Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta-analysis

Abstract

Objectives: Hepatitis C virus (HCV) core antigen (HCVcAg) assay is an alternative for diagnosing HCV infection in a single step. This meta-analysis aimed to evaluate the Abbott ARCHITECT HCV Ag assay's diagnostic performance (validity and utility) for diagnosing active hepatitis C. Methods: PubMed, EMBASE, Scopus, Web of Science, and Cochrane Library were searched until Jan 10, 2023. The protocol was registered at the prospective international register of systematic reviews (PROSPERO: CRD42022337191). Abbott ARCHITECT HCV Ag assay was the test for evaluation, and nucleic acid amplification tests with a cut-off ≤50 IU/mL were the gold standard. Statistical analysis was performed using STATA with the MIDAS module and random-effects models. Results: The bivariate analysis was conducted on 46 studies (18,116 samples). The pooled sensitivity was 0.96 (95%CI=0.94-0.97), specificity 0.99 (95%CI=0.99-1.00), positive likelihood ratio 141.81 (95%CI=72.39-277.79), and negative likelihood ratio 0.04 (95%CI=0.03-0.06). The area under the SROC curve was 1.00 (95%CI= 0.34-1.00). For active hepatitis C prevalence values of 0.1-15%, the probability that a positive test was a true positive was 12-96%, respectively, indicating that a confirmatory test should be necessary, particularly with a prevalence ≤5%. However, the probability that a negative test was a false negative was close to zero, indicating the absence of HCV infection. Conclusions: The validity (accuracy) of the Abbott ARCHITECT HCV Ag assay for screening active HCV infection in serum/plasma samples was excellent. Although the HCVcAg assay showed limited diagnostic utility in low prevalence settings (≤1%), it might help diagnose hepatitis C in high prevalence scenarios (≥5%).