Evaluation of rapid diagnostic tests to detect dengue virus infections in Taiwan.
Evaluation of rapid diagnostic tests to detect dengue virus infections in Taiwan.
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DOI：
10.1371/journal.pone.0239710
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发表时间：
2020
期刊：
影响因子：
3.7
通讯作者：
Tsai JJ
中科院分区：
文献类型：
--
作者：
Liu LT;Chen CH;Tsai CY;Lin PC;Hsu MC;Huang BY;Wang YH;Tsai JJ
早期诊断对于临床管理登革病毒（DENV）感染引起的疾病非常重要。我们研究了三种市售DENV非结构蛋白1（NS 1）快速诊断测试（RDTs）的性能，使用了2012-2013年台湾DENV爆发期间从登革热疑似患者中收集的173份急性期血清。将NS 1 RDT的结果与qRT-PCR的结果进行比较，以计算NS 1 RDT的灵敏度和特异性。包括抗DENV IgM和IgG RDT结果以增加检测急性DENV感染的可能性。同时将抗DENV IgM/IgG RDT结果与IgM/IgG捕获ELISA结果进行比较。对来自DENV qRT-PCR阳性患者的血清进行NS 1 RDT以及IgM/IgG捕获ELISA。这些结果表明，三种市售DNEV NS 1 RDT的灵敏度无显著差异;考虑特异性时，SD NS 1 RDT结果与qRT-PCR参考结果的一致性最高，其次是Bio-Rad和CTK NS 1 RDT结果。包含IgM或IgG RDT结果增加了诊断原发或继发DENV感染的可能性。NS 1 RDT对原发性感染的检测比继发性感染更敏感，与通过qRT-PCR测定的DENV病毒血症水平相关。这些结果表明，抗DENV抗体降低了NS 1快速检测的灵敏度。结果表明，NS 1 RDT可用于DENV-1、DENV-2和DENV-3急性感染的快速筛查。我们的研究结果表明，NS 1 RDT是一个很好的替代qRT-PCR分析，及时登革热疾病的管理和预防，在登革热流行地区，医疗资源缺乏或在大规模登革热疫情。然而，DENV-4相对较低的灵敏度可能会错过DENV-4感染病例的检测。
Early diagnosis is important for the clinical management of diseases caused by dengue virus (DENV) infections. We investigated the performance of three commercially available DENV nonstructural protein 1 (NS1) rapid diagnostic tests (RDTs) using 173 acute-phase sera collected from dengue fever-suspected patients during the 2012–2013 DENV outbreak in Taiwan. The results of the NS1 RDTs were compared with those of qRT-PCR to calculate the sensitivity and specificity of the NS1 RDTs. The anti-DENV IgM and IgG RDT results were included to increase the probability of detecting acute DENV infection. The anti-DENV IgM/IgG RDT results were also compared with those of IgM/IgG captured ELISA. The sera from DENV qRT-PCR-positive patients were subjected to NS1 RDTs, as well as IgM/IgG captured ELISA. These results suggested that there was no significant difference in the sensitivities of the three commercially available DNEV NS1 RDTs; the SD NS1 RDT results showed the highest agreement with the qRT-PCR reference results, followed in order by the Bio-Rad and CTK NS1 RDT results when the specificity was considered. Inclusion of the IgM or IgG RDT results increased the likelihood of diagnosing either a primary or secondary DENV infection. NS1 RDTs were more sensitive for the detection of primary infections than secondary infections, related to DENV viremia levels determined by qRT-PCR. These results suggested that anti-DENV antibodies reduced the sensitivity of NS1 rapid tests. We also analyzed the sensitivity for the detection of different DENV serotypes, and the results suggested that the NS1 RDTs used in this study were valuable for rapid screening of acute DENV infection with DENV-1, DENV-2 and DENV-3. Our results suggest that the NS1 RDT is a good alternative to qRT-PCR analysis for timely dengue disease management and prevention in dengue-endemic regions where medical resources are lacking or during large dengue outbreaks. However, the relatively low sensitivity for DENV-4 might miss the detection of DENV-4-infected cases.
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