This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
The INDICAID™ COVID-19 Rapid Antigen Test is a non-invasive rapid point-of-care diagnostic test for the qualitative detection of SARS-CoV-2 antigen in respiratory specimens. Each INDICAID™ COVID-19 Rapid Antigen Test is single-use and can analyze one anterior nasal swab sample. The total time required to perform one test is approximately 20 minutes from clinical specimen collection to result.
The INDICAID™ COVID-19 Rapid Antigen Test is a type of test called an antigen test. Antigen tests are designed
to detect proteins from the virus that causes COVID-19. SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. Your
healthcare provider will work with you to determine how best to care for you based on your test result(s) along with your medical history, and your symptoms.
- Nasal swab specimens may be self-collected by the patient if the collection procedure is instructed and observed by a healthcare professional.
- Process the collected specimen immediately after collection.
- Use only the swab provided in the INDICAID™ COVID-19 Rapid Antigen Test Kit.
What is this rapid COVID test kit?
This rapid COVID test for sale is available to qualified healthcare professionals, as well as business owners looking to secure a supply of rapid COVID tests for onsite testing. This rapid test kit will give an easy to read result in about 10 minutes for an active COVID infection. This rapid test kit was also recently approved for a shallow nasal collection, making sample collection much more efficient and comfortable.
This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
|A line appears in regions (C) and (T)||Positive||The presence of both the control line (C) and line (T) indicates the presence of SARS-CoV-2 antigens. The result suggests current COVID-19 infection.|
|A line appears in region (C)||Negative||The presence of only the control line (C) and not the line (T) indicates no detection of SARS-CoV-2 antigens.|
|No line appears in region (C)||Invalid||If the control line (C) does not appear, the result is invalid, regardless whether the line (T) is present. Repeat the test with a new test kit.|
Each Kit Contains:
- 25 Test cassettes
- 25 Sterile swabs
- 25 Extraction buffer vials
- 1 Package insert and quick reference guide