By purchasing this product, you agree that you have carefully read and understood the Terms & Conditions listed below. Freedom For All Diagnostics™, Inc. assumes no liability for testing performed out of compliance with the United States Department of Health and Human Services/Center for Medicare and Medicaid Services’ regulatory standards and requirements, including but not limited to the test being performed in settings not compliant with the Clinical Laboratory Improvement Amendments (CLIA).
- This test is administered by a licensed medical provider with a National Provider Identification (NPI) number in compliance with CMS/CLIA requirements.
- The healthcare provider will administer the test at the point-of-care or in a laboratory with appropriate CLIA designation. This test is not for home testing.
- The healthcare provider is responsible for following the directions for proper use of the test as described in the label and packaging.
- Test has not been reviewed by the FDA, but the manufacturer has notified the FDA and has validated the accuracy of the test and has met the requirements under FDA’s “Policy D” of the March 16, 2020 guidance for serology tests that allow the test to be marketed and distributed in compliance with the law of the United States. The manufacturer has submitted for an Emergency Use Authorization with the FDA for the SARS-CoV-2 IgM/IgG Antibody Assay Kit (Immunochromatography).
- 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 test 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 shown due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- The test manufacturer has provided assurance the test has been properly validated.
