Wuxi Owgels Medical Instruments Co., Ltd
Wuxi Owgels Medical Instruments Co., Ltd
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Oral Saliva test Covid-19 Antigen Rapid Test Kit one step test
The COVID-19 Antigen Rapid Test Kit is a lateral flow immunochromatographic assay. The test uses COVID-19 antibody (test line T) and goat anti-mouse IgG (control line C) immobilized on a nitrocellulose strip.
The quantity of Antigen positive cases was 64 in the 67 oral saliva specimens of Covid-19 patients, the positive rate is 95.52% (64/67)
Antigen detection in the oral saliva specimens of Covid-19 patients has a high consistency with nucleic acid detection.
The positive rate is 95.52% (64/67), 95% confidence interval (CI) for sensitivity is 87.64%-98.47%.
| 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. |
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use.
DO NOT FREEZE. Do not use beyond the expiration date.
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.
