Method and apparatus for analyte measurements using calibration sets

• US 10,475,529 B2
• Filed: 07/18/2012
• Issued: 11/12/2019
• Est. Priority Date: 07/19/2011
• Status: Active Grant

• Current Assignee: OptiScan Biomedical Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Callicoat, David N., Soldo, Monnett H.
• Primary Examiner(s): Negin, Russell S
• Application Number:
  US13/552,542
• Publication Number:
  US 20130297222A1
• Time in Patent Office: 2,673 Days
• Field of Search: None
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G16B 99/00 Subject matter not provided for in other groups of this subclass
• CPC Class Codes: G16C 20/90 Programming languages; Computing architectures; Database systems; Data warehousing
• CPC Class Codes: G16C 99/00 Subject matter not provided for in other groups of this subclass
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Examples of methods and apparatus are described that permit an analyte concentration to be estimated from a measurement in the presence of compounds that interfere with the measurement. In one example, the method can reduce the error in the estimation of analyte concentration in the presence of interferents. The method can include the use of one or more calibration set to determine analyte concentration. From a sample measurement, each calibration set can be tested to determine if it is eligible to estimate the analyte concentration in the sample. An estimate of analyte concentration can then be produced, based at least in part on the eligible calibration sets and on the sample measurement. In some implementations, if no calibration sets are eligible, an action is taken such as not outputting an estimate, displaying an alarm or alert, or providing a notification.

Claims

1. An analyte detection system comprising:

a fluidic system configured to withdraw a fluid sample from a fluid source and direct the withdrawn sample to a sample container;

a sensor system configured to interface with the sample held in the sample container to obtain a measurement of an analyte in the sample;

a hardware processor system configured to execute stored program instructions such that the analyte detection system;

accesses one or more calibration sets each usable to estimate a concentration of the analyte in the sample;

accesses the obtained measurement of the analyte in the sample;

determines, for each of the one or more calibration sets, whether the calibration set is eligible to estimate concentration of the analyte from the measurement of the sample by;

calculating a respective reconstructed measurement of the analyte in the sample based on the calibration set;

obtaining a metric based on a comparison of the reconstructed measurement of the analyte to the obtained measurement; and

comparing the obtained metric to a prediction eligibility threshold; and

determines an estimated concentration of the analyte in the sample based at least in part on the obtained measurement of the analyte in the sample and the calibration sets determined to be eligible; and

a display device configured to (i) display the estimated concentration if at least one of the one or more calibration sets is determined to be eligible to estimate concentration of the analyte or (ii) provide notification if none of the one or more calibration sets is determined to be eligible to estimate concentration of the analyte.

2. The system of claim 1, wherein the one or more calibration sets comprise a plurality of calibration sets.

3. The system of claim 1, wherein the sample includes at least one component of blood, and wherein the analyte comprises glucose.

4. The system of claim 1, wherein to obtain a measurement of an analyte in the sample, the processor system is configured such that the analyte detection system:

accesses a raw measurement of the sample; and

calculates a measurement of an analyte in the sample based at least in part on the raw measurement of the sample.

5. The system of claim 1, wherein the measurement of a sample comprises a measured spectrum.

6. The system of claim 5, wherein each of the one or more calibration sets comprises data usable to estimate an analyte concentration and a reconstructed spectrum from at least the measured spectrum.

7. The system of claim 6, wherein to determine whether the calibration set is eligible to estimate analyte concentration, the processor system is configured such that the analyte detection system:

calculates, for each of the one or more calibration sets, a reconstructed spectrum based at least in part on the measured spectrum and the calibration set; and

compares the reconstructed spectrum to the measured spectrum.

8. The system of claim 7, wherein each of the one or more calibration sets further comprises a prediction eligibility threshold, and wherein to compare the reconstructed spectrum to the measured spectrum, the processor system is configured such that the analyte detection system:

calculates a distance metric based at least on the reconstructed spectrum and the measured spectrum; and

compares the distance metric to the prediction eligibility threshold to determine whether the calibration set is eligible to estimate analyte concentration.

9. The system of claim 8, wherein the distance metric is calculated, at least in part, by a sum of a square of the residuals according to the formula:

10. The system of claim 1, wherein the analyte detection system will not determine an estimated analyte concentration if none of the plurality of calibration sets are eligible to estimate analyte concentration from the measurement of the sample.

11. The system of claim 1, wherein to determine an estimated analyte concentration for the sample, the processor system is configured such that the analyte detection system:

calculates, for each of the eligible calibration sets, an estimate of analyte concentration based at least in part on the measurement of the sample and the calibration set; and

determines an estimated analyte concentration for the sample by combining the estimates of analyte concentrations for each of the eligible calibration sets.

12. The system of claim 11, wherein combining the estimated analyte concentrations for each of the eligible calibration sets comprises using a weighted average to combine the estimated analyte concentrations for each of the eligible calibration sets.

13. The system of claim 12, wherein the weighted average is calculated, at least in part, by assigning a greater weight to estimates of analyte concentration that are either above or below a predetermined threshold level.

14. The system of claim 1, wherein the analyte is glucose.

15. The system of claim 1, wherein to access a measurement of the sample, the processor system is configured such that the analyte detection system:

accesses a raw measurement of the sample; and

processes the raw measurement of the sample to reduce or minimize effect on the estimate of concentration of the analyte caused by one of more interferents to create a measurement of the sample.

16. The system of claim 15, wherein to process the raw measurement of the sample, the processor system is configured such that the analyte detection system corrects for the presence of water or saline in the raw measurement of the sample.

17. The system of claim 16, wherein to process the raw measurement of the sample, the processor system is configured such that the analyte detection system corrects for the presence of a protein or a drug that may be present in the raw measurement of the sample.

18. The system of claim 15, wherein to process the raw measurement of the sample, the processor system is configured such that the analyte detection system receives information on substances likely to be present in the sample, and corrects the measurement for at least some of the substances likely to be present in the sample.

19. The system of claim 18, wherein the processor system is configured such that the analyte detection system determines which potential interferents are to be processed in the measurement.

20. The system of claim 19, wherein to determine which potential interferents are to be processed, the processor system is configured such that the analyte detection system determines whether a potential interferent is present in the measurement above a threshold level.

21. The system of claim 15, wherein to process the raw measurement of the sample to reduce or minimize effect on the estimate of concentration of the analyte caused by one of more interferents, the processor system is configured such that the analyte detection system processes for the one or more interferents in an order.

22. The system of claim 21, wherein the processor system is configured such that the analyte detection system ceases to process for the one or more interferents when a threshold number of interferents have been processed.