Quality assurance for high-throughput bioassay methods
First Claim
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.
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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.
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Citations
24 Claims
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1. A method of initializing a control model for a bioassay process, the method comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method of testing a bioassay process, the method comprising:
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retrieving an aliquot of a preserved molecular mixture;
obtaining data from the retrieved molecular mixture using the bioassay process, the data having a plurality of predetermined features; and
determining a distance based on a plotted location of the predetermined features and a predetermined centroid, the centroid being defined in n-dimensional space. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. A method of testing a bioassay process against a control model, the method comprising:
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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;
computing a location of a centroid in n-dimensional space based on the data obtained form the at least one aliquot of the preserved mixture, the location of the centroid in n-dimensional space defining the control model;
retrieving an aliquot of the preserved molecular mixture at a time following the computing of the control model;
obtaining data from the retrieved molecular mixture using the bioassay process, the data having a plurality of predetermined features; and
determining a distance based on a plotted location of the predetermined features and a predetermined centroid, the centroid being defined in n-dimensional space. - View Dependent Claims (16, 17, 18, 19, 20)
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21. A method, comprising:
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retrieving an aliquot of a preserved molecular mixture;
analyzing data from the retrieved molecular mixture using a bioassay process;
comparing a test set of predetermined features of the retrieved molecular mixture with a control set of predetermined features, the control set of predetermined features defining a centroid in n-dimensional space, the test set of predetermined features of the retrieved mixture being the same as the control set of predetermined features; and
determining a degree of error based on a difference between the position of a control centroid, the position of the control centroid being based on the control set of predetermined features and the position of a test centroid, the position of the test centroid being based on the test set of predetermined features of the retrieved molecular mixture. - View Dependent Claims (22, 23, 24)
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Specification