WHO Approves The First Mpox Diagnostic Test

The World Health Organization (WHO) has approved the first mpox diagnostic test for use in emergency situations to expand access across the globe.

An important step in expanding global access to mpox testing is the organization’s listing of the first mpox in vitro diagnostic (IVD) under its Emergency Use Listing (EUL) procedure.

The Abbott Molecular Inc.-developed Alinity m MPXV assay’s approval for emergency use will be crucial to expanding diagnostic capacity in countries experiencing mpox outbreaks, where the demand for quick and accurate testing has skyrocketed.

Especially when an early diagnosis of mpox allows for prompt treatment, care, and virus control.

In Africa, the virus continues to spread because of a lack of testing capacity and delays in confirming cases.

Over 30,000 suspected cases have been reported in the region by 2024, with the Democratic Republic of the Congo, Burundi, and Nigeria reporting the most. This year, only 37% of suspected cases have been tested in the Democratic Republic of the Congo.

As stated in the WHO Interim Guidance on Diagnostic testing for the Monkeypox Virus (MPXV), nucleic acid amplification testing (NAAT), such as real-time or conventional polymerase chain reaction (PCR), is used to confirm the presence of the monkeypox virus.

Additionally, lesion material is the type of specimen that is recommended for diagnostic confirmation of MPXV infection in suspected cases.

Human skin lesion swabs can be tested for monkeypox virus (clade I/II) DNA using the Alinity m MPXV assay, a real-time PCR test. It was made to be used by trained clinical laboratory workers who are familiar with IVD and PCR procedures.

Laboratories and healthcare professionals are able to quickly and effectively confirm cases of suspected mumps by detecting DNA in pustular or vesicular rash samples.

“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.”, says Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.

In the context of a Public Health Emergency of International Concern (PHEIC), the EUL process accelerates the availability of life-saving medical products like vaccines, tests, and treatments.

As the virus continued to spread, the World Health Organization (WHO) issued a call to manufacturers of mpox IVDs to submit expressions of interest for EUL on August 28, 2024. The WHO recognized the urgent need to increase global testing capacities.

How To Protect Yourself And Others Against Mpox

In order to assist procurement agencies and WHO Member States in making educated decisions regarding time-limited emergency procurement, the EUL process evaluates the quality, safety, and performance of essential health products like diagnostic tests.

In order to ensure a wider variety of quality-assured diagnostic options, WHO has received three additional submissions for EUL evaluation, and discussions with other manufacturers of mpox IVDs are ongoing.

This will help countries that haven’t approved the medical products through their own processes get the tests they need from UN agencies and other partners.

As long as the PHEIC, which justifies the emergency use of mpox in vitro diagnostics, remains in effect, the Alinity m MPXV assay’s EUL, which allows for its use, will remain in effect.