Product Details
Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit Professional Test
Nasopharyngeal and Oropharyngeal Swab Rapid Test Kit
Intend Use
The Labnovation SARS-CoV-2 antigen rapid test kit is intended for
the qualitative detection od SARS-COV-2 infection from patients. It
is used for in vitro qualitative detection of the antigen of novel
virus in human nasopharyngeal or Oropharyngeal swabs.
Product Details
Item | Value |
Model Number | LX-401301 |
Type | 20 Tests/Kit |
Warranty | 24 Months |
Quality Certification | CE |
Safty Standard | ISO13485 |
Sample Type | nasopharyngeal / oropharyngeal |
Test Speed | Within 15 minutes |
Sample Volume | 3 full drops |
Main Components
- Test Cassettes
- Sample tubes with Prefilled Sample extraction buffer
- Swabs
- Tube Stand
- Instruction for use
Analytical Results
- Sensitivity: 98.04%
- Specificity: 100.00%
- Total accuracy: 99.60%
Product Features
- Responsive: High accuracy and stability, sensitivity and
specificity up to 95%
- Quick detected: Easy to use in simple step, within 15 minutes out
of results.
- Clear esults: The detection board is divided into two lines, the
result is clear and easy to read.
Sample treatment
- Take a sample tube with prefilled sample extraction buffer.
- Remove the aluminum foil sealing of the prefilled sample extraction
tube and then put the tube into the tube stand.
- Dip the swab into the sample extraction liquid after sample
collection, fully immerse the tip of the swab, rotate and squeeze
the swab 10 times, then pull out the swab, and take the stranded
liquid as much as possible.
- Close the cap of the sample tube.
Test steps
- Take out the test cassette from the sealed pouch, place it on a
clean and level surface with the sample port well up.
- Apply3 full drops of the treated sample (60μl-70μl) vertically into
the sample well of the test cassette.
- Observe the test results immediately within 15~20 minutes, the
result is invalid over 20 minutes.
Result Interpretation
Positive: Two colored bands appear on the membrane. One band appears in the
control region (C) and another band appears in the test region (T).
Negative: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).
Invalid: If there is no Control line (C) or only a Test line (T) in the result window, the test did not run correctly and the
results are not valid.
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. | Omicron |
Certificate
Company Profile
Labnovation Technologies, Inc. is an original manufacturer
established in Shenzhen, China since 2001. We are dedicated in
developing and manufacturing IVD instruments and reagents including
HbA1c analyzer and reagents, rapid test reader & reagents,
hematology reagents, clinical chemistry reagents, electrolyte
reagents, wash solution and urine test reagents.
Labnovation products are developed in house, tested extensively in
clinics and passed strict quality controls. All of our products are
CE marked and approved by SFDA. In the past 15 years, our products
have been exported to 110 different countries and used in 8000
hospitals worldwide. We provide both ready-to-use final products
and bulk OEM reagents, including ready-to-use reagents,
concentrated, and powder.
With an investment of 10% of our annual sales into R&D, we
release new products every years. We win more and more domestic and international cooperation by
company reputation and products quality while we actively take part
in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we
are well-known by the companies in this field.