IP Library Granted Patent US 7,892,762
Granted Patent B2
US 7,892,762 · App. 12/486,727 · Granted Feb 22, 2011

Method for diagnosing irritable bowel syndrome and monitoring inflammatory bowel disease

Assignee: Techlab, Inc.
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Quick Facts
Patent No.
US 7,892,762
App. No.
12/486,727
Granted
Feb 22, 2011
Kind
B2
Abstract

A method for aiding in differentiating irritable bowel syndrome from inflammatory bowel disease by determining the level of total endogenous human lactoferrin in clinical specimens, such as feces, mucus and bile, wherein an elevated level of lactoferrin substantially precludes diagnoses of IBS and other noninflammatory etiologies, and a kit usable in such method are provided. Further provided is a method for quantitating the level of total endogenous human lactoferrin in clinical specimens, such as feces, mucus and bile, to monitor gastrointestinal inflammation in persons having inflammatory bowel disease.

Claims (34)

1. A method for diagnosing irritable bowel syndrome, the method comprising:

obtaining a fecal sample from a person presenting with symptoms common to inflammatory bowel disease and irritable bowel syndrome;

diluting the sample;

measuring the sample to determine the sample does not contain an elevated level of endogenous lactoferrin; and

upon determining the sample does not contain an elevated level of endogenous lactoferrin, diagnosing the person with irritable bowel syndrome.

2. The method of claim 1 , wherein the step of diluting said sample comprises diluting said sample to a 1:400 dilution factor.

3. The method of claim 1 , wherein the step of measuring the sample to determine the sample does not contain an elevated level of endogenous lactoferrin comprises contacting the sample with immobilized polyclonal antibodies to human lactoferrin to create an antibody bound sample.

4. The method of claim 3 , wherein the step of measuring the sample to determine the sample does not contain an elevated level of endogenous lactoferrin comprises contacting the antibody bound sample with enzyme-linked polyclonal antibodies such that the enzyme-linked polyclonal antibodies are allowed to bind to capture lactoferrin and create an enzyme-linked antibody bound sample.

5. The method of claim 4 , wherein the step of measuring the sample to determine the sample does not contain an elevated level of endogenous lactoferrin comprises adding a substrate to the enzyme-linked antibody bound sample for color development to create a readable enzyme-linked antibody bound sample.

6. The method of claim 5 , wherein the step of measuring the sample to determine the sample does not contain an elevated level of endogenous lactoferrin comprises determining an optical density of said readable enzyme-linked antibody bound sample at 450 nm, wherein the optical destiny corresponds to a level of endogenous lactoferrin in the readable enzyme-linked antibody bound sample.

7. The method of claim 6 , wherein if said optical density of said readable enzyme-linked antibody bound sample is greater than 0.200, said sample contains an elevated level of endogenous lactoferrin.

8. A method for monitoring a human having inflammatory bowel disease for gastrointestinal inflammation, the method comprising:

obtaining a first fecal sample from a human having inflammatory bowel disease at a first time;

determining the concentration of endogenous lactoferrin in said first fecal sample to obtain a first lactoferrin concentration;

obtaining a second fecal sample from the human having inflammatory bowel disease at a time later than the first time;

determining the concentration of endogenous lactoferrin in said second fecal sample to obtain a second lactoferrin concentration; and

comparing said first lactoferrin concentration to said second lactoferrin concentration to determine whether the human has had an increase or decrease in gastrointestinal inflammation.

9. The method of claim 8 , further comprising:

diluting said first and second samples.

10. The method of claim 9 , further comprising:

contacting said first sample with immobilized polyclonal antibodies to endogenous lactoferrin to create a first treated sample;

contacting said first treated sample with enzyme-linked polyclonal antibodies to create a first enzyme-linked antibody bound sample;

adding a substrate to the first enzyme-linked antibody bound sample to create a first readable sample; and

determining the optical density of said first readable sample.

11. The method of claim 10 , further comprising:

contacting said second sample with immobilized polyclonal antibodies to endogenous lactoferrin to create a second treated sample;

contacting said second treated sample with enzyme-linked polyclonal antibodies to create a second enzyme-linked antibody bound sample;

adding a substrate to the second enzyme-linked antibody bound sample to create a second readable sample; and

determining the optical density of said second readable sample.

12. The method of claim 10 , further comprising:

generating a purified lactoferrin standard curve and determining a linear portion of the standard curve.

13. The method of claim 12 , wherein the step of diluting said fecal sample comprises diluting said first and second samples by serial tenfold dilutions until a measured result indicates a concentration of fecal lactoferrin that provides an optical density reading at 450 nm that is within the linear portion of the standard curve.

14. The method of claim 8 , further comprising:

monitoring the human for changing levels of fecal lactoferrin as an indicator of effectiveness of medical therapy.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Aug 19, 2022
From: LBC CREDIT AGENCY SERVICES, LLC, AS AGENT
To: TECHLAB, INC.
Reel/Frame 061234/0473 →
SECURITY INTEREST Recorded Jul 31, 2020
From: TECHLAB, INC.
To: LBC CREDIT AGENCY SERVICES, LLC, AS AGENT
Reel/Frame 053372/0502 →
RELEASE OF SECURITY INTEREST Recorded Jul 31, 2020
From: ELM PARK CAPITAL MANAGEMENT, LLC, AS AGENT
To: TECHLAB, INC.
Reel/Frame 053373/0908 →
SECURITY INTEREST Recorded Sep 16, 2016
From: TECHLAB, INC.
To: ELM PARK CAPITAL MANAGEMENT, LLC, AS AGENT
Reel/Frame 040055/0921 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 26, 2016
From: BOONE, JAMES HUNTER; LYERLY, DAVID MAXWELL; WILKINS, TRACY DALE; GUERRANT, RICHARD LITTLETON
To: TECHLAB, INC.
Reel/Frame 038387/0714 →
Continuity (4)
Continuation 10629975 · Jul 30, 2003
Division 10002842 · Nov 14, 2001
Provisional Application 60248288 · Nov 14, 2000
Related Publication 20090253155A1 · Oct 8, 2009