2 research outputs found
Significance of the hepatitis C virus (HCV) core antigen as an alternative plasma marker of active HCV infection
Purpose: To evaluate the role of core antigen (Ortho trak-C assay) as a
marker of active HCV infection in comparison to HCV RNA as detected by
reverse transcription polymerase chain reaction (RT-PCR). Methods:
This evaluation was carried out during January 2000 to December 2003 in
HCV infected individuals who were treatment naοve or were on
anti-viral therapy. Additionally, sequential plasma samples from
patients on clinical follow-up were included in this study. A total of
167 samples from 61 patients were tested by trak-C and RT-PCR. HCV RNA
detection was achieved by a RT-PCR. Trak-C assay results were also
compared in a limited proportion of these samples with known HCV viral
load and genotype. Results: Of 167 samples tested, 56.9% were RNA
positive and 43.1% were RNA negative while 50.3% were trak-C positive
and 49.7% were trak-C negative, yielding a sensitivity of 85.3% and a
specificity of 95.8% for the trak-C assay (Kappa co-efficient = 0.8).
The concentration of HCVcAg and HCV RNA showed significant correlation
(n=38, r=0.334, P =0.04). The trak-C assay detected the most prevalent
HCV genotypes in India without significant difference ( P =0.335). The
difference between mean absorbance values of HCV RNA positive samples
compared to HCV RNA negative samples in the trak-C assay was highly
significant ( P < 0.000). Qualitative results of trak-C assay and
RT-PCR were comparable in 93% of follow-up samples. Conclusions:
Trak-C assay can be recommended for confirmation of HCV infection and
follow-up in laboratories with resource-poor facilities