750-P: Afinion HbA1c Dx Point-of-Care Test Is Accurate to Diagnose Diabetes in CLIA-Waived Settings

Abstract

No point of care HbA1c (A1c) assays are CLIA waived for use in diagnosing diabetes. The accuracy of the Abbott Afinion HbA1c Dx (Afinion) was evaluated for this purpose. Operators with no laboratory training (N=21) tested fingerstick (FS) and venous (V) whole blood samples from subjects at 7 CLIA waived sites with 2 Afinion analyzer models (AS100 and Afinion 2). Operators self-trained on use of the Afinion using only materials that are provided when the test is purchased. A portion of each subject’s V sample was tested with a recognized comparative method (CM) at an NGSP Secondary Reference Laboratory (SRL). Consistent with FDA requirements for total error of A1c test systems, the percentage of Afinion results within an Allowable Total Error (ATE) zone of ±6% of the CM result was calculated, as well as the bias at 6.5% A1c. A total of 1,229 subjects with A1c values spanning the Afinion assay measuring range were enrolled. For the Afinion 2, 95.04% (95% lower confidence limit, LCL: 93.33%) of FS and 94.86% (95% LCL: 93.12%) of V results were within the ATE zone. For the AS100, 94.22% (95% LCL: 92.38%) and 93.36% (95% LCL: 91.41%) of Afinion results were within the ATE zone for FS and V samples, respectively. The bias at 6.5% A1c for the Afinion 2 was -0.13% (-0.008% A1c units) for FS and 0.01% (0.000% A1c units) for V samples. For the AS100, the bias was 0.62% (0.040% A1c units) and 1.13% (0.073% A1c units) for FS and V samples, respectively. No operator effects and no differences between the Afinion and CM results that could potentially impact clinical decision making were observed in this study. In subjects with unreported hemoglobin variants (detected by CM), 16/16 FS and 15/16 V Afinion results were within the ATE zone when compared to a second NGSP certified method at the same SRL. These data support the use of Afinion in CLIA waived settings to diagnose diabetes. Disclosure M. Clendenin: Employee; Self; Abbott. A. J. Nation: None. R. C. San george: Other Relationship; Self; Abbott. K. Kupfer: Employee; Self; Abbott. K. S. Fortner: Employee; Self; Abbott. R. R. Little: None. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. K. N. Castorino: Consultant; Self; Dexcom, Inc., Research Support; Self; Abbott Diabetes, Abbott Laboratories, Dexcom, Inc., Drawbridge Health, Inc., Lilly Diabetes, Medtronic, Novo Nordisk Inc. D. S. Denham: None. E. Kerwin: Consultant; Self; Amphastar, AstraZeneca, Connect Biopharma, GlaxoSmithKline plc., Mylan N. V., Novartis Pharmaceuticals Corporation, Sunovion Pharmaceuticals Inc., Theravance Biopharma, Speaker’s Bureau; Self; Chiesi USA, Inc. M. Mickiewicz: None.