ISO9001 Rapid Test Device Nasopharyngeal SARS-CoV-2 Antigen Detection Kit
Rapid Antigen Test Kit SARS-CoV-2 Antigen Rapid Test Kit 20Tests/Kit For Professional Detection Use 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/Kit |
| Specificity | 100% |
| Sensitivity | 98.04% |
| Accuracy | 99.60% |
| Warranty | 24 Months |
| Quality Certification | CE,MSDS |
| Safty Standard | ISO13485, ISO9001 |
| Test Speed | <15 minutes |
| Sample Type | Nasopharyngeal or Oropharyngeal |
|
Sample Volum |
3 Drops |
Main Components
- Test Cassettes
- Sample tubes
- Sample extraction buffer
- Swabs
- Instruction for use
Product Features
- Quick Testing Speed, Read the result in 15 minutes
- Easy for use without extra instrument
- CE Certificated , ISO13485,ISO9001 Certificated
Other Information
- 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.
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
-
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).
-
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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