US4731330A
Expired / Lapsed
US
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Whole blood control sample
Assignee: Roche Diagnostics Operations Inc
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Filing: 1986-07-01
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Granted: 1988-03-15
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Expires: 2006-07-01
Abstract
Abstract A whole blood control sample and a method of preparing the sample are disclosed. The method comprises collecting a whole blood sample from one or more donor, separating each sample into red blood cells and plasma, fixing the red blood cells, mixing the fixed red blood cells with plasma from the same or a different donor to produce a suspension, quick-freezing the suspension before the red blood cells can settle, and lyophilizing the frozen suspension. The control sample therefore comprises a lyophilized mixture of fixed red blood cells and plasma solids.
Inventors
- 👤 James L. Hill
- 👤 Laura J. Winfrey
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 18:28
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/96; G01N2496/00; G01N2496/05; Y; Y10; Y10T; Y10T436/00; Y10T436/10; Y10T436/101666; Y10T436/106664; Y10T436/108331
Claims Analysis
Total Claims: 24
Claim 1
Independent Claim
42 words
A whole blood control sample, which comprises: a lyophilized mixture comprising (1) fixed red blood cells, and (2) plasma solids including coagulation factors capable of producing clotting, wherein said mixture prior to lyophilization comprises 30-55% fixed red blood cells and 70-45% plasma.
Claim 2
Dependent Claim
42 words
A whole blood control sample, which comprises: a lyophilized mixture comprising (1) fixed red blood cells, and (2) plasma solids including coagulation factors capable of producing clotting, wherein said mixture prior to lyophilization comprises 30-55% fixed red blood cells and 70-45% plasma.
Claim 3
Dependent Claim
27 words
The control sample of claim 1, wherein said sample contains herapin or a calcium chelating agent selected solely from chelating agents present in unmodified human whole blood.
Claim 4
Dependent Claim
13 words
The control sample of claim 2, wherein said sample contains no added citrate.
Claim 5
Dependent Claim
17 words
The control sample of claim 1, wherein said red blood cells are fixed with an aliphatic dialdehyde.
Claim 6
Dependent Claim
16 words
The control sample of claim 4, wherein said dialdehyde contains from 4 to 10 carbon atoms.
Claim 7
Dependent Claim
11 words
The control sample of claim 5, wherein said dialdehyde is glutaraldehyde.
Claim 8
Dependent Claim
22 words
The control sample of claim 1, wherein heparin is present in from 0.002 to 0.003 percent by weight of said lyophilized mixture.
Claim 9
Dependent Claim
23 words
The control sample of claim 1, wherein said fixed red blood cells and said plasma solids are obtained from two different human donors.
Claim 10
Dependent Claim
13 words
The control sample of claim 8, wherein said individuals have different blood types.
Claim 11
Dependent Claim
27 words
The control sample of claim 1, wherein said mixture further comprises plasma solids from a mammalian host different from the host that supplied the principal plasma solids.
Claim 12
Dependent Claim
16 words
The control sample of claim 10, wherein said plasma solids are human and canine plasma solids.
Claim 13
Independent Claim
87 words
A method of preparing a whole blood control sample, which comprises: collecting a whole blood sample from one or more donors; separating each whole blood sample into red blood cells and plasma; fixing said red blood cells; mixing said fixed red blood cells with plasma from the same or a different donor to produce a suspension containing 30-55% fixed red blood cells and 70-45% plasma including coagulation factors capable of producing clotting; quick-freezing said suspension before said red blood cells can settle; and lyophilizing said frozen suspension.
Claim 14
Independent Claim
87 words
A method of preparing a whole blood control sample, which comprises: collecting a whole blood sample from one or more donors; separating each whole blood sample into red blood cells and plasma; fixing said red blood cells; mixing said fixed red blood cells with plasma from the same or a different donor to produce a suspension containing 30-55% fixed red blood cells and 70-45% plasma including coagulation factors capable of producing clotting; quick-freezing said suspension before said red blood cells can settle; and lyophilizing said frozen suspension.
Claim 15
Dependent Claim
26 words
The method of claim 12 wherein said plasma sample is mixed with plasma from a different mammal prior to said mixing with fixed red blood cells.
Claim 16
Dependent Claim
20 words
The method of claim 13, wherein said different mammal is a dog and said one or ore donors are human.
Claim 17
Dependent Claim
18 words
The method of claim 12, wherein heparin is added to said whole blood sample prior to said separating.
Claim 18
Dependent Claim
21 words
The method of claim 15, wherein the heparin concentration of said whole blood sample is from 0.5 to 3 USP units/ml.
Claim 19
Dependent Claim
16 words
The method of claim 12, wherein said red blood cells are fixed with an aliphatic dialdehyde.
Claim 20
Dependent Claim
10 words
The method of claim 17, wherein said dialdehyde is glutaraldehyde.
Claim 21
Dependent Claim
15 words
The method of claim 12, wherein said quickfreezing is accomplished in less than 60 seconds.
Claim 22
Dependent Claim
32 words
The method of claim 19, wherein said quick-freezing is accomplished by applying a small sample of said suspension to a surface maintained at a temperature below the freezing point of said suspension.
Claim 23
Dependent Claim
14 words
The method of claim 20, wherein said temperature is no more than -20° C.
Claim 24
Dependent Claim
16 words
The method of claim 12, wherein said control sample is stored under vacuum after said lyophilizing.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1991-03-15 | 1991-09-14 | 1992-03-15 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1995-03-15 | 1995-09-14 | 1996-03-15 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1999-03-15 | 1999-09-14 | 2000-03-15 | $7700.00 | Window Closed / Lapsed |