31-May-19

Objectives
• Define POCT
• Describe purpose of POCT in clinical
Point Of Care Testing (POCT) diagnostics
• Describe advantages and concerns in POCT
Zakayo Thaimuta • Outline methodologies of POCT
Human Pathology • Outline best practices for effective POCT
School of Medicine implementation for biochemical analysis

Key steps in biochemistry laboratory diagnostics.

Definition of POCT
Interpret Patient Request
Clinical laboratory testing :
Doctor • Conducted close to site of patient care,
Transmit Phlebotomy
• Usually by clinical personnel whose primary
Report Transport
training is not in the clinical laboratory
sciences
Validate Register • May be done by patients (self-testing).
• Testing performed outside of the traditional,
Analysis Prepare
core or central laboratory.

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Testing Personnel Authorized to Synonyms for POCT

Perform Waived Tests
• Bedside testing
• Licensed Physician Assistant • Ancillary testing
• Registered Nurse • Satellite testing
• Licensed Vocational Nurse • Near patient testing (Side lab testing)
• Certified Perfusionist • Home testing
• Licensed Respiratory Care Practitioner • Remote testing
• Certified Medical Assistant • Physician’s office laboratory
• Others, Providers of Direct Patient Care

Common sites for POCT Advantages of POCT

Primary Care Secondary and Tertiary Care • Simpler sample collection (finger prick)
• Emergency room. • Operating room.
• Intensive care units.
• Simple pre-analytical processes (reduced time
• Home between specimen collection and analysis).
• Special Care Units
• Pharmacy • Wards. • More rapidly available test results
• Health Centres • Outpatient clinics.
• Timely patient treatment
• Doctors offices.
• Ambulances
• Greater satisfaction for the patient
• Aircraft.

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Advantages of POCT
• Rapid test results -Potential to hasten medical
decision-making.
• Small sample volume - patient convenience
(neonates, pediatrics, ICU patients)
• Portable devices – allow testing to be
performed in a variety of locations.
• Lean process – Fewer steps than transporting
specimen to central laboratory.
Progress in POCT
• In early medical practice tests were
performed near the patient.
– Uroscopy (urine visually examined and assessed
for sweetness by tasting – 1500 BC).
• Testing moved to central laboratories as
hospitals were built (1800-1900’s).
• Shifts from the central laboratory to POCT
(late 1900’s to date)
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Challenges in POCT
Patient care issues
• Insufficient quality control
• Increased workload
• Errors due to lack of expertise
• Lack of comparability of results with laboratory.
• Expensive
• Poor documentation of results.
• Biosafety Issues
Drivers of POCT advances (1)
• Demand for faster turnaround times to facilitate
patient care
• Creation of specialty clinics (Renal, Lipid etc).
• Desire for self-testing and patient control.
• Need for simple, testing tools in
– Developing countries
– Military or disaster sites
– Underserved populations
– Patients’ homes (Self testing).
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Drivers of POCT advances (2) Requirements of a POCT device

Technological advancements: • Simple to use.

• Method and operation simplification
• Electronic quality control
• Portability of POCT devices
• Interconnectivity with laboratory and
hospital information systems
• Robust in terms of use and storage.
• Producing results similar to the central lab.
(Accuracy and precision profile similar to
central lab).
• Capable of being safely operated.

Scope of POCT Types of POCT Devices

Biochemistry Haematology Technology Principle Application
• Bilirubin • Haemoglobin (Hb)
• Cardiac markers • Coagulation (INR)
Single- use a) Reflectance. Urine, blood
• Blood gases qualitative or chemistry,
• Diabetes Microbiology semi a) Lateral-flow or hCG, cardiac
• Occult blood • HIV quantitative flowthrough infections
• Parathyroid testing • Hepatitis (B,C) cartridge/strip immunoassay disease agents.
• Renal • VDRL tests.
• Hormones Multiple-use
• Urinalysis Forensic quantitative
• Drugs of abuse Electrochemistry Blood gases,
cartridge/bench Electrolytes.
• Breath Alcohol
top devices.

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Technology Principle Application Examples of POCT devices

a) Reflectance Glucose, blood
Single- use chemistry. Strip devices
quantitative b) Electrochemistry Glucose, blood
Single use qualitative strips or cartridges.
cartridge/ gases. Dipsticks
strip test with c) Lateral-flow - Pad of porous material such as cellulose,
a reader
immunoassay
Cardiac, drugs. impregnated with reagent and then dried
device (urinalysis).
HbA1c, Complex strips
d) Immunoturbidimetry
microalbumin. - Complex pads, several layers, the top layer is a
semi permeable membrane preventing red
e) Spectrophotometry. Blood chemistry. cells from entering the matrix.

Utilization of Strips Immuno sensors

• Sample placed on padded strip.
• For urine, strip is dipped in container with
urine.
• Excess sample wiped off.
• Time lag between placing sample on pad and
reading the result. (Reaction time).
• Result may be read visually or using
reflectance technology machines.
• Total time – 1 or 2 minutes.
• Biological sensors, recognition agent is an
antibody that binds to analyte.
• Detection is by optical mechanisms.
• May use solid phase technology with
• flow through, lateral – flow or
• Immuno chromatography processes

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Lateral flow:
SIGNAL Control
Lateral flow
Sample band band

GLA • Sample added first flows through a glass fibre

Gold Analyte
fleece that separates plasma from whole
labelled GLA Analyte Analyte
blood.
antibody forms
complexes BLA GLA • Two monoclonal antibodies, against the
BLA
with analyte being tested, one conjugated to biotin
Biotin antibodies
Streptavidin Synthetic
and the other labelled with gold particles,
labelled peptide
bind to the analyte in sample.
antibody Fleece

Binding Binding gold-

sandwich labelled
complexes antibodies.

Lateral Flow Lateral Flow

• Complexes flow laterally along cellulose
nitrate test strip to capture zone which
contains streptavidin bound to a solid phase.
• Biotin in the antibody-analyte complex binds
to streptavidin as purple band by gold
particles attached to the complexes.
• Unreacted gold particles move further along strip
and are captured by zone with synthetic peptide.
• Is visualised as separate but similar coloured band.
• This 2nd band is a quality indicator, showing that
sample flowed along the test strip.
• Applications - Cardiac troponin T – qualitative.
- Infectious disease – HIV rapid test
- Allergy tests.
- Drugs of abuse

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Quantitative devices Recommendations for effective POCT

• Single use quantitative cartridge and test • Responsibilities

strip with a monitoring device:
• Devices include a meter (monitoring device) that
allows detection and quantification of the
analyte.
Example - Glucose meters.
- Cardiac readers - multiple analytes.
.
• Purchasing and inventory
• Equipment
• Pre-analytical process
• Analytical process
• Quality assurance
• Post-analytical process (reporting)
• Documentation (Data management)

Implementation of POCT service.

Concerns in POCT
• Ease of use of the POCT device.
• Establish need for POCT. • Quality of result produced.
• Consider clinical, operational and economic • Competence of device operator.
benefits. • Effectiveness of process for transmission of
• Consider costs of POCT– results to care giver.
– Equipment and reagents
• Competence of care giver to interpret results
– Staff training
provided.
– Quality assurance
– Data management. • Accurate recording of results.

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POCT Data management Issues Summary

• Patient samples should be positively identified. (Strip
devices do not carry identification and meters do not
read ID’s).
• Operator access to system should be password
protected. (Not possible with most hand held meters).
• Hard copy record of results, positively identified,
should be generated. (Meters do not carry printers so
results manually transcribed).
• Test Data should be stored. (Capability not available in
many devices).
POCT
• Has grown due to clinical demands for more
rapid results to enhance patient care.
• Must be conducted within a framework of
quality standards so as to ensure that the
quality of results is as close as
• possible to those performed by a traditional
pathology laboratory.

Summary (2)
• Recognise that POCT will be carried out by a
variety of healthcare personnel.
• Many may not have formal laboratory
training. Questions??
• Therefore they may not have the expertise to
assess the quality of results produced by the
POCT device.
• Formal training and competency assessment is
an essential part of running a POCT program.