Control or calibration serum for lipid diagnosis

• US 4,701,417 A
• Filed: 11/21/1985
• Issued: 10/20/1987
• Est. Priority Date: 12/10/1984
• Status: Expired due to Fees

• Current Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Bartl, Knut, Portenhauser, Rudolf
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US06/800,460
• Time in Patent Office: 698 Days
• Field of Search: 436/8-16
• US Class Current: 436/13
• CPC Class Codes: G01N 2496/05 containing blood cells or plasma
• CPC Class Codes: G01N 2800/044 Hyperlipemia or hypolipemia, e.g. dyslipidaemia, obesity
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/104165 Lipid, cholesterol, or triglyceride standard or control
• CPC Class Codes: Y10T 436/106664 Blood serum or blood plasma standard or control
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

The present invention provides a control or calibration serum for lipid diagnosis, wherein it contains the parameters relevant for lipid diagnosis in the normal or pathological concentration range in a single storage-stable form.

The present invention also provides processes for the preparation of this control or calibration serum.

Claims

1. A control or calibration system for lipid diagnosis containing parameters relevant for liquid diagnosis in the normal or human pathological concentration range in a single storage-stable form, said parameters comprising 140-320 mg/dl total cholesterol, 20-80 mg/dl HDL cholesterol, 90-250 mg/dl LDL cholesterol, 70-200 mg/dl triglycerides, 50-140 mg/dl apolipoprotein A1, 20-50 mg/dl apolipoprotein A2 and 80-170 mg/dl apolipoprotein B.

2. The control or calibration serum of claim 1, wherein said parameters comprise 40-80 mg/dl HDL cholesterol, 120-180 mg/dl LDL cholesterol, 100-130 mg/dl apolipoprotein A1, 35-50 mg/dl apolipoprotein A2 and 85-115 apolipoprotein B.

3. The control or calibration serum of claim 1 in lyophilised form.

4. The control or calibration serum of claim 1 wherein said parameters comprise 100-130 mg/dl apolipoprotein A1, 35-50 mg/dl apolipoprotein A2, 85-115 mg/dl apolipoprotein B, 180-280 mg/dl total cholesterol, 40-80 mg/dl HDL cholesterol, 120-180 mg/dl LDL cholesterol, 90-130 mg/dl triglycerides.

5. A process for the preparation of a control or calibration serum containing parameters in the normal or human pathological concentration range, which parameters comprise predetermined amounts of apolipoprotein A1, A2 and B;

total cholesterol;

HDL cholesterol;

LDL cholesterol and triglycerides;

in the normal or human pathological concentration range, said process comprising;

obtaining as starting material, fresh blood serum, blood serum which has been fresh frozen and freshly thawed, or blood serum from plasma which has been freshly frozen and freshly thawed;

determining the amounts of the parameters in said serum;

adjusting the parameter concentrations into said predetermined amount by adding an LDL cholesterol concentrate, an HDL cholesterol concentrate and a triglyceride-rich egg yolk extract; and

;

working up the adjusted serum into storage stable form.

6. The process of claim 5 wherein the starting material is human blood plasma or serum.

7. The process of claim 5 wherein the starting material is bovine serum albumin.

8. The process of claim 5, further comprising adding, as an adjuvant, 4 to 12% by weight of saccharose.

9. The process of claim 5 wherein the serum is worked-up into storage stabile form by lyophilizing the serum.