Multi-analyte reference solutions with stable pO2 in zero headspace containers

• US 6,835,571 B2
• Filed: 08/29/2003
• Issued: 12/28/2004
• Est. Priority Date: 11/02/1995
• Status: Expired due to Term

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Bayer Corporation (Bayer AG)
• Inventors: Rannikko, Minna A., Sullivan, Kevin J., Green, Robert B., Conlon, Dennis R.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US10/652,398
• Publication Number:
  US 20040047771A1
• Time in Patent Office: 487 Days
• Field of Search: 436/8, 436/9, 436/11, 436/16, 436/68, 436/14, 436/15, 436/66, 422/99, 422/100, 422/102, 422/103
• US Class Current: 436/11
• CPC Class Codes: B01L 2200/025 Align devices or objects to ensure defined positions relative to each other
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/10 Means to control humidity and/or other gases
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: B32B 15/08 of synthetic resin
• CPC Class Codes: B65D 75/58 Opening or contents-removing devices added or incorporated during package manufacture B65D75/36, B65D85/1027 take precedence
• CPC Class Codes: B65D 75/5861 Spouts B65D75/5811, B65D75/5822 take precedence
• CPC Class Codes: B65D 75/5877 connected to a planar surface of the package wall
• CPC Class Codes: G01N 2001/2893 Preparing calibration standards
• CPC Class Codes: G01N 2496/70 Blood gas control solutios containing dissolved oxygen, bicarbonate and the like
• CPC Class Codes: G01N 2496/80 Multi-analyte reference solutions containing cholesterol, glucose and the like
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 33/0006 Calibrating gas analysers
• CPC Class Codes: G01N 33/4925 measuring blood gas content, e.g. O2, CO2 , HCO3
• 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 436/104998 Glucose, ketone, nitrate 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 436/25 : including sample preparation

Abstract

Multi-analyte reference solutions having a stable partial pressure of oxygen (pO₂) in zero headspace packaging and methods for preparing such solutions are disclosed. The solutions have long shelf and use lives when stored at room temperature and are packaged in laminated foil containers having low or no oxygen reactivity. Access devices are also disclosed.

Claims

1. A zero headspace container that maintains a stable partial pressure of oxygen in a multi-analyte reference solution housed therein, comprising:

(a) an inner layer forming the interior of the container and composed of a polymeric material that does not react with oxygen or has an oxygen reactivity that is sufficiently low so as to maintain the partial pressure of oxygen of a multi-analyte reference solution therein at a specified value ±

4 mm Hg;

(b) an intermediate layer comprised of aluminum;

(c) an outer layer that serves to protect the intermediate layer from physical damage;

(d) a multi-analyte reference solution housed within the interior of the container; and

(e) an access device housed totally within the interior of the container.

2. The container of claim 1, wherein the inner layer is polypropylene that exhibits low or no oxygen reactivity.

3. The container of claim 2, wherein the partial pressure of oxygen is maintained at the specified value ±

4 mmHg at room temperature for at least six months.

4. The container of claim 2, wherein the inner layer has a thickness of approximately 1.5 mil to 5 mil, the intermediate layer has a thickness of approximately 0.3 mil to 1 mil and the outer layer has a thickness of approximately 0.1 to 2 mil.

5. The container of claim 4, wherein the inner layer has a thickness of about 2 to 5 mil and the intermediate layer has a thickness of about 0.5 to 0.7 mil.

6. The container of claim 5, wherein the inner layer has a thickness of about 4 mil, the intermediate layer has a thickness of about 0.5 mil and the outer layer is either a lacquer coating, polyester, or nylon.

7. The container of claim 2, wherein the outer layer is polyester.

8. The container of claim 1, wherein the specified value is between 20 mmHg and 700 mmHg and the partial pressure is maintained at the specified value ±

4 mmHg at room temperature for at least six months.

9. The container of claim 1, wherein the partial pressure of oxygen is between 20 mxnHg and 700 mmHg, inclusively.

10. The container of claim 1, wherein the partial pressure of oxygen is between 30 mmHg and 500 MmHg, inclusively.

11. The container of claim 1, wherein the access device is connected to one or more walls of the container.

12. The container of claim 1, wherein the container is in the form of a 3-side, center-sealed pouch.

13. The container of claim 1, wherein the multi-analyte reference solution calibrates or controls for partial pressure of oxygen and one or more other analytes selected from the group consisting of pH, pCO₂, electrolytes, metabolites, tHb, CO-Ox fractions and hematocrit.

14. The container of claim 13, wherein the metabolites are selected from the group consisting of glucose, lactate, bilirubin, urea and creatinine.

15. The container of claim 1, wherein the multi-analyte reference solution consists essentially of chemicals having low or no oxygen reactivity.

16. The container of claim 15, wherein at least some of the chemicals are organic.

17. The container of claim 16, wherein the partial pressure of oxygen is between 20 mmHg and 700 mmHg, inclusively.

18. The container of claim 17, wherein the partial pressure of oxygen is between 30 mmHg and 500 mmHg, inclusively.

19. A zero headspace container that maintains a stable partial pressure of oxygen in a multi-analyte reference solution housed therein, comprising:

(a) an inner layer forming the interior of the container and comprised of a polymer;

(b) an intermediate layer comprised of aluminum;

(c) an outer layer that serves to protect the intermediate layer from physical damage;

(d) a multi-analyte reference solution housed within the interior of the container; and

an access device housed totally within the interior of the container, wherein the inner layer and the multi-analyte reference solution are free from any component having an oxygen reactivity that is sufficiently destabilizing so as to allow the partial pressure of oxygen of the multi-analyte reference solution to deviate from a specified value by at least 4 mm Hg.

20. A method for maintaining a stable partial pressure of oxygen in a multi-analyte reference solution, the method comprising:

(a) introducing the reference solution into a laminated container comprising (i) an inner layer that serves as the interior of the container and is composed of a polymeric material that does not react with oxygen or has an oxygen reactivity that is sufficiently low so as to maintain the partial pressure of oxygen of the reference solution at a specified value ±

4 mm Hg, (ii) an intermediate layer of aluminum, (iii) an outer layer that serves to protect the intermediate layer from physical damage, and (iv) an access device housed totally within the interior of the container; and

(b) sealing the container so as to provide zero headspace therein.

21. The method of claim 20, wherein step (b) comprises forming the container into a 3-side, center-sealed pouch.

22. The method of claim 20, wherein step (b) comprises heating and fusing the inner layer so as to seal the container.

23. The method of claim 20, wherein the access device enables removal of the solution from the container'"'"'s interior.

24. The method of claim 23, further comprising, after step (b), piercing the access device with a probe that is connected to an analyzer through tubing that has a durometer in the range of 10 to 100.

25. The method of claim 24, wherein the tubing has a durometer in the range of 70 to 94.

26. The method of claim 25, wherein the tubing has a durometer in the range of 80 to 84.

27. The method of claim 24, wherein the tubing is a polyamide condensation polymer.

28. The method of claim 24, wherein the tubing is a polyester/polyether block co-polymer or a polyester elastomer.

29. The method of claim 20, wherein the access device is composed of a polymeric material that does not react with oxygen or has an oxygen reactivity that is sufficiently low so as to maintain the partial pressure of oxygen of the solution at a specified value ±

4 mm Hg.

30. A method for maintaining a stable partial pressure of oxygen in a multi-analyte reference solution, the method comprising:

(a) introducing the reference solution into a laminated container comprising (i) an inner layer that serves as the interior of the container and is comprised of a polymer, (ii) an intermediate layer of aluminum, (iii) an outer layer that serves to protect the intermediate layer from physical damage, and (iv) an access device housed totally within the interior of the container, wherein the inner layer and the reference solution are free from any component having an oxygen reactivity that is sufficiently high so as to allow the partial pressure of oxygen of the multi-analyte reference solution to deviate from a specified value by at least 4 mm Hg; and

(b) sealing the container so as to provide zero headspace therein.