Method of detecting the presence of a biomarker in a sample of a flowable substance and a detector assembly for use in the detection of the biomarker in the sample

Abstract

In the detection of the presence of a biomarker or the like in a sample of a flowable substance, e.g. a powder or a liquid, usually a body fluid, such as blood, urine, or saliva, for example, a disposable sample receiver ( 3 ) is used, which has a receiving chamber ( 301 ) that is dimensioned to receive a predetermined volume and is surrounded by a depression ( 303 ) receiving any excess volume for which there is no room in the receiving chamber ( 301 ). The receiving chamber ( 301 ) has a bottom outlet ( 302 ) closed by a removable strip ( 33 ), e.g. a plastic strip or foil. Upon pulling away the strip ( 33 ) from the bottom outlet, the sample in the receiving chamber is emptied into a flow path ( 32 ) leading to at least one detection compartment ( 321 ) permitting direct visual inspection. Preferably, disposable sample receiver ( 3 ) is used in a detector assembly ( 1 ) including an electronic camera ( 23 ), a CPU ( 26 ) and a display ( 22 ). Hereby, the volume of the sample to be analyzed will always be the same, and by controlling the exact point of time when the sample is passed on into the flow path ( 32 ), a high degree of repeatability and accuracy is achieved, and thereby also a fail-safe system.

1 . A method of detecting the presence of a biomarker in a sample of a flowable substance, said method comprising the steps of:
 providing a disposable sample receiver ( 3 ) having a receiving chamber ( 301 ), a bottom outlet ( 302 ) from the receiving chamber ( 301 ), a flow path ( 32 ) leading away from the bottom outlet ( 302 );   disposing the sample in the receiving chamber ( 301 ) and permitting the flowable substance to pass through the bottom outlet ( 302 ) into the flow path ( 32 );   providing a depression ( 303 ) surrounding the receiving chamber ( 301 );   filling the receiving chamber ( 301 ) until an excess of the flowable substance spills over into the depression ( 303 );   placing the disposable sample receive ( 3 ) in a place ( 25 ) of a detector assembly ( 1 ); and   emptying the receiving chamber ( 301 ) by closing of a lid ( 21 ) of the detector assembly ( 1 ), thereby passing a protrusion ( 211 ) provided on the lid ( 21 ) through an opening ( 304 ) of the disposable sample receiver ( 3 ) to cause the flowable substance to flow from the receiving chamber ( 301 ) through the bottom outlet ( 302 ) and into the flow path ( 32 )   
     
     
         2 . A method as claimed in  claim 1 , wherein said flow path ( 32 ) comprises a permeable member ( 4 ), which prevents passage of at least one component of the flowable substance but permits passage of another one. 
     
     
         3 . A method as claimed in  claim 2 , wherein said disposable sample receiver ( 3 ) comprises a directly visible detection compartment ( 321 ) located at the opposite end of said flow path ( 32 ) compared to the bottom outlet ( 302 ), wherein said detection compartment ( 321 ) is provided with a reagent which shifts color upon presence of a biomarker in the sample of flowable substance. 
     
     
         4 . A method as claimed in  claim 1 , wherein said disposable sample receiver ( 3 ) comprises a directly visible detection compartment ( 321 ) located at the opposite end of said flow path ( 32 ) compared to the bottom outlet ( 302 ), wherein said detection compartment ( 321 ) is provided with a reagent which shifts color upon presence of a biomarker in the sample of flowable substance. 
     
     
         5 . A method as claimed in  claim 2 , wherein the flowable substance is whole blood, and the permeable member ( 4 ) separates blood cells from plasma containing the biomarker. 
     
     
         6 . A method as claimed in  claim 3 , wherein the flowable substance is whole blood, and the permeable member ( 4 ) separates blood cells from plasma containing the biomarker. 
     
     
         7 . A method as claimed in  claim 5 , wherein the reagent is located in or downstream of the permeable member ( 4 ). 
     
     
         8 . A method as claimed in  claim 3 , wherein the reagent is located in or downstream of the permeable member ( 4 ). 
     
     
         9 . A method as claimed in  claim 8 , further comprising the steps of:
 analyzing the color shift by an electronic camera ( 23 ) and software (in  26 ), and   showing the result on a display ( 22 ).   
     
     
         10 . A detector assembly ( 1 ) for use in detection of the presence of a biomarker in a sample of a flowable substance, said assembly ( 1 ) comprising:
 a portable detector housing ( 2 ) having a place ( 25 ) for reception of a disposable sample receiver ( 3 ), and   a disposable sample receiver ( 3 ) configured to be located in said place ( 25 ), said disposable sample receiver ( 3 ) comprising:
 (i) a receiving chamber ( 301 ) for reception of the sample of flowable substance, a bottom outlet ( 302 ) from the receiving chamber ( 301 ), a flow path ( 32 ) leading away from the bottom outlet ( 302 ); and 
 (ii) a depression ( 303 ) surrounding the receiving chamber ( 301 ) that is dimensioned to receive a predetermined volume, said depression ( 303 ) receiving any excess volume for which there is no room in the receiving chamber ( 301 ); and 
   wherein said detector housing ( 2 ) comprises a lid ( 21 ), provided with a protrusion ( 211 ) to activate the disposable sample receiver ( 3 ), whereby the sample of flowable substance enters the flow path ( 32 ).   
     
     
         11 . A detector assembly ( 1 ) as claimed in  claim 10 , wherein said disposable sample receiver ( 3 ) comprises a directly visible detection compartment ( 321 ) located at the opposite end of said flow path ( 32 ) compared to the bottom outlet ( 302 . 
     
     
         12 . A detector assembly ( 1 ) as claimed in  claim 11 , wherein the detector housing ( 2 ) comprises equipment for analyzing color change marks of the biomarker to be detected, said equipment including an electronic camera ( 23 ), software (in  26 ), and a display ( 22 ) for displaying the result of the analysis. 
     
     
         13 . A detector assembly ( 1 ) as claimed in  claim 10 , wherein the detector housing ( 2 ) comprises equipment for analyzing color change marks of the biomarker to be detected, said equipment including an electronic camera ( 23 ), software (in  26 ), and a display ( 22 ) for displaying the result of the analysis.