For all questions on the efficacy of the iHealth COVID-19 Antigen Rapid Test, if there is any doubt about the result of your test from either ongoing symptoms or exposure, please self isolate as if your result was positive and perform follow up testing as needed.
Statistics
The iHealth® COVID-19 Antigen Rapid Test when conducted by a lay user correctly identified 94.3% of positive samples.
Additionally, the iHealth® COVID-19 Antigen Rapid Test correctly identified 98.1% of negative samples.
More information can be found on page 13 in our Healthcare Provider Instructions for Use.
https://www.fda.gov/media/153923/download
More likely to give you a false negative result
This line from the back of the pack (box) refers to the accuracy of Rapid Antigen Tests compared to lab-based molecular tests, more commonly known as PCR tests. Rapid Antigen tests will be more likely to give you a false negative result, that is you may be positive but the test will show negative. Serial (repeat) testing is recommended to lower the chances of false negatives.
Too many drops
Too many drops should not affect the result of the test.
The only issue this may cause is slight oversaturation of the test strip and may cause wavy purple lines to show up on the test card window.
Any positive results from adding too many drops should be taken as positive.
Vaccines
Vaccines will not affect the test results of our iHealth COVID-19 Antigen Rapid Test.
The CDC website has a page about COVID-19 testing and this page contains a short section addressing this
https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html
"If a person has received a COVID-19 vaccine, it does not affect the results of their SARS-CoV-2 viral tests (nucleic acid amplification tests [NAAT] or antigen)."
Variant - Omicron
the iHealth COVID-19 Antigen Rapid Test can detect the Omicron variant.
The study performed in a third party CLIA Lab can be found at the bottom of this article.
Biotin
Biotin can cause false negative results.
A false negative is when you have the SARS-CoV-2 virus but the test taken shows negative.
Per the Health Care Provider Instructions for Use
"False negative results may occur in individuals who have indicated or whose clinical status or history would indicate they are currently taking high doses of biotin. Biotin levels of 1 µg/mL and greater have been demonstrated to result in false negative test results"
iHealth COVID-19 Antigen Rapid Test support page
https://ihealthlabs.com/pages/support-ihealth-covid-19-antigen-rapid-test
Health Care Provider Instructions for Use
https://www.fda.gov/media/153923/download
Throat Swab
Swabbing the throat does not fall in the 'intended use' of our tests, which means no clinical test of samples collected by swabbing the throat has been done to validate the performance of the product.
If a throat swab was recommended from your doctor, please follow their advice.