COVID-19 "Coronavirus" Rapid Test FAQs

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Published on Sep 2nd, 2020

COVID-19 "Coronavirus" Rapid Test FAQs

Are these tests FDA approved?

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.

The EUA classification allows for the test to be performed in a CLIA moderate- or high-complexity setting *

The tests offered by Confirm BioSciences are manufactured by our BioTech partner, Healgen Scientific LLC

For even more clarification-In Section D. of this guideline, the FDA states:

“......, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-C

Furthermore, on March 25th, 2020, during a town hall webinar, the FDA shared this slide to explain the different sections of the March 16th guideline. Our tests fit into the Policy C section of this guideline.

* Please defer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-19.

Are these tests CLIA waived?

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

How do I collect the blood sample?

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

Who can buy these tests?

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.

Can I be reimbursed for these by insurance?

Please check these two links:

Is my test setting moderate- or high-complexity?

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.

Do you ship to Mexico, Canada, or "XYZ country"?

Please contact your account rep or fill out the International form online to get information about shipping tests to Mexico, Canada or any other country.

Does it test for both antibodies?

Yes, the test will detect both IgG and IgM. To find out more product information please go to our website and fill out a form so we can provide you more information please.

Does it show if there was a recent infection?

Please check the Letter to Health Care Providers on the FDA website regarding use of serological tests.

What if someone tests positive?

Please check the Letter to Health Care Providers on the FDA website regarding use of serological tests.

What is the accuracy of these tests?

Please check the insert of the test you are using for the clinical data provided. If you would like, you can request the full clinical study from your account rep or using forms online.

What is the price of these tests?

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

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