Features
No COVID-19 variants were identified to impact the performance of INDICAID, including Delta and Omicron.
2 For 2+ Years Old
The self test 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 Serial Testing
This test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests.
4 FDA EUA
This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA.
Self Test Instructions
- 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
NegativeIf the control line (C) is visible, but the test (T) line is NOT visible, the test is negative
PositiveIf the control (C) line and the test (T) line are visible, the test is positive. Any faint visible red colored test (T) line with the control (C) line should be read as positive. No serial testing is required if you get a positive result at any point.
InvalidNo red-colored line next to the "C" means the test is invalid. Re-test with a new swab and a new test device.
- Test again in 48 hours if the individual has symptoms on the first day of testing.
- Test 2 more times at least 48 hours apart if the individual does not have symptoms on the first day of testing.
INDICAID Rapid Antigen Tests are 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 |
| Specimen Type | Direct Anterior Nasal Swab |
| Intended Use | The INDICAID® COVID-19 Rapid Antigen Test is intended for non-prescription at-home self test and/or as applicable an adult lay user testing another person 2 years of age or older in a non-laboratory setting. The INDICAID® COVID-19 Rapid Antigen Test is only for in vitro diagnostic use use under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved. |
| Storage Conditions | • 36º-86ºF (2-30ºC) • Do not freeze • Avoid direct sunlight |
| Shelf Life | 12 months |
| Accuracy | • Sensitivity 81.7% • Specificity 99.4% • Overall accuracy 93.4% |
Supplementary Information
FAQs
You can now get INDICAID for free!
Starting from January 15, most people with private health insurance coverage or covered by a group health plan can purchase an over-the-counter COVID-19 diagnostic test authorized by FDA at no cost, either through reimbursement or free of charge through their insurance. This applies to purchases from online, a pharmarcy or store.
As part of the requirement, insurers and plans would reimburse tests at a rate of up to $12 per individual test (or the cost of the test, if less than $12), and would cover 8 free tests per covered individual per month - meaning a family of four can get 32 tests per month for free.
For the detailed reimbursement policy, please contact your health plan providers or visit the CMS website.
A positive test result means that, it is very likely that 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.
A negative test result indicates that antigens from the virus that causes COVID-19 was 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 do not have symptoms and received a negative result, you should test at least two more times with 48 hours in between tests for a total of three 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.
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.