Evaluation of a Zoonotic Orthopoxvirus PCR Assay for the Detection of Monkeypox Virus Infection
An epidemic caused by an outbreak of monkeypox (mpox) in May 2022 rapidly spread internationally, requiring an urgent response from the clinical diagnostics community. A detailed description of the clinical validation and implementation of a laboratory-developed real-time PCR test for detecting nonvariola Orthopoxvirus-specific DNA based on the newly designed RealStar Zoonotic Orthopoxvirus assay is presented. The validation was performed using an accuracy panel (n = 97) comprising skin lesion swabs in universal transport media and from mpox virus genomic DNA spiked into pooled mpox virus–negative remnant universal transport media of lesion specimens submitted for routine clinical testing in the NewYork-Presbyterian Hospital clinical laboratory system.
Source: Journal of Molecular Diagnostics - Category: Pathology Authors: Priya Velu, John Sipley, Jamie Marino, Sanjiv Ghanshani, Georgi Lukose, Lin Cong, Liliana Serrano, Thanh Ly, Raymond K. Yeh, Fan Wu, Mahesh Mansukhani, Greg Berry, Hanna Rennert Tags: Regular article Source Type: research
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