Evaluation of HbA1c on COBAS INTEGRA 800 Closed Tube System Compared with Variant II Turbo / 임상검사와정도관리

ABSTRACT

BACKGROUND: We evaluated the HbA1c assay on COBAS INTEGRA 800 Closed Tube System (Roche Diagnostics, USA). METHODS: Precision was determined following Clinical and Laboratory Standards Institute (CLSI) EP5-A2 using the Lyphochek Diabetes Control (Bio-Rad Laboratories, Canada). Two levels of QC materials were assayed in duplicates at two separate times per day for 20 days. The within-run, between-run and between-day precisions were evaluated. We compared the HbA1c of COBAS INTEGRA 800 Closed tube system using Tina quant Hemoglobin A1c Gen.2 (Roche Diagnostics, Germany) reagent with Variant II Turbo (Bio-Rad Laboratories, USA). Bias was determined following CLSI EP9-A2. RESULT: The HbA1c assay on COBAS INTEGRA 800 Closed Tube System showed excellent precision performance at a level of 5.9%, total, between run, and between day CVs were 1.8%, 0.5%, and 1.6%, respectively. At a level of 9.6%, total, between run, and between day CVs were 1.4%, 0.3%, and 1.1%, respectively. The assay correlated well with the Variant II Turbo (y=0.9x+0.53, r2=0.9857). Mean bias against Variant II Turbo was -0.2%. Compared with Variant II Turbo, the estimate of the predicted bias at a given medical decision level (HbA1c at 6% and 9%) was -0.1% and -0.31%, respectively. CONCLUSIONS: The COBAS INTEGRA 800 Closed Tube System HbA1C assay was precise and equivalent to Variant II Turbo.