COVID-19 Accurate Rapid Antigen Test Kit
Test Principle:
This COVID-19 antigen test kit uses immunochromatography for detection. The specimen will move forward along the test card under capillary action. If the specimen contains a novel corona virus antigen, the antigen will bind to the colloidal gold-labeled new corona virus monoclonal antibody. The immune complex will be captured by corona virus monoclonal antibodies which are membrane fixed form the fuchsia line, display will be corona virus antigen positive. If the line does not show color, the negative result will be displayed. The test card also contains a quality control line, which shall appear fuchsia regardless ofwhether there is a test line.
Warnings and Precautions
1. For in vitro diagnostic use.
2. This test has been authorized only for the detection of nucleoprotein antigen from SARS-CoV-2, not for any other viruses or pathogens.
3. Do not use this kit contents beyond the expiration date.
4. Do not use if the test device package is damaged.
5. Test results are meant to be visually determined.
6. Immediately use after opening the test device in the pouch.
7. To avoid erroneous results, specimens must be processed as indicated in the assay procedure sections.
8. When collections a saliva swab sample, use the sample collection swab supplied in the kit. Use of alternative swabs may result in false negative results.
9. Do not eat, drink, or smoke in the area where the specimens and kit contents are handled.
10. Use appropriate precautions in the collection, handling, storage and disposal of patient samples and used kit contents.
11. Nitrile or latex gloves should be worn when performing this test.
12. If the extraction buffer contacts the skin or eye, flush with copious amounts of water.
13. Handle all specimens as though they contain infectious agents.
14. Proper specimen collection, storage and transport are critical to the performance of this test.
15. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens.
16. Do not interchange kit contents from different lots.
17. Inadequate or inappropriate sample collection, storage and transport can result in incorrect results.
18. Specific training or guidance is recommended if operators are not experienced with specimen collection and handling procedures. Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when specimens are collected and evaluated. Pathogenic microorganisms, including hepatitis viruses and Human immunodeficiency virus, may be present in clinical specimens. Standard precautions and institutional guidelines should always be followed in handling, storing, and disposing of all specimens and all items contaminated with blood or other body fluids.
19. For additional information on hazard symbols, safety, handling and disposal of the components within this kit.
Storage and Stability
1. Store at 2℃~30℃, and it is valid for 18 months. Do not freeze the kit or its components.
2. After the aluminum foil bag is unsealed, the test card should be used immediately.
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