The World Health Organization (WHO) has listed two additional IVD tests under its emergency use listing (EUL) procedure.
The EUL process is intended to increase global access to medical products such as vaccines, tests, and treatments in international public health emergencies, the WHO said.
The two assays are the Cobas MPXV, manufactured by Roche Molecular Systems and listed by the WHO under the EUL on October 14, and the Xpert Mpox, manufactured by Cepheid and listed on October 25. Both are real-time polymerase chain reaction (PCR) tests, which the WHO said in a statement is the gold standard for diagnosing an mpox infection.
The Cobas MPXV assay, intended for use on the Cobas 6800/8800 systems, can detect both mpox clades and provide results in less than two hours. As it can process multiple samples simultaneously, it is suited for labs that handle large volumes of tests, the WHO noted. The Xpert Mpox test runs on compatible GeneXpert systems and is a near-POC testing option, which can support decentralized testing. The test delivers results in under 40 minutes. The Xpert Mpox test detects mpox virus clade II.
According to WHO data, in 2024, over 40,000 suspected mpox cases were reported in 18 countries, with most cases remaining unconfirmed due to limited testing capacity, especially in low- and middle-income countries. Testing increased significantly in the Democratic Republic of Congo, the country hit hardest by mpox, with support from the WHO and its partners. Nevertheless, the WHO noted that only 40% to 50% of suspected cases are currently tested.
The WHO has received more than 60 expressions of interest for an EUL review of mpox diagnostic tests, it said. Seven have progressed to EUL applications, with two products currently under review and two more expected to be reviewed shortly. Abbott's Alinity m MPXV test was listed in early October.
Information on the active EUL candidates and listed diagnostics are on the WHO's website.