Rapid spot test for endotoxin detection using lateral flow immunoassay
A monoclonal antibody-based lateral flow immunoassay designed as a rapid, point-of-care spot test for endotoxins. Delivers results in approximately 10 minutes from a direct sample application without specialized equipment or expertise. Features room-temperature reagent stability, over one-year shelf life, and optional smartphone-based quantification.
Overview
This solution is a monoclonal antibody-based sandwich lateral flow immunoassay (LFIA) developed for the rapid detection of endotoxins at the point of care. Designed for direct sample application, the test delivers qualitative results in approximately 10 minutes, with the added capability of quantification through a companion phone application. The self-contained kit requires no specialized equipment or technical expertise, making it accessible for use outside traditional laboratory settings. Reagents are stable at room temperature with a shelf life exceeding one year, supporting deployment in field conditions and remote environments. The product is positioned as a Class 1 low-risk device under regulatory guidelines.
Technical specifications
- Assay format: Sandwich lateral flow immunoassay using proprietary monoclonal antibodies targeting endotoxins
- Time to result: Approximately 10 minutes from direct sample application
- Sample handling: Direct application without complex preprocessing; designed to mitigate interference from common salts
- Quantification: Qualitative readout with optional smartphone app-based quantitative analysis
- Reagent stability: Stable at room temperature with a shelf life of over 12 months
- Kit design: Self-contained, portable format suitable for spot and field use
- Expertise required: None; intended for use without specialized training or laboratory infrastructure
- Manufacturing: Developed at an ISO 13485 MDSAP-certified facility
Technology readiness level
The project is in the research and development phase. The planned development pathway includes antibody development (3–4 months), assay development (2–4 months), assay optimization (2–4 months), comparative validation against the current gold standard using approximately 100 samples (2 months), and prototype finalization based on cost expectations (2–3 months). A comparative study against approved endotoxin detection methodologies is planned to support regulatory and clinical validation. In-house development capabilities enable faster turnaround through subsequent design and optimization cycles.
About NANOSPEED DIAGNOSTICS INC.
NanoSpeed Diagnostics Inc., founded in 2009 and based in Edmonton, Alberta, specializes in the development and manufacturing of proprietary point-of-care diagnostic screening test kits. The company utilizes Lateral Flow Immuno-Assay (LFIA) and lab-on-a-chip technologies to create rapid, quantitative, and qualitative diagnostic tools. Its flagship product, Test4D, was developed as the world’s first point-of-care test for Vitamin D deficiency. The company operates a dedicated manufacturing and R&D facility in the Edmonton Research Park, which holds ISO 13485 MDSAP certification. Beyond its core vitamin and mineral tests, which include panels for Ferritin, Vitamin B12, and Vitamin A, NanoSpeed is exploring advanced diagnostics, including AI-assisted analysis of blood samples.
These diagnostic solutions are designed to provide cost-effective, reliable, and accessible testing tools for healthcare professionals, clinical settings, and consumers. By enabling rapid health assessments from a single drop of blood, NanoSpeed addresses critical gaps in preventive care and remote monitoring. The company has successfully scaled its operations to reach global markets, with its products sold internationally through distribution networks serving hospitals, pharmacies, and clinics. NanoSpeed’s ongoing innovations, including regulatory-approved test kits and R&D into detection for markers like THC, demonstrate its commitment to advancing point-of-care technology and improving patient health outcomes.
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