Schulte-Spechtel Ulrike, Berth Mario, Lauseker-Hao Yi, Meyer-Schlinkmann Kristin, Bohnert Martin, Jochum Simon, Schuhmann Kerstin
Roche Diagnostics GmbH, Penzberg, Germany.
Algemeen Medisch Laboratorium, Antwerp, Belgium.
Diagn Microbiol Infect Dis. 2021 Nov;101(3):115443. doi: 10.1016/j.diagmicrobio.2021.115443. Epub 2021 May 29.
We evaluated the analytical performance of the Elecsys® Epstein-Barr virus (EBV) immunoassay panel for the in vitro detection of EBV immunoglobulin M (IgM), EBV viral capsid antigen immunoglobulin G (VCA IgG), and EBV nuclear antigen immunoglobulin G (EBNA IgG). Relative sensitivity/specificity were assessed using 1,734 human blood samples (1,068 residual samples from routine EBV testing; 467 presumed acute infection; 199 presumed seronegative) tested with the Elecsys EBV and 2 comparator panels (ARCHITECT EBV; Liaison EBV). EBV infection status was defined by majority approach. The three panels demonstrated comparable relative sensitivities/specificities, ranging between values (%) of 98.3-99.5 / 96.9-97.4 (EBV IgM); 96.3-98.4 / 98.4-98.7 (EBV VCA IgG); and 98.1-99.5 / 99.1-99.5 (EBV EBNA IgG). The Elecsys EBV IgM assay demonstrated superior analytical specificity in samples containing potential interferents. Utilizing the Elecsys EBV panel for the EBNA-first approach showed 97.5% overall agreement versus the majority approach in samples with clear EBV status.
我们评估了Elecsys®爱泼斯坦-巴尔病毒（EBV）免疫分析检测板用于体外检测EBV免疫球蛋白M（IgM）、EBV病毒衣壳抗原免疫球蛋白G（VCA IgG）和EBV核抗原免疫球蛋白G（EBNA IgG）的分析性能。使用1734份人类血液样本（1068份来自常规EBV检测的剩余样本；467份疑似急性感染样本；199份疑似血清阴性样本），通过Elecsys EBV检测板和2种对照检测板（ARCHITECT EBV；Liaison EBV）评估相对敏感性/特异性。EBV感染状态通过多数判定法确定。这三种检测板表现出相当的相对敏感性/特异性，EBV IgM的数值（%）范围为98.3 - 99.5 / 96.9 - 97.4；EBV VCA IgG为96.3 - 98.4 / 98.4 - 98.7；EBV EBNA IgG为98.1 - 99.5 / 99.1 - 99.5。Elecsys EBV IgM检测在含有潜在干扰物的样本中表现出卓越的分析特异性。在EBV状态明确的样本中，采用Elecsys EBV检测板进行EBNA优先检测方法与多数判定法的总体一致性为97.5%。
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