The ORAL RAPID™ Lateral Flow Antigen (LFA) test is a Laboratory Developed Test intended for the qualitative detection of SARS-CoV2 antigen from oropharyngeal swabs collected by a healthcare provider, qualified and trained clinical laboratory
personnel specifically instructed and trained in the techniques of collection and interpretation.
This Test must be utilized with LDT Compliance software & sold by high complexity laboratories. Additional information about Antigen Testing Guidelines can be found at https://www.cdc.gov/coronavirus/2019-cov/lab/resources/antigen-tests-guidelines.html
- Updated December 5th, 2020
This Test provides preliminary test results. Negative results don't preclude SARS-CoV-2 infectionand they cannot be used as the sole basis for treatment or other clinical management decisions. This test has not been FDA cleared or approved. Ongoing clinical evaluation and other information is available upon request.