Cepheid’s Xpert Mpox point-of-care test has been listed by the World Health Organization (WHO) under its Emergency Use Listing (EUL) procedure.
In February 2023, Xpert Mpox was the first point-of-care test to receive Emergency Use Authorization (EUA) from the US Food & Drug Administration for the detection and/or diagnosis of mpox infection. Polymerase chain reaction (PCR) testing, which detects viral DNA, is considered the gold standard for diagnosing mpox infection. Xpert Mpox on the GeneXpert systems provides results for mpox Clade II and for non-variola Orthopoxviruses (including mpox Clade I and II) from lesion swabs. Results are available in less than 40 minutes, and the test can be performed in decentralised near-patient settings.
The EUL process assesses the quality, safety, and performance of essential health products, such as diagnostic tests, to guide procurement agencies and WHO Member States in making informed decisions for time-limited emergency procurement.
In 2024, 18 countries have reported over 40,000 suspected mpox cases with most remaining unconfirmed due to limited testing capacity, especially in low and middle-income countries. In the Democratic Republic of the Congo - the hardest-hit country - testing has significantly increased in 2024, following efforts to decentralise testing with support from WHO and partners.
One of the key signs of mpox infection is fever with development of a maculopapular rash, often appearing as small, raised spots. However, there are many other illnesses, such as chickenpox, measles, bacterial skin infections, syphilis, herpes, and medication-associated allergies that can present with similar symptoms. WHO recommends that suspected cases of mpox be confirmed with a PCR test run on an appropriate human lesion sample.
"Xpert Mpox is the only point-of-care molecular test with WHO Emergency Use Listing (EUL), making it a valuable preparedness and response tool that can be deployed quickly where accurate and actionable information is needed," said Vitor Rocha, President of Cepheid. "Xpert Mpox runs on Cepheid's GeneXpert systems (pictured above), which have the largest installed base of any molecular diagnostic platform."