Yemi Obafemi
The World Health Organization (WHO), has said the Alinity MPXV assay, a diagnostic test for mpox, for emergency use is part of their efforts in assisting countries to contain the spread of the virus.
WHO Assistant Director-General for Access to Medicines and Health Products, Dr Yukiko Nakatani stated this in a statement on as the organisation announced the first mpox diagnostic test listed under the Emergency Use Listing procedure.
He 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.”
According to WHO, the limited testing capacity has contributed to the spread of the virus.
The health organization said the approval of diagnostic test for mpox, it will enables the detection of monkeypox virus (clade I/II) DNA from human skin lesion swabs.
The statement read: “Limited testing capacity and delays in confirming mpox cases persist in Africa, contributing to the continued spread of the virus. In 2024, over 30,000 suspected cases have been reported across the region, with the highest numbers in the Democratic Republic of the Congo, Burundi, and Nigeria. In the Democratic Republic of the Congo, only 37 per cent of suspected cases have been tested this year.
“The presence of the monkeypox virus is confirmed by Nucleic Acid Amplification Testing, such as real-time or conventional Polymerase Chain Reaction, as stated in the WHO Interim Guidance on Diagnostic testing for the monkeypox virus. The recommended specimen type for diagnostic confirmation of monkeypox virus infection in suspected cases is lesion material.
“The Alinity m MPXV assay is a real-time PCR test that enables the detection of monkeypox virus (clade I/II) DNA from human skin lesion swabs. It is specifically designed for use by trained clinical laboratory personnel who are proficient in PCR techniques and IVD procedures. By detecting DNA from pustular or vesicular rash samples, laboratory and health workers can confirm suspected mpox cases efficiently and effectively.”
