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
Ships with minimum 30 Days Dating
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
