Point Of Care Testing (POCT)

DR.C.C.CHEMONGES
 Objectives
• Define POCT
• Describe purpose of POCT in clinical
diagnostics
• Describe advantages and concerns in POCT
• Outline methodologies of POCT
• Outline best practices for effective POCT
implementation for biochemical analysis
Key steps in biochemistry laboratory diagnostics.

Interpret Patient Request

Doctor
Transmit Phlebotomy

Report Transport

Validate Register

Analysis Prepare
 Definition of POCT
Clinical laboratory testing :
• Conducted close to site of patient care,
• Usually by clinical personnel whose primary
training is not in the clinical laboratory
sciences
• May be done by patients (self-testing).
• Testing performed outside of the traditional,
core or central laboratory.
 Synonyms for POCT

• Bedside testing
• Ancillary testing
• Satellite testing
• Near patient testing (Side lab testing)
• Home testing
• Remote testing
• Physician’s office laboratory
 Common sites for POCT
Primary Care Secondary and Tertiary Care
• Emergency room. • Operating room.
• Intensive care units.
• Home
• Special Care Units
• Pharmacy • Wards.
• Health Centres • Outpatient clinics.
• Doctors offices.
• Ambulances
• Aircraft.
 Advantages of POCT
• Simpler sample collection (usually finger prick)
• Simple pre-analytical processes (reduced time
between specimen collection and analysis).
• More rapidly available test results
• Timely patient treatment
• Greater satisfaction for the patient
 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.
 Challenges in POCT
Patient care issues Environmental
• Insufficient quality control issues
• Increased workload • Biosafety
• Errors due to lack of
expertise
• Lack of comparability of
results with laboratory.
• Expensive
• Poor documentation of
results.
 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)
 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).
 Drivers of POCT advances (2)
Technological advancements:
• Method and operation simplification
• Electronic quality control
• Portability of POCT devices
• Interconnectivity with laboratory and
hospital information systems
Point of care molecular testing device
 Requirements of a POCT device
• Simple to use.
• 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
Biochemistry Haematology
• Bilirubin • Haemoglobin (Hb)
• Coagulation (INR)
• Cardiac markers
• Blood gases Microbiology
• Diabetes • HIV
• Occult blood • Hepatitis (B,C)
• Parathyroid testing • VDRL

• Renal
Forensic
• Hormones • Drugs of abuse
• Urinalysis • Breath Alcohol
Types of POCT Devices
Technology Principle Application
Single- use a) Reflectance. Urine, blood
qualitative or chemistry,
semi b) Lateral-flow or hCG, cardiac
quantitative flowthrough infections
cartridge/strip immunoassay disease agents.
tests.
Multiple-use
quantitative Electrochemistry Blood gases,
cartridge/bench Electrolytes.
top devices.
Technology Principle Application
a) Reflectance. Glucose, blood
Single- use chemistry.
quantitative b) Electrochemistry. Glucose, blood
cartridge/ gases.
strip test with c) Lateral-flow
a reader immunoassay. Cardiac, drugs.
device
d) Immunoturbidimetry. HbA1c,
microalbumin.
e) Spectrophotometry. Blood
chemistry.
 Examples of POCT devices

Strip devices
Single use qualitative strips or cartridges.
Dipsticks
- Pad of porous material such as cellulose,
impregnated with reagent and then dried
(urinalysis).
Complex strips
- Complex pads, several layers, the top layer is a
semi permeable membrane preventing red
cells from entering the matrix.
 Utilization of Strips
• 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.
 Immuno sensors
• 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
Lateral flow:
SIGNAL Control
Sample band band

GLA
Gold Analyte
labelled GLA Analyte Analyte
antibody forms
complexes BLA GLA
with
BLA
Biotin antibodies
Streptavidin Synthetic
labelled peptide
Fleece
antibody

Binding Binding gold-

sandwich labelled
complexes antibodies.
 Lateral flow
• Sample added first flows through a glass fibre
fleece that separates plasma from whole
blood.

• Two monoclonal antibodies, against the

analyte being tested, one conjugated to biotin
and the other labelled with gold particles,
bind to the analyte in sample.
 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.
 Lateral Flow
• 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
 Quantitative devices
• Single use quantitative cartridge and test
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.
.
 Recommendations for effective POCT
• Responsibilities
• Purchasing and inventory
• Equipment
• Pre-analytical process
• Analytical process
• Quality assurance
• Post-analytical process (reporting)
• Documentation (Data management)
 Implementation of POCT service.

• Establish need for POCT.

• Consider clinical, operational and economic
benefits.
• Consider costs of POCT–
– Equipment and reagents
– Staff training
– Quality assurance
– Data management.
 Concerns in POCT

• Ease of use of the POCT device.

• Quality of result produced.
• Competence of device operator.
• Effectiveness of process for transmission of
results to care giver.
• Competence of care giver to interpret results
provided.
• Accurate recording of results.
 POCT Data management Issues
• 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).
 Summary
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.
• 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.
Questions??