What does this test do and not do?
The iHealth COVID-19 Antigen Rapid Test is a lateral flow immunoassay device intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 virus. This test is intended to be used as an aid in the clinical diagnosis of active COVID-19. Do not use this test as the only guide to manage your illness.
Please consult a healthcare professional to discuss your results and if any additional testing is required.
Who should and should not use this test?
The iHealth COVID-19 Antigen Rapid Test is authorized for use with self-collected anterior nasal (nares) swab samples from individuals 15 years or older or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older. Do not use this test on anyone under 2 years of age or who is prone to nosebleeds or has had facial injuries or head injuries/surgery in the past six months.
How accurate is this test?
Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. However, due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a negative result when you have COVID-19 than a molecular test would. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU), available at https://www.ihealthlabs.com.
What if I have a Positive Test Result?
A positive result means that it is very likely you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. You should self-isolate from others and contact a healthcare provider for medical advice about your positive result.
What if I have a Negative Test Result?
A negative test result indicates that antigens from the virus that causes COVID-19 were not detected in your sample. However, if you have symptoms of COVID-19, and your first test is negative, you should test again in 48 hours since antigen tests are not as sensitive as molecular tests. If you have a negative result, it does not rule out SARS CoV-2 infection; you may still be infected and you may still infect others. It is important that you work with your healthcare provider to help you understand the next steps you should take.
What does an Invalid Test Result mean?
An invalid result means the test was not able to tell if you have COVID-19 or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and you should test again with a new test.
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 Test (ICO-3000) Quick Reference Instructions 202506.pdf