P B Diagnostic Systems, Inc.

Pb Diagnostics Systems, Inc.

John J Blackwood

Shai Inbar

Donna R Maretsky

James V Patzke

There is described an assay system for the assessment of unoccupied specific ligand binding sites on proteins in biological fluids. The assay is carried out with a multilayer assay element and is based on the principle of equilibrium distribution in which a ligand distributes itself between unoccupied sites on the proteins and the remainder of the element. The ligand can be labeled with a detectable moiety or it may be unlabeled and detected through the use of another detectable species. In one embodiment the assay format is utilized to estimate the number of sites on thyroxine binding globulin (TBG) which are not occupied by thyroxine (T4) or triiodothyronine (T3).

Diagnostic assay system

A method for determining the amount of an analyte in a sample fluid utilizing an assay element which comprises at least one reagent layer. The assay method includes the steps of optically reading a signal producing species, e.g., a fluorescent label, a first time prior to depositing the sample fluid on the assay element and a second time, at the same wavelength and in the same location within the assay element after the sample fluid has been applied to the assay element and the sample analyte has interacted with the reagent(s) present in the assay element. The first, or dry, reading is corrected for relative humidity and/or temperature variations.

Analytical assay

A method for determining the amount of an analyte in a sample fluid utilizes a multilayer assay element which comprises at least one reagent layer and a light-blocking layer. The assay method includes the steps of optically reading a signal producing species, e.g. a fluorescent label, a first time before the sample fluid is applied to the assay element and a second time, at the same wavelength and in the same location within the assay element, after the sample fluid has been applied to the assay element and the sample analyte has interacted with the reagent(s) present in the assay element. The ratio of the two signals is taken and compared with that for known amounts of the analyte to determine the amount of analyte in the sample fluid.

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Foxboro, MA, United States of America

John J Blackwood