Evaluation and comparison of three different anti-hepatitis C virus antibody tests based on chemiluminescence and enzyme-linked immunosorbent assay methods used in the diagnosis of hepatitis C infections in Turkey.
The routine diagnosis of hepatitis C virus (HCV) infection is based on the detection of anti-HCV antibodies by two main methods (enzyme immunoassay [EIA] and chemiluminescence immunoassay [CIA]) but false-positives are a problem. We investigated three anti-HCV tests: two CIAs (Cobas e 601 and Architect i2000SR); and one EIA (Ortho HCV 3.0). Two other anti-HCV tests were also performed as supplementary and confirmatory tests, respectively: a recombinant strip immunoblot assay (RIBA HCV 3.0 SIA) and a reverse transcriptase polymerase chain reaction-based assay for HCV-RNA. After discriminating the false-positive results, the true anti-HCV seropositivity rate in 7156 serum samples was 0.91%. The seropositivity and false-positive rates for the Cobas e 601, Architect i2000SR and Ortho HCV 3.0 anti-HCV tests were 1.9% and 0.99%, 1.2% and 0.29%, and 0.87% and 0.01%, respectively. The mean level of HCV-RNA was 3399 x 10(3) IU/ml. Critical levels for false-positivity for HCV-RNA were a cut-off index of 200 for Cobas e 601, a signal/cut-off (S/CO) of 5 for Architect i2000SR and an S/CO of 1.2 for Ortho HCV 3.0. Positive and negative results for the RIBA HCV 3.0 SIA assay all accorded with the HCV-RNA assay, except for 23 (17%) 'indeterminate' results, all of which were negative with the HCV-RNA assay. In conclusion, to eliminate doubts related to false-positive findings in the initial HCV screening tests, additional confirmatory HCV-RNA assay should be performed.
Kesli
Recep
R
Department of Microbiology, Konya Education and Research Hospital, Meram Yeniyol, Meram, Konya, Turkey. recepkesli@yahoo.com
Ozdemir
M
M
Kurtoglu
M G
MG
Baykan
M
M
Baysal
B
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D016174:Hepacivirus / Q000276:immunology / Q000472:pathogenicity*; D006526:Hepatitis C / Q000097:blood / Q000175:diagnosis* / Q000821:virology*; D018937:Hepatitis C Antibodies / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods*; D007223:Infant; D007231:Infant, Newborn; D008163:Luminescent Measurements / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D014421:Turkey; D055815:Young Adult
D018937:Hepatitis C Antibodies; D011933:Reagent Kits, Diagnostic