Product Details
SARS-CoV-2 Antigen Saliva Rapid Test Kit (Immunochromatography)
Intend Use
- Qualitative detection of SARS-CoV-2 antigen in human saliva sample
- Positive result of the antigen test can be used for early triage
and rapid management of suspected populations
- Negative results do not rule out SARS-CoV-2 infection and should
not be used as the sole basis for treatment or patient management
decisions.
- Nucleic acid detection should be carried out for suspected
population whose antigen test result is positive or negative.
Product Details
Item | Value |
Brand | Labnovation |
Model Number | LX-401603 |
Type | 20 Test |
Warranty | 18 Months |
Quality Certification | CE, MSDS |
Safty Standard | ISO13485 |
Sample Type | Saliva |
Sample volume | 3 Full drops |
Test Speed | Within 15 minutes |
specificity | 99.00% |
sensitivity | 94.29% |
Product Feature
- Fast: Result easy to read within 15 minutes
- Simple: One step operation process
- Reliable: Individual package buffer, safety and reliability
- Accurate: High accuracy, specificity and sensitivity
Main Components
- 20 Test Cassettes
- 20 Saliva Collectors With Collection Tubes
- 20 Sample Extraction Buffer
- 1 Tube stand
- 1 Package Insert
Use Step
- Open the cap of the collection tube and istall saliva collector.
- Put the collection tube with saliva collector close to lips and let
the saliva flow into the collection tube. Tje volum of saliva needs
to be half of 0.5 scal mark(0.25).
- Screw the sample extraction buffer carefully.
- Add all sample extration buffer to the collection tube. Discard the
saliva collector, tighten the cap onto the specimen collection
tube.
- Shake the specimen collection tube at least three time vigorously
to mix the saliva and the extraction buffer. Squeeze bottom of the
collection tube ensure the saliva is thoroughly mixed.
- Add 3 full drops of the solution to the sample well(S). Read the
result at 15 minutes. Do not interpret the result after 20 minutes.
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). The negative result
does not indicate the absence of analytes in the sample, it only
indicates the level of tested analytes in the sample is less than
the minimum detection limit.
INVALID: No colored lines appear, or control line fails to appear,
indicating that the operator error or reagent failure. Verify the
test procedure and repeat the test with a new testing device.
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
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.