Hepatitis C virus core antigen assay: an alternative method for hepatitis C diagnosis.
Background The study aimed to evaluate a fully automated chemiluminescent immunoassay and compared it with a quantitative RNA assay and anti-HCV assay to verify the utility of this automated Ag assay as an alternative method for hepatitis C diagnosis. Methods A total of 229 serum samples previously tested for anti-HCV concentrations by the Architect Anti-HCV assay, were selected for HCV RNA testing by real time RT-PCR kit (Shanghai ZJ Bio-Tec Co., Ltd) and 125 specimens were tested for HCV Ag by the Architect HCV core Antigen kit. Results The log10HCVAg and HCV RNA concentrations were highly correlated [ r = 0.834); with HCV RNA as the comparator test, HCVAg had 100% specificity, 100% positive predictive value (PPV) and 94.8% sensitivity. We found 1 pg/mL of total HCV core Ag is equivalent to approximately 6607HCV RNA international units (IU)/mL. Receiver operator characteristic curve analysis showed that the area under the curve of HCV core Ag (0.989) was greater than HCV Ab (0.871). HCV Ag concentrations and RNA-to-Ag ratio of the groups for HCV RNA concentrations ≤105and >105IU/mL were both significantly different from each other ( P < 0.05). Conclusion The Architect HCV core Ag assay may be an alternative method for hepatitis C diagnosis, performed on the same analytical platform and sample as the anti-HCV assay, shortening the diagnostic window period, demonstrating good correlation with HCV RNA assay with high specificity and positive predictive value.
Department of Clinical Laboratory, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Lijuan
L
Wang
Department of Clinical Laboratory, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Hong
H
Lv
Department of Clinical Laboratory, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Guojun
G
Zhang
D016174:Hepacivirus / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology; D018937:Hepatitis C Antibodies / Q000737:chemistry; D018936:Hepatitis C Antigens / Q000032:analysis* / Q000235:genetics / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000592:standards*; D012367:RNA, Viral / Q000235:genetics*; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000235:genetics / Q000276:immunology
D018937:Hepatitis C Antibodies; D018936:Hepatitis C Antigens; D012367:RNA, Viral
HCV RNA; HCV core antigen; hepatitis C