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Antigen Rapid Test Cassete

Clungene COVID-19 Antigen Rapid Test Professional (pack of 25)

For professionals only

Qualitative throat-nose swab, intended for use by healthcare professionals only.

  • Fast and safe testing with nasopharyngeal swabs
  • Results after 10 – 15 minutes at the latest
  • Sensitivity 97.7%; specificity 99.8%.
  • BfArM-listed and billable
  • Ideal for medical facilities, nursing homes and homes for the elderly
  • Certified according to EN ISO 13485:2016
  • 1 test kit contains 25 tests incl. consumables
  • Individual quantity discounts on request
genius-pharmaceutical-ag-LUNGENE-Rapid-Test-Cassette

More information about this test:

 

This rapid antigen test is a lateral flow immunoassay method used for the qualitative detection of acute COVID-19 infection. A nasopharyngeal or oropharyngeal swab is taken from a person suspected of having COVID-19 infection. The result can be read after 10-15 minutes.

 

The Clungene COVID-19 Antigen Rapid Test is an in vitro diagnostic and therefore a medical device.

 

This test is intended for use by healthcare professionals only. Therefore, the following proof is required when ordering in accordance with the Medical Devices Dispensing Ordinance § 3 paragraph 4.

 

Dispensing of Covid-19 antigen tests >>

 

Please complete and sign this document and send it by e-mail to info@geniuspharma.ch, or by fax to +41 525 880 481.

 

Please note! With your purchase, you confirm that you are placing the order for commercial/medical purposes and that you are handing the test over to appropriate qualified personnel. Each order will therefore be carefully checked! Please understand that we will have to cancel your order if you cannot provide proof that you are an authorised person according to MPAV.

Advantages

  • Fast and secure test execution
  • Can be used flexibly and from any location
  • Easy to use
  • Results after 10 – 15 minutes at the latest
  • Sensitivity 97.1%
  • Specificity 99.4%
  • Storage at room temperature
  • No cross activity with other coronaviruses such as KHU1, MERS, 229E, NL63, influenza viruses or rhinoviruses
  • Storage in sealed bag between 4 and 30 °C

Product features of the Clungene Covid-19 Antigen Rapid Test

  • Listed at the German Federal Institute for Drugs and Medical Devices (BfArM), billable
  • Reference number of the BfArM approval: AT526/21
  • Evaluated by the Paul Ehrlich Institute
  • TÜV Rheinland certified
  • Certified according to EN ISO 13485:2016
  • Only for in-vitro diagnostics
  • For use by healthcare professionals only
  • Sensitivity: 97.7 % (93.5-99.2 %)
  • Specificity: 99.8 % (98.8-100 %)
  • Sample: throat or nasal swab
    Duration of test result: 10 – 15 minutes
  • Test to be carried out at room temperature (15 – 30 °C, please bring test material to room temperature beforehand)
  • Scope of delivery: one test instruction, 25 individually packed test kits, each consisting of 1 x test cassette, reagent tube with reagent solution, sterile swab
  • Return policy: This item is excluded from return

COVID-19 Antigen Rapid Test Cassete - Test Procedure

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Operation manual - COVID-19 Antigen Rapid Test Cassete

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Contact Info

Further informations

If you have any questions or are interested in our products, just give us a call or send us an email.

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