Linearity control compositions and methods of use
AssigneeRoche Diagnostics Hematology, Inc.
InventorsRebecca Timmons, Chris Chace, Louis Bonaparte, II, Jaclyn Ruhl, Lisbeth Blake
Life of this patent
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Abstract
The present disclosure provides methods and compositions for preparing linearity control slides to verify linearity of image-based hematology analyzers without the need to make such control slides over and over again for each analyzer each time the analyzer is verified.
Claims20
A set of linearity control slides for verifying the analytical measuring interval (AMI) or reportable range, or both, of a hematology analyzer comprising at least one, two, three, four, or all five, of:
- a first set of slides for combined red blood cell (RBC) hemoglobin (HGB) and hematocrit (HCT) components;
- a second set of slides for a white blood cell (WBC) component;
- a third set of slides for a platelet (PLT) component
- a fourth set of slides for a reticulocyte (RET) component;
- and
- a fifth set of slides for a nucleated red blood cell (NRBC) component;
- wherein each set of slides includes three or more slides,
- wherein each slide in the set of slides contains a different concentration of the blood component to provide a series of equidistant dilutions within a range of concentrations of the blood component of that set of slides, and
- wherein blood components on each slide in the set of slides are fixed and stained by a hematology analyzer.
A method of producing a set of linearity control slides for verifying linearity on a hematology analyzer with respect to one or more blood components, the method comprising:
- obtaining a whole blood sample or a blood product sample comprising one or more blood components from a healthy human subject;
- preparing a high concentration sample from the whole blood sample or blood product sample for a first blood component;
- preparing a low concentration sample from the whole blood sample or blood product sample for the first blood component;
- preparing a plurality of equidistant dilutions for the first blood component, wherein the plurality of equidistant dilutions comprises the high concentration sample, the low concentration sample, a first dilution comprising one part of the high concentration sample and one part of the low concentration sample, a second dilution comprising one part of the first dilution and one part of the low concentration sample, and a third dilution comprising one part of the first dilution and one part of the high concentration sample;
- and
- preparing a slide for each of the plurality of equidistant dilutions by processing each of the equidistant dilutions for the first blood component in an image-based hematology analyzer to print, fix, and stain the equidistant dilution onto a slide.
Dependencies are inferred from the claim text.