商业 IgM 和 IgG 酶联免疫吸附试验（ELISA）用于诊断 Zika 病毒感染的诊断性能。
Diagnostic performance of commercial IgM and IgG enzyme-linked immunoassays (ELISAs) for diagnosis of Zika virus infection.
机构信息
Instituto Gonçalo Moniz, Fundação Oswaldo Cruz, Rua Waldemar Falcão, 121, Candeal, 40296-710, Salvador, BA, Brazil.
Universidade Federal da Bahia, Salvador, Brazil.
出版信息
Virol J. 2018 Jul 13;15(1):108. doi: 10.1186/s12985-018-1015-6.
BACKGROUND
Serologic detection of Zika virus (ZIKV) infections is challenging because of antigenic similarities among flaviviruses.
OBJECTIVE
To evaluate the sensitivity and specificity of commercial ZIKV IgM and IgG enzyme-linked immunoassay (ELISA) kits.
METHODS
We used sera from febrile patients with RT-PCR-confirmed ZIKV infection to determine sensitivity and sera from RT-PCR-confirmed dengue cases and blood donors, both of which were collected before ZIKV epidemics in Brazil (2009-2011 and 2013, respectively) to determine specificity.
RESULTS
The ZIKV IgM-ELISA positivity among RT-PCR ZIKV confirmed cases was 0.0% (0/14) and 12.5% (1/8) for acute- and convalescent-phase sera, respectively, while its specificity was 100.0% (58/58) and 98.3% (58/59) for acute- and convalescent-phase sera of dengue patients, and 100.0% (23/23) for blood donors. The ZIKV IgG-ELISA sensitivity was 100.0% (6/6) on convalescent-phase sera from RT-PCR confirmed ZIKV patients, while its specificity was 27.3% (15/55) on convalescent-phase sera from dengue patients and 45.0% (9/20) on blood donors' sera. The ZIKV IgG-ELISA specificity among dengue confirmed cases was much greater among patients with primary dengue (92.3%; 12/13), compared to secondary dengue (7.1%; 3/42).
CONCLUSIONS
In a setting of endemic dengue transmission, the ZIKV IgM-ELISA had high specificity, but poor sensitivity. In contrast, the ZIKV IgG-ELISA showed low specificity, particularly for patients previously exposed to dengue infections. This suggests that this ZIKV IgM-ELISA is not useful in confirming a diagnosis of ZIKV infection in suspected patients, whereas the IgG-ELISA is more suitable for ZIKV diagnosis among travelers, who reside in areas free of flavivirus transmission, rather than for serosurveys in dengue-endemic areas.
背景
由于黄病毒之间存在抗原相似性，因此寨卡病毒（ZIKV）感染的血清学检测具有挑战性。
目的
评估商业 ZIKV IgM 和 IgG 酶联免疫吸附试验（ELISA）试剂盒的敏感性和特异性。
方法
我们使用 RT-PCR 确诊的 ZIKV 感染发热患者的血清来确定敏感性，并使用 RT-PCR 确诊的登革热病例和献血者的血清来确定特异性，这两组血清均采集于巴西的 ZIKV 流行之前（分别为 2009-2011 年和 2013 年）。
结果
RT-PCR 确诊的 ZIKV 感染病例中，ZIKV IgM-ELISA 的阳性率分别为 0.0%（14 例中 0 例）和 12.5%（8 例急性和恢复期血清中各 1 例），而其特异性分别为 100.0%（58 例登革热患者急性和恢复期血清中各 58 例）和 98.3%（58 例登革热患者急性和恢复期血清中各 59 例），以及 100.0%（23 例献血者）。ZIKV IgG-ELISA 的敏感性为 100.0%（6/6），检测恢复期 RT-PCR 确诊的 ZIKV 患者血清，而其特异性为 27.3%（55 例恢复期血清中 15 例），以及 45.0%（20 例献血者血清中 9 例）。在登革热确诊病例中，ZIKV IgG-ELISA 的特异性在初次感染登革热的患者中更高（92.3%，12/13），而在二次感染登革热的患者中较低（7.1%，3/42）。
结论
在地方性登革热传播的环境中，ZIKV IgM-ELISA 的特异性高，但敏感性差。相比之下，ZIKV IgG-ELISA 的特异性较低，特别是对先前感染过登革热的患者。这表明该 ZIKV IgM-ELISA 不适合用于确认疑似患者的 ZIKV 感染诊断，而 IgG-ELISA 更适合居住在无黄病毒传播地区的旅行者的 ZIKV 诊断，而不适合在登革热流行地区进行血清学调查。
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