Performance of the Roche Accu-Chek active glucose meter to screen for gestational diabetes mellitus using fasting capillary blood.

ABSTRACT

BACKGROUND: Point-of-care (POC) blood glucose measurement using glucose meters is used by diabetes patients to mange their disease. POC glucose testing also is also used in tight glycemic control protocols and as a screening tool for diabetes. We report the performance and effectiveness of the Accu-Chek® Active (Roche Diagnostics GmbH, Mannheim, Germany) glucose meter to screen for gestational diabetes mellitus (GDM) using blood fasting capillary glucose (FCG). METHODS: To screen for GDM, 1,465 pregnant women underwent an oral glucose glucose tolerance test. Correlation between the FCG and fasting plasma glucose (FPG) levels was determined by Passing and Bablok regression analysis. Total error (TE) of the glucometer was ascertained using the Bland-Altman method with the DXC-800 analyzer (Beckman-Coulter Instruments, Brea, CA) as the reference method. The area under the receiver operator characteristic curve was used to analyze the performance of the FCG to predict GDM. RESULTS: FPG and FCG identified 361 (24.6%) and 338 (23%) women as having GDM, respectively. The Bland-Altman TE at 95% limits of agreement was -11.1% to 10.8%. The area under the receiver operator characteristic curve was 0.953 (95% confidence interval 0.943 to 0.964). CONCLUSIONS: The Roche Accu-Chek Active glucometer meets analytical and clinical quality requirements. A TE of±15% is acceptable for glucose meters used in ambulatory care, including home self-monitoring of blood glucose, and different TE targets should be set for acute critical care settings.