Hepatitis C core antigen highly correlated to HCV RNA. Issue 12 (11th September 2018)

• Record Type: Journal Article
• Authors: Chang, Christine; Hung, Chao‐Hung; Wang, Jing‐Houng; Lu, Sheng‐Nan
• Is Part Of: Kaohsiung journal of medical sciences. Volume 34:Issue 12(2018)
• Page Start: 684
• Page End: 688
• Publication Date: 2018-09-11
• Subjects: Hepatitis C virus (HCV) -- HCV core antigen -- HCV‐Ag immunoassay -- polymerase chain reaction molecular assay; Medicine -- Periodicals; 610.5
• DOI: 10.1016/j.kjms.2018.08.002
• Languages: English
• ISSNs: 1607-551X

Abstract

Abstract: Hepatitis C virus core antigen (HCV‐Ag) immunoassay has been proposed as a more cost and time efficient one‐step alternative to the current two‐step screening and diagnostic process. This study investigates the correlation between the HCV‐Ag immunoassay and the current gold standard of Hepatitis C Virus (HCV) ribonucleic acid (RNA) molecular assay. Stored sera of 221 consecutive treatment‐naive patients tested anti‐HCV positive were selected to undergo both HCV‐Ag immunoassay and HCV RNA molecular assay. Active infection status and HCV genotype were determined using both assays, and correlation was calculated using a logarithmic scale. Among 221 anti‐HCV‐positive sera, 197 were positive for both HCV Ag (≥3 fmol/L) and HCV RNA (>15 IU/mL), 22 were negative for both tests, while 2 were positive to HCV RNA only. The sensitivity and specificity for HCV Ag in predicting HCV RNA were 99% and 100%, respectively. Out of 199 patients (90%) tested positive for HCV viremia, 107 (56%) were of genotype 1, 77 (38.7%) of genotype 2 and 15 of other genotypes. Analysis of 221 anti‐HCV‐positive patient sera found a strong positive correlation between HCV RNA and HCV‐Ag (r = 0.960, p < 0.001). Genotype 1 (log [HCV RNA] = 0.988 x log [HCV‐Ag] + 2.768), with correlation coefficient 0.945, exhibited a stronger correlation than genotype 2 (log [HCV RNA] = 0.859 x log [HCV‐Ag] + 2.859; r = 0.862). Given the strong positive correlation between HCV‐Ag immunoassay and HCV RNA molecular assay in genotyping affected individuals, we propose that HCV‐Ag immunoassay is a more cost and time efficient alternative to the current two‐step diagnostic process.