IIIIIIIIIIIIIIIIII Point of care testing (POCT) Dr K.A.C.Wickramaratne

1. IIIIIIIIIIIIIIIIIIPoint of care testing (POCT)Dr K.A.C.Wickramaratne

2. Definition • Goals of POCT • Uses • Is it a rapid test? • Tests available • Advantages • Disadvantages • Management issues • How to assure quality • Accreditation of POCT

3. 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.

4. 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

5. 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

6. 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.

8. 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.

10. 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 !)

11. 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-

12. 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

13. 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

15. 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

18. 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 ......

19. Thank you