Quality control method

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 making a control including a nucleated blood cell component comprising the steps of: 
 a) providing a blood cell suitable for simulating a nucleated blood cell, said blood cell including a membrane enclosing nucleus and cytoplasm, and wherein said blood cell is selected from the group consisting of reptile nucleated blood cells and fish nucleated blood cells;    b) stabilizing said membrane of said blood cell with said nucleus remaining therein to give a product; and    c) admixing the product of step b) in a suspension medium suitable for delivering said product of step b to a hematology analyzer for analysis.    
     
     
         41 . A method of making a control including a nucleated blood cell component comprising the steps of: 
 a) providing a blood cell suitable for simulating a nucleated blood cell, said blood cell including a membrane enclosing nucleus and cytoplasm;    b) removing cytoplasm from within said membrane, wherein said membrane is maintained around the remaining nucleus;    c) stabilizing said membrane with said nucleus remaining therein to give a product; and    d) admixing the product of step c) in a suspension medium suitable for delivering said product of step c to a hematology analyzer for analysis.    
     
     
         42 . The method of  claim 41 , further comprising delivering a white blood cell component for inclusion in said suspension medium.  
     
     
         43 . The method of  claim 42 , further comprising delivering a white blood cell component from a red blood cell for inclusion in said suspension medium.  
     
     
         44 . The method of  claim 42 , further comprising delivering a white blood cell component from a human white blood cell from whole blood for inclusion in said suspension medium.  
     
     
         45 . The method of  claim 44 , wherein said delivering step includes fixing said human white blood cell prior to lysing red blood cells from said whole blood.  
     
     
         46 . The method of  claim 45 , wherein said delivering step includes contacting said human white blood cell with a lipoprotein.  
     
     
         47 . The method of  claim 46 , wherein said contacting occurs in a said suspension medium.  
     
     
         48 . The method of  claim 41 , further comprising delivering a white blood cell component from a human white blood cell from whole blood for inclusion in said suspension medium.  
     
     
         49 . The method of  claim 48 , wherein said delivering step includes fixing said human white blood cell.  
     
     
         50 . A method of making a control including a nucleated blood cell component, comprising the steps of: 
 a) providing a blood cell suitable for simulating a nucleated blood cell, said blood cell including a membrane enclosing a nucleus and cytoplasm;    b) contacting said blood cell with a lysing agent;    c) contacting a portion of said membrane with said lysing agent but preserving the general structure of said membrane about said nucleus;    d) removing cytoplasm from within said membrane, wherein said membrane is maintained around the remaining nucleus; and    e) suspending said resulting cell in a suspension medium.    
     
     
         51 . The method of  claim 50  wherein the blood cell is an alligator nucleated blood cell.  
     
     
         52 . The method of  claim 51  wherein step c includes permeating the membrane.  
     
     
         53 . The method of  claim 50 , further comprising fixing said blood cell after step d.  
     
     
         54 . The method of  claim 50  wherein said blood cell is a fish nucleated blood cell.  
     
     
         55 . A method of making a hematology control system comprising the steps of: 
 1) preparing a white blood cell component according to a process comprising: 
 a) provided a quantity of whole blood including cells for mimicking human white blood cells;  
 b) lysing red blood cells in said quantity of whole blood; and  
 c) thereafter fixing said cells remaining from said lysing;  
   2) preparing a nucleated blood cell component according to a process comprising the steps of: 
 a) providing alligator nucleated blood cells having a membrane enclosing nucleus and cytoplasm;  
 b) treating said alligator nucleated blood cells for preserving the membrane; and  
   3) suspending said resulting white blood cell component and said resulting nucleated blood cell component in a suspension medium.    
     
     
         56 . The method of  claim 55  further comprising contacting the white blood cell component with a lipoprotein.  
     
     
         57 . A method of making a hematology control system comprising the steps of: 
 1) preparing a nucleated blood cell component according to a process comprising: 
 a) provided a quantity of whole blood including cells for mimicking human white blood cells;  
 b) lysing red blood cells in said quantity of whole blood; and  
 c) thereafter fixing said cells remaining from said lysing;  
   2) preparing a second nucleated blood cell component according to a process comprising the steps of: 
 a) providing alligator nucleated blood cells having a membrane enclosing nucleus and cytoplasm;  
 b) treating said alligator nucleated blood cells for preserving the membrane; and  
   3) suspending said first and second nucleated blood cell components in a suspension medium.    
     
     
         58 . The method of  claim 57  further comprising contacting the first nucleated blood cell component with a lipoprotein.  
     
     
         59 . A method of making a hematology control product comprising the steps of: 
 a) providing a blood cell suitable for simulating a nucleated blood cell, said blood cell including a membrane enclosing a nucleus and hemoglobin, and wherein said blood cell is selected from the group consisting of reptile nucleated blood cells and fish nucleated blood cells;    b) stabilizing the membrane of the nucleated blood cell to give a product; and    c) combining the product of step b) with a suspension medium suitable for a hematology control product.    
     
     
         60 . A method of making a hematology control product comprising the steps of: 
 a) providing a blood cell suitable for simulating a nucleated blood cell which has a membrane enclosing a nucleus and hemoglobin;    b) removing hemoglobin from the blood cell, wherein the membrane is maintained around the remaining hemoglobin and nucleus;    c) stabilizing the membrane of the nucleated blood cell to give a product; and    d) combining the product of step c) in a suspension medium suitable for a hematology control product.    
     
     
         61 . The method of  claim 60 , further comprising adding a white blood cell analog to the suspension medium.  
     
     
         62 . The method of  claim 61 , further comprising adding a white blood cell analog from a red blood cell to the suspension medium.  
     
     
         63 . The method of  claim 61 , further comprising adding a white blood cell analog from a human white blood cell from whole blood to the suspension medium.  
     
     
         64 . The method of  claim 63 , further comprising fixing the white blood cell analog.  
     
     
         65 . The method of  claim 64 , further comprising contacting the white blood cell analog with a lipoprotein.  
     
     
         66 . The method of  claim 65 , wherein the suspension medium comprises the lipoprotein.  
     
     
         67 . The method of  claim 60 , further comprising preparing a white blood cell analog from human white blood cells from whole blood, and adding the white blood cell analog to the suspension medium.  
     
     
         68 . The method of  claim 67 , wherein said preparing step includes fixing the human white blood cells.  
     
     
         69 . A method of making a hematology control product comprising the steps of: 
 a) providing a blood cell suitable for simulating a nucleated blood cell, which said blood cell including a membrane enclosing a nucleus and hemoglobin;    b) contacting the blood cell with a hypoosmotic solution;    c) contacting a portion of the membrane with the hypoosmotic solution but preventing disruption of the membrane;    d) removing hemoglobin from the blood cell but maintaining the membrane around the nucleus;    e) suspending the blood cell in a suspension medium.    
     
     
         70 . The method of  claim 69 , wherein the blood cell is an alligator nucleated blood cell.  
     
     
         71 . The method of  claim 70 , wherein step c includes providing leaking hemoglobin through the membrane.  
     
     
         72 . The method of  claim 69  further comprising fixing the blood cell after removing hemoglobin.  
     
     
         73 . The method of  claim 69  wherein the blood cell is a fish nucleated blood cell.  
     
     
         74 . A method of making a hematology control product comprising the steps of: 
 1) preparing a white blood cell analog;    2) preparing a nucleated blood cell analog according to a process comprising the steps of: 
 a) providing alligator nucleated blood cells having a membrane enclosing nucleus and hemoglobin;  
 b) treating the alligator nucleated blood cells to prevent degradation of the membrane;  
   3) suspending the blood cell analogs in a suspension medium.    
     
     
         75 . The method of  claim 74  wherein the white blood cell analog is prepared from whole blood which includes human white blood cells.  
     
     
         76 . The method of  claim 75  wherein the white blood cell analog is prepared from a process comprising fixing the white blood cells.  
     
     
         77 . The method of  claim 75  wherein the white blood cell component is prepared from a process comprising lysing red blood cells in the whole blood.  
     
     
         78 . The method of  claim 77  wherein the white blood cell component is prepared from a process comprising fixing the white blood cells remaining after the lysing of the red blood cells.  
     
     
         79 . The method of  claim 74  further comprising contacting the white blood cell component with a lipoprotein.  
     
     
         80 . A method of making a hematology control product comprising the steps of: 
 1) preparing a first nucleated blood cell analog;    2) preparing a second nucleated blood cell analog according to a process comprising the steps of: 
 a) providing alligator nucleated blood cells having a membrane enclosing nucleus and hemoglobin;  
 b) treating the alligator nucleated blood cells to prevent degradation of the membrane;  
   3) suspending the blood cell analogs in a suspension medium.    
     
     
         81 . The method of  claim 80  wherein the first nucleated blood cell analog is prepared from a quantity of whole blood, and the whole blood including cells for simulating human nucleated blood cells.  
     
     
         82 . The method of  claim 81  wherein the first nucleated blood cell analog is prepared from a process comprising fixing the white blood cells.  
     
     
         83 . The method of  claim 81  wherein the first nucleated blood cell component is prepared from a process comprising lysing red blood cells in said quantity of whole blood.  
     
     
         84 . The method of  claim 83  wherein the first nucleated blood cell component is prepared from a process comprising fixing the nucleated blood cells remaining after the lysing of the red blood cells.  
     
     
         85 . The method of  claim 80  further comprising contacting the nucleated blood cells with a lipoprotein.  
     
     
         86 . A method of making a hematology control product comprising the steps of: 
 a) providing a blood cell suitable for simulating a nucleated blood cell which has a membrane enclosing a nucleus and hemoglobin;    b) removing from 20% to 80% by weight of the hemoglobin of the blood cell, wherein the membrane is maintained around the remaining hemoglobin and nucleus;    c) stabilizing the membrane of the blood cell to give a product; and    d) combining the product of step c) with a suspension medium suitable for a hematology control product.    
     
     
         87 . A method of making a hematology control product comprising the steps of: 
 a) providing a blood cell suitable for simulating a nucleated blood cell, which said blood cell including a membrane enclosing a nucleus and hemoglobin;    b) contacting the blood cell with a leaking agent;    c) contacting a portion of the membrane with the leaking agent but preventing disruption of the membrane;    d) leaking hemoglobin from the blood cell, wherein the membrane is maintained around the remaining nucleus;    e) suspending the blood cell in a suspension medium.