Implication of variants on COVID-19 antigen test detection
Many stakeholders are concerned about the impact that emerging SARS-CoV-2 strains will have on diagnostic performance. One consideration of how the mutations in these strains will impact antigen test performance is dependent upon whether the test detects nucleocapsid (N) or spike (S) protein.
PATH is actively compiling publicly available data on target proteins and genes for SARS-CoV-2 antigen and molecular diagnostics, and manufacturer claims regarding a test’s ability to detect emerging strains of SARS-CoV-2. This dashboard focuses on antigen diagnostics and the listed information was compiled from product inserts, webpages, and outreach to manufacturers. For many of the antigen tests on the dashboard, the target protein(s) were not specified online and outreach to manufacturers did not yield a response.
Assumptions: Some data shown above may be presumptive based on the assay biochemistry and protein target as indicated in data provided by the manufacturer. While mutations in the s antigen are the most prevalent, very few antigen assays target this biomarker instead of focusing on the detection of the N antigen. Mutations have been reported in the N terminus of the N antigen though most assays target the C terminus and so are not anticipated to impact assay performance. Confirmation of performance via lab testing with clinical specimens representing each variant is recommended.
PATH would like to acknowledge the work of Dr. Leslie Scott and Lara Noble (MSc) from University of Witwatersrand’s Charlotte Maxeke Johannesburg Academic Hospital for their contributions to the development of the variant dashboards.
Explore other COVID-19 Diagnostics dashboards:
- Global availability of COVID-19 diagnostic tests
- Regulatory authorizations by country for COVID-19 diagnostic tests
- COVID-19 antigen diagnostic test pipeline
- Implications of variants on molecular test detection
- COVID-19 diagnostics procurement resource
- COVID-19 self-test dashboard
If you are a developer or manufacturer of one of these tests and would like to update your information, please reach out to DxCOVID@path.org.
Learn more about PATH's diagnostics program.