Dewei Medical Equipment Co., Ltd |
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Self Test Fast Speed Covid-19 (2019-nCoV) Antigen Rapid Test Cassette by Swab
Swab: Nasopharyngeal Swabs and Oropharyngeal Swabs, or Nasal and Oral Swab
【INTENDED USE OF ANTIGEN RAPID TEST】
The product is used for the qualitative detection of SARS-COV-2
infection. The entire detection process takes only 15-20 minutes,
and the operation is simple and sensitive. No instrument required.
It can be used for the screening of early infected patients and
asymptomatic patients. This method is an effective supplement for
nucleic acid detection.
【MAIN CONTENTS OF ANTIGEN RAPID TEST】
• Rapid Test Cassette.
• Extraction Tube.
• Extraction Buffer.
• Nasal Swab.
• Instructions for use.
【STORAGE AND STABILITY】
• Store at 39~ 86 º F (4 ~ 30 º C) in the sealed pouch for 18
months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
【DIRECTION OF USE】
1) Add about 10 drops (300µl) of buffer into the extraction tube.
2) Collect the Oral or Nasal sample according to above instruction.
3) Roll the swab at least 6 times while pressing the head against
the bottom and side of the extraction tube.
4) Leave the swab into the extraction tube for 1 minute.
5) Squeeze the tube by fingers from outside of the tube to immerse
the swab. Remove the swab. The extracted solution will be used as
test sample.
6) Put the tip on the tube and tighten up.
7) Add 3 drops (100µl) of the mixed sample to the cassette and read
the results in 15 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE:
The presence of two lines as control line (C) and test line (T)
within the result window indicates a positive result.
NEGATIVE:
The presence of only control line (C) within the result window
indicates a
negative result.
INVALID:
If the control line (C) is not visible within the result window
after performing the test, the result is considered invalid. Some
causes of invalid results are because of not following the
directions correctly or the test may have deteriorated beyond the
expiration date. It is recommended that the specimen be re-tested
using a new test.
【PRECAUTIONS】
• For in vitro diagnostic use only.
• Do not use after expiration date.
• The test Cassette should remain in the sealed pouch until use.
• The used test Cassette should be discarded according to local
regulations.