COVID-19 Antigen Rapid Test Kit Antigen Rapid Test Device High Specification
Rapid Test Kit COVID-19 Antigen Rapid Test Kit High Specification Professional Use
Antigien Rapid Test Kit
Intend Use
The SARS-CoV-2 antigen rapid test kit is intended for professional detection sars-cov-2 antigen in infection human nasopharyngeal or oropharyngeal swab, the test provides preliminary test results. It's an aid inthe diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. To be attention the test result should no be used as the sole basis for diagnosis.
Product Details
| Item | Value |
| Product Name | SARS-CoV-2 Antigen Rapid Test Kit |
| Model Number | LX-401301 |
| Type | 20 Tests/Box |
| Sensitivity | 98.04%, |
| Specificity | 100% |
| Total Accuracy | More tha 99% |
| Warranty | 24 Months |
| Power Source | Instruction Manual |
| Quality Certification | CE |
| Safty Standard | ISO13485,MSDS |
| Sample Type | Nasal or Oropharyngeal Swab |
| Sample volume | 3 Full drops |
| Test Speed | Within 15 minutes |
Product Feature
- High accuracy, specification and sensitivity
- Simple operation no extra requirement
- Detection of mutation
- Result within 10-15 minutes
- Safety and reliable
Advantage
- Latest design which uses faster and moe convenient operation
- Fast recation, test accuracy up to 99%
- Sampling swab, designed for more specimen collection and relase
- Latest package,more convenient.
Main Components
- Test Cassettes
- Sample tubes
- Sample extraction buffers
- Swabs
- Instruction for 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
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
- What about the lead time for mass production?
it depends on the order quantity and the season you place the order
- How can I do, if some urgent questions?
If you have any questions, you can call us or send us by email or whatsapp.
- What the certification you have?
CE, ISO9001, ISO13485
- Will you help me register the products in my country ?
Sure, we will provide all you documents and samples you need for register.
- MOQ?
The min order quality is 10000 pcs.
- Shipment?
Air Cargo or Ocean Cargo.
Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.