One Step Antigen Rapid Test Kit Nasal Swab CE Certificated For SARS-CoV-2
SARS-CoV-2 Antigen Rapid Test Kit CE Certificated Professional Test Virus Antigen Use One Step Use Rapid Test Kit
Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 infection from patients. It is for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. Results from this test kit should not be used as the sole basis for diagnosis.
Product Details
| Item | Value |
| Model Number | LX-401301 |
| Type | 20 Tests/Kit |
| Warranty | 24 Months |
| Quality Certification | CE |
| Safty Standard | ISO13485 |
Sample Volum | 3 Drops |
| Sample Type | nasopharyngeal / oropharyngeal |
| Store temperature | 2-30℃ |
Main Components
- Test Cassettes
- Sample tubes with Prefilled Sample extraction buffer
- Swabs
- Tube Stand
- Instruction for use
Analytical Results
- Sensitivity: 98.04%
- Specificity: 100.00%
- Total accuracy: 99.60%
Product Features
- Rapid testing for Virus antigen within15 minutes
- Simple , time-saving procedure
- All necessary reagents provided
- High sensitivity, specificity and total accuracy, safety and reliable
Use Step
- Take a sample tube (with prefilled sample extraction solution).Remove the aluminum foil sealing of the prefilled sample extraction tube and then put the tube into the tube stand.
- Dip the swab into the sample extraction liquid after sample collection, fully immerse the tip of the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the stranded liquid as much as possible.
- Close the cap of the sample tube. Add 3 full drops of the mixed solution vertically into the sample well (S) of the test cassette. Read the result 15-20 minutes after adding the sample. Result got after 20 minutes is invalid.
Result Interpretation
Positive: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
Negative: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
Invalid: If there is no Control line (C) or only a Test line (T) in the result window, the test did not run correctly and the results are not valid.
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. | Omicron |
Sample Preservation
Sample of human nasopharyngeal swabs and oropharyngeal swabs should be processed as soon as possible after sample collection. If the test cannot be performed immediately, the sample should be stored in a sealed state, stored at 2~8℃ for 8 hours, and stored below -20℃ for 1 month. Long-term storage is not recommended.
Certificate
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