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The iHealth Flu A&B/COVID-19/RSV Rapid Test 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 non-prescription home 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 and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

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 respiratory 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.

The iHealth Flu A&B/COVID-19/RSV Rapid Test and iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (both versions hereafter also referred to as the candidate device) are lateral flow immunoassay device intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens.

Two versions are available for this over-the-counter (OTC) test: one is labeled for lay-user use and one is labeled for professional use, both with identical designs. The candidate device detects antigens from influenza A, influenza B, SARS-CoV-2, and RSV in anterior nasal swabs collected from individuals exhibiting signs and symptoms of respiratory infection within the first six (6) days of symptom onset, when tested at least twice over a three-day period with a minimum of 48 hours between tests.

The device is validated for testing direct anterior nasal samples (ANS) without the use of transport media. The device does not utilize biotin-streptavidin or avidin chemistry.

The test card contains two test strips, each with a nitrocellulose membrane, enclosed in a plastic case. One test strip has four lines: three test lines (Flu A, Flu B, and CoV) and a control line (Ctrl), while the other test strip has two lines: one test line (RSV) and a control line (Ctrl).

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