Patent ID: 7659086
Filing Date: 2010-02-09
Classification: G01N,Y10S

Abstract:
1. A method for quantitatively measuring the amount of an analyte of interest in a sample, comprising: a) providing a solid phase apparatus comprising a membrane strip comprising an application point, a sample capture zone and a calibration capture zone, wherein the sample capture zone is between the application point and the calibration capture zone; b) providing a sample collection apparatus that is not in fluid contact with the solid phase apparatus, the sample collection apparatus containing: c) either i) introducing the sample into the sample collection apparatus, and subsequently introducing a buffer into the sample collection apparatus; or ii) introducing a buffer into the sample collection apparatus, and subsequently introducing the sample into the sample collection apparatus, thereby producing a buffered, mixed fluid sample containing contacted binding particles, the contacted binding particles comprising: binding particles having calibration analyte bound thereon and/or having analyte of interest bound thereon; and/or binding particles having neither calibration analyte nor analyte of interest bound thereon; d) applying the buffered, mixed fluid sample to the application point of the membrane strip; e) maintaining the membrane strip under conditions which allow fluid to transport contacted binding particles by capillary action through the strip to and through the sample capture zone, the sample capture zone having a sample capture reagent immobilized thereon, wherein the sample capture reagent can bind to analyte of interest; and allow binding of the sample capture reagent to analyte bound on the binding particles, thereby resulting in immobilization of binding particles in the sample capture zone; f) further maintaining the membrane strip under conditions which allow fluid to transport contacted binding particles by capillary action through the strip to and through the calibration capture zone, the calibration capture zone having a calibration capture reagent immobilized thereon, wherein the calibration capture reagent can bind to the calibration analyte; and allow binding of the calibration capture reagent to calibration analyte bound on the binding particles, thereby resulting in immobilization of binding particles in the calibration capture zone; g) further maintaining the membrane strip under conditions which allow the fluid in the sample to transport contacted binding particles not immobilized in the sample capture zone or in the calibration zone, by capillary action beyond the calibration capture zone; h) determining the amount of binding particles in the sample capture zone and the amount of binding particles in the calibration capture zone; i) determining a corrected binding particle amount from the amount of binding particles in the sample capture zone and the amount of binding particles in the calibration capture zone, wherein the amount of analyte of interest in the sample is directly related to the corrected binding particle amount.