15 Minutes Fast Saliva Antigen Test Kit Universal Ag Rapid Test Device
Rapid Test Kit Antigen Saliva Rapid Test Kit SARS-CoV-2 Antigen Saliva Rapid Test Kit High Accuracy Antigen Rapid Test Kit
Intend Use
This rapid test kit is intendedfor the qualitative detection od SARS-CoV-2 antigen in human saliva samples from novel coronavirus suspected person with symptoms within 9 days from onset. The result can be used for early triage and rapid management of suspected populations, but it cannot be used as diagnosis basis of SARS-CoV-2 infection. The negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.
Product Details
| Item | Value |
| Brand | Labnovation |
| Model Number | LX-401603 |
| Type | 20 Tests / Kit |
| Warranty | 24 Months |
| Quality Certification | CE, MSDS |
| Safty Standard | ISO13485,ISO9001 |
| Sample Type | Saliva |
| Sample volume | 3 Full drops |
| Test Speed | Within 15 minutes |
| specificity | 99.00% |
| sensitivity | 94.29% |
Product Feature
- Fast: Result easy to read within 15 minutes
- Simple: One step operation process
- Reliable: Individual package buffer, safety and reliability
- Accurate: High accuracy, specificity and sensitivity
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Main Components
- Test Cassettes
- Saliva Collectors With Collection Tubes
- Sample Extraction Buffer
- Tube stand
- Package Insert
Use Step
- Open the cap of the collection tube and istall saliva collector.
- Put the collection tube with saliva collector close to lips and let the saliva flow into the collection tube. Tje volum of saliva needs to be half of 0.5 scal mark(0.25).
- Screw the sample extraction buffer carefully.
- Add all sample extration buffer to the collection tube. Discard the saliva collector, tighten the cap onto the specimen collection tube.
- Shake the specimen collection tube at least three time vigorously to mix the saliva and the extraction buffer. Squeeze bottom of the collection tube ensure the saliva is thoroughly mixed.
- Add 3 full drops of the solution to the sample well(S). Read the result at 15 minutes. Do not interpret the result after 20 minutes.
Result Interpretation
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POSITIVE: Two (2) distinct colored lines appear. One line should be in the control region (C) and the other line should be in the test region (T).
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NEGATIVE: One (1) colored line appears in the control region(C). No apparent colored line appears in the test region (T). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than the minimum detection limit.
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INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.
Virus Sources
| Global high frequency mutation | Alpha / B.1.1.7(U.K.) | Beta I B.1.351(South Africa) |
| Gemma I P.1(Brazil) | Kappa I B.1.617.1(India) | Delta I B.1.617.2(India) |
| C.37,ect | Alpha I B.1.17(U.K.) | B.1.36.16.etc |
| A.2.5,etc | A.23.1 | Alpha I B.1.17(U.K.) |
| B.1.1.33.etc | C.1.1.etc. | etc. |
Other Information
- This kit is a qualitative detection, which cannot determine the exact content of antigen.
- The test cassette should be used as soon as possible after removal from aluminum foil bags. Avoid exposure to air for too long and affecting test results due to dampness.
- Waste should be treated in accordance with infectious substances and should be discarded properly.
- If the saliva is not well mixed in the sample extraction tube, false negative results may occur.
- Keep away from children. Any child under age 13 shouldn’t perform the test without parental guidance, or professional aid.
Certificate
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