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.
