The QuantiTASE Plus One Step RT-qPCR SARS-CoV-2 assay kit has been submitted to the FDA for Emergency Use Authorization (EUA application number: EUA200790) for use in conjunction with EUA Primer & Probes by CLIA laboratories certified to perform High Complexity testing and is awaiting final review by the U.S. Food and Drug Administration (FDA) for in vitro diagnostic use.
The FDA has made this test available in the USA under an emergency system called an Emergency Use Authorization (EUA).
The relevant EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of the virus that causes COVID-19.
This EUA is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
It is available for sale for IVD use in the United States only.
For other regions, please consider available Research Use Only (RUO) products.
MESSAGE FROM OUR PRESIDENT
We have been closely monitoring the COVID-19 pandemic. We are all experiencing some uncertainty about the near to mid-term future.
We wanted to take this opportunity to reassure you that Empirical Bioscience is considered an essential business and is still operating at full capacity.
For use in COVID 19 diagnostic assays it is recommended that these products be used in conjunction with an approved 2019-nCoV CDC EUA detection kit and the assay set up and run protocol should be as outlined by the CDC.