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塞内加尔流行环境中登革热 NS1 和 IgM/IgG 快速诊断检测的实验室评估和现场测试。

Laboratory Evaluation and Field Testing of Dengue NS1 and IgM/IgG Rapid Diagnostic Tests in an Epidemic Context in Senegal.

机构信息

Diatropix Unit, Institut Pasteur de Dakar, Dakar BP 220, Senegal.

Virology Department, Institut Pasteur de Dakar, Dakar BP 220, Senegal.

出版信息

Viruses. 2023 Mar 31;15(4):904. doi: 10.3390/v15040904.

Abstract

In Senegal, the burden of dengue is increasing and expanding. As case management and traditional diagnostic techniques can be difficult to implement, rapid diagnostic tests (RDTs) deployed at point of care are ideal for investigating active outbreaks. The aim of this study was to evaluate the diagnostic performance of the Dengue NS1 and Dengue IgM/IgG RDTs on the serum/plasma samples in a laboratory setting and in the field. During laboratory evaluation, performance of the NS1 RDT was assessed using NS1 ELISA as the gold standard. Sensitivity and specificity were 88% [75-95%] and 100% [97-100%], respectively. Performance of the IgM/IG RDT was assessed using the IgM Antibody Capture (MAC) ELISA, indirect IgG, and PRNT as gold standards. The IgM and IgG test lines respectively displayed sensitivities of 94% [83-99%] and 70% [59-79%] and specificities of 91% [84-95%] and 91% [79-98%]. In the field, the Dengue NS1 RDT sensitivity and specificity was 82% [60-95%] and 75% [53-90%], respectively. The IgM and IgG test lines displayed sensitivities of 86% [42-100%] and 78% [64-88%], specificities of 85% [76-92%] and 55% [36-73%], respectively. These results demonstrate that RDTs are ideal for use in a context of high prevalence or outbreak setting and can be implemented in the absence of a confirmatory test for acute and convalescent patients.

摘要

在塞内加尔,登革热的负担正在增加和扩大。由于病例管理和传统诊断技术可能难以实施,因此在护理点部署的快速诊断测试(RDT)非常适合调查活跃的疫情。本研究的目的是评估血清/血浆样本中登革热 NS1 和登革热 IgM/IgG RDT 在实验室和现场的诊断性能。在实验室评估中,使用 NS1 ELISA 作为金标准评估 NS1 RDT 的性能。敏感性和特异性分别为 88%[75-95%]和 100%[97-100%]。使用 IgM 抗体捕获(MAC)ELISA、间接 IgG 和 PRNT 作为金标准评估 IgM/IG RDT 的性能。IgM 和 IgG 测试线分别显示出 94%[83-99%]和 70%[59-79%]的敏感性和 91%[84-95%]和 91%[79-98%]的特异性。在现场,登革热 NS1 RDT 的敏感性和特异性分别为 82%[60-95%]和 75%[53-90%]。IgM 和 IgG 测试线显示出 86%[42-100%]和 78%[64-88%]的敏感性和 85%[76-92%]和 55%[36-73%]的特异性。这些结果表明,RDT 非常适合在高流行率或疫情环境中使用,并且可以在没有急性和恢复期患者确认测试的情况下实施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1866/10143717/cb1ec71998e0/viruses-15-00904-g001.jpg

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