Product Details
Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit 20 Test
Professional Antigen Diagnosisi 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 |
Product Name | SARS-CoV-2 Antigen Rapid Test Kit |
Model Number | LX-401301 |
Type | 20 Tests/Kit |
Sensitivity | 98.04%, |
Specificity | 100% |
Total Accurracy | 99% |
Warranty | 24 Months |
Quality Certification | CE |
Safty Standard | ISO13485,MSDS |
Sample Type | Nasal, Oropharynx Swab |
Sample volume | 3 Full drops |
Test Speed | Within 15 minutes |
Product Feature
- Test results in 15 minutes
- No special / additional instruments required
- Detection of mutations
- Deploy at large sacle at point of care
Main Components
- 20 Test Cassettes
- 20 Sample tubes
- 2 Sample extraction buffers
- 20 Swabs
- 1 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
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
We have the MOQ limit, which is 10000 pieces.
- What the certification you have?
CE, ISO9001, ISO13485
After order confirmed, we will arrange your order immediately, and
offer you an estimated delivery date.
Yes, we accept OEM / ODM.
Air cargo or Ocean cargo.
Business to business account.
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.