National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Via Portuense 292, 00149 Rome, Italy.
National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Via Portuense 292, 00149 Rome, Italy.
Int J Infect Dis. 2020 Oct;99:193-198. doi: 10.1016/j.ijid.2020.07.008. Epub 2020 Jul 11.
In Italy, dengue virus is the most frequent agent of imported viral infections. The use of rapid diagnostic tests (RDTs) may be of help as a preliminary user-friendly quick assay to facilitate dengue diagnosis, as ordinary laboratory diagnosis of dengue fever may require special efforts in terms of tools availability, interpretation of results, and skilled personnel. The performance of RDTs, however, may vary according to different epidemiological and laboratory background.
We reviewed five years of laboratory records of two dengue RDT results (Colorimetric SD-Bioline Dengue-Duo-RDT and Fluorimetric SD-Biosensor-STANDARD-F-Dengue-RDT), able to detect viral NS1 antigen and specific IgM and IgG. Diagnostic parameters were calculated using as reference the results of molecular (RT-PCR) and serological (immunofluorescence, IFA) tests. Overall performance, calculated considering the final case definition, was included in the accuracy assessment of RDTs.
The combined use of NS1 and IgM/IgG RDT for the detection of acute dengue cases resulted in an overall sensitivity and specificity of 87.2% and 97.9% for Colorimetric RDT, 96.2% and 96.2% for Fluorimetric RDT. NS1 was the most reliable marker of acute infection, while IgM resulted falsely positive in nine samples, including sera derived from 2 Zika and 4 non-arbovirus infected patients.
The inclusion of RDT in the diagnostic algorithm is of undeniable help in the prompt management and surveillance of dengue infection in non-endemic areas. Confirmatory tests are, however, necessary to rule in or rule out dengue fever diagnosis.
在意大利,登革热病毒是最常见的输入性病毒感染病原体。快速诊断检测(RDT)的使用可能有助于作为初步的用户友好型快速检测方法,以促进登革热的诊断,因为普通的实验室诊断登革热可能需要在工具可用性、结果解释和熟练人员方面付出特殊的努力。然而,RDT 的性能可能因不同的流行病学和实验室背景而异。
我们回顾了两种登革热 RDT 结果(比色 SD-Bioline 登革热双联 RDT 和荧光 SD-Biosensor-STANDARD-F-登革热 RDT)的五年实验室记录,这两种 RDT 都能够检测病毒 NS1 抗原和特异性 IgM 和 IgG。使用分子(RT-PCR)和血清学(免疫荧光,IFA)检测的结果作为参考,计算诊断参数。综合考虑最终病例定义,将总体性能纳入 RDT 准确性评估。
联合使用 NS1 和 IgM/IgG RDT 检测急性登革热病例,比色 RDT 的总体敏感性和特异性分别为 87.2%和 97.9%,荧光 RDT 的总体敏感性和特异性分别为 96.2%和 96.2%。NS1 是急性感染最可靠的标志物,而 IgM 在 9 个样本中呈假阳性,包括来自 2 例 Zika 和 4 例非虫媒病毒感染患者的血清。
在诊断算法中纳入 RDT 无疑有助于在非流行地区对登革热感染进行快速管理和监测。然而,需要进行确认性测试以排除或确诊登革热诊断。