초록 ▼

An assay device for detection or determination of an analyte in a sample uses opposable components and is suitable for assay of human chorionic gonadotropin and other protein or glycoprotein hormones. One embodiment of the device comprises: (1) a first opposable component including: (a) a first chro

An assay device for detection or determination of an analyte in a sample uses opposable components and is suitable for assay of human chorionic gonadotropin and other protein or glycoprotein hormones. One embodiment of the device comprises: (1) a first opposable component including: (a) a first chromatographic medium having first and second ends and an immobilized first specific binding partner for the analyte in a detection zone; (b) a conjugate pad in operable contact with the first end of the first chromatographic medium, the conjugate pad containing a labeled second specific binding partner for the analyte in resolubilizable form; and (c) a second chromatographic medium having first and second ends and having immobilized thereon in a reference zone a third specific binding partner that specifically binds the labeled second specific binding partner for the analyte and does not bind the analyte, the first end of the second chromatographic medium being in operable contact with the conjugate pad; and (2) a second opposable component including a sample application zone. The assay device can include a timing control to indicate when flow through the chromatographic medium has occurred and the assay can be read, and can also contain a validation zone ensuring that interference from human anti-mouse antibody is not present. Other embodiments of devices are included, as well as methods of use.

대표청구항 ▼

[ We claim:] [1.] A chromatographic assay device for detection or determination of an analyte in a test sample comprising:(a) a first opposable opponent including:(i) a first chromatographic medium having first and second ends and an immobilized first specific binding partner for the analyte in a de

[ We claim:] [1.] A chromatographic assay device for detection or determination of an analyte in a test sample comprising:(a) a first opposable opponent including:(i) a first chromatographic medium having first and second ends and an immobilized first specific binding partner for the analyte in a detection zone;(ii) a conjugate pad in operable contact with the first end of the first chromatographic medium so that fluid applied to the conjugate pad flows from the conjugate pad to the first end of the first chromatographic medium, the conjugate pad including:(A) a first portion containing a labeled second specific binding partner for the analyte in resolubilizable form;(B) a second portion; and(C) a third portion containing a labeled second specific binding partner for the analyte in resolubilizable form, the second portion separating the first portion and the third portion; and(iii) a second chromatographic medium having first and second ends and having immobilized thereon in a reference zone a third specific binding partner, other than the analyte or an analyte analogue, that specifically binds the labeled second specific binding partner for the analyte and does not bind the analyte, the first end of the second chromatographic medium being in operable contact with the conjugate pad so that fluid applied to the conjugate pad flows from the conjugate pad to the first end of the second chromatographic medium; and(b) a second opposable component including a sample application zone; wherein the first and second opposable components are brought into opposition to apply a sample applied to the sample application zone to the conjugate pad to resolubilize the labeled second specific binding partner so that the sample and the resolubilized labeled second specific binding partner in the first portion of the conjugate pad are applied to the first chromatographic medium and the sample and the resolubilized labeled second specific binding partner in the third portion of the conjugate pad are applied to the second chromatographic medium for detection of the analyte.