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Evaluation of HbA1c on the Roche COBAS Integra 800 closed tube system
1Laboratory Corporation of America, Elon, NC 27244, USA. fleminj@labcorp.com
Objectives:
Evaluate a new whole blood (WB) HbA1c immunoassay and system with closed tube sampling (CTS) capability.
Design And Methods:
Compare the Tina-quant Haemoglobin A1c Gen.2 (A1C-2) application on the COBAS INTEGRA 800 (I800) and new I800 dedicated system with CTS capability to current Integra applications and a HbA1c method accurate with common haemoglobin (Hb) variants.
Results:
CVs were < or =1.7%. Mean bias against National Glycohaemoglobin Standardization Program (NGSP) samples was 0.3 HbA1c %. Compared to the Hitachi Tina-quant(R) [a] HbA1c II (HbA1c II) assay (accurate with common Hb variants), mean bias was 0.04% and 0.21% HbA1c at 6% and 9%, respectively, with Hb AS variants; and -0.01% and 0.26% HbA1c at 6% and 9%, respectively, with Hb AC variants.
Conclusions:
The Integra A1C-2 application is precise, accurate against NGSP-assigned samples and the Hb variants tested; and, the I800 dedicated system with CTS capability offers increased throughput and reduced sample handling.