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Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing

Key Points
This guidance provides information on the regulatory requirements for SARS-CoV-2 point-of-care and rapid testing, collecting specimens and performing point-of-care and rapid tests safely and correctly, and information on reporting test results.
This guidance is intended for individuals and facilities who are setting up and performing point-of-care testing and is not intended for specimen self-collection and self-testing.

Tips for Using Rapid Antigen Tests
Below are links to documents for select SARS-CoV-2 specific antigen tests procured in large numbers by the U.S. government. Based on CDC experience with these tests, following these tips will help to ensure the tests are performed correctly.

CDC
Guidance – Proposed Use of Point-of-Care (POC) Testing Platforms for SARS-CoV-2 (COVID-19)
How to Use PPE While Testing Others
Safe Healthcare Delivery in All Settings – Recommendations of the Healthcare Infection Control Practices Advisory Committee

FDA
FAQs on Testing SARS-CoV-2
Emergency Use Authorizations For Medical Devices
How to Report Medical Device Problems

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