SARS-CoV-2 Antigen Rapid Test Kit Professional Diagnostic Vireus Antigen Use CE Certificated German BfArm List Approved
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.
- This rapid test kit is for professional use only.
- The Labnovation SARS-CoV-2 antigen rapid test kit 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.
- The test provides preliminary test results.

Product Details
| Item | Value |
| Model Number | LX-401301 |
| Type | 20 Tests/Kit |
| Specificity | 100% |
| Sensitivity | 98.04% |
| Accuracy | 99.60% |
| Warranty | 24 Months |
| Quality Certification | CE,MSDS |
| Safty Standard | ISO13485 |
| Sample Volum | 3 Drops |
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 results - rapid decision
- Self-admin
- Low cost
- Reliable and safety

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.
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 |
Precautions
- For IN VITRO diagnostic use only.
- Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
- 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.
- All specimens and reagents should be considered potentially hazardous and handled in the same manner as an infectious agent after use.
FAQ
We can send by Express, Air cargo or Ocean cargo.
- Does the price is competitive?
As we're manufacturer, we make sure to offer you the best quality with competitive price.
We accept many payment term, such as T/T, D/P, D/A etc.
Certificate
