Microbiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, China.
Research & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd., (Snibe), Shenzhen 518122, China.
Viruses. 2024 Aug 12;16(8):1286. doi: 10.3390/v16081286.
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 Molecision 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 CCID/mL, while the Molecision Monkeypox Virus qPCR Assay had an LoD of 15.55 CCID/mL. The MAGLUMI Monkeypox Virus Ag (CLIA) Assay had an LoD of 0.500 pg/mL. The accuracy of the Molecision 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.
准确和早期诊断猴痘病毒 (MPXV) 对于控制疫情和及时治疗受影响的个体至关重要。本研究旨在评估 Molecision 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（化学发光免疫分析，CLIA）检测试剂盒的分析和临床性能。此外，还旨在比较抗原和核酸检测的临床应用，为使用商业猴痘检测试剂盒提供见解。对 117 例临床患者的标本、连续稀释的病毒细胞培养上清液和人工创建的阳性样本进行测试，以评估这些检测试剂盒对 MPXV 诊断的性能。Biorain 猴痘病毒 ddPCR 检测试剂盒的检测限（LoD）为 3.89 CCID/mL，而 Molecision 猴痘病毒 qPCR 检测试剂盒的 LoD 为 15.55 CCID/mL。MAGLUMI 猴痘病毒 Ag（CLIA）检测试剂盒的 LoD 为 0.500 pg/mL。Molecision 猴痘病毒 qPCR 检测试剂盒的准确性与 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。所有三种用于可能具有交叉反应物质的临床标本的 MPXV 诊断检测试剂盒的特异性均为 100%。总之，本研究为猴痘检测试剂盒的临床应用提供了有价值的见解，支持减轻和控制猴痘传播的努力。
