Blacksell Stuart D, Jarman Richard G, Gibbons Robert V, Tanganuchitcharnchai Ampai, Mammen Mammen P, Nisalak Ananda, Kalayanarooj Siripen, Bailey Mark S, Premaratna Ranjan, de Silva H Janaka, Day Nicholas P J, Lalloo David G
Mahidol University-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
Clin Vaccine Immunol. 2012 May;19(5):804-10. doi: 10.1128/CVI.05717-11. Epub 2012 Mar 21.
Seven commercial assays were evaluated to determine their suitability for the diagnosis of acute dengue infection: (i) the Panbio dengue virus Pan-E NS1 early enzyme-linked immunosorbent assay (ELISA), second generation (Alere, Australia); (ii) the Panbio dengue virus IgM capture ELISA (Alere, Australia); (iii) the Panbio dengue virus IgG capture ELISA (Alere, Australia); (iv) the Standard Diagnostics dengue virus NS1 antigen ELISA (Standard Diagnostics, South Korea); (v) the Standard Diagnostics dengue virus IgM ELISA (Standard Diagnostics, South Korea); (vi) the Standard Diagnostics dengue virus IgG ELISA (Standard Diagnostics, South Korea); and (vii) the Platelia NS1 antigen ELISA (Bio-Rad, France). Samples from 239 Thai patients confirmed to be dengue virus positive and 98 Sri Lankan patients negative for dengue virus infection were tested. The sensitivities and specificities of the NS1 antigen ELISAs ranged from 45 to 57% and 93 to 100% and those of the IgM antibody ELISAs ranged from 85 to 89% and 88 to 100%, respectively. Combining the NS1 antigen and IgM antibody results from the Standard Diagnostics ELISAs gave the best compromise between sensitivity and specificity (87 and 96%, respectively), as well as providing the best sensitivity for patients presenting at different times after fever onset. The Panbio IgG capture ELISA correctly classified 67% of secondary dengue infection cases. This study provides strong evidence of the value of combining dengue virus antigen- and antibody-based test results in the ELISA format for the diagnosis of acute dengue infection.
对七种商业检测方法进行了评估，以确定它们在诊断急性登革热感染方面的适用性：（i）第二代泛博登革病毒全抗原NS1早期酶联免疫吸附测定（ELISA）（澳大利亚Alere公司）；（ii）泛博登革病毒IgM捕获ELISA（澳大利亚Alere公司）；（iii）泛博登革病毒IgG捕获ELISA（澳大利亚Alere公司）；（iv）标准诊断登革病毒NS1抗原ELISA（韩国标准诊断公司）；（v）标准诊断登革病毒IgM ELISA（韩国标准诊断公司）；（vi）标准诊断登革病毒IgG ELISA（韩国标准诊断公司）；以及（vii）普乐可复NS1抗原ELISA（法国伯乐公司）。对239名确诊为登革病毒阳性的泰国患者和98名登革病毒感染阴性的斯里兰卡患者的样本进行了检测。NS1抗原ELISA的敏感性和特异性分别为45%至57%和93%至100%，IgM抗体ELISA的敏感性和特异性分别为85%至8-%和88%至100%。将标准诊断ELISA的NS1抗原和IgM抗体结果相结合，在敏感性和特异性之间取得了最佳平衡（分别为87%和96%），并且对发热发作后不同时间就诊的患者提供了最佳敏感性。泛博IgG捕获ELISA正确分类了67%的二次登革热感染病例。这项研究有力地证明了在ELISA检测中结合基于登革病毒抗原和抗体的检测结果对诊断急性登革热感染的价值。
