Evaluation of the Roche Cobas b 101 Glycosylated Hemoglobin Point-of-Care Analyzer

Background: Glycosylated hemoglobin (HbA1c) is a biomarker to assess long-term glycemic control in diabetic patients and has recently been recommended for diagnosis of diabetes. An evaluation of the Roche Cobas b 101 point-of-care (POC) HbA1c analyzer was conducted to assess its analytical performance. Methods: Precision and accuracy were estimated by analyzing 2 control samples 11 times for the within-run experiment and over 11 days for the between-batch precision. Agreement was correlated to the laboratory method, Tosoh Biosciences G8 HbA1c analyzer (n = 51; range of results, 4.7%–15.1%), and a POC method, the Siemens DCA Vantage Hemoglobin A1c System, using leftover EDTA samples from laboratory analysis (n = 16; range of results, 5.5%–14.2%). Lot-to-lot reproducibility was investigated using 11 patient samples analyzed with 2 different reagent lots. Interference from the presence of hemoglobin variants was also investigated. Results: The Cobas b 101 analyzer showed good precision. Within-run and between-batch coefficient of variations were 1.6% and 3.5% for level 1 control (mean value, 5.2%), and for level 2 control (mean, 10.2%), coefficient of variations were 0.3% for within run and 3% for between batch. The analyzer had a good agreement with both Tosoh G8 (r = 1, P
Source: Point of Care: The Journal of Near-Patient Testing and Technology - Category: Pathology Tags: Original Articles Source Type: research