Miles Inc.

Siemens Healthcare Diagnostics Gmbh

Miles Laboratories, Inc.

Bayer Corporation

Bayer Healthcare LLC

Ronald G Sommer

Michael J Pugia

Angela A Michaels

Richard Dana Johnson

Paul F Corey

Kin F Yip

Alfred C Greenquist

Michael Salvati

Solomon H Murphy

James Arthur Profitt

James P Albarella

Sung-Kwon Jung

Kin-Fai Yip

Linda Anderson-Mauser

Shannon Gleason

Lloyd S Schulman

Gunter Franke

Daya C Wijesuriya

H Volker Runzheimer

Robert W Trimmer

Lois J Proud

H-Volker Runzheimer

Certain monoclonal antibodies are able to detect urinary trypsin inhibitors (UTIs) that are characteristic of disease in humans. In particular, the UTIs include AMBK, Bikunin, Uristatin, Uristatin-1, Uristatin-2, as defined herein, also including the fragments and aggregates thereof.

Monoclonal antibodies for detection of urinary trypsin inhibitors

A microfluidic device containing liquid reagents having an extended shelf life contains the liquid reagents in micro-reservoirs that limit the escape of moisture to less than 10% over the shelf life of the device. The micro-reservoir preferably is made of polypropylene and covered with a metallized plastic film.

Packaging of microfluidic devices

A method and device for carrying out immunoassays in which non analyte specific binding of heterophilic antibodies to a labeled antibody in a capture region produces an incorrect measure of the amount of an analyte attached to the antibody. Immunoglobulin from the same animal source as the labeled antibody is added to the sample fluid to prevent non-specific binding of the heterophilic antibodies in the capture region. One part of specific binding pair is added to said antibody or its label capable of binding to a second part of the binding pair immobilized in a control region downstream of said capture region for trapping the portion of the labeled anti-body which is not bound to the analyte. Preferably said binding pair is biotin/avidin or fluoroscein/anti-fluoroscein.

Use of dual conjugated labels in the elimination of serum interference in immunochromatographic assays

Disclosed is a method for determining the concentration of an analyte in a liquid test sample. The method involves the use of colloidal sized metal particles, which exhibit a spectral response in the agglomerated state which is detectably different than in their unagglomerated state, which bear specific binding partners for the analyte in question on their surface. The specific binding partner treated colloidal particles are combined in a buffered, aqueous medium with a destabilizer material capable of destabilizing the specific binding partner-colloidal particle conjugates thereby permitting the particles to agglomerate. Also included in the liquid medium is a polymer bearing multiple analyte or analyte analog molecules along its surface which serves to protect the specific binding partner coated metal particles from dissociation by the destabilizing agent. Analyte added to the medium, typically in the form of a fluid test sample, competes for the specific binding partner and thereby decreases the amount of protection afforded by the analyte or analyte analog bearing polymer which permits unprotected colloidal particles to agglomerate and provide a detectable spectral response. The magnitude of the change in spectral response is directly proportional to the concentration of analyte in the fluid test sample.

Sol particle decay protection immunoassay

A method for determining the concentration of analyte in a test fluid by immunochromatography techniques which involves quantitatively determining the signals from captured analyte/labeled binding partner complex by an instrument, e.g. reflectance spectrometer. In a preferred embodiment, a reflectance reading is determined for the captured complex and uncomplexed labeled binding partner which is captured in a separate zone of the immunochromatographic strip and the ratio of these reflectances is used to provide additional quantitation to the assay method.

Quantitative detection of analytes on immunochromatographic strips

The detection of protein is accomplished using novel composition and method involving phenolsulfonephthalein protein error indicator, buffer and an aliphatic ether-polycarbonate present in an amount equal to or less than ten percent by weight.

Assay for the determination of protein in a biological sample

A composition, test device and method of determining the presence or concentration of proteins, such as albumin, in a liquid test sample, such as urine. The test device includes a test pad with a carrier matrix incorporating a indicator reagent composition capable of interacting with proteins to produce a detectable response. The indicator reagent composition includes an indicator dye that is capable of interacting with albumin and undergoing a detectable color transition; a buffer; a hydrophobic polymeric compound having the general structural formula: ##STR1## wherein A is ##STR2## and PO is an oxypropylene unit, EO is an oxyethylene unit, y is a number in the range of 0 to about 20, z is a number in the range of 0 to about 20, the sum y+z is a number in the range of about 2 to about 20, and R.sub.2 and R.sub.3 are selected, independently, from the group consisting of hydrogen, an alkyl group, an aralkyl group, and an aryl group; R.sub.1 is either methylene or oxygen; n is a number in the range of one to about 8; and E is hydrogen or methylol when R.sub.1 is methylene, or E is hydroxy when R.sub.1 is oxygen; and a suitable carrier which is water. The indicator reagent composition provides an improved color resolution in the test samples raving negative protein and trace amount of protein.

Composition and device for urinary protein assay and method of using the

The present invention provides an analytical test strip for the detection of protein in a biological sample including a novel combination of protein error indicators. The invention includes, in combination, a partially halogenated phenolsulfonephthalein protein error indicator having nitro or nitroso substituent groups in the B and/or C rings and a merocyanine protein error indicator.

Merocyanine and nitro or nitroso substituted polyhalogenated

The present invention provides a novel group of protein error indicators including nitro or nitroso substituent groups in the B and C rings of a partially halogenated triphenylmethane compound.

Nitro or nitroso substituted polyhalogenated phenolsulfonephthaleins as

An immobilized hapten reagent for use in a specific binding assay for the determination of a hapten or binding analog thereof in a liquid test sample and methods for preparing and using the immobilized hapten reagent. The immobilized hapten reagent comprises a hapten moiety covalenty linked substantially only to the external surface of a gel particle. The immobilized hapten reagent is prepared by forming a reaction mixture comprising the hapten moiety and the carrier material in a nonswelling solvent wherein the gel particle is substantially impervious to the hapten moiety and wherein an analytically insignificant amount of the hapten moiety is nonspecifically bound to the gel particle. The immobilized hapten reagent is characterized by being substantially stable in aqueous solutions and exhibits an insignificant amount of leakage of the hapten moiety into a liquid test medium.

Gel particles having hapten moieties bound thereto as immunoassay reagent

An immobilized hapten reagent for use in a specific binding assay for the determination of a hapten or binding analog thereof in a liquid test sample and methods for preparing and using the immobilized hapten reagent. The immobilized hapten reagent comprises a hapten moiety covalently linked substantially only to the external surface of a polyacrylamide gel particle. The immobilized hapten reagent is prepared by forming a reaction mixture comprising the hapten moiety and the carrier material in a nonswelling solvent wherein the gel particle is substantially impervious to the hapten moiety and wherein an analytically insignificant amount of the hapten moiety is nonspecifically bound to the gel particle. The immobilized hapten reagent is characterized by being substantially stable in aqueous solutions and exhibits an insignificant amount of leakage of the hapten moiety into a liquid test medium.

Polyacrylamide gel particles having hapten moieties bound thereto as

The invention provides an analytical element and a method for preparing an analytical element for evaluation of a liquid sample with respect to a particular analyte by (a) incorporating a carrier with a composition in a liquid, the composition comprising at least one reagent of an analyte-detecting system, under conditions effective to ionize a reagent migration inhibiting substance, which substance is insoluble in said liquid when in its nonionized form and soluble in said liquid when ionized, and drying the carrier; and then (b) incorporating the carrier of (a) with a second composition in a liquid different from that of (a), the composition comprising the remaining reagents of the analyte-detecting system which are reactive with the at least one reagent of (a) and a reagent migration inhibiting substance which is soluble in said liquid when in its nonionized form, which liquid is effective to prevent reaction of the second composition with the at least one reagent of (a) prior to contact of the element with the sample and to prevent the migration inhibiting substance from ionizing prior to contact with the sample, and drying the carrier. Preferably, conditions which ionize the reagent migration inhibiting substance are the use of an aqueous liquid at a pH of at least about 5. Preferably, the reagent migration inhibiting substance is a monoester maleic acid polymer such as a copolymer of methyl vinyl ether and the monomethylester of maleic acid. The liquid of (b) is preferably an organic liquid, such as acetone.

Analytical element and method for preventing reagent migration

A device for the quantitative determination of heparin in mammalian blood plasma, a method for the preparation of such device and a method for determining the plasma's heparin concentration using the device. The device, which is prepared using a freeze-drying technique, comprises a first upper layer of a carrier matrix material containing a buffer, AT-III and thrombin and a second, lower layer of a carrier matrix containing a thrombin sensitive fluorogenic or chromogenic substrate being capable of interacting with thrombin in such a manner that a time-related chemical change detectable by fluorometric or spectrophotometric means takes place when thrombin and the substrate are contacted in a suitable liquid environment.

Device and method for the quantitative determination of heparin in

Disclosed is a method and device for the quantitative determination of AT-III in mammalian blood plasma. The method involves contacting a plasma sample containing excess heparin with a 3 layered reagent strip comprising:

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Elkhart, IN, United States of America

Ronald G Sommer