The assay is a real-time PCR diagnostic tool for identifying mpox virus (clade I/II) DNA in samples taken from human skin lesions. Credit: Flabygasted / Shutterstock.

The World Health Organization (WHO) has approved Abbott Molecular’s mpox diagnostic test, Alinity m MPXV assay, for emergency use.

This first mpox in vitro diagnostic (IVD) listed under WHO’s Emergency Use Listing (EUL) procedure is an important step in improving global access to mpox testing.

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WHO Access to Medicines and Health Products assistant director-general Dr Yukiko Nakatani said: “This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding testing availability in affected countries.

“Increasing access to quality-assured medical products is central to our efforts in assisting countries to contain the spread of the virus and protect their people, especially in underserved regions.”

The Alinity m MPXV assay is a real-time PCR test designed to detect mpox virus (clade I/II) DNA from human skin lesion swabs.

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Intended for use by trained clinical laboratory personnel, the test confirms suspected mpox cases by detecting DNA from pustular or vesicular rash samples.

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The EUL process is designed to expedite the availability of critical medical products such as vaccines and diagnostic tests during a Public Health Emergency of International Concern (PHEIC).

In August 2024, the WHO urged mpox IVD manufacturers to submit expressions of interest for EUL, to strengthen global testing capacities amid the virus’s spread.

It has so far received three additional submissions for EUL assessment and is in discussions with other mpox IVD manufacturers to ensure a broader range of quality-assured diagnostic options.

This will aid countries that have not yet approved these medical products through their processes, allowing them to procure necessary tests through procurement partners and UN agencies.

The Alinity m MPXV assay EUL will remain valid as long as the PHEIC.

The WHO declared the end of the Covid-19 public health emergency in May 2023, which had been in place for more than three years.