Liquid clinical control, standard, and reagent products

• US 4,643,976 A
• Filed: 06/03/1985
• Issued: 02/17/1987
• Est. Priority Date: 06/03/1985
• Status: Expired due to Fees

• Current Assignee: CIBA Vision Corporation (Bayer AG)
• Original Assignee: CIBA Vision Corporation (Bayer AG)
• Inventors: Hoskins, Michael K.
• Primary Examiner(s): Lechert, Jr., Stephen J.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US06/740,861
• Time in Patent Office: 624 Days
• Field of Search: 604/408-411, 220/450, 220/465, 220/1.5, 220/67, 229/3.5 MF, 206/526, 436/8-19
• US Class Current: 436/15
• CPC Class Codes: G01N 2333/76 Assays involving albumins other than in routine use for blocking surfaces or for anchoring haptens during immunisation
• CPC Class Codes: G01N 2496/80 Multi-analyte reference solutions containing cholesterol, glucose 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 436/105831 Protein or peptide standard or control [e.g., hemoglobin, etc.]

Abstract

This invention relates to the field of clinical controls useful for calibrating clinical chemistry analyzers and in manual testing methods, as well as clinical standards and reagents. In addition, it relates to methods for producing stabilized liquid clinical control, standards, and reagents.

Claims

1. A stable liquid clinical chemistry control comprising:

(a) a storage pouch having a reservoir and connected to the reservoir, at least one heat-sealed filling inlet and at least one heat-sealed dispensing outlet;

(b) the pouch material surrounding the reservoir being made of a water and oxygen impermeable material; and

(c) the reservoir containing a clinical chemistry control liquid having a protein and an inert gas.

2. The control of claim 1 wherein the filling inlet also serves as the dispensing outlet.

3. The control of claim 2 wherein the pouch is made of a laminate comprising:

(a) an inner layer which is heat sealable, a water barrier, and inert with respect to the control liquid;

(b) a middle layer which is an oxygen barrier; and

(c) an outer layer which is a puncture-resistant protection barrier.

4. The control of claim 3 wherein the laminate layers comprise polyethylene film as the inner layer, aluminum foil as the middle layer, and polyester film as the outer layer.

5. The control of claim 1 wherein the reservoir has at least two chambers separated by a dividing wall.

6. The control of claim 1 wherein the inert gas comprises argon, krypton, nitrogen or neon.

7. The control of claim 1 wherein the liquid control comprises a multi-parameter control, an isoenzyme control, a hormone control or a coagulation control.

8. A stable liquid clinical chemistry standard comprising:

(a) a storage pouch having a reservoir and connected to the reservoir, at least one heat-sealed filling inlet and at least one heat-sealed dispensing outlet;

(b) the pouch material surrounding the reservoir being made of a water and oxygen impermeable material; and

(c) the reservoir containing a clinical chemistry standard liquid having a protein and an inert gas.

9. The standard of claim 8 wherein the filling inlet also serves as the dispensing outlet.

10. The standard of claim 9 wherein the pouch is made of a laminate comprising:

(a) an inner layer which is heat sealable, a water barrier, and inert with respect to the standard liquid;

(b) a middle layer which is an oxygen barrier; and

(c) an outer layer which is a puncture-resistant protection barrier.

11. The standard of claim 10 wherein the laminate layers comprise polyethylene film as the inner layer, aluminum foil as the middle layer, and polyester film as the outer layer.

12. The control of claim 8 wherein reservoir has at least two chambers separated by a dividing wall.

13. The standard of claim 8 wherein the inert gas comprises argon, krypton, nitrogen or neon.

14. A stable liquid clinical chemistry reagent comprising:

(a) a storage pouch having a reservoir and connected to the reservoir, at least one heat-sealed filling inlet and at least one heat-sealed dispensing outlet;

(b) the pouch material surrounding the reservoir being made of a water and oxygen impermeable material; and

(c) the reservoir containing a clinical chemistry reagent liquid having a protein and an inert gas.

15. The reagent of claim 14 wherein the filling inlet also serves as the dispensing outlet.

16. The reagent of claim 15 wherein the pouch is made of a laminate comprising:

(a) an inner layer which is heat sealable, a water barrier, and inert with respect to the control liquid,

(b) a middle layer which is an oxygen barrier; and

(c) an outer layer which is a puncture-resistant protection barrier.

17. The reagent of claim 16 wherein the laminate layers comprise polyethylene film as the inner layer, aluminum foil as the middle layer, and polyester film as the outer layer.

18. The control of claim 14 wherein the reservoir has at least two chambers separated by a dividing wall.

19. The reagent of claim 14 wherein the inert gas comprises argon, krypton, nitrogen and neon.