Method using a new calibrator and a device and test kit including the calibrator
First Claim
1. A lateral flow method for the determination of an analyte in a sample involving utilizing biospecific affinity reactions, and comprising the following steps:
- i. forming a complex in a lateral flow matrix, the complex comprising;
Reactant I - - - Analyte′
- - - Reactant*, where a. Reactant* and Reactant I exhibit biospecific affinity to the analyte, b. Reactant* is analytically detectable, c. Analyte′
is the analyte or an analyte-related reactant, and subsequently ii. determining the detectable signal constituting a sample value from Reactant* in the complex, and iii. determining the amount of analyte in the sample by comparing the sample value with one or more calibrator values, each of which corresponds to a standard amount of analyte, wherein A) before determination of the calibrator value, either (i) calibrator, or (ii) a binder for the calibrator has been bound to a matrix, and when a binder for the calibrator has been bound to the matrix, calibrator is added or calibrator predeposited in the matrix is released for binding with the binder, and the matrix is insoluble in the liquid medium in which binding of Reactant* to the calibrator occurs, B) the calibrator and the analyte exhibit biospecific affinity to Reactant* by equivalent binding sites, C) two or more calibrator zones CZ comprising calibrator or binder for the calibrator are located in a single process flow stream with Reactant I in a detection zone (DZ), and D) all of the detection zones DZ are downstream of all of the calibrator zones CZ in the lateral flow matrix.
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Accused Products
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.
42 Citations
31 Claims
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1. A lateral flow method for the determination of an analyte in a sample involving utilizing biospecific affinity reactions, and comprising the following steps:
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i. forming a complex in a lateral flow matrix, the complex comprising;
Reactant I - - - Analyte′
- - - Reactant*, wherea. Reactant* and Reactant I exhibit biospecific affinity to the analyte, b. Reactant* is analytically detectable, c. Analyte′
is the analyte or an analyte-related reactant, and subsequentlyii. determining the detectable signal constituting a sample value from Reactant* in the complex, and iii. determining the amount of analyte in the sample by comparing the sample value with one or more calibrator values, each of which corresponds to a standard amount of analyte, wherein A) before determination of the calibrator value, either (i) calibrator, or (ii) a binder for the calibrator has been bound to a matrix, and when a binder for the calibrator has been bound to the matrix, calibrator is added or calibrator predeposited in the matrix is released for binding with the binder, and the matrix is insoluble in the liquid medium in which binding of Reactant* to the calibrator occurs, B) the calibrator and the analyte exhibit biospecific affinity to Reactant* by equivalent binding sites, C) two or more calibrator zones CZ comprising calibrator or binder for the calibrator are located in a single process flow stream with Reactant I in a detection zone (DZ), and D) all of the detection zones DZ are downstream of all of the calibrator zones CZ in the lateral flow matrix. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 26, 27, 28)
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14. A device for transforming measured signal values of a complexed, analytically detectable reactant (Reactant*) to real amounts of analyte in a sample, in connection with performing an analysis method which utilizes biospecific affinity reactions for the determination of the amount of analyte in a sample, wherein the device comprises:
a flow matrix in which there is an area of process flow for the transport of Reactant*, and wherein there are in said area i. two or more calibrator zones (CZ) comprising a calibrator, or binder for the calibrator, which is firmly anchored to the matrix, the amounts of calibrator or calibrator binder, respectively, being different for at least two calibrator zones and the calibrator exhibiting binding sites to which Reactant* binds, when Reactant* is transported through a calibrator zone, ii. an application zone for Reactant* (AR*Z) upstream of said calibrator zones, and iii. one or more detection zones (DZ), all of the detection zones being downstream of all of the calibrator zones. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 29, 30, 31)
Specification