Emergency Use Listing (EUL) for candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2 remains ongoing. WHO has expanded the scope of EUL to include SARS-CoV-2 AgRDTs intended for self-testing.
This Expression of Interest include the following product categories:
- IVDs for the detection of SARS-CoV-2 nucleic acid (multiplex assays, detecting more than one SARS-Cov-2 target).
- Rapid diagnostic tests for the detection of SARS-CoV-2 antigens intended for POC testing.
- Rapid diagnostic tests for the detection of SARS-CoV-2 antigens intended for self-testing.
The status of each application is updated weekly on our webpage. Thus far, 70 expressions of interest for NAT assays, 41 for antibody detection assays and 67 for antigen detection RDTs (inlcuding 5 AgRDT intended for sel-testing) have been received. This month we reached the 100 EUL decision mark, with 33 listed products and 67 products that were not accepted for EUL listing.
WHO EUL listing is time limited and is reviewed after 12 months, or earlier, if new information emerges which changes the risk/benefit assessment of the assay. In light of the continuing pandemic, we will contact manufacturers in the coming weeks/months regarding eligibility for renewal of their EUL listing.