Emergency Use Listing (EUL) for candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2 remains ongoing.
On the 17th of March the scope of EUL was expanded to include SARS-CoV-2 AgRDTs intended for self-testing. Version 6 of “Instructions and requirements for Emergency Use Listing (EUL) submission: In vitro diagnostics detecting SARS-CoV-2 nucleic acid or antigen” has been updated to include requirements for the validation of SARS-CoV-2 AgRDTs intended for self-testing.
This Expression of Interest includes 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, 69 expressions of interest for NAT assays, 41 for antibody detection assays and 62 for antigen detection RDTs have been received. To date 30 products have been listed as eligible for WHO procurement based on their compliance with WHO EUL requirements. 60 products were not accepted for WHO EUL listing. The 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.