An integrated device for fast and sensitive immunosuppressant detection.

Area of Science:

• Biomedical Engineering
• Analytical Chemistry
• Clinical Diagnostics

Background:

• Therapeutic Drug Monitoring (TDM) is crucial for optimizing immunosuppressant dosages.
• Existing TDM methods can be time-consuming and require specialized laboratory settings.
• There is a need for rapid, point-of-care (POC) diagnostic tools for TDM.

Purpose of the Study:

• To develop and validate a compact optical device for POC TDM.
• To enable simultaneous, sensitive detection of immunosuppressants.
• To utilize microfluidics and advanced particle technology for improved assay performance.

Main Methods:

• Design and integration of a disposable plastic microfluidic chip with ten parallel microchannels.
• Incorporation of a microfluidic system for automated sample and reagent handling.
• Utilization of submicrometric fluorescent magnetic particles for enhanced immunoassay efficiency.
• Development of integrated thin-film amorphous silicon photodiodes for fluorescence detection.

Main Results:

• Demonstration of a compact, integrated optical device for TDM.
• Successful simultaneous detection of multiple analytes with replicate measurements.
• Achieved enhanced assay sensitivity and lower limit of detection using fluorescent magnetic particles.
• Validated the device's performance by detecting mycophenolic acid and cyclosporine A in spiked solutions and patient microdialysate samples.

Conclusions:

• The developed optical POC device offers a promising solution for rapid TDM.
• The use of microfluidics and fluorescent magnetic particles significantly improves assay speed and sensitivity.
• This technology has the potential to enhance patient management through timely drug level monitoring.