title: Reliability of hepatitis C virus core antigen assay for detection of viremia in HCV genotypes 1, 2, 3, and 4 infected blood donors: a collaborative study between Japan, Egypt, and Uzbekistan.
abstract: Nucleic acid amplification-based methods are used for confirmation of viremia in antibody to hepatitis C virus (anti-HCV)-positive patients. However, this technology is labor intensive, time consuming, requires complex laboratory conditions, and expensive. The aim of this study was to evaluate the sensitivity and specificity of the HCV core antigen (HCVcAg) assay as an alternative approach for confirmation of viremia in HCV-infected subjects with HCV genotype 1-4. Two hundred forty-six asymptomatic HCV RNA- positive donors were enrolled in this study, consisting of 122 blood donors from Egypt (116 with genotype 4, 4 with genotype 1, and 2 with 1 + 4 genotypes), 109 from Japan (85 with genotype 1, and 24 with genotype 2), and 15 from Uzbekistan (all with genotype 3). A total of 234 (95.1%) of 246 RNA-positive specimens were detected by the HCVcAg assay; the sensitivity of HCVcAg assay consisted 93.4, 100, 100, and 94.8% for genotypes 1, 2, 3, and 4, respectively in comparison with RT-PCR assay. The specificity of the assay was confirmed in the absence of the false-positive results among 53 anti-HCV-negative, but anti-Schistosoma mansoni (anti-Sm) positive donors from Egypt. A positive correlation between HCVcAg and HCV RNA concentration levels (r = 0.671, P < 0.05) was observed among specimens with HCV genotype 4. The mean HCVcAg level was significantly lower in specimens with genotype 4 (2,935 fmol/L) comparing to genotypes 1, 2, and 3 (5,034, 4,962, and 4,740 fmol/L, respectively). No specific mutation was found in the core-encoding region of the studied specimens. In conclusion, HCVcAg is shown to be specific, sensitive, and informative qualitative index for HCV viremia in asymptomatic carriers.
authors.affiliation: Department of Clinical Pathology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
authors.forename: Salah
authors.initials: S
authors.lastname: Agha
authors.forename: Yasuhito
authors.initials: Y
authors.lastname: Tanaka
authors.forename: Niveen
authors.initials: N
authors.lastname: Saudy
authors.forename: Fuat
authors.initials: F
authors.lastname: Kurbanov
authors.forename: Mostafa
authors.initials: M
authors.lastname: Abo-Zeid
authors.forename: Mohamed
authors.initials: M
authors.lastname: El-Malky
authors.forename: Mohamed
authors.initials: M
authors.lastname: Khalaf
authors.forename: Nobuo
authors.initials: N
authors.lastname: Ohta
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yoshizawa
authors.forename: Masashi
authors.initials: M
authors.lastname: Mizokami
mesh_terms: D000595:Amino Acid Sequence; D001782:Blood Donors; D002353:Carrier State / Q000821:virology; D004534:Egypt; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis* / Q000821:virology*; D018936:Hepatitis C Antigens / Q000097:blood*; D006801:Humans; D007564:Japan; D008969:Molecular Sequence Data; D020125:Mutation, Missense; D012367:RNA, Viral / Q000097:blood; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016415:Sequence Alignment; D020539:Sequence Analysis, Protein; D014610:Uzbekistan; D014758:Viral Core Proteins / Q000097:blood* / Q000276:immunology; D019562:Viral Load; D014766:Viremia / Q000175:diagnosis*
chemical_list: D018936:Hepatitis C Antigens; D012367:RNA, Viral; D014758:Viral Core Proteins