WHO grants Emergency Use Listing to first diagnostic test for Bundibugyo virus

The World Health Organization (WHO) has added the first molecular diagnostic test for the Bundibugyo virus (BDBV) to its Emergency Use Listing (EUL). The test, which identifies the virus's genetic material in blood samples, is intended to facilitate rapid and accurate infection confirmation during outbreaks.

The EUL procedure is used by the WHO to assess the quality, safety, and performance of health products, aiming to accelerate access to diagnostic tools in low- and middle-income countries. According to the organization, this listing assists governments and United Nations procurement agencies in selecting products for public health emergencies.

Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, stated that the listing is intended to provide confidence in the quality and performance of health products during fast-moving outbreaks. The WHO reports that the current BDBV outbreak is the largest on record, with 1,406 laboratory-confirmed cases and 438 deaths reported in the Democratic Republic of the Congo.

To support response efforts, the WHO and the Africa Centres for Disease Control and Prevention (Africa CDC) have expanded laboratory testing capacity from a limited number of sites to a network of 10 laboratories across affected provinces. This expansion has increased reported testing capacity to over 2,000 tests per day.

The WHO is currently reviewing additional applications for BDBV diagnostic tests. Furthermore, the organization is collaborating with partners, including Africa CDC, PATH, FIND, CHAI, and Unitaid, to establish a joint validation platform to evaluate the performance of various diagnostic products in outbreak settings.

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