Highly Sensitive System and Methods for Analysis of Troponin

Abstract

The invention provides methods, compositions, kits, and systems for the sensitive detection of cardiac troponin. Such methods, compositions, kits, and systems are useful in diagnosis, prognosis, and determination of methods of treatment in conditions that involve release of cardiac troponin.

What is claimed is: 
     
         1 . A composition comprising a label for cardiac troponin comprising a detection binding partner for cardiac troponin I, wherein the detection binding partner is capable of cross-reacting with cardiac troponin I from at least two species, and a fluorescent moiety, wherein said moiety is capable of emitting at least about 200 photons when simulated by a laser emitting light at the excitation wavelength of the moiety, wherein the laser is focused on a spot not less than about 5 microns in diameter that contains the moiety, and wherein the total energy directed at the spot by the laser is no more than about 3 microJoules. 
     
     
         2 . The composition of  claim 1  wherein the detection binding partner is capable of reacting with cardiac troponin I from at least two species selected from the group consisting of human, monkey, dog, and rat. 
     
     
         3 . The composition of  claim 2  wherein the detection binding partner is capable of reacting with cardiac troponin I from human, monkey, dog, and rat. 
     
     
         4 . The composition of  claim 1  wherein the detection binding partner is an antibody. 
     
     
         5 . The composition of  claim 1  further comprising a capture binding partner for cardiac troponin I, wherein the capture binding partner is capable of cross-reacting with cardiac troponin I from at least two species. 
     
     
         6 . The composition of  claim 5  wherein the capture binding partner is capable of reacting with cardiac troponin I from at least two species selected from the group consisting of human, monkey, dog, and rat. 
     
     
         7 . The composition of  claim 5  wherein the capture binding partner is capable of reacting with cardiac troponin I from human, monkey, dog, and rat. 
     
     
         8 . The composition of  claim 5  wherein the capture binding partner is an antibody. 
     
     
         9 . A method of determining a course of action for an individual comprising: i) obtaining a sample from said individual, ii) detecting the level of cardiac troponin in the sample and iii) if the level of cardiac troponin is more than about 10-fold greater than the 99 th  percentile normal value for cardiac troponin, taking a first action with respect to the individual and if the level of cardiac troponin is not more than about 10-fold of the 99 th  percentile value for cardiac troponin, taking a second action. 
     
     
         10 . The method of  claim 9  wherein the individual is a patient being evaluated for a possible cardiac event or cardiotoxicity. 
     
     
         11 . The method of  claim 9  wherein the first action is admission of the individual to a hospital. 
     
     
         12 . The method of  claim 9  wherein the second action is holding said individual for a period of time and taking a series of samples from said patient over said period of time. 
     
     
         13 . The method of  claim 12  wherein the interval between samples is at less than about 4 hours. 
     
     
         14 . The method of  claim 12  wherein the rate of change in the level of troponin between individual samples in the series of samples is detected. 
     
     
         15 . The method of  claim 14  wherein the change in the level of troponin is a decrease. 
     
     
         16 . The method of  claim 14  wherein the change in the level of troponin is an increase. 
     
     
         17 . The method of  claim 14  wherein a decision is made regarding a course of action for said individual based on said rate of change. 
     
     
         18 . The method of  claim 14  wherein if the rate of change in troponin values exceeds a predetermined upper reference rate of change value, the decision is to admit the individual. 
     
     
         19 . The method of  claim 14  wherein a decision to take a first action is made if one or more spikes in the level of troponin is seen from sample to sample. 
     
     
         20 . The method of  claim 14  wherein the change in the level of troponin indicates an acute cardiovascular disease. 
     
     
         21 . The method of  claim 14  wherein the change in the level of troponin indicates a chronic cardiovascular disease. 
     
     
         22 . The method of  claim 14  wherein the change in the level of troponin indicates cardiotoxicity. 
     
     
         23 . The method of  claim 9  wherein the cardiac troponin is cardiac troponin I.