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KMID : 0985420100320020225
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Laboratory Medicine and Quality Assurance
2010 Volume.32 No. 2 p.225 ~ p.228
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Evaluation of HbA1c on COBAS INTEGRA 800 Closed Tube System Compared with Variant II Turbo
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Lee Eun-Young
Yoon Seo-Young
Kim Sun-Hee
Lee Woon-Hyoung
Kwon Oh-Hun
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Abstract
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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.
Results: 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.
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KEYWORD
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HbA1c, Glycated hemoglobin, Closed Tube System, COBAS INTEGRA 800, Method comparison
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