CRL Rapid Response™ Saliva Test
CRL RAPID RESPONSE™ SALIVA TEST
NEWS!
FDA EUA Authorized to ship directly to donor and does not need to be overseen by a healthcare professional.
CRL RAPID RESPONSE™ is an FDA EUA Authorized saliva-based molecular test that is easily self-collected and shipped to Clinical Reference Laboratory (CRL) for lab testing. As of July 30, 2020, the FDA has authorized this test to be self-collected without being overseen by a healthcare professional!
Results are generally available within 48 hours and will confirm if the COVID-19 virus is detected in the saliva of the individual.
No nasal swab is required, collection is minimally invasive and can be reliably self-administered without the assistance of a healthcare worker.
Developer: Roche Molecular Systems, Inc.
Distributor: Clinical Reference Laboratory, Inc.
Dealer: Staff-Worthy
Test: Elecsys IL-6
Laboratory: Clinical Reference Laboratory, Inc.
This test has been authorized by FDA under an EUA for use by authorized laboratories; Emergency Use Authorization (EUA) request for distribution and/or use of the DNA Genotek OMNIgene® ORAL OM-505 saliva collection device for the collection and stabilization of saliva in buffer to transport viral SARS-CoV-2 RNA from patients suspected of COVID-19 by a healthcare provider. The specimen collection device is for use in conjunction with molecular diagnostic testing performed at a clinical laboratory using an in vitro diagnostic (IVD) test for the detection of SARS-CoV-2 that is authorized for use with the home collected kit. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner.
