Performance of ORTHO® HCV core antigen and trak‐C™ assays for detection of viraemia in pre‐seroconversion plasma and whole blood donors

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Abstract
Objective Logistics and cost of nucleic acid amplification testing (NAT) screening preclude its current use in many developing countries. Development of hepatitis C virus (HCV) core antigen assays offer an alternative to NAT. We evaluated two specimen populations to assess the sensitivity, relative to NAT, of the HCV core antigen (HCVcAg) ELISA (enzyme‐linked immunosorbent assay) test system and the trak‐C assay: (1) plasma donor HCV NAT‐conversion panels and (2) cross‐sectional whole blood donor NAT yield specimens.Methods Differential sensitivities among NAT (NGI; Chiron/Gen‐Probe) and both HCVcAg assays (Ortho‐Clinical Diagnostics, Rochester, NY) were evaluated using: (1) 102 serial ramp‐up phase specimens from 37 plasma donor NAT‐conversion panels (Alpha Therapeutic/BioClinical Partners); and (2) 42 cross‐sectional whole blood donor NAT yield specimens (confirmed RNA positive, antibody negative) plus 54 NAT false‐positive specimens (American Red Cross).Results Viral load among the plasma donor NAT‐conversion panels at the cutoffs for HCVcAg and trak‐C assays were 32 000 copies/ml (95% confidence interval [CI] 8000–120 000) and 8000 copies/ml (95% CI: 2200–28 000), respectively. The mean (95% CI) difference in window period reduction compared to routine mini‐pool NAT screening (estimated sensitivity 100 copies/ml) was delayed 5·2 days (2·2–7·6 days) for HCVcAg assay and 3·8 days (2·1–5·5 days) for the trak‐C assay. Among the 42 NAT yield specimens, the HCVcAg assay detected 31 (74%) as core antigen‐positive while the trak‐C assay detected 37 (88%) as core antigen‐positive. Viral loads for the five specimens not detected by the trak‐C HCVcAg assay ranged from 100 to 7770 copies/ml. All 54 NAT false‐positive specimens were non‐reactive on both HCV core antigen assays.Conclusion These data indicate that the trak‐C assay has sensitivity approaching routine mini‐pool NAT screening for the detection of seronegative HCV infection. In the absence of routine NAT screening for early HCV infection, the use of an HCV core antigen assay should be considered.

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