1. This package insert must be read completely before performing the test. Failure to follow directions in package insert may yield inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after expiration date.
3. Do not eat, drink or smoke in the area where the specimens or kits are handled.
4. Do not use test if pouch is damaged.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout in the collection, handling, storage and disposal of patient samples and used kit contents.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Wash hands thoroughly after handling.
8. Please ensure that appropriate amounts of samples are used for testing. Too much or too little sample size may lead to deviation of results.
9. Viral Transport Media (VTM) may affect the test result; extracted specimens for PCR tests cannot be used for the test.
10.The used test should be discarded according to local regulations.
11.Humidity and temperature can adversely affect results.
SPECIMEN PREPARATION
Only the extraction buffer and tubes provided in the kit is to be used for swab specimen preparation.
Please refer to the Procedure card for detailed information of Specimen Extraction.
1. Place the swab specimen in the Extraction tube with Extraction buffer. Rotate the swab for 10-15 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
2. Remove the swab while squeezing the swab head against the inside of the Extraction tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol.
*NOTE: The storage of the specimen after extraction is stable for 2 hours at room temperature or 24 hours at 2-8 °C.
Nasal swab specimen Collection
1. Insert a sterilized swab less than one inch (about 2 cm) into a nostril (until resistance is met at the turbinates).
2. Rotate the swab 5-10 times against the nasal wall. Using the same swab repeat the collection procedure with the second nostril.
3. Withdraw the sterile swab; avoid excess volume and high-viscous nasal discharge.
Caution: If the swab stick breaks during specimen collection, repeat specimen collection with a new swab.
Specimen Transport and Storage Specimens should be tested as soon as possible after collection. If swabs are not been processed immediately, it is highly recommended the swab sample is placed into a dry, sterile and tightly sealed plastic tube for storage. The swab specimen in dry and sterile condition is stable for up to 24 hours at 2-8 °C.
DIRECTIONS FOR USE
Allow the test, extracted specimen and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Invert the specimen extraction tube and add 3 drops of extracted specimen (approx.75-100μl) to the sample well(S) and then start the timer.
3. Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20 minutes.
Limitation of Detection
The SARS-CoV-2 Antigen Rapid Test (Nasal swab) can detect out SARS-CoV-2 heat-inactivated virus strain as low as 1X102 TCID50/ml.
