Point of care immunization testing system - detection methods

Abstract

A point of care immunization system based upon a range of detection methods to rapidly test a patient in order to ascertain an immunization profile so that vaccinations can be administered to address identified gaps. A point of care system comprised of sample and test strips/cartridges, with said test strips/cartridges configured to meet healthcare requirements of national governing bodies. A point of care system is provided that can function as a stand-alone diagnostic system, a stand-alone kit or with a device.

1 . (canceled) 
     
     
         2 . A method for testing a biological sample from a subject for immunization or sensitization status comprising:
 in a label-based assay contacting an undiluted biological sample obtained from the subject with a plurality of vaccination-indicative antigens or sensitization-indicative antigens disposed on a test strip or cartridge;   detecting the presence or absence of a threshold amount of a plurality of immune mediators reactive to the antigens present in the biological sample based on the contacting, thereby determining immunization or sensitization status with respect to the antigens; and   generating a report on which of the one or more types of vaccination- or sensitization-indicative antigens correspond with a threshold amount of the plurality of antigen-reactive immune mediators present in the biological sample.   
     
     
         3 . The method of  claim 2 , wherein the method is performed at a point-of-care. 
     
     
         4 . The method of  claim 2 , wherein the method is performed at a point-of-assessment. 
     
     
         5 . The method of  claim 2 , wherein the method is performed at a point-of-diagnosis. 
     
     
         6 . The method of  claim 2 , wherein the contacting is conducted in one or more immune-responsive sensors, and the detecting comprises signals from the sensors, wherein the signal size for a given vaccination- or sensitization-indicative antigen is indicative of whether the threshold amount is present. 
     
     
         7 . The method of  claim 2 , wherein the detecting is performed in panel with multiple tests simultaneously or in sequence. 
     
     
         8 . The method of  claim 2 , wherein the detecting comprises one or more assays selected from the group consisting of:
 (a) an enzyme assay;   (b) an ELISA assay;   (c) a fluorogenic reporter assay;   (d) an electrochemiluminescent assay;   (e) a sensor-based assay;   (f) a competitive assay; and   (g) a noncompetitive assay.   
     
     
         9 . The method of  claim 8 , wherein the label-based assay utilizes one or more labels selected from the group consisting of:
 (a) a fluorescence label;   (b) a fluorogenic label;   (c) an electrochemical label;   (d) an electrochemical-luminescent label;   (e) a microparticle label; and   (f) a nanoparticle label.   
     
     
         10 . The method of  claim 8 , wherein the sensor-based assay utilizes one or more sensors selected from the group consisting of:
 (a) a chemical sensor;   (b) an electrical sensor;   (c) an electrochemical sensor;   (d) a paramagnetic sensor; and   (e) an optical sensor.   
     
     
         11 . The method of  claim 2 , wherein the contacting and detecting is performed on a microfluidics lab-on-a-chip. 
     
     
         12 . The method of  claim 2 , wherein the contacting and detecting is performed using the test strip or cartridge and a detector or analyzer. 
     
     
         13 . The method of  claim 12 , wherein the detector or analyzer is a point-of-care detector or point-of-care analyzer. 
     
     
         14 . The method of  claim 2 , wherein the assay is performed using the test strip or cartridge and a handheld device. 
     
     
         15 . The method of  claim 14 , wherein the handheld device is a point-of-care handheld device. 
     
     
         16 . The method of  claim 2 , wherein the biological sample comprises blood, sera, lymph fluid, urine, tears, or saliva. 
     
     
         17 . The method of  claim 2 , wherein the plurality of antigen-reactive immune mediators includes antibodies. 
     
     
         18 . The method of  claim 2 , wherein the test strip or cartridge contains a vaccination-indicative antigen or sensitization-indicative antigen which is selected for a specific patient population. 
     
     
         19 . The method of  claim 18 , wherein the patient population is classified based on age, gender, location, or any combination thereof. 
     
     
         20 . The method of  claim 2 , wherein the plurality of antigen-reactive immune mediators include antibodies. 
     
     
         21 . A method for testing a biological sample from a subject for immunization or sensitization status comprising:
 in a label-based assay contacting a biological sample obtained from the subject with a plurality of vaccination-indicative antigens or sensitization-indicative antigens disposed on a test strip or cartridge; and   with a detector or analyzer, detecting the presence or absence of a threshold amount of a plurality of immune mediators reactive to said antigens present in the biological sample based on the contacting, thereby determining immunization or sensitization status with respect to the antigens.   
     
     
         22 . The method of  claim 21 , further comprising generating a report on which of the one or more types of vaccination- or sensitization-indicative antigens correspond with a threshold amount of the plurality of antigen-reactive immune mediators present in the biological sample. 
     
     
         23 . The method of  claim 21 , wherein the biological sample is an undiluted biological sample. 
     
     
         24 . The method of  claim 21 , wherein the detecting comprises one or more assays selected from the group consisting of:
 (a) an enzyme assay;   (b) an ELISA assay;   (c) a fluorogenic reporter assay;   (d) an electrochemiluminescent assay;   (e) a sensor based assay;   (f) a competitive assay; and   (g) a noncompetitive assay.   
     
     
         25 . The method of  claim 21 , wherein the biological sample comprises blood, sera, lymph fluid, urine, tears, or saliva. 
     
     
         26 . A method for testing a biological sample from a subject for immunization or sensitization status comprising:
 in a label-based assay contacting a biological sample obtained from the subject with a plurality of vaccination-indicative antigens or sensitization-indicative antigens disposed on a test strip or cartridge that contains a vaccination-indicative antigen or sensitization-indicative antigen selected for a specific patient population classified based on age, gender, location, or any combination thereof; and   detecting the presence or absence of a threshold amount of a plurality of immune mediators reactive to the antigens present in the biological sample based on the contacting, thereby determining immunization or sensitization status with respect to the antigens.