Product Details
Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit Best Performance
Antigen Rapid Diagnostic Test Self Test Use
Intend Use
This kit is an immunochromatography assay which detects SARS-CoV-2
nucleocapsid antigen in the samples with the help of the double
antibody sandwich method. These rapid test kit is intended for the qualitative detection of SARS-CoV-2 viral
nucleocapsid antigens from human anterior nasal of secretion from
individuals suspected of COVID-19.
Product Details
| Item | Value |
| Model Number | LX-401302 |
| Package | 1 Test/Kit |
| Sample volume | 3 Full drops |
| Warranty | 24 Months |
Diagnostic Accuracy
| Name | Specificity | Sensitivity | Total Accuracy |
SARS-CoV-2 Antigen Rapid Test Kit | 100% | 97.45% | 99.17% |
Product Feature
- No pre-processing required, simple operation, do not need any
auxiliary equipment.
- Rapid test, easy to interpret the results in 15 minutes.
- Transported and stored at room temperature.
- ISO13485, CE certificated, Safety and reliable
Main Components
- Test Cassette
- Sample tube with prefilled sample extraction buffer
- Swab
- Instruction for use
Use Step
- Take a sample tube (with prefilled sample extraction
solution).Remove the aluminum foil sealing of the prefilled sample
extraction tube and then put the tube into the tube stand.
- Gently, insert the entire absorbent tip of the swab (around 1.5 cm)
into your nostril. Slowly, rotate the swab in a circular against
the inside walls of your nostril 5 times or more. Be sure to
collect any nasal drainage that maybe present on the swab. Gently
remove the swab. Use the same swab to repeat steps in the other
nostril and slowly, take out the swab.
- 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. Add 3 full drops of the mixed
solution vertically into the sample well (S) of the test cassette.
Read the result 15-20 minutes after adding the sample. Result got
after 20 minutes is invalid.
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. | others |
Products Feature
- For Home Use
- Results in 15 minutes
- Simple Operation
- Results are easy to read
- Safety and Reliability
- Store at 2-30 ℃
- Detect COVID-19 virus variants (UK,SA, Brazil, CA, NY, etc.)
- High sensitivity and specificity
- Sterile Swab
- In the anterior nasal swab (approx. 1.5 cm)
Certificate
- CE cetificated
- Iceland registration
- Philipines certificated
- Germant BfArm List
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.