评估MpoxPlex，一种高通量和多路免疫分析法：诊断准确性研究。

IF 20.9 1区生物学 Q1 INFECTIOUS DISEASES

Lancet Microbe Pub Date : 2025-04-01 DOI:10.1016/j.lanmic.2024.100987

Scott Jones PhD , Bethany Hicks BSc , Helen Callaby MRCP , Daniel Bailey PhD , N Claire Gordon DPhil , Tommy Rampling DPhil , Catherine Houlihan PhD , Rachael Jones FRCP , Marcus Pond PhD , Ravi Mehta MRCP , Deborah Wright PGDip , Clarissa Oeser PhD , Simon Tonge MSc , Ezra Linley PhD , Cathy Rowe MSc , Bassam Hallis PhD , Ashley Otter PhD

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引用次数: 0

摘要

背景：2022年5月，全球首次暴发了痘（以前称为猴痘）。作为回应，英国的公共卫生机构已经为感染风险最高的个人提供了天花疫苗。由于全球仍在发现m痘病例，需要新的工具来协助诊断、血清监测和评估感染和接种现有和新的候选疫苗后的免疫反应。在这里，我们描述了一种多重免疫分析法的发展，MpoxPlex，能够同时测量IgG对12种正痘病毒抗原的反应，并区分对感染和疫苗接种的反应。方法：采用Luminex （DiaSorin, Saluggia, Italy）平台，检测猴痘病毒（MPXV）抗原E8、B6、B2、M1、A27、A35、H3、A29、A5和猴痘病毒（MPXV）抗原B5、A27、A33和猴痘病毒（MPXV）感染后（n=24）和接种Ankara-Bavarian Nordic改良VACV后（n=75）的血清抗体反应。通过将接收器工作特征曲线拟合到这些阳性样品和阴性样品的中位数荧光强度来计算检测特征和截止值（n=435）。P值采用非参数Mann-Whitney、Kruskal-Wallis和Dunn多重比较检验计算。结果：使用8种抗原组合的结果，我们能够以98%的灵敏度和95%的特异性将疫苗接种后或感染后的样本与阴性样本区分开来。IgG对MPXV抗原A27的反应能够区分MPXV后感染，敏感性为88%，特异性为97%。疫苗病毒抗原A27和MPXV抗原A29和A5的诊断优势不大。解释：与目前的血清学分析相比，我们相信该分析将为当前全球m痘爆发提供实质性的见解。MpoxPlex可用于疫苗接种和感染的血清监测和免疫学研究。资助：向英国卫生安全局Porton Down的新兴病原体血清学小组提供援助资金。

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Assessment of MpoxPlex, a high-throughput and multiplexed immunoassay: a diagnostic accuracy study

Background

In May, 2022, the first global outbreak of mpox (formerly known as monkeypox) occurred. In response, public health agencies in the UK have made smallpox vaccines available to individuals at the highest risk of infection. With mpox cases still being detected globally, novel tools are required to aid with diagnosis, serosurveillance, and the evaluation of immune responses following infection and immunisation with current and new vaccine candidates. Here, we describe the development of a multiplexed immunoassay, MpoxPlex, able to measure IgG responses to 12 Orthopoxvirus antigens concurrently and distinguish between responses to infection and vaccination.

Methods

Using the Luminex (DiaSorin, Saluggia, Italy) platform, antibody responses to vaccinia virus (VACV) antigens B5, A27, and A33 and monkeypox virus (MPXV) antigens E8, B6, B2, M1, A27, A35, H3, A29, and A5 were assessed in serum from individuals after MPXV infection (n=24) and after vaccination (n=75) with modified VACV Ankara-Bavarian Nordic. Assay characteristics and cutoffs were calculated by fitting receiver operating characteristic curves to the median fluorescence intensities of these positive samples and negative samples that were run alongside (n=435). P values were calculated using non-parametric Mann–Whitney, Kruskal–Wallis, and Dunn’s multiple comparisons tests.

Findings

Using the results from a combination of eight antigens, we were able to distinguish samples as either post-vaccination or post-infection from negative samples with a sensitivity of 98% and a specificity of 95%. IgG responses to MPXV antigen A27 were able to distinguish post-MPXV infection with a sensitivity of 88% and a specificity of 97%. VACV antigen A27 and MPXV antigens A29 and A5 provided little diagnostic advantage.

Interpretation

With additional benefits over current serological assays, we believe this assay will provide substantial insight into the current global outbreak of mpox. MpoxPlex shows use for both serosurveillance and immunological studies of vaccination and infection.

Funding

Grant-in-aid funding to the Emerging Pathogen Serology Group at Porton Down, UK Health Security Agency.

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来源期刊

Lancet Microbe Multiple-

CiteScore

27.20

自引率

0.80%

发文量

278

审稿时长

6 weeks

期刊介绍： The Lancet Microbe is a gold open access journal committed to publishing content relevant to clinical microbiologists worldwide, with a focus on studies that advance clinical understanding, challenge the status quo, and advocate change in health policy.