Method using a new calibrator and a device and test kit including the calibrator

Abstract

A lateral flow method for the determination of an analyte in a sample utilizes biospecific affinity reactions. The method comprises forming a complex comprising Reactant I - - - Analyte' - - - Reactant* wherein Reactant* and Reactant I exhibit biospecific affinity to the analyte, Reactant* is analytically detectable, and Analyte′ is the analyte or an analyte-related reactant, determining a detectable signal from Reactant* in the complex (sample value), and obtaining the amount of analyte in a sample by comparing the sample value with one or more calibrator values, each of which corresponds to a standard amount of analyte. Before determination of the calibrator value, either calibrator or a binder for the calibrator has been bound to a matrix and is released at the determination of calibrator value. The calibrator and the analyte have the ability to biospecifically bind to Reactant* via equivalent binding sites, and one or more calibrator zones comprising calibrator or binder for the calibrator are located in the same process flow as Reactant I in a detection zone. A device for transforming measured signal values for a completed, analytically detectable reactant (Reactant*) to real amounts of analyte in a sample comprises a flow matrix in which there is an area of process flow for the transport of Reactant*, having one or more calibrator zones, an application zone for Reactant* upstream of the one or more calibrator zones, and one or more detection zones downstream of the one or more calibrator zones.