CLUNGENE® COVID-19 Antigen Self Test (Pack of 5)

WHAT IS CLUNGENE COVID-19 ANTIGEN LAY TEST?  

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The Clungene COVID-19 Antigen Lay Test has evolved from the COVID-19 Antigen Rapid Test developed by Clongene. The BfArM has granted the first special approvals according to §11 paragraph 1 of the Medical Devices Act (MPG) for antigen tests for self-administration by laypersons (self-tests) for the detection of SARS-CoV-2.

The Clungene COVID-19 layman's test can be reliably carried out in self-application and thus no medically trained personnel are required any more. 

Aktenzeichen der Sonderzulassung des BfArM 5640-S-168/21 

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ADVANTAGES 

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BfArM listed and therefore reimbursable

anterior nasal swab (about 2.5 cm deep into the nose)

highly accurate results between 15 and 20 minutes

easy handling without additional analysis system

Storage at room temperature  

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PRODUCT DETAILS  

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Specificity 99.40%

Sensitivity 97.10% (Ct =< 33)

Sample material Nasal swab

Test site Point of care (without device)

Test Type Qualitative

Storage temperature 4-30 °C

Reading time 15-20 minutes

Unit 5 tests per pack 

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SCOPE OF DELIVERY

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5 test cassettes

5 extraction reagents

5 extraction tubes

1 instruction manual 

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