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SARS-CoV-2 IVD Reagent Rapid Antigen Self Test Kit Individual Labnovation Test

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.

SARS-CoV-2 IVD Reagent Rapid Antigen Self Test Kit Individual Labnovation Test

Country/Region china
City & Province shenzhen
Categories Laser Pointers
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Product Details

Rapid Antigen Test Kit SARS-CoV-2 Antigen Rapid Test Kit Individual Self Testing Rapid Test Kit

 

Intend Use

  • The SARS-CoV-2 Anigen Rapid Test kit is for in vitro diagnostic use only
  • The rapid test kit is for individual self testing use
  • Immunochromatography assay
  • This rapid test kit is intended for the qualitative detection of SARS-CoV-2 viral nucleocapsid antigens from human anterior nasal of secretion from individuals suspected of COVID-19.
  • Test result should not be used as the sole basis for treatment.
  • Further nucleic acid detection should be carried out for suspected population whose antigen test result is positive or negative.

Product Details

ItemValue
Model NumberLX-401302
Package1 Test/Kit
Specificity100.00%
Sensitivity97.45%
Total Accuracy 99.17%
Sample TypeNasopharyngeal Sample
Sample volume3 Full drops
Test Time< 15 minutes
Warranty24 Months
Quality CertificationCE, MSDS
Safty StandardISO13485, ISO9001

 

Product  Feature

  • Results ready in 15minutes
  • Accurate diagnostic tool
  • Easy to administer and read results
  • Affordable, no need for instrument, highly portable
  • Single Pack  more protable and convenient
  • Individual Self Testing At Home



 
Main Components

  •   Test Cassette
  •   Sample Tube 
  •   Sample Extraction Buffer
  •   Swab
  •   Instruction for use

 
Use Step

  • Open the sealed pouch and remove the test casstette. Lay it face up on a clean, dry and flat surface.
  • Unpack the sample extraction, add all of the sample extraction into the sample tube and then put the tube into tube stand.
  • Gently, insert the entire absorbent tip of the swab (around 1.5 cm) into your nostril. Rotate walls of your nostril 5 times or more. Use the same swab to repeat steps in the other nostril.

  • Insert the swab into the ssample tube with extraction buffer. Mix well. Mix well and squeeze the swab 10-15 times by compressing the walls of the tube against the swab. Roll the swab head against the inner wall of the tubes as you remove it.
  • Close the cape of the sample tube. Add 3 full drops of the mixed solution vertically into the sample well(S) of the test cassette.
  • Read the result 15-20minutes after adding the sample. Result got after 20 minutes is invalid.


 
Result Interpretation

  • POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

  • NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

  • INVALID: If there is no Control line (C) or only a Test line (T) in the result window, the test did not run correctly and the results are not valid.

 

 
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. 

 

Other Information

 

  • This kit is a qualitative detection, which cannot determine the exact content of antigen.
  • The test is intended for use outside the body only.
  • Not to be taken internally. Avoid sample buffer contact with skin and eyes.
  • Protect from sunlight, do not freeze. Store in a dry place between 2°C and 30°C. Do not use after the expiration date printed on the package.
  • Keep out of the reach of children. Any child under age 18 shouldn’t perform the test without parental guidance, or professional aid.
  • Not following the exact instructions can affect the outcome of the test. The final diagnosis must be confirmed by a physician.
  • Do not use the test if the packaging is damaged. Do not use broken test components.
  • All test components are only intended to be used for this test. Do not reuse the test or test components.
  • The test should be carried out immediately or within one hour after opening the foil pouch (15-30°C, humidity <60%).
  • Samples be processed as soon as possible after sample collection. If the test cannot be performed immediately, the sample should be stored in a sealed state, stored at 2~8°C for 8 hours, and stored below -20°C for 1 month.
  • Long-term storage is not recommended.


Certificate

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