Design and validation of a laboratory-developed diagnostic assay for monkeypox virus.

IF 1.9 4区 医学 Q3 GENETICS & HEREDITY Virus Genes Pub Date : 2023-12-01 Epub Date: 2023-08-17 DOI:10.1007/s11262-023-02024-9
Nikola Sklenovská, Mandy Bloemen, Valentijn Vergote, Anne-Sophie Logist, Bert Vanmechelen, Lies Laenen, Emmanuel André, Jean-Jacques Muyembe-Tamfum, Elke Wollants, Marc Van Ranst, Piet Maes, Tony Wawina-Bokalanga
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Abstract

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.

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设计和验证实验室开发的猴痘病毒诊断测定法。
麻疹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流行。该疾病过去曾多次通过受感染的动物或旅行者传入非洲大陆以外的国家,其中一次导致了2022年前所未有的全球疫情,并在人与人之间传播。尽管及时和可靠的诊断是任何疾病控制的基石,但准确诊断分析的可用性和诊断分析的比较性能研究仍然有限,尽管早在1970年就已确定猴痘病毒(MPXV)为人类病原体。我们实验室开发了一种实时PCR检测(LDT),并对其与商业TaqMan™猴痘病毒微生物检测试验(Applied Biosystems, Cat A50137)的性能进行了评估。LDT的检出限为1.2个基因组拷贝/ml。两种方法的敏感性和特异性分别为99.14%和100%,均能检测到MPXV的I和II支。我们的结果证明了LDT从病变拭子样本中确认MPXV感染的有效性和准确性。
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来源期刊
Virus Genes
Virus Genes 医学-病毒学
CiteScore
3.30
自引率
0.00%
发文量
76
审稿时长
3 months
期刊介绍: Viruses are convenient models for the elucidation of life processes. The study of viruses is again on the cutting edge of biological sciences: systems biology, genomics, proteomics, metagenomics, using the newest most powerful tools. Huge amounts of new details on virus interactions with the cell, other pathogens and the hosts – animal (including human), insect, fungal, plant, bacterial, and archaeal - and their role in infection and disease are forthcoming in perplexing details requiring analysis and comments. Virus Genes is dedicated to the publication of studies on the structure and function of viruses and their genes, the molecular and systems interactions with the host and all applications derived thereof, providing a forum for the analysis of data and discussion of its implications, and the development of new hypotheses.
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