Fixed Cellular Control Composition for Flow Cytometry
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Solution Overview
Problem
Current flow cytometric immunophenotyping processes for BD OneFlow™ kits lack a single, compatible process control that is positive for all markers, leading to operational inefficiencies and reduced experimental accuracy.
Innovation Solution
Development of control compositions comprising fixed cellular components with specific positive control markers for white blood cells, hematopoietic stem/progenitor cells, and neoplastic cells, which can be used as positive controls in flow cytometric assays.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple commercially available process controls are used to verify OneFlow™ reagent performance, then comprehensive marker coverage is achieved, but operational efficiency decreases and procedure complexity increases
Solution Approach 1:
The patent combines multiple process control functions into a single control composition that contains fixed cellular components expressing multiple different markers. This single composition replaces the need for multiple separate commercially available process controls, thereby maintaining comprehensive marker coverage while improving operational efficiency by reducing the number of controls that must be managed and processed
Solution Approach 2:
The control composition is designed with universal applicability to verify performance across all OneFlow™ reagent kits. By incorporating fixed cellular components that express a panel of markers relevant to multiple kit types (e.g., ALOT, LST, B-CLPD T1, PCST, PCD), a single control composition can universally verify reagent performance across different diagnostic applications without requiring kit-specific controls
2Ease of operation
If liquid format process controls are used, then immediate assay compatibility is achieved, but shelf life and stability are limited
Solution Approach 1:
The patent changes the physical state parameter of the control composition from liquid to fixed/dried form. This parameter change dramatically improves shelf life and stability by preventing degradation that occurs in liquid formulations. The fixed cellular components can be stored long-term and remain stable without requiring refrigeration or special storage conditions, while still maintaining assay compatibility when rehydrated and used in flow cytometric assays
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The proposed control compositions provide a comprehensive solution by validating the performance of flow cytometric assays and ensuring accurate detection of cell populations, thereby enhancing operational efficiency and experimental accuracy.
Implementation Method 1
flow cytometric immunophenotyping platform that facilitates the standardization of the characterization and diagnosis of various hematological malignancies
Data Source
AI summary
Control compositions and methods of making the same are provided. Aspects of the control compositions include a first white blood cellular component including one or more positive control markers for white blood cells; a second cellular component including one or more positive control markers for hematopoietic stem/progenitor cells; and a third cellular component including one or more positive control markers for neoplastic cells, wherein the first white blood cellular component, the second cellular component, and third cellular component are fixed. Also provided are methods for using the control compositions as positive controls, e.g., in a flow cytometric assay, as well as kits for practicing the subject methods.