Bioteke Supports WHO's "IVD Quality Week" with CE-IVDR Certified 5-in-1 Respiratory Antigen Self-Test Kit

Bioteke Joins Global Efforts to Promote IVD Quality and Safety

Wuxi, China – June 27, 2025 – In response to the World Health Organization's(WHO) third annual “Week of Quality for In Vitro Diagnostics” (IVD Quality Week), Bioteke Corporation is proud to highlight its ongoing commitment to international diagnostic quality standards through its 5-in-1 Respiratory Multipathogen Antigen Self-Test Kit, now fully certified under the EU CE3018 IVDR self-test regulation.

WHO Emphasizes Lifecycle Quality in Diagnostics

From June 3–5, 2025, WHO hosted IVD Quality Week with a clear focus on improving diagnostic quality throughout the entire product lifecycle, including robust product design, clinical validation, and post-market performance. This aligns with the global push for safer, faster, and more accessible testing tools—especially in the field of infectious respiratory diseases.

Bioteke CE3018-Certified Innovation

Bioteke 5-in-1 self-testing solution is developed with the highest quality and user safety in mind, fully meeting the rigorous requirements of EU IVDR (In Vitro Diagnostic Regulation). The test detects 5 common respiratory pathogens, including:

• SARS-CoV-2 (COVID-19)

• Influenza A

• Influenza B

• Respiratory Syncytial Virus (RSV)

• Adenovirus

Key Product Features:

• CE3018 IVDR self-test certified

• Results in just 15 minutes

• 3 simple drops for testing

• Designed for safe home use without professional assistance

• Excellent performance, high specificity, sensitivity and accuracy

  
  

Strengthening Global Public Health Access

With increased demand for reliable at-home testing—especially in the post-pandemic world—Bioteke's kit ensures that both consumers and health systems can benefit from rapid, accessible diagnostics. The IVDR self-test certification not only ensures clinical reliability, but also enables faster market access in the EU and recognized international markets, aligning with WHO's global diagnostic access strategy.

Trusted by Distributors and Health Providers

Bioteke has partnered with medical distributors, importers, and diagnostic chains worldwide to deliver high-quality rapid testing solutions. The IVDR self-certification reflects our commitment to transparent clinical validation, production quality, and patient safety, in harmony with WHO's objectives for safer global diagnostics.

Interested in distributing Bioteke's CE-IVDR certified 5-in-1 respiratory self-test kit?
Contact Bioteke Team or Request a Quote.