Covid-19 Antigen Rapid Test Kit Pharyngeal test 25 tests/kit in box
COVID-19 Antigen Rapid Test Kit is a solid phase immunochromatographic assay for the in vitro qualitative detection of nuleocapsid protein antigen from 2019 Novel Coronavirus in human oral saliva specimen.
COVID-19 is an acute respiratory infectious disease. People are generally susceptible.
Currently, the patients infected by novel coronavirus are the main source of infection, asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days.
| SPECIMEN COLLECTION AND HANDLING |
| 1. | Gargle with clean water before sampling |
| 2. | Unscrew the lid of the Extraction Tube, insert the saliva specimen collection funnel and screw it tightly. |
| 3. | Cough up secretions deep in the throat, accumulated in the oral cavity. |
| 4. | Use a saliva specimen collection funnel to collect fresh secretions in the oral cavity, reach the oral secretion scale mark. |
| 5. | Unscrew the funnel to allow the secretions to slip into the extraction buffer, tighten the funnel immediately and shake the collection tube. |
| 6. | Rotate to remove the funnel, place the white tip into the collection tube. |
TEST PROCEDURE
Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Cover the extraction tube with its dispensing tip.
2. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
3. Place the test device on a clean and level surface.
4. Squeeze the collection tube to add 2 drops of extracted sample into the specimen well(S) of the test device.
5. Read the results at 15 minutes. Do not interpret any result after 20 minutes.
INTERPRETATION OF RESULTS NEGATIVE:
If only the C band is present, the absence of any burgundy color in the T band indicates that no COVID-19 antigens are detected in the specimen. The result is negative.
POSITIVE:
In addition to the presence of C band, if T band also emerged, then the test indicates the presence of COVID-19 antigens in the specimen. The result is positive.
INVALID:
Control line fails to appear. Incorrect procedural techniques and invalid test kit are the most likely reasons for control line failure. Read the instructions carefully again and repeat the test with a new test kit. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
3. Do not use it if the pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results.
8. Do not perform the test in a room with strong air flow, ie. electric fan or strong air- conditioning.
9. Test is only for oral saliva specimens If test other specimens such as nasal, throat or nasopharyngeal swab specimens or serumplasmaurine specimens, the results are only for research.
10. Sample collection and handling procedures require specific training and guidance.
11. Do not pour sample from the Extraction Tube into the Test Cassette sample well. Use the provided dispensing tip of Extraction Tubes when adding the sample to the Test Cassette.
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SGS Covid-19 Antigen Rapid Test Kit Pharyngeal Test 25 Tests/Kit In Box Images
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