Point-of-Care HbA1c Device Matches Lab Methods for Diabetes Diagnosis
A five-center study compared the Afinion AS100 POC HbA1c device against multiple laboratory methods and the NGSP reference method using 618 patient specimens. The POC device achieved comparable accuracy (97.1% within target vs. 94.5% for lab methods) and precision (CV 0.74-2.13% vs. 0.81-3.23%), with minimal bias at the diagnostic threshold of 6.5%. These data supported FDA approval of the Afinion for diabetes diagnosis at the point of care, potentially expanding access to HbA1c-based screening.
The original study
Multicenter assessment of a hemoglobin A1c point-of-care device for diagnosis of diabetes mellitus.
- Authors
- Sobolesky PM, Smith BE, Saenger AK, Schulz K, Apple FS, Scott MG, et al.
- Journal
- Clinical biochemistry
- Type
- Comparative Study, Journal Article, Multicenter Study
- PMID
- 30236830
Original abstract
OBJECTIVE: A multisite investigation compared the analytical performance of a point-of-care (POC) HbA1c device with multiple commonly used HbA1c laboratory methods and an NGSP (National Glycohemoglobin Standardization Program) reference method. RESEARCH DESIGN AND METHODS: The Afinion AS100 POC device analyzed HbA1c using 618 EDTA whole blood excess patient specimens with clinically indicated HbA1c testing. Results were compared to measurements across five clinical laboratories and the NGSP reference method. Precision was evaluated over 8-10 consecutive days for low-, mid-, and high-range HbA1c specimens at all five sites. RESULTS: Over a wide range of HbA1c values (4.0%-15% HbA1c), 97.1% of the POC results and 94.5% of routine laboratory results fell within the target value of ±6% of the NGSP reference method results. The POC HbA1c results at 6.5% exhibited a total relative bias of -0.6% (-0.04% HbA1c) compared to the reference method while the aggregate of laboratory methods displayed a relative bias of -0.9% (-0.06% HbA1c). The total imprecision of the POC results ranged from 0.74-2.13% CV across the analytic measurement range compared to 0.81-3.23% CV for the routine laboratory methods. CONCLUSIONS: The accuracy and precision of the Afinion POC HbA1c method was comparable to the laboratory HbA1c methods supporting the FDA's recent approval of the Afinion HbA1c Dx device for use in the diagnosis of diabetes.