The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2.

The CareStart™ COVID-19 Antigen Home Test is intended for home use to test anterior nasal (nares) swab samples that are self-collected by an individual aged 14 years or older or adult-collected from an individual aged 2 years or older within the first 7 days of symptom onset, including self-testing in a non-laboratory setting. The test is also intended for home use to test nares swab samples that are self-collected by an individual aged 14 years or older or adult-collected from an individual aged 2 years or older with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

The SARS-CoV-2 nucleocapsid protein antigen is generally detectable in nares swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the CareStart™ COVID-19 Antigen Home Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

Negative results should be treated as presumptive and confirmation with a molecular assay for patient management, may be performed if necessary. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of an individual s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.

For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of COVID-19, such as, an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.

Individuals who test negative and continue to experience COVID-like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care from their healthcare provider. Individuals should provide all results obtained with this product to their healthcare provider for public health reporting. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements.

The CareStart™ COVID-19 Antigen Home Test is authorized for self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older.