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1. (WO1993017330) COMPOSITION DE CONTROLE HEMATOLOGIQUE POUR ANALOGUES LEUCOCYTAIRES, METHODE DE PREPARATION ET UTILISATION
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The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A hematology control product comprising treated blood cells which have been treated so that they are resistant to degradation by lytic reagents used in hematological test procedures, and said control product simulates at least two different human leukocytes, characterized in that each having at least two physical properties of a human leukocyte, said properties selected from the group comprising:

a. volume measured by D.C. current,
b. high frequency (RF) size,
c. opacity, and
d. light scatter.

2. The hematology control product of claim 1,
characterized in that one of the physical properties is light scatter.

3. The hematology control product of claim 2,
characterized wherein the treated blood cells used to simulate one of the human leukocytes have been expanded greater than 30% of its original volume.

4. The hematology control product of any one of claims 1, 2, or 3, characterized wherein said hematology control product contains at least four leukocyte analogs which are distributed within at least four different boundaries of analysis, said boundaries of analysis being- made on the basis of light scatter, volume and opacity.

5. The hematology control product of claim 1 or 2, characterized wherein said treated blood cells have a changed hemoglobin content.

6. The hematology control product of claim 5,
characterized wherein the hemoglobin of said blood cells have been denatured within the treated blood cell.

7. The hematology control product of claim 5,
characterized wherein the hemoglobin of said treated blood cells have been leaked from the treated blood cell.

8. The hematology control product of claim 7,
characterized wherein 20% to 80% of the hemoglobin has been leaked from the treated blood cells.

9. A method for using a hematology control product which contains at least two leukocyte analog populations
comprising:

a. placing a hematology control product in an instrument, said control product containing at least two different leukocyte analog populations which have been derived from blood cells which have been treated so that they are resistant to degradation by lytic reagents used in hematological test procedures, characterized wherein said leukocyte analog populations each have at least two physical properties of a human leukocyte said properties selected from the group comprising:

(1) volume measured by D.C. current,
(2) high frequency (RF) size, (3) opacity, and
(4) light scatter;

b. measuring said physical properties of the control product; and

c. reporting the results of such measuring to determine if said instrument is functioning within
specification.

10. The method of claim 9, characterized wherein one of the physical properties is light scatter.

11. The method of claim 9 or 10, characterized wherein said control product comprises at least four leukocyte analogs which are distributed within at least four
different boundaries of analysis of said instrument, said boundaries of analysis being made on the basis of light scatter, volume and opacity.

12. The method of claim 9 or 10, characterized wherein said leukocyte analogs have a changed hemoglobin content.

13. The method of claim 12, characterized wherein said leukocyte analogs have 20% to 80% of the hemoglobin leaked from the blood cell.

14. The method of claim 12, characterized wherein the hemoglobin of said leukocyte analogs have been denatured in the cell.

15. A method for manufacture of leukocyte analogs
comprising:

a. mixing a red blood cell with a hypoosmotic solution to expand the volume of the cell; characterized by,

b. changing the hemoglobin content of the cell to simulate the light scatter properties of human leukocyte cells; and,

c. fixing the cell so that it is resistant to degradation by lytic reagents used in a hematological test procedure, said fixed cell having light scatter and volume properties similar to human leukocytes.

16. The method of claim 15, characterized wherein the changing of the hemoglobin content is accomplished by denaturing the hemoglobin in the cell.

17. The method of claim 15, characterized wherein the changing of the hemoglobin content is accomplished by leaking it from the cell.

18. The method of claim 17, characterized wherein the hemoglobin content of the cell has been reduced between 20% to 80%.

19. The method of claim 15, wherein said mixing is characterized by mixing the cells with a serum substance, and then with a hypoosmotic solution.

20. The method of claim 19, characterized wherein the serum substance is selected from the group comprising cholesterol, cholesterol esters, lipoprotein cholesterol, lipoprotein cholesterol esters, cholesterol combined with phospholipids, and mixtures thereof.

21. The method of any one of claims 15, 19, or 20, characterized wherein the cell has been expanded greater than 75%.

22. The method of claim 15, characterized wherein the said red blood cell is simultaneously expanded and fixed.