Quality Assurance/Quality Control for High Throughput Bioassay Process

Abstract

The present invention relates to a method of quality assurance/quality control for high-throughput bioassay processes. The method includes generating a bioassay process model, and then comparing spectral data based on a combination of a biochip and a test serum to the bioassay process model to determine if the test sample and the bioassay process are producing acceptable data. Alternatively, the method may include comparing spectral data based on a combination of serum and diluents used in an electrospray process to the bioassay process model. If the bioassay process and test sample fall within the model, then the spectrum produced may be further analyzed.

1 . A method, comprising: 
 selecting a diverse group of sera, the diverse group of sera having different characteristics;    applying each of the diverse group of sera to at least one spot on a plurality of different biochips;    performing mass spectrometry on each of said plurality of biochips;    generating a biochip model based at least in part on the spectra obtained from the plurality of different sera and biochips;    applying a test serum to a spot on a biochip;    performing mass spectrometry on the test serum to obtain a spectrum associated with the test serum;    mapping the spectrum obtained from said performing to the biochip model; and    determining whether the spectrum maps to the biochip model.    
   
   
       2 .- 27 . (canceled)