【INTENDED USE】
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】
• Rapid Test Cassette.
• Extraction Tube.
• Extraction Buffer.
• Nasal Swab.
• Instructions for use.
• Working Holder.
【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.
