Cassette One Step Rapid Test Kit SARS-CoV-2 Comfortable Saliva Rtk Test Kit
SARS-CoV-2 Antigen Saliva Rapid Test Kit (Immunochromatography)
Intend Use
This rapid test kit is intedded for the qualitative detection of SARS-CoV-2 antigen in saliva sample wihch also can be used to detect saliva sample from novel coronavirus suspected person with symptoms within 9 days. The test result of antigen test can be used for early triage and rapid management of suspected popu;ations, but it cannot be used as diagnosis basis of SARS-CoV-2 infection and as the sole basis for treatment or patient management decidions. Fuether nucleis acid detection should be carried out for suspected population whose antigen test result is positive or negative
Product Details
| Item | Value |
| Model Number | LX-401603 |
| Type | 20 Test |
| Warranty | 18 Months |
| Quality Certification | CE, MSDS |
| Safty Standard | ISO13485 |
| Sample volume | 3 Full drops |
| specificity | 99.00% |
| sensitivity | 94.29% |
| Storage Temperature | 2℃-30℃ |
Product Feature
- Fast: Fast recation the test result is very easy to read within 15 minutes
- Simple: Operation is very sample, one step to operate
- Accurate: High accuracy, the total accuracy more than 95%
- Protable: Saliva sample, more comfortable sample collection than others
Test Principle
This kit is an immunochromatography assay. According to the gold immunochromatographic test principle, double antibody sandwich method was used to detect SARS-CoV-2 nucleocapsid antigen in the samples. When there is virus antigen presence in the sample, the antigen binds with the corresponding colloidal gold monoclonal antibody and the coated monoclonal antibody at the detection line to form a compound and then condenses into a red band, indicating a positive result. If there is no antigen in the sample, complex cannot be formed at the detection line, and no red band is shown, indicating negative result.
- 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
-
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. |
Certificate
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