Stabilization of labile analytes in reference materials

Patent metadata

Field	Value
Publication number	US-10539581-B2
Application number	US-201615331638-A
Country	US
Kind code	B2
Filing date	Oct 21, 2016
Priority date	May 6, 2013
Publication date	Jan 21, 2020
Grant date	Jan 21, 2020

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 multianalyte control kit comprising:
a first container holding at least one unstable control analyte, wherein the at least one unstable control analyte is lyophilized in the form of beads; and
a second container holding at least one stable control analyte in a base matrix solution from a urine sample from which the unstable control analyte has been removed, wherein the base matrix solution comprises an antibiotic, and wherein the base matrix solution is the urine sample from which creatinine has been removed or processed urine, wherein the processed urine is generated by a method comprising contacting the urine sample with creatinase to remove creatinine from the urine sample.

2. The multianalyte control kit of claim 1 , wherein the base matrix solution comprises a buffer.

3. The multianalyte control kit of claim 2 , wherein the buffer is selected from the group consisting of HEPES and Tris.

4. The multianalyte control kit of claim 1 , wherein the base matrix solution comprises at least one component selected from the group consisting of: a protease inhibitor, a chelating agent, an antioxidant, an antioxidant enzyme, a cryoprotectant, and a surfactant.

5. The multianalyte control kit of claim 1 , further comprising at least one additional container holding the at least one lyophilized unstable control analyte in the form of beads at a different concentration than in the first container, and at least one further additional container holding the at least one stable control analyte at a different concentration than in the second container, wherein the at least one stable control analyte at a different concentration is in a base matrix solution comprising an antibiotic, wherein the base matrix solution is urine from which creatinine has been removed or processed urine, wherein the processed urine is generated by a method comprising contracting urine with creatinase to remove creatinine from urine.

6. The multianalyte control kit of claim 1 , wherein the at least one unstable control analyte is bilirubin or creatinine or both bilirubin and creatinine.

7. The multianalyte control kit of claim 1 , 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.

8. The kit of claim 7 , wherein the at least one stable analyte further comprises one or more of ketones, leukocyte esterase, nitrite, protein, and urobilinogen.

9. The multianalyte control kit of claim 1 , wherein the base matrix solution comprises polyethylene glycol, human serum albumin, bovine serum albumin, or human hemoglobin.

10. The multianalyte control kit of claim 1 , wherein the unstable control analyte is selected from the group consisting of creatinine, bilirubin, salicylate, a triglyceride, alanine aminotransferase (ALT), alkaline phosphatase, high density lipoprotein, pseudocholinesterase, folate, and homocysteine.

11. A method for assembling the multianalyte control kit of claim 1 , the method comprising:
lyophilizing the at least one unstable analyte into the form of beads to generate the at least one unstable control analyte in the form of beads in the first container; and
adding at least one stable analyte to the base matrix solution to generate the at least one stable control analyte in the base matrix solution in the second container.

12. The method of claim 11 , 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.

13. A method for preparing the multianalyte control kit of claim 1 for use in an assay, the method comprising,
resuspending the at least one unstable analyte to form a resuspended unstable analyte, and
combining the at least one resuspended unstable analyte with the at least one stable analyte in the base matrix solution.

14. The method of claim 13 , wherein the resuspending and combining steps are separate.

15. The method of claim 13 , wherein the at least one unstable control analyte is bilirubin or creatinine or both bilirubin and creatinine.

16. The method of claim 15 , wherein the base matrix solution is processed urine that was generated in a method comprising treating urine with creatininase.

17. The method of claim 13 , wherein the base matrix solution comprises at least one component selected from the group consisting of: a protease inhibitor, a chelating agent, an antioxidant, an antioxidant enzyme, a cryoprotectant, and a surfactant.

18. The method of claim 13 , 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.

Assignees

• Bio Rad Laboratories

Inventors

• Ebrahim Alireza
• De Vore Karl
• Spates Christopher

Classifications

• G01N2496/80

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

• F26B5/06

  the process involving freezing · CPC title

• G01N33/96 Primary

  involving blood or serum control standard · CPC title