Products

Intended 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 a 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.

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

Product information

How to use

  1. Wash hands, check expiration date, set up tube holder.
  2. Insert swab ≤3/4 inch (1.5 cm) into nostril, rotate ≥ 5 times for ≥ 15 seconds per nostril.
  3. Swirl swab in prefilled extraction tube, making ≥ 6 circles, leave for 1 minute, squeeze out liquid.
  4. Add 8 drops to cassette, start timer. Read at 15 minutes.

Key features

  • 3-in-1 detection to differentiate COVID-19, Flu A, and Flu B.
  • Anterior nasal swab, results shown after 15 minutes.
  • Do not read before 15 or after 20 minutes.
  • Over the counter(non-prescription): self-testing for ≥14 years.
  • Adult supervision for ages under 14.
  • Not Suitable for ages under 2.

Result interpretation

  • Positive: Any T line at COVID / Flu A / Flu B, with C lines present on both strips → consult a healthcare provider.
  • Negative (presumptive): C lines present, no test lines → if symptoms persist or worsen, seek follow-up, a molecular test may be appropriate.
  • Invalid: Missing C line on one or both strips → retest with a new kit.

Packaging information

What’s in the box  :

  • Cassette(s),
  • sterile nasal swab(s),
  • prefilled extraction tube(s) with Tips,
  • QRI, and tube holder

Storage & stability 

Store at 2–30 °C out of direct sunlight. Once unsealed, use cassette within 1 hour.