Quality assurance/quality control for electrospray ionization processes
First Claim
1. A method, comprising:
- selecting a diverse group of sera, the diverse group of sera having different characteristics;
diluting each serum of the diverse group of sera with a plurality of different diluents;
obtaining information associated with a mass spectrum of each of the diluted sera from the diverse group of sera using an electrospray process;
generating a control model based at least in part on the spectrum obtained from the diverse group of sera;
diluting a test serum with a test diluent;
performing mass spectrometry on the test serum to obtain a test spectrum associated with the test serum;
mapping the test spectrum obtained from said performing to the control model;
determining whether the test spectrum obtained from said performing maps to the control 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
26 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;
diluting each serum of the diverse group of sera with a plurality of different diluents;
obtaining information associated with a mass spectrum of each of the diluted sera from the diverse group of sera using an electrospray process;
generating a control model based at least in part on the spectrum obtained from the diverse group of sera;
diluting a test serum with a test diluent;
performing mass spectrometry on the test serum to obtain a test spectrum associated with the test serum;
mapping the test spectrum obtained from said performing to the control model;
determining whether the test spectrum obtained from said performing maps to the control model. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of quality assurance employing a control model generated based on mass spectra obtained from sera analyzed following an electrospray process, the spectra being associated with a plurality of different sera and a plurality of different diluents, comprising:
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diluting a serum using a diluent;
ionizing the diluted serum using an electrospray ionization process;
performing mass spectrometry on the ionized diluted serum to obtain spectral data associated with the serum and the diluent; and
mapping the spectrum to the control model, said mapping being performed to determine if the serum and the diluent are suitable for further diagnostics. - View Dependent Claims (13, 14)
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15. A method, comprising:
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diluting at least two sera of a diverse group of sera with a diluent having a plurality of different concentrations to yield a plurality of diluted sera samples, the plurality of diluted sera samples having different concentrations of serum to diluent;
ionizing at least some of the plurality of diluted sera samples using an electrospray ionization process to yield a plurality of ionized diluted sera;
obtaining spectral data associated with the ionized diluted sera;
generating a control model associated with the diluted sera samples;
diluting a test serum with a diluent to yield a diluted test serum;
ionizing the diluted test serum using the electrospray ionization process to yield an ionized diluted test serum;
obtaining spectral data associated with the diluted test serum;
mapping the spectral data associated with the diluted test serum to the control model; and
determining whether the diluted test serum produces a spectrum within a predetermined tolerance. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23)
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24. A method, comprising:
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diluting a first serum and a second serum, the first serum having different properties from the second serum, the first serum and the second serum being diluted with a diluent to produce a diluted first serum and a diluted second serum;
ionizing the diluted first serum using an electrospray ionization process;
obtaining spectral data associated with the diluted first serum;
ionizing the diluted second serum using an electrospray ionization process;
obtaining spectral data associated with the diluted second serum;
mapping the spectral information obtained from the diluted first serum and the diluted second serum into n-dimensional space;
generating a control model based on said mapping, the control model being based on the diluted first serum and the diluted second serum;
diluting a test serum with a diluent to yield a diluted test serum;
ionizing the diluted test serum using the electrospray ionization process to yield an ionized diluted test serum;
obtaining spectral data associated with the diluted test serum;
mapping the spectral data associated with the diluted test serum to the control model; and
determining whether the diluted test serum produces a spectrum that satisfies predetermined criteria. - View Dependent Claims (25, 26)
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Specification