Accuracy of a Point-of-Care Hemoglobin A1c Assay. (November 2019)

• Record Type: Journal Article
• Authors: Nathan, David M.; Griffin, Amanda; Perez, Francesca M.; Basque, Erica; Do, Lily; Steiner, Barbara
• Is Part Of: Journal of diabetes science and technology. Volume 13:Number 6(2019:Nov.)
• Page Start: 1149
• Page End: 1153
• Publication Date: 2019-11
• Subjects: glycohemoglobin -- HbA1c -- point of care; Diabetes -- Periodicals; Medical technology -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1177/1932296819836101
• Languages: English
• ISSNs: 1932-2968

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 Affinity TM ) 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 ( r 2 = .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 ( r 2 = .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.