Health authorities approve first smallpox diagnostic test for emergency use, boosting global access
The first diagnostic test for smallpox was listed for emergency use, an important development to expand access to smallpox screening globally. Manufactured by Abbott molecular, the “Alinity mpxv” test has been adopted to be pivotal in improving diagnostic capacity in countries with an outbreak of smallpox, where the need for fast and accurate tests is growing.
The ability to diagnose early enables faster delivery of treatment and care and control the spread of the virus. However, challenges such as limited testing capacity and delayed confirmation of cases remain in Africa, contributing to the continued spread of the virus. In 2024, more than 30,000 suspected cases were reported in the region, with the highest rates recorded in the Democratic Republic of the Congo, Burundi and Nigeria. In the Democratic Republic of Congo, only 37% of suspected cases have been tested this year.
The infection with the monkey pox virus is confirmed using DNA amplification techniques such as polymerase chain reaction, according to the provisional directions of diagnostic tests. Sampling of skin lesions is recommended to confirm infection in suspected cases.
The “alleniti mmpxv” examination is a real-time test for the detection of monkey pox virus DNA (clade I/II) from smears of skin lesions, intended for use in clinical laboratories by trained specialists. Thanks to this examination, suspected cases of chickenpox can be accurately and effectively confirmed from pustular or vesicular rash samples.
Dr. Yukiko Nakatani, Assistant Director General for the provision of medicines and health products, said that this listing is an important step towards enhancing the availability of tests in the affected areas, as the provision of high-quality medical products is essential in helping countries to limit the spread of the virus and protect their communities, especially in underserved areas.
Operation “Encyclopedia of life” seeks to accelerate the availability of life-saving medical products, such as vaccines, tests and treatments, in public health emergencies of international concern. And on August 28, 2024, manufacturers of smallpox virus detectors were invited to submit applications for interest in strengthening global testing capabilities, as the virus continues to spread. This process evaluates the quality and performance of essential health products, to guide international agencies and entities in making informed and emergency purchasing decisions.
The health authorities have so far received additional reports from three parties to evaluate the results of the study, and discussions are continuing with other manufacturers of virus detection devices to ensure a wider variety of reliable diagnostic options, to support countries in purchasing the necessary tests in cooperation with UN agencies and other procurement partners.
