Multiplexed lateral flow assay for micronutrient detection in whole blood
A multiplexed lateral flow assay (LFA) designed to detect key micronutrients such as Vitamin D, B6, and B12 in human whole blood. This point-of-care diagnostic tool offers high sensitivity and specificity, meeting FDA and EU standards for clinical and home use applications.
Overview
Gila Bioscience LLC presents an innovative multiplexed lateral flow assay (LFA) technology for the rapid detection of essential micronutrients, specifically Vitamin D, B6, and B12, in human whole blood. This assay is designed to be a cost-effective, user-friendly point-of-care diagnostic tool that can be utilized in both clinical and home settings. With the growing need for accessible health monitoring solutions, this LFA aims to facilitate early detection and intervention of micronutrient deficiencies, which are linked to various health issues.
Technical specifications
- Immunoassay-based approach: Utilizes optimized antibody/antigen interactions to ensure high sensitivity and specificity.
- Nanoparticle conjugation: Enhances detection capability and assay performance.
- Compliance and ease of use: Designed to align with FDA, EU, and CLSI protocols, ensuring regulatory compliance and clinical applicability.
- Multiplexing capability: Can detect up to three micronutrients in a single test, with options for single or multiple strips per cassette.
- Development phases: Includes feasibility, multiplexing, and optimization phases, focusing on reagent screening, scalability, and manufacturing readiness.
Technology readiness level
This technology is currently at Technology Readiness Level 6, indicating that a prototype has been demonstrated in a relevant environment. Future steps involve final validation and verification, with a structured plan over a six-month period to ensure full commercial readiness.
About Gila Bioscience LLC
Gila Bioscience is a Contract Development and Manufacturing Organization (CDMO) based in Carlsbad, California, that specializes in end-to-end diagnostic solutions. The company provides custom assay development, regulatory consulting, and GMP-compliant manufacturing for various industries, including human health, veterinary, environmental, and biodefense sectors. Their services encompass feasibility studies, reagent development, prototyping, performance optimization, and scalable production, supporting clients from the initial concept phase through to commercial launch and regulatory submission. They leverage expertise in platforms such as lateral flow, ELISA, flow-through, and microfluidics.
Gila Bioscience serves as a dedicated partner for diagnostic companies and government programs, addressing the complex challenges of bringing accurate, high-performance point-of-care tests to market. By integrating design control, documentation, and regulatory navigation—aligned with FDA, USDA, and ISO 13485 standards—they ensure that products are built for reproducibility, clinical trial integration, and commercial scalability. With a team possessing decades of combined industry experience, the company assists partners in overcoming bottlenecks in assay robustness and manufacturing, ultimately helping to facilitate faster, safer, and more accessible diagnostic outcomes in real-world settings.
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