Oropharyngeal Swabs Antigen Rapid Test Kit ISO 13485 SARS-CoV-2 Rapid Ag Test Kit
Antigen Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit
Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 infection from patients. The test provides preliminary test results. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other management decision.
Product Details
| Item | Value |
| Model Number | LX-401301 |
| Type | 20 Tests |
| Warranty | 24 Months |
| Quality Certification | CE,MSDS |
| Safty Standard | ISO13485 |
| After-sale Service | Online technical support |
| Test Speed | Within 15 minutes |
| Sample Type | Nasopharyngeal or Oropharyngeal |
| Specificity | 100.00% |
| Sensitivity | 98.04% |
| Total Accuracy | 99.60% |
Main Components
- 20 Test Cassettes
- 20 Sample tubes
- 1 Sample extraction
- 20 Swabs
- 1 Instruction for use
Product Features
- Fast: Result in 15 minutes
- Simple : Easy to operate without extra instrument
- Sample Type: Patient sample collected by throat swab or nasal swab
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.
Use Step
- Add 550μL sample extraction (about 22-24 drops) into the sample tube.
- Insert the swab into the sample tube prefilled with extraction buffer. Mix well and squeeze the swab 10-15 times by compressing the wall s of the tube against the swab.
- Roll the swab head against the inner wall of the tubes as you remove it. Try to release as much liquid as possibe. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
- 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.
Result Interpretation
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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).
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NEGATIVE: One (1) colored line appears in the control region(C). No apparent colored line appears in the test region (T).
-
INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure.
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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