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HEALGEN RAPID CHECK COVID-19/FLU A&B RAPID ANTIGEN TEST

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HEALGEN

RAPID CHECK

COVID-19/FLU A&B RAPID

ANTIGEN TEST

 

For in vitro diagnostic use.
For over-the-counter use.

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.

Specifications:

  • Specimen: Nasal Swab
  • Time to results: 15 minutes
  • Stability: 24 months
  • Storage: 36-86°F (2-30°C)

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