Who has also brought its diagnostic testing guide up to date to spot the new virus type and is teaming up with countries to put it into action. Before this, WHO put out product specs to help makers create new test kits.
On August 14, 2024, Dr Tedros Adhanom Ghebreyesus, WHO Director-General, said the rise of mpox in the Democratic Republic of the Congo (DRC) and more African countries poses a public health emergency of international concern (PHEIC) under the International Health Regulations (2005).
Companies that make IVDs are now asked to give WHO their available data on quality, safety, and performance as as they can. IVDs are tests done in labs to spot a pathogen. PCR (Polymerase Chain Reaction) testing to find viral DNA is the best way to diagnose mpox. It finds the virus’s DNA in samples from skin sores, like liquid or scabs from blisters or pus-filled bumps. Experts don’t suggest testing blood for regular diagnosis. Doctors might use methods to detect antibodies to classify past cases, but not to diagnose current ones.
The EUL procedure allows WHO to give the green light to medical products like vaccines, tests, and treatments. This process evaluates if specific products are okay to use for limited-time buying in emergencies. It helps countries that haven’t approved these medical products through their own systems to get essential items such as tests via UN agencies and other partners.
Mpox is a sickness that comes from the monkeypox virus, which belongs to the genus Orthopoxvirus. People can catch it by touching someone who has it coming into contact with contaminated stuff, or interacting with infected animals.
There’s a pressing need to make diagnostic services more available because tests play a key role in several vital steps. These steps include boosting lab capabilities, bettering case investigations, tracking contacts, gathering surveillance data, and reporting on time. Together, these steps allow countries to spot transmission chains, catch cases , stop further spread, and keep an eye on the virus as it happens. Setting up Emergency Use Listing procedures for mpox diagnostic tests will help move towards this goal.
