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

• US 6,632,675 B1
• Filed: 08/16/2000
• Issued: 10/14/2003
• 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:
  US09/641,033
• Time in Patent Office: 1,154 Days
• Field of Search: 436/8, 436/9, 436/11, 436/14, 436/15, 436/16, 436/66, 436/68, 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 method for maintaining a partial pressure of oxygen in a multi-analyte reference solution in a zero headspace container at a specified value ±

4 mmHg at room temperature, said method comprising;

(a) providing a container formed from a multi-layer laminate comprising

(i) an inner layer that has low or no oxygen reactivity,

(ii) a middle layer comprising aluminum,

(iii) an outer layer that protects the middle layer from physical damage, and

(iv) an access device that enables removal of the solution from the container'"'"'s interior;

(b) filling the container with the multi-analyte reference solution; and

(c) sealing the container so as to form zero headspace within the container by forming a seal at an edge of the container, thereby sealing the access device entirely within the container without breaching the multi-layer laminate and without interrupting the seal at the edge of the container.

2. The method according to claim 1 wherein said inner layer is polypropylene.

3. The method according to claim 2 wherein the partial pressure of oxygen is maintained at said specified value ±

4 mmHg at room temperature for at least six months.

4. The method according to claim 2 wherein said inner layer has a thickness of approximately 1.5 mil to 5 mil, said middle layer has a thickness of approximately 0.3 mil to 1 mil and said outer layer has a thickness of approximately 0.1 to 2 mil.

5. The method according to claim 4 wherein said inner layer has a thickness of about 2 to 5 mil and said middle layer has a thickness of about 0.5 to 0.7 mil.

6. The method according to claim 5 wherein said inner layer has a thickness of about 4 mil, said middle layer has a thickness of about 0.5 mil and said outer layer is either a lacquer coating, polyester, or nylon.

7. The method according to claim 2 wherein said outer layer is polyester.

8. The method according to claim 1 wherein the specified value is between 20 mmHg and 700 mmHg and said partial pressure is maintained at said specified value ±

4 mmHg at room temperature for at least six months.

9. The method according to claim 1 wherein said partial pressure of oxygen is between 20 mmHg and 700 mmHg, inclusively.

10. The method according to claim 1 wherein said partial pressure of oxygen is between 30 mmHg and 500 mmHg, inclusively.

11. The method according to claim 1 wherein said access device is connected to one or more walls of said container.

12. The method according to claim 1 wherein step (c) further comprises forming said container into a 3-side, center-sealed pouch.

13. The method according to claim 1 wherein said multi-analyte reference solution calibrates or controls for pO₂ and one or more other analytes selected from the group consisting of pH, pCO₂, electrolytes, metabolites, tHb, CO-Ox fractions and hematocrit.

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

15. The method according to claim 1 further comprising, before step (b), formulating said multi-analyte reference solution with chemicals selected for low or no oxygen reactivity.

16. The method according to claim 15 wherein said chemicals are organic.

17. The method according to claim 16 wherein said partial pressure of oxygen is between 20 mmHg and 700 mmHg, inclusively.

18. The method according to claim 17 wherein said partial pressure of oxygen is between 30 mmHg and 500 mmHg, inclusively.

19. A multi-analyte reference solution with stable partial pressure of oxygen in a zero headspace container, wherein said stable partial pressure of oxygen is maintained according to the method of claim 15.

20. A multi-analyte reference solution with stable partial pressure of oxygen in a zero headspace container, wherein said stable partial pressure of oxygen is maintained according to the method of claim 1.

21. The method according to claim 1 further comprising, after step (c), 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.

22. The method according to claim 21 wherein said tubing has a durometer in the range of 70 to 94.

23. The method according to claim 21 wherein said tubing has a durometer in the range of 80 to 84.

24. The method according to claim 21 wherein said tubing is a polyamide condensation polymer.

25. The method according to claim 21 wherein said tubing is a polyester/polyether block co-polymer or a polyester elastomer.