Intended use
The INDICAID® COVID-19 Antigen Quality Controls are intended for quality control testing performed on the INDICAID® COVID-19 Rapid Antigen Test. The Quality Controls provide users with assurance that the device is performing within specification.
The INDICAID® COVID-19 Antigen Quality Controls are external liquid quality controls. The controls are specifically formulated and manufactured to ensure that the test’s reagents and materials work and that the test procedure is correctly performed. The Quality Controls consist of positive and negative control samples that should be run once with every new lot, or shipment, using the test procedure provided.
- 5 x 250 μL single-use COVID-19 Antigen Positive Control Vials (non-infectious recombinant SARS-CoV-2 antigen in buffered solution with preservatives)
- 5 x 250 μL single-use COVID-19 Antigen Negative Control Vials (buffered solution with preservatives)
Summary and Explanation of the Test
It is the responsibility of each laboratory or healthcare operation using the INDICAID® COVID-19 Rapid Antigen Test to establish an adequate quality assurance program to ensure the performance of the test kit under its specific locations and conditions of use. Quality control requirements should be followed in conformance with local, state, and federal regulations or accreditation requirements and the user laboratory’s standard quality control procedures.
- For use under an Emergency Use Authorization (EUA) only for the duration of the COVID-19 declaration justifying the emergency use of in vitro diagnostics (IVD), unless it is terminated or revoked by the FDA (after which the test may no longer be used)
- CLIA number is required from all Purchasers of the tests
To review and download INDICAID® documentation, including Instructions For Use (IFU), Safety Data Sheet, FDA EUA, Fact Sheet for Healthcare Providers, Quick Reference Guide, FAQs, and more, please visit our website 'Download' section.
NOTE: Expiration Date: If you receive a box that has an expiration date that has passed, please do not be concerned. The FDA has granted an extended expiration life by 6 months from the expiration date printed on the back of the box for these tests. Read the FDA EUA Expiration Update document.
CLIA Information
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality. Learn more about CLIA.
Warnings & Precautions
- For in vitro diagnostic use only; refrigerate until ready to use.
- Quality Control Vials are for one-time use only. Do not reuse vials
- Exercise the normal precautions required for handling all laboratory reagents
- Do not swallow or inhale
- Avoid contact with your eyes. If contact occurs, flush with copious amounts of water immediately
Storage and Stability
- Store controls between 36 – 46°F (2°C and 8°C)
- Unopened controls that are stored between 2°C and 8°C (36 – 46°F) can be used until the expiration date. Do not use Quality Controls beyond the expiration date given on the label
- Quality Control Vials should remain sealed until ready for use
- Open a Quality Control Vial only when you are planning to perform a quality control test
Materials required but not provided
- INDICAID® COVID-19 Rapid Antigen Test Device
- INDICAID® COVID-19 Rapid Antigen Test Buffer Solution Vial
- INDICAID® COVID-19 Rapid Antigen Test Individually Wrapped Swab
- Timer
