Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test (OTC)

The Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza and SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should therefore seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

Key Benefits:

· Detect 3 viruses at once (SARS-CoV-2, Flu A&B)

· No repeat testing necessary (compared to EUA kits)

· Two result windows for easy readability.

· Shallow nasal swab sample collection.

· Suitable for 2+ years old.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

Specimen: Nasal Swab

Time to results: 15 minutes

Stability: 24 months

Storage: 36-86°F (2-30°C)

For in vitro diagnostic use.

For over-the-counter use.