在罗氏COBAS Integra 800封闭管系统上对糖化血红蛋白（HbA1c）进行评估。
Evaluation of HbA1c on the Roche COBAS Integra 800 closed tube system.
作者信息
Fleming James K
机构信息
Laboratory Corporation of America, Elon, NC 27244, USA.
出版信息
Clin Biochem. 2007 Jul;40(11):822-7. doi: 10.1016/j.clinbiochem.2007.03.017. Epub 2007 Apr 4.
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.
目的
评估一种具有闭管采样（CTS）功能的新型全血（WB）糖化血红蛋白免疫测定法及系统。
设计与方法
将COBAS INTEGRA 800（I800）上的Tina - quant糖化血红蛋白二代（A1C - 2）应用以及具有CTS功能的新型I800专用系统与当前的Integra应用以及一种对常见血红蛋白（Hb）变体准确的糖化血红蛋白方法进行比较。
结果
变异系数（CVs）≤1.7%。与国家糖化血红蛋白标准化计划（NGSP）样本相比，平均偏差为0.3%糖化血红蛋白。与日立Tina - quant（R）[a]糖化血红蛋白II（HbA1c II）测定法（对常见Hb变体准确）相比，对于Hb AS变体，在6%和9%时糖化血红蛋白的平均偏差分别为0.04%和0.21%；对于Hb AC变体，在6%和9%时糖化血红蛋白的平均偏差分别为 - 0.01%和0.26%。
结论
Integra A1C - 2应用精确，对于NGSP指定的样本以及所测试的Hb变体准确；并且，具有CTS功能的I800专用系统提高了通量并减少了样本处理。
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