The WHO said that the list is intended to serve as a reference for countries to update or develop their own list of essential diagnostics.
With WHO prequalification, global health organizations can consider the Aptima HIV-1 Quant Dx for public-sector procurement in resource-limited countries.
The approval by WHO's Expert Review Panel for Diagnostics makes the test eligible for procurement by organizations that can access Global Fund and Unitaid resources.
The study is the first to demonstrate the design features and operational characteristics of Cepheid's Xpert MTB/RIF Ultra assay.
OraSure is experiencing strong international demand for its HIV self-test that's offsetting declining sales growth in the domestic HIV segment.
GHTC, an advocacy group, said that member nations must contribute needed financial resources so that WHO can implement an effective diagnostics guide.
The IGRA testing market is ballooning as industrialized nations try to curb the spread of tuberculosis, but the assays still fall short in certain settings and patient populations.
The essential diagnostics list — which may be available by early 2019 — has the potential to play an important role in guiding healthcare policies.
The Global Health Technologies Coalition said that an essential diagnostics list would spur innovation and make the correct diagnostic tests available where they are needed the most.
The kit is a qualitative nucleic acid assay designed to test for Zika, dengue, and chikungunya viruses simultaneously.