Intended Use
This product is used only for the detection and differentiation of protein antigens from influenza A, influenza B, SARS-CoV-2 and respiratory syncytial virus (RSV), not for any other viruses or pathogens. This product does not detect influenza C.
- For over the counter use.
- For in vitro diagnostic use.
- For use with anterior nasal swab specimens.
** For a full list of warnings and precautions, please read the quick start guide included in the box.
Video Instructions
Scan the QR code to access the video tutorial.
BEFORE GETTING STARTED
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Check the expiration date on the outside of the box.
Do not use beyond the expiration date. do not use if any of the test kit contents or packaging is damaged. -
Wash your hands with soap and water for 20 seconds and dry them thoroughly before testing and use hand sanitizer.
PREPARE THE MATERIALS
Material Provided
Materials required by not provided
A clock or timer;
Recommended material: disposable gloves and mask if swabbing others.
Do not open the test contents until ready for use.
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Pick up the Extraction Buffer Tube and remove the sealing foil of the tube. Insert the Extraction Buffer Tube in the front of box labeled "Insert tube here".
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Remove the Test Card from its foil pouch. The unsealed test card is valid for 60 minutes.
Remove the Test Card from its foil pouch. The unsealed test card is valid for 60 minutes
PERFORMING THE TEST
- Open the package from the swab's stick end and take out the swab by holding the stick
DO NOT touch the swab head (soft end).
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Gently insert the swab 1/2 to 3/4 inch into a nostril, For young children, the swab should not be inserted more than 1/2 inch.
DO NOT insert the swab any farther if you feel any resistance.
Using medium pressure, rub and rotate the swab against the inside walls of the nostril, making at least 5 circles. Repeat in the other nostri using the same swab
Did you swath BOTH nostrils?
Inaccurate test results may occur if the nasal sample is not properly collected
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.
PERFORMING THE TEST
- Place the swab into the extraction solution making sure the swab head is completely immersed.
Swirl the swab in the solution by rotating the swab forcefully against the side of the Extraction Buffer Tube at least 10 times, keeping the swab tip submerged in the extraction solution the entire time.
NOTE: Failure to rotate the swab 10 times may lead to false negative results.
- Squeeze the swab within the Extraction Buffer Tube 5 times with your fingers to ensure that the sample on the swab is fully mixed into the extraction solution. Discard swab.
Close the dropper cap that is attached to the Extraction Buffer Tube.
Squeeze and massage swab 5x
NOTE: Failure to squeeze the swab within the Extraction Buffer Tube may lead to false negative results.
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Holding the dropper VERTICALLY over the sample well on the test card, squeeze out exactly 5 DROPS of the solution.
NOTE: DO NOT squeeze more than 5 drops from the Extraction Buffer Tube. Additional sample volume may yield inaccurate results.
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Set a timer and read the test results at 15 minutes
DO NOT disturb the card during this time. Inaccurate results can occur if the card is disturbed.
NOTE: DO NOT read the results before 15 minutes or after 30 minutes. Inaacurate test interpretations may occur.
TEST RESULTS INTERPRETATION
Test results are read and interpreted visually. Read result at 15 minutes with good lighting.
Look for lines next to 'Ctrl', 'Flu A', 'Flu B'. 'CoV', and 'RSV'. Make sure there is a visible line next to 'Ctrl' in both result windows.
INVALID RESULTS
Missing 'Ctrl' line on ONE or BOTH strips
Check to see if a line is visible at the control line 'Ctrl' on both strips. If one or both 'Ctrl' lines are missing, even if any test line is visible in the result window, the result is invalid.
UNDERSTANDING YOUR RESULTS
The test could not tell whether or not you have influenza A (Flu A), influenza B (Flu B), COVID-19, or Respiratory Syncytial Virus (RSV). The test needs to be repeated with a new kit and sample.
NOTE: The 3 images displayed above are examples only; additional invalid outcomes are possible. For a complete set of invalid results, please go to https://support.ihealthlabs.com/4-in-1-results.
POSITIVE RESULTS
Both "Ctrl' lines mu be PRESENT
If the control lines at 'Ctrl' are visible and any other single line or multiple lines on 'Flu A', 'Flu B', 'CoV', and/or 'RSV' appear, the test is positive.
NOTE: Any pink line in the correct, indicated locations, no matter how faint, should be considered an indication of a positive result.
For example, the images displayed below should all be considered Flu A positive.
UNDERSTANDING YOUR RESULTS:
The Flu A, Flu B, COVID-19, and/or RSV virus(es) were detected in your sample. It is very likely that you have the respective infection(s) and are contagious. Please contact your healthcare provider or your local health authorities and follow local guidelines for self-isolation. There is a small chance that this test can give you a positive result that is incorrect (a false positive).
Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definitive cause of disease.
AFTER TEST IS COMPLETED, DISPOSE OF USED MATERIAL IN HOUSEHOLD TRASH AND WASH HANDS.
iHealth Customer Service
iHealth Customer Service Can be reached via phone at 1-855-816-7705 (Monday-Friday 8:30am to 5:30 PM PT) or via email at support@ihealthlabs.com. Self Help can be obtained 24 hours at the Help Center.