Muzembo B A, Mbendi N C, Nakayama S F
Center for Health and Environmental Risk Research, National Institute for Environmental Studies, Tsukuba, Japan.
Gastroenterology Department, Kinshasa University, Kinshasa, DR Congo.
Public Health. 2017 Dec;153:128-136. doi: 10.1016/j.puhe.2017.08.008. Epub 2017 Oct 14.
Dried blood spots (DBS) specimens can be used for hepatitis C virus (HCV) infection screening in cases where serum specimens are difficult to obtain. However, uncertainties surround the sensitivity and specificity of DBS for HCV antibodies (anti-HCV) serology testing. We aimed to evaluate the accuracy of DBS use to screen for HCV infection.
We carried out a systematic review and meta-analysis.
Medline and EMBASE databases were searched for articles published between 1989 and November 2016. We included studies comparing DBS to plasma/serum specimens to detect anti-HCV in adults. Two authors extracted data and assessed the quality of the studies using an adapted standards for reporting diagnostic accuracy studies (STARD) and independently checked the data for accuracy. Meta-analysis was computed with the bivariate and the hierarchical summary receiver-operating characteristic models.
Twelve studies (3307 specimens) were analyzed, where 11 of them evaluated the anti-HCV using enzyme immunoassays (EIAs), and the remaining one used rapid diagnostic tests. The studies were mostly case-controls (83.3%) and from developed countries (66.7%). The overall pooled sensitivity (95% confidence interval; CI) and specificity (95% CI) of DBS to detect anti-HCV was 98.1% (96.1-99.1%) and 99.7% (98.9-99.9%), respectively. In studies using EIAs, the pooled sensitivity and specificity were 97.3% (94.3-98.8%) and 99.6% (98.5-99.9%), respectively. Considering only studies using EIAs, sensitivity analysis excluding one study carried out in people who inject drugs showed the pooled sensitivity of 97.8% (96.2-98.8%) and specificity of 99.5% (98.5-99.9%).
In testing for anti-HCV by means of EIAs, the efficacy of DBS is found to be similar or slightly lower than that of serum specimens. However, the risk of finding negative and positive results that are both false when using DBS remains present. Therefore, further work including optimal storage and processing methodologies are recommended. This is to help establish consensus guidelines for use of DBS specimens for anti-HCV screening.
在难以获取血清样本的情况下，干血斑（DBS）样本可用于丙型肝炎病毒（HCV）感染筛查。然而，DBS用于HCV抗体（抗-HCV）血清学检测的敏感性和特异性仍存在不确定性。我们旨在评估使用DBS筛查HCV感染的准确性。
我们进行了一项系统评价和荟萃分析。
检索Medline和EMBASE数据库中1989年至2016年11月发表的文章。我们纳入了比较DBS与血浆/血清样本以检测成人抗-HCV的研究。两名作者提取数据，并使用改编的诊断准确性研究报告标准（STARD）评估研究质量，并独立检查数据的准确性。采用双变量和分层汇总接受者操作特征模型进行荟萃分析。
分析了12项研究（3307个样本），其中11项使用酶免疫测定（EIA）评估抗-HCV，其余1项使用快速诊断试验。这些研究大多为病例对照研究（83.3%），且来自发达国家（66.7%）。DBS检测抗-HCV的总体合并敏感性（95%置信区间；CI）和特异性（95%CI）分别为98.1%（96.1-99.1%）和99.7%（98.9-99.9%）。在使用EIA的研究中，合并敏感性和特异性分别为97.3%（94.3-98.8%）和99.6%（98.5-99.9%）。仅考虑使用EIA的研究，排除一项在注射毒品者中进行的研究后的敏感性分析显示，合并敏感性为97.8%（96.2-98.8%），特异性为99.5%（98.5-99.9%）。
在通过EIA检测抗-HCV时，发现DBS的效果与血清样本相似或略低。然而，使用DBS时仍存在出现假阴性和假阳性结果的风险。因此，建议开展进一步工作，包括优化储存和处理方法。这有助于建立使用DBS样本进行抗-HCV筛查的共识指南。
