Not so fast, Point-of-Care

stop

The American Diabetes Association (ADA) has revised its recommendation for diagnosis of diabetes and now recommends using hemoglobin A1c to diagnose diabetes (1). They also say:

A1C tests to diagnose diabetes should be performed using clinical laboratory equipment. Point-of-care instruments have not yet been shown to be sufficiently accurate or precise for diagnosing diabetes.

Maybe this is a trend to slow down the adoption of point-of-care (POC) assays.

Scott, et. al. speculate that one of the reasons that tight glycemic control (TGC) in ICUs has been dropped as a guideline is that the use of POC glucose meters (meaning less accurate) as opposed to laboratory assays may have contributed to the adverse findings of TGC.

This will also mean that the CLSI standard POCT09-P Selection Criteria for Point-of-Care Testing Devices will need to be revised since although they suggest conducting performance evaluations, their examples of benefits of POC assays now include two examples where the accuracy of POC tests have either been rejected or questioned (1-2). POCT09-P also cites the benefit of a POC troponin assay, where performance was tested by surveying clinicians – hardly a rigorous test (3) and not conforming to their own recommendation for a real evaluation.

References

  1. International Expert Committee Report on the Role of the A1C Assay in the Diagnosis of Diabetes. Diabetes Care 2009;32:1327-1334.
  2. Scott MG, Bruns DE, Boyd JC, and Sacks DB. Tight glucose control in the intensive care unit: Are glucose meters up to the task? Clin Chem 2009;55:18-20.
  3. Lee-Lewandrowski E, Corboy D, Lewandrowski, K, Sinclair J, McDermot S,  Benzer, TI. Implementation of a Point-of-Care Satellite Laboratory in the Emergency Department of an Academic Medical Center. Archives of Pathology and Laboratory Medicine 2003;127:456–460.
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