The Lumipulse HBsAg assay showed a detection limit of 0.005xA0;IU/mL.
The assay identified 1% more clinical samples with trace amount of HBsAg.
The Lumipulse assay showed high correlation (R2 ≥ 0.97, P < 0.01) with the Architect and Elecsys assays in quantifying HBsAg.
The Lumipulse assay yielded similar patterns of HBsAg fluctuation when used for the treatment monitoring as compared to the Architect and Elecsys assays.
HBsAg measured by the Lumipulse assay was slightly lower than that by the Architect (0.19 log10 IU/mL) and Elecsys assay (0.07 log10 IU/mL).