Rapid Screening Assay for Qualitative Detection of Multiple Febrile Illnesses

Abstract

A single-use multiplex, or assay, screening test for the detection of one or more of a plurality of unrelated febrile illnesses is provided. The febrile illnesses for which the test is designed are unrelated, in that the illnesses may be caused, by way of example, by infection from viruses, bacterium and/or parasites; by infection from viruses, bacterium, parasites or other contagions that are animal borne; by infection from viruses, bacterium, parasites, or other contagions that can be aerosolized for transmission; by infection from viruses, bacterium, parasites or other contagions that are transmitted from direct contact; by infection from viruses, bacterium, parasites or other contagions that are generally transmitted in the tropics and/or subtropics; and/or by infection from a virus, bacteria, parasite sharing one or more related feature and which causes a febrile illness. The assay test provides rapid results to a point of care center or other facility requiring such results to facilitate treatment and or containment of the illnesses.

What is claimed is: 
     
         1 . A test device for the qualitative detection of one febrile illness from a plurality of pathogenically unrelated febrile illnesses, the test device for use with a solution and for use with a conjugate having a marker, the test device for determining the presence of one of a plurality of ligands respectively associated with one of the plurality of pathogenically unrelated febrile illnesses in a liquid sample so as to identify which, if any, of the pathogenically unrelated febrile illnesses is detected in the test sample, comprising:
 a) a sorbent material having a first width and a first length substantially longer than said first width, and a first location for receiving the solution and defining a first migration path for the solution and conjugate; and 
 b) a test site located on or in the sorbent material having a plurality of separately located immobilized ligand-binding mechanisms for receiving the liquid sample, at least one ligand-binding mechanism associated with each of the plurality of ligands for the pathogenically unrelated febrile illnesses. 
 
     
     
         2 . A test device according to  claim 1 , wherein:
 at least two of the febrile illnesses are prevalent within a geographical proximity.   
     
     
         3 . A test device according to  claim 1 , wherein:
 at least one of the febrile illnesses is a viral infection and at least one of the febrile illnesses is a bacterial infection.   
     
     
         4 . A test device according to  claim 1 , wherein:
 each of febrile illnesses is caused by a different type of bacteria, virus, or parasite.   
     
     
         5 . A test device according to  claim 1 , wherein:
 at least a plurality of the febrile illnesses are animal borne by different animals.   
     
     
         6 . A test device according to  claim 5 , wherein:
 at least one of the febrile illnesses is borne by at least one of a bat, a rodent, a mosquito, and a flea, and at least another of the febrile illnesses is borne by a different animal.   
     
     
         7 . A test device according to  claim 1 , wherein:
 at least one of the febrile illnesses can be transmitted by an aerosolized pathogenic agent.   
     
     
         8 . A test device according to  claim 1 , wherein:
 at least one of the febrile illnesses can be transmitted by direct contact.   
     
     
         9 . A test device according to  claim 1 , wherein:
 at least one of the febrile illnesses is a tropical and/or subtropical illness.   
     
     
         10 . A test device according to  claim 1 , wherein:
 each of the febrile illnesses is caused by a different type of bacteria, virus, or parasite,   at least a plurality of the febrile illnesses are animal borne by different animals, and   at least a plurality of the febrile illnesses are tropical and/or subtropical illnesses.   
     
     
         11 . A test device according to  claim 10 , wherein:
 at least two of the febrile illnesses are prevalent in a common geographical region.   
     
     
         12 . A test device according to  claim 10 , wherein:
 at least one of the febrile illnesses can be transmitted through air and at least one of the febrile illnesses can be transmitted by direct contact.   
     
     
         13 . A test device according to  claim 1 , wherein:
 the ligand binding-mechanism are adapted to bind with at least three of Ebola Virus, Malaria, Dengue virus, Plague, Melioidosis, Anthrax, Lassa fever, Tularemia, Leptospirosis, Rickettsial disease, Thyphoid, Chikungunya, Marburg hemorrhagic Fever Q-fever, Meningococcal, Pneomococcus, and Crimean-Congo haemorrhagic fever (CCHF).   
     
     
         14 . A test device according to  claim 1 , wherein:
 the plurality of ligand binding-mechanism are respectively adapted to bind with antigens or antibodies for at least three of Ebola Virus, Malaria, Dengue virus, Plague, and Melioidosis.   
     
     
         15 . A test device according to  claim 1 , wherein:
 time is required for the liquid sample to laterally flow from the first location to the test site such that the liquid sample does not immediately wet the test site upon application.   
     
     
         16 . A test device according to  claim 1 , wherein:
 said separately located immobilized ligand-binding mechanisms are related to bioterrorism pathogens.   
     
     
         17 . A test device according to  claim 1 , further comprising:
 c) a second sorbent material having a second width and a second length substantially longer than said second width, the second sorbent material distinct from the first sorbent material and defining a second migration path distinct from the first migration path, the second sorbent material intersecting the first sorbent material at or adjacent the test site, the second sorbent material having a second location for receiving the liquid sample,
 wherein time is required for the liquid sample to laterally flow from the second location to the test site such that the liquid sample does not immediately wet the test site upon application. 
   
     
     
         18 . A test device for the qualitative detection of one febrile illness from a plurality of pathogenically unrelated febrile illnesses, the test device for use with a solution and for use with a conjugate having a marker, the test device for determining the presence of one of a plurality of ligands respectively associated with one of the plurality of febrile illnesses in a liquid sample so as to identify which, if any, of the unrelated febrile illnesses is detected in the test sample, comprising:
 a) a first sorbent material having a first width and a first length substantially longer than said first width, and a first location for receiving the solution and defining a first migration path for the solution and conjugate;   b) a test site located on or in the first sorbent material having a plurality of immobilized ligand-binding mechanisms, at least one ligand-binding mechanism associated with each of the plurality of ligands for the febrile illnesses, wherein the febrile illness are related by having prevalence within a geographical proximity; and   c) a second sorbent material having a second width and a second length substantially longer than said second width, the second sorbent material distinct from the first sorbent material and defining a second migration path distinct from the first migration path, the second sorbent material intersecting the first sorbent material at or adjacent the test site, the second sorbent material having a second location for receiving the liquid sample,
 wherein time is required for the liquid sample to laterally flow from the second location to the test site such that the liquid sample does not immediately wet the test site upon application. 
   
     
     
         19 . A test device according to  claim 18 , wherein:
 the febrile illnesses are related by having prevalence within a common country.   
     
     
         20 . A test device according to  claim 17 , wherein:
 the febrile illnesses are related by having prevalence within neighboring countries.   
     
     
         21 . A test device according to  claim 17 , wherein:
 the febrile illnesses are related by having prevalence within a continent.   
     
     
         22 . A test device according to  claim 17 , wherein:
 the febrile illnesses are related by having prevalence within a ±20° of latitude.   
     
     
         23 . A test device according to  claim 17 , wherein:
 the febrile illnesses are related to are related to bioterrorism pathogens.