IP Library Granted Patent US 7,482,161
Granted Patent B2
US 7,482,161 · App. 11/777,864 · Granted Jan 27, 2009

Preparation of a red blood cell component for a hematology control

Assignee: Bio-Rad Laboratories, Inc.
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Quick Facts
Patent No.
US 7,482,161
App. No.
11/777,864
Granted
Jan 27, 2009
Kind
B2
Abstract

Red blood cells from a vertebrate are treated to make them effective components of a hematology control, allowing the control to be used for detecting all blood cell components, including white blood cells and platelets. The treatment includes the use of a fixative under limited conditions of concentration and exposure time, and the resulting red blood cells are stable but lysable in a hematology instrument and have a reduced tendency to form particulates.

Claims (12)

1. A method for verifying the accuracy of a hematology instrument that analyzes a sample of mammalian blood containing red blood cells by a process that includes lysing said red blood cells in said instrument and that determines relative amounts of different types of blood cells in said sample, said method comprising:

analyzing in said instrument according to said process a blood control having a known composition and comprising a red blood cell component, a white blood cell component, and a platelet component, of known relative amounts, suspended in a simulated plasma, said red blood cell component consisting of non-nucleated Type B1mammalian red blood cells that have been pre-conditioned by incubation with butane-1,4-dial at a concentration of about 0.05% to about 2.5% (weight/volume) for a period of time of about 16 hours to about 48 hours at a temperature of about 2° C. to about 8° C., to crosslink said red blood cells while leaving said red blood cells lysable in said instrument, and comparing the results of said analysis with said known composition.

2. The method of claim 1 wherein said blood control is devoid of lysis promoters.

3. A method for verifying the accuracy of a hematology instrument that analyzes a sample of mammalian blood containing red blood cells by a process that includes lysing said red blood cells in said instrument and that determines relative amounts of different types of blood cells in said sample, said method comprising:

analyzing in said instrument according to said process a blood control having a known composition and comprising a red blood cell component, a white blood cell component, and a platelet component, of known relative amounts, suspended in a simulated plasma, said red blood cell component consisting of non-nucleated mammalian Type B2 red blood cells that have been preconditioned by incubation with, glutaraldehyde at a concentration of about 0.001% to about 0.25% (weight/volume) for a period of time of about 0.5 hour to about 4 hours at a temperature of about 15° C. to about 25° C., followed by butane-1,4-dial at a concentration of about 0.05% to about 2.5% (weight/volume) for a period of time of about 16 hours to about 48 hours at a temperature of about 2° C. to about 8° C., and comparing the results of said analysis with said known composition.

4. The method of claim 3 wherein said blood control is devoid of lysis promoters.

5. A blood control comprising a red blood cell component, a white blood cell component, and a platelet component, of known relative amounts, suspended in a simulated plasma, said red blood cell component consisting of non-nucleated Type B1 mammalian red blood cells that have been pre-conditioned by incubation with butane-1,4-dial at a fixative concentration of about 0.05% to about 2.5% (weight/volume) for a period of time of about 16 hours to about 48 hours at a temperature of about 2° C. to about 8° C., to crosslink said red blood cells while leaving said red blood cells lysable in a hematology instrument.

6. The blood control of claim 5 wherein said blood control is devoid of lysis promoters.

7. The blood control of claim 5 wherein said non-nucleated mammalian red blood cells, after said incubation with said butane-1,4-dial, have been further pre-conditioned by incubation in simulated plasma in the absence of a fixative for about 7 days to about 30 days at about 2° C. to about 8° C.

8. A blood control comprising a red blood cell component, a white blood cell component, and a platelet component, of known relative amounts, suspended in a simulated plasma, said red blood cell component consisting of non-nucleated mammalian Type B2 red blood cells that have been pre-conditioned by incubation with glutaraldehyde at a concentration of about 0.001% to about 0.25% (weight/volume) for a period of time of about 0.5 hour to about 4 hours at a temperature of about 15° C. to about 25° C., followed by butane-1,4-dial at a concentration of about 0.05% to about 2.5% (weight/volume) for a period of time of about 16 hours to about 48 hours at a temperature of about 2° C. to about 8° C., to crosslink said red blood cells while leaving said red blood cells lysable in a hematology instrument.

9. The blood control of claim 8 wherein said blood control is devoid of lysis promoters.

10. The blood control of claim 8 wherein said non-nucleated mammalian red blood cells, after said incubation with said glutaraldehyde and butane-1,4-dial, have been further pre-conditioned by incubation in simulated plasma in the absence of a fixative for about 7 days to about 30 days at about 2° C. to about 80° C.

Continuity (2)
Provisional Application 6080758500 · Jul 17, 2006
Related Publication 20080026468A1 · Jan 31, 2008