HIBERNIA MEDICAL SARS-CoV-2 Antigen Self Test Nasal User Guide

HIBERNIA MEDICAL SARS-CoV-2 Antigen Self Test Nasal

Important safety information

Warning!

• Wash your hands with soap and water or use a hand sanitizer before and after performing the test.
• Keep the swab clean. Avoid touching the tip of the swab and ensure that it does not come into contact with any surfaces prior to use.
• Use the test kit only once.
• Avoid contact with skin and eyes. In case of accidental contact, rinse well in order to avoid skin irritations. In case of concerns, consult your doctor. In the event of a spillage, ensure that it is cleaned thoroughly using a suitable disinfectant.
• Do not use any of the test components in the body with the exception of the swab included in the kit. Do not swallow any of the components.

Components of the test kit

Pouch 1 containing a test device and a desiccant package (x5)

Pouch 2 containing 5 tubes with liquid and 5 nozzle caps (x1)

Sterile swab Tube holder

Materials required but not provided:

•  Timer
•  Tissue

Preparing for a test

1. Carefully read the Instructions for Use for patients for the SARS-CoV-2 Antigen Self Test Nasal.
2. Wash your hands with soap and water or use a hand sanitizer before performing the test.
3. Check the expiry date on the back of the foil pouches. Do not use the test if the expiry date has passed.
4. 4. Open one of the foil pouches 1 by tearing along the tear-line and take out the test device and the desiccant package.

Collecting and preparing nasal sample

1.  Open the foil pouch 2 by tearing along the tear-line and take out one of the tubes with liquid and one nozzle cap and place them on the table.

2.  Open the seal of the tube carefully without spilling the liquid inside the tube. Place the tube in the tube holder.

3.  Blow your nose once using a tissue.

4.  Remove the swab from the packaging. Ensure that you only touch the handle of the swab and not the soft pad at the tip.

5.  Slightly tilt your head backwards.

6.  Insert the swab with the soft pad at the front into your left nostril. Slowly slide the swab approx. 2 cm forward (parallel to the roof of your mouth – not upwards) until you encounter resistance. Do not apply any pressure.

7.  Rotate the swab 4 times (for a total of approx. 15 seconds) against the lining of the nasal wall before removing it from the nostril.

8.  Repeat steps 6 and 7 in your right nostril using the same swab.
   Note : Samples must be collected from both nostrils using the same swab.

9.  Insert the swab into the tube until the soft pad is in the liquid. Squeeze the tube at the bottom and hold it tight. Stir the swab more than 10 times to transfer the biological material from the swab to the liquid.

10.  Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. Dispose the swab and seal the tube securely with the nozzle cap. > 10x

WARNING! Failure to squeeze the tube can lead to incor-rect results due to excess buffer in the swab.

Performing a test

1.  Place the test device on a fl at surface.

2.  Hold the tube upright above the circular well marked on the picture below (not over the rectan-gular result window).

3.  Drop exactly 4 drops onto the circular well. Gently squeeze the sides of the tube together if necessary.
   Note: You can continue with the test even if you accidentally drop 5 drops onto the test device.

4. Set the timer and read the test result after 15 to 30 minutes.
   WARNING! Test results that are read before 15 minutes or after 30 minutes may be incorrect.

5.  Wash your hands with soap and water or use a hand sanitizer after performing the test.

Interpreting results

Invalid test result

1. If a control line (C) is not visible, the result must be considered invalid. The test is not working correctly and you should perform another test using a different test kit. You may have performed the test incorrectly. Carefully read the Instructions for Use and repeat the test. If your test result is still invalid, please contact your doctor or a COVID-19 test center.
   Positive test result

2.  If a test line (T) is visible together with a control line (C), this means that the result is positive. Look carefully at the result: The test should be considered positive if two lines are visible – even if they are faint. A positive test result means it is very likely that you have COVID-19. Please contact your doctor/primary care physician or your local health authority immediately and adhere to the local guidelines regarding self-isolation. Your doctor may require you to undergo a PCR test to confi rm the result.
   Negative test result 3. If a control line (C) is visible (regardless of how faint it is) and a test line (T) is not visible, this means that the result is negative. It is unlikely that you have COVID-19. However, even if your test is negative, continue to observe all hygiene and safety measures. If you suspect that you have an infection (i.e., if you have pro-longed symptoms or if your symptoms are worsening), contact your doctor/primary care physician. You may have another infection, or your test result may be false. You may repeat the test after 1–2 days, as COVID-19 cannot be detected with complete accuracy during all stages of an infection.

SD Biosensor, Inc. C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA Made in Korea Authorized representative: MT Promedt Consulting GmbH Altenhofstrasse 80
D-66386 St. Ingbert, Germany Distributed by: Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim, Germany www.roche.com

References

• Roche - Doing now what patients need next

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