Control or calibration standard for use with instruments for optical measurement of hemoglobin concentration in blood samples

• US 6,174,728 B1
• Filed: 04/03/1998
• Issued: 01/16/2001
• Est. Priority Date: 04/03/1998
• Status: Expired due to Term

• Current Assignee: Avl Medical Instruments AG (Roche Holding AG)
• Original Assignee: Avl Medical Instruments AG (Roche Holding AG)
• Inventors: Tusa, James K., Laughinghouse, Charles L., Ben-David, Daniel, Ziegler, Werner, Kroneis, Herbert, Jöbstl, Ewald
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US09/054,461
• Time in Patent Office: 1,019 Days
• Field of Search: 436/8, 436/10, 436/11, 436/15, 436/16, 436/18, 436/63, 436/66, 436/68, 436/74, 436/79, 252/408.1, 73/10.1, 73/10.2, 73/10.3, 702/19, 702/21
• US Class Current: 436/16
• CPC Class Codes: G01N 21/4785 Standardising light scatter apparatus; Standards therefor
• 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 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]
• 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

A control or calibration standard for use with instruments for the optical measurement of the hemoglobin content in blood samples, features scattering particles or beads dispersed in aqueous electrolyte solution. To prevent sedimentation of the beads during storage, they have a mean diameter of <0.6 μm, preferably about 0.3 μm, and a volume concentration of <1%, preferably <0.3%. To prevent long term agglomeration, a non-ionic surfactant with an added antioxidant can be included in the formulation.

Claims

1. A control or calibration standard for use with instruments for optical measurement of hemoglobin concentration in blood samples, said standard being comprised of scattering calibration particles dispersed in an aqueous electrolyte solution, wherein said dispersed particles have a mean diameter of <

0.06 μ

m and a volume concentration <

0.3%, the mass density of said electrolyte solution substantially corresponding to a mass density of said scattering particles.

2. A control or calibration standard as claimed in claim 1, wherein said scattering particles consist of substantially spherical particles made of a polymer from the group consisting of polystyrene, polyvinyl toluene, styrene butadiene copolymers, polydivinyl benzene, polyolefin, polymethyl methacrylate, polyacrylate and latex.

3. A control or calibration standard as claimed in claim 1, wherein a radiation absorber for wavelengths in a 600-1200 nm range is provided on the surface or in the interior of said scattering particles.

4. A control or calibration standard as claimed in claim 1, wherein said electrolyte solution contains water-soluble polymers from the group consisting of polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), polyethylene glycol (PEG), and polyvalent alcohols, in concentrations of up to 90 percent by volume.

5. A control or calibration standard as claimed in claim 4, wherein said polyvalent alcohol is at least one alcohol selected from the group consisting of glycerol, propylene glycol and ethylene glycol.

6. A control or calibration standard as claimed in claim 1, wherein said standard additionally contains a surfactant.

7. A control or calibration standard as claimed in claim 6, wherein said surfactant is a non-ionic tenside selected from the group consisting of polyoxyethylene alkyl ether and alkylphenyl polyoxyethylene ether.

8. A control or calibration standard according to claim 7, wherein said polyoxyethylene alkyl ether is polyoxyethylene hexadecylic ether.

9. A control or calibration standard according to claim 7, wherein said alkylphenyl polyoxyethylene ether is octylphenyl polyoxyethylene ether.

10. A control or calibration standard as claimed in claim 1, wherein said scattering particles have a mean diameter of about 0.3 μ

m and a volume concentration of <

0.3%.

11. A control or calibration standard for use with blood gas measuring systems and instruments for optical measurement of hemoglobin concentration in blood samples, said standard comprising scattering particles dispersed in an aqueous electrolyte solution, wherein said scattering particles have a mean diameter of <

0.6 μ

m and a volume concentration of <

0.3%, wherein said electrolyte solution contains a buffer providing a pH of 6.7 to 7.9 and wherein values for PCO₂ are between 10 and 100 mm Hg, and for PO₂ are between 15 and 400 mm Hg.

12. A control or calibration standard as claimed in claim 11, wherein said electrolyte solution contains at least one ion selected from the group of a group consisting of Ca²⁺, Na⁺, K⁺, Mg²⁺ and Cl⁻

at concentrations corresponding to ion concentrations found in human blood.

13. A control or calibration standard as claimed in claim 11, wherein said standard contains a Good'"'"'s buffer as said buffer.

14. A control or calibration standard according to claim 13, wherein said Good'"'"'s buffer is selected from the group consisting of HEPES, MOPS and TES.

15. A control or calibration standard as claimed in claim 11, wherein said standard comprises a series of three solutions (Level 1, Level 2, Level 3) of the following compositions:

16. A control or calibration standard as claimed in claim 15, wherein said scattering particles are non-functionalized polystyrene beads of a diameter of about 0.3 μ

m.

17. A control or calibration standard as claimed in claim 11, wherein said standard contains a preservative.

18. A control or calibration standard as claimed in claim 11, wherein said scattering particles consist of substantially spherical particles made of a polymer selected from the group consisting of polystyrene, polyvinyl toluene, styrene butadiene copolymers, polydivinyl benzene, polyolefin, polymethyl methacrylate, polyacrylate and latex.

19. A control or calibration standard as claimed in claim 11, wherein a mass density of said electrolyte solution substantially corresponds to a mass density of said scattering particles.

20. A control or calibration standard as claimed in claim 19, wherein said electrolyte solution contains water-soluble polymers selected from the group consisting of polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP), polyethylene glycol (PEG), and polyvalent alcohols, in concentrations of up to 90 percent by volume.

21. A control or calibration standard as claimed in claim 20, wherein said polyvalent alcohol is at least one alcohol selected from the group consisting of glycerol, propylene glycol and ethylene glycol.

22. A control or calibration standard as claimed in claim 11, wherein said standard additionally contains a surfactant.

23. A control or calibration standard according to claim 11, wherein said pH is between 7.1 and 7.7.

24. A control or calibration standard according to claim 11, wherein said PCO₂ value is between 20 and 80 mmHg.

25. A control or calibration standard according to claim 11, wherein said PO₂ value is between 45 and 160 mmHg.