Multi-Analyte Reference Solutions

• US 20090215181A1
• Filed: 09/03/2008
• Published: 08/27/2009
• Est. Priority Date: 12/11/2002
• Status: Active Grant

• Current Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Original Assignee: Instrumentation Lab Co (Instrumentation Lab)
• Inventors: Conlon, Dennis Robert, Mansouri, Sohrab, Vago, Giannantonio
• Granted Patent: US 7,732,210 B2
• Time in Patent Office: Days
• US Class Current: 436/10
• CPC Class Codes: G01N 33/4915 using flow cells flow cytometry G01N15/14
• CPC Class Codes: G01N 33/492 Determining multiple analytes
• 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 436/101666 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 436/104998 Glucose, ketone, nitrate 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 reference solution for use in instruments that determine hematocrit levels in biological samples by measuring the resistance and/or conductivity of the biological samples. A reference solution according to the invention achieves conductivities representative of known hematocrit levels in blood, while maintaining tolerable levels of interference with the measurement of other analytes in the reference solution.

Claims

1. A reference solution for use in instruments that analyze biological samples, comprising 9-15% of a water soluble polymer by weight, 6-10% of a glycol by weight, and 6-10% of a polysaccharide by weight, wherein the reference solution has a conductivity corresponding to a known hematocrit level of a blood sample.

2. The reference solution according to claim 1, wherein the water soluble polymer is non-ionic.

3. The reference solution according to claim 1, wherein the water soluble polymer is polyethylene glycol.

4. The reference solution according to claim 1, wherein the glycol comprises at least one glycol selected from the group consisting of ethylene glycol, propylene glycol, dipropylene glycol, and glycerol.

5. The reference solution according to claim 1, wherein the polysaccharide is non-ionic.

6. The reference solution according to claim 1, wherein the polysaccharide is dextran.

7. The reference solution according to claim 1, further comprising at least one analyte.

8. The reference solution according to claim 7, wherein the analyte is an ion is selected from the group consisting of hydrogen, sodium, potassium, calcium, chloride, bicarbonate, lithium, magnesium, and ammonium.

9. The reference solution according to claim 8, wherein the concentration of the ion in the reference solution corresponds to the physiological concentration of the ion in human blood.

10. The reference solution according to claim 7, wherein the analyte comprises a biological metabolite selected from the group consisting of glucose, lactate, urea, creatine, and creatinine.

11. The reference solution according to claim 10, wherein the concentration of the biological metabolite in the reference solution corresponds to the physiological concentration of the biological metabolite in human blood.

12. The reference solution according to claim 7, wherein the analyte comprises a gas selected from the group consisting of oxygen and carbon dioxide.

13. The reference solution according to claim 12, wherein the partial pressure of the gas in the reference solution corresponds to the physiological partial pressure of the gas in human blood.

14. The reference solution according to claim 1, further comprising one or more additives selected from the group consisting of pH buffer solutions, preservatives, stabilizers, surfactants, dyes, and anticoagulants.

15. The reference solution according to claim 1, wherein the hematocrit level corresponds to the physiological hematocrit level in human blood.

16. The reference solution according to claim 1, wherein the hematocrit level is greater than the physiological hematocrit level in human blood.

17. The reference solution according to claim 1, wherein the hematocrit level is less than the physiological hematocrit level in human blood.

18. The reference solution according to claim 1, wherein the biological sample comprises blood.

19. A reference solution for use in instruments that analyze biological samples, comprising:

9-15% polyethylene glycol by weight,

6-10% ethylene glycol by weight, and

6-10% dextran by weight,

wherein the reference solution has a conductivity corresponding to a known hematocrit level of a blood sample.

20. The reference solution according to claim 19, further comprising one or more analytes.