Rapid Antigen Test Kit Professsional Diagostic Use SARS-CoV-2 Antigen Rapid Test Kit CE Certificated High Accuracy
Intend Use
The Labnovation SARS-CoV-2 antigen 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.
Product Details
| Item | Value |
| Test Item | SARS-CoV-2 Antigen Rapid Test Kit |
| Type | 20 Tests/Kit |
| Warranty | 24 Months |
| Quality Certification | CE |
| Safty Standard | ISO13485 |
| Sample Type | nasopharyngeal / oropharyngeal |
| Test Speed | Within 15 minutes |
| Sample Volume | 3 full drops |
Main Components
- Test Cassettes
- Sample tubes with Prefilled Sample extraction buffer
- Swabs
- Tube Stand
- Instruction for use
Analytical Results
| SARS-CoV-2 Antigen Rapid Test Kit |
| Sensitivity | Specificity | Total accuracy |
| 98.04% | 100.00% | 99.60% |
Product Features
- High Accuracy, Sensitivity and specificity
- Detection of mutations
- Safety and reliability
- Simple Operation, No extra instrument
- Results in 15 minutes and easy to read
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
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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).
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Negative: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
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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 |
Limitations
1. This reagent is a qualitative detection reagent, which cannot determine the exact content of antigen.
2. The test results of this reagent are only for the reference of clinicians and should not be taken as the sole basis for clinical diagnosis and treatment. Clinical management of patients should be considered in the light of their symptoms/signs, medical history, other laboratory tests and treatment responses.
3. Restricted by antigen detection reagent method, the lowest detection limit (sensitivity analysis) is generally lower than that of nucleic acid detection, so the researchers deal with negative result to give more attention, should be combined with other test results comprehensive judgment, advice to doubt the negative result of nucleic acid detection or virus isolation culture identification method for review.
4.False negative results may be caused by unreasonable sample collection, transport and treatment, and low viral load in samples.
Certificate
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