Summary: The FDA granted Emergency Use Authorization for Labcorp’s Mpox PCR Test Home Collection Kit, facilitating the early detection and management of monkeypox (mpox) infections.

Key Takeaways:

  • This at-home collection kit allows patients suspected of mpox infection, aged 18 and older, to collect samples for PCR testing and is designed to provide accessible and convenient diagnostic options.
  • Physicians can order the test through Labcorp’s provider interface platform, with the kit being sent directly to patients for at-home collection. 
  • Testing of collected specimens employs PCR technology in authorized laboratories certified under CLIA. Results are electronically delivered to prescribing physicians and accessible to patients via Labcorp’s patient portal.

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Labcorp’s Mpox PCR Test Home Collection Kit to aid in the diagnosis of infection with non-variola Orthopoxvirus, including the monkeypox virus that causes monkeypox (mpox). 

Mpox Test Home Collection Kit

This mpox at-home collection kit is available to physicians to order for patients 18 years of age or older who are suspected of mpox infection.

“The FDA’s emergency authorization of Labcorp’s Mpox PCR Test Home Collection Kit will enable us to play a vital role within the healthcare community in the early detection and management of mpox,” says Brian Caveney, MD, Labcorp’s chief medical and scientific officer. “The collection kit reflects our ongoing commitment to providing critical diagnostic tools to physicians and accessible and convenient testing options to patients.”

Ordering the Labcorp Mpox Test Kit

Physicians can order a test through Labcorp’s provider interface platform for patients they suspect may be infected with the virus. Labcorp will send the test kit directly to patients for at-home collection. The kit includes detailed instructions for patients on correctly collecting a lesion swab, securing the sample in the provided collection tube, and preparing the package for return to an authorized laboratory for analysis.

Testing for Mpox

Testing of specimens collected using the test kit will employ PCR (polymerase chain reaction) technology and will be conducted in authorized laboratories designated by Labcorp and certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to meet the requirements for performing high-complexity testing criteria for the detection of non-variola Orthopoxvirus DNA. Results are electronically delivered to the prescribing physician and made available to the patient in Labcorp’s patient portal at patient.labcorp.com. The company also aims to make the test available on its Labcorp OnDemand platform.

Further reading: Self-Sampling Proves Effective for Asymptomatic Mpox Diagnosis

Rising Mpox Cases

The authorization comes amid reported increases in mpox cases in the United States. 

According to the Centers for Disease Control and Prevention (CDC), there have been 511 mpox cases reported in 2024 through March 16, compared to fewer than 300 cases reported by late March 2023. Since the onset of the national 2022-2023 mpox virus outbreak, part of a larger global outbreak of human mpox caused by the West African clade of the monkeypox virus, the CDC notes more than 32,000 cases and 58 deaths have been reported nationally.

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA.