Rapid Test Kit Antigen Rapid Test SARS-CoV-2 Antigen Rapid Test Kit
High Accuracy For Professional Use Antigen Rapid 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 |
Model Number | LX-401301 |
Type | 20 Tests /Kit |
Sensitivity | 98.04% |
Specificity | 100% |
Total Accuracy | 99.6% |
Warranty | 24 Months |
Power Source | Instruction Manual |
Quality Certification | CE, MSDS |
Safty Standard | ISO13485 |
After-sale Service | Online technical support |
Sample volume | 3 Full drops |
Test Speed | Within 15 minutes |
Product Feature
- High Accuracy, Sensitivity and Specificity, Accuracy rate more
than 95%
- Fast recation speed, read the result within 15 minutes
- CE certificated,Stric quality control
- Easy for use, One step operation process
![](http://img.everychina.com/nimg/99/5e/de7830fdf40b15aa5caaed93fb56.jpg)
![](http://img.everychina.com/nimg/32/22/e7e9db61302768945d21926edc6c.jpg)
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. When there is virus antigen presence in the sample, the
antigen binds with the corresponding colloidal gold monoclonal
antibody and the coated monoclonal antibody at the detection line
to form a compound and then condenses into a red band, indicating a
positive result. If there is no antigen in the sample, complex
cannot be formed at the detection line, and no red band is shown,
indicating negative result.
- Whether the sample contains antigen or not, the gold monoclonal
antibody will bind to the enveloped antibody at the quality control
line, form a compound and condense into a red band.
Main Components
- 20 Test Cassettes
- 20 Sample tubes
- 2 Sample extraction
- 20 Swabs
- 1 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.
![](http://img.everychina.com/nimg/11/3f/5636de47a30a0ddabeb1b1197c27.jpg)
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.
![](http://img.everychina.com/nimg/c8/7e/c45363fe74e39d368e0de6b1ea20.jpg)
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. | |
Other Information
- This reagent is a qualitative detection reagent, which cannot
determine the exact content of antigen.
- The test results of this reagent are only for the reference of
clinicians and should not be taken as the sole basis for clinical
diagnosis and treatment. Clinical management of patients should be
considered in the light of their symptoms/signs, medical history,
other laboratory tests and treatment responses.
Certificate
![](http://img.everychina.com/nimg/8a/77/9ddafc4d340bafdbb0743b00bf20.jpg)