Diagnostic test

Abstract

Disclosed are methods for conducting diagnostic tests for the detection of the inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis. Also described are methods for monitoring a patient by administering tests of the present invention. Also described are methods for monitoring patient's treatment by administering tests of the present invention. Also described are methods for evaluating the effectiveness of a drug or a drug candidate by administering tests of the present invention to samples from patients, animal models, and cell cultures treated with a drug or a drug candidate. Also disclosed are methods for determining the usefulness of analytes, e.g. cytokines, for acting as diagnostic and monitoring markers for inflammatory bowel disease in the various methods of the invention.

What is claimed is: 
     
         1 . A method for treating an inflammatory bowel disease in a human comprising the steps of:
 a) obtaining a sample from a patient suspected of having an inflammatory bowel disease and performing an assay to measure a level of soluble TNF receptor II (sTNFRII) in said sample;   b) performing an assay to measure in said sample or another sample obtained from said patient a level of an additional analyte, wherein said additional analyte is MIP-1(3; and   c) administering a suitable drug to said human if said sTNFRII level is above a predetermined level and said additional analyte level is below a predetermined level.   
     
     
         2 . The method of  claim 1 , wherein said administering step comprises comparing said sTNFRII level and said additional analyte level to an analyte profile indicative of inflammatory bowel disease. 
     
     
         3 . The method of  claim 1 , wherein said administering step further comprises distinguishing ulcerative colitis from Crohn's disease on the basis of said sTNFRII level and said additional analyte level. 
     
     
         4 . The method of  claim 3 , wherein said distinguishing ulcerative colitis from Crohn's disease comprises comparing said analyte level and said additional analyte level to profiles indicative of Crohn's disease or ulcerative colitis. 
     
     
         5 . The method of  claim 1 , wherein a ratio of said sTNFRII level to said additional analyte level above a detection cut-off ratio value is considered indicative of inflammatory bowel disease. 
     
     
         6 . The method of  claim 3 , wherein said distinguishing ulcerative colitis from Crohn's disease comprise comparing said sTNFRII level to a sTNFRII discrimination cut-off value, wherein sTNFRII levels above said discrimination cut-off value are considered indicative of Crohn's disease and below said discrimination cut-off value are considered indicative of ulcerative colitis. 
     
     
         7 . The method of  claim 3 , wherein said distinguishing ulcerative colitis from Crohn's disease comprises comparing said sTNFRII level to a sTNFRII discrimination cut-off value, wherein sTNFRII levels below said discrimination cut-off value are considered indicative of Crohn's and above said discrimination cut-off value are considered indicative of ulcerative colitis. 
     
     
         8 . The method of  claim 3 , wherein said distinguishing ulcerative colitis from Crohn's disease comprises comparing said sTNFRII levels to a sTNFRII profile defined as at least one area or volume situated between a first detection cut-off line, curve, or surface and a second discrimination cut-off line, curve, or surface on a correlation plot. 
     
     
         9 . The method of  claim 1 , wherein said performing step is conducted on a single sample. 
     
     
         10 . The method of  claim 1 , wherein said performing step is conducted in a single assay chamber. 
     
     
         11 . The method of  claim 10 , wherein said assay chamber is a single well of an assay plate. 
     
     
         12 . The method of  claim 10 , wherein said assay chamber is an assay chamber of a cartridge. 
     
     
         13 . The method of  claim 1 , further comprising conducting a diagnostic test to determine if said patient has viral or bacterial infection. 
     
     
         14 . The method of  claim 1 , wherein said sample is selected from the group consisting of blood, serum or plasma. 
     
     
         15 . The method of  claim 1 , wherein said sample is a fecal sample. 
     
     
         16 . The method of  claim 1 , wherein said sample is selected from the group consisting of biopsy tissue, intestinal mucosa or urine. 
     
     
         17 . The method of  claim 1 , wherein said level is measured using an immunoassay. 
     
     
         18 . The method of  claim 1 , further comprising determining from said level of sTNFRII the extent of inflammation from said disease. 
     
     
         19 . The method of  claim 1 , further comprising determining from said measured levels the extent of inflammation from said disease. 
     
     
         20 . A method for treating an inflammatory bowel disease in a human comprising the steps of:
 a) obtaining a plurality of samples at different points in time from a patient that has or is suspected of having an inflammatory bowel disease and performing an assay to measure levels of soluble TNF receptor II (sTNFRII) in said samples;   b) performing an assay to measure levels of an additional analyte in said samples, wherein said additional analyte is MIP-1β; and   c) administering a suitable drug if said sTNFRII level is above a predetermined level and said additional analyte level is below a predetermined level in any of the obtained samples.   
     
     
         21 . The method of  claim 1 , wherein said assay to measure a level of sTNFRII and said assay to measure a level of an additional analyte are selected from the group consisting of: an immunoassay; an immunochromatographic assay; a solid-phase assay and an agglutination assay.