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FAQ - Specification and Troubleshooting the iHealth COVID-19 / Flu A&B (3-in-1) Rapid Test (ICF-3000)

Updated
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INTENDED USE

 

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

This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four (4) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Results are for the simultaneous identification of SARS-CoV-2 influenza A virus, and influenza 8 virus protein antigens, but do not differentiate between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens.
 

The viral antigens targeted by this test are generally detectable from specimens collected using nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definitive cause of disease, Individuals who test positive with the iHealth COVID-19/Flu A&B Rapid Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
All negative results are presumptive and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2, influenza A, and influenza B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions such as isolating from others and wearing masks. Ne 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 SARS-CoV-2, influenza A, and influenza B 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.
 

The iHealth COVID-19/Flu A88 Rapid Test is only for use under the Food and Drug Administration's Emergency Use Authorization.

 

WARNINGS, PRECAUTIONS AND SAFETY INFORMATION
 

  • Read all instructions carefully before performing the test. Failure to follow the instructions may result in inaccurate test results.
     
  • For in vitro diagnostic use.
     
  • This test may only be used in symptomatic individuals.
     
  • In the USA, this product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner
     
  • Serial testing should be performed in individuals with SARS-CoV-2 negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals. You may need to purchase additional tests to perform this serial testing.
     
  • Consistent with serial testing recommendations for SARS-CoV-2, for multi-analyte tests, symptomatic individuals who test positive for influenza A or B on the initial test but test negative for SARS-CoV-2 should be tested again in 48 hours to evaluate for co-infection with SARS-CoV-2 infection.
     
  • An anterior nasal swab sample can be self-collected by an individual aged 14 years and older. Children aged 2 to 13 years should be tested by an adult.
     
  • Do not use on anyone under 2 years of age.
     
  • Wear a safety mask or other face-covering when collecting a specimen from a child or another individual.
     
  • Do not use if any of the test kit contents or packaging is damaged.
     
  • Test components are single-use. Do not re-use the test card, test tube, or swab.
     
  • If any liquid spills from the test tube, discard test components and re-start test using new test components.
     
  • Do not use the test kit after its expiration date shown on the external packaging.
     
  • Only use the nasal swabs provided in the kit.
     
  • Do not touch the swab tip prior to testing.
     
  • Wash hands thoroughly with water to remove all traces of soap. Exposure to liquid soap and hand sanitizer may cause false negative results with this test.
     
  • Ensure all kit components are at room temperature before use.
     
  • Once opened, the test device 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.
     
  • Eyewear protection is recommended.
     
  • Make sure there is sufficient light for testing. For best results, read test in a well-lit area.
     
  • Wash hands thoroughly for at least 20 seconds before and after handling nasal swab samples.
     
  • 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.
     
  • The test sample must be collected from both nostrils with the same swab.
     
  • Do not conduct this test if prone to nose bleeds or have a nose injury Injury Exposure to blood may cause false negative results with this test.
     
  • Keep testing kit and kit components away from children and pets before and after use.
     
  • Do not ingest any kit components.
     
  • 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 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 the test kit between 36-86 °F (2-30 °C) in a place out of direct sunlight.
     
  • Reagents and devices must be used at room temperature (65-86 °F/18-30 °C).
     
  • The unsealed test card is valid for 60 minutes. It is recommended to use the test kit immediately after opening. The expiration date is on the package.

LIMITATIONS

 

  • The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between October 2023 and February 2024. 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 COVID-19 and influenza and their prevalence, which change over time. 
     
  • 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 COVID-19 and influenza as compared to a molecular test, especially in samples with low viral load.
     
  • All antigen test negative results, for SARS-CoV-2 or influenza, are presumptive and confirmation with a molecular assay may be necessary.
     
  • If the test is positive, then proteins from the viruses that causes COVID-19 or influenza have been found in the sample and the individual likely has a respiratory infection with SARS-CoV-2 or influenza.
     
  • If you continue to have symptoms consistent with COVID-19 and influenza, and both your first and second tests are negative, you may not have COVID-19 or influenza, however, you should follow-up with a healthcare provider. Incorrect test results may occur if a specimen is incorrectly collected or handled.
     
  • This test is read visually and has not been validated for use by those with impaired vision or color-impaired vision.
     
  • Individuals who recently received nasally administered influenza A or influenza B vaccine may have false positive test results after vaccination.
     
  • The use of oral biotin supplements and use of biotin as a topical application may impact the performance of the test. Exposure to biotin may cause false negative results with this test.
     
  • Based on sequence analysis, a potential for cross-reactivity between the SARS-CoV-2 test and HKU1 exists. Wet testing for HKUT coronavirus was not conducted and therefore, cross-reactivity between SARS-CoV-2 and HKU1 coronavirus cannot be ruled out.
     

  • This device is a qualitative test and does not provide information on the viral load present in the specimen. Incorrect test results may occur if a specimen is incorrectly collected or handled.

     

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.

Information Source:COVID-19:Flu A&B Test (ICF-3000) Quick Start Guide 20250728.pdf

 

 

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