CRL Rapid Response™ is a saliva-based molecular test, which is authorized by the FDA under an Emergency Use Authorization (EUA), that can be self-collected and shipped to our lab when determined to be appropriate by a healthcare provider. Results of the test can confirm if the virus is detected in the saliva of an individual. Since no nasal swab is required, collection is minimally invasive and can be self-administered without the assistance of a healthcare worker.

Client provides supply order details.

Collection kits are shipped.

Upon receipt, client distributes to donors.

Donors follow kit instructions.



Register the kit and take a brief health survey online.


Complete specimen collection.


Return sample using the provided pre-paid envelope.

Results returned within 48 hours of receipt and posted to Frasco portal along with text notification to donor with link to results.

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 has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by Clinical Reference Laboratory, Inc. located in Lenexa, Kansas. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.