In the United States this is not an over-the-counter product for home use. The test must be administered by an FDA authorizedlaboratory medical professional with any and all appropriate prescription as required by law. Because the test is a POC (point of care) test that does not require sending samples to a lab, the results can be obtained on-site at a clinic. Laws in other countries may differ, please check your local laws and regulations as we are responsible that these tests are provided only to FDA authorized organizations, we will not be present to ensure that proper policies and procedures are implemented.
Generally yes. Factories are running non-stop and increasing production line capacity every day. For FDA approved clients our pipeline can supply quantities as small as 20 or up to several hundred thousand per week. For larger orders over 50,000 units please reach out directly so that we can discuss what you need and when.
It depends on your insurance provider. Please check with the appropriate provider to see if the test is covered under the applicable policy. Laboratory tests that are not conducted by the CDC may or may not be covered by insurance.
These kits are for in vitro diagnostic use and have been submitted for Emergency Use Authorization following guidance from the FDA on March 16, 2020. The tests have not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.
You can order here online or call (740) 837-8548. In either case we will need to follow up to verify your credentials with the FDA before officially taking your order or shipping product. If you are outside North America, please contact us as we have the supply line to get what is needed almost anywhere on the planet.
Yes. The FDA requires that any advertising or actual product specifically address this type of testing device. Specifically as found on the FDA website describing devices under Section IV.D:
-This test has not been reviewed by the FDA
-Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
-Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
-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.