Recently, Biotest announced exciting news! The company's self-developed "COVID-19 + Flu A&B+ RSV+ Adenovirus Antigen Combo Rapid Test Cassette (Nasal Swab)" has successfully passed the rigorous audit by an EU Notified Body and officially obtained CE certification under the new EU In Vitro Diagnostic Medical Device Regulation (IVDR, EU 2017/746). This achievement marks a significant milestone for the company in the field of respiratory pathogen testing.

This product is Biotest's first respiratory pathogen test kit to receive IVDR CE certification. This successful certification not only signifies a critical breakthrough for the company in adapting to the new EU regulations but also lays a solid foundation for the continued sales and global expansion of such test kits in the EU and other markets.

As an innovative product combining high efficiency and practicality, this test kit boasts three core advantages:

1. High Efficiency: It can simultaneously detect antigens of five common respiratory pathogens from a single sample within 10 minutes.

2. Versatile Application: It is suitable for various usage scenarios, including laboratory use, point-of-care testing, and home self-testing.

3. High Quality: Fully compliant with the EU's high standards, it delivers outstanding performance in sensitivity, specificity, and stability.

Sertio Oy, as an EU Notified Body officially authorized under IVDR, issues certifications with global credibility. This certification underscores Biotest's strong R&D capabilities and commitment to quality.

Looking ahead, Biotest will continue to deepen its expertise in the in vitro diagnostics field and accelerate the compliance process for more products, providing comprehensive diagnostic solutions to the global market.