FAQ - Troubleshooting and Specifications for the iHealth COVID-19 Antigen Rapid Test (ICO-3000)

What is included in your iHealth COVID-19 Test (ICO-3000)

Before Usage

Check the expiration date on the outside of the box. 
Do not use beyond the expiration date. do not use if any of the test kit contents or packaging is damaged.

(Note: The GTIN and Lot No. will be specific to your test)

Occasionally, expiration date extensions may be granted by the FDA. Click here to see if there has been any extensions granted for your particular test lot number.

Intended Use

The iHealth COVID-19 Antigen Rapid Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19 within the first 6 days from symptom onset. This test is for non-prescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.

The iHealth COVID-19 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.

All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

The performance characteristics for SARS-CoV-2 were established from October 2022 to June 2023 when the COVID-19 variant Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g.. PCR) should be considered in situations where a new virus or variant is suspected.

Storage and operation conditions

Store iHealth COVID-19 Antigen Rapid Test in a dry place between 36-86 "F (2-30 °C). Ensure all test components are at room temperature 65-86 °F (18-30 °C) before use. It is stable before the expiration date marked on the packaging.

Possible Harmful Chemical Contact

The reagent solution contains harmful chemicals (see table below). If the solution contacts your skin, eyes, nose or mouth,  flush with large amounts of water. 

If irritation persists, seek medical advice: visit https://www.poison.org/contact-us 
or call 1-800-222-1222
 

Limitations

• 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 as compared to a molecular test, especially in samples with low viral load.
• The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between October, 2022 and June, 2023. 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 SARS-CoV-2 and their prevalence, which change over time.
• All COVID-19 antigen test negative results are presumptive and confirmation with a molecular assay may be necessary. If you continue to have symptoms of COVID-19, and both your first and second tests are negative, you may not have COVID-19, 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. Individuals with impaired vision or color impaired vision should ensure help in interpretation of their test results.
• 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.