Quality assurance/quality control for high throughput bioassay process
First Claim
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.
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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.
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Citations
27 Claims
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1. A method, comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method of quality assurance employing a biochip model generated based on mass spectra obtained from application of a diverse group of sera to each of a plurality of different biochips, comprising:
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applying a serum to a spot on a biochip;
performing mass spectrometry on the serum to obtain a spectrum associated with the serum and the biochip;
mapping the spectrum to a biochip model; and
if the spectrum maps to the biochip model, submitting the spectrum to a biological diagnostic. - View Dependent Claims (9, 10, 11, 12)
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13. A method, comprising:
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applying each of a 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 and on each serum of the diverse group of sera;
generating a biochip model based at least in part on the spectra obtained from all of the plurality of different biochips;
performing mass spectrometry on a test serum applied to a spot on a test biochip to obtain a spectrum associated with the test serum and the test biochip;
mapping the spectrum to the biochip model; and
determining whether the test serum and biochip produce a spectrum within a predetermined tolerance. - View Dependent Claims (14, 15, 16, 17)
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18. A method of quality assurance employing first and second biochip models, each generated based on mass spectra obtained from application of a diverse group of sera to each of a first and second different biochip types and having a cluster associated with each of the first and second biochip types, comprising:
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applying a serum to a spot on a first biochip associated with a biochip model;
performing a first mass spectrometry on the serum disposed on the first biochip to obtain a spectrum associated with the serum;
mapping the spectrum obtained from said performing a first mass spectrometry to the biochip model;
determining that the spectrum does not map to a cluster associated with the first biochip;
applying the serum to a spot on a second biochip the second biochip being associated with a second cluster;
performing a second mass spectrometry on the serum applied to the second biochip to obtain a second spectrum associated with the serum; and
mapping the spectrum obtained from said performing a second mass spectrometry to the biochip model. - View Dependent Claims (19, 20, 21, 22)
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23. A method, comprising:
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selecting a diverse group of sera, the diverse group of sera having different characteristics;
separating proteins within at least one sera of the diverse group of sera using a bioassay process;
performing mass spectrometry on at least one serum of the diverse group of sera;
generating a control model based at least in part on the spectra obtained from the at least one serum of the diverse group of sera;
separating proteins within a test serum using a bioassay process;
obtaining data from the at least one serum of the diverse group of sera, the data including a spectrum associated with the test serum and the bioassay process;
mapping the spectrum obtained from said performing to the control model; and
determining whether the spectrum maps to the model. - View Dependent Claims (24, 25, 26, 27)
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Specification