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ISO9001 CoV-19 White Antigen Self Test Kit Non Invasive

Labnovation Technologies, Inc.
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ISO9001 CoV-19 White Antigen Self Test Kit Non Invasive

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Brand Name : LABNOVATION

Model Number : LX-401602

Certification : ISO13485,ISO9001

Place of Origin : China

MOQ : 10000 Pieces

Price : Negotiation

Payment Terms : T/T, D/A, D/P

Supply Ability : 500000/Day

Delivery Time : 5-7 work day

Packaging Details : Carton

Storage : 2℃-30℃

Test Time : Within 15 min

Color : White

Material : Plastic

Sunshine : Avoided

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Rapid Test Kit Antigen Saliva Rapid Test CoV-19 Antigen Saliva Rapid Test Single Pack For Self Test Use


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

Item Value
Name SARS-CoV-2 Antigen Saliva Rapid Test Kit (Self Test)
Model Number LX-401602
Type 1 Test / Box
Warranty 18 Months
Quality Certification CE
Safty Standard ISO13485
Sample Type Saliva
Sample volume 3 Full drops
Test Speed Within 10-15 minutes
Total Accuracy Over 95%
Sensitivity 94.29%
Specificity 99.00%


ISO9001 CoV-19 White Antigen Self Test Kit Non Invasive

Product Feature

  • High Accuracy, Specificity and Sensitivity
  • Test results within 15 minutes
  • Stable, with high accuracy
  • Saliva Sample Avaliable

ISO9001 CoV-19 White Antigen Self Test Kit Non Invasive
Advantage

  • No special/additional instruments required
  • All required accessories are provided in the test kit
  • Non-invasive
  • Inexpensive, cost-efficiency
  • Stable, Safety and Reliable

Main Components

  • 1 Test Cassette
  • 1 Saliva Collectors With Collection Tube
  • 1 Sample Extraction Buffer
  • 1 Instruction For Use

ISO9001 CoV-19 White Antigen Self Test Kit Non Invasive
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.

ISO9001 CoV-19 White Antigen Self Test Kit Non Invasive

  • 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.

ISO9001 CoV-19 White Antigen Self Test Kit Non Invasive
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.



ISO9001 CoV-19 White Antigen Self Test Kit Non Invasive
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. Others

Storage And Expiry

Store as packaged in the sealed pouch at 2-30℃, avoid heat and sunshine, dry place, valid for 24 months. Do not freeze. Do not open the inner packaging until ready, it must be used within one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity>60%.

Precaution

There should be appropriate biosafety assurance procedures for those substances containing and suspected sources of infection. The following are relevant considerations:

  • Handle samples and reagents by wearing gloves;
  • Do not ingest samples or reagents;
  • Do not smoke, eat, drink, cosmetic or touch contact lenses while handling these items;
  • Disinfect the spilled sample or reagents with disinfectant;
  • Disinfect and treat all samples, reagents and potential pollutants in accordance with relevant local regulations;
  • Each component of the reagent remains stable until the expiry date under proper handling and storage conditions. Do not use the expired reagent kit.

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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