Immunoassay apparatus for diagnosis

Abstract

Immunoassay analytical test apparatus for allergy diagnosis, which apparatus comprises a zone for receiving a sample containing an analyte, a zone for receiving a mobile phase (the zone may be the same as the sample receiving zone, or different thereto), a detection means for permitting detection of the analyte by immunoreaction, a first flow path for flow of the analyte in the mobile phase from the sample receiving zone to the detection means, and a second flow path permitting flow of a mobile phase to the detection means.

What is claimed is:  
     
         1 . Immunoassay analytical test apparatus, which apparatus comprises: 
 a) a zone for receiving a sample containing an analyte;    b) a zone for receiving a mobile phase, which zone may be the same as the sample receiving zone, or different thereto;    c) detection means for permitting detection of said analyte by immunoreaction;    d) a first flow path for flow of said analyte in said mobile phase from said sample receiving zone to said detection means; and    e) a second flow path permitting flow of said mobile phase to said detection means.    
     
     
         2 . Apparatus according to  claim 1 , wherein said second flow path includes labelled immunoreactive material.  
     
     
         3 . Apparatus according to  claim 1 , wherein said first flow path includes a material selected form the group consisting of: 
 (i) unlabelled immunoreactive material;    (ii) hapten labelled immunoreactive material;    (iii) unlabelled capture material;    (iv) hapten labelled capture material; and    (v) detector labelled material;    said material being upstream of said sample receiving zone.    
     
     
         4 . Apparatus according to  claim 1 , wherein said first flow path includes a material selected form the group consisting of: 
 (i) unlabelled immunoreactive material;    (ii) hapten labelled immunoreactive material;    (iii) unlabelled capture material;    (iv) hapten labelled capture material; and    (v) detector labelled material;    said material being downstream of said sample receiving zone.    
     
     
         5 . Apparatus according to  claim 1 , wherein said first flow path includes a material selected form the group consisting of: 
 (i) unlabelled immunoreactive material;    (ii) hapten labelled immunoreactive material;    (iii) unlabelled capture material;    (iv) hapten labelled capture material; and    (v) detector labelled material;    said material being upstream and downstream of said sample receiving zone.    
     
     
         6 . Apparatus according to  claim 1 , wherein said flow paths are such that said mobile phase is allowed to traverse more than one path simultaneously, said first flow path being continuous from said mobile phase receiving zone to said detection means, said second flow path being continuous from said mobile phase receiving zone to said detection means.  
     
     
         7 . Apparatus according to  claim 1 , wherein said detection means is movable from a first position in communication with said first flow path to a second position in communication with said second flow path.  
     
     
         8 . Apparatus according to  claim 7 , wherein said detection means is movable from a first position in contact with said first flow path to a second position in contact with said second flow path.  
     
     
         9 . Apparatus according to  claim 7 , wherein said detection means is movable to be in communication with said first and second flow paths in sequence.  
     
     
         10 . Apparatus according to  claim 7 , wherein said detection means is movable to be in contact with said first and second flow paths in sequence.  
     
     
         11 . Apparatus according to  claim 1 , wherein said first flow path potentiates flow towards said detection means.  
     
     
         12 . Apparatus according to  claim 11 , wherein said first flow path potentiates flow towards said detection means by a capillary action.  
     
     
         13 . Apparatus according to  claim 1 , wherein said second flow path potentiates flow towards said detection means.  
     
     
         14 . Apparatus according to  claim 13 , wherein said second flow path potentiates flow towards said detection means by a capillary action.  
     
     
         15 . Apparatus according to  claim 1 , wherein said first flow path is selected from the group consisting of: 
 a) elongate sheet material;    b) elongate strip material; and    c) material absorbent to said mobile phase.    
     
     
         16 . Apparatus according to  claim 15 , wherein said elongate sheet or strip comprises a portion contactable with said first flow path.  
     
     
         17 . Apparatus according to  claim 1 , wherein said second flow path is defined by a material selected from the group consisting of: 
 a) elongate sheet material;    a) elongate strip material; and    b) material absorbent to said mobile phase.    
     
     
         18 . Apparatus according to  claim 17 , wherein said elongate sheet or strip comprises a portion contactable with said second flow path.  
     
     
         19 . Apparatus according to  claim 1 , wherein said analyte is allergen specific IgE.  
     
     
         20 . Apparatus according to claim I, wherein said apparatus further comprises a sink for collection of excess material exiting the detection means.  
     
     
         21 . Apparatus according to  claim 1 , wherein said detection means is manually movable from said first pathway to said second pathway.  
     
     
         22 . Apparatus according to  claim 19 , wherein said first flow path comprises a matrix for the removal of non-IgE components.  
     
     
         23 . Apparatus according to  claim 22 , wherein said matrix is provided between said sample receiving zone and said detection means.  
     
     
         24 . Apparatus according to  claim 22 , wherein said matrix is provided in said sample receiving zone.  
     
     
         25 . Apparatus according to  claim 1 , wherein said first flow path comprises a filter arranged to separate components of said sample, said filter selected from a group consisting of: 
 i) a blood filter arranged to permit plasma to pass whilst capturing other blood constituents; and    ii) a matrix for the removal of material other than said analyte.    
     
     
         26 . Apparatus according to  claim 25 , wherein said filter is provided between said sample receiving zone and said detection means.  
     
     
         27 . Apparatus according to  claim 25 , wherein said filter is provided in said sample receiving zone.  
     
     
         28 . Apparatus according to  claim 1 , wherein material comprising said first flow path enables transport of said sample along said first flow path.  
     
     
         29 . Apparatus according to  claim 1 , wherein material comprising said first flow path enables transport of at least a constituent of said sample along said first flow path.  
     
     
         30 . Apparatus according to  claim 1 , which includes a store of mobile phase arranged to be released upstream of said sample.  
     
     
         31 . Apparatus according to  claim 30 , wherein said store is contactable with at least a part of said first flow path.  
     
     
         32 . Apparatus according to  claim 30 , wherein said store is contactable with at least a part of said first flow path and at least a part of said second flow path.  
     
     
         33 . Apparatus according to  claim 1 , further comprising a separate container which contains said mobile phase, wherein said mobile phase may be released into said mobile phase receiving zone.  
     
     
         34 . Apparatus according to  claim 1 , wherein said second flow path is convoluted and includes a zone containing labelled immunoreactive material capable of reacting with said analyte to produce labelled analyte, such that unlabelled analyte may reach and becomes immobilized in said detection zone via said first path before said labelled immunoreactive material reaches said detection zone via said second path whereby said labelled immunoreactive material can react with immobilized analyte.  
     
     
         35 . Apparatus according to  claim 34 , wherein said second flow path comprises at least a part of said first flow path.  
     
     
         36 . Apparatus according to  claim 34 , wherein said second flow path comprises substantially the entirety of said first flow path.  
     
     
         37 . Apparatus according to claim I which comprises a plurality of flow paths, wherein said plurality of flow paths are stacked.  
     
     
         38 . An immunoassay analytical test method utilizing apparatus according to  claim 1 .  
     
     
         39 . Immunoassay analytical test apparatus, which apparatus comprises: 
 a) a zone for receiving a sample containing an analyte;    b) a zone for receiving a mobile phase, which zone may be the same as the sample receiving zone, or different thereto;    c) detection means for permitting detection of said analyte by immunoreaction;    d) a first flow path for flow of said analyte in said mobile phase from said sample receiving zone to said detection means; and    a) a second flow path permitting flow of said mobile phase to said detection means;    wherein said detection means is movable from a first position in communication with said first flow path to a second position in communication with said second flow path.    
     
     
         40 . Apparatus according to  claim 39 , wherein said detection means is movable from a first position in contact with said first flow path to a second position in contact with said second flow path.  
     
     
         41 . Apparatus according to  claim 39 , wherein said detection means is movable to be in communication with said first and second flow paths in sequence.  
     
     
         42 . Apparatus according to  claim 39 , wherein said detection means is movable to be in contact with said first and second flow paths in sequence.  
     
     
         43 . Apparatus according to  claim 39 , wherein said second flow path includes labelled immunoactive material.  
     
     
         44 . Apparatus according to  claim 39 , wherein said first flow path includes a material selected form the group consisting of: 
 (i) unlabelled immunoreactive material;    (ii) hapten labelled immunoreactive material;    (iii) unlabelled capture material;    (iv) hapten labelled capture material; and    (v) detector labelled material;    said material being upstream of said sample receiving zone.    
     
     
         45 . Apparatus according to  claim 39 , wherein said first flow path includes a material selected form the group consisting of: 
 (i) unlabelled immunoreactive material;    (ii) hapten labelled immunoreactive material;    (iii) unlabelled capture material;    (iv) hapten labelled capture material; and    (v) detector labelled material;    said material being downstream of said sample receiving zone.    
     
     
         46 . Apparatus according to  claim 39 , wherein said first flow path includes a material selected form the group consisting of: 
 (i) unlabelled immunoreactive material;    (ii) hapten labelled immunoreactive material;    (iii) unlabelled capture material;    (iv) hapten labelled capture material; and    (v) detector labelled material;    said material being upstream and downstream of said sample receiving zone.    
     
     
         47 . Apparatus according to  claim 39 , wherein said first flow path potentiates flow towards said detection means.  
     
     
         48 . Apparatus according to  claim 47 , wherein said first flow path potentiates flow towards said detection means by a capillary action.  
     
     
         49 . Apparatus according to  claim 39 , wherein said second flow path potentiates flow towards said detection means.  
     
     
         50 . Apparatus according to  claim 49 , wherein said second flow path potentiates flow towards said detection means by a capillary action.  
     
     
         51 . Apparatus according to  claim 39 , wherein said first flow path is selected from the group consisting of: 
 a) elongate sheet material;    b) elongate strip material; and    c) material absorbent to said mobile phase.    
     
     
         52 . Apparatus according to  claim 51 , wherein said elongate sheet or strip comprises a portion contactable with said first flow path.  
     
     
         53 . Apparatus according to  claim 39 , wherein said second flow path is defined by a material selected from the group consisting of: 
 a) elongate sheet material;    a) elongate strip material; and    b) material absorbent to said mobile phase.    
     
     
         54 . Apparatus according to  claim 53 , wherein said elongate sheet or strip comprises a portion contactable with said second flow path.  
     
     
         55 . Apparatus according to  claim 39 , wherein said analyte is allergen specific IgE.  
     
     
         56 . Apparatus according to  claim 39 , wherein said apparatus further comprises a sink for collection of excess material exiting the detection means.  
     
     
         57 . Apparatus according to  claim 39 , wherein said detection means is manually movable from said first pathway to said second pathway.  
     
     
         58 . Apparatus according to  claim 55 , wherein said first flow path comprises a matrix for the removal of non-IgE components.  
     
     
         59 . Apparatus according to  claim 58 , wherein said matrix is provided between said sample receiving zone and said detection means.  
     
     
         60 . Apparatus according to  claim 58 , wherein said matrix is provided in said sample receiving zone.  
     
     
         61 . Apparatus according to  claim 39 , wherein said first flow path comprises a filter arranged to separate components of said sample, said filter selected from a group consisting of: 
 i) a blood filter arranged to permit plasma to pass whilst capturing other blood constituents; and    ii) a matrix for the removal of material other than said analyte.    
     
     
         62 . Apparatus according to  claim 61 , wherein said filter is provided between said sample receiving zone and said detection means.  
     
     
         63 . Apparatus according to  claim 61 , wherein said filter is provided in said sample receiving zone.  
     
     
         64 . Apparatus according to  claim 39 , wherein material comprising said first flow path enables transport of said sample along said first flow path.  
     
     
         65 . Apparatus according to  claim 39 , wherein material comprising said first flow path enables transport of at least a constituent of said sample along said first flow path.  
     
     
         66 . Apparatus according to  claim 39 , which includes a store of mobile phase arranged to be released upstream of said sample.  
     
     
         67 . Apparatus according to  claim 66 , wherein said store is contactable with at least a part of said first flow path.  
     
     
         68 . Apparatus according to  claim 66 , wherein said store is contactable with at least a part of said first flow path and at least a part of said second flow path.  
     
     
         69 . Apparatus according to  claim 39 , further comprising a separate container which contains said mobile phase, wherein said mobile phase may be released into said mobile phase receiving zone.  
     
     
         70 . Apparatus according to  claim 39 , wherein said second flow path is convoluted and includes a zone containing labelled immunoreactive material capable of reacting with said analyte to produce labelled analyte, such that unlabelled analyte may reach and becomes immobilized in said detection zone via said first path before said labelled immunoreactive material reaches said detection zone via said second path whereby said labelled immunoreactive material can react with immobilized analyte.  
     
     
         71 . Apparatus according to  claim 70 , wherein said second flow path comprises at least a part of said first flow path.  
     
     
         72 . Apparatus according to  claim 70 , wherein said second flow path comprises substantially the entirety of said first flow path.  
     
     
         73 . Apparatus according to  claim 39  which comprises a plurality of flow paths, wherein said plurality of flow paths are stacked.  
     
     
         74 . An immunoassay analytical test method utilizing apparatus according to  claim 39.