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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 glucose testing,
 urine dipstick

 moderate‐complexity procedures -
 microscopy of urine

 or 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 outcome and patient education
 cost 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 ?

 Doctor or a nursing officer - training

 Responsibility ?
 Ward staff or Laboratory

 Documentation and monitoring

 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 ......