Systems and methods for improving medical treatments

Abstract

This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

What is claimed is: 
     
         1 . A method of alerting a patient to test a sample of bodily fluid using a fluidic device, comprising:
 a) providing a protocol located on an external device to be run on said fluid device, said protocol associated with said patient and comprising a time and/or date to test said sample of bodily fluid; and   b) notifying said patient to test said bodily fluid on said time and/or date if said sample has not yet been tested.   
     
     
         2 . The method of  claim 1 , wherein the fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows the sample of bodily fluid to react with reactants contained within said assay assembly based on a protocol transmitted from an external device to yield a detectable signal indicative of the presence of said analyte; a reader assembly comprising a detection assembly for detecting said detectable signal; and a communication assembly for transmitting said detected signal to an external device. 
     
     
         3 . The method of  claim 1 , wherein said notification is transmitted electronically. 
     
     
         4 . The method of  claim 1 , wherein said notification is transmitted wirelessly. 
     
     
         5 . The method of  claim 1 , wherein said notification is transmitted via a handheld device. 
     
     
         6 . The method of  claim 1 , the sample of bodily fluid is less than about 500 ul. 
     
     
         7 . The method of  claim 1 , wherein the reactants comprise immunoassay reagents. 
     
     
         8 . The method of  claim 2 , wherein the detectable signal is a luminescent signal. 
     
     
         9 . A business method of assisting a clinician in providing an individualized medical treatment, comprising:
 a) collecting at least one pharmacological parameter from an individual receiving a medication, said collecting step is effected by subjecting a sample of bodily fluid to reactants contained in a fluidic device, which is provided to said individual to yield a detectable signal indicative of said at least one pharmacological parameter;   b) cross referencing with the aid of a computer medical records of said individual with the at least one pharmacological parameter of said individual, thereby assisting said clinician in providing individualized medical treatment.   
     
     
         10 . The business method of  claim 9 , wherein the pharmacological parameter is a pharmacokinetic parameter. 
     
     
         11 . The business method of  claim 9 , wherein the pharmacological parameter is a pharmacodynamic parameter. 
     
     
         12 . The business method of  claim 9 , wherein the reactants comprises immunoassay reagents. 
     
     
         13 . A business method of monitoring a clinical trial of a therapeutic agent, comprising:
 a) collecting at least one pharmacological parameter from a subject in said clinical trial at a plurality of time intervals, said collecting step is effected at each time interval by subjecting a sample of bodily fluid from said subject to reactants contained in a fluidic device, wherein said fluidic device is provided to said subject to yield detectable signals indicative of the values of said at least one pharmacological parameter at a plurality of time intervals;   b) comparing the detected values to a threshold value predetermined for said pharmacological parameter;   c) notifying a clinician and/or a sponsor involved in said clinical trial when a statistically significant discrepancy exists between the detected values and the threshold value.   
     
     
         14 . The business method of  claim 13 , further comprising taking a medical action based on the statistically significant discrepancy. 
     
     
         15 . The business method of  claim 14 , wherein said medical action involves adjusting dosage of the therapeutic agent. 
     
     
         16 . The business method of  claim 13 , further comprising taking a business decision that involves continuing, modifying, or terminating the clinical trial. 
     
     
         17 . The business method of  claim 13 , wherein the fluidic device comprising a sample collection unit and an assay assembly, wherein said sample collection unit allows the sample of bodily fluid to react with reactants contained within said assay assembly based on a protocol transmitted from an external device to yield the detectable signal; a reader assembly comprising a detection assembly for detecting said detectable signal; and a communication assembly for transmitting said detected signal to an external device. 
     
     
         18 . The business method of  claim 17 , wherein the reactants comprise immunoassay reagents.