Adapting Rapid Diagnostic Tests to Detect Historical Dengue Virus Infections.
Adapting Rapid Diagnostic Tests to Detect Historical Dengue Virus Infections.
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调整快速诊断测试以检测历史登革热病毒感染。
DOI：
10.3389/fimmu.2021.703887
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发表时间：
2021
影响因子：
7.3
通讯作者：
Katzelnick LC
中科院分区：
文献类型：
--
作者：
Echegaray F;Laing P;Hernandez S;Marquez S;Harris A;Laing I;Chambers A;McLennan N;Sugiharto VA;Chen HW;Villagran SV;Collingwood A;Montoya M;Carrillo FB;Simons MP;Cooper PJ;Lopez A;Trueba G;Eisenberg J;Wu SJ;Messer W;Harris E;Coloma J;Katzelnick LC
唯一获得许可的登革热疫苗Dengvaxia®在给予先前没有登革热病毒（DENV）感染的个体时会增加严重登革热的风险，但在先前具有DENV免疫力的个体中对未来疾病具有保护作用。世界卫生组织建议使用快速诊断测试（RDT）来确定先前的DENV感染史和是否适合接种疫苗。登革热专家建议，这些检测方法应具有高度特异性（≥98%），以避免错误地接种先前未感染DENV的个体，并具有足够的灵敏度（≥95%）以检测先前感染过DENV的个体。我们使用从非流行区和DENV和ZIKV流行区的个体在感染后>6个月收集的样品评估了一种现有的和两种新开发的抗黄病毒RDT。我们首先评估了SD BIOLINE Dengue IgG/IgM RDT的IgG组分，该RDT的开发旨在帮助确认急性/近期DENV感染（n=93份样本）。当按照制造商的说明进行评估时，SD BIOLINE Dengue RDT对非地方性和地方性样本的特异性均为100%，但检测DENV血清阳性的灵敏度较低（非地方性为0%，地方性为41%）。当允许测试运行超过制造商建议（0.5至3小时）时，灵敏度增加（53%非地方病，98%地方病），但特异性降低地方病样本（36%）。当使用定量读数器评价检测时，可以达到最佳特异性（≥98%），同时在非地方病（44-88%）和地方病样本（31-55%）的早期时间点仍保持灵敏度。接下来，我们评估了Excivion开发的新型登革热和寨卡RDT，以检测先前的DENV或ZIKV感染并降低交叉黄病毒反应性（n=207个样本）。目视评价时，Excivion Dengue RDT的灵敏度和特异性值为79%，但使用定量读数器评价时，可达到最佳特异性（≥98%），同时仍保持中等灵敏度（48-75%）。当定量评估时，Excivion Zika RDT具有高特异性（>98%）和灵敏度（>93%），这表明它可以与登革热RDT一起使用，以最大限度地减少由于交叉反应导致的错误分类。我们的研究结果表明，RDTs可用于登革热疫苗接种前筛查，以减少疫苗诱导的严重登革热引发，并显示检测设计调整以及定量评估如何进一步改善RDTs用于此目的。
The only licensed dengue vaccine, Dengvaxia®, increases risk of severe dengue when given to individuals without prior dengue virus (DENV) infection but is protective against future disease in those with prior DENV immunity. The World Health Organization has recommended using rapid diagnostic tests (RDT) to determine history of prior DENV infection and suitability for vaccination. Dengue experts recommend that these assays be highly specific (≥98%) to avoid erroneously vaccinating individuals without prior DENV infection, as well as be sensitive enough (≥95%) to detect individuals with a single prior DENV infection. We evaluated one existing and two newly developed anti-flavivirus RDTs using samples collected >6 months post-infection from individuals in non-endemic and DENV and ZIKV endemic areas. We first evaluated the IgG component of the SD BIOLINE Dengue IgG/IgM RDT, which was developed to assist in confirming acute/recent DENV infections (n=93 samples). When evaluated following the manufacturer’s instructions, the SD BIOLINE Dengue RDT had 100% specificity for both non-endemic and endemic samples but low sensitivity for detecting DENV seropositivity (0% non-endemic, 41% endemic). Sensitivity increased (53% non-endemic, 98% endemic) when tests were allowed to run beyond manufacturer recommendations (0.5 up to 3 hours), but specificity decreased in endemic samples (36%). When tests were evaluated using a quantitative reader, optimal specificity could be achieved (≥98%) while still retaining sensitivity at earlier timepoints in non-endemic (44-88%) and endemic samples (31-55%). We next evaluated novel dengue and Zika RDTs developed by Excivion to detect prior DENV or ZIKV infections and reduce cross-flavivirus reactivity (n=207 samples). When evaluated visually, the Excivion Dengue RDT had sensitivity and specificity values of 79%, but when evaluated with a quantitative reader, optimal specificity could be achieved (≥98%) while still maintaining moderate sensitivity (48-75%). The Excivion Zika RDT had high specificity (>98%) and sensitivity (>93%) when evaluated quantitatively, suggesting it may be used alongside dengue RDTs to minimize misclassification due to cross-reactivity. Our findings demonstrate the potential of RDTs to be used for dengue pre-vaccination screening to reduce vaccine-induced priming for severe dengue and show how assay design adaptations as well quantitative evaluation can further improve RDTs for this purpose.
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影响因子：
3.8
作者：
Montoya M;Gresh L;Mercado JC;Williams KL;Vargas MJ;Gutierrez G;Kuan G;Gordon A;Balmaseda A;Harris E
通讯作者：
Harris E
DOI：
10.1093/bioinformatics/btq046
发表时间：
2010-04-01
期刊：
Bioinformatics (Oxford, England)
影响因子：
--
作者：
Pau G;Fuchs F;Sklyar O;Boutros M;Huber W
通讯作者：
Huber W
影响因子：
3.8
作者：
Narvaez F;Gutierrez G;Pérez MA;Elizondo D;Nuñez A;Balmaseda A;Harris E
通讯作者：
Harris E
影响因子：
6.4
作者：
Olkowski, Sandra;Forshey, Brett M.;Stoddard, Steven T.
通讯作者：
Stoddard, Steven T.
影响因子：
3.3
作者：
Khosavanna, Ruchira R.;Kareko, Bettie W.;Messer, William B.
通讯作者：
Messer, William B.