College of American Pathologists
 Point of Care Testing Toolkit


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Point of Care Testing Toolkit

Download POCT Toolkit (PDF, 245 KB)

  • Introduction & Definitions
  • Advantages & Disadvantages
  • History
  • Current & Projected Technology
  • References
  • Tools
  • Toolkit Authors
  • Pathologist Roles
  • Pathologist as Laboratory Director
  • Pathologist as Clinical Consultant
  • Pathologist’s Regulatory Role
  • Pathologist as Technical Consultant
  • POCT has a variety of advantages and disadvantages that should be weighed when considering POCT as an option.

    1. Give us your feedback on this sectionAdvantages
      1. Rapid test results with the potential to expedite medical decision-making
      2. Small sample volume – patient convenience (capillary fingerstick vs. venous phlebotomy), neonatal and pediatric benefit, and less blood loss and anemia for patients requiring frequent testing (e.g., “ICU”)
      3. Portable devices with wide menu of analytes – allow testing to be performed in a variety of locations, with flexibility to meet the diversity of medical needs
      4. Unprocessed specimen – whole blood analysis not requiring time for clotting, centrifugation or aliquoting
      5. Lean process – testing on-site requires fewer steps than transporting a specimen to a core laboratory, processing, aliquoting, testing, and communicating results back to clinical staff
      6. Clinical staff efficiency – works within the clinical management setting. As the physician examines the patient and determines the need for testing, POCT is conducted and medical care is promptly implemented, avoiding the need for physicians to refamiliarize themselves with a case after test results are returned from a central laboratory
      7. Potential to improve patient outcome or workflow by having results immediately available, especially when POCT results can be linked to patient management in order to move individual patients through the system faster or handle more patients at a time
      8. Ability to provide laboratory testing in a wider variety of sites or circumstances, such as underserved populations, rural areas, and locations with limited infrastructure or personnel (e.g., disaster, accident or military sites)
      9. Reduced potential for sample deterioration – most POC tests are initiated and performed rapidly once the sample is obtained. This reduces the potential changes that may occur to samples sent to the central laboratory due to continued cellular metabolism, cooling, analyte instability, exposure to the environment, etc.

    2. Give us your feedback on this sectionDisadvantages
      1. Reliability of POCT results
        1. Questionable quality can occur, given the variety of educational and experience levels and turnover of staff that perform the tests
        2. Greater inter-individual variability in results (compared to central laboratory testing) is common
        3. Waived category does not guarantee reliability. Simplicity is deceptive and there are many ways that staff can inadvertently generate a wrong result with waived or “simple” tests.
      2. Cost – per test costs for POCT are often significantly higher than the cost of central laboratory testing. However, the overall cost of care may be lower when POCT is employed, especially if patients may be treated or moved through the system more quickly and care outcomes are improved
      3. Number of testing personnel– the number of operators to manage is orders of magnitude larger than centralized laboratory staff.
      4. Management of POCT is challenging – there can be dozens of sites, hundreds of POCT devices/kits, and thousands of operators to manage to assure quality of testing.
      5. Personnel performing POCT may inappropriately use a test kit or device outside of its intended use or the written procedure (e.g. performing guaiac testing on nipple secretions instead of feces).
      6. POC tests often employ different methods – POCT methods can have unique interferences and limitations compared to central laboratory methods (e.g. POCT glucose interference from maltose, galactose, xylose).
      7. POCT results are not necessarily comparable to central laboratory results – Standard methods may not be used in POCT and thus it may not be possible to compare results across sites (e.g. when patients travel and are tested at different sites, or when treatment protocols derived from more accurate results are being followed). Differences in specimen types, (e.g. serum, plasma, or whole blood,) may also affect results between traditional central laboratory methods and POCT. Thus, clinical protocols based on central laboratory results may need to be revised when utilizing POCT results.
      8. Not all methods are appropriate for diagnosis or monitoring treatment. Some POCT may only be adequate for screening with follow up testing required for definitive results.
      9. POCT kits and devices may not be FDA approved for all uses that a similar test in the central laboratory can be used for (e.g. waived PT/INR approved for monitoring Coumadin Warfarin therapy but not for diagnosis or assessment of bleeding diathesis).
      10. POCT does not necessarily mean improved patient outcome – POCT only provides faster test results. The entire clinical pathway must be optimized to expedite clinical management based on a faster test result in order to achieve improved outcomes.
      11. Documentation of test results, normal range values, units, operator ID, internal control results, etc. may be haphazard and difficult to standardize.
      12. Documentation of physician order and appropriate information for billing may be problematic.
      13. Reagent storage is decentralized and widespread, making management of supplies and monitoring of storage conditions problematic.
      14. The significance of an error is not uniform. Producing a false test result at home or in a POL may have less potential for adverse outcome than in an acute care facility where a patient may have a procedure or treatment based on that result (e.g., a false negative pregnancy test followed by a radiology test or a falsely high glucose followed by insulin injection).
      15. Error management may be more problematic than centralized testing and harder to track given less control over the testing process.
      16. Interfacing results to the electronic patient record may be more difficult.
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