Abstract
BackgroundAlthough direct-acting antivirals can achieve sustained virological response rates greater than 90% in Hepatitis C Virus (HCV) infected persons, at present the majority of HCV-infected individuals remain undiagnosed and therefore untreated. While there are a wide range of HCV serological tests available, there is a lack of formal assessment of their diagnostic performance. We undertook a systematic review and meta-analysis to evaluate he diagnostic accuracy of available rapid diagnostic tests (RDT) and laboratory based EIA assays in detecting antibodies to HCV.MethodsWe used the PRISMA checklist and Cochrane guidance to develop our search protocol. The search strategy was registered in PROSPERO (CRD42015023567). The search focused on hepatitis C, diagnostic tests, and diagnostic accuracy within eight databases (MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Science Citation Index Expanded, Conference Proceedings Citation Index-Science, SCOPUS, Literatura Latino-Americana e do Caribe em Ciências da Saúde and WHO Global Index Medicus. Studies were included if they evaluated an assay to determine the sensitivity and specificity of HCV antibody (HCV Ab) in humans. Two reviewers independently extracted data and performed a quality assessment of the studies using the QUADAS tool. We pooled test estimates using the DerSimonian-Laird method, by using the software R and RevMan. 5.3.ResultsA total of 52 studies were identified that included 52,673 unique test measurements. Based on five studies, the pooled sensitivity and specificity of HCV Ab rapid diagnostic tests (RDTs) were 98% (95% CI 98-100%) and 100% (95% CI 100-100%) compared to an enzyme immunoassay (EIA) reference standard. High HCV Ab RDTs sensitivity and specificity were observed across screening populations (general population, high risk populations, and hospital patients) using different reference standards (EIA, nucleic acid testing, immunoblot). There were insufficient studies to undertake subanalyses based on HIV co-infection. Oral HCV Ab RDTs also had excellent sensitivity and specificity compared to blood reference tests, respectively at 94% (95% CI 93-96%) and 100% (95% CI 100-100%). Among studies that assessed individual oral RDTs, the eight studies revealed that OraQuick ADVANCE® had a slightly higher sensitivity (98%, 95% CI 97-98%) compared to the other oral brands (pooled sensitivity: 88%, 95% CI 84-92%).ConclusionsRDTs, including oral tests, have excellent sensitivity and specificity compared to laboratory-based methods for HCV antibody detection across a wide range of settings. Oral HCV Ab RDTs had good sensitivity and specificity compared to blood reference standards.
Highlights
Direct-acting antivirals can achieve sustained virological response rates greater than 90% in Hepatitis C Virus (HCV) infected persons, at present the majority of HCV-infected individuals remain undiagnosed and untreated
P: Persons identified for HCV testing; I: Rapid diagnostic tests and enzyme immunoassays for HCV HCV antibody (Ab) detection; C: 1), EIA; 2), Nucleic acid testing (NAT); 3), Immunoblot or similar assay; 4), A combination of 1,2,3 above; O: Diagnostic accuracy [Sensitivity (SE), Specificity (SP), Positive predictive value (PPV), Negative predictive value (NPV), True Negative, True Positive (TP), False negative (FN), and False positive (FP)]
Of the 52 studies, 32 studies evaluated the accuracy of 30 different rapid diagnostic tests (RDTs) [19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50], of which 5 evaluated RDTs compared to EIA alone [25, 26, 31, 34, 49], compared RDT results to NAT or immunoblot [19,20,21,22, 27, 29, 32, 37, 42, 43, 45, 47, 50], and focused on evaluating RDT by comparing with the results of EIA or immunoblot or NAT [23,24,25,26, 30, 34, 35, 38, 39, 41, 44, 48, 49, 51]
Summary
Direct-acting antivirals can achieve sustained virological response rates greater than 90% in Hepatitis C Virus (HCV) infected persons, at present the majority of HCV-infected individuals remain undiagnosed and untreated. Hepatitis C is a liver disease caused by the hepatitis C virus (HCV) that causes acute and chronic infection [1, 2]. The introduction of direct-acting antivirals (DAAs) has led to a sustained virological response (SVR) in greater than 90% of treated individuals [4, 5]. Despite the availability of effective treatment, most HCV-infected individuals remain undiagnosed and untreated [7]. Approximately 15–30% of individuals with chronic HCV infection progress to cirrhosis, leading to end-stage liver disease and hepatocellular carcinoma [1, 2]
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