Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute, KU Leuven, Leuven, Belgium.
Department of Laboratory Medicine, UZ Leuven University Hospital, Leuven, Belgium.
Virus Genes. 2023 Dec;59(6):795-800. doi: 10.1007/s11262-023-02024-9. Epub 2023 Aug 17.
Mpox is a viral zoonosis with endemic circulation in animals and humans in some West and Central African countries. The disease was imported a few times in the past to countries outside the African continent through infected animals or travelers, one of which resulted in an unprecedented global outbreak sustained by human-to-human transmission in 2022. Although timely and reliable diagnosis is a cornerstone of any disease control, availability of accurate diagnostic assays and comparative performance studies of diagnostic assays remains limited despite of the long-known identification of monkeypox virus (MPXV) as a human pathogen since 1970. We laboratory-developed a real-time PCR test (LDT) and evaluated its performance against the commercial TaqMan™ Monkeypox Virus Microbe Detection Assay (Applied Biosystems, Cat A50137). The limit of detection of the LDT was established at 1.2 genome copies/ml. The sensitivity and specificity of both assays were 99.14% and 100%, respectively, and both are capable of detecting both clade I and clade II of MPXV. Our results demonstrate the validity and accuracy of the LDT for confirmation of MPXV infection from lesion swabs samples.
猴痘是一种病毒性人畜共患病，在一些西非和中非国家的动物和人类中存在地方性流行。过去，这种疾病曾通过受感染的动物或旅行者几次传入非洲大陆以外的国家，其中一次导致 2022 年人类之间传播的史无前例的全球疫情爆发。尽管及时和可靠的诊断是任何疾病控制的基石，但尽管自 1970 年以来已明确确定猴痘病毒（MPXV）为人病原体，但仍然缺乏准确的诊断检测方法和诊断检测方法的比较性能研究。我们实验室开发了一种实时 PCR 检测方法（LDT），并评估了其针对商业 TaqMan™猴痘病毒微生物检测试剂盒（Applied Biosystems，Cat A50137）的性能。LDT 的检测限设定为 1.2 个基因组拷贝/ml。两种检测方法的灵敏度和特异性分别为 99.14%和 100%，均可检测 MPXV 的 I 型和 II 型。我们的结果证明了 LDT 用于从病变拭子样本中确认 MPXV 感染的有效性和准确性。
