Blood biochemistry control standard

• US 4,324,687 A
• Filed: 06/23/1980
• Issued: 04/13/1982
• Est. Priority Date: 02/15/1979
• Status: Expired due to Term

• Current Assignee: Allan L. Louderback, Paul R. Szatkowski
• Original Assignee: Allan L. Louderback, Paul R. Szatkowski
• Inventors: Louderback, Allan L., Szatkowski, Paul R.
• Primary Examiner(s): Gron, Teddy S.
• Application Number:
  US06/162,065
• Time in Patent Office: 659 Days
• Field of Search: 252/408, 23/230 B, 435/4, 435/21, 435/17, 435/22, 435/26, 435/16, 435/2, 435/183, 424/2, 424/3
• US Class Current: 436/10
• CPC Class Codes: G01N 2496/05 containing blood cells or plasma
• CPC Class Codes: G01N 2496/80 Multi-analyte reference solutions containing cholesterol, glucose and the like
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/101666 Particle count or volume standard or control [e.g., platelet count standards, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

A blood biochemistry control standard for the quality control of the analytical measurement of blood biochemistry components is disclosed. The control standard comprises an aqueous suspension of red blood cells which have been stabilized by mild treatment with aldehyde and saline and then slowly equilibrated with at least one additionally incorporated non-gaseous biochemical analyte in a concentration of clinical significance.

Claims

1. A blood biochemistry control standard for the quality control of the analytical measurement of non-gaseous blood biochemistry components comprising an aqueous suspension of red blood cells which are (a) stabilized by mild treatment with aldehyde and saline at ambient temperature whereby said cells are lyseable in water and then (b) slowly and gradually equilibrated by washing over a period of at least about five minutes with an aqueous biochemical wash solution of at least one additionally incorporated non-gaseous biochemical analyte selected from the group consisting of the following analytes in the following concentrations of clinical diagnostic significance:

Sodium;

120 to 160 meq/l

Potassium;

2 to 9 meq/l

Urea;

10 to 130 mg/dl

Glucose;

25 to 500 mg/dl

Uric acid;

2 to 12 mg/dl

Chloride;

80 to 130 meq/l

Magnesium;

0.5 to 5 meq/l

Creatinine;

0.5 to 10 mg/dl

Phosphorus;

0.5 to 10 mg/dl

Calcium;

0.5 to 14 mg/dl

Bicarbonate;

3 to 40 meq/l

Iron;

25 to 300 μ

gm/dl

Lithium;

0.2 to 4 meq/l

Bilirubin;

0.5 to 30 mg/dl.

2. The blood biochemistry control standard of claim 1 including additionally blood serum protein in an amount of from about 3% to about 9%.

3. The method of making the blood biochemistry control standard of claim 1 comprising thoroughly washing red blood cells in saline solution, mildly admixing with a solution of aldehyde and saline, thoroughly washing in saline solution to remove substantially all the residual aldehyde, slowly equilibrating by gentle washing with an aqueous solution of at least one additionally incorporated non-gaseous biochemical analyte in a concentration of clinical diagnostic significance and thereafter collecting the thus treated red cells in aqueous suspension in a sealed receptacle.

4. The method of claim 3 in which the biochemical wash solution contains additionally blood serum protein to a level such that after washing the red cells the concentration of serum protein in the control standard is from about 3% to about 9%.