Ascentet Group Co.,Ltd
Ascentet Group Co.,Ltd
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Main Components
1. Test card: binding pad (SARS-COV-2 antigen labeled with red latex microspheres, rabbit IgG labeled with red latex microspheres), nitrocellulose membrane (C line coated with goat anti-rabbit IgG polyclonal antibody, G line coated with anti-human IgG Monoclonal antibody, M line coated with mouse anti-human IgM monoclonal antibody), hemofiltration pad, sample pad, suction pad and PVC plate.
2. Disposable plastic pipette (sample dropper)
3. Desiccant;
4. Sample diluent: 20Mm PBS Ph7.4 ± 0.5
5. Packaging box and instruction manual.
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.
