Journal of Viral Hepatitis
Volume 0 Issue 0 - September 2005
doi:10.1111/j.1365-2893.2005.00646.x


Combination hepatitis C virus antigen and antibody immunoassay as a new tool
for early diagnosis of infection

F. Ansaldi1, B. Bruzzone1, G. Testino2, M. Bassetti3, R. Gasparini1, P.
Crovari1 and G. Icardi1

Summary. Reduction of the window period of hepatitis C virus (HCV) infection
represents an important goal in the transfusional and diagnostic setting. A
prototype assay designed to simultaneously detect circulating HCV antigen
and anti-HCV, has been developed. Aim of this study was to evaluate the
performance of this new assay in terms of specificity and sensitivity and to
compare its efficacy with commercial assays. To evaluate the specificity of
the assay, 400 samples from the general population and 100 'difficult' sera,
negative for anti-HCV, were tested. To assess sensitivity, the new test was
used on 76 PCR-positive and anti-HCV negative sera, seven natural or
commercial seroconversion panels that included 17 RNA-positive and anti-HCV
negative sera and 31 anti-HCV positive sera, 20 weak anti-HCV positive sera,
80 viraemic and anti-HCV-positive sera from patients infected with different
subtypes and 10 sera from patients with HBVHCV or HIVHCV co-infections. Of
500 anti-HCV negative samples, 499 (99.8%) were negative with a cut-off
index <0.5, while one sample was within the grey zone. Of the 93 HCV-RNA
positive and anti-HCV negative sera from patients and panels, 85 (91.4%)
resulted positive, and one had the cut-off index in the grey zone. The
reduction in the diagnostic window period observed with the new test and
HCV-RNA assays were equal, on average, to 24 and 34.4 days respectively. All
anti-HCV positive sera were positive. The new assay shows high sensitivity
and specificity and could be a useful tool not only in the diagnostic
setting, where procedures to reduce the window period, such as antigen or
HCV-RNA detection, are not currently recommended, but also in the screening
of blood donations, when nucleic acid technologies is not feasible because
of costs, organization, emergency and/or logistic difficulties.






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