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Labcorp, CDC Receive FDA EUA for Sample Collection Kit, Molecular Mpox Assay

NEW YORK – Laboratory Corporation of America and the US Centers for Disease Control and Prevention received Emergency Use Authorizations from the US Food and Drug Administration last week for a sample collection kit and a mpox test, the FDA said. 

Labcorp received EUA for its Labcorp Monkeypox PCR Test Home Collection Kit, which is intended for the home self-collection of lesion swab specimens by people with acute, generalized pustular or vesicular rash suspected of mpox by a healthcare provider. The swab specimen is placed in media and transported to the laboratory for testing non­-variola Orthopoxvirus DNA extracted from the sample, according to the EUA summary.

Testing of specimens collected using the kit is limited to Labcorp's Center for Esoteric Testing in Burlington, North Carolina, and labs designated by Labcorp under CLIA to run high-complexity tests and that use the collection kit and the CDC test that also received EUA last week.

The CDC's Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set-EUA, meantime, is a real-time PCR test for the qualitative detection of DNA from non-variola Orthopoxvirus in human pustular or vesicular rash specimens and viral cell culture lysates submitted to a CDC-designated laboratory from people suspected of infection by their healthcare provider. The assay is also authorized for use with human pustular or vesicular rash specimens collected using authorized home specimen collection kits, such as Labcorp's, the EUA summary said. 

The CDC's test doesn't differentiate vaccinia virus or mpox virus from other orthopoxviruses detected by the assay and does not detect variola virus, the FDA said. The test's procedure and uses were modified from the original CDC assay for non-variola Orthopoxvirus cleared by the FDA.