Model: ICR-3000P
- For professional use.
- For in vitro diagnostic use.
- For use with anterior nasal swab specimens.
INTENDED USE
The iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to influenza, SARS-CoV-2, and RSV can be similar.
This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months 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, SARS-CoV-2, RSV, or other pathogens.
Individuals who test negative and/or experience continued or worsening symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens. Test results should not be used as the sole basis for treatment or other patient management decisions.
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