Core calibration of analyzers
AssigneeBeckman Coulter, Inc.
InventorsMark HOLLAND, Conan DEWITT
Life of this patent
Estimating the term…
Abstract
Methods and systems for determining a dose of an analyte in an unknown sample on an instrument, such as a nucleic acid analyzer, immunoassay analyzer, or clinical chemistry analyzer using a reagent from a selected assay lot are described. The methods and systems use core dose-response information based on measurements of response values to a set of calibrators on a plurality of other instruments and assay lot-specific response information to calibrate the instrument.
Claims21
1-47. (canceled)
A system for determining a dose of an analyte in an unknown sample using a reagent from a selected assay lot, the system comprising:
- a measurement device to measure response information of the analyte using a reagent from the assay lot;
- and
- a processor in communication with the measurement device, the processor configured to:
- receive a core dose-response curve defined by a model including at least one parameter estimate, wherein each parameter estimate is associated with at least one probability density, and wherein each probability density is a combination of a lot-specific density contribution and an instrument-specific density contribution;
- receive information based on measurements of response values of one or more calibrator adjusters on the instrument using the assay lot;
- receive a measured response of the unknown sample made on the instrument using the assay lot;
- and
- determine the dose of the unknown sample using an instrument-specific, selected lot-specific dose-response curve and the measured response of the unknown sample, wherein the instrument-specific, selected lot-specific dose-response curve is generated using the model, the transmitted plurality of parameter estimates, the transmitted plurality of probability densities, and the response values of the one or more calibration adjusters.
A method for determining a dose of an analyte in an unknown sample on an instrument using a reagent from a selected assay lot, comprising:
- receiving, at a computer processor, a core dose-response curve defined by a model including at least one parameter estimate, wherein each parameter estimate is associated with at least one probability density, and wherein each probability density is a combination of a lot-specific density contribution and an instrument-specific density contribution;
- receiving, at the computer processor, information on measurements of response values of one or more calibration adjusters on the instrument using the selected assay lot;
- receiving, at a computer processor, an instrument-specific, selected lot-specific dose-response curve using the model, the transmitted plurality of parameter estimates, the transmitted plurality of probability densities, and the response values of the one or more calibration adjusters;
- receiving, at the computer processor, measurements of the unknown sample made on the instrument using the selected assay lot;
- and
- determining, at the computer processor, the dose of the analyte in the unknown sample using the instrument-specific, selected lot-specific dose-response curve and the measurements of the unknown sample.
A method of generating a dose-response curve for an instrument configured to determine an analyte with a selected assay lot, the method comprising:
- measuring response values to one or more calibrators using a plurality of source instruments and a plurality of assay lots;
- generating a core dose-response curve defined by a model including a model parameter, wherein the core dose-response curve includes at least one parameter estimate of the model parameter that fits the model to the response values of the one or more calibrators, wherein the parameter estimate is associated with at least one probability density, and wherein the probability density is a combination of a lot-specific density contribution and an instrument-specific density contribution;
- receiving, from the instrument, measured response values of one or more calibration adjusters on the instrument using the selected assay lot;
- generating an instrument-specific, lot-specific dose-response curve using the model, the at least one parameter estimate, the at least one probability density, and the measured response values of the one or more calibration adjusters;
- and
- transmitting the instrument-specific, lot-specific dose-response curve to the instrument.
Dependencies are inferred from the claim text.