SYSTEMS and METHODS for DETECTING INFECTIOUS DISEASES

Abstract

Systems, methods, and devices for detecting infections in a clinical sample are provided. Small-volume clinical samples obtained at a point-of-service (POS) location and may be tested at the POS location for multiple markers for multiple diseases, including upper and lower respiratory diseases. Samples may be tested for cytokines, or for inflammation indicators. Dilution of samples, or levels of detection, may be determined by the condition or past history of a subject. Test results may be obtained within a short amount of time after sample placement in a testing device, or within a short amount of time after being obtained from the subject. A prescription for treatment of a detected disorder may be provided, and may be filled, at the POS location. A bill may be automatically generated for the testing, or for the prescription, may be automatically sent to an insurance provider, and payment may be automatically obtained.

1 . A system for detecting the presence of one or more of a plurality of markers indicative of an infectious disease in a small-volume clinical sample, comprising:
 a) a sample handling system;   b) a detection station comprising an optical sensor;   c) a fluidically isolated sample collection unit configured to retain a clinical sample;   d) an assay station comprising at least a first, second, and third fluidically isolated assay unit, wherein the first unit comprises a first reagent comprising an antibody, the second unit comprises a second reagent comprising an oligonucleotide, and the third unit comprises a third reagent comprising a chromogen, dye, or other label; and   e) a controller, wherein the controller comprises a local memory and is operatively coupled to the sample handling system and the detection station;   wherein the system is configured to perform assays with any one or more of the first, second, and third assay units; wherein the local memory of the controller comprises a protocol comprising instructions for: i) directing the sample handling system to transfer a portion of the clinical sample to the first assay unit for performance of an immunoassay, the second assay unit for performance of a nucleic acid assay, and the third assay unit for performance of a general chemistry assay comprising a chromogen, dye, or other label; and ii) directing the sample handling system to transfer the first unit, the second unit, and the third assay unit to the detection station.   
     
     
         2 . The system of  claim 1  for detecting the presence of one or more of a plurality of markers indicative of an infectious disease in a small-volume clinical sample, further comprising:
 f) a fluid handling system configured to transport fluids between components of said system, wherein said transport of fluids comprises transport of isolated aliquots of fluid; 
 
     
     
         3 . A clinical sample processing device, comprising:
 a) a sample handling system;   b) a detection station comprising an optical sensor;   c) a fluidically isolated sample collection unit configured to retain a clinical sample;   d) an assay station comprising at least a first, second, and third fluidically isolated assay unit, wherein the first unit comprises an antibody, the second unit comprises an oligonucleotide, and the third unit comprises a chromogen, dye or other label; and   e) a controller, wherein the controller is operatively coupled to the sample handling system, wherein the sample handling system is configured to transfer a portion of the clinical sample from the sample collection unit to each of the first assay unit, the second assay unit, and the third assay unit, and the device is configured to perform an immunoassay, a nucleic acid assay, and a general chemistry assay comprising a chromogen, dye, or other label.   
     
     
         4 . The system of claim wherein the system comprises a point-of service system. 
     
     
         5 . The system of  claim 2 , wherein the system is located at a point-of-service location, and is configured for use in analyzing a sample at said point-of-service location. 
     
     
         6 . The system of  claim 2 , wherein the system is a point-of service system configured to perform a plurality of assays on a single small volume sample, or on aliquots thereof. 
     
     
         7 . The point-of-service (POS) system of  claim 6 , wherein a small volume comprises a volume selected from volumes less than about 500 μL less than about 250 μL, less than 150 μL, less than about 100 μL, less than about 50 μL, less than about 25 μL, less than about 10 μL, less than about 5 μL, and less than about 1 μL. 
     
     
         8 . The point-of-service (POS) system of  claim 6 , wherein the POS location is selected from a retail pharmacy, a supermarket, a clinic, a hospital, and a doctor's office. 
     
     
         9 . The system of any of  claim 2 , wherein the system is contained within a housing. 
     
     
         10 . The system of  claim 9 , wherein the fluid handling system is configured to transport fluid within said housing. 
     
     
         11 . A clinical sample processing device, comprising:
 a) a sample handling system;   b) a detection station comprising an optical sensor;   c) a fluidically isolated sample collection unit configured to retain a clinical sample;   d) an assay station comprising at least a first, second, and third fluidically isolated assay unit, wherein the first unit comprises an antibody, the second unit comprises an oligonucleotide, and the third unit comprises a chromogen or a dye or other label; and   e) a controller, wherein the controller is operatively coupled to the sample handling system, wherein the sample handling system is configured to transfer a portion of the clinical sample from the sample collection unit to each of the first assay unit, the second assay unit, and the third assay unit, and the device is configured to perform an immunoassay, a nucleic acid assay, and a general chemistry assay comprising a chromogen, dye, or other label.   
     
     
         12 . The device of  claim 11 , wherein the device comprises a point-of service device. 
     
     
         13 . The device of  claim 11 , wherein the device is located at a point-of-service location, and is configured for use in analyzing a sample at said point-of-service location. 
     
     
         14 . The device of  claim 11 , wherein the device is a point-of service device configured to perform a plurality of assays on a single small volume sample, or on aliquots thereof. 
     
     
         15 . The point-of-service (POS) device of  claim 14 , wherein a small volume comprises a volume selected from volumes less than about 500 μL, less than about 250 μL, less than 150 μL, less than about 100 μL, less than about 50 μL, less than about 25 μL, less than about 10 μL, less than about 5 μL, and less than about 1 μL. 
     
     
         16 . The point-of-service (POS) device of  claim 12 , wherein the POS location is selected from a retail pharmacy, a supermarket, a clinic, a hospital, and a doctor's office. 
     
     
         17 . The device of  claim 11 , wherein the device comprises a housing. 
     
     
         18 . The device of  claim 17 , wherein the fluid handling system is configured to transport fluid within said housing. 
     
     
         19 - 276 . (canceled) 
     
     
         277 . The clinical sample processing device of  claim 3 , wherein said detection station comprises a cytometry station comprising an imaging device and a stage for receiving a microscopy cuvette. 
     
     
         278 . The clinical sample processing device of  claim 3 , wherein said detection station comprises station comprises an assay station comprising at least a first, a second, a third, and a fourth independently movable assay unit.