Respiratory Test Kit On/Go™ Antigen Detection COVID-19 At-Home Rapid Antigen Test Nasal Swab Sample 232 Boxes per Case / 2 Tests per Box

Features

• The on/go™ COVID-19 Antigen Self-Test has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA): https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• Ships with minimum 30 Days Dating
• The on/go™ COVID-19 Antigen Self-Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2
• This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
• This test is also authorized for non-prescription home use with adult-collected nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
• 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
• 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
• Detects the antigen protein of all known major COVID-19 variants of concern (including Delta and Omicron)
• Material required but not provided: Smartphone: iOS13 or newer / Android 10 or newer, Mobile App (Prior to testing, the user should download the free mobile application, on/go™ App, for iOS or Android smartphones)

More Information

• CareStart COVID-19 Antigen Home Test FDA EUA
• On/Go COVID-19 Antigen Self Test IFU
• On/Go COVID-19 Antigen Self-Test Individuals Fact Sheet
• On/Go COVID-19 Antigen Self-Test Healthcare Provider Fact Sheet
• COVID-19 Dec 2021 Variant Brief
• COVID-19 Antigen Self-Test Extension Confirmation Jan 20 2022
• On/Go COVID-19 Ag Self-Test Exp Date Extension Notification May 2022
• On/Go COVID-19 Ag Self-Test Exp Date Extension Notification August 2022