CareSuperb™ COVID-19 Antigen Home Test - 2 Tests/kit

The CareSuperb COVID-19 Antigen Home 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 lateral flow test is FDA 510(k) cleared (K241915) for over-the-counter (OTC) use and provides visual results in just 15 minutes.

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.

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 either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out 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 symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

Performance characteristics for SARS-COV-2 were established from October 2023 to April 2024 when SARS-CoV-2 Omicron variant was dominant. Test accuracy may change as new SARSCoV-2 viruses emerge. Additional testing with lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.