Sensitive endotoxin detection using organic electrochemical transistors

Overview

Endotoxin contamination poses significant risks in pharmaceutical manufacturing, medical devices, and clinical diagnostics, where rapid and sensitive detection is critical. This technology leverages organic electrochemical transistors (OECTs) to create disposable biosensors capable of detecting endotoxins at concentrations below 0.03 EU/mL, delivering results within 15 minutes at a cost under $1 per test. By adapting proven OECT biosensor architectures originally validated for SARS-CoV-2 detection, this approach offers a scalable, low-cost solution for continuous endotoxin monitoring across multiple industries.

Technical specifications

• Detection platform: Thin-film organic electrochemical transistors fabricated via solution deposition, enabling low-cost, scalable production
• Biorecognition elements: Lipopolysaccharide-binding protein (LBP) and monoclonal antibodies that bind LPS with high affinity (KD approximately 10^-9 M)
• Sensitivity target: Detection limit below 0.03 EU/mL, exceeding preferred endotoxin sensor requirements
• Response time: Results delivered within 15 minutes
• Selectivity: Designed to specifically detect endotoxins while minimizing interference from dissolved organics and salts
• Operation: Compatible with a potentiostat and laptop computer, requiring minimal training and infrastructure
• Form factor: Disposable devices fabricated individually for each test, with potential for multiple independent measurements before replacement
• Cost target: Under $1 per test, enabling high-frequency or continuous monitoring workflows

Technology readiness level

The underlying OECT biosensor platform has been experimentally validated through SARS-CoV-2 detection, achieving sensitivity down to 10^-18 M (0.1 fg/mL) for the SARS-CoV-2 spike protein and 40 pfu/mL for inactive virus, with no cross-reactivity to influenza A, OC43, or SARS-CoV-1. The current proposal focuses on adapting this validated architecture to endotoxin detection by incorporating LPS-specific biorecognition elements. Future validation work will establish sensitivity to endotoxins, evaluate interference from dissolved organics and salts, and characterize response time and stability over multiple tests. The technology is at an early-to-mid stage of development, with a proven sensor platform ready for application-specific adaptation and testing.