Methods and compositions for detection of microbial contaminants in peritoneal dialysis solution

• US 7,618,392 B2
• Filed: 07/13/2006
• Issued: 11/17/2009
• Est. Priority Date: 02/27/2004
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Patel, Mehul, Martis, Leo, Giertych, Joseph A., Owen, William F. Jr., Kunzler, Jacqueline A., Mongoven, James W.
• Primary Examiner(s): Ford; Allison M
• Application Number:
  US11/457,330
• Publication Number:
  US 20060263842A1
• Time in Patent Office: 1,223 Days
• Field of Search: None
• US Class Current: 604/29
• CPC Class Codes: A61K 31/716 Glucans
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: G01N 2333/4722 Proteoglycans, e.g. aggreccan
• CPC Class Codes: Y10S 436/815 Test for named compound or class of compounds

Abstract

Methods and compositions for detection of microbial contaminants in peritoneal dialysis solutions are provided. The methods and compositions employ modified bioburden testing and the detection of peptidoglycan. A novel cause of aseptic peritonitis is provided—aseptic peritonitis associated with gram positive microbial contamination of a dialysis solution. Peptidoglycan is a major component of a gram positive bacterial cell wall and thus can serve as a marker for gram positive bacteria. In this regard, testing for peptidoglycans can be utilized to effectively prevent peritonitis in patients that use the peritoneal dialysis solutions, such as peritoneal dialysis solutions that contain a glucose polymer including an icodextrin and the like.

Claims

1. A method of providing dialysis to a patient, the method comprising:

preparing a dialysis solution including;

a) providing a glucose polymer in a powder form;

b) performing a modified bioburden test on the glucose polymer to detect contaminating Alcyclobacillus acidocaldarius;

c) preparing a glucose polymer solution using the powder form of the glucose polymer;

d) sterilizing the glucose polymer solution;

e) adding a reagent derived from silkworm larvae plasma to the sterilized glucose polymer solution, wherein the reagent is reactive with peptidoglycan to determine a peptidoglycan concentration; and

f) using the sterilized glucose polymer solution to prepare the dialysis solution if the peptidoglycan concentration is determined to be about 10 ng/mL or less; and

providing the dialysis solution to the patient.

2. The method of claim 1, wherein the dialysis solution is a peritoneal dialysis solution.

3. The method of claim 2, wherein the peritoneal dialysis solution is provided during peritoneal dialysis selected from the group consisting of an automated peritoneal dialysis and a continuous peritoneal dialysis.

4. The method of claim 1, wherein the reaction with the reagent initiates a serine protease cascade.

5. The method of claim 4, wherein the serine protease cascade includes a prophenol oxidase cascade.

6. The method of claim 1, wherein the peptidoglycan concentration is determined by a calorimetric measurement.

7. The method of claim 1, wherein the modified bioburden test includes testing for the Alicyclobacillus acidocaldarius at a pH of less than about 5.0.

8. The method of claim 1, wherein the modified bioburden test includes testing for the Alicyclobacillus acidocaldarius at a temperature of 50°

C. to 60°

C.

9. The method of claim 1, wherein the glucose polymer includes icodextrin.