🔬 CorDx Infectious Disease Tests: Rapid Diagnostics for Global Public Health CorDx’s Infectious Disease Test portfolio is a cornerstone of global public health strategy, providing rapid, accurate, and scalable diagnostic solutions that empower immediate clinical decisions and effective disease surveillance worldwide.
🧬 Diagnostic Technology: Speed and Precision at the Point-of- Care
The core of our infectious disease testing platform is the Lateral Flow Immunoassay (LFIA) technology. This tried-and-tested method enables rapid, visual detection of specific antigens (indicating an active infection) or antibodies (indicating a current or past immune response) in various sample types, including Whole Blood, Serum/Plasma, Nasal Swabs, and Feces.
The CorDx advantage lies in:
Diverse Targets: Our expansive catalog covers major global threats, from seasonal respiratory viruses (COVID-19, Influenza, RSV) to endemic diseases (Malaria, Dengue, HBsAg, HIV, Syphilis) and co-infections (Typhoid, H. Pylori).
Multiplexing: We offer advanced Multi-Panel and Combo Tests (e.g., Influenza A/B + COVID-19/RSV Combo Ag Test; Infectious Disease Test Panels) which use a single sample to simultaneously detect multiple pathogens, saving time and resources critical in fast-moving outbreaks.
Optimised Formats: We utilise reliable formats like Cassettes and Strip/Cassette combinations, designed for ease of use by both trained healthcare professionals and lay users (for authorized Over-The-Counter products). Our tests consistently deliver results with high sensitivity and specificity, often exceeding 97% in performance.
🔗 Global Reach Through Vertical Integration
As a vertically integrated manufacturer, CorDx controls the entire supply chain—from producing key raw materials like antibodies to final assembly and global distribution. This critical infrastructure is the key to our global impact:
Assured Supply: We guarantee consistent, high-volume product availability, which is essential for mass testing campaigns and preventing shortages during pandemics.
Cost-Effectiveness: Control over manufacturing costs ensures our diagnostics remain affordable, significantly improving accessibility in low- and middle-income countries where rapid, point-of-care testing is vital.
Uncompromising Quality: Our adherence to global standards, including ISO 13485:2016 and Good Manufacturing Practices (GMP), ensures every cassette and strip meets rigorous quality checks before deployment.
🌐 Regulatory Compliance and Worldwide Trust
CorDx products are trusted globally, evidenced by comprehensive regulatory clearances:
US Market: We hold necessary FDA Emergency Use Authorizations (EUA) or other clearances for products like our COVID-19 Ag Test, ensuring compliance for the United States.
European Market: A large portion of our portfolio carries the CE Mark (e.g., CE, CE 1434, CE 2934, CE 2265, CE 91), confirming conformity with the European Union’s health, safety, and performance requirements for In Vitro Diagnostic (IVD) Devices.
By delivering clinically validated, high-volume diagnostics backed by a global supply chain and stringent regulatory compliance, CorDx fulfills its mission to safeguard global communities against infectious disease threats.