COVID-19 Testing

Helping the fight against COVID-19 Confirm BioSciences are proud to offer a range of diagnostic and serological test devices as well as our network of lab solutions. Let us be your partner in helping your business, community or practice safely open and operate.

COVID-19 Testing FAQs

Are these COVID-19 Rapid tests FDA approved?

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

Confirm BioSciences is Healgen Scientific’s Largest Distributor in North America.

Are these COVID-19 Rapid tests CLIA waived?

Under the EUA our COVID-19 Testing Kit 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 Test
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.

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.

Does it test for both antibodies?

Yes, the test will detect both IgG and IgM. To find out more detailed product information and study results please fill out an interest form.

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

Can I be reimbursed for these by insurance?

Please check these two links:

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.

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 purchase our instant covid test . Our COVID-19 testing devices follow the highest quality standards. Interested in Instant Coronavirus Antigen Tests?

Warning

This test has been authorized by FDA under an EUA for use by authorized laboratories.

This test has not been FDA cleared or approved.

This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This product is intended for professional use and not for home use.

Not for the screening of donated blood.