For in vitro diagnostic use

For Over-the-Counter Use

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 using self-collected anterior nasal swab samples from individuals aged 14 years or older with symptoms of SARS-CoV-2, influenza A, and influenza B infection within the first 5 days of symptom onset. This test is also intended for non-prescription home use with adult-collected anterior nasal swab samples from individuals 2 to 13 years of age with symptoms of SARS-CoV-2, influenza A, and influenza B within the first 5 days of symptom onset. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

Results are for the in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus protein antigens, but do not differentiate, between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens.

These viral antigens are generally detectable in anterior nasal swab specimens during the acute phase of infection. Individuals who test positive with the Healgen^® Rapid Check COVID-19/Flu A&B Antigen Test should self-isolate and seek follow-up care with their physician or healthcare provider, as additional testing may be necessary. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay, if necessary, for patient management. Negative results do not rule out influenza or SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control measures such as isolating from others and wearing masks. Negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with each respiratory infection. Individuals who test negative and continue to experience SARS-CoV-2 and/or influenza-like symptoms of fever, cough, and/or shortness of breath may still have SARS-CoV-2 and/or influenza infection and should seek follow-up care with their physician or healthcare provider. Individuals should provide all results obtained with this product to their healthcare provider for public health reporting and to receive appropriate medical care.

The performance characteristics of this test were established based on the evaluation of a limited number of clinical specimens collected during the 2023-2024 season. The clinical performance has not been established for all circulating variants but is anticipated to be reflective of the predominant variants in circulation at the time and location of the clinical evaluation. When other SARS-CoV-2 or influenza viruses are emerging, performance characteristics may vary.

The Healgen^® Rapid Check™ COVID-19/Flu A&B Antigen Test is intended for non-prescription self-use and/or, as applicable, an adult lay user testing another person 2 years or older in a non-laboratory setting.