Accuracy of a Point-of-Care Hemoglobin A1c Assay

Abstract

Point-of-care test (POCT) HbA1c assays provide rapidly available results for clinical decision-making. Accuracy and precision must be established. Venous blood samples from 300 patients were assayed for HbA1c by a laboratory technician (“laboratory assessment”) with the POCT Alere Afinion™ assay and a laboratory (Premier AffinityTM) assay. POCT results from 402 patients’ fingerstick samples assayed by nine nontechnician staff (“clinical assessment”) were compared with the laboratory assay. The laboratory assessment showed tight correlation ( r2= .977, P < .001) between the assays. Mean absolute and relative differences were 0.01 percentage points and 2.1%, respectively. CVs for the POCT and laboratory assays were <2% and <1%, respectively. The clinical assessment also showed a tight correlation between the assays ( r2= .978, P < .001), with mean absolute and relative differences of 0.2 percentage points and 3.41%, respectively. CV for the POCT assay was <2%. The POCT performed acceptably compared to the laboratory assay under realistic clinical conditions.