Dan Chen1, Lawrence Kaplan, Qiang Liu. 1. Department of Pathology, New York University, School of Medicine, Clinical Chemistry Laboratory of Bellevue Hospital, USA. chend09@med.nyu.edu
Abstract
BACKGROUND: This study evaluated the performance of 2 Bayer Hepatitis B Chemiluminescent Assays by comparing their performance to the corresponding DPC Immulite 2000 assays. METHODS: 953 samples were tested by both Immulite 2000 and Centaur HBsAg methods; and 75 samples were tested by both Immulite 2000 and Centaur anti-HBc IgM methods. RESULTS: The overall agreement between Immulite 2000 and ADVIA Centaur anti-HBc IgM assays was 100%. The agreement between Immulite 2000 and Centaur HBsAg assays was 100% for Immulite 2000 positive samples. The overall agreement for HBsAg negative samples was 99.9% after confirmation result was included. However, discrepancy between the 2 assays was observed in 53 samples which were tested initially as "weakly reactive"(index 1.0-1.95) but were not confirmed subsequently by the neutralization test on Immulite 2000. All 53 samples tested negative by Centaur HBsAg assay at the initial run. Furthermore, one Immulite 2000 HBsAg negative sample was reactive and confirmed by Centaur assay. CONCLUSIONS: While the performance of Bayer Hepatitis B HBsAg and aHBc IgM assays are in good agreement with corresponding DPC assays, the Bayer HBsAg assay is more efficient than the Immulite 2000 assay with its better separation of signal and background noise, and its complete automation features.
BACKGROUND: This study evaluated the performance of 2 Bayer Hepatitis B Chemiluminescent Assays by comparing their performance to the corresponding DPC Immulite 2000 assays. METHODS: 953 samples were tested by both Immulite 2000 and Centaur HBsAg methods; and 75 samples were tested by both Immulite 2000 and Centaur anti-HBc IgM methods. RESULTS: The overall agreement between Immulite 2000 and ADVIA Centaur anti-HBc IgM assays was 100%. The agreement between Immulite 2000 and Centaur HBsAg assays was 100% for Immulite 2000 positive samples. The overall agreement for HBsAg negative samples was 99.9% after confirmation result was included. However, discrepancy between the 2 assays was observed in 53 samples which were tested initially as "weakly reactive"(index 1.0-1.95) but were not confirmed subsequently by the neutralization test on Immulite 2000. All 53 samples tested negative by Centaur HBsAg assay at the initial run. Furthermore, one Immulite 2000 HBsAg negative sample was reactive and confirmed by Centaur assay. CONCLUSIONS: While the performance of Bayer Hepatitis B HBsAg and aHBc IgM assays are in good agreement with corresponding DPC assays, the Bayer HBsAg assay is more efficient than the Immulite 2000 assay with its better separation of signal and background noise, and its complete automation features.