The LumiraDx SARS-CoV-2 Ag Quality Controls are liquid quality controls. The controls are specifically formulated and manufactured to ensure performance of the test and are used to verify the user’s ability to properly perform the test and interpret the results.It is the responsibility of each laboratory or healthcare setting using the LumiraDx SARS-CoV-2 Ag Test to establish an adequate quality assurance program to ensure the performance of the device under its specific locations and conditions of use.Quality control requirements should be followed in conformance with local, state, and federal regulations or accreditation requirements and the user laboratory’s standard quality control procedures.