Multiple control standard for blood analysis

• US 4,843,013 A
• Filed: 03/02/1988
• Issued: 06/27/1989
• Est. Priority Date: 04/09/1986
• Status: Expired due to Term

• Current Assignee: Ferraris Group, Inc.
• Original Assignee: Bionostics, Inc. (Bio-Techne Corporation)
• Inventors: Chiang, Ching
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Wallen, T. J.
• Application Number:
  US07/163,330
• Time in Patent Office: 482 Days
• Field of Search: 436/8-19, 436/66-68, 252/408.1, 378/48, 514/6, 356/39-42
• US Class Current: 436/11
• CPC Class Codes: A61B 2560/0233 Optical standards
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: G01N 2496/15 containing dyes to mimic optical absorption of, e.g. hemoglobin
• CPC Class Codes: G01N 2496/25 containing added polymers to stabilise biological material against degradation or maintain viscosity or density, e.g. gelatin, polyacrylamides or polyvinyl alcohol
• 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 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/100833 Simulative of a gaseous composition
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent
• CPC Class Codes: Y10T 436/109163 Inorganic standards or controls

Abstract

This invention discloses a multiple control standard for the use in the quality assurance of blood analysis instrumentation systems. The liquid control standard is able to act as a control standard for blood gas instrumentation systems measuring pH, pCO2 and pO₂ of blood, as a control standard for a co-oximeter measuring the amount of total hemoglobin present in the blood and the relative amounts of other hemoglobin fractions present in the blood, and as a liquid control standard for ion selective electrode instrumentation systems for the measuring of electrolytes such as Na, K, Li and Ca ions in the blood.

Claims

1. A multiple liquid control standard comprising an aqueous solution useful as a control for blood gas instrumentation systems buffered by a buffering agent to a pH of from about 7.1 to about 7.7 and containing sufficient bicarbonate ions to provide a pCO₂ from about 15 to about 80 mm Hg, gaseous oxygen to provide a pO₂ of from about 50 to about 400 mm Hg retained, absorbance means to provide a control test which corresponds to a predetermined level of hemoglobin and hemoglobin fractions and salts of electrolytes to provide ions selected from the group consisting of ionic lithium, ionic calcium, ionic sodium and ionic potassium, said composition providing a control test for a corresponding ion selective electrode systems.

2. The liquid control standard as recited in claim 1, wherein said liquid control standard contains a predetermined concentration of Na, K, Li, and Ca ions so that the control standard can be used to test an ion selective electrode instrumentation system which measures the amount of Na, K, Li, and Ca ions present in blood.

3. A multiple liquid control standard as in claim 2, wherein the pH ranges from about 7.10 to about 7.20, the pCO₂ ranges from about 60 to about 70 mm Hg, the pO₂ ranges from about 50 to about 65 mm Hg, and the ion concentrations and the absorbacce means simulate blood having a low level of total hemoglobin.

5. A multiple liquid control standard as in claim 2, wherein the pH ranges from about 7.55 to about 7.65, the pCO₂ ranges from about 15 to about 25 mm Hg, the pO₂ ranges from about 140 to about 160mm Hg, and the ion concentrations and the absorbance means simulate blood having a high level of total hemoglobin.

4. A multiple liquid control standard as in claim wherein the pH ranges from about 7.35 to about 7.45, the pCO₂ ranges from about 35 to about 45 mm Hg, the pO₂ ranges from about 95 to about 110 mm Hg, and the ion concentrations and the absorbance means simulate blood having a normal level of total hemoglobin.

6. A multiple control standard for use in the quality assurance of blood analysis instrumentation systems, said liquid control standard being able to act as a control standard for blood gas instrumentation systems measuring pH, pCO₂ and pO₂ of blood, as a control standard for a co-oximeter measuring the amount of total hemoglobin present in the blood and the relative amounts of other hemoglobin fractions present in the blood, and a control standard for ion selective electrode instrumentation systems measuring the concentration of Na, K, Li and Ca ions in the blood, wherein the control standard is an aqueous solution buffered by a buffering agent to a pH of from about 7.1 to about 7.7 and containing sufficient bicarbonate ion to provide a pCO₂ from about 15 to about 80 mm Hg, gaseous oxygen to provide a pO₂ of from about 50 to about 400 mm Hg retained, absorbance means to provide a control test which corresponds to a predetermined level of hemoglobin and hemoglobin fractions, said absorbance means being comprised of Acid Red Dye #27 (CI 16185), Acid Yellow Dye #23 (CI 19140) and Acid Blue Dye #9 (CI 42090), and salts of Na, K, Li and Ca to provide a control test for a corresponding ion selective electrode instrumentation system.

7. A multiple control standard for use in the quality assurance of blood analysis instrumentation systems, said liquid control standard being able to act as a control standard for blood gas instrumentation systems measuring pH, pCO₂ and pO₂ of blood, as a control standard for a co-oximeter measuring the amount of total hemoglobin present in the blood and the relative amounts of other hemoglobin fractions present in the blood, and a control standard for ion selective electrode instrumentation systems measuring the concentration of Na, K, Li and Ca ions in the blood, wherein the control standard is an aqueous solution buffered by a buffering agent to a pH of from about 7.1 to about 7.7 and containing sufficient bicarbonate ion to provide a pCO₂ from about 15 to about 80 mm Hg, gaseous oxygen to provide a pO₂ of from about 50 to about 400 mm Hg retained, absorbance means to provide a control test which corresponds to a predetermined level of hemoglobin and hemoglobin fractions, said absorbance means being comprised of Ponceau 3R Red Dye (CI 16155) and Acid Blue Dye #9 (CI 42090).