Intended Use

The CorDx COVID-19 Ag Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus. 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.

• FOR use under emergency use authorization (EUA) only.
• FOR in vitro diagnostic use only.
• FOR use with anterior nasal swab specimens.
• Shelf life：18 months

TEST PREPARATION

A. Wash hands before testing.

B. Check Expiration Date on the package. Do not use expired test kit! For most current shelf-life information of this test lot please refer to the following link: http://www.fda.gov/covid-tests

C. Remove the test cassette from the pouch and place it on a clean, flat surface.

D. Insert the tube in the pre-made hole on the back of the kit box.

E. Remove the foil from the top of the tube.

Test Procedure：

STEP 1: COLLECT SAMPLE

• Remove the swab from the pouch.
• Carefully insert the swab tip into one nostril about 1/2 to 3/4 inch. Firmly and slowly rotate the swab 5 times, brushing against the inside walls of the nostril to ensure both mucus and cells are collected.
• Using the same swab, repeat this process for the other nostril to ensure an adequate sample is collected from both nostrils.

STEP 2: PROCESS SAMPLE

• Insert the swab in tube to the bottom.
• Rotate the swab at least 10 times while pressing the swab head against the bottom and side of the tube.
• Remove the swab while squeezing the sides of the tube to express as much liquid as possible from the swab.
• Attach the dropper tip firmly onto the tube.

STEP 3: ADD SAMPLE

Gently squeeze the tube and dispense 3 drops of solution into the sample well.

STEP 4:READ RESULT

TEST INTERPRETATION

Results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.

COVID-19 Positive (+)

If the Control (C) line and the Test (T) line are visible, the test is positive. Any faint visible colored test (T) line with the control line (C) should be read as positive.

You do not need to perform repeat testing if you have a positive result at any time.

COVID-19 Negative (-)

If the Control (C) line is visible, but the Test (T) line is not visible, the test is negative.

To increase the chance that the negative result for COVID-19 is accurate, you should:

• Test again in 48 hours if you have symptoms on the first day of testing.
• Test 2 more times at least 48 hours apart if you do not have symptoms on the first day of testing.

Invalid

If the control (C) line is not visible, the test is invalid. Re-test with a new swab and new test device.