Evaluation of a new hemoglobin A1c analyzer for point-of-care testing

Background: There has been an increasing desire for the use of point-of-care testing (POCT) by both primary care clinicians and patients. This study aimed to evaluate the performance of a new POCT analyzer for hemoglobin A1c (HbA1c) testing.

Methods: We assessed the accuracy, precision, and linearity of the POCT HbA1c analyzer (A1C EZ 2.0) with the Tosoh G8 Analyzer as comparative instrument, following the Clinical and Laboratory Standards Institute (CLSI) protocols. We evaluated sensitivity and specificity of the A1C EZ 2.0 in the clinical diagnosis of diabetes among 842 subjects from 79 communities in Beijing, China.

Results: Using regression analysis, the slope of the A1C EZ 2.0 vs the Tosoh G8 Analyzer was 0.9938, with an intercept of 0.0964 and a concordance correlation coefficient of 0.978. For precision, the reproducibility of CV (CV_T ) were 3.7% and 2.7% at a lower (36 mmol/mol (5.4%)) and higher (107 mmol/mol (11.9%)) level of HbA1c respectively. The area under the receiver operating characteristic (ROC) curve for clinical diagnosis of diabetes was 0.911 with the HbA1c cut-off value of 44 mmol/mol (6.14%). At the HbA1c level of 48 mmol/mol (6.5%), the sensitivity and specificity were76.1% and 86.6%.

Conclusion: The A1C EZ 2.0 has a high accuracy and precision, with a wide range of linearity, compared to a comparative laboratory instrument. It met analytical quality specifications and could be suitable for the clinical management of diabetes mellitus.