COVID-19 antigen diagnostic test pipeline
This dashboard focuses on the antigen test pipeline. Antigen tests detect specific proteins made by the SARS-CoV-2 virus and are used to identify individuals with a current viral infection. Because most antigen tests are lower cost than molecular tests and can be conducted at the point-of-care, they offer a practical solution to support COVID-19 response efforts in LMICs.
- The funnel image provides a visual snapshot of the current antigen diagnostic pipeline and the natural attrition observed in attaining regulatory approvals and WHO TPP performance. Regulatory approvals are inclusive of emergency use authorizations and CE-IVD. SRA or Stringent Regulatory Authority [HO1] approvals and currently include US FDA, Canada (Health Canada), Japan (PMDA), and WHO EUL.
- The heat map table at the bottom lists all antigen tests and compares the sensitivity and specificity of each product against the WHO TPP. The first two columns represent the manufacturer’s reported claims on sensitivity and specificity; the last two columns represent the sensitivity and specificity as reported by an independent evaluation if one exists. Green represents tests that meet the requirements outlined in the WHO TPP, red represents the tests that do not meet the WHO TPP requirements, and gray indicates there is currently no publicly available data on that test.
- Details on the allowable sample matrix types (e.g. Nasopharyngeal swab, saliva, plasma, etc.) are also provided to guide product selection decisions related to specific test use cases.
Assumptions: This dashboard may not represent a comprehensive landscape of all independent evaluations reported. If one or more independent evaluations have occurred for a particular product, the product will be considered to meet WHO TPP if one independent evaluation resulted in performance aligned with the WHO TPP. If multiple time points for testing occurred, the average sensitivity and specificity was used to evaluate against the WHO TPP. Regulatory approvals are currently inclusive of emergency use authorizations and CE-IVD. SRA or Stringent Regulatory Authority approvals currently include US FDA, Canada (Health Canada), Japan (PMDA), and WHO EUL.
Explore other COVID-19 Diagnostics dashboards:
- Global availability of COVID-19 diagnostic tests
- Regulatory authorizations by country for COVID-19 diagnostic tests
- Implications of variants on antigen test detection
- Implications of variants on molecular test detection
- COVID-19 diagnostics procurement resource
- COVID-19 self-test dashboard
Please contactdxCOVID@path.org to provide data for inclusion in the dashboard or to report missing or inaccurate data.