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Point of care testing (POCT)
Dr K.A.C.Wickramaratne

Definition

Goals of POCT

Uses

Is it a rapid test?

Tests available

Advantages

Disadvantages

Management issues

How to assure quality

Accreditation of POCT
What is POCT ?

Analytical test performed outside the laboratory by
health care providers

Performance of tests –“bed side”

“POCT is medical testing at or near the site of
care.”

“Point‐of‐care testing (POCT) refers to any testing
conducted outside a lab, in a hospital, in a clinic or
by a health care organization providing ambulatory
care.
Goals of POCT

Improve quality of patient care

Enhance efficiency of patient care

Increase physician and patient satisfaction

Improve patient education

Decrease liability risk

? ? Minimize burden at central level
Where POCT is used?

ICU, Accident and emergency department

Operating theatres

Dialysis units, Neonatal units

OPD, casualty wards, domestic care (health care
team)

Other special treatment centers – DF

Mass disasters
Does the POCT need to be an instrument‐free
dipstick or RDT?


•
Widely used ASSURED criteria for rapid tests by WHO:

A = affordable

S = sensitive

S = specific

U = user friendly -simple to perform

R = robust and rapid (results available in less than 30 minutes)

E = equipment free

D = deliverable to those who need the test •
The type of device does not define a POCT test. POCT range from
simplest dipsticks to sophisticated automated molecular tests on
portable analysers and imaging systems.
What tests available?
POCT ranges between three levels of complexity,
 simple
procedures -
 capillary
 urine
glucose testing,
dipstick
 moderate‐complexity
 microscopy
 or
procedures -
of urine
high‐complexity procedures  PCR,
TEG, resonant micro sensing platform for
ultrasonic characterization of blood coagulation.
Advantages

Identify critical diagnosis / screen quickly

Evidence available on site

Speed – less turnaround time !

Smaller sample volume – less waste

Full time equivalent (FTI)

Impact
 doctor
patient confidence
 Improved
 cost
outcome and patient education
saving – (not always !)
Disadvantages

Lower accuracy and precision – future can be promising

Less skilled personnel to perform tests – can be trained

Higher supply cost - ??

Lack of comparability – need standardization

Lack of data systems -

Difficulty in assuring quality-

Difficulty in managing testing-
Management issues

Who should perform ?


Responsibility ?


Ward staff or Laboratory
Documentation and monitoring


Doctor or a nursing officer - training
Test results not linked to devices, no printouts, no signatures, no
validation !
Maintenance


Quality assurance –

Test method – validation – ? Compared with gold standard ?

Test calibration – metrological traceability

IQC - Very difficult –

EQA – not available freely
Market driven concerns

Highly competitive and rapidly evolving

The device available today may not be usable next year

Repetition in both POCT and central – test duplication
How to assure quality

Selection of a

validated method with traceability

method with a reasonable accuracy,

precision and measurement uncertainty

Selection of a method with ability to monitor performance
(IQC and EQA)

Setting up POCT management team

Training of personnel

Establishing documentation system

Preparation of SOPs/manuals
Accreditation of POCT.!

Accreditation as per ISO 22870 ; Point of care testing
requirements for quality and competence

Similar to ISO 15189

All the requirements of ISO 15189 and ISO 22870

Management requirements


QMS, quality objectives, preventive, corrective ,review
Technical requirements

Personnel , training, accommodation and environment, equipment,
pre- examination, examination, post examination ......