WELLlife COVID-19/Flu A & B Audio Described Video Transcript
(Audio Description) Note, all on screen information is presented through audio content. Text appears: “WELLlife COVID-19 slash Flu A and B, Home Test Instruction Guide.”
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 2-13 years should be tested by an adult.
Carefully review the instructions before performing the test. Failure to follow the instructions may result in inaccurate test results.
(Audio Description) Graphics and text appear: a player showing this video’s title screen with text “Instruction Video”, the word “or”, and the front page of this product’s Quick Reference Instructions with text “QRI”.
For more complete information, refer to the instructions for use, IFU, available online at wondfousa.com.
(Audio Description) W-O-N-D, F-O, U-S-A, dot com.
Materials Provided
A tube holder as part of the box.
(Audio Description) The back of the test box appears. A red outline highlights a perforated red circle labeled “Tube Holder” centered near the bottom, purple end. A QR code with a raised border is printed in the bottom right corner.
A sealed test cassette in a notched foil pouch.
(Audio Description) A rectangular pouch with tear notches in the long sides near one short end, and text labeling on the front.
An anterior nasal swab in a peel pouch.
(Audio Description) A swab in a narrow paper and plastic pouch with peel tabs by the thinner, stick end of the swab.
And a buffer tube with a twist cap.
(Audio Description) A cylindrical tube with fluid inside. It has a cap with two parts: a larger, blue, main body screwed onto the tube with a narrow dropper tip, and a second, smaller twist cap covering the tip.
Preparing for the Test
Do not open the test materials until ready for use.
(Audio Description) The front of the test box appears.
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 box rotates to the small, bottom end, showing text printed in two columns. On the left, manufacturing codes. On the right, from top to bottom: REF number, LOT number, and the expiration date as an hourglass symbol and 4-digit year, dash, 2-digit month, dash, 2-digit day. A red outline highlights the right column.
Wash your hands with soap and water for 20 seconds and dry them thoroughly, or use hand sanitizer.
(Audio Description) Hands wash with soap and water under a running faucet.
Locate the tube holder on the box. Look for the red circle on the kit’s box.
(Audio Description) The box, test cassette pouch, swab pouch, and tube appear. The view zooms to the perforated red circle on the large, back panel of the box.
Insert the buffer tube into the tube holder. Ensure that the buffer tube is stable and upright.
(Audio Description) The bottom of the buffer tube moves into the perforated red circle labeled “Tube Holder”.
Remove the large cap from the buffer tube and set it aside for later use.
(Audio Description) The entire two-part cap unscrews from the tube and is placed nearby.
Remove test cassette from sealed pouch and lay it on a flat surface.
(Audio Description) The short end of the rectangular foil pouch tears off at the notches, revealing the end of a test cassette. The flat, narrow, rectangular test cassette slides out and is placed nearby. The side with two indentations faces up.
Sample Collection
Remove the swab from the pouch.
(Audio Description) The narrow pouch peels apart from the tabs to expose the thinner, stick end of the swab. A red circle highlights the rounded swab tip on the opposite end, and a red text box appears:
Be careful not to touch the swab tip, which is the soft end, with your hand.
Carefully insert the swab no more than three quarters of an inch, 1.5 centimeters, into the nostril.
Slowly rotate the swab at least five times against the nostril wall.
(Audio Description) A face appears, and the entire swab head slides into a nostril and moves around the inside, making five circles. Red text box:
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 moves into the other nostril and moves around the inside, making five circles. Red text box:
Check, did you swab both nostrils?
If you are swabbing others, please wear a face mask.
(Audio Description) Icon of a face mask.
With children, the maximum depth of insertion into the nostril may be less than 1/2-3/4 of an inch, and you may require another adult to hold the child’s head while swabbing.
(Audio Description) Photo of a child’s nose. A swab appears over one nostril, showing that the entire swab tip does not fit inside.
Running the Test
Immerse the swab into the buffer tube and swirl the swab in the buffer. Ensure the sample is mixed thoroughly by making at least 10 circles.
(Audio Description) The swab tip moves into the tube and touches the bottom, then moves in circles against the sides of the tube several times. Red text box:
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) The test box reappears, with the tube standing in the tube holder. The swab is still inside the tube with the tip at the bottom. A timer counts down with text: “1 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.
Remove and discard the swab.
(Audio Description) Two arrows squeeze the tube around the swab tip, then the swab rises out of the tube and disappears.
Hold the buffer tube upright and screw the large cap back onto the tube. Ensure a tight fit to prevent leaking.
(Audio Description) The entire two-part cap appears and screws onto the tube.
Twist to open the small cap at the top of the tube.
(Audio Description) The smaller cap twists off the tube, uncovering the narrow dropper tip but leaving the larger main cap attached to the tube.
Invert the buffer tube and squeeze four drops of test sample into the sample well on the test cassette. Then discard the buffer tube.
(Audio Description) The tube flips upside down, and the test cassette appears below it. The tube’s dropper tip is just above a round indentation near the bottom end of the cassette. Four drops fall from the tip into the round indentation, then the tube disappears.
Note, incorrect results may be observed if less than four drops of sample are added.
(Audio Description) Red text box:
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 ten minutes.
(Audio Description) An icon of a 10-minute timer appears. Red text box:
Do not interpret results before 10 minutes or after 20 minutes. Inaccurate test interpretations may occur.
Interpreting Your Results
Look for lines next to C, F-A, F-B, and C-o-V.
(Audio Description) A test cassette appears, and the view focuses on the indented, rectangular results window near the middle. The window is labeled along the right side in an evenly spaced column from top to bottom: a letter “C”, “F dash A”, “F dash B”, and “C-o-V”. A horizontal, dark pink line appears across the window next to each of the four labels. A red circle highlights each line one by one:
C is the control line. F-A is the Flu A test line. F-B is the Flu B test line. C-o-V is the COVID-19 test line.
A red line should always appear at the C position. This is a control line and signals that the test is working properly.
(Audio Description) The lines next to F-A, F-B, and C-o-V disappear, and a red circle highlights the line next to the C at the top.
Invalid Result
Check to see if a pink to red line is visible at the control line, C, in the results window.
(Audio Description) Text: “If control line is missing — result is INVALID.”
If a line is not visible at C, even if any other line is visible in the results window, the result is considered invalid.
(Audio Description) Eight examples of the results window from the cassette appear with labels. Each window shows a different combination of 0, 1, 2, or 3 horizontal, dark pink lines, one line by each of the labels F-A, F-B, and/or C-o-V. An arrow highlights that none of the examples have a line by the C. Red text box:
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
If a control C line is visible, and you do not see a line at F-A, F-B, or C-o-V, it means the test is negative. The Flu A, Flu B, or COVID-19 virus have not been detected.
(Audio Description) A results window appears, showing only one, horizontal, dark pink line across the top by the C.
If respiratory symptoms persist, seek follow-up care with your healthcare provider.
Positive Result
If the control line at C is visible, and any other line or multiple lines on F-A, F-B, and/or C-o-V 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.
(Audio Description) Seven results windows appear, each showing a dark pink line across the top of the window by the C with a different combination of one, two, or three additional horizontal pink lines below it. Each line appears next to one of the other labels, F-A, F-B, or C-o-V.
Flu A Positive, showing two lines: one by C, and one by F-A just below that.
Flu B Positive, showing two lines: one by C, and one by F-B near the middle.
COVID-19 Positive, showing two lines: one by C, and one by C-o-V at the bottom.
Flu A, Flu B, and COVID-19 Positive, showing four lines: one by C, one by F-A just below that, one by F-B near the middle, and one by C-o-V at the bottom.
Flu A and COVID-19 Positive, showing three lines: one by C, one by F-A just below that, and one by C-o-V at the bottom.
Flu B and COVID-19 Positive, showing three lines: one by C, one by F-B near the middle, and one by C-o-V at the bottom.
Flu A and Flu B Positive, showing three lines: one by C, one by F-A just below that, and one by F-B near the middle.
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) WELLlife logo with a heartbeat symbol appears. The symbol spins once.
