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