Sars-CoV-2 Antigen Rapid Test WizBiotech 1 Test

Sars-CoV-2 Antigen Rapid Test WizBiotech - Nasal Swab

Rapid test intended for the qualitative detection of the SARS-CoV-2 antigen (nucleocapsid protein) found in the sample of the nasal cavity (anterior nasal) from individuals with suspected COVID-19 infection. The test kit is intended for self-test or home testing.

Indications

This test uses immune lateral chromatography technology.
When the test sample contains SARS-CoV-2, the SARS-CoV-2 antigen will react with the antibody coated on the test line (T) to cause a red band to appear in the test line area (T); when the SARS-CoV-2 content in the test sample is too low or does not exist, a red band does not appear in the test line area (T). Regardless of whether the test sample contains SARS-CoV-2, a red band will appear in the area of the quality control line (C), which is the basis for judging whether the test is effective.

Method of use and dosage

Use the test kit at room temperature (15 ° C-30 ° C). If the kit was previously stored in a cool place (temperature below 15 ° C), balance at 15 ° C-30 ° C for 30 minutes before testing.

Prepare a timer, tissues, hand sanitizer / soap and warm water.

Wash your hands thoroughly (at least 20 seconds) with soap and warm / hand sanitizer water.
Then dry your hands.

Check the components in the box and check for damage or breakage.

Sample collection

Extract the sample extraction tube; unscrew the tube cap.

Place the extraction tube on the bracket (fixed to the box) to avoid liquid spills.

Tear off the swab package from the end of the swab and remove the swab.

Insert the soft head of the tampon into the nostril less than 1 inch; gently rotate the swab against the nasal wall with moderate force at least five times; use the same swab to repeat the collection procedure in the other nostril.

Sample processing

Remove the extraction tube, dip the soft swab head into the extraction solution and immerse it in the liquid.

Press the soft swab head firmly against the inner wall of the extraction tube and rotate the swab clockwise or counterclockwise approximately 10 times.

Push the swab head along the inner wall of the sample extraction tube under the liquid in the tube as far as possible, withdraw the swab.

Tighten the cap of the stand-by tube.

Sample test

Tear off the foil pouch, take out the test card and place it horizontally on the test stand.

Disconnect the lid of the sample addition hole of the extraction tube.

Gently squeeze the extraction tube and drop 2 drops of liquid into the Test Card sample well.

Start timing, read test results at 15 minutes.
Do not read before 15 minutes or after 30 minutes.

After testing is complete, place all kit materials in the biohazard waste bag and dispose of it according to your local biohazard waste disposal policy.

Rinse your hands thoroughly for at least 20 seconds with soap and warm / hand sanitizer water.

Negative : The quality control line (line C) appears in the red band, while the test line (line T) does not appear in the red band.
Positive : Both the quality control line (line C) and the test line (line T) appear red bands.

Warnings

For in vitro diagnostic use only.

For use with nasal cavity (anterior nasal) swab specimens.

For SARS-CoV-2 protein detection only, not for detecting other viruses or pathogens.

The person under the age of 18 must be tested with the assistance of the legal guardian or an authorized person.

Keep the test kit or kit components out of the reach of children and pets before and after use.

The test paper package contains a desiccant, it is forbidden to eat.

The sample extraction solution in the extraction tube contains chemicals. Direct contact should be avoided and eating prohibited. If the solution comes into contact with the skin, mucous membranes or eyes, rinse with plenty of water. Please contact your family doctor or professional or seek medical advice if needed.

The use of gloves and other protective equipment is recommended when performing tests.

The test kits must be stored according to the storage conditions required in the instructions for use. It is forbidden to use the test kit that has not been stored as required.

Do not use the test kit beyond the expiration date.

Do not use kit components that have been opened or modified.

Leave the sealed test card in the foil pouch until just before use. Do not use if pouch is damaged or open.

Disposable swabs are sterile products. Do not use if the swab package is damaged or open.

The use of the tampon must strictly follow the instructions for use; otherwise it can cause nasal cavity bleeding, tampon rupture and retention, and other risks.

Do not immerse the swab in the extraction solution or other liquid before collecting the sample with disposable swabs.

Do not touch the soft tip of the swab when handling the swab sample.

Proper specimen collection and handling are critical for correct results.

Do not mix components from different kit lots.

All kit components are single use items. Do not use with multiple samples. Do not reuse used test kit or kit components.

Before deciding to make relevant management or treatment decisions, it is recommended that you communicate with family doctors or professionals. Do not take medication in private or any action that may endanger you.

Used test components and samples can be placed in plastic bags along with normal household waste. If the test result is positive, carefully dispose of waste components and relevant samples and thoroughly clean and disinfect the work surface to ensure hygiene. If there are special waste requirements in local laws and regulations, they must be strictly observed.

Do not eat, drink or smoke in the area where specimens or test kits are handled.

storage

Store between 2 ° C and 30 ° C, in a dry place and away from direct sunlight (do not freeze the kit or its components).
Validity for intact packaging: 12 months.
Validity after opening: 60 minutes.

Format

The kit contains

Test device.
Extraction tube.
Disposable pad.
Biohazard waste bag.
Instructions for Use.