背景:自2022年7月23日以来,全球水痘病例达到92,546例,美国超过31,000例。无症状携带是影响水痘全球传播的关键机制。血清阳性率研究对于确定流行病的真正负担至关重要,但是血清学检测性能和天花疫苗接种如何影响检测结果的解释方面仍然存在不确定性.
目的:我们的研究旨在评估几种诊断方法在痘痘阳性患者中的表现,已接种疫苗和爆发前阴性对照样本。这项调查旨在加强我们对未来水痘爆发的理解和管理。
方法:来自10个水痘阳性,五个未被感染的疫苗,并获得137个爆发前对照进行血清学检测。在症状发作后约100天获得了水痘阳性样本,和接种疫苗的患者在接种疫苗后约90天取样。采用了多种诊断方法,包括四个商业ELISA(Abbexa,RayBioTech,FineTest,ProteoGenix)和多重测定(中尺度诊断(MSD)),测量五种天花和五种天花抗原。
结果:三种市售ELISA试剂盒的特异性较低(<50%)。靶向E8L抗原的ProteogenixELISA具有94%的灵敏度和87%的特异性。MSD测定的E8L抗原在暴露组之间表现出最大的区别,98%的灵敏度和93%的特异性。
结论:没有一种测定能够区分痘痘阳性和接种疫苗的样品。靶向MPXVE8L抗原的MSD测定显示了痘痘阳性和爆发前阴性样品之间的最大区别。我们的发现强调了确定敏感和特异性检测方法以监测人群水平的水痘暴露和感染的必要性。
BACKGROUND: Since July 23, 2022, global mpox cases reached 92,546, with over 31,000 in the United States. Asymptomatic carriage is a critical mechanism influencing the global dissemination of mpox. Seroprevalence studies are crucial for determining the epidemic\'s true burden, but uncertainties persist in serologic assay performance and how smallpox vaccination may influence assay interpretation.
OBJECTIVE: Our study aimed to assess the performance of several diagnostic assays among mpox-positive, vaccinated, and pre-outbreak negative control samples. This investigation sought to enhance our understanding and management of future mpox outbreaks.
METHODS: Serum samples from 10 mpox-positive, five vaccinated uninfected, and 137 pre-outbreak controls were obtained for serological testing. The mpox-positive samples were obtained around 100 days post symptom onset, and vaccinated patients were sampled approximately 90 days post-vaccination. Multiple diagnostic assays were employed, including four commercial ELISAs (Abbexa, RayBioTech, FineTest, ProteoGenix) and a multiplex assay (MesoScale Diagnostics (MSD)) measuring five mpox and five smallpox antigens.
RESULTS: Three commercial ELISA kits had low specificity (<50 %). The Proteogenix ELISA targeting the E8L antigen had a 94 % sensitivity and 87 % specificity. The E8L antigen on the MSD assay exhibited the greatest distinction between exposure groups, with 98 % sensitivity and 93 % specificity.
CONCLUSIONS: None of the assays could distinguish between mpox-positive and vaccinated samples. The MSD assay targeting the MPXV E8L antigen demonstrated the greatest differentiation between mpox-positive and pre-outbreak negative samples. Our findings underscore the imperative to identify sensitive and specific assays to monitor population-level mpox exposure and infection.