INDICAID® COVID-19 Rapid Self Test
Rapid Antigen At-Home Self Test (OTC)
On January 11, 2023, the FDA granted a three-month shelf-life extension for the INDICAID COVID-19 Antigen Rapid Test, increasing its shelf life from 6 months to 15 months for longer usability.
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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.
Instructions
- 1Collect anterior nasal swab specimen
- 2Stir the swab into the buffer solution by twisting the swab back and forth 20 times
- 3Drop 3 drops of the buffer solution into the test device
- 4Read the results promptly in 20 minutes (results after 25 minutes should not be used)
We recommended that you use the INDICAID® COVID-19 Rapid Antigen At-Home Test kit if you are experiencing COVID-19 type symptoms, such as fever, cough, breathing difficulties, fatigue, and/or loss of smell or taste. We also suggest you utilize a COVID-19 test kit if you have been exposed to someone testing positive for COVID-19 (even if you are ‘asymptomatic’).
Testing is also useful before or after travel, or even just to provide you and your family ‘peace of mind’ as you go back to the office, back to school, or attend events with larger groups of people.
Anyone age 14 or older can self test using INDICAID® COVID-19 Rapid Antigen test kit on their own, and an adult (age 18 or older) should collect the nasal swab sample from children ages 2 to 13 years old and then perform the test on behalf of the child. Note that this test kit is not approved for use with children under the age of 2.
- Individuals at the highest risk include those aged 60 years and older, as well as individuals of any age who have underlying medical conditions such as high blood pressure, heart or lung disease, diabetes, or cancer. Nonetheless, it's essential to recognize that COVID-19 can affect anyone, irrespective of their health status, and can lead to severe illness, even in individuals who are generally considered healthy and low risk.
Since reimbursement policies vary from one insurance company to another, we suggest that you contact your health insurance company to determine their specific policy related to OTC (or At-Home) COVID-19 Rapid Antigen Test reimbursement. Our INDICAID® COVID-19 Rapid Antigen At-Home Test (OTC) is now eligible for HSA/FSA reimbursement.
The buffer solution contains two different reagents that are hazardous ingredients that should not be ingested. Please refer to the Instructions for Use (IFU) for more information. Keep testing kit and kit components away from children and pets before and after use. Avoid contact with your skin, eyes, nose, or mouth. Do not ingest any kit components. The reagent solution contains harmful chemicals (see table below). If contact to the skin or eye occurs, flush with large amounts of water. If irritation persists or any substances were ingested, seek medical advice: https://www.poisonhelp.org or 1-800-222-1222.
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.