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ISO High Specificity Safety Saliva Self Test Kit 60% Humidity

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 High Specificity Safety Saliva Self Test Kit 60% Humidity

Country/Region china
City & Province shenzhen
Categories Silver & Sterling Silver Jewelry
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Product Details

Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit Single Pack Self Testing High Specificity Antigen Test


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 from novel coronavirus suspected person with symptoms within 9 days from onset. The test result can be used for early detection and triage of people suspected of being infected.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 (Self Test)
Model NumberLX-401602
Type 1 Test / Box
Warranty18 Months
Quality CertificationCE
Safty StandardISO13485
Sample TypeSaliva
Sample volume3 Full drops
Test SpeedWithin 10-15 minutes
Total AccuracyOver 95%
Sensitivity94.29%
Specificity99.00%

 

Product  Feature

  • High Accuracy, Specificity and Sensitivity
  • Test results within 15 minutes
  • No special/additional instruments required
  • Non-invasive
  • Inexpensive, cost-efficiency
  • Stable, Safety and Reliable

Main Components

  • Test Cassette
  • Saliva Collectors With Collection Tube
  • Sample Extraction Buffer
  • 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

 

Precaution

  • Components in different batch should not be mixed; Viral Transport Media (VTM) may affect the test result; extracted specimens for PCR tests cannot be used for the test.
  • 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.
  • 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.

FAQ

  • Production quantity?

It depends on the specification of the products. For big orders, we can produce 100k-250k per day.

  • Have after-sale service?

 Yes we support technical services. And if the goods are missing due to our fault, we promise to compensate.

  • Register your products in our country?

Yes. We can offer full files for you to register.

  • Lead time?

Stock 3-7 days in general. Or please contact us by email for specific lead time base on your order quantities.

 

  • Support ODM or OEM?

Yes we support both. If needed,welcome to discuss details with us.

 

 

 

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