Original Evaluation of a new point-of-care test to determine prior dengue infection for potential use in pre-vaccination screening
Original Evaluation of a new point-of-care test to determine prior dengue infection for potential use in pre-vaccination screening
复制标题
DOI：
10.1016/j.cmi.2020.08.026
复制
发表时间：
2021-05-26
影响因子：
14.2
通讯作者：
Lopez, Anna Lena
中科院分区：
文献类型：
--
作者：
Daag, Jedas Veronica;Ylade, Michelle;Lopez, Anna Lena
目的：第一支获许可的登革热疫苗只推荐给曾感染过登革病毒（DENV）的人接种。具有95%的期望灵敏度和98%的特异性的即时检测可以促进疫苗接种前筛查。我们评估了一种新开发的，自动化的登革热免疫球蛋白荧光免疫测定确定登革热serostatus.Methods：我们使用的血清样本收集之前，大规模登革热疫苗接种在菲律宾的宿务。居住在Bogo和Balamban的健康儿童，在大规模登革热疫苗接种时将是9-14岁，有资格参加。我们评估了ichromaTM II登革热荧光免疫测定法（Boditech Med Incorporated，Gang-won-do，Republic of Korea）使用中和试验（NT）作为参考assay.Results：我们在队列中招募了2996名儿童（平均年龄10.39岁，51.7%女性），并在本研究中纳入了1000名子样本（平均年龄10.56岁，54.4%女性）。在1000名儿童中，通过中和试验，86/1000（8.6%）的DENV抗体为血清阴性，914/1000（91.4%）为血清阳性。与NT相比，登革IgG荧光免疫法检测血清学阳性的特异性为90.7%（95%CI：82.5-95.9%），敏感性为91.8%（95%CI：89.8-93.5%）。的灵敏度下降到51.2%（42.3-61.0%）的单型登革热profile.Conclusion的子集的检测：特异性和灵敏度不足（特别是在以前的单型登革热感染的检测）将使测试，在其目前的状态下，不足以用于接种前筛查。考虑到其用户友好的界面和床旁使用的可能性，可以进一步开发和验证该测试，以改善其性能特征。Jedas Veronica Daag，Clin Microbiol Infect 2021;27：904（c）2020作者。由Elsevier Ltd代表欧洲临床微生物学和传染病学会出版。这是一个在CC BY-NC-ND许可证下的开放获取文章（http：//creativecommons.org/licenses/by-nc-nd/4.0/）。
Objective: Vaccination with the first licensed dengue vaccine is recommended only for those who have had previous infection with dengue virus (DENV). A point-of-care test with the desired sensitivity of 95% and specificity of 98% could facilitate pre-vaccination screening. We evaluated a newly developed, automated dengue immunoglobulin fluorescence immunoassay for determining dengue serostatus.Methods: We used serum samples collected just prior to a mass dengue vaccination in Cebu, Philippines. Healthy children residing in Bogo and Balamban who would be 9-14 years old at the time of the mass dengue vaccination were eligible to participate. We evaluated the ichromaTM II dengue fluorescence immunoassay (Boditech Med Incorporated, Gang-won-do, Republic of Korea) using a neutralization test (NT) as the reference assay.Results: We enrolled 2996 children (mean age 10.39 years, 51.7% female) in the cohort and included a subsample of 1000 (mean age 10.56 years, 54.4% female) in this study. Of the 1000 children, 86/1000 (8.6%) tested seronegative and 914/1000 (91.4%) seropositive for DENV antibodies by neutralization testing. Compared with the NT, the dengue IgG fluorescence immunoassay had an overall specificity of 90.7% (95%CI: 82.5-95.9%) and a sensitivity of 91.8% (95%CI: 89.8-93.5%) for determining dengue seropositivity. The sensitivity declined to 51.2% (42.3-61.0%) for the detection of the subset with a monotypic dengue profile.Conclusion: The insufficient specificity and sensitivity (particularly in the detection of a previous monotypic dengue infection) would render the test, in its current state, inadequate for pre-vaccination screening. Considering its user-friendly interphase and possibility of point-of-care use, the test could be further developed and validated to improve its performance characteristics. Jedas Veronica Daag, Clin Microbiol Infect 2021;27:904(c) 2020 The Authors. Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).