Flow cytometry-based hematology system

A flow cytometry-based hematology system for classifying and counting biological cells in a blood sample or blood-derived sample, comprising:

• a hydraulic system including a flow cell, said hydraulic system being capable of mixing said blood sample or blood-derived sample with the contents of one or more of a disposable vessel, a lyse tube or a sheath tube, and being capable of moving the contents of one or more of said disposable vessel, said lyse tube, said sheath tube, or a mixture of said blood sample or said blood-derived sample with one or more of said contents of said disposable vessel, said lyse tube and said sheath tube through said flow cell;
• a diode laser, said diode laser emitting light to irradiate cells present in said flow cell, said cells being derived from said blood sample or said blood-derived sample;
• a lensless light detection system, said lensless light detection system having a first portion capable of detecting one or more of axial light loss, low-angle scattered light and high-angle scattered light, and a second portion capable of detecting right angle scattered light scattered at a high numerical aperture, said second portion being physically distinct from said first portion, said first portion and said second portion being capable of converting said axial light loss, said low-angle scattered light, said high-angle scattered light, and said right angle scattered light into electrical signals;
• and
• a signal processor, said signal processor being capable of analyzing said electrical signals generated from said first portion and said second portion of said lensless light detection system, and generating data therefrom;
• a reservoir for a sheath solution;
• at least one syringe connected to said reservoir, said at least one syringe being driven by a motor;
• a single HGB module, said HGB module being connected on an inlet side to a sample inlet;
• said sample inlet being connected to said flow cell by a single flow path passing through said HGB module;
• a single flow cell, said single flow cell being connected to said HGB module and said at least one syringe on an inlet side of said flow cell, and to a waste container on an outlet side of said flow cell.

A method for analyzing a blood sample or a blood-derived sample using a flow cytometry-based hematology system, comprising the steps of:

• a) mixing a first portion of said blood sample or blood-derived sample with a reagent in a disposable vessel containing a known number of reference particles to form a red cell solution, said reference particles having one of a plurality of predetermined diameters such that when said reference particles are illuminated by light, said light is scattered such that said scattered light falls into one of a plurality of predetermined light scatter channels;
• b) standardizing said red cell solution and said flow cytometry-based hematology system using said reference particles by measuring at least one of axial light loss, low-angle forward scattered light, high-angle forward scattered light, right angle scattered light, and time-of-flight for each of said reference particles, and comparing said measurements to predetermined values obtained for said reference particles;
• c) counting at least a portion of red blood cells, reticulocytes, and platelets present in said red cell solution;
• d) measuring at least one parameter from the group measured in step b) for each of one or more cells in said red cell solution, to produce a red cell solution measurement value for each parameter for one or more of said red blood cells, reticulocytes, and platelets from said sample;
• e) mixing a second portion of said blood sample or blood-derived sample with a lyse solution in said disposable vessel containing a known number of reference particles to form a white cell solution;
• f) counting at least a portion of white blood cells present in said white cell solution;
• g) measuring at least one parameter from the group measured in step b) for each of one or more cells in said white cell solution, to produce a white cell solution measurement value for each parameter for said white blood cells;
• and
• h) analyzing said red cell solution measurement values and said white cell solution measurement values to classify each cell.