Rapid Test Kit InteliSwab® Antigen Detection COVID-19 Rapid Test (OTC) Nasal Swab Sample 2 Tests per Kit, 24 Kits per Box
The InteliSwab COVID-19 Rapid Test OTC is 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
Product Specifications
Description
This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 18 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
This test is authorized for non-prescription home use with adult-collected nasal 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 18 years or older, or adult collected anterior nasal 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
The InteliSwab® COVID-19 Rapid Test does not differentiate between SARS-CoV-1 and SARS-CoV-2
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
Use at home or anywhere there is a flat surface
No professional supervision or video consultation required