Opposable-element chromatographic assay device for detection of analytes

摘要

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.