Systematic review with meta-analysis: performance of dried blood spots for hepatitis C antibodies detection

Objectives: 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.

Study design: We carried out a systematic review and meta-analysis.

Methods: 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.

Results: 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%).

Conclusions: 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.