RIDASCREEN 普马拉病毒 IgG/IgM ELISA 检测法的分析性能。
Analytical Performance of the RIDASCREEN Hantavirus Puumala IgG/IgM ELISA Assay.
机构信息
National Reference Center for Hantavirus, Department of Laboratory Medicine, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium.
Institute of Tropical Medicine Antwerp, Kronenburgstraat 43/3, 2000 Antwerp, Belgium.
出版信息
Viruses. 2020 Feb 18;12(2):226. doi: 10.3390/v12020226.
UNLABELLED
The National Reference Center for Hantavirus in Belgium is currently using the Hantavirus IgM/IgG ELISA Progen kit (Heidelberg, Germany) for the detection of the most prevalent Hantavirus in Western Europe, Puumala virus (PUUV). Two commercially available PUUV kits were compared: Progen and RIDASCREEN Hantavirus Puumala IgM/IgG ELISA assay (Darmstadt, Germany).
METHODS
The sensitivity was evaluated with a panel of 68 samples from patients with an acute infection ( = 44) or a past infection ( = 24). Specificity was evaluated with a panel of 62 samples from patients with potentially false borderline results ( = 7) (no seroconversion), seronegative samples ( = 25) and potentially cross reacting samples ( = 30). Discordances were resolved by immunoblot. Substantial agreement was calculated using Cohen kappa coefficient.
RESULTS
The RIDASCREEN kit showed a higher specificity (IgM: 94.3%; IgG: 94.4%) than the Progen kit (IgM: 77.0% IgG: 93.0%). The sensitivity for IgM ELISA was 100% for both assays. IgG sensitivity was, respectively, 98.3% and 100% for Progen and RIDASCREEN. A Cohen kappa coefficient of 0.76 and 0.90 was found between Puumala IgM and IgG, respectively.
CONCLUSIONS
This study showed a higher specificity for the RIDASCREEN kit than the Progen kit, while the sensitivity was as good as for the Progen kit.
未加标签
比利时的汉坦病毒国家参考中心目前正在使用汉坦病毒 IgM/IgG ELISA Progen 试剂盒（德国海德堡）来检测西欧最常见的汉坦病毒，普马拉病毒（PUUV）。比较了两种市售的 PUUV 试剂盒：Progen 和 RIDASCREEN 汉坦病毒普马拉 IgM/IgG ELISA 检测试剂盒（德国达姆施塔特）。
方法
用一组 68 份急性感染（n = 44）或既往感染（n = 24）患者的样本评估敏感性。用一组 62 份可能存在假边界结果（n = 7）（无血清转换）、血清阴性样本（n = 25）和可能交叉反应样本（n = 30）的样本评估特异性。通过免疫印迹解决分歧。使用 Cohen kappa 系数计算实质性一致性。
结果
RIDASCREEN 试剂盒的特异性（IgM：94.3%；IgG：94.4%）高于 Progen 试剂盒（IgM：77.0%；IgG：93.0%）。两种检测方法的 IgM ELISA 敏感性均为 100%。Progen 和 RIDASCREEN 的 IgG 敏感性分别为 98.3%和 100%。IgM 和 IgG 之间的 Cohen kappa 系数分别为 0.76 和 0.90。
结论
本研究显示 RIDASCREEN 试剂盒的特异性高于 Progen 试剂盒，而敏感性与 Progen 试剂盒相当。
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