A Comparative Evaluation of Three Diagnostic Assays for the Detection of Human Monkeypox
Author:
Qu Jing1, Zhang Xiaomin1, Liu Kun2, Li You2, Wang Ting2, Fang Zhonggang2, Chen Cheng2, Tan Xiao3, Lin Ying1, Xu Qing1, Yang Yan1, Wang Wanqing1, Huang Manyu1, Guo Shiliang1, Chen Ziqiu1, Rao Wei2, Shi Xiaolu1, Peng Bo14ORCID
Affiliation:
1. Microbiology Laboratory, Shenzhen Center for Disease Control and Prevention, Shenzhen 518055, China 2. Research & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd., (Snibe), Shenzhen 518122, China 3. Shenzhen Biorain Biotechnology Co., Ltd., Shenzhen 518122, China 4. National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China
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.
Funder
Sanming Project of Medicine in Shenzhen Shenzhen Science and Technology Program
Reference42 articles.
1. Monkeypox (Mpox) Virus: Classification, Origin, Transmission, Genome Organization, Antiviral Drugs, and Molecular Diagnosis;Karagoz;J. Infect. Public Health,2023 2. (2024, June 25). Edouard Mathieu, Fiona Spooner, Saloni Dattani, Hannah Ritchie and Max Roser (2022)—“Mpox”. Available online: https://ourworldindata.org/mpox#explore-our-data-on-mpox. 3. The First Imported Case of Monkeypox in the Mainland of China—Chongqing Municipality, China, September 16, 2022;Zhao;China CDC Wkly.,2022 4. Virological Characterization of the 2022 Outbreak-Causing Monkeypox Virus Using Human Keratinocytes and Colon Organoids;Watanabe;J. Med. Virol.,2023 5. Vakaniaki, E.H., Kacita, C., Kinganda-Lusamaki, E., O’Toole, Á., Wawina-Bokalanga, T., Mukadi-Bamuleka, D., Amuri-Aziza, A., Malyamungu-Bubala, N., Mweshi-Kumbana, F., and Mutimbwa-Mambo, L. (2024). Sustained Human Outbreak of a New MPXV Clade I Lineage in Eastern Democratic Republic of the Congo. Nat. Med.
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献
1. Oh no, all we needed was monkeypox!;European Journal of Internal Medicine;2024-09
|
|