Freeze-stable liquid blood control standard

• US 4,199,471 A
• Filed: 11/16/1978
• Issued: 04/22/1980
• Est. Priority Date: 11/16/1978
• 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): Marantz, Sidney
• Application Number:
  US05/961,184
• Time in Patent Office: 523 Days
• Field of Search: 23/230 B, 23/928, 252/408
• US Class Current: 436/11
• CPC Class Codes: G01N 2496/05 containing blood cells or plasma
• CPC Class Codes: G01N 2496/70 Blood gas control solutios containing dissolved oxygen, bicarbonate 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 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/107497 Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

A freeze-stable liquid blood control standard and method is provided for the quality control of the measurement of blood pH and gases in the clinical laboratory. The blood control standard comprises a sealed receptacle containing specially treated red cells and a gaseous head space at least equal to about the volume of the red cells. The special treatment comprises thorough washing and separating the red cells from the plasma components and mild treatment with aldehyde, slow admixture with lower aliphatic diol or triol, and retention in a buffered solution. The special treatment optionally includes treating at least a portion of the red cells with carbon monoxide. The head space comprises from 0-15% CO₂, 0-25% O₂ and the balance N₂ and/or inert gas.

Claims

1. A freeze-stable blood control standard for the quality control of the measurement of blood pH and gases comprising a sealed receptacle containing treated erythrocytes and a gaseous head space having a volume which is at least equal to about the volume of said erythrocytes, said erythrocytes being treated by thorough washing in saline solution, mild admixing with a solution of aldehyde and saline, thorough washing in saline solution, then slow admixing with a cryoprotective agent selected from the group consisting of lower aliphatic diols and triols to a concentration of from about 20 to about 40 volume percent of said cryoprotective agent, said gaseous head space comprising from about 0% to about 15% CO₂, from about 0% to about 25% O₂ and the balance selected from the group consisting of N₂ and inert gases and mixtures thereof.

2. The freeze-stable blood control standard of claim 1 in which the cryoprotective agent is ethylene glycol.

3. The freeze-stable blood control standard of claim 2 in which the ethylene glycol concentration is about one-half the volume of the erythrocytes.

4. The freeze-stable blood control standard of claim 1 wherein the erythrocytes are buffered to a pH of from about 7 to about 7.7 and admixed with bicarbonate ion to a pCO₂ of from about 20 to about 55 mm Hg.

5. The freeze-stable blood control standard of claim 4 in which the buffer is selected from the group consisting of HEPES and TES buffers.

6. The freeze-stable blood control standard of claim 1 in which the aldehyde is an aliphatic aldehyde having from 1 to about 6 carbon atoms.

7. The freeze-stable blood control standard of claim 6 in which the aldehyde is formaldehyde.

8. The freeze-stable blood control standard of claim 1 in which the aldehyde concentration is from about 0.1 to about 0.6 molar.

9. The freeze-stable blood control standard of claim 1 in which the mild admixing with aldehyde is at about 20°

to about 26°

C. for about 15 minutes to about 4 hours.

10. The freeze-stable blood control standard of claim 1 in which at least a portion of the erythrocytes are treated with carbon monoxide and then combined with that portion of the erythrocytes that have been untreated with carbon monoxide.

11. The freeze-stable blood control standard of claim 1 in which the saline is normal physiological saline.

12. The freeze-stable blood control standard of claim 1 in which the erythrocytes are buffered to a pH of from about 7 to about 7.7, and in which at last a portion of the erythrocytes are treated with carbon monoxide and then combined with that portion of the erythrocytes that have been untreated with carbon monoxide and admixed with bicarbonate ion to a pCO₂ of from about 20 to about 55 mm Hg.

13. The freeze-stable blood control standard of claim 12 in which the cryoprotective agent is ethylene glycol.

14. The freeze-stable blood control standard of claim 12 in which the aldehyde is formaldehyde.

15. The freeze-stable blood control standard of claim 12 in which the saline is normal physiological saline.

16. The method of making a freeze-stable blood control standard for the quality control of the measurement of blood pH and gases comprising thoroughly washing erythrocytes in saline solution, mildly admixing with a solution of aldehyde and saline, thoroughly washing in saline solution, then slowly admixing with a cryoprotective agent selected from the group consisting of lower aliphatic diols and triols to a concentration of from about 20 to about 40 volume percent of said cryoprotective agent, transferring to receptacles while leaving a gaseous head space of at least about equal to the volume of said erythrocytes, flushing said head space with a gas comprising from about 0% to about 15% CO₂, from about 0% to about 25% O₂ and the balance selected from the group consisting of N₂ and inert gases and mixtures thereof, and immediately thereafter sealing said receptacles to form a gas tight closure.

17. The method of claim 16 in which following the admixing with the cryoprotective agent the erythrocytes are buffered to a pH of from about 7 to about 7.7, and in which at least a portion of the erythrocytes are treated with carbon monoxide and then combined with that portion of the erythrocytes that have been untreated with carbon monoxide and admixed with bicarbonate ion to a pCO₂ of from about 20 to about 55 mm Hg.