Method and apparatus for calibration and testing of scientific measurement equipment

• US 10,332,621 B2
• Filed: 09/16/2013
• Issued: 06/25/2019
• Est. Priority Date: 07/21/2009
• Status: Active Grant

• Current Assignee: Ccqcc Corporation
• Original Assignee: Ccqcc Corporation
• Inventors: Cembrowski, George S., Tran, David Vu
• Primary Examiner(s): Barbee, Manuel L
• Assistant Examiner(s): Nimox, Raymond L
• Application Number:
  US14/027,463
• Publication Number:
  US 20140172311A1
• Time in Patent Office: 2,108 Days
• Field of Search: 702 85
• CPC Class Codes: G01N 2035/00653 statistical methods comparing labs or apparatuses
• CPC Class Codes: G01N 2035/0094 optimisation; experiment design
• CPC Class Codes: G01N 35/00613 Quality control
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records

Abstract

Discussed herein are methods and apparatuses to produce profiles for scientific measurement equipment, and to use those profiles for various purposes in using, designing, calibrating and managing such equipment, such as to carry out critical laboratory testing. In this approach, either the analyzers'"'"' quality control data or serial patient data are numerically reduced to generate graphical precision profiles. Precision profiles for serial patient data show increased (im)precision vs time implying increased patient variation over increased time. Precision profiles for quality control data, according to one implementation, can demonstrate three different zones: 1) increased imprecision for quality control determinations that are close spaced (implies the discovery of an error condition and rapid reanalysis, 2) the usual imprecision and 3) a zone of increased imprecision which indicates either a need for a quality control analysis or re-calibration.

Claims

1. A method of calibrating laboratory analyzer equipment comprising:

using the laboratory analyzer equipment to generate sample results, the sample results including measurements of a single analyte from multiple persons;

determining a within-patient variation including;

determining average intra-patient variations of the sample results provided by the laboratory analyzer over a period of time;

determining an axis-intercept using a regression of the average intra-patient variations versus time between the sample results;

determining the within-patient variation as a function of the axis-intercept; and

calibrating the laboratory analyzer equipment as a function of the determined within-patient variation; and

using the calibrated laboratory analyzer equipment to generate further sample results of the single analyte.

2. The method of claim 1, further comprising obtaining the sample results by data-mining previous results provided by the laboratory analyzer.

3. The method of claim 2, wherein obtaining sample results includes obtaining sample results that were only provided for clinical care of the multiple persons.

4. The method of claim 1, further comprising grouping the sample results by a time interval in which the sample results were provided, and wherein calculating the average intra-patient variation includes calculating the average intra-patient variation for each time interval.

5. The method of claim 1, further comprising removing out-lying sample results before calculating the average intra-patient variation.

6. The method of claim 5, wherein removing out-lying sample results includes removing out-lying sample results as a function of a frequency histogram and removing sample results from a repeated measurement made within a specific time period.

7. The method of claim 5, wherein removing out-lying sample results includes removing sample results from a repeated measurement made within two hours.

8. The method of claim 1, wherein calculating the within-patient variation includes using the formula:

within-patient variation=((axis-intercept)²−

(analytic variation)²)^1/2.

9. The method of claim 8, further comprising calculating the analytic variation as a function of a chemical concentration and an experimental coefficient of variation.

10. A system comprising:

laboratory analyzer equipment that performs measurements on biological samples, including one or more analytes of multiple persons, to generate sample results;

a memory storing the sample results obtained from measuring the biological samples using the laboratory analyzer equipment;

a display;

a processor communicatively coupled to the memory, the display, and the laboratory analyzer equipment;

the memory storing instructions, which when executed by the processor, cause the processor to;

calculate a within-patient variation including;

determining average intra-patient variations of the sample results obtained from the memory;

determining an axis-intercept using a regression of the average intra-patient variations versus time between the sample results;

determining the within-patient variation as a function of the axis-intercept; and

determine calibration information as a function of the within-patient variation; and

calibrate the laboratory analyzer equipment based on the calibration information; and

wherein the laboratory analyzer equipment performs further measurements, after calibration, on the biological samples to generate calibrated sample results.

11. The system of claim 10, wherein the memory further stores instructions, which when executed by the processor, cause the processor to perform operations comprising obtaining the sample results by data-mining previous results provided by the laboratory analyzer equipment.

12. The system of claim 11, wherein the sample results only sample results provided for clinical care of the multiple persons.

13. The system of claim 12, wherein the memory further stores instructions, which when executed by the processor, cause the processor to group the sample results into groups of time intervals, and wherein the instructions for determining the average intra-patient variation include instructions for determining the average intra-patient variation for each time interval.

14. The system of claim 10, wherein the memory further stores instructions, which when executed by the processor, cause the processor to perform operations comprising removing out-lying sample results before calculating the average intra-patient variation.

15. The system of claim 14, wherein the instructions for removing out-lying sample results include instructions for removing out-lying sample results as a function of a frequency histogram and removing sample results from repeated measurements made within a specific time period of each other.

16. The system of claim 15, wherein the instructions for removing out-lying sample results include instructions for removing sample results from a repeated measurement made within two hours.

17. The system of claim 10, wherein the instructions for calculating the within-patient variation include instruction for calculating the within-patient variation using the formula:

within-patient variation=((axis-intercept)²−

(analytic variation)²)^1/2,

18. The system of claim 17, wherein the memory further stores instructions, which when executed by the processor, cause the machine to perform operations comprising calculating the analytic variation as a function of a chemical concentration and an experimental coefficient of variation.

19. The system of claim 10, the memory further stores instructions, which when executed by the processor, cause the processor to determine a precision profile of the user and send the precision profile to the display, wherein the precision profile includes a graph of the average intra-patient variations of the sample results provided by the laboratory analyzer equipment over a period of time.