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

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

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Brand Name : LABNOVATION

Model Number : LX-401301

Certification : ISO13485,ISO9001,CE

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

Quanlity Guarantee Period : 24 months

Test Time : Within 15 min

Group : Universal

Type : IVD Diagnostic Equipment

Certificated : CE Certificated, ISO13485

Application : Professional Test Use

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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.


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

Item Value
Model Number LX-401301
Type 20 Tests/Kit
Warranty 24 Months
Quality Certification CE
Safty Standard ISO13485
Sample Type nasopharyngeal / oropharyngeal
Sample Volume 3 full drops


Main Components

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

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

SARS-CoV-2 Antigen Rapid Test Kit
Sensitivity Specificity Total Accuracy
98.04% 100.00% 99.60%

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


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

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

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.

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

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.


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

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


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