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

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 outb...

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Bibliographic Details
Published in:Virus genes 2023-12, Vol.59 (6), p.795-800
Main Authors: Sklenovská, Nikola, Bloemen, Mandy, Vergote, Valentijn, Logist, Anne-Sophie, Vanmechelen, Bert, Laenen, Lies, André, Emmanuel, Muyembe-Tamfum, Jean-Jacques, Wollants, Elke, Van Ranst, Marc, Maes, Piet, Wawina-Bokalanga, Tony
Format: Article
Language:English
Subjects:
Africa
animal pathogens
Animals
Biomedical and Life Sciences
Biomedicine
detection limit
Disease control
Disease Outbreaks
Disease transmission
genome
Genomes
Humans
Medical Microbiology
Monkeypox virus
Monkeypox virus - genetics
Mpox
Mpox (monkeypox) - diagnosis
Original Paper
Plant Sciences
quantitative polymerase chain reaction
Real-Time Polymerase Chain Reaction
Sensitivity and Specificity
Viral diseases
Virology
Viruses
zoonoses
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Summary: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.
ISSN:0920-8569
1572-994X
DOI:10.1007/s11262-023-02024-9