Unidad de Infección Viral e Inmunidad. Centro Nacional de Microbiología - Instituto de Salud Carlos III, Majadahonda, Spain.
Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Sci Rep. 2019 May 13;9(1):7316. doi: 10.1038/s41598-019-41139-8.
The dried blood spot (DBS) is increasingly used for the hepatitis C virus (HCV) screening. Our objective was to perform a meta-analysis of the methodology for HCV screening in DBS samples, particularly in the type of diagnostic assay used. We performed a meta-analysis of all eligible studies published to date (March 2018). The literature search revealed 26 studies: 21 for detection of anti-HCV antibodies and 10 for detection of HCV-RNA. Statistical analyses were performed using Meta-DiSc and STATA (MIDAS module). For detection of HCV antibodies, pooled diagnostic accuracy measures were as follows: sensitivity 96.1%, specificity 99.2%, positive likelihood ratio (PLR) 105, negative likelihood ratio (NLR) 0.04, diagnostic odds ratio (DOR) 2692.9, and summary receiver operating characteristic (SROC) 0.997 ± 0.001. For detection of HCV-RNA, the pooled diagnostic accuracy measures were as follows: sensitivity 97.8%, specificity 99.2%, PLR 44.8, NLR 0.04, DOR 1966.9, and SROC 0.996 ± 0.013. Similar values of pooled diagnostic accuracy measures were found according to the type of anti-HCV antibody detection assay (enzyme-linked immunosorbent assay, rapid diagnostic test, and chemiluminescence assays) and HCV-RNA detection assay (real-time polymerase chain reaction and transcription-mediated amplification). The analysis of external validity showed a high negative predicted value (NPV) for both approaches, but a low positive predicted value (PPV) when prevalence was < 10%, particularly in HCV-RNA tests. Finally, this meta-analysis is subject to limitations, especially publication bias and significant heterogeneity between studies. In conclusion, HCV screening in DBS samples has an outstanding diagnostic performance, with no relevant differences between the techniques used. However, external validity may be limited when the HCV prevalence is low.
干血斑（DBS）越来越多地用于丙型肝炎病毒（HCV）筛查。我们的目的是对 DBS 样本中 HCV 筛查的方法进行荟萃分析，特别是对所用诊断检测方法的类型进行分析。我们对截至 2018 年 3 月发表的所有合格研究进行了荟萃分析。文献检索显示共有 26 项研究：21 项用于检测抗 HCV 抗体，10 项用于检测 HCV-RNA。使用 Meta-DiSc 和 STATA（MIDAS 模块）进行统计分析。用于检测 HCV 抗体的综合诊断准确性测量结果如下：灵敏度 96.1%，特异性 99.2%，阳性似然比（PLR）为 105，阴性似然比（NLR）为 0.04，诊断比值比（DOR）为 2692.9，综合受试者工作特征（SROC）为 0.997±0.001。用于检测 HCV-RNA 的综合诊断准确性测量结果如下：灵敏度 97.8%，特异性 99.2%，PLR 为 44.8，NLR 为 0.04，DOR 为 1966.9，SROC 为 0.996±0.013。根据抗 HCV 抗体检测方法（酶联免疫吸附试验、快速诊断试验和化学发光试验）和 HCV-RNA 检测方法（实时聚合酶链反应和转录介导扩增）的不同，发现综合诊断准确性测量结果相似。外部有效性分析显示，两种方法的阴性预测值（NPV）都很高，但在流行率<10%时，阳性预测值（PPV）较低，尤其是在 HCV-RNA 检测中。最后，本荟萃分析受到一些限制，特别是发表偏倚和研究之间存在显著的异质性。总之，DBS 样本中的 HCV 筛查具有出色的诊断性能，使用的技术之间没有明显差异。然而，当 HCV 流行率较低时，外部有效性可能受到限制。
