These tests are authorized by the FDA for emergency use as of May 29, 2020. On March 16th, 2020 the FDA published a guideline to cover this that can be found on the FDA website.

Under the EUA our COVID-19 Rapid Test is certified for use in high- and moderate-complexity laboratories.

To learn more, see the FDA’s guidelines.

If you require additional guidance, please contact your Local State or County Health Agency to ask for about using devices under emergency use authorization.

You can also review these links that might be helpful:

• Covered COVID-19 tests include all FDA-authorized COVID-19 diagnostic tests, COVID-19 diagnostic tests that developers request authorization for on an emergency basis, and COVID-19 diagnostic tests developed in and authorized by states.
• CPT Codes for COVID 19 Tests

Please review the product insert regarding what type of blood sample will be appropriate to use in your test.

Medical providers such as hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have appropriately trained personnel or medical supply distribution companies that currently sell medical products to these settings.

CLIA (The Clinical Laboratory Improvement Amendments) has established quality standards for all lab testing to ensure the accuracy, reliability, and timeliness of patient test results. Under CLIA, a lab is any facility that tests human specimens for a health assessment or to diagnose, prevent, or treat disease. Facilities that meet this definition must obtain CLIA certification to operate legally.

For more information, visit the CLIA Test Complexities page on CDC.gov or the CLIA Categorizations page on FDA.gov.

If you need help obtaining moderate- or high-complexity status during the COVID-19 pandemic, please contact us to learn about available CLIA Lab Umbrella resources.

Please fill out the form to request information regarding price, minimum quantity and payment terms applicable to the test you are looking for.