On September 7th, Boditai (Xiamen) Biotechnology Co., Ltd. RAPID SARS-COV-2 ANTIGEN TEST CARD
(for self–test) (FRONT NOSE) successfully passed the performance verification of the Paul-Ehrlich-Institut (PEI*, Paul-Ehrlich-Institut) in Germany. The product was listed on the German BfArm as early as April this year. This means that Bodite's SARS-COV-2 antigen (nose swab) test card (for self-test) has passed the test with the highest gold content and recognition in Europe, and successfully entered the German market. At the same time, it is also an affirmation of the quality of Bodithai products, providing firm confidence and strong support for Bodithai products to further open up the international market, and also contributing a solid force to the global prevention and control of the new crown epidemic.
PEI performance testing column name
List of new crown diagnostic reagents registered by BfArm in Germany-Antigen
At present, the new crown epidemic is still spreading at an alarming rate around the world, and the large demand for nucleic acid testing has caused a relatively serious medical run, and hospitals are operating at full capacity. Rapid household
antigen reagents are an important tool for fighting the epidemic in the future.
RAPID SARS-COV-2 ANTIGEN TEST CARD (for self-test) (FRONT NOSE) self-developed by Boditai is a one-step in vitro detection based on immunochromatography , can quickly and qualitatively determine the SARS-CoV-2 virus antigen in
the anterior nasal (anterior nasal) swab of a suspected SARS-CoV-2 individual, which has great advantages:
1. Sampling is convenient, (the matching swab is convenient for personal or family self-sampling and testing)
2. Rapid detection (test results can be obtained within 15 minutes)
3. Easy to operate (no need for equipment and tedious operation)
4. The result is accurate (the detection sensitivity is 98.16%, the specificity is 99.18%, and the accuracy is 99.13%)
Boditai (Xiamen) Biotechnology Co., Ltd. was founded by a team of overseas returnees, specializing in the development and production of diagnostic reagents. The core technical team has gathered a group of doctors, returnees and foreigners. The company has accumulated profound cooperation resources in domestic and foreign medical and health systems, and has established long-term and stable cooperation channels in many overseas countries. This performance verification is another affirmation of the quality of Bodite products. At present, the global epidemic prevention and control work has achieved initial results. However, in the post-epidemic era, Bodite continues to show the world the strength of independent research and development and innovative development. Brand strength, continuously optimize the new crown epidemic solution, and contribute to building a global anti-epidemic firewall!
*Note: PEI: German Paul Ehrlich Institute (German: Paul-Ehrlich-Institut), also known as the German Federal Institute for Vaccines and Biomedicine, is a research institution and medical regulatory agency of the German Federation, currently under the Federal Ministry of Health (BMG), which independently performs the functions of biological product inspection, clinical trial approval, product approval and marketing, and batch release, and also undertakes the drafting and revision of relevant regulations for different organizations, especially for some EU countries, EU and international committees Provide scientific advice, but also provide professional advice to the German government, local agencies and Congress, and provide relevant information to patients and consumers.