The World Health Organization (WHO) has made an urgent appeal to manufacturers of mpox testing kits, known as in vitro diagnostics (IVDs), to join the Emergency Use Listing (EUL) process. This step comes as the global spread of mpox continues to rise, making reliable testing crucial for early detection, treatment, and preventing further transmission of the virus.
Increasing Need for Reliable Mpox Testing
Testing is key to managing the mpox outbreak, and the WHO has been proactive in distributing diagnostic tests worldwide. Since 2022, approximately 150,000 tests have been sent to different countries, with over 25% going to the African Region. More tests are on their way—an additional 30,000 are expected to be delivered to Africa in the coming weeks.
The Democratic Republic of the Congo (DRC) is particularly hard-hit, with around 1,000 new suspected mpox cases reported in just one week. To tackle this alarming rise, the WHO has been working closely with various organizations to boost the country’s testing capabilities. Since May 2024, six new laboratories have been set up, including two in South Kivu, specifically designed to test for the new Ib strain of the virus. These efforts have significantly improved testing in the region.
Updated Guidelines and Global Efforts
As the virus evolves, the WHO has updated its guidelines for mpox diagnostics to ensure the new strain is accurately detected. Countries are now being encouraged to implement these updated protocols to enhance their testing efforts. On August 14, WHO Director-General Dr. Tedros Adhanom Ghebreyesus declared the mpox situation in the DRC and other African countries a Public Health Emergency of International Concern (PHEIC).
PCR (Polymerase Chain Reaction) testing remains the most reliable method for diagnosing mpox. This test detects the presence of viral DNA in samples taken from skin lesions. By urging manufacturers to join the EUL process, the WHO aims to speed up the approval of essential medical products, especially in countries that lack strong national approval systems. This will make it easier for these countries to access the necessary diagnostic tools to combat the outbreak.
Understanding Mpox and Its Spread
Mpox is caused by the monkeypox virus and can spread through direct contact with an infected person, contaminated materials, or animals. Expanding access to testing services is critical for identifying, tracking, and controlling this growing public health threat, according to the WHO.
India’s Response to Mpox
In India, the situation is being closely monitored, with a total of 30 mpox cases detected so far. Unfortunately, one death occurred in Kerala in March. The Indian government confirmed that WHO declared mpox a PHEIC on August 14 due to the emergence of the new Clade Ib strain of the virus. This strain has caused concern worldwide, with 15,600 reported cases and 537 deaths this year alone. The virus has also spread to several African countries that had not previously reported mpox.
Symptoms and High-Risk Groups
Doctors advise that mpox should be suspected in individuals who develop symptoms like fever, headache, muscle pain, back pain, weakness, and fatigue, along with a skin rash. The rash typically starts in the mouth and tongue before spreading to other parts of the body. These symptoms are particularly concerning for those who have traveled to endemic regions or have been in contact with a suspected or confirmed mpox case. Swollen lymph nodes often accompany the condition. High-risk groups include immunocompromised individuals, children, the elderly, pregnant women, and those with multiple sexual partners.
Enhancing Testing in India
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. This lab is one of 35 across the country equipped to test suspected cases. The lab in Nagpur is fully equipped with the necessary kits and reagents, supplied by the ICMR-National Institute of Virology (NIV), Pune, and is now accepting samples for mpox testing.
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