Blacksell Stuart D, Jarman Richard G, Bailey Mark S, Tanganuchitcharnchai Ampai, Jenjaroen Kemajittra, Gibbons Robert V, Paris Daniel H, Premaratna Ranjan, de Silva H Janaka, Lalloo David G, Day Nicholas P J
Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Road, Bangkok 10400, Thailand.
Clin Vaccine Immunol. 2011 Dec;18(12):2095-101. doi: 10.1128/CVI.05285-11. Epub 2011 Oct 19.
Six assays were evaluated in this study to determine their suitability for the diagnosis of acute dengue infection using samples from 259 Sri Lankan patients with acute fevers (99 confirmed dengue cases and 160 patients with other confirmed acute febrile illnesses): (i) the Merlin dengue fever IgG & IgM combo device (Merlin), (ii) the Standard Diagnostics Dengue Duo nonstructural 1 (NS1) antigen and IgG/IgM combo device (Standard Diagnostics, South Korea), (iii) the Biosynex Immunoquick dengue fever IgG and IgM (Biosynex, France) assay, (iv) the Bio-Rad NS1 antigen strip (Bio-Rad, France), (v) the Panbio Dengue Duo IgG/IgM Cassette (Inverness, Australia), and (vi) the Panbio dengue NS1 antigen strip (Inverness, Australia). The median number of days of fever prior to admission sample collection was 5 days (interquartile range, 3 to 7 days). Sensitivity and specificity of the NS1 antigen tests ranged from 49 to 59% and from 93 to 99%, respectively, and sensitivity and sensitivity of the IgM antibody test ranged from 71 to 80% and from 46 to 90%, respectively. Combining the NS1 antigen and IgM antibody results from the Standard Diagnostics Dengue Duo test gave the best compromise of sensitivity and specificity (93% and 89%, respectively) and provided the best sensitivity in patients presenting at different times after fever onset. The Merlin IgM/IgG antibody tests correctly classified 64% and 86% of the primary and secondary dengue infection cases, respectively, and the Standard Diagnostics IgM/IgG antibody tests correctly classified 71% and 83% of the primary and secondary dengue infection cases, respectively. This study provides strong evidence of the value of combining dengue antigen- and antibody-based test results in the rapid diagnostic test (RDT) format for the acute diagnosis of dengue.
本研究评估了六种检测方法，以确定其使用来自259名斯里兰卡急性发热患者（99例确诊登革热病例和160例其他确诊急性发热性疾病患者）的样本诊断急性登革热感染的适用性：（i）梅林登革热IgG和IgM组合检测试剂（梅林）；（ii）标准诊断登革热双联非结构蛋白1（NS1）抗原和IgG/IgM组合检测试剂（韩国标准诊断公司）；（iii）碧欧新免疫快速登革热IgG和IgM检测（法国碧欧新公司）；（iv）伯乐NS1抗原检测条（法国伯乐公司）；（v）泛博登革热双联IgG/IgM检测卡（澳大利亚英维尼斯公司）；（vi）泛博登革热NS1抗原检测条（澳大利亚英维尼斯公司）。入院样本采集前发热的中位天数为5天（四分位间距为3至7天）。NS1抗原检测的敏感性和特异性分别为49%至59%和93%至99%，IgM抗体检测的敏感性和特异性分别为71%至80%和46%至90%。将标准诊断登革热双联检测的NS1抗原和IgM抗体结果相结合，在敏感性和特异性方面达到了最佳平衡（分别为93%和89%），并且在发热开始后不同时间就诊的患者中提供了最佳敏感性。梅林IgM/IgG抗体检测分别正确分类了64%的原发性登革热感染病例和86%的继发性登革热感染病例，标准诊断IgM/IgG抗体检测分别正确分类了71%的原发性登革热感染病例和83%的继发性登革热感染病例。本研究为将基于登革热抗原和抗体的检测结果以快速诊断检测（RDT）形式用于登革热的急性诊断的价值提供了有力证据。
