INTENDED USE
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.
WARNINGS AND PRECAUTIONS
- Do not use the test if you have had symptoms for more than 6 days or no symptoms at all.
- Do not use the test on anyone under 6 months of age.
- It is recommended that at least two adults are present to appropriately perform sample collection for ages Users aged 6 - 24 months.
- All viruses tested by this test can cause severe disease, especially RSV in infants and young children.
- Certain people should not use this test. These people could get much sicker very quickly or even die if they don't get medical help right away: persons showing signs or symptoms of ongoing severe disease, [e.g., short and shallow breathing, flaring of the nostrils or straining (retractions) of the chest or stomach while breathing, or turning blue around the lips and fingertips advance disease] infants born prematurely (birth before 29 weeks of gestation), certain types of congenital chronic lung or heart disease, neurologic or neuromuscular conditions especially those who have difficulty swallowing or clearing mucus secretions. If you or your child have any of these conditions, see a healthcare provider right away instead of using this test.
- Infants and young children can get hurt more easily when collecting the nose swab sample. If the swab is not used the right way, it could hurt the inside of the nose, causing nosebleeds. It could also mean not getting enough sample to test properly, which might provide the wrong test results.
- If your infant has received monoclonal antibodies (e.g., Clesrovimab-cfor), you may need a healthcare provider to interpret test results.
- This product is used only for the detection and differentiation of protein antigens from influenza A, influenza B, SARS-CoV-2 and respiratory syncytial virus (RSV), not for any other viruses or pathogens. This product does not detect influenza C.
- Test components are single use. Do not re-use the test card, extraction buffer tube, or swab.
- Do not touch the swab tip prior to testing. Accidental contamination can lead to inaccurate results. Repeat sample collection with a new test kit if swab head touches another surface.
- Wash hands thoroughly with water to remove all traces of soap. Exposure to liquid soap may cause false negative results with this test.
- Ensure all kit components are at room temperature before use.
- Once removed from the pouch, the Test Card should be used immediately.
- DO NOT read test results before 15 minutes or after 30 minutes. Results read before 15 minutes or after 30 minutes may lead to a false positive, false negative, or invalid result.
- Make sure there is sufficient light for testing. For best results, read test in a well-lit area.
- Keep the test device on a flat surface during the testing.
- Do not use any nasal sprays, gels or creams at least 30 minutes before you collect a nasal sample.
- Do not use this test if you have recently received a nasally administered influenza A or B vaccine.
- Do not use this test if you have recently used nasal fluticasone propionate.
- Do not conduct this test if prone to nose bleeds or have a nose injury.
- Remove any piercings from nose before starting the test.
- If you continue to have symptoms consistent with influenza, COVID-19, and RSV, you may not have influenza, COVID-19, or RSV, however, you should follow-up with a healthcare provider.
- All users should contact a healthcare provider if symptoms worsen.
- Keep testing kit and kit components away from children and pets before and after use.
- Do not ingest any kit components.
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The extraction solution contains harmful chemicals (see table in the next column). Avoid contact with your skin, eyes, nose, or mouth. If the solution contacts your skin, eyes, nose, or mouth, flush with large amounts of water. If you have a known skin allergy or are sensitive to the use of aminoglycosides, we recommend the use of gloves while performing the test. If irritation persists, seek medical advice: https://www.poison-help.org or 1-800-222-1222.
STORAGE AND STABILITY
- Store iHealth Flu A&B/COVID-19/RSV Rapid Test in a dry location between 36-86 °F (2-30 °C) out of direct sunlight.
- Ensure all test components are at room temperature (65-86 °F/18-30 °C) before use. It is stable until the expiration date marked on the packaging.
- The unsealed test card is valid for one hour. It is recommended to use the test kit immediately after opening.
- DO NOT FREEZE.
LIMITATIONS
- The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between November 2024 and November 2025. The clinical performance has not been established for all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of influenza, COVID-19, and RSV and their prevalence, which change over time. Additional testing with a laboratory-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
- A negative test result may occur if the level of antigen in the sample is below the detection limit of the test or if the sample is collected, handled or transported improperly.
- There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with influenza, COVID-19, or RSV as compared to a molecular test, especially in samples with low viral load.
- Positive results do not rule out co-infection with other respiratory pathogens.
- Persons with risk factors for severe disease from respiratory pathogens (e.g., infants and young children, elderly individuals, chronic lung disease, heart disease, compromised immune system, diabetes and other conditions) should contact a healthcare provider; users should also contact a healthcare provider if symptoms persist or worsen, (specially for individuals 6 to 24 months of age), independently of test results, or if you have any concerns.
- False positive test results are more likely when the prevalence of RSV, Flu A/B, and SARS-CoV-2, is low in the community.
- This test is read visually and has not been validated for use by those with impaired vision or color-impaired vision. Because test lines can be very faint, users with conditions affecting their vision- such as far-sightedness, glaucoma, or color blindness-are encouraged to seek assistance to interpret results accurately (e.g., reading glasses, additional light source, or another person).
- FluMist/FluMist quadrivalent live intranasal influenza virus vaccine may cause false positive influenza A and B results with this test.
- Fluticasone propionate at concentrations >10% v/v may interfere with SARS-CoV-2, Flu B, and RSV results.
- Hand Sanitizer (80% ethanol, fast drying) may cause false negative results with this test.
- This test does not differentiate between SARS-CoV and SARS-CoV-2 and does not detect influenza C.
- The performance of this test was evaluated with a limited number of RSV positive samples from individuals aged 60 years and older.
iHealth Customer Service
iHealth Customer Service Can be reached via phone at 1-855-816-7705 (Monday-Friday 8:30am to 5:30 PM PT) or via email at support@ihealthlabs.com. Self Help can be obtained 24 hours at the Help Center.