Early Detection of Hepatitis B Surface Antigen - Prototype of a New Fully Automated HBsAg Microparticle Enzyme Immunoassay (MEIA)
Pfeifer K; Pelzer C; Coleman P; Pope M; Kapprell HP
Clinical Laboratory 49(3-4): 161-166
2003
ISSN/ISBN: 1433-6510 PMID: 12705699 Document Number: 8758
HBsAg is the most important serological marker of acute and chronic hepatitis B infection. Therefore, sensitivity of the currently used detection systems for HBsAg is of major importance for blood screening, diagnosis of HBV infection and therapy monitoring of HBV infected individuals. A Prototype Microparticle Enzyme Immunoassay (MEIA) for qualitative determination of hepatitis B surface antigen (HBsAg) has recently been developed for the fully automated AxSYM® analyzer with the intention to provide a test displaying improved sensitivity when compared to the currently marketed HBsAg assays. The present study was conducted to demonstrate sensitivity of the new Prototype AxSYM®HBsAg MEIA and the corresponding, fully automated Prototype AxSYM®HBsAg Confirmatory MEIA. Analytical sensitivity of the Prototype AxSYM®HBsAg MEIA was assessed by testing quantitative HBsAg panels. Sensitivity for HBsAg subtypes ad and ay was found to be 0.15 ng/ml and 0.09 ng/ml, respectively. The detection level for HBsAg subtype ad Standard provided by the Paul Ehrlich Institute was estimated to be 0.03 PEI U/ml. Analysis of hepatitis B seroconversion panels suggests that the new Prototype AxSYM®HBsAg MEIA significantly reduces the seroconversion window when being compared to other highly sensitive commercial HBsAg assays. The corresponding Prototype AxSYM®HBsAg Confirmatory MEIA demonstrated the ability to confirm low titer seroconverters found reactive with the Prototype AxSYM®HBsAg Screening MEIA.
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