GENEYE® Monkeypox Virus ERA Assay: A Response to WHO's Call for Action to Benefit African People
update time:2024-09-03 Reading times: 78 +
update time:2024-09-03 Reading times: 78 +
WHO has asked manufacturers of mpox in vitro diagnostics (IVDs) to submit an expression of interest for Emergency Use Listing (EUL). WHO has been in ongoing discussions with manufacturers about the need for effective diagnostics, particularly in low-income settings. The request for EUL expressions of interest by manufacturers is the latest development in these discussions.
Testing is key for people to get treatment and care as early as possible and prevent further spread. Since 2022, WHO has delivered around 150 000 diagnostic tests for mpox globally, of which over a quarter have gone to countries in the African Region. In the coming weeks, WHO will deliver another 30 000 tests to African countries.
With as many as 1000 suspected cases reported in the Democratic Republic of the Congo alone this week, the demand for diagnostic tests is on the rise. In this heavily affected country, WHO has worked with partners to scale up diagnostic capacity to respond to the upsurge of cases. Since May 2024, six additional labs have been equipped to diagnose mpox, enabling a decentralization of testing capacity from major cities to affected provinces. Two of these labs are in South Kivu, selected to respond to the outbreak of the new viral strain, called Ib. Thanks to these efforts, testing rates have dramatically improved in the country, with four times as many samples tested in 2024 so far as compared to 2023.
WHO has also updated its diagnostic testing guidance to detect the new virus strain and is working with countries to roll it out. Earlier, WHO issued target product profiles to guide manufacturers in the development of new diagnostic tests.
WHO Director-General Dr Tedros Adhanom Ghebreyesus declared on 14 August 2024 that the upsurge of mpox in the Democratic Republic of the Congo (DRC) and in a growing number of countries in Africa constitutes a public health emergency of international concern (PHEIC) under the International Health Regulations (2005).
Expanding access to diagnostic services is urgently needed as tests are essential to critical measures such as strengthened laboratory capacity, improved case investigation, contact tracing, surveillance data collection, and tly reporg.
GENEYE® Monkeypox Virus ERA Assay is designed with specific primers and probes targeting the conserved region of Monkeypox species, generating fluorescence signals on a constant temperature nucleic acid amplification instrument. By employing POCT detection, it realizes qualitative and genotypic identification of Monkeypox at the nucleic acid level.
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