Product Details
Rapid Test Kit COVID-19 Antigen Rapid Test Kit High Specification
Professional Use
Antigien Rapid Test Kit
Intend Use
The SARS-CoV-2 antigen rapid test kit is intended for professional
detection sars-cov-2 antigen in infection human nasopharyngeal or
oropharyngeal swab, the test provides preliminary test results.
It's an aid inthe diagnosis of the patients with suspected
SARS-CoV-2 infection in conjunction with clinical presentation and
results of other laboratory tests. To be attention the test result
should no 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/Box |
Sensitivity | 98.04%, |
Specificity | 100% |
Total Accuracy | More tha 99% |
Warranty | 24 Months |
Power Source | Instruction Manual |
Quality Certification | CE |
Safty Standard | ISO13485,MSDS |
Sample Type | Nasal or Oropharyngeal Swab |
Sample volume | 3 Full drops |
Test Speed | Within 15 minutes |
Product Feature
- High accuracy, specification and sensitivity
- Simple operation no extra requirement
- Detection of mutation
- Result within 10-15 minutes
- Safety and reliable
Advantage
- Latest design which uses faster and moe convenient operation
- Fast recation, test accuracy up to 99%
- Sampling swab, designed for more specimen collection and relase
- Latest package,more convenient.
Main Components
- Test Cassettes
- Sample tubes
- Sample extraction buffers
- Swabs
- 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.
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. | |
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
- What about the lead time for mass production?
it depends on the order quantity and the season you place the order
- How can I do, if some urgent questions?
If you have any questions, you can call us or send us by email or
whatsapp.
- What the certification you have?
CE, ISO9001, ISO13485
- Will you help me register the products in my country ?
Sure, we will provide all you documents and samples you need for
register.
The min order quality is 10000 pcs.
Air Cargo or Ocean Cargo.
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.