RESUMEN
Hepatitis B virus-e-antigen (HBeAg) is a viral marker to assess hepatitis B virus (HBV) replication. We have evaluated the reliability of three commonly available HBeAg immunoassays using World Health Organization-International Standard and clinical samples. In addition the performance of enzyme immunoassays (EIAs) was assessed by kinetic binding and reagent exchange experiments. Analytical and diagnostic sensitivity were significantly different among HBeAg assays (P < 0.01). The affinity of capture/detector antibodies varied significantly between EIAs (P < 0.01). Our findings suggest that significant difference in the affinity of capture/detector antibodies to HBeAg may impact the overall performance and the reliability of currently available HBeAg assays in HBV diagnosis and management.
Asunto(s)
Ensayo de Inmunoadsorción Enzimática , Antígenos e de la Hepatitis B/análisis , Virus de la Hepatitis B/química , Hepatitis B/diagnóstico , Hepatitis B/inmunología , Hepatitis B/tratamiento farmacológico , Antígenos e de la Hepatitis B/inmunología , Virus de la Hepatitis B/inmunología , Humanos , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND & AIM: Hepatitis B virus-e-antigen (HBeAg) is an affordable viral marker to assess viral replication kinetics and response to antiviral therapy. In the absence of confirmatory assays, discrepant or false-positive HBeAg results are resolved by screening for other HBV markers. We standardized an in-house HBeAg neutralization assay (HBeAg-NT) to confirm HBeAg in clinical samples. METHODS: The performance and reliability of this assay were evaluated by first WHO International Standard for HBeAg (first WHO-IS HBeAg) from Paul Ehrlich Institute and clinical samples (n = 150) from chronic HBV carriers. Of these, 71 HBeAg-positive sera were used for HBeAg-NT. RESULTS: Concentrations spanning 0.25-10 U of first WHO-IS HBeAg and clinical samples (S/Co ranges from 1.00 to 10.00) were neutralized completely in the HBeAg-NT. CONCLUSIONS: HBeAg-NT is a simple, cost-effective, and reliable direct approach to confirm HBeAg in clinical samples which precludes the need for screening additional HBV markers in low resource settings.