Point of Care Testing for HbA1c in Primary Care—cobas b 101 Instrument Evaluation. Issue 4 (December 2016)

• Record Type: Journal Article
• Authors: Tirimacco, Rosy; Cowley, Penelope J.; Simpson, Paul A.; Siew, Limei; St John, Andrew; Tideman, Philip A.
• Is Part Of: Point of care. Volume 15:Issue 4(2016)
• Publication Date: 2016-12
• Subjects: diabetes -- rural and remote -- primary care -- point-of-care testing -- HbA1c; Point-of-care testing -- Periodicals; Point-of-Care Systems -- standards -- Periodicals; 616.075
• DOI: 10.1097/POC.0000000000000106
• Languages: English
• ISSNs: 1533-029X

Abstract

Abstract : Objective: This study aims to evaluate the suitability of the cobas b 101 instrument for the measurement of HbA1c in primary care. Methods: Ten primary health care centres were involved in the evaluation of the cobas b 101 instrument. Inter-assay imprecision was assessed through quality control testing by practice nurses in the primary health care centers. Intra-assay imprecision was assessed through quality control testing by scientific staff in a laboratory setting. Accuracy was assessed through 15 patient comparison samples at each site, with samples tested on the b 101 instrument and sent to the local laboratory for analysis. Surveys were conducted assessing user satisfaction. Results: All imprecision results met the minimum and desirable precision goals. Overall patient comparison results demonstrated good correlation ( r ≥ 0.97). An overall instrument bias of 6.5% was seen. All laboratory-diagnosed diabetic patients were classified as diabetic on the b 101 instrument. User satisfaction results were high, recognizing confidence in the b 101 results and advantages to laboratory testing. Conclusions: This study demonstrates that HbA1c testing in primary care through the cobas b 101 instrument is a suitable alternative to laboratory methods, with good precision, correlation, and user satisfaction results.