1 Pack SARS-CoV-2 Saliva Antigen Test Kit No Equipment Need
Rapid Test Kit SARS-CoV-2 Antigen Saliva Rapid Test Single Pack 1 Test Kit For Professional Use
Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 antigen in human saliva samples from novel coronavirus suspected person with symptoms within 9 days from onset. Positive result of the antigen test 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. 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-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% |
| Quality | ISO13485, ISO9001 |
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
- 1 Test Cassette
- 1 Saliva Collector
- 1 Collection Tube
- 1 Sample Extraction Buffer (Single does)
- 1 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. |
PRECAUTION
- Waste should be treated in accordance with infectious substances and should be discarded properly.
- Incorrect operation may affect the accuracy of the results, such as sample extraction reagent insufficient or excessive, insufficient sample mixing, insufficient amount, inaccurate detection time, etc.
- Components in different batch should not be mixed; Viral Transport Media (VTM) may affect the test result; extracted specimens for PCR tests cannot be used for the test.
- 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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