Active Member
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[China]
Address: 703-1, Building 33, 258 Xinbrick Road, Hi-tech Park, Caohejing Development Zone, Shanghai
Contact name:Julie
Ascentet Group Co.,Ltd |
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INTEND USE
The rapid test kit is used for qualitative determination of novel coronavirus (SARS-CcV-2) antigen in human nasal swab samples in vitro.. This kit is offered to clinical laboratories and healthcare workers for point-of-care testing, and not for at home testing, in compliance with Section IV.D. of the FDA’s Policy for COVID-19 Diagnostic Test.
MAIN COMPONENTS
• Test Cassette.
• Extraction Tube.
• Extraction Reagent.
• Nasal/Oral Swab.
• Working Holder.
HOW TO PERFORM THE TEST?
1. Remove a Test Device from the foil pouch by tearing at the notch and place it on a level surface.
2. Holding Extraction Reagent bottle vertically, add 10 drops (400μL) to the Extraction tube.
3. Insert the nasopharyngeal (and oropharyngeal) swab sample(s) into the extraction solution, then, mix the swab 10 times.
4. Remove the swabs while pressing against the solution tube in order to extract most of the specimen
5. Place the dropper cap and drop 3 drops (60~70μl) into the sample well.
6. Read the result in 10-15 minutes. Do not read results after more than 20 minutes.
Prior to testing, all reagents were returned to room
temperature.Testing shall be performed at room temperature.
I. Sample extraction (see Figure 1)
1. Add 400 L (about 10 drops) of sample buffer vertically to the
sample extraction tube and then insert the sample into the tube and
rotate against the inner wall about 10 times so that the samples in
the solution dissolve as much as possible.
2. Squsample q-tip along the inner wall of the extraction tube to
retain as much liquid in the tube as possible from the sample, then
removed and discarded.
3. Cover the dropper.
two.Test procedure (see Figure 2)
1. Remove the test card from the sealing bag.
2. Add 2 drops (about 80 L) of the treated sample extract to the
sample hole of the test card and start the timer.
3. The results were read after placing the test card for 15 minutes
at room temperature.The results were invalid after 20 minutes.
Schematic diagram of the test card result judgment:
Invalid ① result: the quality control line (C line) has no reaction
line, the detection is invalid, and the test shall be repeated.
② negative result: red ribbon, quality control line (C line) is in
color.
③ positive result: two red bands, detection line (T line) and
quality control line (C line) are in color.
