Maseru, Nov. 03 — As part of its initiative to contain Mpox, the World Health Organisation (WHO) under its Emergency Use Listing (EUL) procedure has listed two mpox in vitro diagnostics.
According to a statement by WHO, Xpert Mpox, a real-time PCR test manufactured by Cepheid together with the cobas MPXV assay, developed by Roche Molecular Systems Inc., have been listed. It states that Polymerase Chain Reaction (PCR) testing, which detects viral DNA is considered the gold standard for diagnosing mpox infection.
It indicates that the Xpert Mpox test is easy to operate and delivers results in under 40 minutes while the cobas MPXV assay which is intended for use on the cobas 6800/8800 Systems is capable of detecting both mpox clades and delivering results in under 2 hours.
The statement says WHO is working with manufacturers of the EUL-listed products and national regulatory authorities in affected countries to facilitate domestic registration or emergency listing. It adds that fast-tracking approvals and applying reliance principles will enhance access to quality-assured mpox tests.
