Germany BfArM Listed

CE Notified Body Certificate 

COVID-19  SARS-CoV-2 Antigen Kit for both Self-testing (zur Eigenanwendung) and Professional Use English Deutsch bilingual packaging

SARS-CoV-2 Antigen Test is used for detection of proteins from the virus that causes COVID-19. A positive result indicates the presence of viral antigens, implying current viral infection. Like RT-PCR test, the antigen test also detects the virus directly, and performs best when the person is tested in the early stages of infection with SARS-CoV-2. The antigen test is very specific, indicating that a positive result is highly accurate. Compared with RT-PCR test, the antigen test is much easier, affordable, and faster. 

In addition, the antigen test can be performed at the point-of-care without the requirements for highly complex instruments and expertise.

FEATURES

• EASY. No special equipment and expertise needed.

• RAPID. Only 12 mins waiting time.

• Nasal swab

• Good correlation with RT-PCR detection.

• Room temperature storage

• Over the counter (OTC) accessible in Germany and Europe. both for professional use and self testing.

• Bfarm Listed in Germany

• Passed PEI evaluation
  

Kit components