Hygeia Sciences, Inc.

Eric C Sigillo

Francis X Cole

Gene A Davis

L Edward Cannon

Alicia G Danti

Nancy J Cicia

Charles C Ditlow

Izak Bahar

Wendy Jones

Walter D Cantarow

Elliott Block

Mary Coseo

Cheryl A Eaton

Paul C MacDonnell

Frank Cole

An immunoassay procedure for detection of analytes in urine wherein an immunological reaction is conducted in an aqueous phase containing the urine and a filterable immunocomposite containing an inherently colored gold sol particle is formed if the assay is positive. The colored, gold sol particle containing immunocomposite is collected for direct visual observation on a filter element. False positive readings are minimized by (1) removing contaminants from the urine to prevent clogging of the filter element and non-specific binding of unreacted reactants thereto by contacting the urine with a porous contact element having a detergent material dispersed on its external and interstitial surfaces; (2) preventing non-specific binding of unreacted immunoreactive substances to the filter element by blocking the latter with polyvinyl pyrrolidone; and/or (3) including a green dye material in the aqueous reaction phase to improve the optical distinction after washing the collection filter between negative and positive results on the filter.

Sol capture immunoassay kit and procedure

An immunoassay method comprising applying an aqueous solution containing the analyte antigen to one end of a multi-zoned test strip device such that the solution moves along the strip by capillary action. The zones are arranged so that the solution (a) first contacts and reconstitutes dry, diffusible labelled component comprising colloidal gold conjugated to an antibody specific for said analyte antigen and then (b) contacts and reconstitutes dry, diffusible biotinylated second antibody specific for said analyte antigen such that a diffusible, dispersed sandwich reaction product forms. The reaction product diffuses along the strip with the solution and into a zone containing capture component consisting of a latex and avidin complex which avidin collects the reaction product by means of reaction with its biotin moiety. Thus, gold particles are collected and concentrated in the detection zone for visual determination.

Porous strip form assay device method

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

Antibody coated gold sol particles and antibody coated solid phase particles dispersed in an aqueous system react immunologically as a function of the presence of an analyte in a sample to be analyzed to produce a collectible, solid phase, gold-containing composite. The composite is collected on a filter or at the bottom of a test tube by centrifugation or gravitation and the analyte in the sample is determined or detected by direct visual examination of the collected solid phase composite which has a pink or red or purplish coloration as a result of the gold contained thereby. The materials required for conducting the assay comprise coated gold particles, coated solid phase particles and a collector element such as a filter. The collected, solid phase, metal-containing composite, which may be directly visually examined to determine or detect the gold therein and thus the analyte in the sample, is stable and remains available for confirmation of test results at a later time.

Metal sol capture immunoassay procedure, kit for use therewith and

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Meuthen, MA, United States of America

Eric C Sigillo