National Center for Clinical Laboratories, Beijing Hospital, Beijing, China.
Clin Chim Acta. 2013 Oct 21;425:139-47. doi: 10.1016/j.cca.2013.07.026. Epub 2013 Aug 2.
Remarkable progress has been made in the quality assurance of Hepatitis B virus (HBV) DNA nucleic amplification techniques (NAT) during the past decade. And this report presents a 10-year external quality assessment (EQA) program performed by National Center for Clinical Laboratories in China since 2003.
EQA panels were produced using freeze-dried HBV plasma or negative controls and then calibrated against the first International Standard for HBV DNA.
By 2012, total 35,570 qualitative EQA reports and 56,826 quantitative reports have been collected. The overall correct recognition rate in qualitative test increased from 95.15% in 2003 to 97.99% in 2012. The proportion of participants with acceptable quantitative results also rose to 87.99% in 2012 compared with that of 27.53% in 2003. Besides, we observed a satisfactory reproducibility of <5% in all parallel samples. However, some laboratories still had difficulties in exact quantification of some low viral loads, which near to the limits of the dynamic range of the assays.
Taking together, current EQA program showed an encouraging improvement of HBV DNA NAT in China. Distributing more challenging samples and increasing the subtypes are still needed in the future.
在过去的十年中，乙型肝炎病毒（HBV）DNA 核酸扩增技术（NAT）的质量保证取得了显著进展。本报告介绍了中国国家临床检验中心自 2003 年以来开展的十年间的外部质量评估（EQA）计划。
使用冻干 HBV 血浆或阴性对照物制备 EQA 试剂盒，并针对第一个 HBV DNA 国际标准进行校准。
截至 2012 年，共收集了 35570 份定性 EQA 报告和 56826 份定量报告。定性检测的总体正确识别率从 2003 年的 95.15%上升至 2012 年的 97.99%。定量结果可接受的参与者比例也从 2003 年的 27.53%上升至 2012 年的 87.99%。此外，我们观察到所有平行样本的重复性均<5%，结果令人满意。然而，一些实验室仍然难以对接近检测限附近的低病毒载量进行准确定量。
总的来说，当前的 EQA 计划显示中国 HBV DNA NAT 取得了令人鼓舞的进展。未来仍需要分发更具挑战性的样本并增加亚型。
