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Oropharyngeal Swabs Antigen Rapid Test Kit ISO 13485 SARS-CoV-2 Rapid Ag Test Kit

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Oropharyngeal Swabs Antigen Rapid Test Kit ISO 13485 SARS-CoV-2 Rapid Ag Test 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

Specificity : 100.00%

Sensitivity : 98.04%

Total Accuracy : 99.60%

Specimen : Nasopharyngeal Swab Or Oropharyngeal swabs

Test Time : <15 min

Quanlity Guarantee Period : 24 months

Group : All People

Storage Condition : 2℃-30℃

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Antigen Rapid Test Kit SARS-CoV-2 Antigen Rapid Test Kit

Intend Use
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 infection from patients. The test provides preliminary test results. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or other management decision.


Product Details

Item Value
Model Number LX-401301
Type 20 Tests
Warranty 24 Months
Quality Certification CE,MSDS
Safty Standard ISO13485
After-sale Service Online technical support
Test Speed Within 15 minutes
Sample Type Nasopharyngeal or Oropharyngeal
Specificity 100.00%
Sensitivity 98.04%
Total Accuracy 99.60%


Oropharyngeal Swabs Antigen Rapid Test Kit ISO 13485 SARS-CoV-2 Rapid Ag Test Kit

Main Components

  • 20 Test Cassettes
  • 20 Sample tubes
  • 1 Sample extraction
  • 20 Swabs
  • 1 Instruction for use

Oropharyngeal Swabs Antigen Rapid Test Kit ISO 13485 SARS-CoV-2 Rapid Ag Test Kit

Product Features

  • Fast: Result in 15 minutes
  • Simple : Easy to operate without extra instrument
  • Sample Type: Patient sample collected by throat swab or nasal swab

Oropharyngeal Swabs Antigen Rapid Test Kit ISO 13485 SARS-CoV-2 Rapid Ag Test Kit

Test Principle

This kit is an immunochromatography assay. According to the gold immunochromatographic test principle, double antibody sandwich method was used to detect SARS-CoV-2 nucleocapsid antigen in the samples.

Use Step

  • Add 550μL sample extraction (about 22-24 drops) into the sample tube.
  • Insert the swab into the sample tube prefilled with extraction buffer. Mix well and squeeze the swab 10-15 times by compressing the wall s of the tube against the swab.
  • Roll the swab head against the inner wall of the tubes as you remove it. Try to release as much liquid as possibe. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
  • 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.

Oropharyngeal Swabs Antigen Rapid Test Kit ISO 13485 SARS-CoV-2 Rapid Ag Test Kit

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).

  • INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure.


Oropharyngeal Swabs Antigen Rapid Test Kit ISO 13485 SARS-CoV-2 Rapid Ag Test 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.


Certificate
Oropharyngeal Swabs Antigen Rapid Test Kit ISO 13485 SARS-CoV-2 Rapid Ag Test Kit


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