Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Salvador, Bahia, Brazil.
Instituto de Saúde Coletiva, Universidade Federal da Bahia, Salvador, Bahia, Brazil.
PLoS One. 2019 Mar 6;14(3):e0213301. doi: 10.1371/journal.pone.0213301. eCollection 2019.
Rapid diagnosis tests (RDTs) are easy to carry out, provide fast results, and could potentially guide medical treatment decisions. We investigated the performance of a commercially available RDT, which simultaneously detects the non-structural 1 (NS1) dengue virus (DENV) antigen, and IgM and IgG DENV antibodies, using representative serum samples from individuals in a dengue endemic area in Salvador, Brazil.
METHODOLOGY/PRINCIPAL FINDINGS: We evaluated the accuracy of the SD BIOLINE Dengue Duo RDT (Abbott, Santa Clara, USA; former Alere Inc, Waltham, USA) in a random collection of sera. Samples included acute-phase sera from 246 laboratory-confirmed dengue cases and 108 non-dengue febrile patients enrolled in a surveillance study for dengue detection, 73 healthy controls living in the same surveillance community, and 73 blood donors. RDT accuracy was blindly assessed based on the combined results for the NS1 and the IgM test components. The RDT sensitivity was 46.8% (38.6% for the NS1 component and 13.8% for the IgM component). Sensitivity was greater for samples obtained from patients with secondary DENV infections (49.8%) compared to primary infections (31.1%) (P: 0.02) and was also influenced by the result in the confirmatory dengue diagnostic test, ranging from 39.7% for samples of cases confirmed by IgM-ELISA seroconversion between paired samples to 90.4% for samples of cases confirmed by a positive NS1-ELISA. The RDT specificity was 94.4% for non-dengue febrile patients, 87.7% for the community healthy controls, and 95.9% for the blood donors.
CONCLUSIONS/SIGNIFICANCE: The SD BIOLINE Dengue Duo RDT showed good specificities, but low sensitivity, suggesting that it may be more useful to rule in than to rule out a dengue diagnosis in dengue endemic regions.
快速诊断检测（RDT）易于操作，结果快速，并且有可能指导治疗决策。我们调查了一种市售 RDT 的性能，该 RDT 同时检测非结构蛋白 1（NS1）登革热病毒（DENV）抗原以及 IgM 和 IgG DENV 抗体，使用的是巴西萨尔瓦多登革热流行地区的个体的代表性血清样本。
方法/主要发现：我们在一项随机采集的血清样本中评估了 SD BIOLINE Dengue Duo RDT（雅培，美国圣克拉拉；前 Alere 公司，美国沃尔瑟姆）的准确性。样本包括 246 例实验室确诊的登革热病例的急性相血清，以及 108 例非登革热发热患者的血清，这些患者参加了登革热检测监测研究，73 例健康对照来自同一监测社区，73 例献血者。根据 NS1 和 IgM 检测组件的联合结果，盲法评估 RDT 的准确性。RDT 的敏感性为 46.8%（NS1 组件为 38.6%，IgM 组件为 13.8%）。在继发感染 DENV 的患者样本中（49.8%）比原发感染患者（31.1%）中（P：0.02），RDT 的敏感性更高，并且还受到确诊的登革热诊断检测结果的影响，从配对样本中 IgM-ELISA 血清转换的病例的样本中 39.7%到 NS1-ELISA 阳性的病例的样本中 90.4%不等。对于非登革热发热患者、社区健康对照和献血者，RDT 的特异性分别为 94.4%、87.7%和 95.9%。
结论/意义：SD BIOLINE Dengue Duo RDT 具有良好的特异性，但敏感性低，表明在登革热流行地区，该 RDT 可能更有助于确诊而非排除登革热诊断。
