This product is for in vitro diagnostic use, over-the-counter use, and use with anterior nasal swab specimens.

An anterior nasal swab sample can be self-collected by individuals aged 14 years or older.

Children aged 2 to 13 years should be tested by an adult.

Carefully review the instructions before performing the test.

(Audio Description) A visual of the QRI (Quick Reference Guide) and a screenshot of the Instruction Video are shown

Failure to follow the instructions may result in inaccurate test results.

For more complete information, refer to the

instructions for use, IFU, available online at wondfousa.com.

Materials provided.

(Audio Description) The test contents are displayed on screen. This includes the product’s box, with its included “Tube Holder”, a sealed test cassette, a nasal swab, and a buffer tube.

A tube holder as part of the box, a sealed test cassette in a notched foil pouch, an anterior nasal swab in a peel pouch, and a buffer tube with a twist cap.

Preparing for the test.

Do not open the test materials until ready for use.

If the test cassette is open for an hour or longer, invalid test results may occur.

Check the expiration date of the test printed on the right side of the outer box.

(Audio Description) The product box appears in the middle of the screen and rotates to show the expiration date printed on the right side of the box.

Wash your hands with soap and water for 20 seconds and dry them thoroughly, or use hand sanitizer.

(Audio Description) An animation of hands scrubbing under a faucet with plenty soap. Afterwards the box reappears on screen.

Locate the tube holder on the box.

(Audio Description) A circle appears on the screen to highlight the location of the tube holder on the top right corner of the box. It is a perforated hole that allows the buffer tube to easily rest upright.

Look for the red circle on the kit’s box.

Insert the buffer tube into the tube holder.

(Audio Description) The buffer tube is placed inside of the tube holder

Ensure that the buffer tube is stable and upright.

Remove the large cap from the buffer tube and set it aside for later use.

(Audio Description) The cap of the buffer tube is twisted off and placed to the side. The small cap that is connected to the top of the large cap is left attached to the large cap.

Remove test cassette from sealed pouch and lay it on a flat surface.

(Audio Description) The sealed cassette pouch is in the middle of the screen. The pouch is torn open and the test cassette is removed from it.

Sample Collection

Remove the swab from the pouch.

(Audio Description) The nasal swab pouch is opened and the swab is carefully pulled from it.

Be careful not to touch the swab tip, which is the soft end, with your hand.

Carefully insert the swab no more than 3 quarters of an inch, 1.5 centimeters, into the nostril.

(Audio Description) An illustration shows the swab going roughly 3/4ths of an inch into a nostril. It slowly rotates around the inside of the nostril to ensure adequate sample collection.

Slowly rotate the swab at least 5 times against the nostril wall.

Do not insert the swab any further if you feel any resistance.

Remove the swab and repeat in the other nostril using the same swab.

(Audio Description) The swab is taken out of the first nostril and placed into the other nostril. The same procedure is done with the second nostril as was done with the first.

Check, did you swab both nostrils?

If you are swabbing others, please wear a face mask.

(Audio Description) An illustration of a medical face mask (like an N95) is displayed in the center of the screen.

With children, the maximum depth of insertion into the nostril may be less than one half to three quarters of an inch, and you may require another adult to hold the child’s head while swabbing.

(Audio Description) An illustration of the swab demonstrates the depth used for a young child’s nostril.

Running the test.

Immerse the swab into the buffer tube and swirl the swab in the buffer.

(Audio Description) The swab is shown being inserted into the buffer tube and swirled around the inside of the tube for 10 turns. The buffer tube remains upright.

Ensure the sample is mixed thoroughly by making at least 10 circles.

Sample must be adequately mixed into the buffer, otherwise incorrect results may occur.

Leave the swab in the buffer tube for one minute.

(Audio Description) A timer shows on screen for 1 minute while the buffer tube is left in the tube holder on the box. The swab is left inside the buffer tube for the whole minute.

A timer is recommended for this step.

After one minute, pinch the tip of the swab from the outside of the tube to remove any excess liquid from the swab.

(Audio Description) The buffer tube is carefully lifted out of the tube holder, with the swab still inside of it, and the bottom of the buffer tube is pinched to squeeze the rest of the sample out of the swab’s tip.

Remove and discard the swab.

(Audio Description) The swab is thrown away.

Hold the buffer tube upright and screw the large cap back onto the tube.

(Audio Description) The large cap is screwed back onto the tube.

Ensure a tight fit to prevent leaking.

Twist to open the small cap at the top of the tube.

(Audio Description) The small cap is removed from the large cap, revealing the nozzle at the top of the large cap.

Invert the buffer tube and squeeze four drops of test sample into the sample well on the test cassette.

(Audio Description) Four drops of test sample are carefully squeezed into the sample well of the test cassette.

Then discard the buffer tube.

(Audio Description) The buffer tube is discarded.

Note, incorrect results may be observed if less than four drops of sample are added.

Sample must be applied to the test cassette within one hour of mixing the swab sample into the buffer tube.

Start a timer and read results at 10 minutes.

(Audio Description) An illustration of a timer shows 10 minutes

Do not interpret results before 10 minutes or after 20 minutes; inaccurate test interpretations may occur.

Interpreting your results

(Audio Description) A test cassette slides into view with focus on the results window of the test. Green circles appear highlighting the C, F-A, F-B, and CoV regions of the results window.

Look for lines next to C, F-A, F-B, and CoV.

(Audio Description) Red lines appear for each region of the results window.

C is the control line, F-A is the flu A test line, F-B is the flu B test line, CoV is the COVID-19 test line.

A red line should always appear at the C position.

(Audio Description) A red circle appears over the C region of the results window to highlight its importance for accurate results.

This is a control line and signals that the test is working properly.

Invalid result.

Check to see if a pink to red line is visible at the control line, C, in the results window.

(Audio Description) A series of results windows appear on screen to demonstrate the possible combinations of results that would be interpreted as NEGATIVE. It is every configuration of results that does not include a C line.

If a line is not visible at C, even if any other line is visible in the results window, the result is considered invalid.

If you do not see a C line, do not continue reading the results.

It means your test is invalid.

Repeat the test with a new sample and new test kit materials.

Negative result.

(Audio Description) A results window appears on screen showing only the C line present. All other regions are empty, which means the results are negative for all 3 of the tests.

If a control C line is visible and you do not see a line at F-A, F-B, or CoV, it means the test is negative.

The flu A, flu B, or COVID-19 virus have not been detected.

To increase the chance that the negative result for COVID-19 is accurate, you should test again in 48 hours after the first day of testing.

If respiratory symptoms persist, seek follow-up care with your healthcare provider.

Positive result.

(Audio Description) Seven results windows show up on screen to demonstrate the possible combinations that can correctly be interpreted as a POSITIVE result.

If the control line at C is visible and any other line or multiple lines on F-A, F-B, and or COV are visible, the test is positive for that virus.

Note, any pink to red test line, no matter how faint, should be considered a positive result when the control line is also present.

Consult your health care provider to discuss your positive test result.

Self-isolate at home per CDC recommendations to stop spreading the virus to others.

(Audio Description) The WELLlife logo appears on screen and then fades to black.