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ISO Universal Rapid Antigen Saliva Self Test Kit For Home Use

Labnovation Technologies, Inc.
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Address: 101 and 5th Floor, Building 1, No. 68,18th Road, Guangming Hi-Tech Park, Tangjia Community, Fenghuang Street, Guangming District, Shenzhen 518107 ,China

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Labnovation Technologies, Inc.

ISO Universal Rapid Antigen Saliva Self Test Kit For Home Use

Country/Region china
City & Province shenzhen
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Product Details

Rapid Test Kit Antigen Saliva Testing CoV-2 Antigen Saliva Rapid Test Kit Self Test For Home Use


Intended Use

This rapid tets kit is intended for the qualitative detection of SARS-CoV-2 Antigen in human saliva sampecimen, the test result can be used 

for early triage and rapid management of suspected populations, 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. To be notic that the results cannot be used as diagnosis basis of SARS-CoV-2 infection.

Advantage

  • Without Nasopharyngeal Swab NO More Painful Sampling
  • Easy And Simple
  • Accuracy More Than 95%
  • One Step Test
  • Fast: The result is available in 15 minutes
  • Easy: Easy To Collect Samples and Easy To Read Result
  • Early:Identify Acute or Early Infection
  • Convenient: No need instrument and fewer steps to get result
  • Efficient: Suitable For Large-Scale Rapid Screening

Product Details

ItemValue
Model NumberLX-401602
Package 1 Test / Kit
Warranty24 Months
Safty StandardISO13485, ISO9001
Sample TypeSaliva
Sample volume3 Full drops
Sensitivity94.29%
Specificity99.00%
Total coincidence rate98.02%
Test SpeedWithin 15 minutes
UseFor Self-test At Home

 

Product  Feature

  • One-step Operation without extra step
  • Individual Package, easy to carry
  • Saliva specimen, easy to collect
  • Unique design, simple and convenient



 Test Principle

This kit is an immunochromatography assay. According to the gold immunochromatographic test principle, double antibody sandwich method was used to detect SARS-CoV-2 nucleocapsid antigen in the samples. 

Main Components

  • 1 Test Cassette
  • 1 Saliva Collectors With Collection Tube
  • 1 Sample Extraction Buffer
  • 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 mutationAlpha / 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,ectAlpha I B.1.17(U.K.)B.1.36.16.etc
A.2.5,etcA.23.1Alpha I B.1.17(U.K.)
B.1.1.33.etcC.1.1.etc. 

 

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