VALUE ASSIGNMENT FOR CUSTOMIZABLE QUALITY CONTROLS

摘要

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.

主权项

1. A method of preparing a quality control for an analyte, wherein the quality control can be measured using a diagnostic measurement procedure, and the nominal concentration of the analyte in the quality control corresponds to a desired recovery of the measurement procedure for the analyte, the method comprising:
scaling the desired recovery by a correlation factor to estimate a target nominal concentration of the analyte in the quality control, wherein the correlation factor is based on data previously obtained using the measurement procedure; providing one or more solid beads containing the analyte, and a base matrix; determining a number of solid beads and a volume of the base matrix needed to prepare the quality control with the target nominal concentration of the analyte; and dissolving the number of beads in the volume of the base matrix, thereby preparing the quality control for the analyte.