The World Health Organization (WHO) approved the first in vitro diagnostic for mpox for emergency use. According to the entity, the inclusion of the test in the Emergency Use Listing (EUL) is a step towards improving global access to testing for the disease and expanding diagnostic capacity in countries facing outbreaks.
The test, called Alinity m MPXV was manufactured by Abbott Molecular Inc. and works as a real-time polymerase chain reaction (RT-PCR) test that allows the detection of mpox virus DNA in its two variants (clade 1 and clade 2), the from the use of swabs on skin lesions of those infected. It is specifically designed for use in a trained clinical laboratory proficient in PCR techniques and in vitro diagnostic procedure.
By detecting DNA from rash samples, laboratory and healthcare professionals can confirm suspected cases of mpox efficiently and effectively.
“This first mpox diagnostic test listed under the Emergency Use Listing procedure represents a significant milestone in expanding the availability of tests in affected countries,” says Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, in press release. “Increasing access to quality-assured medical products is essential to our efforts to help countries contain the spread of the virus and protect their people, especially in underserved regions.”
By 2024, more than 30,000 suspected cases of mpox had been reported in Africa, according to the WHO, with the highest numbers reaching the Democratic Republic of the Congo (DRC), Burundi and Nigeria. In the DRC, only 37% of suspected cases have been tested this year. Approval of the test for emergency use could speed up the confirmation of cases, allowing for early treatment and greater control of the spread of the virus.
On August 28 of this year, the WHO requested that manufacturers of in vitro diagnostic tests submit an expression of interest to EUL, recognizing the urgent need to bolster global testing capabilities as the virus continues to spread.
According to the entity, the EUL process evaluates the quality, safety and performance of essential health products, such as diagnostic tests, to guide procurement agencies and WHO member states in making informed decisions for limited-time emergency procurement. .
To date, the WHO says it has received three additional submissions for EUL assessment, and discussions are ongoing with other mpox test manufacturers to ensure a wider range of quality-assured diagnostic options.
This content was originally published in Mpox: WHO approves first diagnostic test for emergency use on the CNN Brasil website.
Source: CNN Brasil
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