Hygeia Sciences, Inc.

Btc Diagnostics Limited Partnership

Mary Coseo

Izak Bahar

Wendy Jones

Walter D Cantarow

Elliott Block

Eric C Sigillo

L Edward Cannon

Bego Gerber

Nancy J Cicia

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

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

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Arlington, MA, United States of America

Mary Coseo