Rapid lateral flow test for bacterial endotoxin detection in aqueous solutions

Overview

Bacterial endotoxin contamination poses a significant safety risk in pharmaceutical manufacturing, medical device production, and water quality management. Traditional endotoxin detection methods, such as the Limulus Amebocyte Lysate (LAL) assay, can be time-consuming, expensive, and require specialized laboratory infrastructure. This project proposes a rapid and economic lateral flow test (LFT) for detecting bacterial endotoxins in aqueous solutions, bringing point-of-care diagnostics capabilities to endotoxin screening.

Lateral flow tests are widely recognized as proven, user-friendly point-of-care devices capable of detecting molecular targets quickly and affordably. By adapting this established technology to endotoxin detection, the solution aims to deliver a field-deployable, cost-effective alternative that reduces turnaround time and lowers testing costs for quality control workflows.

Technical specifications

Core technology:

• Lateral flow test (LFT) platform using a sandwich assay methodology to enhance sensitivity
• Designed to detect the polysaccharide chain and lipid A complex of bacterial lipopolysaccharide (LPS)

Development pathway:

• Plan A utilizes commercially available endotoxin antibodies; preliminary ELISA testing has identified two antibodies with promising specificity and sensitivity
• Plan B involves proprietary in-house antibody development using the company's antibody development platform to reduce costs and improve performance
• Methods are being optimized to conjugate the low-antigenic LPS complex with suitable carriers for reliable detection
• Interference exclusion parameters are being refined to improve overall test accuracy

Key features:

• Rapid point-of-care results compared to conventional laboratory-based assays
• Economic design intended to lower per-test costs
• Sandwich methodology to increase detection sensitivity
• Potential applicability across pharmaceutical water testing, bioprocess monitoring, and medical device quality control

Technology readiness level

The project is currently in the early-to-mid development stage. Preliminary ELISA validation has identified two endotoxin antibodies with relatively high specificity and sensitivity. Optimization of parameters to exclude interference and improve sensitivity is underway. The team is actively developing conjugation methods for the LPS antigen complex with suitable carriers. Two parallel development plans are in progress—one leveraging existing commercial antibodies for accelerated development, and a backup plan involving proprietary antibody development. The technology has not yet completed full LFT validation, and sensitivity, specificity, and cost criteria are still being evaluated against desired performance benchmarks.