Features
No COVID-19 variants were identified to impact the performance of INDICAID, including Delta and Omicron.
2 For 2+ Years Old
The kit should not be used on children under 2 years old. For children age 2-13 years, nasal swab sample must be collected and tested by an adult.
3 FDA EUA
This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA.
Instruction
- Collect anterior nasal swab specimen
- Stir the swab into the buffer solution by twisting the swab back and forth 20 times
- Drop 3 drops of the buffer solution into the test device
- Read the results promptly in 20 minutes (results after 25 minutes should not be used)
Interpret Your Test Results
NegativeA line appears in the region (C)
PositiveA line appears in regions (C) and (T)
InvalidNo line appears in the region (C)
Available in 2-Test Packs & 12-Test Packs
Specifications
| Features | Specifications |
|---|---|
| Product Code | EUA220152 |
| Items Per Box | 2, 12 |
| NDC Numbers | • 60008-0407-80 (2-Test Pack) • 60008-0407-81 (12-Test Pack) |
| HSA/FSA | Eligible |
| SpecimenType | Direct Anterior Nasal Swab |
| Intended Use | The INDICAID® COVID-19 Rapid Antigen At-Home Test is intended for non-prescription self-use and/or as applicable an adult lay user testing another person 2 years of age or older. The INDICAID® COVID-19 Rapid Antigen At-Home Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. |
| Storage Condition | • 36º-86ºF (2º-30ºC) • Do not freeze • Avoid direct sunlight |
| Shelf Life | 12 Months |
| Accuracy | • Sensitivity 81.7% • Specificity 99.4% • Overall accuracy 93.4% |
Supplementary Information
FAQs
A positive test result means that the virus that causes COVID-19 was detected in your sample and it is very likely you have COVID-19 and are contagious. Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding self-isolation. There is a very small chance that this test can give a positive result that is incorrect (a false positive). Your healthcare provider will work with you to determine how best to care for you based on your test results along with medical history and your symptoms.
A negative test result indicates that antigens from the virus that causes COVID-19 were not detected from the specimen. A negative result does not rule out COVID-19. There is higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is higher chance this test will give you a negative result when you have COVID-19. If you test negative and continue to experience COVID-19 like symptoms of fever, cough, and/or shortness of breath you should seek follow up care with your healthcare provider.
If no control line shows up on the test, the result is invalid (even if any test line shows up). 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 the test should be run again, using all new test components.