Modular point-of-care devices, systems, and uses thereof

Abstract

The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.

1 - 78 . (canceled) 
     
     
         79 . A method of detecting a therapeutic agent, or a metabolite thereof, in a biological sample obtained from a patient, comprising:
 receiving a cartridge by a device for detection of the therapeutic agent, or a metabolite thereof, in a biological sample obtained from the patient; wherein the device comprises (a) a fluid transfer device, and (b) an optical detector;   wherein the cartridge comprises (i) a sample collection unit comprising the biological sample obtained from the patient at a first time point, (ii) at least one pipette tip, (iii) at least one assay unit, wherein the at least one assay unit is movable, (iv) and all reagents for performing one or more assays on the biological sample to detect the therapeutic agent, or a metabolite thereof;   engaging the fluid transfer device with the at least one pipette tip,   transferring at least a portion of the sample to the at least one assay unit,   reacting the sample with a reagent in the at least one assay unit; and   detecting a signal indicative of the therapeutic agent, or a metabolite thereof, with said optical detector in the device.   
     
     
         80 . The method of  claim 79 , wherein the biological sample is a blood sample. 
     
     
         81 . The method of  claim 80 , wherein the blood sample is a blood sample obtained by a fingerstick. 
     
     
         82 . The method of  claim 80 , wherein the blood sample is less than about 500 μl. 
     
     
         83 . The method of  claim 79 , wherein the device is provided at a pharmacy. 
     
     
         84 . The method of  claim 79 , wherein the device is in communication with an external device, and wherein the external device determines a concentration of the therapeutic agent, or a metabolite thereof, and transmits the concentration of the therapeutic agent, or a metabolite thereof, to an end user. 
     
     
         85 . The method of  claim 84 , wherein the concentration of the therapeutic agent, or a metabolite thereof, is transmitted to the end user wirelessly. 
     
     
         86 . The method of  claim 85 , wherein the external device further compares said concentration with a known profile of the concentration of the therapeutic agent, or a metabolite thereof. 
     
     
         87 . The method of  claim 86 , wherein the external device further determines compliance or non-compliance with treatment with the therapeutic agent based on the comparison. 
     
     
         88 . The method of  claim 87 , wherein the external device determines non-compliance with the treatment if the concentration of the therapeutic agent, or a metabolite thereof, in the patient is at an elevated level compared to the known profile, and the external device transmits the determination of compliance or non-compliance to the end user. 
     
     
         89 . The method of  claim 84 , further comprising receiving by the device a biological sample obtained from the patient at a second time point and performing the one or more assays in the device on the biological sample obtained from the patient at the second time point, wherein the external device performs a trend analysis comprising determining the concentration of the therapeutic agent, or a metabolite thereof, in the biological sample obtained from the patient at the second time point and determining a change in the concentration of the therapeutic agent, or a metabolite thereof, at the first and second time points, and transmits the trend analysis to the end user. 
     
     
         90 . The method of  claim 89 , wherein the end user is a patient or medical personnel. 
     
     
         91 . The method of  claim 79 , wherein the cartridge comprises a plurality of assay units, and wherein the assay units are movable and not in fluid communication with each other. 
     
     
         92 . The method of  claim 79 , wherein the cartridge further comprises a plurality of reagent units, and wherein the reagent units are movable and not in fluid communication with each other. 
     
     
         93 . The method of  claim 79 , further comprising engaging the fluid transfer device with the at least one assay unit and moving the at least one assay unit from a first location to a second location in the device. 
     
     
         94 . The method of  claim 79 , further comprising diluting the sample in the device prior to performing the one or more assays. 
     
     
         95 . A system for detecting a therapeutic agent, or a metabolite thereof, in a biological sample obtained from a patient, comprising:
 a cartridge, wherein the cartridge comprises (i) a sample collection unit to receive a biological sample obtained from the patient, (ii) at least one pipette tip, (iii) at least one assay unit, wherein the at least one assay unit is movable, (iv) and all reagents for performing one or more assays on the biological sample to detect the therapeutic agent, or a metabolite thereof;   a device for detection of the therapeutic agent, or a metabolite thereof, in the biological sample obtained from the patient, wherein the system comprises (a) a location for receiving the cartridge, (b) a fluid transfer device for engaging the at least one pipette tip to transfer at least a portion of the biological sample to the at least one assay unit, and for engaging the at least one assay unit to move the at least one assay unit from a first location to a second location in the device, and (c) an optical detector;   and an external device, wherein the external device is in communication with the device for detection of the therapeutic agent, or a metabolite thereof and wherein the external device determines a concentration of the therapeutic agent, or a metabolite thereof, from a signal detected by the optical detector from the one or more assays performed in the at least one assay unit and transmits the concentration of the therapeutic agent, or a metabolite thereof, to an end user.   
     
     
         96 . The system of  claim 95 , wherein the sample collection unit is configured to receive a blood sample obtained by a fingerstick of the patient. 
     
     
         97 . The system of  claim 95 , wherein the cartridge comprises a plurality of assay units, wherein the assay units are movable and not in fluid communication with each other. 
     
     
         98 . The system of  claim 95 , wherein the cartridge further comprises a plurality of reagent units, wherein the reagent units are movable and not in fluid communication with each other.