Quint W G, Heijtink R A, Schirm J, Gerlich W H, Niesters H G
Department of Molecular Biology, Diagnostic Center SSDZ, Delft, The Netherlands.
J Clin Microbiol. 1995 Jan;33(1):225-8. doi: 10.1128/jcm.33.1.225-228.1995.
A quality assurance program has been established by the European Group for Rapid Viral Diagnosis and the European Expert Group on Viral Hepatitis for monitoring nucleic acid detection methods for hepatitis B virus (HBV) DNA in serum samples. Thirty-nine laboratories participated in this quality program and generated 43 data sets. Of the participating laboratories, all but one used the PCR technique to detect HBV DNA. A coded panel was tested that was composed of seven undiluted HBV DNA-positive serum samples and five HBV DNA-negative donor serum samples. Furthermore, two dilution series, one from a positive patient and one from a full-length recombinant DNA, were included. Twenty-six data sets (60.5%) had faultless results with both dilution series. Twelve data sets (27.9%) recognized the undiluted serum samples, and 19 data sets (44.2%) had false-negative and/or false-positive results. Ten data sets (23.3%) performed well with the entire panel of samples. From these results, it can be concluded that in a large group of laboratories HBV detection by PCR shows specificity and sensitivity problems; therefore, PCR test interpretation should be done with great care.
欧洲快速病毒诊断小组和欧洲病毒性肝炎专家组已经建立了一个质量保证计划，用于监测血清样本中乙型肝炎病毒（HBV）DNA的核酸检测方法。39个实验室参与了该质量计划，并生成了43个数据集。在参与的实验室中，除了一个实验室外，其他所有实验室都使用PCR技术检测HBV DNA。检测了一个编码样本组，该样本组由7份未稀释的HBV DNA阳性血清样本和5份HBV DNA阴性供体血清样本组成。此外，还包括两个稀释系列，一个来自阳性患者，一个来自全长重组DNA。26个数据集（60.5%）在两个稀释系列中都有完美的结果。12个数据集（27.9%）识别出了未稀释的血清样本，19个数据集（44.2%）有假阴性和/或假阳性结果。10个数据集（23.3%）在整个样本组中表现良好。从这些结果可以得出结论，在一大组实验室中，通过PCR检测HBV存在特异性和敏感性问题；因此，PCR检测结果的解释应该格外谨慎。
