CRL Covid-19 Testing

A saliva-based PCR 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.

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, KS. 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.

CRL offers a venipuncture serum antibody test that is administered by a health professional and shipped to the lab for testing. This Roche Elecsys Anti-SARS-CoV-2 test is authorized by the FDA under an Emergency Use Authorization (EUA). Results of antibody testing can confirm the presence, or lack of, COVID antibodies in the individual. All positive antibody tests should be reflexed to a molecular test to confirm if active virus is present.

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.