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 SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), is detected in the saliva of an individual.
The test simply requires that an individual's saliva be deposited in a provided collection vial and sent back to our laboratories using the prepaid one-day shipping package. Specimens are typically processed within 24-48 hours of receipt at our laboratory and individuals can access their test results online through a two-factor authentication protected portal. Individuals have the option to speak with a licensed physician about their results.
Once your order has been confirmed, a kit will be shipped to your home for you to continue the collection process.
Testing performed by Clinical Reference Laboratory, Inc. Restrictions may apply. This test does not detect antibodies or immunity. It is designed to determine active infection with the virus that causes COVID-19.
Clinical Reference Laboratory, Inc. (CRL) offers this test and collection kit with an FDA Emergency Use Authorization. This means that while the laboratory performing this test has validation data to support offering this test and the collection kit, neither have 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 (i.e., the COVID-19 virus), 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 may modify or cease to offer the test and the test kit upon direction of state or federal regulators in its sole discretion. Please see the Patient Fact Sheet and the Health Care Provider Fact Sheet on CRL's website for additional information.