CareStart™ COVID-19 Antigen Home Test - 2 Tests Each

The CareStart™ COVID-19 Antigen Home Test is a rapid, lateral flow immunoassay intendedfor the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens from individualswith or without symptoms or other epidemiological reasons to suspect a COVID-19 infectionwhen tested twice over two or three days with at least 24 hours and not more than 48 hoursbetween tests. This test is authorized for non-prescription home use with self -collected directanterior nasal (nares) swab samples from individuals aged 14 years or older or adult collectedanterior nasal swab samples from individuals aged 2 years or older.Click for Individual Fact Sheet Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The antigen isgenerally detectable in anterior nasal swab specimens during the acute phase of infection.Positive results indicate the presence of viral antigens, but clinical correlation with past medicalhistory and other diagnostic information is necessary to determine infection status. Positiveresults do not rule out bacterial infection or co-infection with other viruses and the agentdetected may not be the definite cause of disease. Individuals who test positive with theCareStart™ COVID-19 Antigen Home Test should self-isolate and seek follow-up care withtheir physician or healthcare provider as additional testing may be necessary.Negative results should be treated as presumptive and confirmation with a molecular assay forpatient 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 patientmanagement decisions, including infection control decisions. Negative results should beconsidered in the context of an individual’s recent exposures, history, and the presence ofclinical 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 witha close contact with COVID-19 or with suspected exposure to COVID-19 or in communitieswith 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 inindividuals without known exposures to COVID-19 or residing in communities with lowprevalence of infection.

Lateral flow assay Detect SARS-CoV-2 nucleocapsid protein antigen Rapid results within 10 minutes For use with direct anterior nasal and nasopharyngeal swab specimens Detects all known COVID-19 variants Comfortable lower nasal specimen collection Companion native app All-in-one package, including collection swabs