Patent NZ-521534-A (NZ)
Title: Method for correlating blood coagulation activity with markers in urine
Inventor: LASSEN MICHAEL RUD
IPC: G01N33/53
Filed: 2001-02-23
Abstract: A method of correlating a hypercoagulate state in an individual with the amount of at least one blood coagulation activity marker comprised in a urine sample obtained from an individual, comprises; i) providing a urine sample comprising at least one blood coagulation activity marker from an individual; and ii) determining the amount of the marker present in the urine sample based on a cut off point, above which one visible colour indicates the presence of the marker and below the cut-off point another visible colour or no colour change indicates that the marker is present in an amount less than that indicated cut-off point, wherein determining the amount of the activity marker comprises; a) contacting the urine sample comprising said blood coagulation activity marker with at least one quantifiably detectable reporter species; b) operably linking the blood coagulation activity marker in the urine sample to the at least one quantifiably detectable reporter species; c) detecting the quantifiably detectable reporter species operably linked to the blood coagulation activity marker in the urine sample; d) determining the amount of the quantifiably detectable reporter species operably linked to the blood coagulation activity marker comprised in the urine sample, where the amount of the quantifiably detectable reporter species is determined by at least one coloured dye molecule or a colour developing reagent connected to the reporter species and visual detection is based in the cut-off point above which one visible colour indicate the presence of the blood coagulation activity marker above a certain minimum amount; e) correlating the determined amount of the quantifiably detectable reporter species with the amount of the blood coagulation activity marker comprised in the urine sample; and f) based on the correlation of step e), determining the amount of the blood coagulation activity marker comprised in the urine sample, iii) correlating the determined amount of the blood coagulation activity marker present in the urine sample with the coagulation state in the individual wherein the presence of the marker above the cut off point indicates a hypercoagulate sate and presence of the marker below the cut off point indicates no hypercoagulate state; and wherein iv) the correlation also is a determination of whether the individual is in a hypercoagulate state. Preferably the blood coagulation activity marker is selected from peptides comprising a fragment of prothrombin and fibrinogen. Also described is system for quantification of a blood coagulation activity marker present in a urine sample comprising i) a zone for applying a blood coagulation marker, the zone comprising at least one movable reporter species capable of binding the marker, the application zone being in liquid contact with; ii) a zone for detecting the presence, amount or concentration of the reporter species bound to the marker, the zone further comprising a binding species for immobilizing onto the detection zone at least a substantial amount of the marker in the urine sample; and optionally iii) a positive control zone generating a positive control confirming the transfer of the at least part of the sample of the application zone to the detection zone; and wherein such determination is based on a cut off point of at least 0.1 nM above which indicates the presence of the marker and below which cut off point another visible colour or no colour indicates that the marker is present in an amount less than the indicated cut off point.