title: Evaluation of HbA1c on the Roche COBAS Integra 800 closed tube system.
abstract: OBJECTIVE
  Evaluate a new whole blood (WB) HbA1c immunoassay and system with closed tube sampling (CTS) capability.
  
  
  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.
authors.affiliation: Laboratory Corporation of America, Elon, NC 27244, USA. fleminj@labcorp.com
authors.forename: James K
authors.initials: JK
authors.lastname: Fleming
mesh_terms: D004912:Erythrocytes / Q000378:metabolism; D006442:Glycated Hemoglobin / Q000032:analysis* / Q000378:metabolism; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D006442:Glycated Hemoglobin