title: Hepatitis C virus core antigen assay: can we think beyond convention in resource limited settings?
abstract: Hepatitis C virus infects over 15 million patients from India and 2.86 million from Brazil. Detection of anti-hepatitis C virus antibodies has limited sensitivity during acute phase: the pre-seroconversion window period. Hepatitis C virus-RNA detection techniques are used to overcome this shortfall, but are costly and unavailable widely in developing countries. Estimation of hepatitis C virus core-antigen, a protein with highly conserved sequence, by enzyme-immunoassays is an economic and simpler alternative to RNA detection. This study was conducted in Delhi, involving 300 acute and chronic liver disease patients, tested for anti-hepatitis C virus 3rd-generation ELISA, hepatitis C virus core-antigen-ELISA and hepatitis C virus-RNA reverse transcription-polymerase chain reaction. Among the acute patients, hepatitis C virus core-antigen assay could identify 13 out of 14 pre-seroconversion window period cases and 6 out of 8 seroconverted cases, with a pre-seroconversion window period sensitivity of 92.9% and specificity of 100%. In hepatitis C virus core-antigen-positive cases, the viral load was in the range of 4900 to 1.46×10(6)IU/mL, whereas in hepatitis C virus core-antigen-negative cases, the range of viral load was 100-4500IU/mL. The cost of the hepatitis C virus core-antigen-ELISA was estimated around 3-4 times lesser than the in-house reverse transcription-polymerase chain reaction and 9-10 times lesser than the United States Food and Drug Administration approved reverse transcription-polymerase chain reaction. With a good sensitivity and specificity in the acute phase of infection, hepatitis C virus core-antigen-ELISA can thus be a useful alternative in the developing nations.
authors.affiliation: Department of Microbiology, Maulana Azad Medical College & Associated Lok Nayak Hospital, New Delhi, India. anitachakravarti@gmail.com
authors.forename: Anita
authors.initials: A
authors.lastname: Chakravarti
authors.forename: Mayank S
authors.initials: MS
authors.lastname: Chauhan
authors.forename: Gaurav
authors.initials: G
authors.lastname: Dogra
authors.forename: Sayantan
authors.initials: S
authors.lastname: Banerjee
mesh_terms: D016174:Hepacivirus / Q000235:genetics / Q000276:immunology; D006526:Hepatitis C / Q000175:diagnosis*; D018936:Hepatitis C Antigens / Q000097:blood*; D006801:Humans; D007194:India; D011237:Predictive Value of Tests; D012367:RNA, Viral / Q000097:blood*; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D014758:Viral Core Proteins / Q000097:blood*; D019562:Viral Load
chemical_list: D018936:Hepatitis C Antigens; D012367:RNA, Viral; D014758:Viral Core Proteins; C069130:nucleocapsid protein, Hepatitis C virus