Berth Mario, Bosmans Eugene
Algemeen Medisch Laboratorium, Immunology Department, Desguinlei 88, 2018 Antwerp, Belgium.
Clin Vaccine Immunol. 2010 Apr;17(4):559-63. doi: 10.1128/CVI.00372-09. Epub 2010 Feb 10.
In this study we compared the performances of three commercially available Epstein-Barr virus (EBV) immunoglobulin M (IgM) assays on highly automated immunoassay platforms: BioPlex 2200 (Bio-Rad Laboratories), Immulite 2000 (Siemens Healthcare Diagnostics), and Liaison (DiaSorin). As a confirmatory method, immunoblotting was performed. The specificity of the three EBV IgM assays was evaluated by testing 293 selected sera from patients with various infectious and noninfectious diseases. After the exclusion of 30 samples, the specificities were 96.2% for Liaison, 98.1% for Immulite, and 97.0% for BioPlex. For evaluation of the sensitivity, samples from 70 consecutive patients with a positive heterophile antibody test were examined, irrespective of clinical or biological findings. After the exclusion of six samples, the sensitivities were 89.1% for Liaison, 84.4% for Immulite, and 89.1% for BioPlex. Finally, in a prospective study performed with 500 samples obtained from consecutive patients and sent in by general practitioners, we also determined Epstein-Barr nuclear antigen IgG and viral capsid antigen IgG in a two-phase approach. Concordance of the EBV serologic status was 96.2% between Liaison and Immulite, 96.4% between Immulite and BioPlex, and 97.8% between BioPlex and Liaison. The three EBV IgM immunoassays that we evaluated have acceptable and comparable performances.
在本研究中,我们比较了三种市售的爱泼斯坦-巴尔病毒(EBV)免疫球蛋白M(IgM)检测方法在高度自动化免疫分析平台上的性能:BioPlex 2200(伯乐公司)、Immulite 2000(西门子医疗诊断公司)和Liaison(索灵公司)。采用免疫印迹法作为确证方法。通过检测从患有各种感染性和非感染性疾病的患者中选取的293份血清,评估这三种EBV IgM检测方法的特异性。排除30份样本后,Liaison的特异性为96.2%,Immulite为98.1%,BioPlex为97.0%。为评估敏感性,检查了70例嗜异性抗体检测呈阳性的连续患者的样本,无论其临床或生物学检查结果如何。排除6份样本后,Liaison的敏感性为89.1%,Immulite为84.4%,BioPlex为89.1%。最后,在一项对全科医生送来的500份连续患者样本进行的前瞻性研究中,我们还采用两阶段方法测定了爱泼斯坦-巴尔核抗原IgG和病毒衣壳抗原IgG。Liaison与Immulite之间的EBV血清学状态一致性为96.2%,Immulite与BioPlex之间为96.4%,BioPlex与Liaison之间为97.8%。我们评估的三种EBV IgM免疫分析方法具有可接受的且相当的性能。