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Rapid Tets Kit Antigen Rapid Test SARS-CoV-2 Antigen Saliva Rapid Test Kit
Intend Use
The rapid test kit is intended for the qualitative detection of SARS-CoV-2 antigen in hunman saliva samples from novel coronavirus suspected person with symptoms within 9 days from onset.
Product Details
Item
Value
Model Number
LX-401603
Type
20 Test
Warranty
18 Months
Quality Certification
CE, MSDS
Safty Standard
ISO13485
Sample volume
3 Full drops
specificity
99.00%
sensitivity
94.29%
Storage Temperature
2℃-30℃
Product Feature
Fast: Quick test speed, you can read the result within 15 minutes
Accurate: High accuracy, specificity and sensitivity, accuracy rate more than 95%
Protable: Easy to collect sample, you can do the test anywhere, anytime
Simple: Easy to operate, one step testing process
Test Principle
Immunochromatography assay.
Gold immunochromatographic test principle, double antibody sandwich method was used to detect SARS-CoV-2 nucleocapsid antigen in the samples.
There is virus antigen presence in the sample, the antigen binds with the corresponding colloidal gold monoclonal antibody and the coated monoclonal antibody at the detection line to form a compound and then condenses into a red band, indicating a positive result.
There is no antigen in the sample, complex cannot be formed at the detection line, and no red band is shown, indicating negative result.
Notic: Whether the sample contains antigen or not, the gold monoclonal antibody will bind to the enveloped antibody at the quality control line, form a compound and condense into a red band.
Main Components
Test Cassettes
Saliva Collectors With Collection Tubes
Sample Extraction Buffers
Tube stand
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 Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer
Year Established:
2001
Total Annual:
10000000-50000000
Employee Number:
100~600
Ecer Certification:
Active Member
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 reagent... 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 reagent...