The World Health Organization added a molecular diagnostic test for Bundibugyo species Ebola virus to its Emergency Use Listing. The first test approved under the pathway is an RT-qPCR assay manufactured by Shanghai ZJ Bio-Tech, designed to detect and distinguish Ebola virus species including Bundibugyo. WHO said the EUL pathway supports UN agencies and governments during public health emergencies by establishing minimum standards for quality, safety, and performance of tests intended for use in lower- and middle-income countries. WHO also said three additional related tests are under evaluation for potential EUL inclusion. The listing comes amid an outbreak response in the Democratic Republic of the Congo and Uganda, which WHO described as a public health emergency of international concern declared in mid-May. WHO cited ongoing lab-confirmed case and death counts as of late last week. The decision also referenced an Africa CDC validation program that supports lab-based and near-point-of-care molecular diagnostics, along with rapid antigen tests, in partnership with groups including PATH, FIND, and Unitaid.
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