Six of Eight Hemoglobin A1c Point-of-Care Instruments Do Not Meet the General Accepted Analytical Performance Criteria
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Open Access
- 1 January 2010
- journal article
- Published by Oxford University Press (OUP) in Clinical Chemistry
- Vol. 56 (1), 44-52
- https://doi.org/10.1373/clinchem.2009.130641
Abstract
Background: Hemoglobin A1c (Hb A1c) point-of-care (POC) instruments are widely used to provide rapid-turnaround results in diabetic care centers. We investigated the conformance of various Hb A1c POC instruments (In2it from Bio-Rad, DCA Vantage from Siemens, Afinion and Nycocard from Axis-Shield, Clover from Infopia, InnovaStar from DiaSys, A1CNow from Bayer, and Quo-Test from Quotient Diagnostics) with generally accepted performance criteria for Hb A1c. Methods: The CLSI protocols EP-10, EP-5, and EP-9 were applied to investigate imprecision, accuracy, and bias. We assessed bias using 3 certified secondary reference measurement procedures and the mean of the 3 reference methods. Assay conformance with the National Glycohemoglobin Standardization Program (NGSP) certification criteria, as calculated from analyses with 2 different reagent lot numbers for each Hb A1c method, was also evaluated. Results: Because of disappointing EP-10 results, 2 of the 8 manufacturers decided not to continue the evaluation. The total CVs from EP-5 evaluations for the different instruments with a low and high Hb A1c value were: In2it 4.9% and 3.3%, DCA Vantage 1.8% and 3.7%, Clover 4.0% and 3.5%, InnovaStar 3.2% and 3.9%, Nycocard 4.8% and 5.2%, and Afinion 2.4% and 1.8%. Only the Afinion and the DCA Vantage passed the NGSP criteria with 2 different reagent lot numbers. Conclusions: Only the Afinion and the DCA Vantage met the acceptance criteria of having a total CV <3% in the clinically relevant range. The EP-9 results and the calculations of the NGSP certification showed significant differences in analytical performance between different reagent lot numbers for all Hb A1c POC instruments.Keywords
This publication has 7 references indexed in Scilit:
- Analytic Bias Among Certified Methods for the Measurement of Hemoglobin A1cAmerican Journal of Clinical Pathology, 2008
- Haemoglobin A1c: Evaluation of three point of care analysers for use in a paediatric diabetes clinicAnnals of Clinical Biochemistry: International Journal of Laboratory Medicine, 2005
- Rapid A1c Availability Improves Clinical Decision-Making in an Urban Primary Care ClinicDiabetes Care, 2003
- Effect of Immediate Hemoglobin A1c Results on Treatment Decisions in Office PracticeEndocrine Practice, 2001
- Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients.Diabetes Care, 1999
- The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes MellitusNew England Journal of Medicine, 1993
- Tests of Equality Between Sets of Coefficients in Two Linear RegressionsEconometrica, 1960