title: Performance characteristics of a combined hepatitis C virus core antigen and anti-hepatitis C virus antibody test in different patient groups.
abstract: We evaluated the performance of a hepatitis C virus (HCV) antigen/antibody combination test [Murex HCV Antigen/Antibody Combination Test (Murex Ag/Ab test)] by comparing it with the current third-generation HCV antibody enzyme immunoassay (anti-HCV). A total of 403 serum samples were consecutively collected from four patient groups: healthy controls (n=100); HCV-infected patients (HCV group, n=102); Human immunodeficiency virus (HIV)/HCV-infected patients (HIV/HCV group, n=100); and patients with uremia (uremia group, n=101). Performances were evaluated for the Murex Ag/Ab, anti-HCV, and HCV RNA in the HIV/HCV and uremia patient groups. In the HCV group, all 102 samples showed concordant positive and negative results for anti-HCV, Murex Ag/Ab, and HCV RNA tests. In the HIV/HCV group, all 100 samples were positive for both anti-HCV and Murex Ag/Ab tests, whereas 88 patients (88%) were HCV RNA positive. In the uremia group, 14 (69.0%) of the 23 anti-HCV-positive patients were HCV RNA positive, whereas 14 (77.8%) of the 18 Murex Ag/Ab-positive patients were HCV RNA positive. None of anti-HCV-negative or Murex Ag/Ab-negative patients were HCV RNA positive. Based on the HCV RNA assay, the sensitivities for both anti-HCV and Murex Ag/Ab assays were 100%, whereas the specificities of these two assays were 89.7% and 95.4%, respectively. With good sensitivity and specificity, the Murex Ag/Ab assay could be a useful alternative diagnostic tool, especially in immunocompromised populations, such as patients with uremia or those infected with HIV.
authors.affiliation: Department of Preventive Medicine, Kaohsiung Medical University Hospital, Taiwan. jf71218@gmail.com
authors.forename: Jeng-Fu
authors.initials: JF
authors.lastname: Yang
authors.forename: Ya-Yun
authors.initials: YY
authors.lastname: Lin
authors.forename: Meng-Hsuan
authors.initials: MH
authors.lastname: Hsieh
authors.forename: Chiu-Hung
authors.initials: CH
authors.lastname: Tsai
authors.forename: Shu-Fen
authors.initials: SF
authors.lastname: Liu
authors.forename: Ming-Lung
authors.initials: ML
authors.lastname: Yu
authors.forename: Chia-Yen
authors.initials: CY
authors.lastname: Dai
authors.forename: Jee-Fu
authors.initials: JF
authors.lastname: Huang
authors.forename: Wen-Yi
authors.initials: WY
authors.lastname: Lin
authors.forename: Zu-Yau
authors.initials: ZY
authors.lastname: Lin
authors.forename: Shinn-Chern
authors.initials: SC
authors.lastname: Chen
authors.forename: Wan-Long
authors.initials: WL
authors.lastname: Chuang
mesh_terms: D000328:Adult; D000368:Aged; D016022:Case-Control Studies; D005260:Female; D006678:HIV / Q000254:growth & development; D015658:HIV Infections / Q000276:immunology / Q000821:virology; D016174:Hepacivirus / Q000276:immunology; D006526:Hepatitis C / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D018937:Hepatitis C Antibodies / Q000097:blood* / Q000276:immunology; D018936:Hepatitis C Antigens / Q000097:blood* / Q000276:immunology; D006801:Humans; D007124:Immunoenzyme Techniques / Q000592:standards / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D012367:RNA, Viral / Q000097:blood / Q000276:immunology; D011933:Reagent Kits, Diagnostic / Q000592:standards / Q000706:statistics & numerical data*; D012680:Sensitivity and Specificity; D014511:Uremia / Q000097:blood / Q000276:immunology
chemical_list: D018937:Hepatitis C Antibodies; D018936:Hepatitis C Antigens; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic