Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit 20 Test Professional Antigen Diagnosisi Test Kit
Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit 20 Test Professional Antigen Diagnosisi Test Kit
Intend Use
- This 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. Results from this test kit should not be used as the sole basis for diagnosis.
- 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 |
| Product Name | SARS-CoV-2 Antigen Rapid Test Kit |
| Model Number | LX-401301 |
| Type | 20 Tests/Kit |
| Sensitivity | 98.04%, |
| Specificity | 100% |
| Total Accurracy | 99% |
| Warranty | 24 Months |
| Quality Certification | CE |
| Safty Standard | ISO13485,MSDS |
| Sample Type | Nasal, Oropharynx Swab |
| Sample volume | 3 Full drops |
| Test Speed | Within 15 minutes |
Product Feature
- Test results in 15 minutes
- No special / additional instruments required
- Detection of mutations
- Deploy at large sacle at point of care
Main Components
- 20 Test Cassettes
- 20 Sample tubes
- 2 Sample extraction buffers
- 20 Swabs
- 1 Instruction Manual
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. | Others |
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
- MOQ is ?
We have the MOQ limit, which is 10000 pieces.
- What the certification you have?
CE, ISO9001, ISO13485
- Delivery date?
After order confirmed, we will arrange your order immediately, and offer you an estimated delivery date.
- Accept OEM/ODM?
Yes, we accept OEM / ODM.
- Shipment?
Air cargo or Ocean cargo.
- Payment Method
Business to business account.
Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.