ISO13485 Sars-Cov-2 Antigen Test Kit 15min Test Time 20 Tests/Kit

Brand Name:LABNOVATION
Certification:ISO13485,ISO9001,CE
Model Number:LX-401301
Minimum Order Quantity:10000 Pieces
Delivery Time:5-7 work day
Payment Terms:T/T, D/A, D/P
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Location: Shenzhen China
Address: 101 and 5th Floor, Building 1, No. 68,18th Road, Guangming Hi-Tech Park, Tangjia Community, Fenghuang Street, Guangming District, Shenzhen 518107 ,China
Supplier`s last login times: within 29 hours
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Product Details

Rapid Antigen Test Kit SARS-CoV-2 Antigen Rapid Diagnostic Test Professional Use CE Certificated


Intend Use

This rapid test kit is intended for the qualitative detection of SARS-CoV-2 infection from patients. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 infection in conjunction with clinical presentation and results of other laboratory tests. The test provides preliminary test results. It is for professional use only.



Product Details

ItemValue
Model NumberLX-401301
Type20 Tests/Kit
Warranty24 Months
Quality CertificationCE
Safty StandardISO13485
Sample Typenasopharyngeal / oropharyngeal
Sample Volume3 full drops


Main Components

  • Test Cassettes
  • Sample tubes with Prefilled Sample extraction buffer
  • Swabs
  • Tube Stand
  • Instruction for use


Analytical Results

SARS-CoV-2 Antigen Rapid Test Kit
SensitivitySpecificityTotal Accuracy
98.04%100.00%99.60%


Product Features

  • Fast: Quick detected virus directly and get result rapidly (within 15 minutes)
  • Simple: Easy to operate, no extra equipment needed
  • Convenient: Room temperature storage, 20 tests/kit
  • Reliable: High accuracy, sensitivity and specificity

Test steps

  1. Take a sample tube (with prefilled sample extraction solution).Remove the aluminum foil sealing of the prefilled sample extraction tube and then put the tube into the tube stand.
  2. Dip the swab into the sample extraction liquid after sample collection, fully immerse the tip of the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the stranded liquid as much as possible.
  3. Close the cap 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 15-20 minutes 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.Omicron

FAQ

  • How about the deliver?

We can send by Express, Air cargo or Ocean cargo.

  • Does the price is competitive?

As we're manufacturer, we make sure to offer you the best quality with competitive price.

  • How about the payment?

We accept many payment term, such as T/T, D/P, D/A etc.


Certificate

China ISO13485 Sars-Cov-2 Antigen Test Kit 15min Test Time 20 Tests/Kit supplier

ISO13485 Sars-Cov-2 Antigen Test Kit 15min Test Time 20 Tests/Kit

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