FAQs

Are the tests FDA cleared?

The PCR (24hr) Tests are FDA Cleared as these tests have been in existence prior to COVID-19

Regarding the Rapid (10min) Tests: On March 16, 2020, the U.S. government took an unprecedented step towards access to COVID-19 testing by allowing developers of certain tests to commercialize the products in the U.S. without the requirement for an FDA approval or Emergency Use Authorization (EUA). There are 3 scenarios:

1) No EUA Required – An EUA is not required if the test complies with four requirements issued by the FDA to administer the test (in most states). Some physicians fear to bill without an EUA.

2) EUA Issued – Our manufacturers have registered to receive the EUA status. The FDA is now requiring an independent study from either NIH or NCI before they will issue the EUA. The EUA is issued for two of our manufacturers, Healgen Scientific, and Premier Biotech.

3) FDA Cleared – Standard pre-pandemic process – Our manufacturers will be submitting applications to receive the 510K approval from the FDA for the permanent FDA clearance (the old standard process - which is a long process). This is separate from receiving a CLIA waiver. A CLIA waiver will allow an employer, restaurant, school, etc. to administer the test without a healthcare provider.

Are there any third-party validation studies on the accuracy of the rapid test manufacturers?

Yes. Healgen Scientific– ErasmusMC, a large lab in the Netherlands, validated the specificity to be 100% (see Articles #4 in the portal). Also, the National Institutes of Health (NIH) validated the specificity.

Premier Biotech – Stanford University did a 3,300 person case study and concluded that the specificity was 99.5%. Johns Hopkins also did a study and the results should be published the first part of May.

More details available upon request.

How long does it take to receive the test kits?

The PCR Test Kits typically arrive withing 10 days of order placement.

The Rapid Test Kits typically arrive within 7 days of order placement. Enrollment paperwork must be completed prior to ordering.