2026-08-29T14:08:00Zhttps://repisalud.isciii.es/rest/oai/requestoai:repisalud.isciii.es:20.500.12105/171882025-03-24T16:04:13Zcom_20.500.12105_2052com_20.500.12105_2051com_20.500.12105_15322col_20.500.12105_19609col_20.500.12105_16978
Repisalud
author
Sepulveda-Crespo, Daniel
author
Treviño-Nakoura, Ana
author
Bellón, José María
author
Fernandez-Rodriguez, Amanda
author
Ryan, Pablo
author
Martinez, Isidoro
author
Jimenez-Sousa, Maria Angeles
author
Resino, Salvador
funder
Instituto de Salud Carlos III
funder
Gilead Sciences (Spain)
funder
Centro de Investigación Biomédica en Red - CIBERINFEC (Enfermedades Infecciosas)
funder
Ministerio de Ciencia e Innovación (España)
funder
Unión Europea. Comisión Europea. NextGenerationEU
2024-01-17T10:19:17Z
2024-01-17T10:19:17Z
2023-05
Rev Med Virol. 2023 May;33(3):e2436.
10.1002/rmv.2436
1099-1654
Reviews in medical virology
36811353
http://hdl.handle.net/20.500.12105/17188
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%).
eng
Chronic hepatitis C
Diagnostic performance
HCV core antigen
HCV screening
HCVcAg
Diagnostic performance of hepatitis C core antigen assay to identify active infections: A systematic review and meta-analysis
review article
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DiagnosticPerformanceHepatitisC_2023.pdf
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DiagnosticPerformanceHepatitisC_2023.pdf.txt