Hygeia Sciences, Inc.

Btc Diagnostics Limited Partnership

Walter D Cantarow

Izak Bahar

Wendy Jones

Elliott Block

Mary Coseo

Eric C Sigillo

L Edward Cannon

Nancy J Cicia

Bego Gerber

Frank Cole

Patricia Kovac

Cheryl Eaton

Cheryl A Eaton

John Bruins

Detection of bindable substances such as antibodies and antigens using enzyme linked immunosorbent assays having particular utility in home diagnostic applications. The preferred implementation of the invention is characterized by the steps of admixing a sample suspected of containing the bindable substance to be detected with an antibody-enzyme conjugate, immersing an antibody coated solid support into the mixture and then exposing the coated support to an activated chromogenic solution. The conjugate for use in the home diagnostic assay is preferably contained within a lyophilized mixture. The lyophilized mixture contains components which preserve the antibody-conjugate's reactivity and immunologic binding specificity even if the lyophilized mixture had been subjected to hot, humid environmental conditions. Active components in the lyophilized mixture include polyethylene glycol, sugars, and surfactant. The antibody coated support is treated with an improved blocking solution containing a blocking agent such as bovine serum albumin or milk protein in admixture with a sugar. The blocking solution prevents nonspecific binding of immunologic reagents to the support and protects the antibody on the support from loss of reactivity and immunologic binding specificity even if the antibody coated support had been subjected to hot, humid environmental conditions.

Enzyme immunoassays and immunologic reagents

A chromogenic solution for enzyme immunoassay. A stabilizing agent is added to chromogenic solutions containing chromogen of the hydrogen donor type. The stabilizing agent is an alkylhydroxylamine, preferably N,N-diethylhydroxylamine. The N-N diethylhydroxylamine retards degradation of the solution of the chromogen in solvent and is particularly effective in retarding discoloration of a chromogen-solvent solution placed in storage over an extended period of time. The alkylhydroxylamine preferably in the form of N,N-diethylhydroxylamine has the additional property that it does not adversely affect the activity of enzymes employed in enzyme immunoassays. It also does not interfere with binding specificity or reactivity of antibodies.

Chromogenic solution for immunoassay

Colorimetric detection of bindable substances such as antibodies and antigens using chromogens of improved sensitivity and stability. The chromogens take the form of activated solutions containing tetramethylbenzidine or water soluble derivatives of tetramethylbenzidine. Such chromogens are of particular use in home testing applications for detection of antigens such as human chorionic gonadotropin, human luteinizing hormone, and gonococcus bacteria, as well as the detection of antibodies for these substances.

Enzyme immunoassay with two-part solution of tetramethylbenzidine as

Growing community of inventors

Norwood, MA, United States of America

Walter D Cantarow