Performance characteristics of an improved version of the ABBOTT IMx HBsAg (V2) MEIA

The ABBOTT IMx HBsAg (V2) microparticle enzyme immunoassay (MEIA) is a fully automated two-step assay for the qualitative determination of hepatitis B surface antigen (HBsAg). 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 critical to blood screening, diagnosis of HBV infection and therapy monitoring of HBV infected individuals. The design of the assay has been modified and performance characteristics of the modified test were compared to its predecessor. Precision and specificity of the modified assay are comparable to its predecessor. PEI standard subtype ad is detected at 0.026 U/ml versus 0.053 U/ml with the previous assay version. HBsAg subtypes ad and ay are detected at 0.22 ng/ml and 0.17 ng/ml, respectively. The seroconversion window is reduced by 2-28 days versus the predecessor test. The modified assay has the capability to detect HBsAg mutants not detected by some other commercial assays. The modified version of the ABBOTT IMx HBsAg (V2) MEIA provides significantly improved sensitivity combined with the capability to detect prevalent and less prevalent HBsAg mutants.