Schloss Lottie, van Loon Anton M, Cinque Paola, Cleator Graham, Echevarria José-Manuel, Falk Kerstin I, Klapper Paul, Schirm Jurjen, Vestergaard Bent Faber, Niesters Hubert, Popow-Kraupp Therese, Quint Wim, Linde Annika
Quality Control Concerted Action, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, United Kingdom.
J Clin Virol. 2003 Oct;28(2):175-85. doi: 10.1016/s1386-6532(03)00003-9.
There is an increasing awareness of the need for external quality control of diagnostic virology.
To assess the quality of nucleic acid amplification tests (NAT) of herpes simplex within Europe.
Herpes simplex virus (HSV) proficiency panels were produced at the Swedish Institute for Infectious Disease Control on behalf of the European Union Concerted Action for Quality Control of Nucleic Acid Amplification in 1999 and 2000. Nine reference laboratories evaluated the production process. Each panel consisted of 12 coded samples with various concentrations of inactivated, freeze-dried HSV type 1 (HSV-1), and HSV type 2 (HSV-2), or negative controls. Positive samples included HSV-1 and HSV-2 in a range of concentrations (2 x 10(2) to 2 x 10(7) genome copies per ml) similar to those found in cerebrospinal fluids from patients with HSV encephalitis.
Sixty-six participants reported a total of 76 data sets for panel 1, and 71 reported 78 data sets for panel 2. The majority of the participants employed qualitative 'in-house' polymerase chain reaction (PCR) methods, either in a single, nested or semi-nested format. For panel 2, 9 laboratories reported use of 'real-time' PCR in contrast to 3 for panel 1. Three laboratories submitted quantitative results on both panels. Thirty percent of the data sets had correct results for the entire panel 1. In 6 data sets (8%) a total of 11 false positive results were reported. For panel 2, 28% of the data sets had correct result. Nineteen false positive results were reported in 14 data sets (18%), but most of the incorrect results reflected a lack of test sensitivity.
The relatively high frequency of false positive results and the large number of false-negative results, albeit at low copy number, stress the need for improvement in the quality of HSV NAT and for external quality control programmes.
对诊断病毒学进行外部质量控制的必要性日益受到关注。
评估欧洲范围内单纯疱疹核酸扩增检测（NAT）的质量。
1999年和2000年，瑞典传染病控制研究所代表欧盟核酸扩增质量控制联合行动制作了单纯疱疹病毒（HSV）能力验证样本。九个参考实验室对制作过程进行了评估。每个样本组由12个编码样本组成，这些样本含有不同浓度的灭活冻干1型单纯疱疹病毒（HSV-1）、2型单纯疱疹病毒（HSV-2）或阴性对照。阳性样本中HSV-1和HSV-2的浓度范围（每毫升2×10²至2×10⁷个基因组拷贝）与HSV脑炎患者脑脊液中的浓度相似。
66名参与者报告了样本组1的总共76个数据集，71名参与者报告了样本组2的78个数据集。大多数参与者采用定性的“内部”聚合酶链反应（PCR）方法，采用单重、巢式或半巢式形式。对于样本组2，9个实验室报告使用了“实时”PCR，而样本组1为3个。三个实验室在两个样本组上都提交了定量结果。30%的数据集对整个样本组1的检测结果正确。在6个数据集（8%）中，共报告了11例假阳性结果。对于样本组2，28%的数据集检测结果正确。在14个数据集（18%）中报告了19例假阳性结果，但大多数错误结果反映出检测灵敏度不足。
假阳性结果出现频率相对较高，且假阴性结果数量较多（尽管拷贝数较低），这凸显了提高HSV NAT质量以及开展外部质量控制项目的必要性。
