[Audio Description] Note, all on-screen text is read aloud. QuidelOrtho logo appears.
 

[Narrator] QuidelOrtho. QuickVue® COVID-19 Test, User Instructions. For in vitro diagnostic use. Store at room temperature, 59°F to 86°F (15°C to 30°C).

Scan the QR code on the front of the instructions included in your test kit to get digital instructions and to download the QVue^® Mobile App, for a stress-free testing experience.
 

[AD] A red circle highlights a QR code in the left column of the QuickVue User Instructions. A smartphone shows a QVue, spelled Q V U E, app download page. The phone changes to the QVue home screen.
 

[Narrator] The QVue mobile app helps you interpret, save and share your results with: Visual step-by-step instructions to perform the test, guided test result interpretation steps, and options to save, share and send your result. Timing is essential for accurate test results. Therefore, we suggest using EITHER the guided app experience OR these printed instructions to perform the entire test procedure.
 

[AD] The User Instructions appear next to the QVue home screen.
 

[Narrator] The QVue mobile app has convenient built-in timers (but you cannot skip the countdown once initiated).
 

[AD] A red text box appears:
 

[Narrator] WARNING: Failure to follow the instructions may result in inaccurate test results.

Before you start testing, wash your hands or use hand sanitizer. Make sure your hands are dry before starting.
 

[AD] Hands rub together with bubbles under a running faucet.

Check the expiration date on the back of the box, in the bottom right corner with E-X-P next to it.
 

[AD] A purple QuickVue COVID-19 Test kit box appears and flips to the back side. A red circle highlights an expiration date in year-month-day format, printed in the bottom right corner as “EXP:2026-MAY-14”. A red text box appears:
 

[Narrator] WARNING: Do not use the kit past its expiration date.
 

Now find the kit components:
 

[AD] The box appears and opens from the small right side labeled “Open Here”. Test kit components slide out.
 

[Narrator] The tube holder, on the back of the box.
 

[AD] The back of the box appears, and a large purple arrow points to a perforated circle, labeled “Tube Holder”, near the bottom right corner above the expiration date.
 

[Narrator] A tube.
 

[AD] The tube is short and narrow with a wider, textured cap at the top and a small amount of fluid inside.
 

[Narrator] A test strip pouch.
 

[AD] The test strip pouch is a flat, rectangular foil pouch with text near the center, and an arrow at the top pointing to a tear line in the middle of one short end.
 

[Narrator] A swab pouch.
 

[AD] The swab pouch is a long, thin paper and plastic pouch with two flaps that peel apart at the top end near the swab handle.
 

[Narrator] And the strip placement card.
 

[AD] The strip placement card is a paper card with a dark stripe down the middle and a thin, rectangular outline in the center. The top, short edge of the card is labeled "Strip Placement Card".
 

[Narrator] A watch or timer will also be needed if you are not using the QVue mobile app.
 

[AD] A clock appears with text: “Not provided”.
 

[Narrator] If swabbing others, the use of disposable gloves and a mask are recommended.
 

[AD] Disposable gloves and a face mask appear with text: “Not provided. Recommended for swabbing others.”

Locate the hole for the tube holder on the back of the box.
 

[AD] The back of the box appears. A red circle emphasizes the tube holder in the bottom right corner.
 

[Narrator] Gently push the tube through the hole.
 

[AD] A hand places the tube upright in the tube holder.
 

[Narrator] Then remove the cap from the tube.
 

[AD] The hand twists the cap off of the tube.

Part A. Remove the swab from its wrapper.
 

[AD] The swab pouch appears. The paper and plastic peel apart from the top, then a hand removes the swab from the pouch by its thinner, stick end. The hand holds the swab by the handle, and a red text box appears:
 

[Narrator] WARNING: Be careful not to touch the head of the swab.
 

[AD] A red circle emphasizes the soft, rounded tip of the swab at the other end.
 

[Narrator] Part B. Gently insert the swab one half to three-fourths of an inch into the nostril, depending on the size of the person’s nose.
 

[AD] A hand inserts the swab tip into a person's nose.
 

[Narrator] Firmly rub the swab in a circular motion around the inside wall of EACH NOSTRIL at least 4 times.
 

[AD] The hand moves the swab tip in circles around the inside of one nostril 4 times. A red text box appears:
 

[Narrator] STOP: Be sure to rub BOTH nostrils with the SAME SWAB.
 

[AD] The hand moves the swab tip into the other nostril and repeats the circling motion 4 times.
 

[Narrator] NOTE: If you are swabbing others, please wear a face mask. With children, you may not need to insert the swab as far into the nostril. For very young children, you may need another person to steady the child’s head while swabbing.
 

[AD] A red text box appears:
 

[Narrator] WARNING: Failure to swab properly may cause false negative results.

Part A. Immediately place the swab into the liquid inside the tube. Ensure it is touching the bottom.
 

[AD] The open tube standing in the tube holder appears. A hand lowers the swab into the tube and pushes the tip all the way to the bottom.
 

[Narrator] Stir 3 to 4 times.
 

[AD] With the swab tip touching the bottom, the hand moves the swab in circles 3 times.
 

[Narrator] Part B. Leave the swab in the liquid for ONE MINUTE.
 

[AD] The hand leaves the swab tip at the bottom of the tube, and a 1-minute timer appears. A red text box appears:
 

[Narrator] WARNING: If the swab is in the liquid for more than 10 minutes, it should not be used.

Part A. After ONE MINUTE, remove the swab from the tube by rubbing the swab head against the inside wall of the tube, to squeeze out as much liquid as possible.
 

[AD] The 1-minute timer and swab in tube reappear. Then a hand presses the swab tip in circles against the walls of the tube several times while removing it.
 

[Narrator] Part B: Dispose of the swab in a trash container.
 

[AD] The hand drops the swab into a trash can.

Hold the test strip pouch with the arrow pointing up. Locate the notch in the middle of the pouch and tear straight down.
 

[AD] A hand holds the test strip pouch upright so the short end with a notch in the middle is at the top. Red circles emphasize the arrow pointing up and the notch. Another hand tears the pouch down from the notch, revealing the top end of a thin, rectangular test strip.
 

[Narrator] Hold the test strip as indicated, with arrows pointing down.
 

[AD] Fingers pinch the top end of the test strip and remove it from the pouch. Text and a bracket indicate “Hold here” for the top half of the strip, marked “QuickVue COVID-19”. On the bottom half, there is a blank white area, and a black area below it with arrows pointing down. A bracket appears on half of the strip with a red text box:
 

[Narrator] CAUTION: Do not touch the bottom half of the test strip.

Place the test strip into the tube with the arrows pointing down.
 

[AD] Holding the top of the test strip, the hand lowers the strip until it touches the bottom of the tube.
 

[Narrator] Leave the strip in the tube for a FULL 10 MINUTES.
 

[AD] A 10-minute timer appears. The strip rests at the bottom of the tube, and a red text box appears:
 

[Narrator] WARNING: DO NOT disturb or remove the strip during this timeframe. Inaccurate results can occur if the strip is disturbed or removed. Leave the strip in for AT LEAST 10 minutes, with the arrows pointing down.

At 10 MINUTES, remove the test strip from the TUBE.
 

[AD] The 10-minute timer and test strip in the tube reappear. Fingers pinch the top end of the strip and pull it up out of the tube.
 

[Narrator] Do not touch the bottom half of the test strip.
 

[AD] A red circle emphasizes the bottom half of the test strip. The white area near the middle of strip now shows a horizontal blue line above a pink line.
 

[Narrator] On a flat surface in good lighting, place the test strip exactly over the strip outline on the strip placement card included in the kit before reviewing the results.
 

[AD] The strip placement card appears. The hand places the test strip on the rectangular outline in the center of the card. The top end of the strip is under the card’s title. The card has a label that lines up with the blue line on the strip named “Control”, and another for the pink line named “COVID-19”. A red text box appears:
 

[Narrator] WARNING: Read the test strip right away! Do not read after 15 minutes. If the results are read after 15 minutes, the results may be inaccurate, and the test should be repeated.

Three types of results are possible. Check whether your result is positive, negative, or invalid by following the next steps. Please follow this table in the instructions when interpreting test results for COVID-19.
 

[AD] The view zooms to a table on the front of the user instructions in the top right corner, under Step 10.
 

[Narrator] Repeat testing is needed to improve accuracy. 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.
 

[AD] The table indicates how to interpret repeat testing results for COVID-19 if you have symptoms on the first day of testing. If the First Result Day 1 is positive, interpret results as positive. If the First Result Day 1 is negative, but a Second Result Day 3 is positive, interpret results as positive. If the First Result Day 1 and the Second Result Day 3 are both negative, interpret results as negative. A Third Result Day 5 is not needed.

A POSITIVE result must show BOTH a BLUE line AND a PINK line next to the blue line.
 

[AD] The middle of the test strip appears. It shows a blue line, for control, above a pink line, for COVID-19, near the middle of the white area. A red text box appears:
 

[Narrator] Look closely! Even a VERY FAINT, PINK COVID-19 line AND a BLUE control line is a POSITIVE result. Pink shading or a line near the labels on the strip is not considered a positive result.
 

[AD] Two more test strips appear, showing fainter blue Control and pink COVID-19 lines.
 

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

A NEGATIVE result will show a BLUE line, but NO PINK line.
 

[AD] The middle of a test strip appears. It shows only a blue line, for Control, near the middle of the white area with no pink line, for COVID-19, below it. A red text box appears:
 

[Narrator] STOP: To increase the chance that the negative result for COVID-19 is accurate, you should test again in 48 hours.

If there is NO LINE, or if there is ONLY a PINK line, the test is INVALID.
 

[AD] Two test strips appear. One shows no lines, and the other shows only a pink line, for COVID-19, near the middle of the white area with no blue line, for Control, above it.
 

[Narrator] Repeat the steps starting at the beginning using a new tube, swab and test strip.
 

[AD] A red text box appears:
 

[Narrator] STOP: If the second test is also invalid, call 833-QUICKVUE for assistance. That's eight three three, Q-U-I-C-K-V-U-E, or eight three three, seven eight four, two five, eight eight.

After the test is completed, dispose of all used test components in your household waste and wash your hands.
 

[AD] The opened pouches, tube, swab, test strip, and test strip placement card fall into a trash can.
 

[Narrator] For more information on the QuickVue COVID-19 Test, please visit quidelortho dot com slash quickvue or the instructions in your test kit.
 

[AD] The QuidelOrtho logo appears with a URL: Q U I D E L O R T H O dot com slash Q U I C K V U E.
 

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