HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
HUS Diagnostic Center, HUSLAB, Clinical Microbiology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Translational Immunology Research Program and Department of Bacteriology and Immunology, University of Helsinki, Helsinki, Finland.
J Clin Virol. 2022 Aug;153:105219. doi: 10.1016/j.jcv.2022.105219. Epub 2022 Jun 18.
Independent evaluations that deploy clinical patient samples are important in assessing the performance of commercial tests used for serological screening of viral hepatitis and HIV in clinical laboratories.
We compared the analytical performance of Abbott Architect i2000SR, Abbott Alinity i, DiaSorin Liaison XL, and Siemens Atellica for the following analytes: anti-HAV IgG/anti-HAV total, anti-HAV IgM, HBsAg, anti-HBc IgM, Anti-HBc, HBeAg, anti-HBe, anti-HBs, anti-HCV, and HIV Ag/Ab. In addition, anti-HBc IgM, HBeAg, and anti-HBe were evaluated for Abbott Architect, Abbott Alinity and DiaSorin Liaison.
Pseudonymized clinical serum specimens (N = 98-200 for each analyte) were selected for the analysis according to their reactivity on the Abbott Architect. The results were compared against Abbott Architect and against consensus.
A generally high agreement was observed between the tests. Abbott Alinity had the lowest anti-HAV IgG/total specificity (75.9% against Abbott Architect and 83.0% against consensus). The comparatively low sensitivity of Siemens Atellica (78.2%), Abbott Alinity (87.5%) and DiaSorin Liaison (89.3%) for anti-HAV IgM against Abbott Architect may reflect a higher false-positive rate of Abbott Architect. Particular variation was observed in the sensitivity values of anti-HBc, HBsAg and HIV Ag/Ab between the test methods. DiaSorin Liaison anti-HBs gave consistently higher values as compared to the other tests.
The serodiagnostic methods for HIV and viral hepatitis of Abbott Architect, Abbott Alinity, DiaSorin Liaison, and Siemens Atellica performed well in comparison with each other. The observed differences between the tests will provide useful information for clinical laboratories in planning their workflows for screening and confirmation.
在评估用于临床实验室病毒肝炎和 HIV 血清学筛查的商业检测的性能时，采用独立的临床患者样本进行评估非常重要。
我们比较了 Abbott Architect i2000SR、Abbott Alinity i、DiaSorin Liaison XL 和 Siemens Atellica 对以下分析物的分析性能：抗-HAV IgG/抗-HAV 总抗体、抗-HAV IgM、HBsAg、抗-HBc IgM、抗-HBc、HBeAg、抗-HBe、抗-HBs、抗-HCV 和 HIV Ag/Ab。此外，还评估了 Abbott Architect、Abbott Alinity 和 DiaSorin Liaison 对抗-HBc IgM、HBeAg 和抗-HBe 的检测。
根据在 Abbott Architect 上的反应性，从每个分析物的 98-200 个匿名临床血清标本中选择用于分析。将结果与 Abbott Architect 及共识进行比较。
测试之间观察到高度一致的高符合率。Abbott Alinity 对抗-HAV IgG/总抗体的特异性最低（对 Abbott Architect 为 75.9%，对共识为 83.0%）。Siemens Atellica（78.2%）、Abbott Alinity（87.5%）和 DiaSorin Liaison（89.3%）对 Abbott Architect 抗-HAV IgM 的相对较低的敏感性可能反映了 Abbott Architect 较高的假阳性率。在测试方法之间，抗-HBc、HBsAg 和 HIV Ag/Ab 的敏感性值存在明显差异。与其他测试相比，DiaSorin Liaison 的抗-HBs 始终给出更高的值。
Abbott Architect、Abbott Alinity、DiaSorin Liaison 和 Siemens Atellica 的 HIV 和病毒肝炎血清诊断方法相互之间性能良好。测试之间的差异将为临床实验室在规划筛查和确认的工作流程时提供有用的信息。
