ISO13485 Labnovation Saliva Antigen Test Kit 1 Test Rapid Antigen Kit
Rapid Test Kit Antigen Saliva Test SARS-CoV-2 Antigen Rapid Test Kit
Intend Use
The test kit intended for the qualitative detection of SARS-CoV-2 antigen in human saliva samples, it also can detect who have suspected with symptoms within 9 days from onset. Test result can be used for early triage and rapid kmanagement of suspected populatio but not the only diagnosis basis, for the negative results it need to do futher nucleic acid and detection.
Product Details
| Item | Value |
| Brand | Labnovation |
| Model Number | LX-401601 |
| Type | 1 Test / Kit |
| Warranty | 24 Months |
| Quality Certification | CE, MSDS |
| Storage Temperature | 2℃-30℃ |
| Sample Type | Saliva |
| Sample volume | 3 Full drops |
| Test Speed | Within 15 minutes |
| sensitivity | 94.29% |
| specificity | 99.00% |
| Total coincidence rate | 98.02% |
Product Feature
- Fast results as soon as 15 minutes
- Facilitates patient treatment decisions quickly
- Simple, time-saving procedure
- All necessary reagents provided and no equipment need
- High sensitivity and specificity
- Main Components
- Test Cassette
- Saliva Collector
- Collection Tube
- Sample Extraction Buffer (Single does)
- 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
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).
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.
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. |
Certificate
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