CorDx COVID-19 Antigen Home Test Kit

The CorDx COVID-19 Antigen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus, delivering results in just 10 minutes.

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal (nares) swab samples from individuals aged two years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 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.

Kit Contents

1. Instructions
   • Quick reference instructions including step-by-step guidance on how to perform a test.
2. Test kit and workstation
   • Each test kit contains materials to perform 1 rapid antigen test. The workstation tube holder is located on the back of the test kit box.
3. Sterile swab
   • Individually wrapped, single use sterile nasal swabs. Avoid touching the swab tip (specimen collection area) when handling the swab.
4. Test cassette
   • The cassette is the test device. They are packaged individually.
5. Tube with sample processing solution

Test Preparation

1. Wash hands before testing.
2. Check the Expiration Date on the package. Do not use an expired test kit!
3. Remove the test cassette from the pouch and place it on a clean, flat surface.
4. Insert the tube in the pre-made hole on the back of the kit box.
5. Remove the foil from the top of the tube.