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iHealth Flu A&B/COVID-19 Rapid Test:

The iHealth Flu A&B/COVID-19 Rapid 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 protein 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, 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 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.

iHealth Flu A&B/COVID-19 Rapid Test Pro:

The iHealth Flu A&B/COVID-19 Rapid Test Pro 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 protein 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 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, 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 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 Rapid Test and iHealth Flu A&B/COVID-19 Rapid Test Pro is a lateral flow immunoassay device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens.

This over the counter (OTC) test has two versions, one labeled for self-testing use, the (iHealth Flu A&B/COVID-19 Rapid Test), and one labeled for professional use (iHealth Flu A&B/COVID-19 Rapid Test Pro) (generically referred to as iHealth Flu A&B/COVID-19 Rapid Test for the remainder of this document). Both versions of the iHealth Flu A&B/COVID-19 Rapid Test have an identical general design and are intended to separately detect antigen from influenza A, influenza B, and SARS-CoV-2 in anterior nares swabs from individuals with signs and symptoms of respiratory infection within the first five (5) days of symptom onset. The iHealth Flu A&B/COVID-19 Rapid Test is validated for testing direct anterior nares samples (ANS) without transport media. The iHealth Flu A&B/COVID-19 Rapid Test does not use biotin-streptavidin/avidin chemistry.

The test card in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with four lines: three test lines (Flu A line, Flu B line and SARS CoV-2 line) and a control line (Ctrl line).

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