FDA Emergency Use Authorized

Coronavirus (COVID-19) Antibody Rapid Test Kit.

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Effective Test Kits

Coronavirus (COVID-19) Instant Test Kits

  • FDA Emergency Use Authorization (EUA)
  • Rapid results within 10 minutes
  • Small sample size
  • Sold in packs of 25
  • Shelf life of up to 24 months from manufacture date
  • Test to be performed in a CLIA moderate- or high-complexity setting *
  • Verification of use case prior to shipping is mandatory

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.

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SOURCE : FDA 

Scientific Evaluation

Negative:

The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.

IgM Positive:

The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.

IgG Positive:

The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies

IgG and IgM Positive:

The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.

Invalid:

Control line is partially red, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Interpretation of Results

Know More

Frequently Asked Questions

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 : 

American Brands LLC is an authorized distributor for Healgen Scientific’s.

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?

Only Medical providers such as Laboratories, hospitals, physician offices, urgent care, outreach clinics, and temporary patient care settings that have an active CLIA Moderate or high complexity license and appropriately trained personnel or medical supply distribution companies that currently sell medical products to these settings –  a PO with CLIA ID number should be provided to backup each order-. 

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.

Can I be reimbursed for these by insurance?

Please check these two links:

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

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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