Stabilization of labile analytes in reference materials

Patent metadata

Field	Value
Publication number	US-10495653-B2
Application number	US-201715411775-A
Country	US
Kind code	B2
Filing date	Jan 20, 2017
Priority date	May 6, 2013
Publication date	Dec 3, 2019
Grant date	Dec 3, 2019

Abstract

Provided herein are assay control materials comprising stable analytes and lyophilized unstable analytes, and methods of making and using the same.

First claim

What is claimed is:

1. A method of preparing a control from an analyte control kit, the method comprising,
suspending in a solution at least one unstable control analyte that is lyophilized in the form of beads or microspheres that contain a pre-determined amount of the at least one unstable control analyte to form a suspended unstable analyte, wherein the solution is a base matrix solution from a biological sample from which the unstable control analyte has been removed, wherein the base matrix comprises an antibiotic agent, wherein the base matrix comprises polyethylene glycol or human hemoglobin, and wherein the base matrix is a biological sample selected from processed urine, lymph, urine from which bilirubin or creatinine or both bilirubin and creatinine have been removed from the urine, milk, mucus, cell lysate, or tissue culture, wherein the processed urine is generated by a method comprising contacting urine with creatininase to remove creatinine from the urine.

2. The method of claim 1 , wherein the base matrix comprises at least one stable control analyte.

3. The method of claim 2 , wherein the at least one stable control analyte is selected from the group consisting of amylase, calcium, chloride, cortisol, glucose, hCG, magnesium, microalbumin, phosphorus, potassium, sodium, urea nitrogen, and uric acid.

4. The method of claim 3 , wherein the base matrix further comprises one or more of ketones, leukocyte esterase, nitrite, protein, and urobilinogen.

5. The method of claim 1 , wherein the at least one unstable control analyte is suspended in the solution to form two separate suspended unstable analyte solutions, wherein the two separate unstable analyte solutions have different concentrations of the unstable analyte.

6. The method of claim 1 , further comprising: combining a stable control analyte with the suspended unstable analyte.

7. The method of claim 1 , wherein the at least one unstable control analyte is selected from the group consisting of creatinine, bilirubin, salicylate, triglyceride, alanine aminotransferase (ALT), alkaline phosphatase, high density lipoprotein, pseudocholinesterase, folate, and homocysteine.

8. A method of preparing a control from an analyte control kit, the method comprising,
suspending in a solution at least one unstable control analyte that is lyophilized in the form of beads or microspheres that contain a pre-determined amount of the at least one unstable control analyte to form a suspended unstable analyte, wherein the at least one unstable control analyte is bilirubin or creatinine or both bilirubin and creatinine, wherein the solution is a base matrix solution from a biological sample from which the unstable control analyte has been removed, wherein the base matrix comprises an antibiotic agent, and wherein the base matrix is urine.

9. The method of claim 8 , wherein the base matrix comprises at least one stable control analyte.

10. The method of claim 8 , wherein the at least one unstable control analyte is suspended in the solution to form two separate suspended unstable analyte solutions, wherein the two separate unstable analyte solutions have different concentrations of the unstable analyte.

11. The method of claim 8 , wherein the base matrix comprises polyethylene glycol, human serum albumin, bovine serum albumin, or human hemoglobin.

12. A method of preparing a control from an analyte control kit, the method comprising,
suspending in a solution at least one unstable control analyte that is lyophilized in the form of beads or microspheres that contain a pre-determined amount of the at least one unstable control analyte to form a suspended unstable analyte, wherein the solution is a base matrix solution from a biological sample from which the unstable control analyte has been removed, wherein the base matrix comprises an antibiotic agent, and wherein the base matrix is processed urine that was generated in a method comprising contacting urine with creatininase to remove creatinine from the urine.

13. The method of claim 12 , wherein the base matrix comprises at least one stable control analyte.

14. The method of claim 12 , wherein the at least one unstable control analyte is suspended in the solution to form two separate suspended unstable analyte solutions, wherein the two separate unstable analyte solutions have different concentrations of the unstable analyte.

15. The method of claim 12 , wherein the base matrix comprises polyethylene glycol, human serum albumin, bovine serum albumin, or human hemoglobin.

16. The method of claim 12 , wherein the at least one unstable control analyte is selected from the group consisting of creatinine, bilirubin, salicylate, triglyceride, alanine aminotransferase (ALT), alkaline phosphatase, high density lipoprotein, pseudocholinesterase, folate, and homocysteine.

17. The method of claim 12 , wherein the at least one unstable control analyte is bilirubin or creatinine or both bilirubin and creatinine.

Assignees

• Bio Rad Laboratories

Inventors

• Ebrahim Alireza
• De Vore Karl
• Spates Christopher

Classifications

• G01N33/96 Primary

  involving blood or serum control standard · CPC title

• G01N2496/80

  Multi-analyte reference solutions containing cholesterol, glucose and the like · CPC title

• F26B5/06

  the process involving freezing · CPC title