Colorcom Bio Medical Diagnostics Announces EU IVDR Certification for Strep A Rapid Antigen Test Kit.
Hangzhou, China – Colorcom Bio, a global leader in innovative diagnostic solutions, today announced that its Strep A Rapid Antigen Test Kit has successfully obtained Class C self-testing certification under the European Union’s In Vitro Diagnostic Medical Device Regulation (IVDR, EU 2017/746). This milestone underscores the product’s compliance with the EU’s most stringent safety, efficacy, and quality standards, positioning it as a trusted solution for at-home detection of Group A Streptococcus (GAS) infections worldwide.
The IVDR framework, enacted to prioritize clinical safety and transparency, mandates rigorous performance evaluation, clinical validation, and manufacturing quality audits. Colorcom Bio’s certification demonstrates alignment with global benchmarks, enabling rapid deployment across 27 EU member states and reinforcing its role in combating antimicrobial resistance through targeted diagnosis.
Group A Streptococcus (GAS), a leading cause of pharyngitis and scarlet fever, contributes to over 500,000 global deaths annually. Traditional bacterial culture methods, though accurate, require 24-48 hours for results. Colorcom Bio’s kit delivers lab-comparable accuracy within 5 minutes, empowering households, schools, and clinics to make timely treatment decisions. Key advantages include:
- >95% Clinical Sensitivity & Specificity
- User-Friendly Design: No specialized training required
- Dual Application: Validated for both adults and children (age 3+)
Simple Three-Step Testing
Collect: Swab the throat tonsil area.
Process: Mix the swab with extraction buffer and apply to the test cassette.
Read: Results visible in 5 minutes—clear positive/negative lines.
By enabling early detection, the kit helps reduce unnecessary antibiotic use and prevent severe complications like rheumatic fever.
Post time: 2025-05-12 16:57:27