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19th July 2021  Content supplied by: Jiangsu Bioperfectus Technologies Co., Ltd.

Self-Test for COVID-19 Given BfArM Stamp of Approval


Bioperfectus are thrilled to announce that our Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (self-test) has received the approval of BfArM1. This marks another milestone after we passed the PEI evaluation. It means that we are allowed to sell the self-test kit in Germany for direct pathogen detection of coronavirus SARS-CoV-2. 

In the case of a special approval of antigen tests for self-testing, BfArM evaluates not only the performance in a clinical setting, which has received a positive evaluation by the Paul Ehrlich Institute (PEI), but also the usability of its sample collection and test handling, and the instructions for use (IFU), which are specially designed for use by the general public.

Bioperfectus Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (self-test) passed the PEI assessment with clinical sensitivity 97.1% and clinical specificity 99.2%. With the flexible packaging of 1T/2T/5T/10T/15T, Bioperfectus meets the various test demands of self-testing.

The Bioperfectus Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit (self-test) has been verified to detect all SARS-CoV-2 variants and received a positive result on asymptomatic patient samples from a CLIA certified laboratory2. As one of the leading professional manufacturers of infectious disease diagnostic solutions, we Bioperfectus are looking forward to bringing our high-quality and user-friendly self-test kit to your home.

References 
1. BfArM Antigen Tests for SARS-CoV-2  
2. Centres for Medicare and Medicaid Services: Clinical Laboratory Improvement Amendments (CLIA)

For more details, please use the 'Request Information' button provided below or visit the Bioperfectus website


    

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Date Published: 19th July 2021

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