The World Health Organization (WHO) has approved the first diagnostic test for mpox, amid rising outbreaks in Africa. The Alinity m MPXV assay, developed by Abbott Molecular Inc. is a real-time PCR test that detects mpox virus DNA from human skin lesion swabs. This approval is crucial in enhancing global diagnostic capacity and combating the spread of the virus.
More than 800 people have died from mpox across Africa, with 16 countries reporting cases. The African Union's disease control center notes that limited testing capacity and delays in confirming cases contribute to the virus's continued spread.
How The Test Works:
The approved test, known as the Alinity m MPXV assay, is a real-time PCR test developed by Abbott Molecular Inc.
It enables the detection of mpox virus DNA from human skin lesion swabs, providing a reliable and efficient means of confirming suspected cases.
This diagnostic tool is specifically designed for use by trained clinical laboratory personnel.
This assay is specifically designed for use by trained clinical laboratory personnel.
By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected mpox cases efficiently and effectively.
The approval of the test 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.Dr Yukiko Nakatani, Assistant Director-General, WHO (World Health Organization)
The WHO's Emergency Use Listing (EUL) procedure accelerates the availability of life-saving medical products, such as vaccines and tests, during public health emergencies. The WHO called on mpox IVD manufacturers to submit expressions of interest for EUL on August 28, recognizing the urgent need to enhance global testing capacities.
Impact and Next Steps:
Increasing access to quality-assured medical products is central to containing the spread of the virus. The WHO has received three additional submissions for EUL evaluation and is working with other manufacturers to provide more diagnostic options.
The WHO declared mpox a global public health emergency for the second time in two years in August, following an outbreak of the viral infection in the Democratic Republic of Congo, which has spread to neighboring Burundi, Uganda, and Rwanda.
The WHO is currently evaluating three more mpox diagnostic tests for emergency use Cases of the clade Ib type have been confirmed outside Africa, including Sweden, Thailand, and India. The international community must work together to enhance testing capacity, support affected countries, and contain the spread of mpox (previously known as monkeypox). The approval of the Alinity m MPXV assay is a critical step in this global response.
(Input From Various Sources)
(Rehash/Neha Kamble/MSM)