Mass Spectrometry Quantitation of Chromogranin A Without Immunoassays

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Current immunoassays for measuring chromogranin A (CgA) in blood face challenges due to non-specific binding and reduced dynamic range, limiting their effectiveness in diagnostic laboratories.

Innovation Solution

A method for detecting CgA using mass spectrometry, involving purification, ionization, and quantitation of CgA ions through techniques like solid phase extraction, enzymatic digestion, and liquid chromatography, without the use of antibodies, enabling precise measurement of CgA levels.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If immunoassays are used to measure chromogranin A, then the measurement can be performed with standard laboratory equipment, but non-specific binding and reduced dynamic range occur

Engineering Contradiction:
Improveease of assay implementationVSAvoidmeasurement accuracy
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent replaces the immunoassay system (which relies on antibody-antigen binding) with a mass spectrometry-based system that uses peptide sequencing and mass-to-charge ratio detection. This substitution eliminates non-specific binding issues inherent in antibody-based assays while maintaining laboratory implementability through standardized MS protocols.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the detection parameter from signal intensity (as in immunoassays) to mass-to-charge ratio and peptide sequence identification. This parameter transformation enables precise quantification without the dynamic range limitations of antibody-based methods, as mass spectrometry can accurately detect and quantify peptides across a wide concentration range.

Inventive Principle:
Principle #35Parameter changes

2Ease of manufacture

If immunoassays are used for chromogranin A measurement, then the assay can be performed with standard equipment, but dynamic range is reduced requiring sample dilution

Engineering Contradiction:
Improveease of assay implementationVSAvoiddynamic range
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The patent substitutes the immunoassay detection mechanism with mass spectrometry, which inherently provides a wider dynamic range. The MS system can detect and quantify chromogranin A peptides across multiple orders of magnitude without requiring sample dilution, as the mass-to-charge ratio detection is linear and not saturation-limited like antibody binding assays.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If mass spectrometry is used to detect chromogranin A, then measurement precision and sensitivity are improved, but the complexity of the detection system increases

Engineering Contradiction:
Improvequantitation accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the chromogranin A protein into specific peptide fragments through enzymatic digestion (e.g., using trypsin). This segmentation allows the mass spectrometry system to detect and quantify specific peptide sequences (such as residues 1-10 or 11-20) rather than requiring analysis of the entire protein, thereby reducing the complexity of the measurement process while maintaining high precision.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces an intermediary step of enzymatic digestion to convert the complex chromogranin A protein into simpler peptide fragments that are more suitable for mass spectrometry analysis. This intermediary process simplifies the detection requirement, allowing standard MS instruments to achieve precise quantification without requiring complex sample preparation or specialized instrumentation.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Measurement precision

If chromogranin A is purified and ionized for mass spectrometry, then detection sensitivity is enhanced, but the sample preparation steps increase

Engineering Contradiction:
Improvedetection sensitivityVSAvoidsample preparation complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent performs preliminary enzymatic digestion of chromogranin A into peptides before mass spectrometry analysis. This preliminary action simplifies subsequent purification steps and enhances detection sensitivity, as the peptide fragments are more volatile and ionizable than the intact protein, requiring less extensive sample preparation while achieving higher MS detection sensitivity.

Inventive Principle:
Principle #10Preliminary action

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

The method provides accurate and sensitive quantitation of CgA with a low limit of detection and quantitation, suitable for diagnosing neuroendocrine tumors and monitoring treatment response, with high reproducibility and wide linear range.

Implementation Method 1

purifying CgA in the sample comprising subjecting the sample to solid phase extraction

Methodology Applied
Scientific EffectSolid phase extraction:

Implementation Method 2

enzymatically digesting the CgA

Methodology Applied
Scientific EffectEnzymatic digestion: Enzyme

Implementation Method 3

subjecting the CgA to liquid chromatography

Methodology Applied
Scientific EffectLiquid chromatography: Chromatography

Implementation Method 4

the ionization comprises electrospray ionization (ESI)

Methodology Applied
Scientific EffectElectrospray ionization:

Implementation Method 5

the ionization comprises atmospheric pressure chemical ionization (APCI)

Methodology Applied
Scientific EffectAtmospheric pressure chemical ionization:

Implementation Method 6

determining the amount of the ion(s) from step (b) by mass spectrometry, measuring the amount of fragment ion having a mass-to-charge ratio of 831.5 ± 0.5 or 989.5 ± 0.5

Methodology Applied
Scientific EffectMass spectrometry:

Data Source

PatentEP3765858B1Methods for detecting chromogranin a by mass spectrometry
Publication Date: 2025.11.26 QUEST DIAGNOSTICS INVESTMENTS INC
  • EP3765858B1 patent drawingFigure 1
  • EP3765858B1 patent drawingFigure 2
  • EP3765858B1 patent drawingFigure 3

AI summary

Provided are methods for detecting chromogranin A by mass spectrometry. In another aspect, provided herein are methods for quantitating chromogranin A by mass spectrometry. In another aspect, provided herein are methods for prognosis of or measuring the size of neuroendocrine tumors by mass spectrometry.