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ISO 13485 SARS-CoV-2 Antigen Rapid Test Kit Saliva Universal

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

Contact name:Aimee li

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Labnovation Technologies, Inc.

ISO 13485 SARS-CoV-2 Antigen Rapid Test Kit Saliva Universal

Country/Region china
City & Province shenzhen
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Product Details

Rapid Test Kit SARS-CoV-2 Antigen Saliva Rapid Test Saliva Sample Easy For Use Single Pack Professional Antigen Saliva Rapid Test Kit

Intend Use

SARS-CoV-2 antigen saliva rapid test kit is intended for detection SARS-CoV-2 antigen in human saliva sample. The test kit is an qualitative detection rapid test kit for professional use. About the test result, the positive result can be used forearly triage and rapid management of suspected populations, further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.
Product Details

ItemValue
NameSARS-CoV-2 Antigen Saliva Rapid Test Kit
Model NumberLX-401601
Type20 Tests/Kit
Warranty18 Months
Quality CertificationCE, MSDS
Safty StandardISO13485
Sample TypeSaliva
Sample volume3 Full drops
Test SpeedWithin 10-15 minutes
Specificity99.00%
Sensitivity94.29%
Total Accuracy >95%

 
Product  Feature

  • Single Pack, Protable and covenient
  • Saliva Swab, Easy to collect
  • Fast Testing Speed, Get the result in 10-15 minutes
  • High Accuracy, Specificity and Sensitivity, Total Accuracy up to 99%
  • Latest Package ,Professional and Beautiful



 
 

 

 

 

 

 

 

 

Material Maybe Need But Not Provided

  • Timer.
  • Personal protective equipment, such as protective gloves, medical mask, goggles.
  • Appropriate biohazard waste container and disinfectants.

Main Components

  • 1 Test Cassettes
  • 1 Saliva Collectors With Collection Tubes 
  • 1 Sample Extraction Buffer
  • 1 Tube stand
  • 1 Instruction Manual

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.

 
 
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. If there is antigen in the sample, complex can be formed at the detection line, and red band is shown, indicating negative result. If there is no antigen in the sample, complex cannot be formed at the detection line, and no red band is shown, indicating negative result.
  • 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.

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.etc.

Certificate

FAQ

  • MOQ

We have the MOQ limit, which is 10000 pieces.

  • Shipment

Air Cargo, Ocean Cargo or by Express

  • Payment

Business to Business  account

  • Contact

Whatsapp, E-mail or Phone.

  • Delivery Date

After order confirmed, we will arrange your order immediately,and offer you an estimated delivery date.

 

 

 

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