Evaluation of the new ARCHITECT anti-HCV screening test under routine laboratory conditions.
BACKGROUND
An improved test version of the Abbott ARCHITECT anti-hepatitis C virus (HCV) test became available at the end of 2005.


METHODS
We compared the new test version with the Ortho Vitros anti-HCV test by evaluating 2034 serum samples in parallel on both systems under routine laboratory conditions. Discordant samples were tested in the Inno-LIA HCV Score assay as well as in the RIBA HCV 3.0.


RESULTS
Of the 2034 samples 140 (6.9%) yielded positive and 1856 (91.2%) negative results in both assays. We observed discordant results in 38 samples (1.9%). All discrepant samples showed a low S/CO ratio of 1.0-6.9 (mean 2.8) in the Ortho assay and of 1.3-3.0 (mean 1.96) in the ARCHITECT assay. As expected, most of them could not be confirmed by immunoblot testing. Comparison of the results of the two immunoblots (Inno-LIA and RIBA) revealed a great variability in test results.


CONCLUSIONS
This study represents the first comparative evaluation of the modified version of the Abbott ARCHITECT anti-HCV assay in comparison with the Ortho Vitros anti-HCV test. Under routine laboratory testing, we observed good overall concordance between the two assays and no evidence that one assay shows more false-reactive or negative results than the other.
Berger
Annemarie
A
Institute for Medical Virology, Frankfurt University Medical School, Paul Ehrlich-Street 40, D-60596 Frankfurt am Main, Germany. Annemarie.Berger@em.uni-frankfurt.de
Rabenau
Holger
H
Allwinn
Regina
R
Doerr
Hans Wilhelm
HW
D005260:Female; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis* / Q000276:immunology; D018937:Hepatitis C Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods; D015151:Immunoblotting; D008163:Luminescent Measurements; D008403:Mass Screening; D011237:Predictive Value of Tests; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods
D018937:Hepatitis C Antibodies; D011933:Reagent Kits, Diagnostic