Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2011
Performance of the DiaSorin LIAISON(®) anti-HBs II for the detection of hepatitis B surface antibodies: comparison with the Abbott Architect anti-HBs assay.
Сравнительное исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Kinn Sophie, Akhavan Sepideh, Agut Henri, Thibault Vincent
Аннотация
BACKGROUND: Detection of hepatitis B virus (HBV) surface antibodies (anti-HBs) is required in order to evaluate the response to hepatitis B vaccination and to optimize post-exposure monitoring. The widespread use of vaccines has highlighted the need for accurate and consistent quantification, yielding comparable quantitative results.
OBJECTIVES: This study assessed the adequacy of DiaSorin LIAISON(®) anti-HBs II assay in detecting anti-HBs antibodies and determined the correlation with Abbott Architect anti-HBs quantification.
STUDY DESIGN: Anti-HBs levels were measured in parallel using Abbott and DiaSorin kits on WHO international standard dilutions and 350 routine samples pre-screened with Abbott Architect anti-HBs. Three different serological panels were tested: vaccinated subjects (n=121); subjects with past HBV infection (n=109); and subjects with no HBV infection marker (n=69). Serial dilutions from nine high-titer anti-HBs samples were used to address linearity.
RESULTS: Anti-HBs concentration measured on WHO standard dilutions indicated a good calibration of DiaSorin values against international units, while results for Abbott were below those expected. A strong impact of the dilution matrix used was observed when performing dilutions on high-titer samples. Despite difference in absolute quantification, the overall clinical agreement between the two assays was 96.9%, with strong correlation (r=0.92) between concentrations and good linearity over the quantification range.
CONCLUSIONS: The DiaSorin LIAISON(®) anti-HBs II assay shows excellent standardization to the WHO standard and good linearity. The assay is suitable for current clinical laboratory practice.
OBJECTIVES: This study assessed the adequacy of DiaSorin LIAISON(®) anti-HBs II assay in detecting anti-HBs antibodies and determined the correlation with Abbott Architect anti-HBs quantification.
STUDY DESIGN: Anti-HBs levels were measured in parallel using Abbott and DiaSorin kits on WHO international standard dilutions and 350 routine samples pre-screened with Abbott Architect anti-HBs. Three different serological panels were tested: vaccinated subjects (n=121); subjects with past HBV infection (n=109); and subjects with no HBV infection marker (n=69). Serial dilutions from nine high-titer anti-HBs samples were used to address linearity.
RESULTS: Anti-HBs concentration measured on WHO standard dilutions indicated a good calibration of DiaSorin values against international units, while results for Abbott were below those expected. A strong impact of the dilution matrix used was observed when performing dilutions on high-titer samples. Despite difference in absolute quantification, the overall clinical agreement between the two assays was 96.9%, with strong correlation (r=0.92) between concentrations and good linearity over the quantification range.
CONCLUSIONS: The DiaSorin LIAISON(®) anti-HBs II assay shows excellent standardization to the WHO standard and good linearity. The assay is suitable for current clinical laboratory practice.