CTK Biotech, Poway, California, USA.
Sanofi, Marcy l'Etoile, France.
Microbiol Spectr. 2022 Jun 29;10(3):e0071121. doi: 10.1128/spectrum.00711-21. Epub 2022 May 23.
The World Health Organization has recommended prevaccination screening for prior dengue infection as the preferred approach prior to vaccination with the dengue vaccine CYD-TDV. These screening tests need to be highly specific and sensitive, and deliverable at the point-of-care. We evaluate here the sensitivity and specificity of the newly developed Dengue IgG rapid diagnostic test (RDT). A retrospective double-blind study of the sensitivity and specificity of the Dengue IgG RDT was performed using a sample panel consisting of archived serum specimens collected during CYD-TDV clinical trials in Latin American and Asia, with the reference serostatus for each sample determined by an algorithm using measured dengue PRNT, PRNT, and NS1 IgG ELISA. An additional panel of dengue seronegative samples positive for other flaviviruses and infections was used to assess cross-reactivity. Samples were included from 579 participants; 346 in the specificity panel and 233 in the sensitivity panel. The dengue IgG RDT exhibited a specificity of 98.0% (95% CI = 95.9 to 99.2) and sensitivity of 95.3% (95% CI = 91.7 to 97.6). The sensitivity for samples exhibiting a multitypic immune profile (PRNT-positive to >1 dengue serotype) was 98.8% while for monotypic immune samples (PRNT-positive to a single dengue serotype) it was 88.1%. The dengue IgG RDT showed minimal to no cross-reactivity to related flaviviruses. These findings support the use of the dengue IgG RDT to determine dengue serostatus in CYD-TDV prevaccination screening. Dengue remains a significant public health issue, with over 5.2 million cases reported to the World Health Organization (WHO) in 2019. The tetravalent dengue vaccine (CYD-TDV) is currently licensed for use in those aged ≥9 years; however, vaccinees with no previous exposure to dengue experience an increased risk of hospitalized and severe dengue upon subsequent heterotypic infection. Consequently, WHO recommends screening for prior dengue infection before vaccination. Screening tests for previous infection need to be highly specific and sensitive, and deliverable at the point-of-care. High sensitivity ensures that the largest number of individuals with previous infection can be identified and vaccinated, while high specificity prevents the inadvertent vaccination of those without previous infection. This study of the OnSite Dengue IgG Rapid Test, which was explicitly developed to meet this need, found that it had both high specificity (98.0% [95% CI = 95.9 to 99.2]) and sensitivity (95.3% [95% CI = 91.7 to 97.6]).
世界卫生组织建议在接种登革热疫苗 CYD-TDV 之前进行疫苗接种前的登革热感染预筛查。这些筛查测试需要具有高度的特异性和敏感性，并可在护理点进行。我们在这里评估新开发的登革热 IgG 快速诊断检测（RDT）的敏感性和特异性。使用由拉丁美洲和亚洲的 CYD-TDV 临床试验中收集的存档血清标本组成的样本面板，对登革热 IgG RDT 的敏感性和特异性进行了回顾性双盲研究，每个样本的参考血清阳性状态由使用测量的登革热 PRNT、PRNT 和 NS1 IgG ELISA 的算法确定。还使用了一组针对其他黄病毒和感染呈阳性的登革热血清阴性样本来评估交叉反应性。该研究纳入了 579 名参与者的样本；346 名在特异性面板中，233 名在敏感性面板中。登革热 IgG RDT 表现出 98.0%（95%CI=95.9 至 99.2）的特异性和 95.3%（95%CI=91.7 至 97.6）的敏感性。对表现出多型免疫特征（对>1 种登革热血清型的 PRNT 阳性）的样本的敏感性为 98.8%，而对单型免疫样本（对单一登革热血清型的 PRNT 阳性）的敏感性为 88.1%。登革热 IgG RDT 对相关黄病毒的交叉反应性最小或没有。这些发现支持使用登革热 IgG RDT 来确定 CYD-TDV 疫苗接种前筛查中的登革热血清阳性状态。登革热仍然是一个重大的公共卫生问题，2019 年世界卫生组织（WHO）报告了超过 520 万例病例。四价登革热疫苗（CYD-TDV）目前获准用于 9 岁及以上人群；然而，在随后的异型感染中，没有登革热既往暴露史的疫苗接种者患住院和严重登革热的风险增加。因此，世界卫生组织建议在接种疫苗前进行登革热感染预筛查。既往感染的筛查测试需要具有高度的特异性和敏感性，并可在护理点进行。高灵敏度确保能识别和接种最大数量的既往感染个体，而高特异性则防止意外接种无既往感染的个体。这项针对登革热 IgG 快速检测试剂盒（OnSite Dengue IgG Rapid Test）的研究发现，该试剂盒具有高特异性（98.0%[95%CI=95.9 至 99.2]）和高敏感性（95.3%[95%CI=91.7 至 97.6]）。
