This technology developed a new way to measure protein levels in blood samples without the usual hassles of purification and calibration. The method accurately detected specific proteins even in complex samples like serum. It could tell the difference between healthy people and those with infections, and even determine how severe the infection was. This approach could be a game-changer for diagnosing diseases and developing new treatments.
Figure (1) Bar diagram showing the cumulative concentration of pure β2M and β2M in serum samples which equal the measured concentration of the protein in β2M-spiked serum samples.
Traditional methods for measuring protein levels in blood samples require purification steps and calibration, which can be time-consuming and prone to error. Additionally, these methods may not accurately detect specific proteins in complex samples like serum, limiting their utility in disease diagnosis and treatment development.
- Label-Free Method: This invention offers a label-free approach for detecting and quantifying protein biomarkers, eliminating the need for complex labeling processes, which can introduce variability and additional steps.
- Versatility: The method can be applied to various sample including serum or plasma, making it adaptable to different clinical and research settings.
- Simplicity: By immobilizing a specific ligand on a CM5 sensor chip, the method streamlines the process.
- Rapid Detection: With sample injection at varying flow rates over the sensor surface, the method enables quick detection and quantification of protein biomarkers within a short timeframe.
- Broad Applicability: The method can quantify a range of protein biomarkers, including β2-microglobulin (β2M), serum amyloid A (SAA), or apolipoprotein E, enhancing its utility in diverse clinical diagnostics and biomarker studies.
The invention introduces a laboratory-tested prototype for a label-free, real-time detection and quantification method of protein biomarkers using Surface Plasmon Resonance (SPR) coupled with Calibration-Free Concentration Analysis (CFCA). This approach eliminates the need for standard calibration curves and allows direct measurement of active biomolecules in complex biological fluids such as human serum or plasma. The system uses a Biacore T200 optical biosensor with a CM5 dextran matrix sensor chip, onto which monoclonal or polyclonal antibodies are immobilized via amine coupling. The prototype has been successfully used to quantify three clinically relevant biomarkers—β2-microglobulin (β2M), Serum Amyloid A (SAA), and Apolipoprotein E—in over 150 human serum samples from both infectious and non-infectious disease cases. It has demonstrated high sensitivity (detecting β2M at levels as low as 13 ng/mL), excellent reproducibility, and the ability to function with serum dilutions ranging from 1:50 to 1:2000.
The technology is currently at the stage of demonstration and validation in a laboratory environment. It has been extensively tested using real-world clinical samples and has shown strong agreement with conventional ELISA results, confirming its diagnostic reliability. The method has proven to be robust, reproducible, and capable of analyzing complex, unpurified biological samples without additional processing. Its performance across multiple biomarkers and disease conditions highlights its potential for further development into a point-of-care diagnostic tool or clinical lab solution, pending real-world trials and regulatory validation.
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The invention offers enhanced diagnostics by improving the accuracy and speed of disease detection, enabling more timely and effective medical interventions. It contributes to better patient care through personalized treatment strategies based on precise biomarker quantification. Additionally, it supports non-invasive testing methods, reducing patient discomfort by relying on less invasive serum or plasma samples.
- Clinical Diagnostics: Early disease diagnosis and monitoring disease progression.
- Pharmaceuticals: Identifying biomarkers for drug development and monitoring therapeutic responses.
- Biotechnology: Discovering new protein biomarkers and ensuring protein purity and activity.
- Food and Environmental Safety: Detecting protein-based contaminants and ensuring food and environmental quality.
Geography of IP
Type of IP
2587/MUM/2015
394414