Methods and Devices for Diagnosis of Appendicitis

Abstract

A method is provided for determining the severity of appendicitis in a patient that includes testing a blood, serum or plasma sample from the patient for the quantity of MRP8/14 in the sample and comparing it with the quantity of MRP8/14 present in standard samples correlated with an appendicitis severity scoring system. A histologically-based appendicitis severity scoring system is also provided. Immunoassays and kits for performing the appendicitis assays of this invention are also provided, as are standard samples and data correlating MRP8/14 quantities present in patient samples to histologically-based appendicitis severity grades. The methods and immunoassay devices and kits of this invention are useful for managing the treatment of patients presenting with appendicitis symptoms.

1 . A method for medical management of patients suspected of appendicitis comprising:
 performing an immunoassay on a sample from said patient comprising comparing the degree of binding of MRP8/14 in said sample to an antibody to MRP8/14 to the degree of binding to said antibody of MRP8/14 in a standard sample containing an amount of MRP8/14 correlated to a predetermined appendicitis severity grading category; and   planning the patient's treatment in accordance with the results of said immunoassay.   
     
     
         2 . The method of  claim 1  further comprising, prior to performing said immunoassay, contacting a sample from said patient with a first antibody to MRP8/14 in an immunoassay device capable of determining the degree of binding of MRP8/14 in said sample to an anti-MRP8/14 antibody, wherein a visually-detectable signal is produced in said immunoassay device in response to a degree of binding indicative of appendicitis. 
     
     
         3 . The method of  claim 1  wherein said grading category is selected from the group consisting of:
 Grade 1 No identifiable inflammation in appendix tissue;   Grade 2 Inflammation extending through the mucosa and into the submucosa of the appendix   Grade 3 Inflammation extends past the submucosa into the muscular levels of the appendix   Grade 4 All layers of the appendix, including the serosa, inflamed, and perforation identified.   
     
     
         4 . The method of  claim 1  wherein the immunoassay is an ELISA. 
     
     
         5 . The method of  claim 4  wherein the sample is diluted at least about 100-fold before testing in said ELISA. 
     
     
         6 . The method of  claim 4  wherein said ELISA also comprises means for testing standard and control samples. 
     
     
         7 . The method of  claim 4  wherein said ELISA is completed within sixty minutes or less. 
     
     
         8 . The method of  claim 1  wherein, if said signal is not indicative of appendicitis, the patient is examined for other conditions having symptoms consistent with those of the patient. 
     
     
         9 . The method of  claim 1  wherein the patient's treatment plan is based on the results of said immunoassay. 
     
     
         10 . The method of  claim 9  wherein said treatment plan includes decisions regarding at least one parameter selected from the group consisting of:
 anticipated length of hospital stay; antibiotics dosage; type of antibiotics;   timing of administration of antibiotics; and timing of surgery.   
     
     
         11 . An immunoassay kit for determining the severity grade of appendicitis comprising an anti-MRP8/14 antibody and a means for detecting an immunoreaction product comprising MRP8/14 and the antibody. 
     
     
         12 . The immunoassay kit of  claim 11  also comprising a specific binding agent capable of binding to said anti-MRP8/14 antibody or to MRP8/14. 
     
     
         13 . The immunoassay kit of  claim 11  also comprising at least one enzyme-linked immunosorbent assay surface. 
     
     
         14 . The immunoassay kit of  claim 11  further comprising standard data showing a correlation of the quantity of MRP8/14 with appendicitis severity. 
     
     
         15 . The kit of  claim 11  further comprising at least one MRP8/14 standard. 
     
     
         16 . A standard sample comprising a quantity of MRP8/14 corresponding to a quantity of MRP8/14 known to be present in samples from patients having a known appendicitis grade. 
     
     
         17 . A set of standard samples of  claim 16  each comprising a quantity of MRP8/14 known to be present in samples from patients having a known appendicitis grade, wherein each standard sample in the set comprises a different quantity of MRP8/14. 
     
     
         18 . The set of standard samples of  claim 17  wherein each standard sample comprises a plurality of pooled samples from patients having the same known appendicitis grade. 
     
     
         19 . The set of standard samples of  claim 17  wherein said standard samples are synthetic samples comprising quantities of MRP8/14 known to correlate with a set of appendicitis grades. 
     
     
         20 . The set of standard samples of  claim 17  comprising at least two samples, each having a quantity of MRP8/14 correlated with a different appendicitis grade. 
     
     
         21 . The set of standard samples of  claim 17  comprising at least four samples, each having a quantity of MRP8/14 correlated with a different appendicitis grade. 
     
     
         22 . An electronic storage medium comprising a data set comprising data representative of MRP8/14 quantities correlated with appendicitis grades for which said quantities are diagnostic. 
     
     
         23 . A method of scoring the severity of appendicitis corresponding to histological condition of tissue of a patient suspected of suffering from appendicitis, said method comprising:
 examining tissue of the appendix and tissue adjacent thereto and assigning grade scores to describe the severity of appendicitis in said patient corresponding to the following condition of the tissue:   Grade 1 No identifiable inflammation in appendix tissue;   Grade 2 Inflammation extending through the mucosa and into the submucosa of the appendix;   Grade 3 Inflammation extends past the submucosa into the muscular levels of the appendix;   Grade 4 All layers of the appendix, including the serosa, inflamed, and perforation identified.