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Diasorin LIAISON® XL Zika 捕获 IgM CLIA 测试的性能评估。

Performance evaluation of the Diasorin LIAISON® XL Zika capture IgM CLIA test.

机构信息

National Reference Center for Arboviruses, Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium; Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel, Department of Microbiology, Brussels, Belgium.

Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel, Department of Microbiology, Brussels, Belgium.

出版信息

Diagn Microbiol Infect Dis. 2019 Oct;95(2):144-148. doi: 10.1016/j.diagmicrobio.2019.05.004. Epub 2019 May 10.

DOI:10.1016/j.diagmicrobio.2019.05.004
PMID:31171395
Abstract

Because Zika virus (ZIKV) can cause serious birth defects and is involved in cases of Guillain-Barré syndrome, the ZIKV outbreak in the American continent in 2015 resulted in an enormous need for ZIKV diagnostic tools. We evaluated the LIAISON® XL Zika Capture IgM test on 106 samples from patients, mainly travelers, with a confirmed or probable ZIKV infection. Sensitivity between 0 and 84 days after onset of symptoms was 92.5%. Specificity was evaluated on a panel of 56 samples known to cause possible cross-reactions. Cross-reaction with DENV antibodies was limited (10.5%) but false-positive results occurred in samples from patients with malaria, CMV and EBV infections.

摘要

由于寨卡病毒(ZIKV)可导致严重的出生缺陷,并与吉兰-巴雷综合征有关,因此,2015 年美洲大陆的寨卡病毒爆发导致对寨卡病毒诊断工具的巨大需求。我们评估了 LIAISON®XL Zika Capture IgM 检测试剂盒对 106 份来自确诊或疑似寨卡病毒感染患者(主要为旅行者)样本的检测性能。症状出现后 0 至 84 天的敏感性为 92.5%。我们在一个已知可能发生交叉反应的 56 份样本的面板上评估了特异性。与登革热病毒抗体的交叉反应有限(10.5%),但疟疾、巨细胞病毒和 EBV 感染患者的样本中出现了假阳性结果。

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