Point of care immunization testing system

Abstract

A point of care immunization system based upon microfluidics and micro-titration technologies 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 uniquely shaped and color distinguishing sample and test cartridges, with said test cartridges configured to meet healthcare requirements of national governing bodies. A point of care system including an easy access vaccine storage device with indicators to provide data on viability of stored vaccines.

1 .- 16 . (canceled) 
     
     
         17 . A point-of-care testing device for testing a biological sample from a subject for immunization/sensitization status comprising:
 an analytical module adapted to make one or more dilutions of a fluid that is or is derived from the biological sample, contact said dilutions with separate replicates of vaccine- or sensitization-indicative antigens so as to generate signals indicative of the amount of antigen-reactive immune molecules in the biological fluid dilutions.   
     
     
         18 . The immunization/sensitization testing device of  claim 17  for testing a biological sample from a subject comprising,
 the analytical module comprising 
 a controller, 
 an data output device, and 
 one or more input ports having a conjugate input comprising an immunization test cartridge, 
 wherein the analytical module is adapted to receive an ID from an immunization test cartridge, 
 wherein the controller is adapted to operate the analytical module to make the two or more dilutions of a fluid that is or is derived from the biological sample, contact said dilutions with the separate replicates of vaccine- or sensitization-indicative antigens so as to generate signals indicative of the amount of antigen-reactive immune molecules in the fluid dilutions, interpret the received ID to identify one of a pre-set plurality of available immunization test cartridges, and to utilize the generated signals and the immunization test cartridge to output a report on the immune status of the subject with respect to an array of separate vaccine- or sensitization-indicative antigens, optionally wherein any ports present are shaped to accept their conjugate input and not accept the conjugate inputs of other ports present, 
 optionally wherein the immunization testing device is in the form of a handheld sampling device. 
 
     
     
         19 . The immunization testing device of  claim 17 , wherein a controller is adapted to operate with
 a collection of immunization test cartridges comprising reagents for testing immune status against an array of vaccine- or sensitization-indicative antigens, the collection including two or more cartridges for testing separate arrays of vaccine- or sensitization-indicative antigens, the separate arrays adapted for use with separate patient populations, the cartridges having IDs that are distinctive of the separate arrays,   wherein the testing device reads the ID of a given utilized test cartridge and presents an output report correlating the vaccination status results with the respective vaccine- or sensitization-indicative antigens based on the read ID.   
     
     
         20 . The immunization testing device of  claim 19 , wherein the controller is adapted to operate with
 packs of immunization compositions, separate packs matching the separate arrays of the immunization test cartridges, the distinct immunization compositions identifiably spatially segregated on the packs, the packs having IDs that are distinctive of the separate arrays of immunization compositions,   wherein the immunization testing device comprises an immunization pack ID reader, and wherein after presenting an output report the controller compares the ID of a presented pack with the ID of the utilized test cartridge to confirm that the cognate pack has been presented.   
     
     
         21 . The immunization testing device of  claim 20 , wherein the compositions have distinctive IDs, and
 wherein the immunization testing device comprises an immunization composition ID reader, and wherein after presenting an output report the controller compares an ID of a presented immunization composition with the output report data to confirm that the immunization composition matches the immunization composition called for by the immune status report.   
     
     
         22 . The immunization testing device of  claim 19 , wherein the controller is adapted to operate with
 packs of immunization compositions, separate packs matching the separate arrays of the immunization test cartridges,   
       wherein the immunization testing device comprises an immunization composition ID reader, and wherein after presenting an output report the controller compares an ID of a presented immunization composition with the output report data to confirm that the immunization composition matches the tested vaccine-indicative antigens. 
     
     
         23 . The immunization testing device of  claim 22 , wherein the controller further confirms that the presented immunization composition matches a vaccine-indicative antigen found to have a deficient immune response. 
     
     
         24 . The immunization testing device of  claim 17 , wherein the vaccine indicative antigens are arrayed on a test strip adapted to contact the dilutions by flow of the dilution material through columns of the test strip so as to serially contact the antigens, optionally wherein the test strips are incorporated into the immunization test cartridges. 
     
     
         25 . A collection of immunization test cartridges comprising reagents for testing immune status against an array of vaccine- or sensitization-indicative antigens, the collection including two or more cartridges for testing separate arrays of vaccine- or sensitization-indicative antigens, the separate arrays adapted for use with separate patient populations, the cartridges having IDs that are distinctive of the separate arrays. 
     
     
         26 . A kit comprising
 a collection of immunization test cartridges of  claim 25 ,
 packs of immunization compositions, separate packs matching the separate arrays of the immunization test cartridges, the distinct immunization compositions identifiably spatially segregated on the packs, the packs having IDs that are distinctive of the separate arrays of immunization compositions, 
 the collections and packs adapted to be operative with an analytical module that utilizes the immunization test cartridges to provide subject immune statuses for the antigens of given immunization test cartridges, and which compares the ID of a utilized immunization test cartridge and that of a presented pack to confirm that the cognate pack has been presented, 
 optionally wherein the test strips are incorporated into the immunization test cartridges. 
   
     
     
         27 . The kit of  claim 26 , wherein the immunization composition packs comprise a temperature sensor, electronic memory for tracking temperature from the sensor over time, and wherein the packs are adapted to communicate the temperature tracking to the analytical module. 
     
     
         28 . A method of operating the testing device of  claim 17 , comprising operating the testing device with a biological sample from a patient utilizing an immunization test cartridge, and thereby outputting a report on the immune status of the subject with respect to an array of separate vaccine- or sensitization-indicative antigens. 
     
     
         29 . A method of operating the testing device of  claim 20 , comprising
 operating the testing device with a biological sample from a patient utilizing a said immunization test cartridge, and thereby outputting a report on the immune status of the subject with respect to an array of separate vaccine-indicative antigens;   presenting a said immunization pack to the immunization pack ID reader to generate output from the testing device confirming or negating that the immunization pack is the cognate of the test cartridge.   
     
     
         30 . The method of  claim 29 , wherein the controller obtains from the immunization pack information on immunization stock, calculates the further utilization implied by the immune status report, and, if needed based on this data, generates (i) a report identifying vaccine restocking needs or (ii) a purchase order to a vaccine supplier. 
     
     
         31 . A method of operating the testing device of  claim 22 , comprising
 operating the testing device with a biological sample from a patient utilizing a said immunization test cartridge, and thereby outputting a report on the immune status of the subject with respect to an array of separate vaccine-indicative antigens; and   presenting a said immunization composition to the immunization composition ID reader to generate output from the testing device confirming or negating that the immunization composition is the immunization composition called for by the immune status report.   
     
     
         32 . The method of  claim 31  wherein the analytical module is comprised in a handheld sampling device, and/or the method is conducted at the point-of-care. 
     
     
         33 . A method of operating the testing device of  claim 23 , comprising
 operating the testing device with a biological sample from a patient utilizing a said immunization test cartridge, and thereby outputting a report on the immune status of the subject with respect to an array of separate vaccine-indicative antigens; and   presenting a said immunization composition to the immunization composition ID reader to generate output from the testing device confirming or negating that the immunization composition is the immunization composition called for by the immune status report.   
     
     
         34 . The method of  claim 33  wherein the analytical module is comprised in a handheld sampling device, and/or the method is conducted at the point-of-care. 
     
     
         35 . The method of  claim 28  wherein the analytical module is comprised in a handheld sampling device, and/or the method is conducted at the point-of-care. 
     
     
         36 . The method of  claim 29  wherein the analytical module is comprised in a handheld sampling device, and/or the method is conducted at the point-of-care.