A Comparative Evaluation of Three Diagnostic Assays for the Detection of Human Monkeypox

Viruses Pub Date : 2024-08-12 DOI:10.3390/v16081286

Jing Qu, Xiaomin Zhang, Kun Liu, You Li, Ting Wang, Zhonggang Fang, Cheng Chen, Xiao Tan, Ying Lin, Qing Xu, Yan Yang, Wanqing Wang, Manyu Huang, Shiliang Guo, Ziqiu Chen, Wei Rao, Xiaolu Shi, Bo Peng

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Abstract

Accurate and early diagnosis of monkeypox virus (MPXV) is crucial for controlling epidemics and treating affected individuals promptly. This study aimed to assess the analytical and clinical performance of the MolecisionTM Monkeypox Virus qPCR Assay, Biorain Monkeypox Virus ddPCR Assay, and MAGLUMI® Monkeypox Virus Ag (chemiluminescence immunoassay, CLIA) Assay. Additionally, it aimed to compare the clinical application of antigen and nucleic acid assays to offer insights into using commercial monkeypox assay kits. Specimens from 117 clinical patients, serial diluted virus cell culture supernatant, and artificially created positive samples were tested to evaluate the performance of these assay kits for MPXV diagnostics. The Biorain Monkeypox Virus ddPCR Assay had a limit of detection (LoD) of 3.89 CCID50/mL, while the MolecisionTM Monkeypox Virus qPCR Assay had an LoD of 15.55 CCID50/mL. The MAGLUMI® Monkeypox Virus Ag (CLIA) Assay had an LoD of 0.500 pg/mL. The accuracy of the MolecisionTM Monkeypox Virus qPCR Assay was comparable to the Biorain Monkeypox Virus ddPCR Assay, and the MAGLUMI® Monkeypox Virus Ag (CLIA) Assay demonstrated high sensitivity. The specificity of all three MPXV diagnostic assays for clinical specimens with potential cross-reacting substances was 100%. In conclusion, this study provides valuable insights into the clinical application of monkeypox assays, supporting efforts to mitigate and control the spread of monkeypox.

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检测人类猴痘的三种诊断测定的比较评估

猴痘病毒（MPXV）的早期准确诊断对于控制疫情和及时治疗患者至关重要。本研究旨在评估 MolecisionTM 猴痘病毒 qPCR 检测试剂盒、Biorain 猴痘病毒 ddPCR 检测试剂盒和 MAGLUMI® 猴痘病毒 Ag（化学发光免疫测定，CLIA）检测试剂盒的分析和临床性能。此外，该研究还旨在比较抗原和核酸检测法的临床应用，为使用商业猴痘检测试剂盒提供启示。对来自 117 名临床患者的标本、连续稀释的病毒细胞培养上清液和人工制造的阳性样本进行了测试，以评估这些用于 MPXV 诊断的检测试剂盒的性能。Biorain 猴痘病毒 ddPCR 检测试剂盒的检出限（LoD）为 3.89 CCID50/mL，而 MolecisionTM 猴痘病毒 qPCR 检测试剂盒的检出限（LoD）为 15.55 CCID50/mL。MAGLUMI® 猴痘病毒 Ag (CLIA) 检测试剂盒的 LoD 为 0.500 pg/mL。MolecisionTM 猴痘病毒 qPCR 检测试剂盒的准确度与 Biorain 猴痘病毒 ddPCR 检测试剂盒相当，而 MAGLUMI® 猴痘病毒 Ag (CLIA) 检测试剂盒则表现出较高的灵敏度。对于存在潜在交叉反应物质的临床样本，所有三种 MPXV 诊断测定的特异性均为 100%。总之，这项研究为猴痘检测方法的临床应用提供了宝贵的见解，有助于减轻和控制猴痘的传播。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Viruses

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