Value assignment for customizable quality controls

Patent metadata

Field	Value
Publication number	US-10697981-B2
Application number	US-201715849514-A
Country	US
Kind code	B2
Filing date	Dec 20, 2017
Priority date	Aug 25, 2014
Publication date	Jun 30, 2020
Grant date	Jun 30, 2020

Abstract

Methods are provided for end users of diagnostic measurement procedures to prepare quality controls having desired analyte recoveries, estimate recoveries of quality controls already prepared, and compare estimated and measured recoveries. To prepare a quality control containing a particular analyte, a desired recovery of a measurement procedure for the analyte can be scaled by a correlation factor to obtain a target nominal concentration of the analyte in the quality control. Alternatively, the nominal concentration of an analyte in a quality control can be scaled by a correlation factor to obtain a predicted recovery of a measurement procedure for the analyte. The correlation factors can be based on recovery data previously obtained using the measurement procedure and optionally one or more reference procedures, and can be calculated using regression analysis of these data. Each quality control can be prepared by dissolving a number of solid beads containing the analyte(s) of interest in a volume of base matrix.

First claim

What is claimed is:

1. A method of determining a correlation factor of an analyte in a quality control using two or more measurement procedures for the analyte, the method comprising:
providing one or more solid beads containing the analyte, and a base matrix;
dissolving a number of the solid beads in a volume of the base matrix to form a quality control;
for each measurement procedure:
testing the quality control, thereby obtaining a measurement response for the analyte, and
determining a reported concentration for the analyte based on the measurement response;

comparing the reported concentrations for the analyte determined by each of the measurement procedures to calculate the correlation factor;
determining a reported concentration for the analyte in a new quality control using a first of the two or more measurement procedures; and
predicting a reported concentration of the analyte in the new quality control using a second of the two or more measurement procedures, based on the correlation factor.

2. The method of claim 1 , wherein comparing the reported concentrations of the measurement procedures comprises calculating a ratio of the reported concentrations.

3. The method of claim 1 , further comprising:
forming a reference quality control, wherein a concentration of the analyte in the reference quality control is different from a concentration of the analyte in the quality control;
for each measurement procedure:
testing the reference quality control, thereby obtaining a reference measurement response for the analyte, and
determining a reference reported concentration for the analyte based on the reference measurement response; and

comparing the reference reported concentrations of the analyte using each of the measurement procedures to identify a systematic agreement or disagreement among the two or more measurement procedures.

4. The method of claim 3 , wherein comparing the reported concentrations of the measurement procedures comprises performing regression analysis to establish a function between the reported concentrations of two or more measurement procedures.

5. The method of claim 4 , wherein performing regression analysis comprises fitting a regression line to a plot of the reported concentrations using one of the two or more measurement procedures versus the reported concentrations using another of the two or more measurement procedures.

6. The method of claim 3 , further comprising:
testing sensitivities of the two or more measurement procedures to the analyte at the concentration of the analyte in the reference quality control and the concentration of the analyte in the quality control.

7. The method of claim 6 , further comprising:
identifying analyte concentrations for which the reported concentrations of the two or more measurements procedures are in agreement or disagreement with one another.

8. The method of claim 3 , further comprising:
forming one or more additional reference quality controls, wherein the concentration of the analyte in each of the one or more additional reference quality controls is different from the concentration of the analyte in the quality control and in each other reference quality control;
for each measurement procedure and additional reference quality control:
testing the additional reference quality control, thereby obtaining an additional reference measurement response for the analyte, and
determining an additional reference reported concentration for the analyte based on the additional reference measurement response; and

comparing the additional reference reported concentrations of the analyte using each of the measurement procedures.

9. The method of claim 1 , wherein
the comparing comprises calculating a ratio of (1) the reported concentration for the analyte in the quality control using the second measurement procedure to (2) the reported concentration for the analyte in the quality control using the first measurement procedure, and wherein
the predicting comprises multiplying the ratio by the reported concentration for the analyte in the new quality control using the first measurement procedure.

10. The method of claim 1 , wherein
the comparing comprises performing regression analysis to establish a function of the reported concentration using the second measurement procedure in terms of the reported concentration using the first measurement procedure, and wherein
the predicting comprises applying the function to the reported concentration for the analyte in the new quality control using the first measurement procedure.

11. A method for predicting a reported concentration of an analyte in a quality control using a measurement procedure, the method comprising:
preparing two or more reference quality controls, wherein each reference quality control has a different concentration of the analyte, and wherein for each reference quality control the preparing comprises:
providing a base matrix and one or more solid beads containing the analyte; and
dissolving a number of the solid beads in a volume of the base matrix to form the reference quality control;

for each of the measurement procedure and a reference measurement procedure:
testing each of the two or more reference quality controls, thereby obtaining measurement responses for the analyte; and
determining reported concentrations for the analyte based on the measurement responses;

comparing for each of the two or more reference quality controls the reported concentration using the measurement procedure and the reported concentration using the reference measurement procedure, thereby establishing a numerical relationship;
preparing a new quality control by dissolving a number of the solid beads in a volume of the base matrix;
determining a reported concentration for the analyte in the new quality control using the reference measurement procedure; and
applying the numerical relationship to the reported concentration for the analyte in the new quality control using the reference measurement procedure, thereby predicting the reported concentration for the analyte in the new quality control using the measurement procedure.

12. The method of claim 11 , wherein
the numerical relationship is a ratio of (1) the reported concentration for the analyte in each of the two or more reference quality controls using the measurement procedure to (2) the reported concentration for the analyte in each of the two or more reference quality controls using the reference measurement procedure, and wherein
the applying comprises multiplying the ratio by the reported concentration for the analyte in the new quality control using the reference measurement procedure.

13. The method of claim 11 , wherein the comparing comprises performing regression analysis, and wherein the numerical relationship comprises a function of the reported concentration using the measurement procedure in terms of the reported concentration using the reference measurement procedure.

14. The method of claim 13 , wherein the regression analysis comprises fitting a regression line to a plot of the reported concentrations using the measurement procedure versus the reported concentrations using the reference measurement procedure.

Assignees

• Bio Rad Laboratories

Inventors

• Ebrahim Alireza
• De Vore Karl
• Spates Christopher

Classifications

• G01N33/96 Primary

  involving blood or serum control standard · CPC title

• G01N33/78 Primary

  Thyroid gland hormones {, e.g. T3, T4, TBH, TBG or their receptors} · CPC title

• G01N33/48

  Biological material, e.g. blood, urine (G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence); Haemocytometers (counting blood corpuscules distributed over a surface by scanning the surface G06M11/02) · CPC title

• Y10T436/10

  Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing · CPC title