Professional Diagnostic Antigen Swab Test Kit High Accuracy For SARS-CoV-2
Rapid Antigen Test Kit SARS-CoV-2 Antigen Rapid Test Professional Diagnostic Use High Accuracy CE Certificated
Intend Use
The SARS-CoV-2 Antigen Rapid Test Kit is used for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP), oropharyngeal (OP) and nasl swab specimen.
Product Details
| Item | Value |
| Model Number | LX-401301 |
| Package | 20 Tests/Kit |
| Warranty | 24 Months |
| Quality Certification | CE |
| Safty Standard | ISO13485 |
|
Sample Volum |
3 Drops |
| Sample Type | Nasopharyngeal ( NP), oropharyngeal ( OP) and nasal swab specimen |
| Test Speed | Within 15 minutes |
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
- Reliable, High sensitivity, specificity and total accuracy
- Simple operation, Do not require test equipment, easy to use
- Rapid Test, Test result available within 15 minutes.
- Wide range of applications
Use Steps
- 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 invald.
Note: When using viral transport medium (VTM), it is important to ensure that the VTM containing the sample is warmed to room temperature. Cold samples will not flow correctly and can lead to erroneous or invalid results. Several minutes will be required to bring a cold sample to room temperature.
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 |
Precautions
1. For IN VITRO diagnostic use only.
2. Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
3. The test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don’t use after the expiration date.
4. All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.
Application
- Families
- Shopping Malls
- Concertes
- Stadiums
- Pharmacies
- Hospitals
Certificate
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