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首页> 外文期刊>Journal of Clinical Microbiology >Multicountry Prospective Clinical Evaluation of Two Enzyme-Linked Immunosorbent Assays and Two Rapid Diagnostic Tests for Diagnosing Dengue Fever
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Multicountry Prospective Clinical Evaluation of Two Enzyme-Linked Immunosorbent Assays and Two Rapid Diagnostic Tests for Diagnosing Dengue Fever

机译：两种酶联免疫吸附测定和两种快速诊断测试对登革热的多国前瞻性临床评价

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We evaluated four dengue diagnostic devices from Alere, including the SD Bioline Dengue Duo (nonstructural [NS] 1 Ag and IgG/IgM), the Panbio Dengue Duo Cassette (IgM/IgG) rapid diagnostic tests (RDTs), and the Panbio dengue IgM and IgG capture enzyme-linked immunosorbent assays (ELISAs) in a prospective, controlled, multicenter study in Peru, Venezuela, Cambodia, and the United States, using samples from 1,021 febrile individuals. Archived, well-characterized samples from an additional 135 febrile individuals from Thailand were also used. Reference testing was performed on all samples using an algorithm involving virus isolation, in-house IgM and IgG capture ELISAs, and plaque reduction neutralization tests (PRNT) to determine the infection status of the individual. The primary endpoints were the clinical sensitivities and specificities of these devices. The SD Bioline Dengue Duo had an overall sensitivity of 87.3% (95% confidence interval [CI], 84.1 to 90.2%) and specificity of 86.8% (95% CI, 83.9 to 89.3%) during the first 14 days post-symptom onset (p.s.o.). The Panbio Dengue Duo Cassette demonstrated a sensitivity of 92.1% (87.8 to 95.2%) and specificity of 62.2% (54.5 to 69.5%) during days 4 to 14 p.s.o. The Panbio IgM capture ELISA had a sensitivity of 87.6% (82.7 to 91.4%) and specificity of 88.1% (82.2 to 92.6%) during days 4 to 14 p.s.o. Finally, the Panbio IgG capture ELISA had a sensitivity of 69.6% (62.1 to 76.4%) and a specificity of 88.4% (82.6 to 92.8%) during days 4 to 14 p.s.o. for identification of secondary dengue infections. This multicountry prospective study resulted in reliable real-world performance data that will facilitate data-driven laboratory test choices for managing patient care during dengue outbreaks.
机译：我们评估了Alere的四种登革热诊断设备，包括SD Bioline Dengue Duo（非结构性[NS] 1 Ag和IgG / IgM），Panbio Dengue Duo盒式磁带（IgM / IgG）快速诊断测试（RDT）和Panbio登革热IgM在秘鲁，委内瑞拉，柬埔寨和美国进行的一项前瞻性，对照，多中心研究中，使用了1,021名发热个体的样本，对IgG和IgG捕获酶联免疫吸附测定（ELISA）进行了研究。还使用了来自泰国另外135名发热人士的存档，特征明确的样本。使用涉及病毒分离，内部IgM和IgG捕获ELISA以及斑块减少中和测试（PRNT）的算法对所有样品进行参考测试，以确定个体的感染状况。主要终点是这些设备的临床敏感性和特异性。 SD Bioline Dengue Duo在症状发作后的前14天总体敏感性为87.3％（95％置信区间[CI]为84.1至90.2％），特异性为86.8％（95％CI为83.9至89.3％）。 （pso）。 Panbio Dengue Duo卡式磁带在下午4到14天的测试中显示出92.1％（87.8至95.2％）的灵敏度和62.2％（54.5至69.5％）的特异性。 Panbio IgM捕获ELISA的p.s.o.第4天灵敏度为87.6％（82.7至91.4％），特异性为88.1％（82.2至92.6％）。最终，Panbio IgG捕获ELISA在p.s.o.第4天的敏感性为69.6％（62.1至76.4％），特异性为88.4％（82.6至92.8％）。用于鉴定继发登革热感染。这项多国前瞻性研究得出了可靠的真实世界表现数据，这些数据将有助于以数据驱动的实验室测试选择，以管理登革热暴发期间的患者护理。

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