (Bronshoj, Denmark) bench-top,
proportional to the concentration of HbA1c. random access immunoassay analyzer uses a proprietary
Measurement takes place when the cartridge is placed into dry-chemistry concept and a detection method based on
a temperature-controlled reader, and the analytical perfor- europium nonenhanced time-resolved fluorescence (TRF)
mance of the Siemens DCA device (Siemens Healthineers, technology. The AQT 90 has a unique, walk-away, closed-
Munich, Germany) is sufficient for quantitative monitoring tube sampling device (Fig. 30.8) from which the instrument
of glycemic control and can also be used for measurement of dispenses sample into a cup containing dried reagents in-
urinary albumin and creatinine.51 Increasingly more diabetes cluding antibodies to the analytes of interest and europium
care is being delivered closer to the patient in various health lanthanide chelate as the signal reagent.57 The europium-
care settings outside of the hospital, and this has driven the based chelates have certain natural advantages that allow
production of other POCT devices that can measure diabe- sensitive and rapid detection methods. Analysis takes place
tes-related analytes. In addition to the Siemens DCA, there is in a small reagent cup on which are immobilized biotinylated
the Affinion (Abbott Point of Care, Princeton, NJ) which has capture antibodies and streptavidin and europium-labeled
a similar menu to the DCA, and adds C-reactive protein tracer antibodies. After addition of the patient sample and
(CRP)52 and more recently the Roche Cobas b101 (Roche incubation, an antibody-antigen-antibody “sandwich” com-
Diagnostics, Basel, Switzerland), which can measure HbA1c plex is formed, and after washing and drying, the europium
and lipids.53 The three devices share common features such as response to excitation light is measured, the amount of which
intervals. These include packs or bottles of QC material that

are contained within the instrument and sampled at prede-
termined intervals with on-board software interpreting the
results and generating alerts, if necessary. Such devices also
have the capability to be remotely monitored and pro-
grammed to respond to problems on instruments located
long distances from the central laboratory.66 Box 30.3 shows
the various features that are incorporated into a critical care
analyzer that contribute to its ease of use and reduce the po-
tential for errors.
Hematologic and immunologic testing analyzers. Small bench-
top devices are currently available to perform hematologic
and immunologic analysis at the point of care. Again, they are
often scaled-down versions of laboratory instruments, but
these modified instruments have also been reduced in com-
plexity, thus also reducing the risk from misoperation by
nontechnically trained staff. The range of hematology instru-
FIGURE 30.8 Touchscreen and sample port of the Radiometer ments include ones that measure just hemoglobin and white
AQT Flex analyzer. (Courtesy Radiometer, Copenhagen.) cell counts to the Sysmex pocH-100i (Sysmex, Lincolnshire,
IL), which can report up to 17 parameters.67 An instrument
with similar capabilities is the QBC Star (Drucker Diagnos-
is directly proportional to the antigen present. The menu in- tics, Port Matilda, PA), which is a so-called dry hematology
cludes troponin, brain natriuretic peptide (BNP), D-dimer, system, using dry reagents as opposed to bulky wet reagents,
b-human chorionic gonadotropin (hCG), and CRP. thus lending its use to POCT locations. The instrument
Critical care testing analyzers. These remain the most can produce a nine-parameter blood count using a special
commonly used type of POCT bench-top analyzers with hematocrit tube system. A recent evaluation showed compa-
their expanded menu of analytes with the potential for use in rable measurements with that of a conventional laboratory
many clinical areas. These devices use the same type of thick- analyzer, and it was deemed suitable for use outside of the
film sensors or electrodes in strips as described earlier, but in laboratory.68
this case, the sensors are designed to be reusable.58 They are Another relatively new product is the PIMA device
manufactured from thick films of paste and inks using (Abbott Point of Care, Princeton, NJ), which is small enough
screen-printing techniques to produce individual or multiple to be used for POC measurement of T-helper cells, or CD4
sensors for metabolites, blood gases, and electrolytes. Further counts. The PIMA uses the same imaging and cell counting
details of the analytical principles behind these sensor tech- technology used in laboratory instruments but redesigned
nologies can be found in Chapter 17. The sensors have been into a smaller, more compact instrument, which is simple to
incorporated with reagents and calibrators into a single car- operate. These measurements are essential to guiding antiret-
tridge or pack, which is placed in the body of a small- to roviral therapy for HIV and monitoring the course of
medium-sized, portable critical care analyzer. Each pack con- immunosuppression. All of the required reagents including
tains reagents sufficient to measure a certain number of labeled antibodies to CD3 and CD4 antigens are contained in
samples during a certain time period, after which it is rela- a small disposable cartridge to which is added 5 mL of whole
tively simple to replace. An example of such a device is the blood, with the cartridge then being inserted into a small
GEM Premier 4000 (Instrumentation Laboratory, Bedford, battery-powered desktop instrument. After mixing of the
MA), and Fig. 30.9 shows the components and the fluid and sample with the reagents and incubation, fluorescence is
patient sample pathways within this instrument. Evaluations measured in the stained sample by a CCD camera, and the
of several different cartridge-based devices are available in results are displayed on the screen. Several evaluations both
the literature.59–62 in developed and emerging markets show that this instru-
These devices can also measure the various hemoglobin ment in the hands of non–laboratory-trained personnel
species and perform co-oximetry determinations. The latter provides a comparable quality of results with those obtained
relies on multiwavelength spectrophotometry in which light from the central laboratory.69,70 By providing CD4 results at
absorption by hemolyzed blood is measured at up to 60 or point of care, there is the potential to significantly improve
more wavelengths to determine the concentration of the five treatment by offering prompt therapy to those in need.
hemoglobin species.63 Multiwavelength spectrophotometry Molecular diagnostic analyzers. The so-called Lab on a
can be extended to measure bilirubin directly in whole Chip (LOC) concept has been translated into devices for tar-
blood.64 Details of the analytical principles of co-oximetry geted measurement of nucleic acids at the point of care,
are given in Chapter 37. particularly for detection of infectious agents. LOC devices
Other key developments in critical care instruments in- have grown from the microelectronics industry through
clude liquid calibration systems that use a combination of techniques of miniaturization and microfabrication,71 incor-
aqueous base solutions and conductance measurements to porate features such as microfilters, microchannels, microar-
calibrate the pH and PCO2 electrodes, with oxygen being rays, micropumps, microvalves, and bioelectronics chips, and
calibrated with an oxygen-free solution and room air.65 In perform analysis at microscopic scales (i.e., 1 to 500 mm).71
addition, automated QC packages are integrated into these One such device commercially available is the Cepheid
analyzers that ensure that QC samples are analyzed at regular GeneXpert system (Cepheid, Sunnyvale, CA). Although a
Process Reference
control Sample port solution
solution A
Lysing
solution
Peristaltic
Process pump
control
solution B Waste bag
Process “T”
Connector
control Five-way
solution C Waste
rotary valve
Process
control tBili/CO-Ox
solution D optical cell
Sample Reference Waste Lysing
Diverter
valve
Reference
Hct
Gnd Mixing
valve
O2 CI Na+ Ca++ K+ pH CO2 Lac Glu Sensor card
FIGURE 30.9 Schematic diagram of the components and fluidic pathways of the GEM Premier 4000
critical care analyzer. Gnd, Ground; Hct, hematocrit; Lac, lactate; Glu, glucose. (Courtesy Instrumenta-
tion Laboratory.)
BOX 30.3 Features of Critical Care sizeable benchtop device, its ability to perform real-time quan-
Analyzers That Contribute to Ease of Use titative polymerase chain reaction (PCR) in approximately
and Reduce the Risk of Errors 90 minutes with minimal operator interaction means that it of-
Long-life, maintenance-free electrodes or disposable sensor
fers the potential to perform rapid molecular testing in situations
packs
when the need for results is urgent.72 The system uses single-use
Touch screens as the user interface
cartridges that each contain multiple chambers to hold the
Software that can demand user and patient identification
sample; various purification and elution buffers, and all the PCR
Built-in barcode scanners
reagents, including enzymes. In addition, all waste is retained
Sample aspiration instead of injection
within the cartridge. Attached to the cartridge is a PCR tube
Reduced sample sizes
around which are heating and cooling tubes together with opti-
Clot detection within analysis chamber
cal blocks that perform the amplification and fluorescence-
Sample detection to prevent short samples
based detection of the products. Within the cartridge is a
Liquid calibration systems instead of gas bottles
syringe body designed in such a way to virtually eliminate
Automated calibrations
sample contamination. Through a series of valves in the syringe,
Automated quality control sampling
sample is moved through the various stages of the PCR process
Sophisticated quality control programs, including interpreta-
using the reagents stored in the cartridge and culminating in
tion of data
real-time detection of the amplified products.73 Due to the sen-
Connectivity to information systems, allowing remote moni-
sitivity conferred by nucleic acid amplification, molecular diag-
toring and control
nostic analyzers are able to overcome the limited sensitivity of
Training videos incorporated
traditional lateral flow assays, which is an advantage for some
clinical applications, including infectious disease detection.
Several evaluations have been performed of the GeneX- seen them refined and packaged into smaller devices, and, in
pert system for a number of clinical applications, including many cases, there has been an improvement in analytical
infectious and sexually transmitted diseases, using various performance and a reduced risk of error. That trend in incre-
sample types. Thus Spencer and colleagues74 showed the mental improvements will continue because no device is risk
GeneXpert system had 100% sensitivity and specificity for free, and, in some cases, there remains a need for better ana-
methicillin-resistant Staphylococcus aureus in pediatric speci- lytical performance. In addition, the search for fundamen-
mens, and Buchan and colleagues75 tested stool specimens tally different technologies continues because there are
and demonstrated near perfect sensitivity and specificity for known limitations to existing technologies. For example, lat-
Clostridioides difficile detection. An economic-based analysis eral flow strip technology continues to dominate the POCT
of tuberculosis testing showed that the GeneXpert system was market, but lateral flow strips have a number of limitations,
also cost effective.76 including inadequate sensitivity and difficulty with multiplex
More molecular diagnostic point-of-care analyzers have or measurement of more than two or three analytes on the
been commercialized in recent years, such as the binx io same strip. Some emerging and growing POCT technologies
(Binx Health, Trowbridge, Wilts, United Kingdom), Alere i are summarized in a review (Table 30.3).13 These encompass
(Abbott Point of Care, Pricenton, NJ), Roche Cobas Liat (Roche innovations in multiple aspects, including specimen types
Diagnostics, Basel, Switzerland), Biofire FilmArray (Biofire and acquisition method, testing methods, fabrication, detec-
Diagnostics, Salt Lake City, UT), and Biocartis Idylla (Biocartis, tion technologies, connectivity and integration of analyzers,
Mechelen, Belgium). The binx io system consists of a test- choice of materials, data processing methods, and testing
specific disposable cartridge containing all the necessary menu. The overall trend of the innovations in the POCT field
reagents to perform the test (Fig. 30.10) and uses a number is to facilitate more convenient, accurate, and cost-efficient
of electrochemical labels.77,78 Most of these platforms still measurement of a broader range of analytes near the patient.
require electricity and are best suited for the physician’s office Another notable trend is to transition from in vitro and
or central laboratory setttings. There are also platforms that snapshot-based analysis to more continuous and real-time
are powered by batteries or laptops/tablets and target in-field monitoring. Continuous glucose monitoring systems are al-
POC use. Some examples include GeneXpert Omni (Cepheid, ready available in which glucose measurements in interstitial
Sunnyvale, CA), and QuantuMDx Q-POC (QuantuMDX, fluid are fed back to a monitor linked to an insulin pump.82
Newcastle upon Tyne, United Kingdom). Isothermal amplifi- Contact lens sensors that detect glucose in tears have also
cation instead of PCR is used in some of these platforms to been described,83 and other promising technologies include
decrease temperature cycling control requirements. tattoo-based sensors84 and smart holograms.85 Clearly,
changes in analyte concentrations may vary in different body
Newer and Emerging Point-of-Care Testing Technologies fluid compartments, so this will have to be taken into account
Many of the technologies that have been discussed earlier when designing and developing analytical technologies, as
were devised several decades ago. The intervening time has well as performing clinical validation studies.
Four electrochemical
Sample detection
addition and Capture
chambers
lysis chamber column
Exit to waste
chamber
Coarse filter and Two PCR

Elution
internal control reaction
chamber
DNA addition chambers
FIGURE 30.10 Schematic diagram of a microfluidic card using a molecular test for Chlamydia tracho-
matis. PCR, Polymerase chain reaction. (Courtesy Atlas Genetics Ltd., Bristol, United Kingdom.)
TABLE 30.3 Point-of-Care Testing These standards are incorporated in a Clinical and Labora-
tory Standards Institute (CLSI) approved standard “Point-of-
Growth Points and Emerging Trends Care Connectivity: Approved Standard—Second Edition.
Specimen CLSI Document POCT01-A2,”87 and the potential benefits of
Type Breath (volatolomics), interstitial fluid POCT connectivity and what users should look for in
Acquisition Painless sampling POCT01-A2–compliant devices have been described by
the CLSI in POCT02-A.25 Adherence to these connectivity
Testing standards ensures that POCT devices meet critical user
Noninvasive Infrared-based testing requirements, such as (1) bidirectionality, (2) device connec-
Invasive Micro-needle devices tion commonality, (3) commercial software interoperability,
Continuous Wearables, implantables, insertables (4) security, and (5) QC or regulatory compliance.
monitoring Improved connectivity has enabled two major trends.
Multiplexing Multiple detection zones, multiple First, and primarily because of demand from those respon-
labels, label-free sible for the management of POCT, there has been the devel-
opment of a range of commercial and specialized products
Analyzer for data management of POCT results with software devoted
Fabrication 3D printing to ensuring compliance with procedures and managing
Fluidics Digital microfluidics data.88 These systems offer a range of features and benefits,
Detection Nanopores, nanoelectronics, rapid PCR, which include the ability of central laboratories to both
technologies nuclear magnetic resonance, mass monitor and remotely control their instruments in locations
spectrometry, ultrafast gas chromatog- outside of the main laboratory (e.g., real-time control of
raphy approved operators, reagent, and QC lot information).89
Connectivity Wireless enabled Although these systems are designed to interface primarily to
Integration Plug-in devices for smartphones, tablets, the vendors’ particular instruments, some systems can also
smart watches incorporate competitive products.
The second trend is that connectivity standards, together
Disposables
with less expensive network technology, widespread access to
Paper-based tests 2D and 3D mPads, Bluetooth-enabled
the internet, and smart mobile phones, have provided the
lateral flow
capability to establish POCT networks across major second-
Data ary and tertiary care institutions and perhaps more impor-
Processing Apps, Artificial intelligence, Cloud, tele- tantly to incorporate data collected in the community and in
medicine primary care into the those same POCT networks of major
institutions. The structure of such a typical community
Menu POCT network is shown in Fig. 30.11. Nurses and other care-
Expansion Nucleic acid sequencing and targeted givers working within a clinic can enter test requests via a
testing, marijuana in breath, sperm computer workstation; POCT devices interfaced to the same
count and motility computer workstation can then combine the results with the
test request and patient demographics that are received from
From Wang P, Kricka L. Current and emerging trends in point-of-care a central patient management system. The data are uploaded
technology and strategies for clinical validation and implementation. to a POCT portal website, which provides a central reposi-
Clin Chem. 2018;64(10):1439–1452. tory of all results and patient details that can be accessed for
review and audit as required. It also contains all of the quality
data that are required to ensure that the network meets the
Informatics and Point-of-Care Testing required accreditation standards. The portal also sends com-
Most analytical devices used in clinical laboratories are di- pleted results back to the patient management system that is
rectly linked or connected via an electronic interface to a responsible for delivering results into individual patient re-
laboratory information system (LIS). In this progression, cords. Caregivers can access the results via a computer work-
many different informatics functions are used, including the station or other handheld device such as a smart phone or
electronic transfer of data from the analyzers to the LIS tablet computer. Networks similar to the one discussed ear-
and ultimately into a patient’s electronic medical record. lier now exist in many places and have been described in the
This provides health care professionals with quick, accurate, literature.90–92
and appropriate access to the patient’s medical history and The most important benefit of connectivity remains that
information. of facilitating the transfer and capture of patient POCT and
Considerable effort has been expended to incorporate quality-related data into permanent medical records. Additional
these same processes into POCT devices because of the vital benefits include provision of alerts of abnormal results particu-
importance of capturing analytical data in a patient’s medical larly those that may be critical. However, the increasing ability to
record to avoid the errors associated with manual transcrip- interface devices more easily to other information systems
tion of data.86 Thus newer POCT devices have addressed this should also enable the development of applications that add
problem by incorporating the prerequisite hardware and value to patient data such as the use of decision support software
software into their designs, and in the past decade, so-called to assist with interpretation and therapy. One such example is
connectivity standards have also been introduced that facili- the use of dosing software in combination with POCT INR
tate linking devices to information management systems. measurements to manage patients taking warfarin.93
Medical Clinic
POCT Portal Website
Manual
entry Decision support
appropriate test ordering
Nurse enters a
pathology
test request
POCT portal Electronic Decision support server
client software transfer
Electronic
transfer Interpretation
Transmission of
patient demographics
POCT is
performed Secure electronic transfer via
(all POCT devices third-part messaging provider
supported, including
ECG, INR, and so on) Patient access
to their own
POCT sent back to test results
patient management Electronic POCT portal website
system transfer (provides accreditation)
POCT test and decision support accessed by the doctor

via email, web, or iPad or Android application Summary and deidentified
patient statistics and reporting
FIGURE 30.11 Schematic diagram of a point-of-care testing (POCT) network showing the relation-
ships between the user, POCT device, other health information systems and the patient’s caregiver.
ECG, Electrocardiography; INR, international normalized ratio. (Courtesy R. Tirimacco, ICCNET.)
QUALITY MANAGEMENT BOX 30.4 Assessing the Need for a

Management and maintenance of a POCT service in any
Point-of-Care Testing Service
health care facility require planning, oversight, inventory Which tests are required?
control, and assurance of the reliability of test results through What is the turnaround time required?
adequate training and QC. Several guidelines document these What clinical question is being asked when requesting this
requirements as based on the ISO standard 22870: 2016 test?
(“Point-of-Care Testing [POCT]; Requirements for Quality What clinical decision is likely to be made on receipt of the
and Competence”)94 and are available from various profes- result?
sional laboratory organizations.24 Key aspects of quality What action is likely to be taken on receipt of the result?
management are described next. What outcome should be expected from the action taken?
Why isn’t the laboratory able to deliver the required service?
Establishment of Need Will POCT provide the required accuracy and precision of result?
As with centralized laboratory testing, the decision to imple- Are there staff available to perform the test?
ment a POCT service requires (1) establishment of the un- Are there adequate facilities to perform the test and store the
met need, which may be clinical, operational, or economic equipment and reagents?
in origin; (2) critical appraisal of the evidence supporting Will you abide by the organization’s POCT policy?
the claimed clinical, operational, and economic benefits; and Are there operational benefits to this POCT strategy?
(3) examination of the costs and changes in the clinical pro- Are there economic benefits to this POCT strategy?
cess involved. This will form the foundation on which an Will a change in practice be required to deliver these benefits?
implementation plan is built, together comprising the busi- Is it feasible to deliver the change in practices that might be
ness case (see later in chapter). required?
Addressing the questions listed in Box 30.4 is useful for POCT, Point-of-care testing.
establishing the requirement for a POCT service.11 Answer-
ing them will help to identify the test itself but should also
explain why the current service is not meeting the needs of Organization and Implementation of a Point-of-Care
the patient or the clinician. A risk assessment should also be Testing Coordinating Committee
conducted that will focus primarily on the procedures and When organizing and implementing a POCT service, it is
processes that have to be put in place to ensure the mainte- important to consult with all of the stakeholders. ISO
nance of a high-quality service.95 22870:2016 states that the governing body of the health care
organization should task a health professional grouping BOX 30.5 Elements of a Point-of-Care
(e.g., a Medical Advisory Committee) with the responsibility
of defining the scope of POCT to be made available within
Testing Policy
the organization.94 The laboratory director should establish a Document information—
multidisciplinary POCT management group that is charged • Approved by
with managing the whole process of delivering a high-quality • Scheduled review interval
POCT service. Membership of the POCT management group • Original distribution
should include representatives from the laboratory, clinical • Related policies
services, and the organization’s management team. Labora- • Further information
tory representatives should have expertise in the delivery of • Policy replaces previous one
diagnostic and therapy services close to the patient. Repre- Introduction and background
sentatives from clinical services may include physicians, phy- • Definition
sician assistants, family nurse practitioners, nurses, other • Accreditation of services
health care providers, and patients. Typically, a laboratory • Audit of services
professional will chair the management group because it is Laboratory services in the organization—location
the laboratory that will provide the necessary backup if there • Logistics
is a service failure; furthermore, the laboratory professional • Policy on diagnostic testing
will have had training and expertise in the analytical issues Management of point-of-care testing—management group
that are likely to arise. The POCT management group should and accountability
have a formal reporting line within the health care organiza- • Officers
tion; typically this would be to the medical director or other • Committee members
senior executive officer. The POCT management group • Terms of reference
should designate members who will take responsibility for • Responsibilities
the evaluation and selection of POCT devices, overseeing the • Meetings
training and accreditation of all POCT operators and for QC Equipment and consumable procurement—criteria for pro-
and quality assurance. The work of the management group curement
should be governed by the organization’s policy on POCT. • Process of procurement
Standard operating procedures
Point-of-Care Testing Policy and Accountability • Training and certification of staff—training
Implementation of a POCT service requires a POCT policy • Certification
that establishes all of the procedures required to ensure the • Recertification
delivery of a high-quality service, together with the responsi- Quality control and quality assurance—procedures
bility and accountability of all staff associated with the • Documentation and review
POCT.94 This may be (1) part of the organization’s total qual- Health and safety procedures
ity management system,95 (2) part of its clinical governance Bibliography
policy,95 and (3) required for accreditation purposes.94,95 The
elements of a POCT policy are listed in Box 30.5.
This concordance may be difficult to assess, and it may be
Equipment Procurement and Evaluation necessary to seek endorsements from current users of the
After establishing the requirement for POCT, establishing the systems and possibly conduct some form of internal trial.
POCT management group and writing the organization’s An economic assessment of the planned POCT service,
POCT policy, the next stage in the process is equipment pro- including the cost of consumables and servicing, should also
curement. This involves first identifying candidate POCT be made.24,96 This is likely to be a comparative exercise be-
equipment having the prerequisite analytical and operational tween the various point-of-care systems under consideration.
capabilities to meet the clinical requirements of a POCT ser- Any comparison of costs with the laboratory service will be
vice. A CLSI protocol (CLSI Document POCT09-P. Selection demonstrating only the cost per test, which will not give an
Criteria for Point of Care Testing Devices) describes the fea- accurate assessment of the cost-effectiveness of the system;
tures of the evaluation process,96 and further guidance can be details of the latter exercise are described later in the chapter.
sought from other evaluations described in the literature.97 In However, it is helpful at this point to have a good assessment
addition, the educational and certification requirements of the of the relative staff costs associated with different systems
device operator also have to be identified and the potential because these are likely to be key aspects in the decision-
for operator error determined. Independent validation of these making process. It is probable that the chosen system will be
analytical and operational characteristics is obtained from operated by staff already performing a wide range of other
(1) the manufacturer, (2) published evaluations performed duties involving the care of patients, and therefore the
by government agencies, (3) reports in the peer-reviewed amount of time required to operate the device may be critical
literature, and (4) discussions with colleagues who are oper- (i.e., will they have sufficient time to perform the testing as
ating similar equipment. When reviewing performance data, required?).
particular attention should be paid to the precision and After the comparison data have been obtained, tabulated,
accuracy of measurement, including the concordance between and interpreted, a POCT device is selected. It is then recom-
the results produced by the POCT device and by the routine mended that the laboratory professional conduct a short
laboratory method used at the same institution, because pa- evaluation of the equipment to gain familiarization with the
tients are likely to be managed using both analytical systems. system. This evaluation will help to determine the content of
the training routine that will have to be subsequently devel- training modules. Whatever the training strategy is used, it
oped and what sort of problem troubleshooting may be is important to document the satisfactory completion of
required. Such an evaluation should document the concor- training and that the individual has been tested and found
dance between the results generated with the device and competent with a combination of questions concerned with
those provided by the laboratory. All of this information understanding and practical demonstration of the skills
should then be recorded in a logbook associated with the gained.24 The latter may be achieved by performing tests on a
equipment. In addition, the organization may wish to under- series of QC materials and repeat testing of patient samples
take some form of safety check (e.g., electrical safety). All that have recently been analyzed in the laboratory or on an-
POCT devices should be added to a local inventory of POCT other device—so-called parallel testing. Finally, the operator
equipment, including serial number and unique identification, should be directly observed through the whole POCT proce-
manufacturer/supplier, purchase date, and service history.94 dure (i.e., the pre-examination, examination, and postexami-
It should be noted that the processes described may differ nation phases of testing).24
among countries and organizations, particularly in relation Competence on a long-term basis is maintained through
to the order in which they are carried out and the relative regular practice of skills and continuing education, and it is
emphasis on in-house evaluation compared with perfor- important to build these features into any education and
mance data available in the literature or from other users. training program. Regular review of performance in QC and
quality assurance programs will provide a means of oversee-
Training, Competency, and Certification ing the competence of operators. However, this is not always
The confidence of the clinician, caregiver, and patient in the sufficient, particularly when operators are employed on ir-
results generated by a POCT device depends on the perfor- regular shifts or may not always be called on to perform
mance and robustness of the instrument and the competence POCT. In this latter situation, it may be necessary to create
of the operator. Many of the agencies involved in the regula- specific arrangements for individuals to undertake tests on
tion of health care delivery now require that all personnel QC material. The error log may also highlight when prob-
associated with the delivery of diagnostic results demonstrate lems are arising. However, it is important to encourage an
their ongoing competence through a process of local accredi- open approach to the assessment of competence so that
tation (certification of competence), and this applies equally operators themselves seek help if they believe that problems
to POCT personnel. Typically, health care professionals in- are occurring. Such an open approach should be supported
volved in POCT will not have received training in the use of with audit and performance review meetings during which
analytical devices as part of their core professional training problems are aired and developments discussed. The regular
but may be called upon to operate a number of what might assessment of competence should be built into a formal pro-
be relatively complex pieces of equipment. gram for recertification that will be a requirement of most
The elements of a training program are listed in Box 30.6. accreditation programs, and web-based technology allows
Clearly, the extent of this program will, to a certain extent, competency and other QA programs to be delivered to op-
depend on how well the complexity of the analytical method erators who are remote from the laboratory.98 POCT con-
has been engineered to minimize operator requirements. In nectivity allows real-time control of approved operators and
practice, such a program is tailored to meet the needs of the can ensure that operators who have not completed recertifi-
individual and the organization. These may include formal cation are locked out.
presentations to groups or on a one-to-one basis, self-directed
learning using agreed documentation, or computer-aided Infection Control
learning. For example, several of the current models of blood POCT has been associated with patient-to-patient transmis-
gas and electrolyte analyzers have on-board computer-aided sion of infection (e.g., hepatitis B) (with recorded fatalities)
through contaminated equipment or the contaminated hands
of operators.99 Training of POCT operators should cover ap-
BOX 30.6 The Main Elements of a Point- propriate hygiene steps such as hand hygiene, changing
of-Care Testing Training Program gloves between patients, instrument decontamination, safe
Understanding the context of the test—pathophysiologic
practice to prevent needlestick injuries, and handling/
context
disposal of infectious waste.24
• Clinical requirement for the test Quality Control, Quality Assurance, and Audit
• Action taken on basis of result
• Nature of test and method used
QC, external quality assurance (EQA), and audits provide a
Patient preparation required—relevance of diurnal variation
formal means of monitoring the quality of a service. The QC
• Relevance of drug therapy
program is a relatively short-term view and typically com-
Sample requirement and specimen collection
pares the current performance of a device with that of the last
Preparation of analytical device—machine or consumables
time the analysis was made. EQA is a more comprehensive
Performance of test
process that includes comparing testing performance of dif-
Performance of quality control
ferent sites or different pieces of equipment or methods. An
Documentation of test result and quality control result
audit is a more retrospective form of analysis of performance
Reporting of test result to appropriate personnel
and, furthermore, takes a more holistic view of the whole
Interpretation of result and sources of advice
process. However, the foundation to ensuring good quality
Health and safety issues (e.g., disposal of sample and test
remains a successful training and certification scheme.
device, cleaning of machine and test area)
Classically, quantitative QC involves the analysis of a
sample for which the analyte concentration is known and the
mean and range of acceptable results is quoted for the EQA is used in POCT to determine and document long-term
method used. There are several challenges to the classical performance. However, EQA samples and results generally
approach with POCT. The first concerns are the frequency cannot be used to establish concordance between POCT and
of testing—should a QC sample be analyzed every time that central laboratory results because such samples do not be-
(1) a sample is analyzed, (2) a new operator uses the system, have in the same way as patient samples (refer to Chapter 6
(3) a new lot number of reagents is used, or (4) the system is for additional information on matrix effect of EQA samples).
recalibrated? There is no consistent agreement on the correct Analysis of the latter is required to determine to what degree
approach, and one should be guided by the reproducibility POCT results compare with those from the central labora-
and overall analytical performance of the system, workload, tory. It is also possible to operate an EQA scheme within a
and type of test performed,24 but it should never be less than hospital or organizational setting; such a scheme would typi-
what is recommended by the manufacturer. The approach cally be run by qualified laboratory personnel. This provides
used is also influenced by local circumstances, such as the the opportunity to compare the results being reported by
number and competence of the operators, together with the both the laboratory and other POCT sites within the same
frequency with which the system is used. For a bench-top or organization. This is important when patients are managed
multitest analyzer, two different concentrations of QC sam- in several departments or when machines break down and
ples should be run at a minimum of once per shift, or typi- samples are taken to other sites for testing. When deteriorat-
cally three times a day. Critical care analyzers (e.g., for blood ing or poor performance is identified in one of these schemes,
gas and electrolyte measurements) are generally programmed it is important to document the problem and then provide
to perform an automated QC check at intervals set by the and document a solution. It may be necessary as part of this
manufacturer or those responsible for the device with auto- exercise to review some of the patients’ notes to ensure that
matic user lockout if the QC fails to meet prespecified targets. incorrect results have not been reported and inappropriate
For single-use POCT disposable devices, the aforemen- clinical actions taken. In addition, if the solution highlights a
tioned strategy does not completely monitor the quality of vulnerable feature of the process overall or for one particular
the test system. For example, when conventional QC material operator, then a process of retraining must be instituted.
is analyzed on a unit-use or single-test POCT system, only More details of QC and quality management as applied to
that testing unit is monitored.100 Thus it is impossible to test POCT can be found in Chapter 6.
every unit with control material because, by definition, these
are single-test systems, and it is not possible to analyze both Maintenance and Inventory Control
control material and a patient sample with the single unit. The implementation and maintenance of a POCT service
Under these circumstances, there is greater dependence require that a supply of devices and associated consumables
placed on the manufacturing reproducibility of the devices to be maintained at all times and a formal program for doing so
ensure a good-quality service. Some single-test systems con- used. The key points in this process are to (1) adhere to the
tain internal/procedural checking devices. For some systems recommended storage conditions, (2) be aware of the stated
the manufacturer supplies an electronic simulator device that shelf-life of the consumables, and (3) ensure that stocks are
acts as a check on electronic circuitry, optics, and signal read- released in time for any preanalytical preparation to be ac-
ing. As with conventional QC, any electronic process checks commodated (e.g., thawing). When multiple sites are using
should not be less than those recommended by the manufac- the same materials, then a central purchasing, supply, and
turer. However, such checks do not test the whole process.101 inventory control system should be implemented. This will
They should therefore be used in conjunction with the analy- maximize the benefit from bulk purchasing and ensure that
sis of QC solutions to monitor the stability of reagents in individual systems are not supplied unknowingly with differ-
cartridges and test strips (CLSI POCT04 2.8.4.9).24 Different ent batches of consumables.
strategies may be adopted for the frequency of QC testing— The complexity in the maintenance of reusable devices
for example the analysis of one QC sample during each shift will vary from system to system, but clear guidelines will be
or whenever there is a change to the testing system, such as a available from the manufacturer and should be adhered to
different batch of testing materials or a different operator. A rigorously. Issues that usually require particular vigilance in-
2002 CLSI guideline (CLSI, Document EP18-A, Quality clude expiration dates, biocontamination, electrical safety,
Management for Unit-Use Testing: Approved Guideline) de- maintenance of optics, and inadvertent use of inappropriate
scribes quality management procedures for unit-use testing consumables.
from both a manufacturer’s and a user’s perspective.100
EQA is a systematic approach to QC monitoring in which Documentation
blinded samples are analyzed by multiple laboratories to as- The documentation of all aspects of a POCT service contin-
sess comparability of results. In this approach, the operator ues to be a major issue. The documentation should extend
has no knowledge of the analyte concentration, and therefore from the standard operating procedure(s) for the POCT sys-
it is considered closer to a “real testing situation.” The results tems to records of training and certification of operators and
are transmitted to a central authority, who then prepares a internal QC and quality assurance data, together with error
report and returns a copy to each participating laboratory. logs and any corrective actions taken. The requirements for
The report will identify the acceptable range of results documentation are outlined in CLSI POCT04.24 The docu-
obtained for the complete group of participants and may mentation of POCT results on individual patients in the
be classified according to the different methods used by par- laboratory or hospital information systems is too often lim-
ticipants in the scheme. The scheme may encompass both ited or inconsistent. Thus it is critically important to keep an
laboratory and POCT users, which gives an opportunity to accurate record (in the medical record) of the (1) test request,
compare results with laboratory-based methods. In practice, (2) result, and (3) action taken. Some of these challenges are
now being resolved with the advent of the patient electronic This can be challenging because stakeholder perspectives may
record, electronic requesting, and better connectivity of differ across a care pathway (e.g., the current desire to shift
POCT instrumentation to information systems and the pa- care closer to home may have an adverse impact on the rev-
tient record (see earlier discussion). enue received by the secondary care facility).
Accreditation and Regulation of Point-of-Care Testing Clinical Effectiveness

The features of the organization and management of POCT The core outcome measures of clinical effectiveness are mor-
described earlier are the same as those for the accreditation of bidity and mortality; however, these can be challenging to
any diagnostic services.95 Accreditation of POCT should be document and quantify. More commonly, surrogate or inter-
part of the overall accreditation of laboratory medicine ser- mediate outcome measures are used for evidence of effective-
vices or indeed as part of the accreditation of the full clinical ness in both the generation of evidence and in performance
service, as has been the case in many countries, including the management and audit. Other important outcome measures
United States and the United Kingdom, for a number of years. include diagnostic accuracy and patient satisfaction with
Thus the Clinical Laboratory Improvement Amendments of both the diagnostic or treatment phases of care. Some ex-
1988 (CLIA) legislation in the United States stipulates that all amples of outcome measures are given in Table 30.4. The
POCT must meet certain minimum standards.102–104 In the generation of evidence of clinical effectiveness in the field of
United States, the Centers for Medicare & Medicaid Services, diagnostics including POCT is challenging primarily because
the Joint Commission (formerly the Joint Commission on (1) delivery of a result alone does not lead to improved out-
Accreditation of Healthcare Organizations), and the College comes, (2) variability can occur with both the decisions taken
of American Pathologists are among those responsible for on receipt of the result and the quality of the clinical care
inspecting sites, and each is committed to ensuring compli- delivered, and (3) it is difficult to design studies on diagnos-
ance with testing regulations for POCT. tics that minimize the generally accepted risks of introducing
bias (e.g., operator bias; see Chapter 10 on evidence-based
laboratory medicine). The latter is particularly the case with
EVIDENCE OF EFFECTIVENESS POCT when attempting to blind the operator (in this case,
The objective of using POCT is to enable clinical decisions to the “user of the result,” e.g., a clinician) to the use of POCT
be made at the time of the consultation with the patient; or the comparator (the central laboratory service). For this
these decisions may relate to screening, diagnosis, treatment, reason, alternative approaches have been considered, includ-
or monitoring. The outcomes of these decisions should lead ing (1) observational studies in which appropriate outcome
to clinical, operational, or economic benefits if implementa- metrics are collected over a period of current practice (i.e.,
tion is to be considered. At the level of the patient-caregiver using the laboratory service) and then compared with the
interaction, POCT will help in the dialogue between patient same outcome metrics using the point-of-care service, over
and caregiver and improve both the efficiency and effective- the same time period; (2) comparison between a care pro-
ness of the assess-decide-act cycle (Fig. 30.12) (e.g., INR test- vider using POCT and a care provider using a laboratory
ing in the primary care setting105 or antidiabetes medication service (as current practice). One approach that is currently
adjustment for HbA1c testing).106 Typically, those involved in being increasingly used in health technology assessment for
the management decisions to implement POCT will look for diagnostic studies is the use of “linked evidence.” This
evidence of clinical and cost-effectiveness; those involved in approach evaluates the clinical utility of tests in the absence
implementation will, in addition, look for evidence of opera- of direct clinical trial evidence by linking systematically
tional effectiveness as that evidence will inform the imple- acquired evidence from the separate components of the test-
mentation plan. It follows therefore that the evidence of ef- treatment pathway (i.e., diagnostic accuracy of the test,
fectiveness that is used in making the case for adoption of impact on clinical decision making, and the effectiveness of
POCT and the supporting business cases and implementa- consequent treatment options).109 However, this may not be
tion plan must address the needs of all of the stakeholders appropriate for POCT as the key is changing the practice
involved in delivering the care package being addressed.107,108 across the whole assess-decide-act cycle.
In the following paragraphs, examples of the clinical ef-
Presentation
fectiveness of POCT are given for a range of test utilities, in-
History cluding the limitations of the evidence. In some instances
Monitor when the benefits are more of an operational or economic
Examination nature, the studies, particularly those in a diagnostic setting,
Act Assess may appear in the section on cost effectiveness.
Treat Tests
Treatment
Rapid Diagnosis of Chlamydia Infection

Diagnosis
There are two primary reasons for considering POCT for the
detection of chlamydia infection: (1) improving patient ac-
cess to screening programs and (2) reducing the number of
Physician Patient patients lost to follow-up after the specimen is collected. The
Plan Diagnosis key clinical outcome measures are the incidence of the infec-
Decide tion and its complications. It has been established that
Explain Discuss screening for chlamydia helps to identify more individuals
FIGURE 30.12 Schematic diagram of the patient-physician in- with the infection while reducing the complications associ-
teraction and the steps of assess-decide-act. ated with the infection.110 Both modeling and expert views
TABLE 30.4 Outcome Measures Used to Assess Point-of-Care Testing Technologies

OUTCOME MEASURE
Test Application Clinical Process
Urinalysis Rule out UTI Reduce antibiotic use Reduce the need for laboratory
tests
Urine albumin creatinine ratio Rule out albuminuria Early detection of renal disease Advise the patient at the clinic visit
Natriuretic peptide Rule out a diagnosis of Faster and earlier diagnosis Reduced clinic visits
heart failure Use of echocardiography
Chlamydia Screening for infection Reduced complication rate Reduced nonattendance at the
clinic
Reduced clinic visits
INR Self-monitoring Increased period within the Reduced clinic visits
Self-dose adjustment therapeutic window Reduced hospitalization
Reduced complication rate
HbA1c in primary care Primary care management Improved glycemic control Reduced clinic visits
of diabetes indicated by HbA1c
Troponin I or T in ED Rule out acute coronary Faster triage to therapeutic Reduced length of stay in ED
syndrome intervention
D dimer in primary care Rule out DVT Faster diagnosis and treatment Reduced clinic visits
DVT, Deep vein thrombosis; ED, emergency department; HbA1c, glycated hemoglobin; INR, international normalized ratio; UTI, urinary tract
infection.
suggest that the use of POCT will help in improving out- improved mortality rates with a 26% reduction in death.93,105
comes.111 Modeling studies have suggested that higher sensi- There is some evidence that the best outcomes are obtained
tivity tests based on nucleic acid amplification rather than in patients younger than 55 years of age, which may reflect
antigen based tests will offer the greatest benefits in improv- operator ability.117 Improvements in connectivity and net-
ing outcomes.112 Although one large study in a remote care work technology also offer the possibility of capturing home
setting using molecular POC for chlamydia showed a signifi- testing results into the patient’s electronic health care record.
cant reduction in time to treatment,113 there are no robust
studies published as yet to show that POCT improves clinical Managing Patients With Diabetes Using HbA1c
outcomes. A systematic review of randomized controlled trials (RCTs)
found an “absence of evidence from clinical trials data for the
Ruling out a Diagnosis of Deep Vein Thrombosis effectiveness for POCT of HbA1c.”118 However, the analysis was
The diagnosis of deep vein thrombosis (DVT) can be chal- compromised by the use of different surrogate outcome mea-
lenging because the symptoms are often mild and nonspe- sures, as well as a limited amount of information on stratifica-
cific, which could be one of the reasons why primary care tion of patients at the time of selection and action taken when
physicians in several countries put it high on their list of the HbA1c result was produced.106 On the other hand, there was
POCT requirements.114 In a diagnostic meta-analysis, Geers- a more positive message from observational studies, including
ing and colleagues115 concluded that POCT for D-dimer in one conducted over a significantly longer period of time dem-
the outpatient or physician office setting could safely rule out onstrating the benefit of POCT HbA1c, as shown by a reduction
a diagnosis of DVT in low-risk patients. They also found that in the mean HbA1c value in the population being monitored.119
quantitative assays performed better than the semiquantita- A narrative review of 11 studies concluded that POCT HbA1c
tive assays. Van der Helde and colleagues116 demonstrated improved patient quality of life and contributed to greater com-
that the use of POCT D-dimer testing together with a clinical pliance with HbA1c testing frequency requirements.120 The use
decision rule in a primary care setting could rule out the need of POCT HbA1c in facilitating more timely treatment changes
to refer patients for further investigations in 45 to 49% of is recognized in the American Diabetes Association (2019)
cases. The data demonstrate the potential for reliable rule out “Standards of Medical Care in Diabetes” guidelines.121
of a diagnosis at the time of presentation. In turn, this has the
potential to reduce pressure on emergency rooms, reduce Cost-effectiveness
patient costs, and increase patient satisfaction with care. Economic assessment is becoming more important because
of the growing debate around so-called value for money in
Managing Warfarin Treatment With International health care; consequently, health care economics is seen as an
Normalized Ratio Self-monitoring integral part of evidence-based practice. Economic assess-
There is now substantial evidence to demonstrate that self- ments often encompass both the operational efficiency and
testing with INR with or without self-dosing guided by a assessment of resource utilization, generally equated to the
treatment algorithm leads to improved patient outcomes, cost. However, it is important to consider each element as
including reduction in thromboembolic episodes without an management decisions based on this information will require
increased risk of major bleeding events, more time spent in attention be given to process change and resource utilization.
the therapeutic range, and evidence from some studies of In the examples given later in this section, both aspects will
be identified. Drummond and colleagues122 define economic Ideally, the measure or indicator of effectiveness would be
evaluation as the comparative analysis of alternative courses one that could be compared across studies such as quality-
of action in terms of both costs and consequences. Thus an adjusted life years (QALYs), which combines both length and
economic assessment of POCT would ask the question: quality of life into a single outcome and where 1 is perfect
“What are the complete consequences and costs of using health and 0 is death. When QALYs are used as the clinical
POCT compared with testing done in the centralized labora- effectiveness measure, the analysis is sometimes referred to a
tory?” The consequences would include any operational cost-utility analysis.
changes involved with introducing POCT. To obtain the best Because of the difficulty of applying the QALY measure in
level of evidence, the study would be conducted as an RCT. A relation to tests, both POC and central laboratory, it is more
decision on whether to implement POCT would require full common to compare effectiveness in terms of other mea-
quantitation of the consequences and costs in both arms of sures. For example, Laurence and colleagues,126 in an RCT of
the trial, and this is possible by a number of techniques.122 POCT compared with laboratory testing of a number of ana-
The reality is that relatively few studies of economic assess- lytes, used the proportion of patients within the therapeutic
ment have been conducted in this way for laboratory tests range for each analyte at the end of the trial as the clinical
and even fewer for POCT. More recently, attention has been outcome indicator. More details of this study can be found in
given to alternative approaches to obtaining evidence of ef- the cases section of this chapter.
fectiveness such as the linked evidence approach.109 This may The difficulty of performing RCTs of testing strategies has
be more appropriate, not only for obtaining evidence of led to less robust but nevertheless informative assessments,
clinical effectiveness but also for cost effectiveness and par- including those of modeling.127 Modeling tools generate deci-
ticularly when the process of care changes significantly, as in sion trees that map out all the possible consequences or out-
the case of POCT. Such an approach is similar to the tech- comes that can flow from all of the alternative testing options.
nique of time-driven activity-based costing, a technique that Each of the consequences has a mathematical probability of
estimates the cost of all of the processes involved in delivery occurrence, and such data are usually available in the literature
of a care intervention.124 Thus if POCT was used to enable a from a variety of reported sources. The probabilities in each
clinical decision and action to be taken in one visit, rather arm of the decision tree must sum to 1.0. There will also be a
than two, there would be a net cost saving if the additional payoff or cost associated with each consequence, and the ex-
cost of the POCT was less than the cost of the second visit. pected value of a particular strategy can be calculated from the
This approach is often used in quality improvement studies. probabilities and costs. The overall validity of modeling is de-
Instead of robust economic studies, there has been a focus pendent on several factors, one of which is the quality or ro-
in the past on simplistic comparisons of the cost of POCT bustness of the data that are input into the model. These data
technology with that used in the central laboratory without include test performance, such as sensitivity and specificity, the
any consideration of the patient outcomes from using the prevalence of the disease and its complications in the popula-
tests. Thus many studies in the literature are of the cost tion on whom the model is being used, and accurate treatment
minimization type and, not surprisingly, have shown that costs. Some of the limitations of decision tree modeling can be
POCT is more expensive than the central laboratory in which addressed by Markov models, which take into account the ef-
economies of scale can deliver obvious efficiencies. However, fect of time on disease progression and treatment effects.128 By
this situation is changing to one that moves beyond a com- way of example, Huntington and colleagues describe the chal-
parison of testing costs to one that includes assessment of the lenges of modeling-based evaluations of POC multipathogen
complete process of patient care and identification of the testing for sexually transmitted infections (STIs).129
economic outcomes that can be achieved with POCT.125 A recent review of economic studies of POCT concluded
Some of the economic benefits may result from a clinical that, although there was high-quality evidence to support
impact on the patient, but others may be what are sometimes POCT including RCTs, the number of studies was relatively
called operational benefits such as more rapid treatment or few and the quality variable.125 Appraisal of published studies
reduction in length of stay. can be facilitated by the use of checklists that highlight the key
There are various types of economic analysis, but it is be- attributes that should be contained within any economic as-
yond the scope of this chapter to describe these in detail, and sessment (e.g., Consolidated Health Economic Evaluation
they can be found in the literature.122,123,125 One of the more Reporting Standards [CHEERS] statement).130 Additional
common forms of economic evaluation of diagnostic tests is insight in how to interpret economic evidence of testing is
cost-effectiveness analysis (CEA).124 For example, if applied contained in the paper by Goodacre and colleagues,131 which
to the diagnosis of heart failure, it would compare the costs reviews some of the challenges in conducting studies of the
of two or more interventions, such as POCT BNP versus cost-effectiveness of newer cardiac markers such as troponin
central laboratory BNP testing; the effectiveness could be in the diagnosis of acute coronary syndrome. In the following
calculated from the number of heart failure cases diagnosed paragraphs, several specific examples are given of the cost-
by the two tests. From CEA analysis, it is possible to calculate effectiveness of POCT, with an emphasis on the operational
another key economic parameter called the incremental cost- changes required and the potential associated operational sav-
effectiveness ratio (ICER). The ICER compares the net differ- ings that can help to fund, or perhaps even more than offset,
ence in the cost of two interventions a and b (POCT BNP vs. the required changes in the care pathway and processes.
central laboratory BNP) with the net difference in effective-
ness (cases of heart failure diagnosed) as: Use of C-reactive Protein in Primary Care to Reduce
Antibiotic Prescribing
ICER 5 DC/DE Inappropriate prescribing of antibiotics wastes resources and
5 Costsa 2 Costsb/Effectivenessa 2 Effectivenessb drives antimicrobial resistance. Butler and colleagues investigated
CRP measurement by POCT in patients presenting to pri- consultation, offers the possibility to reduce the resources
mary care with an acute exacerbation of chronic obstructive required for each patient diagnosis and treatment. It can also
pulmonary disease: CRP-guided treatment was associated reduce costs associated with other issues, such as reduction in
with a 20.4% reduction in antibiotic use without any evi- patients lost to follow-up, improved morbidity and mortality,
dence of detriment.132 This study backed up the findings of and reduction in patient overtreatment, as well as facilitating
previous studies such as Cals and colleagues,133 who investi- more efficient and effective screening programs. Turner and
gated the impact of CRP measurement by POCT and physi- colleagues140 undertook an economic simulation of the intro-
cian communication skills training in primary care on the duction of a molecular POCT-based service for chlamydia
amount of antibiotic prescribing in patients presenting with and gonorrhea for a population of 1.2 million individuals.
suspected lower respiratory tract infections. They found a The simulation indicated that there would be a 10% reduc-
significant reduction in antibiotic prescribing with all combi- tion in baseline costs, a 9.5% avoidance of inappropriate
nations of the two interventions (i.e., single or combined), treatments, and a possible prevention of 189 case of pelvic
from 68% to as low as 23%. The authors did not take into inflammatory disease. Simulation modeling of a multipatho-
consideration the potential long-term economic effects of the gen POCT panel incorporating chlamydia, gonorrhea,
development of antibiotic resistance, currently a topic of Trichomonas vaginalis, and Mycobacterium genitalium testing
considerable interest at a societal level. However, the adop- compared with standard care also demonstrated significant
tion of point-of-care CRP remains variable, with lower levels cost savings, fewer clinic attendances, fewer onward STI
of adoption in the United States than in Europe, and there transmissions, and inappropriate treatments.128
have been calls for robust cost-effectiveness data that would
facilitate greater uptake.134 Intraoperative Testing
There is currently considerable use of POCT in the OR; much
Managing Long-term Conditions in Primary Care of this is for monitoring vital parameters with reflexive treat-
Policymakers in many parts of the world who are seeking to ment to maintain body and organ functions. One of the al-
move care of long-term conditions into the community and ternative POCT strategies that has radically altered the way
shorten or eliminate the time to travel to distant health care that patients are treated has been in the use of intraoperative
facilities have focused on POCT use to improve accessibility POCT measurement of PTH.141 Primary hyperparathyroid-
and patient experience and to contain costs. The largest study ism is caused by a solitary adenoma in 85% of cases, with
of this topic has been the Australian POCT in General Prac- multiple adenomas (multiglandular disease) occurring in
tice Trial.126 The study found that the cost of POCT for urine 15% of cases. Patients with a solitary adenoma may be
albumin creatinine ratio (ACR) was less that of the central suitable for focused surgery through minimally invasive
laboratory, but that for INR, HbA1c, and lipids was more ex- parathyroidectomy (MIP); other patients may require bilat-
pensive, although none was significant. On the other hand, eral parathyroid exploration. Although preoperative imaging
POCT led to less cost incurred by patients and their families is sensitive in identifying solitary adenomas, it is much less
compared with current practice. The ICER was unfavorable sensitive in identifying multiglandular disease. Intraoperative
for INR and favorable for urine ACR, with uncertainty in the PTH monitoring during MIP following removal of an image
data regarding HbA1c and lipid testing. identified abnormal parathyroid gland provides assurance
that multiglandular disease is not being missed and is associ-
Improving Triage in the Emergency Department ated with high cure rates of 97 to 99% (i.e., a reduced
Numerous studies have demonstrated a reduction in TAT for requirement for further surgery, shorter postoperative stays,
a range of analytes commonly measured in the emergency and better cosmetic outcomes).141 Conversely, if during MIP,
department (ED) (e.g., pregnancy testing, D dimer, lac- PTH monitoring suggests residual hypersecretion, surgery
tate).135 This resulted in reduced waiting times, reduced can be converted to bilateral parathyroid gland exploration.
length of stay in ED, more rapid treatment decisions, and a PTH is measured at baseline and then at 10 to 20 minutes
reduction in the number of patients leaving without being following excision of the suspected adenoma; a reduction in
seen. POCT troponin studies have demonstrated a reduction PTH concentration of greater than 50% from baseline is con-
in the TAT for cardiac results for patients presenting with sidered to indicate confirmation of a solitary adenoma as the
acute chest pain, together with a consequent reduction in the etiology of the hyperparathyroidism and that this has been
length of stay and a reduction in resource use.136,137 The ad- successfully removed.
vent of high-sensitivity troponin assays which currently are
available only as laboratory-based tests has allowed the im- ADOPTION AND IMPLEMENTATION
plementation of 1-hour rule-out strategies138; however, this is
not possible at present with current POCT troponin assays. The adoption of POCT into routine clinical practice is often
For lactate measurement in patients with suspected sepsis, very slow and patchy. This may reflect gaps in the evidence
the use of POCT was associated with a reduced time to base for its clinical and cost-effectiveness and broader impact
administration of intravenous fluids and a reduction in mor- but also organizational challenges in adoption and imple-
tality.139 Despite this substantial evidence of benefit, there is mentation.142,143
as yet relatively limited evidence of cost-effectiveness. The potential benefit of using POCT is to satisfy unmet
needs associated with improving both the effectiveness and
Improving the Efficiency and Effectiveness of Sexually the efficiency of the care of individual patients. A generic
Transmitted Infection Services description of the interaction between patient and care pro-
The ability to undertake the test-and-treat cycle in a single vider is described in the assess-decide-act cycle (see Fig.30.12),
visit through using POCT, albeit with a slightly longer in which the care provider makes an assessment of the patient
presentation (and that may involve the use of medical tests) BOX 30.7 Key Elements of the Business
followed by a decision about the nature of the problem and Case for Point-of-Care Testing to Inform
then takes appropriate action.11 Adoption of POCT therefore
by definition, implies that the process of care, as well as the
the Adoption and Implementation (Plan)
resource utilization and outcomes, will change compared Using the Example of D-Dimer Testing in
with current (non-POCT–mediated) practice. As indicated Primary Care
earlier, the demonstration of effectiveness is primarily di- • Unmet need: triage of patients presenting in primary care
rected at policymakers, but the translation of this evidence with suspected DVT
into practice can be challenging because it has an impact on • Evidence of effectiveness of proposed intervention: POCT
a number of stakeholders.10 Any technological innovation is for D dimer is an effective in the context of a decision sup-
likely to reflect similar challenges, as outlined earlier, which port tool, for ruling out DVT
may explain the many observations on the sluggish nature of • Expected benefits associated with introduction of new inter-
technology adoption in health care.142 Although adoption vention: reduction in number of patients referred to secondary
can be considered as the transition from aspiration to inten- care for ultrasonography, reduction in contracted require-
tion, implementation is the transition from intention to ment for ultrasonography, improved patient experience
outcome. The basis of the aspiration is that there is a recog- • Proposed change in care pathway process: POCT at
nized unmet need in a particular setting, and an informed presentation to primary care, with decision to refer within
aspiration is one in which it has been demonstrated that the 30 min
unmet need can be met—in the case of this discussion, • Resource utilization in current pathway and proposed
through the use of POCT. This can be achieved through the revision of that pathway: investment in POCT in primary
development of a value proposition for the technology and care setting; disinvestment in a proportion of referrals to
the delivery of a different process of care.107 secondary care
Implementation involves the development of a plan com- • Metrics to enable implementation and adoption according
prising four phases: (1) establishment of the unmet need, which to the business case expectations: number of patients
may be clinical, operational, or economic in origin; (2) critical presenting to primary care, number of D-dimer tests, num-
appraisal of the evidence supporting the claimed clinical, ber of referrals, number of negative ultrasound investiga-
operational, and economic benefits; (3) examination of the tions compared with baseline, follow-up of patients for 6
costs and changes in the clinical process involved; and (4) a months to determine any missed cases, financial measures
detailed implementation plan, including responsibilities, to match current and revised pathway (e.g., time in primary
time frames, and performance metrics.1119 This can be sum- care, cost utilization of primary and secondary care visits,
marized in the steps identified in Box 30.7. including cost of relevant diagnostics)
A crucial feature of implementation is audit to support DVT, Deep vein thrombosis; POCT, point-of-care testing.
performance management of the implementation phase. A
set of metrics that represent the process, resource utilization,
and outcomes (clinical, operational, and economic) from the clinical and economic outcomes. Furthermore, it is now be-
current and revised practices, with particular attention being coming increasingly evident that there is a desire of both
given to the changes that are part of the value proposition. A patients and policymakers to develop more care closer to
crucial part of this activity is to adopt a care pathway–wide home and to encourage more patient involvement in the de-
approach to the changes in performance metrics. One field in livery of care.
which this has proved to be particularly challenging is in the However, there remains the need to produce devices that
areas of investment and disinvestment in resources.107 Thus are more user friendly and reduce the risk of errors. In addi-
in the case study featured in Box 30.7, the major investments tion, devices are being developed that provide alternatives to
will be in the activities associated with operating POCT in fingerstick blood collection. Two examples are mentioned in
primary care, such as training, operation, and QC, as well as the chapter, (1) with the use of tattoo-based noninvasive glu-
the POCT system. The disinvestments will be primarily in the cose monitoring and (2) the use of tear fluid for glucose
use of the laboratory service and approximately 50% of the monitoring and providing an alternative noninvasive ap-
ultrasonography contract and associated clinic visits. The proach for continuous monitoring. Furthermore, it is also
challenges and approaches to disinvestment will depend on important that any technology delivers the required analyti-
the resource, as well as the approach to reimbursement or cal and clinical performance when operated by a person with
payment for services in the overall health economy. Clearly, it no previous technical experience. It is important to stress the
is not possible to disinvest in large pieces of equipment or importance of clinical performance as we enter an era when
estate or even a service in a fully integrated health system, but analysis may be undertaken on alternative biologic fluids or
it is fairly straightforward when using outsourced services. In compartments to those on which our knowledge base in
these situations, other ways may have to be found to achieve laboratory medicine has been developed.
the expected disinvestment. Individual solutions may have to The trends described in this chapter illustrate the potential
be found for each health economy. opportunities to disrupt longstanding and inefficient prac-
tices of delivering health care and provide the means to de-
CONCLUSIONS liver more patient-centered care, including patients being
more involved in their own care and health decision making.
The technological vehicles to deliver diagnostic tests outside However, this may represent the greatest challenge because
of the laboratory currently exist, and there is also evidence the adoption of new technologies, particularly POCT, is un-
to demonstrate that this technology can deliver improved doubtedly slow. This may, in part, be due to limited data on
the health economics of diagnostic testing, but it is also be- 17. Ivanova Reipold E, Easterbrook P, Trianni A, et al. Optimising
cause of the challenges involved in delivering a more inte- diagnosis of viraemic hepatitis C infection: the development
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17(Suppl 1):707.
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than might occur as a result of laboratory testing. clinicians and others offering sexually transmitted infection
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established technologies such as glucose sensors and 94. Point-of-care testing (POCT) – Requirements for quality and
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M U LT I P L E CHOICE QUESTIONS 7. The most informative economic assessment of the use of

point-of-care testing involves:
1. Which of the following statements best describes the value a. A comparison of the costs of the point-of-care con-
of point-of-care testing? sumable and the cost of the laboratory test consumable
a. Testing performed outside of the laboratory b. A comparison of the cost of the point-of-care con-
b. Testing performed at the bedside sumable and operator time with the fee charged by
c. Over the counter testing the laboratory
d. Testing that enables the clinician or caregiver to make c. A comparison of the reimbursement figure for point-
a decision at the time the clinical problem arises of-care testing and laboratory testing in your institution
e. Testing near the patient d. A negotiation with the financial officer of the institu-
2. The benefits of using point-of-care testing are best as- tion or health system
sessed by: e. A comparison of the full costs for the whole care epi-
a. Comparing the analytical results of the device with sode (i.e., including clinic and/or ward and treatment
those obtained by the central laboratory costs) when using point-of-care testing or laboratory
b. Asking the operators what they think of the device testing
c. Performing a study of clinical and cost effectiveness 8. Quality control of point-of-care testing for lateral flow
d. Assessing the performance of the device in an external strips read with a reflectance meter is best achieved by:
quality assurance program a. Analysis of a designated QC specimen at least as fre-
e. Asking the patient what they think quently as recommended by the manufacturer
3. Which of the following is a disadvantage of using point- b. Use of the reflectance control strip supplied by the
of-care testing: manufacturer
a. Tests are performed by lab staff c. Comparison of analysis of a specimen using the
b. Decrease in administrative work associated with train- point-of-care testing with the results from sending
ing and competency assessment the same specimen to the laboratory
c. Increased testing costs d. Analysis of an aqueous solution prepared for the purpose
d. Decreased risk of errors e. Reliance on the manufacturer to provide a quality-
e. Decreased costs of overall care controlled product
4. The technical performance of a point-of-care testing de- 9. The most important benefit of connectivity for point-of-
vice is best determined by: care testing devices is:
a. Assessing the results obtained by the person(s) who a. Monitoring that the machine is working
will be operating the device in the intended setting b. Facilitating the transfer and capture of patient POCT
b. Reviewing the manufacturer’s literature and quality-related data into permanent medical records
c. Testing the device in the laboratory c. Monitoring the number of tests performed
d. Asking the opinions of other health professionals d. Monitoring the machine’s battery
e. Looking for information on the internet e. Monitoring the certificated status of the operators
5. The operator interface of a well-designed point-of-care using the system
device should: 10. The first step to be considered in the implementation of
a. Require multiple-step operator interactions a point-of-care testing solution is:
b. Leave it to the user to decide how to perform the test a. The analytical imprecision of the point-of-care test-
steps ing device
c. Identify the operator and the test being performed b. The analytical bias of the point-of-care testing device
d. Gather no information on key test steps c. The unmet clinical need
e. Report a result regardless of test performance d. The time taken to generate a result
6. Which of the following contains two frequently used ana- e. The cost of each test
lytical principles in point-of-care testing?
a. reflectance/liquid chromatography
b. liquid chromatography/electrochemistry
c. electrochemistry/lateral flow
d. gas chromatography/lateral flow
e. spectrophotometry/gas chromatography

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30

INTRODUCTION dedicated laboratory areas. This reflects a similar evolution in

TABLE 30.1 Classification of Types of Point-of-Care Testing Instruments and Devices

Reaction Cell Control and Communications Systems

TABLE 30.2 Examples of Single-Pad or Multipad Stick Tests

Application zone Detection zone

Immunoreaction: Binding of Binding of

Spreading Glucose Glucose

Larger Cartridge Type and Bench-top Point-of-Care

Sensor module Measurement region

Blood waste chamber

Sealed calibrator module

Sample entry port

Test card—bottom Test card—top

intervals. These include packs or bottles of QC material that

Sample Reference Waste Lysing

O2 CI Na+ Ca++ K+ pH CO2 Lac Glu Sensor card

Coarse filter and Two PCR

POCT test and decision support accessed by the doctor

QUALITY MANAGEMENT BOX 30.4 Assessing the Need for a

Accreditation and Regulation of Point-of-Care Testing Clinical Effectiveness

Rapid Diagnosis of Chlamydia Infection

TABLE 30.4 Outcome Measures Used to Assess Point-of-Care Testing Technologies

REFERENCES 22. Khandurina J, Guttman A. Bioanalysis in microfluidic devices.

M U LT I P L E CHOICE QUESTIONS 7. The most informative economic assessment of the use of

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