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Transforming Iron Deficiency and Anemia Diagnosis with BioAnalyt's Microfluidic Point-of-Care Device
Iron deficiency (ID) and iron deficiency anemia (IDA) impact a significant portion of the global population, often going undiagnosed due to the complexity and cost of current diagnostic methods. BioAnalyt, with the support of the Microfluidics Innovation Hub (MIH) and its partners, is developing a groundbreaking point-of-care (PoC) diagnostic device aimed at simplifying and accelerating the detection of these conditions. This interview with Dr. Anna Zhenchuk, Managing Director of BioAnalyt GmbH, delves into the company’s innovative approach and the profound impact of their project.
Understanding BioAnalyt's Mission
BioAnalyt is committed to revolutionizing the field of food and nutrition analysis, making diagnostics more accessible and impactful, particularly in resource-limited settings. Since its inception in 1999, BioAnalyt has developed and commercialized a range of iCheck devices for measuring vitamins and minerals in food and biological samples. These devices are used in over 60 countries, supporting nutrition programs, animal health, and food quality, particularly for fortified foods.
Their current focus is on launching an analytical platform for single-drop analysis in the PoC diagnostic market. The first application of this platform targets the diagnosis of iron deficiency and associated anemia, leveraging multi-modal sensing technology to detect and monitor these conditions early in both clinical and field settings. This portable and user-friendly solution aims to transform iron deficiency diagnostics from acute care to preventive measures, improving health outcomes globally.
The Diagnostic Dilemma
Traditionally, diagnosing ID and IDA involves multiple, invasive blood tests and expensive laboratory equipment, leading to delays in diagnosis and treatment. This complexity often results in misdiagnosis or underdiagnosis, exacerbating health issues and economic burdens. BioAnalyt’s innovative solution addresses these challenges by providing a rapid, cost-effective, and accurate PoC diagnostic tool that simplifies the process.
BioAnalyt's Innovative Approach
BioAnalyt’s device, iCheck Anemia, employs a disposable microfluidic cuvette to collect a drop of blood from a finger prick. This microfluidic platform integrates advanced optical technologies to simultaneously measure zinc protoporphyrin (ZPP) and hemoglobin (Hb), the key biomarkers for iron deficiency and anemia, respectively. The result is delivered in under a minute, without the need for sample preparation, making it ideal for use in both clinical settings and remote locations.
Goal
Develop a microfluidic platform for rapid, accurate diagnosis of iron deficiency and anemia.
Simplify and accelerate the diagnostic process to make it more accessible and user-friendly.
Ensure reliable and reproducible sample handling and optical measurements.
Solution
Project Management and Communication: MIC coordinates the project, ensuring efficient planning, monitoring, and support.
Design Optimization and Prototyping: MIC and BST collaborate on optimizing the microfluidic chip design and producing rapid prototypes.
Injection Molding: Payer specializes in producing the micro-cuvettes using high-precision injection molding techniques.
Flow Simulation and Optimization: BST conducts simulations to ensure efficient and bubble-free sample handling within the microfluidic chip.
Documentation and Quality Control: MIC and Payer prepare all necessary documentation and ensure the quality of the manufactured components.
Requirements
High sensitivity and specificity in detecting and quantifying biomarkers for iron deficiency and anemia.
Rapid and reliable diagnostic process using a single drop of blood.
Reproducible and user-friendly microfluidic chip design that meets ISO 13485 standards.
The Role of the #MIHfamily
Micronit b.v. (MIC): Provides project management, design optimization, and prototyping of the microfluidic components.
Payer (external Partner): Specializes in the injection molding of the micro-cuvettes, ensuring precision and scalability in production.
Bionic Surface Technologies GmbH (BST): Focuses on flow simulation and optimization of the microfluidic chip design to ensure efficient sample handling and bubble-free filling.
Partners Involved
Services and Technologies
BioAnalyt’s collaboration with MIH and its members highlights the power of collective innovation in healthcare. Together, we are creating a groundbreaking diagnostic tool that promises to transform the landscape of iron deficiency and anemia diagnostics.
This project has received funding from the European Union’s HORIZON 2020 research & innovation programme under grant agreement no. 862092.
