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The CorDx Tyfast COVID- 19 Ag Rapid Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. The CorDx Tyfast COVID- 19 Ag Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. The performance characteristics for SARS-CoV-2 were established from September, 2023, to December, 2023, when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected. The CorDx Tyfast COVID-19 Ag Rapid Test is intended for non-prescription self-use and/or as applicable an adult lay user testing another person 2 years of age or older in a nonlaboratory setting.

The CorDx Tyfast COVID-19 Ag Rapid Test is a rapid, immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 from anterior nasal swab specimens. This test does not differentiate between SARS-CoV and SARS-CoV-2. The test kit includes the: test cassette, swab, tube with sample processing solution, tube holder (back of the box) and the Quick Reference Instructions (QRI). The test strip enclosed in a cassette housing is comprised of the following components: sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains colloidal-gold conjugated with a monoclonal antibody against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibody for the nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic cassette. When the sample extract is added into the sample well, conjugates dried onto the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 nucleocapsid antigen is present in the sample, a complex formed between the anti-SARS-2 conjugate and the viral antigen will be captured by the specific anti-SARS-2 monoclonal antibody coated on the test line region (T). Absence of the test line (T) suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.