Abstract
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.
Highlights
About 71 million people have chronic Hepatitis C virus (HCV) infection and around 80% are undiagnosed[1], leading to the development of liver disease and/or transmission of hepatitis C virus (HCV) infection to others unknowingly[2,3,4]
A total of 9679 dried blood spots (DBS) samples from 9679 individuals were included for anti-HCV antibody detection, and 2201 DBS samples from 2015 individuals were included for HCV-ribonucleic acid (RNA) detection
Most of the studies (n = 15) were based on DBS samples obtained by spotting whole venous blood on filter paper, 12 were based on capillary DBS samples[24,25,27,29,31,33,37,38,41,42,43,49, 2] on DBS samples obtained by either capillary or venous blood[33,41], and 1 on mock DBS made by diluting the Second WHO International Standard for HCV-RNA in negative blood[46]
Summary
About 71 million people have chronic Hepatitis C virus (HCV) infection and around 80% are undiagnosed[1], leading to the development of liver disease and/or transmission of HCV infection to others unknowingly[2,3,4]. One is the use of dried blood spots (DBS), which are obtained by finger puncture and depositing the blood drops on a filter paper Such an approach can be used for HCV diagnosis in serological tests (anti-HCV antibodies) and in virological tests (HCV-RNA)[9]. DBS samples are highly stable at room temperature, and it is not necessary to maintain the cold chain for the storage of the samples and transport to the processing laboratory[10]. These advantages have made DBS sampling a promising approach to HCV screening and epidemiological surveillance in LMICs and risk groups[11,12,13,14]. Our aim was to carefully analyze the diagnostic performance of the methodology that enables the detection of HCV infection in DBS samples, in the type of diagnostic assay used, by conducting a meta-analysis of all eligible studies published to date (March 2018)
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