Antigen Test SARS-CoV-2 Antigen Rapid Test Kit ISO13485 MSDS In 10-15 Minutes
Rapid Test Kit Antigen Test SARS-CoV-2 Antigen Rapid Test High Accuracy Professional Antigen Test Kit 20 Tests / 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.
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 | Over 99% |
| Warranty | 24 Months |
| Quality Certification | CE |
| Safty Standard | ISO13485,MSDS |
| Sample Type | Nasal, Oropharynx Swab |
| Sample volume | 3 Full drops |
| Test Speed | Within 10-15 minutes |
Product Advantage
- High accuracy, Specificity and Sensitivity
- One-Step operation without extra instruments
- Fast recation, test accuracy up to 99%
- Sampling swab, designed for more specimen collection and relase
Main Components
- Test Cassettes
- Sample tubes
- Sample extraction buffers
- Swabs
- 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
Application
- Suspected population(Families and close contacts of confirmed or suspected cases)
- High-risk groups(the elderly and children with basic illness or people with poor immunity)
- Center for Disease Control and Prevention
- Primary Health Care Institution
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.