Recently, two respiratory multi-pathogen detection reagents developed by Gensure Biotech Inc. — the COVID-19/Flu A+B Ag Rapid Test and the COVID-19/RSV/Flu A+B Ag Rapid Test — simultaneously received EU CE IVDR certifications for professional medical use and self-testing. This marks another milestone for GenSure Biotech Inc. after four home test kits were IVDR certified in August 2025. 

With solid product strength, the company aligns once again with EU standards, providing more convenient and reliable diagnostic options for both professional and home self-testing in Europe and around the world.

COVID-19/Flu A+B Ag Rapid Test：Simultaneously detects COVID-19, Influenza A, and Influenza B viruses, completing the detection of three types of pathogens with a single step.

COVID-19/RSV/Flu A+B Ag Rapid Test：Building on COVID-19/Flu A+B Ag Rapid Test, the addition of Respiratory Syncytial Virus (RSV) detection allows for a four-in-one test with a single sample, significantly saving time and enhancing the user experience.

1.Strictly control quality to build product competitiveness with international standards

The success of this certification is due to GenSure Biotech's strict control over the entire product lifecycle. The company established a cross-departmental special team and invested millions of yuan to fully align with EU IVDR high standards from research and development to clinical stages.

R&D Phase: Internationally recognized EU standard substances were used for multiple rounds of verification to ensure that key indicators such as product sensitivity and specificity met regulatory requirements.

Clinical Validation: On-site evaluations were carried out at clinical centers in Europe. Both products demonstrated stable performance and accurate results, receiving recognition from international institutions, making them suitable for both home self-testing and professional use.

Innovative Design, Simplifying Complexity

The certified products feature GenSure’s innovative technology and unique fan-shaped card box design, which have been patented in both China and Germany. This design truly realizes "one sample, one addition." It breaks away from the complex processes of repeated drops and batch operations in traditional tests, addressing users' core pain points and making the testing process simpler, more efficient, and better suited to the practical needs of home self-testing.

2.Certification empowers and accelerates global expansion

The EU CE IVDR certification is one of the authoritative standards for market access in the international medical device sector. The successful acquisition of these two certifications marks that GenSure's quality system, production management, and clinical performance have all aligned with international standards. This not only paves the way for the company's products to enter the European market but also lays the foundation for expanding into other major global markets. GenSure Biotech will continue to drive global public health and prevention efforts with innovative technologies and reliable quality, providing high-quality in vitro diagnostic solutions for more users.

About Us

GenSure Biotech Inc. is a high-tech enterprise specializing in the research, development, manufacturing, and commercialization of in vitro diagnostic (IVD) products. Our portfolio covers multiple fields, including respiratory, gastrointestinal, infectious diseases, cancer screening, and chronic disease management. GenSure products have been registered and widely adopted in dozens of countries and regions worldwide.

Contact Us

Website: www.gensbio.com

Email: info@gensbio.com

Tel: +86-10-56370138