聚合酶链反应检测丙型肝炎病毒的可靠性

Reliability of polymerase chain reaction for detection of hepatitis C virus.

作者信息

Zaaijer H L, Cuypers H T, Reesink H W, Winkel I N, Gerken G, Lelie P N

机构信息

Central Laboratory of the Netherlands Red Cross Blood Transfusion Service, Amsterdam, Netherlands.

出版信息

Lancet. 1993 Mar 20;341(8847):722-4. doi: 10.1016/0140-6736(93)90488-3.

DOI:10.1016/0140-6736(93)90488-3

PMID:8095626

Abstract

The polymerase chain reaction (PCR) is used to detect hepatitis C virus (HCV) RNA, and the results of this assay may have a bearing on management of patients. We tested 31 laboratories for performance of HCV PCR with a coded panel that comprised 4 HCV-positive plasma samples, 6 HCV-negative samples, and two dilution series of HCV-positive plasma. 15 (48%) laboratories had faultless results with both dilution series, and 16 (52%) laboratories reported erroneous results with one or both series. 10 (32%) laboratories had faultless results when testing undiluted plasma samples, 11 (35%) produced a false-negative result with a weak-positive sample, and 10 (32%) produced false negative and/or false positive results. Only 5 (16%) laboratories performed faultlessly with the entire panel of samples. Reports of presence of HCV should be interpreted with care until reliable HCV-RNA detection becomes widely available.

摘要

聚合酶链反应（PCR）用于检测丙型肝炎病毒（HCV）RNA，该检测结果可能对患者的管理产生影响。我们用一个编码样本组对31个实验室进行了HCV PCR检测性能测试，该样本组包括4份HCV阳性血浆样本、6份HCV阴性样本以及两份HCV阳性血浆的稀释系列样本。15个（48%）实验室对两个稀释系列样本的检测结果均无误，16个（52%）实验室报告一个或两个系列样本的检测结果有误。10个（32%）实验室在检测未稀释血浆样本时结果无误，11个（35%）实验室对弱阳性样本得出假阴性结果，10个（32%）实验室得出假阴性和/或假阳性结果。只有5个（16%）实验室对全部样本组的检测均无误。在可靠的HCV-RNA检测广泛应用之前，对HCV存在情况的报告应谨慎解读。