Automated Mass Spectrometry System with Mixture of Standards
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Solution Overview
Problem
Current biomedical and healthcare assays face challenges in rapidly determining analyte concentrations in biological samples due to limitations in specificity, selectivity, and turnaround time, particularly with immunoassays and mass spectrometry techniques, which often require batch processing and external calibration curves, leading to prolonged analysis times and complex data management.
Innovation Solution
An automated system for mass spectrometry that prepares biological samples and determines analyte concentrations using a mixture of standards with unique molecular masses, eliminating the need for external calibration curves and batch processing, allowing for rapid analysis and simplified data management with a single data file per sample.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If mass spectrometry is used for analyte determination, then selectivity and specificity are improved, but analysis time and complexity increase due to batch processing requirements
Solution Approach 1:
The system performs preliminary actions by adding multiple standards with unique molecular masses to the sample before analysis, preparing internal calibration data within the same measurement run. This eliminates the need for separate batch processing and external calibration curve generation, reducing analysis time while maintaining high selectivity through the mass spectrometry detection
Solution Approach 2:
The invention merges the calibration process with the sample analysis process by using multiple standards added to each sample. Both the unknown analyte and multiple standards are analyzed simultaneously in a single mass spectrometry run, combining what were previously separate operations (calibration and measurement) into one unified process, thereby eliminating batch processing delays
2Measurement precision
If external calibration curves are used for quantitation, then measurement accuracy is improved, but device complexity and data management increase
Solution Approach 1:
The invention extracts the calibration function from the external calibration curve approach and embeds it within each sample analysis. By adding multiple standards with unique molecular masses directly to each sample, the calibration data is extracted from separate batch processes and integrated into the individual sample measurement, simplifying data management while maintaining quantitation accuracy
Solution Approach 2:
The multiple standards with unique molecular masses serve multiple functions simultaneously: they act as internal calibrants for quantitation, provide quality control references, and enable signal normalization all within a single measurement run. This multi-functionality eliminates the need for separate external calibration curves and reduces data management complexity
3Productivity
If batch processing is used for sample analysis, then throughput is improved, but turnaround time for individual samples increases
Solution Approach 1:
The system performs preliminary calibration actions within each sample run by adding multiple standards to every sample. This preliminary incorporation of calibration data eliminates the need to wait for separate calibration batches, allowing each sample to be processed and reported independently with minimal delay while maintaining high throughput through parallel processing of multiple samples
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach significantly reduces analysis time to minutes, enhances selectivity and specificity, and simplifies data management, enabling near-real-time results and flexibility in analyzing pharmaceutical compounds, including those with metabolites, while minimizing blood volume requirements and streamlining sample handling and storage.
Implementation Method 1
a sample analysis portion comprising a mass spectrometer, where the mass spectrometer produces a spectra for an analyte of interest in a sample of a bodily fluid
Implementation Method 2
the mass spectrometer produces a spectra for an analyte of interest
Implementation Method 3
a chromatography system for the purification of the analyte of interest
Implementation Method 4
a filtration unit for the removal of insoluble components like cells or platelets
Data Source
AI summary
Embodiments of the present disclosure present novel systems, devices and methods for an automated biological sample analysis using mass-spectrometry. The time from sample introduction to the reporting of data, in some embodiments, takes a relatively short amount of time (e.g., several minutes). In some embodiments, a biological sample to be analyzed is a blood sample. For many applications, only a single drop of blood may be sufficient. Through the use of a mixture of standards with unique molecular mass, a quantitative analysis of the target analyte can be performed in a single MS run (for example), eliminating the need to create and analyze standard curves. One advantage of such embodiments may be that the system, devices, and methods can eliminate the need for batch creation since the requirement to amortize the time and effort of creating and analyzing standard curves can be eliminated.