Assay device and methods

Abstract

The present invention relates to the use of amphipathic polymers to enhance lateral flow and reagent mixing on assay devices. More specifically, the invention relates to use of an amphipathic polymer in assay methods including a device for determining the concentration of lipids in blood serum or plasma.

1 - 47 . (canceled) 
     
     
         48 . An assay device for detecting the presence or quantity of an analyte residing in an aqueous sample, the device comprising:
 (i) at least one application area suitable for application of an aqueous sample to the device;   (ii) at least one probe, reporter or reagent wherein, in use the at least one probe, reporter or reagent is able to react with an analyte residing in the aqueous sample;   (iii) at least one test area wherein, in use the result and/or progress of a reaction between the analyte and the at least one probe, reporter or reagent may be determined;   (iv) at least one flow path being in fluid communication with the at least one application area and the at least one test area;   
       wherein the at least one flow path comprises at least one amphipathic polymer that is soluble in water and wherein, in use the passage of fluid along the at least one flow path is greater than that expected by capillary action alone. 
     
     
         49 . The device of  claim 48  wherein the flow path is coated with the at least one amphipathic polymer. 
     
     
         50 . The device of  claim 49  wherein the amphipathic polymer is printed and/or sprayed onto a surface of the device. 
     
     
         51 . The device of  claim 50  wherein the amphipathic polymer forms one or more arrays of nano-, pico- or femto-litre droplets. 
     
     
         52 . The device of  claim 48  wherein the at least one flow path comprises the at least one probe, reporter or reagent. 
     
     
         53 . The device of  claim 52  wherein the at least one probe, reporter or reagent are combined with the amphipathic polymer. 
     
     
         54 . The device of  claim 52  wherein the at least one probe, reporter or reagent are arranged above, below or beside the amphipathic polymer. 
     
     
         55 . The device of  claim 48  wherein the result and/or progress of a reaction is determined by means of optical measurement. 
     
     
         56 . The device of  claim 48  wherein the result and/or progress of a reaction is determined by visual inspection. 
     
     
         57 . The device of  claim 55  wherein the result and/or progress of a reaction is determined by means of fluorescence. 
     
     
         58 . The device of  claim 57  wherein the device comprises at least two separable components. 
     
     
         59 . The device of  claim 58  wherein the at least two separable components are a reader and a test cartridge. 
     
     
         60 . The device of  claim 59  wherein the reader comprises excitation means and detection means. 
     
     
         61 . The device of  claim 60  wherein the excitation means are operable to excite the sample so that it fluoresces, and the detection means are operable to detect the fluorescence emitted by the sample. 
     
     
         62 . The device of  claim 59  wherein the test cartridge comprises the at least one flow path. 
     
     
         63 . The device of  claim 62  wherein the test cartridge is disposable. 
     
     
         64 . The device of  claim 59  wherein the reader is re-usable. 
     
     
         65 . The device of  claim 59  wherein the reaction is an immunoassay. 
     
     
         66 . The device of  claim 64  wherein the reaction is an ELISA. 
     
     
         67 . The device of  claim 57  wherein the reaction is a fluorometric assay. 
     
     
         68 . The device of  claim 67  wherein the fluorometric assay is a cholesterol assay. 
     
     
         69 . The device of  claim 67  wherein the fluorometric assay is a lipoprotein assay. 
     
     
         70 . The device of  claim 67  wherein the fluorometric assay is a triglyceride assay. 
     
     
         71 . The device of  claim 48  which comprises at least three test areas and at least three flow paths wherein, a first flow path is in fluid communication with the application area and a first test area, a second flow path is in fluid communication with the application area and a second test area and a third flow path is in fluid communication with the application area and a third test area. 
     
     
         72 . The device of  claim 48  wherein the at least one probe, reporter or reagent is selected from the group consisting of Amplex Red, K37, Nile Red, cholesterol esterase, cholesterol oxidase and horse radish peroxidase. 
     
     
         73 . The device of  claim 72  wherein a first flow path comprises Amplex Red, a second flow path comprises K37 and a third flow path comprises Nile Red. 
     
     
         74 . The device of  claim 72  wherein a first test area comprises Amplex Red, a second test area comprises K37 and a third test area comprises Nile Red. 
     
     
         75 . The device of  claim 73  wherein the first flow path further comprises cholesterol esterase, cholesterol oxidase and horse radish peroxidise. 
     
     
         76 . The device of  claim 73  wherein the first test area further comprises cholesterol esterase, cholesterol oxidase and horse radish peroxidise. 
     
     
         77 . The device of  claim 71  wherein the application area comprises the at least one probe, reporter or reagent selected from the group consisting of Amplex Red, K37, Nile Red, cholesterol esterase, cholesterol oxidase and horse radish peroxidise. 
     
     
         78 . The device of  claim 48  wherein the at least one probe, reporter or reagent is in dry form. 
     
     
         79 . The device of  claim 78  wherein the at least one probe, reporter or reagent further comprises a stabilizing agent. 
     
     
         80 . The device of  claim 79  wherein the stabilizing agent is a copolymer of vinyl pyrrolidine and dimethylaminoethyl methacrylate. 
     
     
         81 . The device of  claim 48  wherein the amphipathic polymer is polyethylene glycol (PEG). 
     
     
         82 . The device of  claim 81  wherein the amphipathic polymer is polyethylene glycol with a molecular weight of from 1000 Da to 20,000 Da. 
     
     
         83 . The device of  claim 82  wherein the amphipathic polymer is polyethylene glycol with a molecular weight of from 1000 Da to 6000 Da. 
     
     
         84 . A process for enhancing lateral fluid flow in a membrane-free device for point of care use comprising coating a surface along which a fluid may flow with an amphipathic polymer that is soluble in water.