False negatives are when you have SARS-CoV-2 but the test shows negative.
Negative results are presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
False negatives may occur with improper use of the test kit.
Improper uses include:
- Performing the test with insufficient testing solution
- Improper/insufficient swabbing of the nostrils
- Not stirring the swab in the solution
- Not squeezing the swab within the tube to express liquid
- Adding too few drops to the test card
- Reading the test card before 15 minutes or after 30 minutes
Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider.
Please self isolate per CDC recommendations if you are experiencing symptoms of COVID-19
The iHealth COVID-19 Antigen Rapid Test was compared to an FDA authorized molecular SARS-CoV-2 test using fresh self-collected or parent/guardian collected anterior nasal swab specimens and healthcare provider collected NP swab specimens. Subjects 2 years or older with or without symptoms participated in this study. The iHealth COVID-19 Antigen Rapid Test correctly identified 33 out of 35 (94.3%) of symptomatic positive samples and correctly identified 102 out of 104 (98.1%) of symptomatic negative samples in this study.
Reporting a false negative
If you believe that you are positive for COVID-19 but still tested negative using an iHealth COVID-19 Antigen Rapid Test, please email firstname.lastname@example.org with the following information
1. Photos of the outer box (the carton) and the front and back of the individual test kit packaging box. (UPC and lot number)
2. The date and time of your suspected false positive.
3. Any follow up test results? The types of tests those were, the dates and times those tests were taken and results received.
4. Where you purchased the test from, and if you have an order number and contact information for that purchase.