Rapid Test Kit Clinitest® Antigen Detection At-Home OTC COVID-19 Test Anterior Nasal Swab Sample 5 Tests per Kit

Features

• The CLINITEST At-Home OTC COVID-19 Test is only for use under an FDA 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
• The CLINITEST® At-Home OTC COVID-19 Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen 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 anterior nasal (nares) swab samples from individuals aged 2 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 self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult-collected anterior nasal (nares) swab samples from individuals 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
• Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in anterior nasal (nares) swabs 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
• Individuals who test positive with CLINITEST® Rapid COVID-19 Antigen Self-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, if necessary, for patient management, may be performed
• 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
• Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
• 86.5% Sensitivity; 99.3% Specificity
• Qualitative; visually interpreted, no instrument required

More Information

• CLINITEST Rapid COVID-19 Antigen Self-Test FDA EUA Letter
• CLINITEST Rapid COVID-19 Antigen Self-Test Quick Reference Instructions
• CLINITEST Rapid COVID-19 Antigen Self-Test Healthcare Provider IFU
• CLINITEST Rapid COVID-19 Antigen Self-Test Healthcare Professionals Fact Sheet