Just weeks after urging vaccine manufacturers to submit Expressions of Interest (EOI) for Emergency Use Listing (EUL), the World Health Organization (WHO) has now called on manufacturers of mpox in vitro diagnostics (IVDs) to participate in the EUL process as the global burden of the disease grows.
Reliable testing is essential for early treatment and controlling the spread of the virus. Since 2022, WHO has distributed approximately 150,000 diagnostic tests worldwide, with over 25% allocated to countries in the African Region. An additional 30,000 tests are set to be delivered to Africa in the coming weeks.
The Democratic Republic of the Congo (DRC) is experiencing a sharp rise in suspected mpox cases, reporting around 1,000 new cases this week alone. To address this increase, WHO has partnered with various organizations to enhance diagnostic capacities, establishing six new laboratories since May 2024. This includes two labs in South Kivu, specifically equipped to handle the new Ib virus strain, which has significantly improved the nation’s testing capabilities.
WHO has updated its diagnostic guidelines to detect the new virus strain and is working with countries to implement these changes. On August 14, WHO Director-General Dr Tedros Adhanom Ghebreyesus declared the mpox situation in the DRC and other African nations a Public Health Emergency of International Concern (PHEIC).
PCR (Polymerase Chain Reaction) testing remains the primary method for diagnosing mpox, detecting viral DNA in samples from skin lesions. Through the EUL process, WHO aims to expedite the approval of critical medical products, helping countries with limited national approval mechanisms access necessary diagnostics.
Mpox, caused by the monkeypox virus, can spread through contact with infected individuals, contaminated materials, or animals. Expanding access to diagnostic services is crucial for identifying, tracking, and controlling this growing public health threat, the apex global public health agency said.
India steps up preparation
In India, a total of 30 cases of mpox have been detected to date with one death occurring in Kerala in March. The Union government stated that the WHO declared mpox a PHEIC on August 14 due to the emergence of a new strain of the virus: Clade Ib. This new strain has raised concerns because, this year alone, among 15,600 reported cases, there have been 537 documented deaths. It has also spread to several African countries that had not previously reported the disease.
Mpox should be suspected in a person who develops fever, headache, muscle pain, back pain, weakness, and/or fatigue, along with a skin rash that begins in the tongue and mouth before spreading to other parts of the body, as per doctors. This is especially pertinent for individuals who have traveled to endemic countries or come into contact with a suspected or confirmed case of mpox. The condition is also accompanied by swollen lymph nodes. High-risk groups include those who are immunocompromised, children, the elderly, pregnant women, and people with multiple sexual partners.
The Indian Council of Medical Research (ICMR) and the Department of Health Research (DHR) have designated AIIMS, Nagpur as a Regional Testing Centre for mpox, among the 35 laboratories across the country designated for testing suspected cases.
“The characteristic rash associated with mpox can be confused with other diseases more commonly encountered in clinical practice, such as chickenpox, syphilis, Varicella zoster, measles, scabies, and hand, foot, and mouth disease. Therefore, if the mentioned symptoms are observed along with a travel history to endemic areas or contact with a suspected or confirmed case, it is advised to seek medical assistance,” said Dr Prashant Joshi, Executive Director of AIIMS, Nagpur.
The laboratory is equipped with the necessary kits and reagents for mpox testing, provided by the ICMR-National Institute of Virology (NIV), Pune, and is currently accepting samples suspected of mpox.
“There is no need to panic, but precautions should be taken to prevent the disease from spreading, identify vulnerable groups, and determine the spreading strain type in the population,” Dr Joshi added.