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Process for preparing a biological composition for use as a reference control in diagnostic analysis

Assignee: Beckman Coulter Inc
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Filing: 1978-07-17
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Granted: 1979-06-19
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Expires: 1998-07-17
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Abstract

Abstract A process for making a biological composition for use as a blood serum reference composition in diagnostic analysis. The process comprises: (a) adding calcium to citrated plasma and mixing well to form decitrated plasma; (b) adding thrombin to the decitrated plasma and mixing well to form a clot of fibrin; (c) performing at least one freeze-thaw routine on the clot to cause the fibrin to contract; (d) removing the fibrin to thereby obtain serum; (e) molecular washing and ultrafiltering the serum and thereby obtaining concentrated serum; and (f) adding to the concentrated serum at least one alkylene polyol having from 2-5 carbon atoms in an amount such that said composition's non-biological component comprises from about 40 to about 85 weight percent water and from about 15 to about 60 weight percent of said alkylene polyol.

Inventors

  • 👤 Allan L. Louderback

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-28 10:01
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/96; G01N2333/00; G01N2333/435; G01N2333/745; G01N2333/75; G01N2333/90; G01N2333/914; G01N2333/948; G01N2333/974; G01N2496/00; G01N2496/05; Y; Y10; Y10T; Y10T436/00; Y10T436/10; Y10T436/106664; Y10T436/107497; Y10T436/108331

Claims Analysis

Total Claims: 11
Claim 1
Independent Claim 133 words
A process for making a biological composition for use as a blood serum reference composition in diagnostic analysis comprising: (a) adding calcium to citrated plasma and mixing well to form decitrated plasma; (b) adding thrombin to said decitrated plasma and mixing well to form a clot of fibrin; (c) performing at least one freeze-thaw routine on said clot to cause the fibrin to contract; (d) removing the fibrin to thereby obtain serum; (e) molecular washing and ultrafiltering the serum and thereby obtaining concentrated serum; and (f) adding to the concentrated serum at least one alkylene polyol having from 2-5 carbon atoms in an amount such that said composition's non-biological component comprises from about 60 to about 80 weight percent water and from about 20 to about 40 weight percent of said alkylene polyol.
Claim 2
Dependent Claim 133 words
A process for making a biological composition for use as a blood serum reference composition in diagnostic analysis comprising: (a) adding calcium to citrated plasma and mixing well to form decitrated plasma; (b) adding thrombin to said decitrated plasma and mixing well to form a clot of fibrin; (c) performing at least one freeze-thaw routine on said clot to cause the fibrin to contract; (d) removing the fibrin to thereby obtain serum; (e) molecular washing and ultrafiltering the serum and thereby obtaining concentrated serum; and (f) adding to the concentrated serum at least one alkylene polyol having from 2-5 carbon atoms in an amount such that said composition's non-biological component comprises from about 60 to about 80 weight percent water and from about 20 to about 40 weight percent of said alkylene polyol.
Claim 3
Dependent Claim 47 words
The process of claim 1 wherein after step (d), the serum is acid-treated by first dropping the pH thereof to from about 3.0 to 4.5 to thereby inactivate all endogenous enzyme action and then raising the pH of said serum to from about 6.0 to about 9.0.
Claim 4
Dependent Claim 24 words
The process of claim 2 wherein said pH is first dropped to about 4 and then raised to from about 6.5 to about 8.5.
Claim 5
Dependent Claim 16 words
The process of claim 2 wherein at least three freeze-thaw routines are performed on said clot.
Claim 6
Dependent Claim 14 words
The process of claim 4 wherein four freeze-thaw routines are performed on said clot.
Claim 7
Dependent Claim 22 words
The process of claim 2 wherein after step (e), fumed silicon dioxide is contacted with said concentrated serum, mixed, and separated therefrom.
Claim 8
Dependent Claim 25 words
The process of claim 2 wherein after step (f), fumed silicon dioxide is contacted with said alkylene polyol containing biological composition, mixed, and separated therefrom.
Claim 9
Dependent Claim 22 words
The process of claim 1 wherein after step (e), fumed silicon dioxide is contacted with said concentrated serum, mixed, and separated therefrom.
Claim 10
Dependent Claim 25 words
The process of claim 1 wherein after step (f), fumed silicon dioxide is contacted with said alkylene polyol containing biological composition, mixed, and separated therefrom.
Claim 11
Dependent Claim 16 words
The process of claim 1 wherein at least three freeze-thaw routines are performed on said clot.

References Cited (Backward Citations)

US2664403A Cited
US2770602A Cited
US3466249A Cited
US3629142A Cited
US3876375A Cited
US3876375B1 Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1982-06-18 1982-12-18 1983-06-19 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1986-06-18 1986-12-18 1987-06-19 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1990-06-18 1990-12-18 1991-06-19 $7700.00 Window Closed / Lapsed

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