Quality assurance for high-throughput bioassay methods

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.

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 . (canceled)