在1型登革热疫情期间对OneStep登革热NS1快速检测试剂盒和OneStep登革热IgG/IgM快速检测卡进行评估。

Evaluation of OneStep Dengue NS1 RapiDip™ InstaTest and OneStep Dengue Fever IgG/IgM RapiCard™ InstaTest during the course of a dengue type 1 epidemic.

作者信息

Vickers Ivan, Harvey Kevin, Nelson Kereann, Brown Michelle, Bullock-DuCasse Marion, Lindo John

机构信息

Department of Microbiology, The University of the West Indies, Mona, Kingston 7, Jamaica.

Ministry of Health, Kingston, Jamaica.

出版信息

Diagn Microbiol Infect Dis. 2017 Dec;89(4):271-275. doi: 10.1016/j.diagmicrobio.2017.08.019. Epub 2017 Aug 26.

DOI:10.1016/j.diagmicrobio.2017.08.019

PMID:29021087

Abstract

We determined the diagnostic performance of the OneStep NS1 and the OneStep IgG/IgM RDT kits against a panel of samples which comprised of 174 dengue positive and 165 dengue negative sera characterized by three reference enzyme-linked immunosorbent assays (ELISAs). The diagnostic sensitivities of the OneStep kits for the detection of individual biomarkers of NS1, IgM and IgG were 90% (95% CI: 82.1-94.7), 32.4% (95% CI: 24.8-40.8) and 44.4% (95% CI: 38.2-50.7), respectively. The combination of the OneStep IgG/IgM kit with the OneStep NS1 kit demonstrated significantly higher sensitivities for the combined NS1/IgM (96.8%; 95% CI: 90.9-99.3) and NS1/IgM/IgG (99.5%; 95% CI: 97.1-99.9)(P<0.001). In conclusion, the OneStep NS1 kit has high sensitivity and specificity and is highly recommended for use. The low sensitivities for IgG (44.4%) and for IgM (32.4%) of the OneStep IgG/IgM kit when used alone suggest it is best used in combination with the OneStep NS1 kit to enhance its overall diagnostic performance.

摘要

我们使用三种参考酶联免疫吸附测定法（ELISA）对一组包含174份登革热阳性血清和165份登革热阴性血清的样本，测定了一步法NS1和一步法IgG/IgM快速诊断检测试剂盒的诊断性能。一步法试剂盒检测NS1、IgM和IgG单个生物标志物的诊断敏感性分别为90%（95%置信区间：82.1-94.7）、32.4%（95%置信区间：24.8-40.8）和44.4%（95%置信区间：38.2-50.7）。一步法IgG/IgM试剂盒与一步法NS1试剂盒联合使用时，对NS1/IgM联合检测（96.8%；95%置信区间：90.9-99.3）和NS1/IgM/IgG联合检测（99.5%；95%置信区间：97.1-99.9）的敏感性显著更高（P<0.001）。总之，一步法NS1试剂盒具有高敏感性和特异性，强烈推荐使用。一步法IgG/IgM试剂盒单独使用时对IgG（44.4%）和IgM（32.4%）的敏感性较低，表明它最好与一步法NS1试剂盒联合使用，以提高其整体诊断性能。