Beckman Coulter, Inc.

Larry LaPointe

Howard Milne Chandler

Daniel Joseph Fitzgerald

A chromatographic assay device according to the present invention provides a unidirectional immunoassay for an analyte in a whole blood sample with improved sensitivity and freedom from interference. Such a device comprises: (1) a first opposable component including: (a) a sample application zone containing a matrix of porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; and (b) a chromatographic medium having first and second ends and including: (i) a detection zone having immobilized thereon a first specific binding partner for the analyte; and (ii) a conjugate zone having a labeled second specific binding partner for the analyte in a resolubilizable form; the sample application zone being in operable contact with the first end of the chromatographic medium and the conjugate zone being located closer to the first end of the chromatographic medium than the detection zone; and (2) a second opposable component including: (a) an applicator; and (b) an absorber. In the device, the first and second opposable components are brought into operable contact to cause the applicator to come into operable contact with the sample application zone to apply a wash liquid thereto and cause the absorber to come into operable contact with the second end of the chromatographic medium. Also within the scope of the invention are multiplex devices that can perform more than one assay simultaneously and test kits.

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Ryde, Australia

Larry LaPointe