Key result
Future studies on HbA1c point-of-care testing devices should focus on clinical settings, internationally standardized reference methods, and new-to-market devices.
Why the study?
Despite growing publications comparing HbA1c point-of-care testing devices to routine laboratory instruments, the key requirements and focus areas for future performance evaluations remained undefined.
Highlights the need for future studies on HbA1c POCT devices to be conducted in clinical settings against internationally standardized reference methods.
POCT HbA1c performance data remain limited for practice; leaves open optimal study designs in clinical settings.
There are a growing number of publications evaluating the performance of HbA1c point-of-care testing (POCT) devices when compared to routine laboratory instruments, but is this what we need from future studies? Here we describe the current understanding of the performance of POCT for HbA1c, which areas need further studies, and the key requirements for future publications based on performance evaluations of these devices. These include studies in clinical settings, performance measured against internationally standardized reference methods, and the need to evaluate new to the market devices that do not currently have a detailed performance history. In addition we highlight the need for external quality assessment schemes that are designed to support POCT in a wide range of clinical settings.
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Lenters‐Westra et al. (2019) conducted a review in HbA1c point-of-care testing (POCT). HbA1c point-of-care testing (POCT) devices vs. routine laboratory instruments was evaluated. Future studies on HbA1c point-of-care testing devices should focus on clinical settings, internationally standardized reference methods, and new-to-market devices.
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