Automated Hematology Flow Cytometry for Extended Differential Analysis
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Solution Overview
Problem
Current hematology systems face challenges in accurately performing a comprehensive five-part white blood cell differential, especially in the presence of atypical leukocyte populations or abnormal conditions, leading to high false positive or false negative rates and requiring manual review or missed clinically significant abnormalities.
Innovation Solution
A composition containing specific antibodies and a nucleic acid dye, or a lytic system, is introduced into a biological sample to enable simultaneous measurement of multiple parameters through a single flow cytometer, allowing for the enumeration of multiple hematologic cell populations in a single analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional hematology instruments with discrete transducers are used, then automated high throughput analysis is achieved, but measurement precision and reliability deteriorate due to inability to detect atypical and immature cells
Solution Approach 1:
The patent combines multiple transducers (optical, electrical, fluorescent) into an integrated flow cytometry system that simultaneously measures multiple parameters on the same cell population, enabling detection of atypical and immature cells that conventional discrete transducer systems miss
Solution Approach 2:
The flow cytometry system is designed to perform multiple functions: it can detect all five mature white blood cell types, identify atypical cells, enumerate immature cells, and provide comprehensive cellular indices through a single integrated analysis platform
2Measurement precision
If manual microscopic examination is performed to obtain extended differential analysis, then detection precision of atypical cells improves, but productivity and ease of operation deteriorate due to time-consuming manual review
Solution Approach 1:
The patent replaces manual microscopic examination with an automated flow cytometry system that uses optical, electrical, and fluorescent transducers to automatically detect, classify, and enumerate all blood cell populations including atypical and immature cells, eliminating the need for manual review while maintaining high detection accuracy
Solution Approach 2:
The system performs self-analysis by automatically acquiring multi-parameter data, processing signals through correlation algorithms, and generating extended differential reports without requiring manual intervention or microscopic review by technologists
3Extent of automation
If multiple discrete transducers are used for cell analysis, then automated analysis capability is maintained, but measurement precision deteriorates due to inability to correlate data from different transducers on the same cell population
Solution Approach 1:
The patent merges multiple transducers into a single flow cytometry platform where optical, electrical, and fluorescent measurements are simultaneously acquired on the same cell population, enabling direct correlation of data from different transducer types without requiring separate analysis or manual reconciliation
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
This approach enables rapid and accurate enumeration of up to 10 hematologic cell populations, reducing false positives and negatives, and eliminating the need for manual review by providing a robust extended differential analysis.
Implementation Method 1
A composition containing specific antibodies and a nucleic acid dye... enable simultaneous measurement of multiple parameters through a single flow cytometer
Implementation Method 2
or a lytic system, is introduced into a biological sample to enable simultaneous measurement of multiple parameters
Data Source
AI summary
A method useful for the enumeration of cell populations in a biological sample includes the steps of reacting in a single reaction mixture a sample, a first antibody labeled with a fluorochrome having a first emission spectrum and an additional antibody. The first antibody binds to an antigenic determinant differentially expressed on leukocytes and non-leukocytes. The additional antibody binds to an antigenic determinant differentially expressed on mature and immature granulocytes or myeloid cells, and is labeled either with the first fluorochrome or an additional fluorochrome having an emission spectrum distinguishable from the first emission spectrum. The reaction mixture can be mixed with a nucleic acid dye having an emission spectrum that overlaps with one of the first or additional emission spectra. The reaction mixture may be treated with a lytic system that differentially lyses non-nucleated red blood cells and conserves leukocytes. Populations of hematological cells are detected and enumerated using at least two parameters (fluorescence, optical, and electrical) for each population.