2019-nCoV Antigen Test Wondfo

2019-nCoV Antigen Test Wondfo - Medical Device

In Vitro Diagnostic

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a rapid test that is used for laymen to detect the novel coronavirus (2019-nCoV) protein N antigen extracted from the nasal swab sample. It is intended to aid in the diagnosis of coronavirus infection disease (COVID-19) for symptomatic patients within 7 days of symptom onset, which is caused by 2019-nCoV. The test can be performed correctly for anyone over the age of 18. However, the nasal swab specimen from individuals under the age of 18 must be collected and performed by another adult. While users over the age of 75 should be aware of removing their nasal swab or having nasal swabs assisted.

How to use

Choose a place to take this test where it can remain UNDISTURBED for 20 minutes. Bring the test components to room temperature (10 ~ 30 ° C).
- Take out the extraction buffer tube, unscrew the lid and put the tube into the tube holder (the tube holder is in the outer box, see above).
- Take the test cassette out of the foil pouch and lay it flat.
- Remove the swab from the container, being careful not to touch the soft end, which is the absorbent tip.
- Carefully insert the ENTIRE absorbent tip of the swab into the nostrils. Firmly sample the nasal wall by rotating the swab in a circular path five times against the nasal wall. Slowly remove the swab from the nostril (this step should take about 15 seconds, making sure to collect the mucus and cells). Repeat the above sampling in the other nostril with the same swab.
- Insert the swab into the extraction buffer tube and dip the entire swab tip into the extraction buffer. Twist about 10 times and squeeze the absorbent tip through the bottom swab tube.
- Detach the swab at the breaking point, leave the tip of the swab in the tube, cap the lid and leave the tube on the rack for 1 minute. - Unscrew the small cap on top of the extraction buffer tube.
- Place the cassette and add 4 drops of treated sample to the sample well. Wait 15 minutes and read the results. DO NOT read results after 20 minutes.
- Once the test is complete, put all test kit materials in the biowaste bag and dispose of it according to your local biowaste disposal policy. - Reapply the hand sanitizer.
- Interpretation of the results.
POSITIVE: Two red lines will appear. One on the top half and one on the bottom half. COVID-19 was detected.
NOTE: It does not matter if one of the lines that make up the test line (T) is lighter or darker than the other; the result is "Positive".
NEGATIVE: A single red line on the top half. COVID-19 was not detected.
INVALID: If no line appears on the top half, the test is invalid. It is recommended to repeat the test by collecting a new nasal swab.

Warnings

1. Read the Instructions for Use completely before using the product. Follow the instructions carefully. Otherwise, the result may be inaccurate.
2. This kit is for external use only, do not ingest.
3. Avoid getting the buffer solution into the eyes or skin.
4. Keep out of reach of children.
5. The test kit is for single use only, do not reuse any of the test kit components.
6. Do not use this test beyond the expiration date printed on the outer carton. Always check the expiration date before testing.
7. Do not touch the reaction area of the test cassette.
8. Do not use the kit if the pouch is punctured or not well sealed.
9. ARRANGEMENT: All samples and the kit used have an infectious risk. After use, discard all test components in the biohazard waste bag provided. The diagnostic kit disposal process must follow local, state and federal laws / regulations regarding infectious disposal.
10. Do not eat, drink or smoke in the area where specimens or test kits are handled.

storage

The kit should be stored at 2-30 ° C (refrigeration is allowed). Do not store the kit in the freezer. Improper storage can cause an inaccurate result. The test cassette is sensitive to humidity and temperature. Once removed from the foil pouch, the Test Cassette is stable for up to 1 hour. The test kit is stable until the expiration date printed on the outer carton.
Do not use it beyond the expiration date.
The test cassette should remain in the sealed pouch until use.
Validity: 24 months.

Format

The package contains:

• Sealed bag
• Extraction pad
• Disposable sterile swab
• Biohazard waste bag
• Instructions for Use
• Rack (in outer box)