Diagnosing dengue at the point-of-care: utility of a rapid combined diagnostic kit in Singapore.
Diagnosing dengue at the point-of-care: utility of a rapid combined diagnostic kit in Singapore.
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DOI：
10.1371/journal.pone.0090037
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Ng LC
中科院分区：
文献类型：
--
作者：
Gan VC;Tan LK;Lye DC;Pok KY;Mok SQ;Chua RC;Leo YS;Ng LC
世卫组织建议登革热诊断需要实验室设施。基于抗体的快速诊断测试（RDT）表现不佳，临床诊断仍然是登革热流行国家的支柱。我们评估了在高患病率环境中用于即时检测的抗原抗体组合 RDT。在这项前瞻性队列研究中，从 2011 年 10 月至 2012 年 5 月期间，从三级传染病中心招募了成年人，以评估未分化的发热性疾病。根据基于 WHO 的病毒分离、RT-PCR、NS1-、IgM- 和 IgG-ELISA 参考标准，在护理点对 SD Bioline Dengue Duo 进行了评估。纳入了 246 名成年人（中位年龄 34 岁，范围 18-69 岁），其中 197 名可以明确确诊为登革热或非登革热。 DENV-2是主要血清型（79.5%），原发病例与继发病例之比为1∶1.1。没有测试失败，观察者间差异极小，Fleiss kappa 为 0.983 (95% CI 0.827–1.00)。总体敏感性和特异性分别为 93.9% (95% CI 88.8–96.8%) 和 92.0% (95% CI 81.2–96.9%)。单独使用 WHO 临床标准进行诊断具有相似的敏感性（95.9%，95% CI 91.4–98.1%），但特异性较低（20.0%，95% CI 11.2–33.0%）。在测试早期与晚期报告者、原发性病例与继发性病例、或 DENV-1 与 DENV-2 感染时，没有发现表现存在显着差异。组合 RDT 的使用符合 WHO ASURED 即时检测标准，并且可以增强流行环境中登革热的诊断。这有可能显着改善现场登革热的临床管理。
WHO recommendations for dengue diagnosis require laboratory facilities. Antibody-based rapid diagnostic tests (RDTs) have performed poorly, and clinical diagnosis remains the mainstay in dengue-endemic countries. We evaluated a combination antigen-antibody RDT for point-of-care testing in a high-prevalence setting. In this prospective cohort study, adults were enrolled from a tertiary infectious disease centre for evaluation of undifferentiated febrile illness from October 2011 to May 2012. SD Bioline Dengue Duo was evaluated at point-of-care against a WHO-based reference standard of viral isolation, RT-PCR, NS1-, IgM-, and IgG-ELISA. 246 adults were enrolled (median age 34 years, range 18–69), of which 197 could be confirmed definitively as either dengue or non-dengue. DENV-2 was the predominant serotype (79.5%) and the ratio of primary to secondary cases was 1∶1.1. There were no test failures and minimal interobserver variation with a Fleiss’ kappa of 0.983 (95% CI 0.827–1.00). Overall sensitivity and specificity were 93.9% (95% CI 88.8–96.8%) and 92.0% (95% CI 81.2–96.9%) respectively. Using WHO clinical criteria alone for diagnosis had similar sensitivities (95.9%, 95% CI 91.4–98.1%) and lower specificities (20.0%, 95% CI 11.2–33.0%). No significant difference in performance was found when testing early versus late presenters, primary versus secondary cases, or DENV-1 versus DENV-2 infections. The use of a combination RDT fulfills WHO ASSURED criteria for point-of-care testing and can enhance dengue diagnosis in an endemic setting. This has the potential to markedly improve clinical management of dengue in the field.
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登革热快速测试测定的诊断灵敏度通过使用组合的抗原和抗体测试方法可显着增强。
影响因子：
3.8
作者：
Fry SR;Meyer M;Semple MG;Simmons CP;Sekaran SD;Huang JX;McElnea C;Huang CY;Valks A;Young PR;Cooper MA
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Cooper MA
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作者：
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通讯作者：
de Vries, Peter J.
影响因子：
3.8
作者：
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影响因子：
4.8
作者：
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通讯作者：
Parra, Beatriz