Diagnostic performance of hepatitis C virus core antigen testing for detecting hepatitis C in people living with hepatitis B:a systematic review and meta-analysis  

作　　者：Ana Treviño‑Nakoura Daniel Sepúlveda‑Crespo JoséM Bellon Helena Codina Marta Quero‑Delgado Pablo Ryan Isidoro Martínez Salvador Resino 

机构地区：[1]Servicio de Medicina Preventiva y Salud Pública,Hospital Universitario Nuestra Señora de la Candelaria,Santa Cruz de Tenerife,Spain [2]Instituto Mixto de Investigación Escuela Nacional de Sanidad‑Universidad Nacional de Edu‑cación a Distancia(IMIENS‑UNED),Madrid,Spain [3]Unidad de Infección Viral e Inmunidad,Centro Nacional de Microbiología‑Instituto de Salud Carlos III,Km 2.2,28220 Majadahonda(Madrid),Spain [4]Centro de Investigación Biomédica en Red en Enfermedades Infecciosas(CIBERINFEC),Instituto de Salud Carlos III,Madrid,Spain [5]Instituto de Investigación Sanitaria Gregorio Marañón(IiSGM),Madrid,Spain [6]Servicio de Medicina Interna,Hospital Universitario Infanta Leonor,Madrid,Spain

出　　处：《Infectious Diseases of Poverty》2024年第6期15-27,共13页贫困所致传染病(英文)

基　　金：supported by grants from Instituto de Salud Carlos III(ISCII,grant#PI20CIII/00004 to SR,PI19CIII/00009 to IM,and PI23CIII/00018 to DSC and IM)and Gilead Science(grant#GLD20_0144 to SR);This research was also supported by CIBER‑Consorcio Centro de Investigación Biomédica en Red‑(CB 2021);Instituto de Salud Carlos III,Ministerio de Ciencia e Innovación and Unión Europea-NextGenerationEU(CB21/13/00044);DSC is a‘Miguel Servet’researcher from ISCIII(grant#CP23CIII/00004);AT‑N is a Ph.D.student in the Biomedical Sciences and Public Health program at the UNED International Doctoral School.

摘　　要：Background The current diagnostic strategy for hepatitis C virus(HCV)infection involves a two-step approach:antibody HCV screening followed by confirmatory nucleic acid testing.This study aimed to evaluate the diagnostic performance of the Abbott ARCHITECT HCV Ag assay in serum/plasma samples as a potential one-step alterna-tive for diagnosing active HCV infection in people living with hepatitis B virus(PLWHB)through a systematic review and meta-analysis.Methods A systematic review and meta-analysis were conducted following PRISMA-DTA guidelines.This protocol was registered on PROSPERO(CRD42023402093).A comprehensive search of electronic databases identified studies published up to 1 November 2024,comparing the ARCHITECT HCV Ag assay to an HCV-RNA reference standard.Sen-sitivity,specificity,and likelihood ratios were pooled using a random-effects model within the MIDAS module of Stata software.Study quality was assessed using QUADAS-2.Heterogeneity was evaluated using the Q statistic,quantified using the I2,and further explored through meta-regression.Results Ten studies(n=494 participants)met inclusion criteria.The Abbott ARCHITECT HCV Ag assay demonstrated high sensitivity[91%,95%confidence interval(CI):76-97%]and specificity(99%,95%CI:99-100%).The positive likeli-hood ratio(PLR)was 81.20(95%CI:12.34-534.36),and the negative likelihood ratio(NLR)was 0.09(95%CI:0.03-0.27).The area under the summary receiver operating characteristic curve(AUC-SROC)was 99%(95%CI 98-100%).In regions with high HCV prevalence(≥10%),the test accurately confirmed active HCV infection in over 90%of cases.However,confirmatory testing remains necessary in low-prevalence settings(≤5%).The assay demonstrated an excel-lent ability to identify individuals without HCV infection,with a low false-negative rate(≤2%)regardless of HCV prevalence.Heterogeneity analysis revealed moderate to substantial variation in test performance(I2=72.09%for sensitivity,35.47%for PLR,and 78.33%for NLR).QUADAS-2 applicability concerns predicted heterogeneity,

关 键 词：Hepatitis C HCV core antigen Diagnostic performance Clinical applicability HCV/HBV‑coinfection 

分 类 号：R51[医药卫生—内科学]