Challenges in Hb A1c Point-of-Care Testing: Only 5 of 19 Hb A1c Point-of-Care Devices Meet IFCC and NGSP Certification Criteria on Independent Evaluation

Abstract

Background: Access to Hb A1c testing in low- and middle-income countries (LMICs) can be limited, especially in rural areas. This has led to an increased interest in the potential role of point-of-care testing (POCT) for Hb A1c. The analytical performance of many of these devices is poorly understood but accurate and precise measurement is essential for effective diabetes management.

Methods: Verification of the manufacturers' claims, for accuracy, imprecision, and interference from hemoglobin variants, was performed using protocols based on established guidance using Clinical and Laboratory Standards Institute (CLSI) protocols (EP-15-A3 and EP-9-A3), international quality targets and 4 certified International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and National Glycohemoglobin Standardization Program (NGSP) Secondary Reference Measurement Procedures (SRMP). Each of the 19 POC devices were assessed for performance against both IFCC and NGSP certification criteria.

Results: Out of 19 Hb A1c POC devices, only 5 (26%) met international quality criteria (IFCC and NGSP with at least one SRMP), 5 (26%) only met IFCC criteria, and 9 (47%) did not meet either IFCC or NGSP criteria, despite most of these devices having an IFCC and/or NGSP certificate at the time of the study. Three devices showed clear interference from Hb variants.

Conclusions: This study shows the importance of independent evaluations for assessing the performance of Hb A1c POC devices. The analytical performance of the devices was very poor overall, with 74% not meeting both IFCC and NGSP criteria. These evaluations were performed under ideal conditions; performance may worsen further when used in a clinical setting.