What serology tests are being offered under the policy outlined in section IV.D of the Policy of Diagnostic tests?
A: As stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the 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:
This test has not been reviewed by the FDA.
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-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
To help ensure the above information is provided in the test report, as described in the guidance, commercial manufacturers could include this information in their Instructions for Use (IFU) or other labeling provided to laboratories.
This policy does not apply to at home testing.
The commercial manufacturers and laboratories in the two lists below have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. Unless an Emergency Use Authorization (EUA) has also been submitted and reviewed, the FDA has not reviewed the validation of tests offered by these developers, who may not be pursuing EUAs. FDA is including this list here to provide transparency regarding the notifications submitted to FDA.
Laboratories that have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D:
Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the laboratory's validation and issued an EUA for the laboratory's test, and the test is included in this list to provide transparency regarding the notifications submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing.
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Laboratory Authorization Status Settings for Use1
Access Medical Laboratories Not FDA Authorized H
Arrayit Corporation Not FDA Authorized H
Beaumont Health Not FDA Authorized H
BioDiagnostic Labs LLC Not FDA Authorized H
Bioreference Laboratories Inc. Not FDA Authorized H
Boston Heart Diagnostics Not FDA Authorized H
DLS Research & Ventures Not FDA Authorized H
EDP Biotech Corporation Not FDA Authorized H
Emory Medical Laboratories Not FDA Authorized H
HealthQuest Esoterics Not FDA Authorized H
IMMYLabs Not FDA Authorized H
Lenco Diagnostic Laboratory Not FDA Authorized H
Mayo Clinic Not FDA Authorized H
Michigan Health Clinics Not FDA Authorized H
Otogenetics Not FDA Authorized H
Roseland Community Hospital/American Medical Lab Not FDA Authorized H
University of Minnesota Advanced Research and Diagnostic Laboratory Not FDA Authorized H
US Specialty Labs Not FDA Authorized H
Vibrant America Clinical Labs Not FDA Authorized H
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