Wellion VivaDiag Rapid SARS-COV-2 AG Antigen swab test Covid-19 from the nasal region (also for children) 1 piece

SAMPLING AND HANDLING

1. Sampling

• Nasal swab sample (recommended) is important to take as much secretion as possible.Insert a sterile swab into one nostril.The tip of the swab should be inserted up to 2.5 cm (1 inch) from the edge of the nostril.Rotate the swab 5 times along the mucous membrane inside the nostril to ensure that both mucus and cells are collected.Repeat the same procedure for the other nostril to ensure that an adequate sample is taken from both nasal pasSages (use the same swab).
• Oropharyngeal swab sample (optional) It is important to collect as much secretion as possible.Insert a sterile swab into the throat, where most of the secretion is present in the red area of the pharyngeal wall and maxillary tonsils, to take a throat swab sample.Take a sample by rubbing gently along the tonsils in the throat and pharyngeal wall.Do not touch your tongue when pulling out the tampon.
• Nasopharyngeal swab sample (optional) It is important to collect as much secretion as possible.By visual inspection, insert a sterile swab into the nostril that shows the most secretion.Hold the swab close to the nasal septum and gently press it towards the back of the nasopharynx.Twist the swab 5 times and then remove it from the nasopharynx.Nasal swab Nasal swab Nasal swab Nasal swab Nasal swab Pharyngeal swab 2. Sample processing Freshly collected samples should be tested as soon as possible.Proper sampling and preparation procedures are essential.

PROCEDURE FOR PERFORMING RAPID DIAGNOSTIC TESTS

• it is recommended to use disposable gloves when performing the rapid diagnostic test and hand hygiene before and after testing with soap and Water or hand sanitizer gel.
• Allow the test equipment and reagent solution to reach a temperature of 15-30 °C before testing.

1. Hold the sealed bag vertically and allow all the Extraction solution to flow into the flask.Break off the end of the bag and squeeze the flask to pour all the solution into the Extraction tube.
2. To take a sample, see Sampling.
3. Insert the swab with the collected sample into the tube filled with the reagent solution.Rotate the swab 5 times by pressing the swab head against the bottom and side of the reagent tube.Remove the swab by pressing it against the sides of the tube to Extract the fluid.Try to get as much fluid out as possible.Dispose of the used swab as biohazardous waste.
4. Put the cap on the tube.Connect the cap to the reagent.
5. Remove the test device from the sealed foil bag and place it on a clean, flat surface.
6. Apply 3 drops (approximately 60 μL) of the collected sample to the sample well.Prevent bubbles from forming during application.
7. After 15 minutes, read the test result.Do not read the result after 20 minutes.15 min Read the test result after 15 minutes, do not evaluate after more than 20 minutes.

NOTE

• Do not mix or mix the solution with reagents from different batches.
• handle the reagent solution with care, avoid contact with eyes or skin.In case of contact with eyes or skin, wash thoroughly with Water.
• Follow local regulations for disposal of used materials.

READING TEST RESULTS

1. Positive result: the quality control band C and the detection band T are displayed.
2. Negative result: only quality control band C is displayed, while no other bands appear on the detection band.
3. Invalid result: no control strip C appears, which means the test is invalid, regardless of whEther the detection strip is displayed or not.Take a new sample and perform another test with the new device.

Positive: both the detection strip (T) and the quality control strip (C) are reddish-purple in the detection area.

Negative: only the quality control bar (C) appears in the detection area.

Invalid: No red-violet quality control bar (C) appears in the detection area, regardless of whEther the detection bar (T) is coloured or not.

QUALITY CONTROL
The test includes internal procedural controls.The colored bar shown in the control area (C) represents an internal procedural control.Confirm sufficient sample volume and successful procedure.Control standards are not included in this kit; however, it is recommended that positive and negative controls be performed in accordance with good laboratory practice to confirm the test procedure and verify proper function.

Contents of one pack

• 1× Test set
• 1× Extraction tube and solution
• 1× Sterile swab
• 1× Tube stand
• 1× Packaging information