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

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IIIIIIIIIIIIIIIIIIPoint of care testing
(POCT)Dr K.A.C.Wickramaratne
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• Definition
• Goals of POCT
• Uses
• Is it a rapid test?
• Tests available
• Advantages
• Disadvantages
• Management issues
• How to assure quality
• Accreditation of POCT

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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.

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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

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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

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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.

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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.

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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 !)

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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-

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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

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• 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

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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

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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 ......

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Thank you