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Jing Qu1, Xiaomin Zhang1, Kun Liu2
1Microbiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, China.
Viruses
|August 29, 2024
概括
准确的病毒 (MPXV) 诊断非常重要. 这项研究评估了三个商业套件,发现qPCR和ddPCR分析的准确性相似,对抗原分析的高灵敏度有助于MPXV控制工作.
科学领域:
- 病毒学 病毒学
- 诊断微生物学 诊断微生物学
- 流行病学 流行病学
背景情况:
- 准确及时诊断病毒 (MPXV) 对于有效的流行病控制和患者管理至关重要.
- 有几种商业诊断试验,包括核酸放大试验 (NAAT) 和基于抗原的试验,可用于MPXV检测.
- 了解这些测试的性能特征对于其适当的临床应用至关重要.
研究的目的:
- 评估MolecisionTM Monkeypox Virus qPCR测试,Biorain Monkeypox Virus ddPCR测试以及MAGLUMI® Monkeypox Virus Ag (CLIA) 测试的分析和临床性能.
- 为了比较基于抗原和基于核酸的测试对MPXV检测的临床实用性.
- 提供有关商业MPXV测试套件用于诊断的使用的见解.
主要方法:
- 通过对病毒细胞培养的连续稀释和人工创建的阳性样本来评估分析性能.
- 用117名患者的样本来评估临床性能.
- 检测极限 (LoD),准确性,灵敏度和特异性被确定为每个测试.
主要成果:
- 在Biorain Monkeypox Virus ddPCR 试验中显示的LoD为3.89 CCID50/mL,而MolecisionTM Monkeypox Virus qPCR试验的LoD为15.55 CCID50/mL.
- 在MAGLUMI® Monkeypox Virus Ag (CLIA) 试验中,显示了0.500 pg/mL的低负载值和高灵敏度.
- 这三种测定均为临床试样实现了100%的特异性,即使是与潜在的交叉反应物质.
结论:
- 莫莱西森TM麻疹病毒qPCR试验和Biorain麻疹病毒ddPCR试验在MPXV检测中显示出可比的准确性.
- 在MAGLUMI® Monkeypox病毒Ag (CLIA) 测试提供了一个敏感的选项MPXV诊断.
- 这项研究提供了商业MPXV测定临床应用的宝贵数据,支持知情选择和用于疾病控制的使用.
相关概念视频
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