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ODM Covid-19 KKM Approved Saliva Test Kit 99.00% Specificity

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.

ODM Covid-19 KKM Approved Saliva Test Kit 99.00% Specificity

Country/Region china
City & Province shenzhen
Categories Other Chemicals
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Product Details

Rapid Antigen Saliva Rapid Test Kit CoV-19 Antigen Rapid Test Kit 20 Tests Professional Rapid Test Kit

Intend Use

SARS-CoV-2 Antigen Saliva Rapid Test Kit is intended for the qualitative detection of SARS-CoV-2 antigen in human saliva sample. The test result can be used for early triage and rapid management of suspected populations. But the test kit 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

ItemValue
NameSARS-CoV-2 Antigen Saliva Rapid Test Kit
Model NumberLX-401603
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

  • Fast results as soon as 10-15 minutes
  • Facilitates patient treatment decisions quickly
  • Simple, time-saving procedure
  • All necessary reagents provided and no equipment needed
  • High sensitivity and specificity


 
 

 

 

 

 

 

 

 

Advantage 

  • Easy to collect simple, saliva swab
  • Single package, safety and clean
  • Best Performance with High Accuracy, Sensitivity and Specificity

Main Components

  • 20 Test Cassettes
  • 20 Saliva Collectors With Collection Tubes 
  • 20 Sample Extraction Buffer
  • 1 Tube stand
  • 1 Instruction For Use


 
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.Others

Certificate

Precaution

  • For IN VITRO diagnostic use only.
  • The kit is a disposable rapid test kit, which is only used for the detection of human saliva samples. The operation should be carried out strictly according to the instructions. Do not use expired or damaged products.
  • The strength of the quality control line does not mean the quality of the test kit. As long as its color is clear and visible, that means it is effective.
  • The kit should be sealed and kept away from moisture. Reagents or samples stored at low temperature should be balanced to room temperature before using.
  • The test cassette should be used as soon as possible after removal from aluminum foil bags. Avoid exposure to air for too long and affecting test results due to dampness.

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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