Quality assurance for high-throughput bioassay methods

• US 20080195323A1
• Filed: 01/02/2008
• Published: 08/14/2008
• Est. Priority Date: 07/29/2002
• Status: Abandoned Application

• Current Assignee: Vermillion, Inc.
• Original Assignee: Vermillion, Inc.
• Inventors: Coleman, Timothy A., Levine, Peter J., Hitt, Ben A.
• Application Number:
  US11/968,260
• Publication Number:
  US 20080195323A1
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: C40B 30/04 by measuring the ability to specifically bind a target molecule, e.g. antibody-antigen binding, receptor-ligand binding
• CPC Class Codes: G01N 33/6803 General methods of protein analysis not limited to specific proteins or families of proteins
• CPC Class Codes: G01N 33/6848 Methods of protein analysis involving mass spectrometry
• CPC Class Codes: G16B 25/00 ICT specially adapted for hybridisation; ICT specially adapted for gene or protein expression
• CPC Class Codes: G16B 40/00 ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
• CPC Class Codes: G16B 40/10 Signal processing, e.g. from mass spectrometry [MS] or from PCR
• CPC Class Codes: Y10T 436/24 Nuclear magnetic resonance, electron spin resonance or other spin effects or mass spectrometry

Abstract

The invention relates to a method of quality assurance/quality control for high-throughput bioassay processes. The method permits monitoring of an entire system for obtaining spectral data from biological samples. Generally, the method includes generating a bioassay process model, comparing a test sample against the bioassay process model. The bioassay process model may be based on the position of a centroid in n-dimensional space. The comparing may include comparing the location of a centroid associated with the test model against the centroid associated with the control model to determine the distance between the two centroids. By generating a trend plot of the distance between the centroid associated with the test sample and the centroid associated with the control model, overall system performance may be monitored over time.

Claims

1. A method of initializing a control model for a bioassay process, the method comprising:

preparing a mixture of molecules;

dividing the mixture of molecules into a number of aliquots;

preserving the aliquots of the mixture of molecules;

retrieving at least one aliquot of the preserved mixture;

obtaining data from the at least one aliquot of the preserved mixture using the bioassay process; and

computing a location of a centroid in n-dimensional space based on the data obtained from the at least one aliquot of the preserved mixture, the location of the centroid in n-dimensional space defining the control model.

2-24. -24. (canceled)