Value assignment for customizable quality controls

Patent metadata

Field	Value
Publication number	US-11385245-B2
Application number	US-202016880705-A
Country	US
Kind code	B2
Filing date	May 21, 2020
Priority date	Aug 25, 2014
Publication date	Jul 12, 2022
Grant date	Jul 12, 2022

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 evaluating a predicted recovery of a measurement procedure for an analyte, wherein the analyte occurs in a quality control prepared by adding a number of solid beads containing the analyte to a volume of a base matrix, and the predicted recovery corresponds to a nominal concentration of the analyte in the quality control, the method comprising:
determining, based on the number of solid beads and the volume of the base matrix, the nominal concentration of the analyte in the quality control;
scaling the nominal concentration by a correlation factor, wherein the scaling comprises multiplying the nominal concentration by the correlation factor, and wherein the correlation factor is calculated by performing regression analysis of data previously obtained for two or more historical analyte concentrations using the measurement procedure, thereby obtaining the predicted recovery of the measurement procedure for the analyte;
testing the quality control using the measurement procedure, thereby obtaining a measurement response;
determining an actual recovery of the measurement procedure for the analyte based on the measurement response; and
comparing the predicted recovery with the actual recovery, thereby evaluating the predicted recovery of the measurement procedure for the analyte.

2. The method of claim 1 , further comprising obtaining a range of recoveries of the measurement procedure for the analyte, wherein the range contains the predicted recovery.

3. The method of claim 1 , wherein:
the scaling of the nominal concentration by the correlation factor includes converting a reference recovery to the predicted recovery of the measurement procedure;
the reference recovery is an estimate of the recovery of a reference measurement procedure for the analyte at the nominal concentration of the analyte in the quality control; and
the correlation factor is calculated by performing regression analysis of data previously obtained for the two or more historical analyte concentrations using the measurement procedure and the reference measurement procedure.

Assignees

• Bio Rad Laboratories Inc

Inventors

• Ebrahim Alireza
• De Vore Karl
• Spates Christopher

Classifications

• G01N33/96 Primary

  involving blood or serum control standard · CPC title

• Y10T436/10

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