Image source: GenSure

World’s First Dual IVDR-Certified One-Step Strep A Rapid Test by GenSure Biotech Sets New Benchmark for Rapid Respiratory Infection Diagnostics

An innovative Group A Streptococcus “One-Step Antigen Extraction + Detection” Kit (immunochromatography), developed by GenSure Biotech Inc., has successfully obtained both Class B and Class C EU IVDR certifications for in vitro diagnostic medical devices.

It is the first and only single-step Strep A Rapid Test in the world to receive dual certification for both professional use and self-testing, setting a new global standard for next-generation rapid diagnostic technology.

This milestone is not just a compliance breakthrough. It marks a new global benchmark in the rapid detection of Group A Streptococcus for Chinese companies—with original technology and an international-level quality system, GenSure Biotech Inc. has successfully set a new standard, and showcased the technical and regulatory capabilities of China’s IVD industry in the respiratory rapid-diagnosis field.

1. IVDR: “Ceiling” of Diagnostic Industry Regulation & Touchstone of Technical Capability

The EU’s IVDR centres on full-lifecycle regulation and clinical evidence, creating a robust safety-and-efficacy shield for IVD products. Many traditional rapid-test products have faced elimination due to inability to meet its stringent performance validation and clinical traceability requirements.

GenSure Group A Streptococcus Rapid Test Kit is the first and only one-step antigen extraction + detection product worldwide to obtain IVDR certification. Its breakthrough lies in the proprietary 2-in-1 reaction buffer system, which simplifies the procedure into a single-step operation while maintaining accuracy comparable to central laboratory reference methods. This innovation solves the long-standing challenge of balancing simplicity and precision, enhancing diagnostic efficiency in both clinical and home settings.

2. Precision Diagnostics: Addressing the Global Burden of GAS

Group A Streptococcus (GAS) infection remains a major public health concern globally. According to The Lancet, there are over 600 million cases of GAS pharyngitis and 110 million cases of skin infections each year. In Europe, GAS infections are prevalent among children, with 20–30% of acute pharyngitis caused by GAS. Invasive GAS infections (iGAS) have high mortality, with EU data reporting 10–25% fatality rates.

Rapid and accurate diagnostics are critical for rational medication use, controlling infection, and reducing complications. This innovative kit provides instant and reliable testing for clinics, pharmacies, and home use, reducing the “testing-to-treatment” window from 24–48 hours to just a few minutes.

3. Redefining Market Landscape: From “Regulatory Access” to “Value Leadership”

Achieving IVDR certification means that GenSure one-step antigen extraction + detection kit holds the “passport” for unobstructed access to the EU market. More importantly, it is reshaping industry competition logic and market structure:

For medical institutions, IVDR certification is the most authoritative endorsement of product performance and quality. In procurement decisions it is no longer merely a gateway but a core criterion for assessing clinical value and reliability, helping institutions quickly identify top solutions.

For industry competition, this certificate sets a new technological benchmark. It signals a shift in IVD rapid-test competition from “price-driven” / “function-driven” to a higher dimension of “evidence-driven” / “value-creation” competition. Companies must provide clinical evidence verified to international standards and implement full-lifecycle quality management to win future markets.

4. Core Advantages: Simple, Accurate, Reliable

The kit emphasizes “simplicity, accuracy, and reliability”, optimizing the workflow for professional and home settings. Key features include:

Simplified, Reliable, Ready-to-Use

GenSure Strep A Rapid Test features a unique 2-in-1 buffer system with a preloaded antigen extraction buffer, streamlining sample processing to just 2 minutes. By combining two traditional buffers into one and eliminating stepwise reagent addition, it reduces operational errors, shortens processing time, and ensures accurate results—even for non-professional users.

5-Minute Rapid Readout

While most competitor products require 10–15 minutes, GenSure’s product delivers clear interpretation as fast as in just 5 minutes—accelerating clinical decision making and home-check experience.

24-Month Extended Shelf Life: Stable storage under 4–30 °C, outperforming most similar products (typically 12–18 months), reducing inventory pressure and resource waste.

Dual Use for Professional and Self-Test: Suitable for both adults and children, serving diverse scenarios from emergency, pediatrics to home self-testing.

5. Future Prospects: Advancing Global Public Health Through Diagnostic Innovation

“IVDR certification means a comprehensive validation of our scientific team, R&D and quality systems,” said Dr. Terry Chan, CEO of GenSure Biotech Inc.

“Our goal is not just market access, but solving real clinical challenges and providing better solutions for global respiratory-infection prevention and control.”

The company will continue to advance global registration and application of this product in more markets, delivering a high-performance diagnostic solution that meets the highest global standards.

6. Expanding the IVDR Portfolio: Accelerating Global Access to Trusted Diagnostics

In addition to the Strep A Rapid Test, three other GenSure Biotech products — the Flu A+B Rapid Test, HCG Pregnancy Rapid Test, and LH Ovulation Rapid Test — were also successfully IVDR-certified in August 2025. Furthermore, five additional products, including the COVID-19 Rapid Test, COVID-19/Flu A+B Combo Test, COVID-19/RSV/Flu A+B Combo Test, Fecal Occult Blood (FOB) Rapid Test, and H. pylori Antigen Rapid Test, are expected to join the IVDR-certified portfolio soon, strengthening GenSure’s commitment to global quality standards and clinical excellence.

With continuous innovation and stringent regulatory compliance, GenSure Biotech Inc. is empowering healthcare professionals and patients worldwide with faster, more accurate, and more accessible diagnostic solutions.

For partnership or product inquiries, please contact info@gensbio.com or call +86-10-56370138.