Hunsperger Elizabeth A, Yoksan Sutee, Buchy Philippe, Nguyen Vinh Chau, Sekaran Shamala Devi, Enria Delia A, Vazquez Susana, Cartozian Elizabeth, Pelegrino Jose L, Artsob Harvey, Guzman Maria G, Olliaro Piero, Zwang Julien, Guillerm Martine, Kliks Susie, Halstead Scott, Peeling Rosanna W, Margolis Harold S
Dengue Branch, Centers for Diseases Control and Prevention, San Juan, Puerto Rico.
Center for Vaccine Development, Mahidol University, Bangkok, Thailand.
PLoS Negl Trop Dis. 2014 Oct 16;8(10):e3171. doi: 10.1371/journal.pntd.0003171. eCollection 2014 Oct.
Commercially available diagnostic test kits for detection of dengue virus (DENV) non-structural protein 1 (NS1) and anti-DENV IgM were evaluated for their sensitivity and specificity and other performance characteristics by a diagnostic laboratory network developed by World Health Organization (WHO), the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Pediatric Dengue Vaccine Initiative (PDVI). Each network laboratory contributed characterized serum specimens for the panels used in the evaluation. Microplate enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT formats) were represented by the kits. Each ELISA was evaluated by 2 laboratories and RDTs were evaluated by at least 3 laboratories. The reference tests for IgM anti-DENV were laboratory developed assays produced by the Armed Forces Research Institute for Medical Science (AFRIMS) and the Centers for Disease Control and Prevention (CDC), and the NS1 reference test was reverse transcriptase polymerase chain reaction (RT-PCR). Results were analyzed to determine sensitivity, specificity, inter-laboratory and inter-reader agreement, lot-to-lot variation and ease-of-use. NS1 ELISA sensitivity was 60-75% and specificity 71-80%; NS1 RDT sensitivity was 38-71% and specificity 76-80%; the IgM anti-DENV RDTs sensitivity was 30-96%, with a specificity of 86-92%, and IgM anti-DENV ELISA sensitivity was 96-98% and specificity 78-91%. NS1 tests were generally more sensitive in specimens from the acute phase of dengue and in primary DENV infection, whereas IgM anti-DENV tests were less sensitive in secondary DENV infections. The reproducibility of the NS1 RDTs ranged from 92-99% and the IgM anti-DENV RDTs from 88-94%.
世界卫生组织（WHO）、联合国儿童基金会/联合国开发计划署/世界银行/世卫组织热带病研究和培训特别规划（TDR）以及儿科登革热疫苗倡议（PDVI）建立的诊断实验室网络，对用于检测登革热病毒（DENV）非结构蛋白1（NS1）和抗DENV IgM的商用诊断检测试剂盒的敏感性、特异性及其他性能特征进行了评估。每个网络实验室都提供了用于评估的特征血清标本。试剂盒包括微孔板酶联免疫吸附测定（ELISA）和快速诊断检测（RDT形式）。每个ELISA由2个实验室评估，RDT由至少3个实验室评估。抗DENV IgM的参考检测是由武装部队医学科学研究所（AFRIMS）和疾病控制与预防中心（CDC）开发的实验室检测方法，NS1的参考检测是逆转录聚合酶链反应（RT-PCR）。对结果进行分析以确定敏感性、特异性、实验室间和读数间的一致性、批次间差异及易用性。NS1 ELISA的敏感性为60 - 75%，特异性为71 - 80%；NS1 RDT的敏感性为38 - 71%，特异性为76 - 80%；抗DENV IgM RDT的敏感性为30 - 96%，特异性为86 - 92%，抗DENV IgM ELISA的敏感性为96 - 98%，特异性为78 - 91%。NS1检测通常在登革热急性期标本和初次DENV感染中更敏感，而抗DENV IgM检测在二次DENV感染中敏感性较低。NS1 RDT的重复性范围为92 - 99%，抗DENV IgM RDT的重复性范围为88 - 94%。
