Method of using a hematology control product

Abstract

A method of quality control to diagnose the cause of a malfunction of an instrument. The method uses measurements of the physical property of a sample to diagnose the cause of a malfunction of an instrument. The spatial position of a control product sample is analyzed. Alternatively, the spatial position of a statistically significant number of patient blood samples can be used. The method enables the monitoring of an instrument for problems associated with debris and noise caused by red cell lysis inefficiency; instrument reagents pump volume settings; instrument laser alignments; instrument gain settings; and flow noise caused by partial plugs, residual plugs or other flow problems. The method provides a more specific indication of the type and cause of an instrument malfunctioning than non specific flagging provided by prior art methods.

1 - 39 . (Canceled)  
     
     
         40 . A method of using a hematology control product including at least one nucleated blood cell analog comprising the steps of: 
 a) providing a hematology control product including a nucleated blood cell analog, wherein the analog is a blood cell including a membrane enclosing a nucleus, wherein the blood cell has been treated so that said membrane is resistant to degradation, and wherein 20% to 80% by weight of the hemoglobin in the blood cell has been removed;    b) providing an instrument for analyzing a blood cell sample by at least two physical properties selected from the group comprising DC volume, RF size, opacity, and light scatter;    c) passing the control product through the instrument for detection of said nucleated blood cell analog; and    d) reporting said nucleated blood cell analog in the control product.    
     
     
         41 . The method of  claim 40 , wherein the analog is a nucleated red blood cell.  
     
     
         42 . The method of  claim 40 , wherein 70% to 80% by weight of the hemoglobin in the blood cell has been removed.  
     
     
         43 . A method of using a hematology control product including a nucleated blood cell analog comprising the steps of: 
 a) providing a hematology control product that is suitable for use up to about 6 months, including: 
 i) a first nucleated blood cell analog, wherein the analog is a blood cell including a membrane enclosing a nucleus, wherein the blood cell has been treated so that said membrane is resistant to degradation, and wherein 20% to 80% by weight of the hemoglobin in the blood cell has been removed;  
 ii) a second blood cell analog for simulating at least one subpopulation of white blood cells;  
   b) providing an instrument for differentiating white blood cells and for analyzing a blood cell sample by at least one angle of light scatter measurement;    c) passing the control product through the instrument for detection of said first nucleated blood cell analog and said at least one population of white blood cells;    d) reporting said at least one population of white blood cells in the control product; and    e) reporting said first nucleated blood cell analog in the control product.    
     
     
         44 . The method of  claim 43 , wherein said first nucleated blood cell analog is a nucleated red blood cell.  
     
     
         45 . A method of using a hematology control product including at least one nucleated blood cell analog comprising the steps of: 
 a) providing a hematology control product that is suitable for use up to about 6 months, including:    i) a first nucleated blood cell analog, wherein the analog is a blood cell including a membrane enclosing a nucleus, wherein the blood cell has been treated so that said membrane is resistant to degradation, and wherein 20% to 80% by weight of the hemoglobin in the blood cell has been removed;    ii) a second blood cell analog for simulating at least one subpopulation of white blood cells, said second analog having been prepared from a red blood cell, a white blood cell, or a mixture thereof, at least one of which has been contacted with a lipoprotein;    b) providing an instrument for differentiating white blood cells and for analyzing a blood cell sample by at least two physical properties selected from the group comprising DC volume, RF size, opacity, and light scatter;    c) passing the control product through the instrument for detection of said first nucleated blood cell analog and said at least one population of white blood cells; and    d) reporting said at least one population of white blood cells in the control product; and    e) reporting said first nucleated blood cell analog in the control product.    
     
     
         46 . The method of  claim 45 , wherein said first nucleated blood cell analog is a nucleated red blood cell.  
     
     
         47 . A method of using a hematology control product including at least one nucleated blood cell analog comprising the steps of: 
 a) providing a hematology control product including a nucleated blood cell analog, wherein the analog is a blood cell including a membrane enclosing a nucleus, wherein the blood cell has been treated so that said membrane is resistant to degradation, and wherein the blood cell is selected from the group consisting of reptile blood, fish blood and mixtures thereof;    b) providing an instrument for analyzing a blood cell sample by at least two physical properties selected from the group comprising DC volume, RF size, opacity, and light scatter;    c) passing the control product through the instrument for detection of said nucleated blood cell analog; and    d) reporting said nucleated blood cell analog in the control product.    
     
     
         48 . The method of  claim 47 , wherein said blood cell is a nucleated red blood cell.  
     
     
         49 . A method of using a control including a nucleated blood cell component comprising the steps of: 
 a) providing a control including a stabilized blood cell suitable for simulating a nucleated blood cell, the stabilized blood cell including a membrane enclosing a nucleus and wherein the hemoglobin of the stabilized blood cell has been substantially removed from within the membrane;    b) providing a hematology analyzer for analyzing a blood cell sample by at least two angles of light scatter measurement to differentiate blood cells;    c) passing the control through the hematology analyzer for detection of the simulated nucleated blood cells; and    d) reporting nucleated blood cells in the control.    
     
     
         50 . The method of  claim 49 , wherein the stabilized blood cell is a nucleated red blood cell.  
     
     
         51 . A method of using a control including a nucleated blood cell component comprising the steps of: 
 a) providing a control that is suitable for use up to about 6 months, including: 
 i) a stabilized blood cell suitable for simulating a nucleated blood cell, the stabilized blood cell including a membrane enclosing a nucleus and wherein the hemoglobin of the stabilized blood cell has been substantially removed from within said membrane;  
 ii) a white blood cell component for simulating at least three subpopulations of white blood cells;  
   b) providing a hematology analyzer for differentiating white blood cells and for analyzing a blood cell sample by at least one angle of light scatter measurement;    c) passing the control through the hematology analyzer for detection of the simulated nucleated blood cells and subpopulations of white blood cells;    d) reporting simulated white blood cells in the control; and    e) reporting simulated nucleated blood cells in the control.    
     
     
         52 . A method of using a control including a nucleated blood cell component comprising the steps of: 
 a) providing a control that is suitable for use up to about 6 months, including: 
 i) a stabilized blood cell suitable for simulating a nucleated blood cell, the stabilized blood cell including a membrane enclosing a nucleus and wherein the hemoglobin of the stabilized blood cell has been substantially removed from within said membrane;  
 ii) a white blood cell component for simulating at least five subpopulations of white blood cells, the white blood cell component having been prepared from a red blood cell, a white blood cell, or a mixture thereof, at least one of which has been contacted with a lipoprotein;  
   b) providing a hematology analyzer for differentiating white blood cells and for analyzing a blood cell sample by at least two angles of light scatter measurement, both being low angles of light scatter below 100 to differentiate nucleated blood cells;    c) passing the control through the hematology analyzer for detection of the simulated nucleated blood cells and subpopulations of white blood cells;    d) reporting simulated white blood cells in the control; and    e) reporting simulated nucleated blood cells in the control.    
     
     
         53 . A method of using a control including a nucleated blood cell component comprising the steps of: 
 a) providing a control including a stabilized blood cell suitable for simulating a nucleated blood cell, the blood cell including a membrane enclosing a nucleus and wherein the stabilized blood cell is selected from the group consisting of reptile blood, fish blood and mixtures thereof;    b) providing a hematology analyzer for analyzing a blood cell sample by at least two angles of light scatter measurement to differentiate nucleated blood cells;    c) passing the control through the hematology analyzer for detection of the simulated nucleated blood cells; and    d) reporting nucleated blood cells in said control.    
     
     
         54 . A method of using a control including a nucleated blood cell component comprising the steps of: 
 a) providing a control including a stabilized blood cell suitable for simulating a nucleated blood cell, the stabilized blood cell including a membrane enclosing a nucleus and wherein the cytoplasm of the stabilized blood cell has been substantially removed from within said membrane;    b) providing a hematology analyzer for analyzing a blood cell sample by at least two angles of light scatter measurement to differentiate nucleated blood cells;    c) passing the control through the hematology analyzer for detection of the simulated nucleated blood cells; and    d) reporting nucleated blood cells in the control.    
     
     
         55 . A method of using a control including a nucleated blood cell component comprising the steps of: 
 a) providing a control that is suitable for use for at least 3 days, including: 
 i) a stabilized blood cell suitable for simulating a nucleated blood cell, the stabilized blood cell including a membrane enclosing a nucleus and wherein the cytoplasm of the stabilized blood cell has been substantially removed from within said membrane;  
 ii) a white blood cell component for simulating at least three subpopulations of white blood cells;  
   b) providing a hematology analyzer differentiating white blood cells and for analyzing a blood cell sample by at least one angle of light scatter measurement to differentiate nucleated blood cells;    c) passing the control through the hematology analyzer for detection of the simulated nucleated blood cells and subpopulations of white blood cells;    d) reporting simulated white blood cells in the control; and    e) reporting simulated nucleated blood cells in the control.    
     
     
         56 . A method of using a control including a nucleated blood cell component comprising the steps of: 
 a) providing a control that is suitable for use for at least 45 days, including: 
 i) a stabilized blood cell suitable for simulating a nucleated blood cell, the stabilized blood cell including a membrane enclosing a nucleus and wherein the cytoplasm of the stabilized blood cell has been substantially removed from within said membrane;  
 ii) a white blood cell component for simulating at least five subpopulations of white blood cells, the white blood cell component having been prepared from a red blood cell, a white blood cell, or a mixture thereof, at least one of which has been contacted with a lipoprotein;  
   b) providing a hematology analyzer for differentiating white blood cells and for analyzing a blood cell sample by at least two angles of light scatter measurement both less than about 10° to differentiate nucleated blood cells;    c) passing the control through the hematology analyzer for detection of the simulated nucleated blood cells and subpopulations of white blood cells;    d) reporting simulated white blood cells in the control; and    e) reporting simulated nucleated blood cells in the control.    
     
     
         57 . A method of using a control including a nucleated blood cell component comprising the steps of: 
 a) providing a control that is suitable for use for at least 3 days, including: 
 i) a stabilized blood cell suitable for simulating a nucleated blood cell, the stabilized blood cell including a membrane enclosing a nucleus and wherein the cytoplasm of the stabilized blood cell has been substantially removed from within said membrane;  
 ii) a white blood cell component for simulating at least three subpopulations of white blood cells;  
   b) providing a hematology analyzer differentiating white blood cells and for analyzing a blood cell sample by at least one angle of light scatter measurement to differentiate nucleated blood cells;    c) passing the control through the hematology analyzer for detection of the simulated nucleated blood cells and said at least three subpopulations of white blood cells;    d) reporting said simulated at least three subpopulations of white blood cells in the control; and    e) reporting simulated nucleated blood cells in the control.    
     
     
         58 . A method of using a hematology control product including at least one nucleated blood cell analog comprising the steps of: 
 a) providing a hematology control product including a nucleated blood cell analog, wherein the analog is a blood cell including a membrane enclosing a nucleus, wherein the blood cell has been treated so that said membrane is resistant to degradation, and wherein the majority of the hemoglobin in the blood cell has been released;    b) providing an instrument for analyzing a blood cell sample by at least two physical properties selected from the group comprising DC volume, RF size, opacity, and light scatter;    c) passing the control product through the instrument for detection of said nucleated blood cell analog; and    d) reporting said nucleated blood cell analog in the control product.    
     
     
         59 . A method of using a control including a nucleated blood cell component comprising the steps of: 
 a) providing a control including a stabilized blood cell suitable for simulating a nucleated blood cell, the stabilized blood cell including a membrane enclosing a nucleus and wherein the majority of the hemoglobin has been released from within said membrane;    b) providing a hematology analyzer for analyzing a blood cell sample by at least two angles of light scatter measurement to differentiate nucleated blood cells;    c) passing the control through the hematology analyzer for detection of the simulated nucleated blood cells; and    d) reporting nucleated blood cells in the control.    
     
     
         60 . A method of using a hematology control product including a nucleated red blood cell comprising the steps of: 
 a) providing a hematology control product including a stabilized nucleated red blood cell suitable for simulating a nucleated blood cell, wherein the majority of the hemoglobin has been released from the nucleated red blood cell;    b) providing an instrument for analyzing a blood cell sample by light scatter at various angular ranges;    c) passing the control product through the instrument for detection of said stabilized nucleated red blood cell; and    d) reporting said stabilized nucleated red blood cell in the control product.    
     
     
         61 . A method of using a hematology control product including a nucleated red blood cell comprising the steps of: 
 a) providing a hematology control product including a stabilized nucleated red blood cell suitable for simulating a nucleated blood cell, wherein 20% to 80% by weight of the hemoglobin in the stabilized nucleated red blood cell has been removed;    b) providing an instrument for analyzing a blood cell sample by at least two physical properties selected from the group comprising DC volume, RF size, opacity, and light scatter;    c) passing the control product through the instrument for detection of said stabilized nucleated red blood cell; and    d) reporting said stabilized nucleated red blood cell in the control product.    
     
     
         62 . A method of using a hematology control product including a nucleated blood cell analog comprising the steps of: 
 a) providing a hematology control product that is suitable for use up to about 6 months, including: 
 i) a first analog for simulating a nucleated blood cell, wherein said first analog is a blood cell which has been treated so that it is resistant to lysing and wherein 20% to 80% by weight of the hemoglobin in the blood cell has been removed;  
 ii) a second analog for simulating a nucleated blood cell, wherein said second analog simulates at least one subpopulation white blood cells;  
   b) providing an instrument that differentiates white blood cells and analyzes a blood cell sample by at least one angle of light scatter measurement;    c) passing the control product through the instrument for detection of nucleated blood cells and subpopulations of white blood cells; and    d) reporting said first analog in the control product;    e) reporting said second analog in the control product.    
     
     
         63 . A method of using a hematology control product including a nucleated red blood cell comprising the steps of: 
 a) providing a hematology control product including a stabilized reptile nucleated red blood cell suitable for simulating a human nucleated blood cell, wherein 20% to 80% by weight of the hemoglobin in the stabilized reptile nucleated red blood cell has been removed;    b) providing an instrument for analyzing a blood sample by light scatter at various angular ranges;    c) passing the control product through the instrument for measurement of the simulated human nucleated blood cell; and    d) reporting such measurement of the simulated human nucleated blood cell.    
     
     
         64 . A method of using a hematology control product containing a nucleated red blood cell comprising the steps of: 
 a) providing a hematology control product including a stabilized nucleated red blood cell suitable for simulating a nucleated blood cell, wherein 20% to 80% by weight of the hemoglobin in the stabilized nucleated red blood cell has been removed;    b) providing an instrument for analyzing a blood sample by light scatter at various angular ranges;    c) passing the control product through the instrument for measurement of the simulated nucleated blood cell; and    d) reporting such measurement of the simulated nucleated blood cell.    
     
     
         65 . The method of  claim 40 , wherein said light scatter is at least one of low angle light scatter, median angle light scatter, and high angle light scatter.  
     
     
         66 . The method of  claim 40 , wherein two of said at least two physical properties are light scatter properties selected from low angle light scatter, median angle light scatter, and high angle light scatter.  
     
     
         67 . A method of using a hematology control product including at least one nucleated blood cell analog comprising the steps of: 
 a) providing a hematology control product including a nucleated blood cell analog, wherein the analog is a blood cell including a membrane enclosing a nucleus, wherein the blood cell has been treated so that said membrane is resistant to degradation, and wherein 20% to 80% by weight of the hemoglobin in the blood cell has been removed;    b) providing an instrument for analyzing a blood cell sample by light scatter at various angular ranges;    c) passing the control product through the instrument for detection of said nucleated blood cell analog; and    d) reporting said nucleated blood cell analog in the control product.