Clinical assay calibration adjustment method
AssigneeMayo Foundation for Medical Education and Research
InventorGeorge G. Klee
Life of this patent
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Abstract
A method for calibrating a clinical laboratory analytical instrument that includes generating control pool data from a commutable control pool, wherein the control pools have target analyte values for an assay, generating patient specimen data from a distribution of test values from patient specimens, determining tolerance limits from the control pool data and the patient specimen data; and adjusting the calibration of the instrument with respect to the tolerance limits.
Claims30
A method for calibrating a clinical laboratory analytical instrument, comprising:
- generating control pool data from a commutable control pool, wherein the control pool has target analyte values for an assay;
- generating patient specimen data from a distribution of test values for the target analyte from patient specimens;
- determining tolerance limits from the control pool data and the patient specimen data;
- and
- adjusting the calibration of the instrument with respect to the tolerance limits.
A method for calibrating a clinical laboratory instrument, comprising:
- (a) generating a serum control rule by:
- (i) providing a control pool that is commutable with patient specimen data for a particular target analyte used in an assay, and
- (ii) determining traceable target analyte values for the control pool;
- (b) generating a patient distribution index by:
- (i) reducing variation in a patient distribution, and
- (ii) tracking normalized patient test values for the target analyte;
- (c) determining tolerance limits for the maximum allowable variation of the serum control rule and the patient distribution index;
- (d) comparing the patient distribution index and the serum control rule to detect a bias with respect to the tolerance limits;
- and
- (e) adjusting the calibration of the instrument to modify the bias.
A computer readable medium encoded with a computer program, the program being arranged such that, when the program is executed, a computer performs acts comprising:
- generating control pool data from a commutable control pool, wherein the control pool has target analyte values for an assay;
- generating patient specimen data from a distribution of test values for the target analyte from patient specimens;
- determining tolerance limits from the control pool data and the patient specimen data;
- and
- adjusting the calibration of an instrument with respect to the tolerance limits.
A chemical analyzer comprising a processor responsive to a computer program, the program being arranged such that, when the program is executed, the processor performs acts comprising:
- generating control pool data from a commutable control pool, wherein the control pool has target analyte values for an assay;
- generating patient specimen data from a distribution of test values for the target analyte from patient specimens;
- determining tolerance limits from the control pool data and the patient specimen data;
- and
- adjusting the calibration of an instrument with respect to the tolerance limits.
A clinical analytical instrumentation system, comprising a central computer and a network of chemical analyzers, wherein at least one of the central computer and the analyzers comprise a processor responsive to a computer program, the program being arranged such that, when the program is executed, the processor performs acts comprising:
- generating control pool data from a commutable control pool, wherein the control pool has target analyte values for an assay;
- generating patient specimen data from a distribution of test values for the target analyte from patient specimens;
- determining tolerance limits from the control pool data and the patient specimen data;
- and
- adjusting the calibration of a chemical analyzer with respect to the tolerance limits.
A method for analyzing data in an analytical laboratory, wherein the laboratory comprises a central computer networked with at least one chemical analyzer, the method comprising:
- transferring assay data from the analyzers to the central computer, wherein a processor in the central computer:
- generates control pool data from a commutable control pool, wherein the control pool has target analyte values for an assay;
- generates patient specimen data from a distribution of test values for the target analyte from patient specimens;
- determines tolerance limits from the control pool data and the patient specimen data;
- and
- adjusts the calibration of at least one chemical analyzer with respect to the tolerance limits.
A method for calibrating a clinical laboratory analytical instrument, comprising:
- generating a serum control rule from a commutable control pool, wherein the control pool has target analyte values for an assay;
- generating a patient distribution index from patient specimens;
- determining tolerance limits from the serum control pool and the patient distribution index;
- and
- adjusting the calibration of the instrument with respect to the tolerance limits.
Dependencies are inferred from the claim text.