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Background: In North America, diagnosis of active hepatitis C virus (HCV) infection is currently performed using RNA testing which is highly sensitive and specific but is associated with three major limitations: lability of RNA molecules, higher costs, and longer turn-around time as compared with commercially-available HCV core antigen testing. In the current study, a new HCV core antigen assay product was evaluated for the diagnosis of HCV infection and its cost reducing potential.
Methods: Ninety plasma specimens positive for HCV RNA along with 25 negative HCV specimens were used for HCV antigen assay. Twenty-four specimens positive for a panel of agents were used for possible cross-reactivity. Sixty-four HCV antibody-positive specimens with negative HCV RNA and indeterminate HCV immunoblot results were also employed.
Results: In the first group, 78/90 (86.6%) tested positive for HCV antigen with regression analysis showing no significant deviation from linearity. None of the prenatal specimens tested positive for HCV antigen. Non-specific reactions were not observed. In the HCV antibody-indeterminate group, only 2/64 (3.1%) were antigen positive. In the last group, none of the HCV antibody very-low-positive specimens tested positive for HCV antigen. Both inter- and intra-run reproducibility of 100% were noted. The cost analysis showed a minimum of 52.13% reduction in costs associated with qualitative RNA testing.
Conclusions: Considering the complexity of HCV infection diagnosis and the significant cost and turn-around time burden it imposes on clinical laboratories, HCV antigen testing seems an attractive adjunct to the current battery of laboratory diagnosis that demands more attention.
DOI: 10.7754/Clin.Lab.2013.130634
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