Product Details
Rapid Test Kit CoV-19 Antigen Rapid Test Kit Self Testing 5 Tests
Simple Operation Rapid Test
Intend Use
This rapid test kit is intended for the qualitative detection of
SARS-CoV-2 viral nucleocapsid antigens from human anterior nasal of
secretion. Testing result of the antigen test can be used for early
isolation of patients with suspected infection, but it cannot be
used as diagnosis basis of SARS-CoV-2 infection. Further nucleic
acid detection should be carried out for suspected population whose
antigen test result is positive or negative.
Product Details
Item | Value |
Model Number | LX-401305 |
Package | 5 Tests/Kit |
Warranty | 24 Months |
Quality Certification | CE, MSDS |
Safty Standard | ISO13485 |
Sample Type | Nasal Swab |
Sample volume | 3 Full drops |
Test Speed | Within 15 minutes |
Specificity | 100.00% |
Sensitivity | 97.45% |
Product Feature
- Fast: Fast recation speed within 15 minutes
- Accurate: High Accuracy rate >90%
- Reliable: Individual Sample buffer, safety and reliability
- Simple: Simple operate step without extra step
Advantage
- Fast results as soon as 10-15 minutes
- Facilitates patient treatment decisions quickly
- Simple, time-saving procedure
- Little specimens, only few Nasal swabs
- All necessary reagents provided and no equipment needed
- High sensitivity and specificity
Main Components
- 5 Test Cassettes
- 5 Sample tubes
- 5 Extraction Buffer
- 5 Swabs
- 1 Tube stand
- 1 Instruction for use
Use Step
- Open the sealed pouch and remove the test casstette. Lay it face up
on a clean, dry and flat surface.
- Unpack the sample extraction, add all of the sample extraction into
the sample tube and then put the tube into tube stand.
- Gently, insert the entire absorbent tip of the swab (around 1.5 cm)
into your nostril. Rotate walls of your nostril 5 times or more.
Use the same swab to repeat steps in the other nostril.
- Insert the swab into the ssample tube with extraction buffer. Mix
well. Mix well and squeeze the swab 10-15 times by compressing the
walls of the tube against the swab. Roll the swab head against the
inner wall of the tubes as you remove it.
- Close the cape 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 15-20minutes 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. | |
Other Information
- This kit is a qualitative detection, which cannot determine the
exact content of antigen.
- The test is intended for use outside the body only.
- Not to be taken internally. Avoid sample buffer contact with skin
and eyes.
- Protect from sunlight, do not freeze. Store in a dry place between
2°C and 30°C. Do not use after the expiration date printed on the
packag
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.