Bayer Corporation

Miles Inc.

Miles Laboratories, Inc.

Meitak Teresa Yip

Paul F Corey

Robert P Hatch

Kin F Yip

Gary W Rheinheimer

Elva Kurchacova

Frederick E Ward

Lloyd A Schick

Carol A Miller

James P Albarella

Chris Thomas Zimmerle

Hai-Hang Kuo

Koleen K Messenger

Dayaweera Wijesuriya

Kin Fai Yip

Disclosed is an improvement in the analysis for an analyte in a urine test sample in which the urine is contacted with a labeled antibody specific to the analyte and the concentration of the analyte is determined by measuring the response from the label. The improvement involves maintaining the concentration of urea in the test sample above the threshold value which value is the concentration of urea at which increases in the urea concentration do not affect the accuracy of the assay such as by interfering with the binding between the analyte and the labeled antibody.

Formulation for reducing urea effect for immunochromatography assays using urine samples

Disclosed is a method for determining the concentration of an analyte in a sample of body fluid. The method involves contacting the body fluid sample with a test strip containing mobile, labeled specific binding partner for the analyte, through which strip the test fluid, analyte and any complex formed by interaction of the analyte and labeled specific binding partner therefore can flow by capillarity. The strip contains at least one zone for capture of the labeled specific binding partner and at least one separate zone for retention of the analyte/labeled specific binding partner complex. By determining the magnitude of the signal from the detectable label in the capture zone(s) and retention zone(s) and determining a final response signal by correlating signals using an algorithm and number of zones chosen in a manner that provides a final response signal best suited for the particular assay, the concentration of the analyte can be determined with greater precision.

Device and method for obtaining clinically significant analyte ratios

Disclosed is a method for the immobilization of an analyte such as deoxypyridinium (DPD) onto a solid support. The method involves binding an antigen-amino acid-deoxypyridinium complex to the support via an anti-antigen binding partner located in a capture zone of the solid support. Preferably, the support is nitrocellulose and the antigen has the fluorescein structure.

Method and device for the detection of analyte in a fluid test sample

Disclosed is an improvement to the technique for immobilizing an analyte onto a solid surface for use in a competitive immunoassay. The improvement involves immobilizing the analyte on the solid surface by reacting the analyte or derivative thereof with polyethylene glycol which has been functionalized with a group which is reactive with the analyte contacting the resulting conjugate with the solid surface to thereby immobilize the analyte.

Method and device for the detection of analyte in a fluid sample

Disclosed is an improved method for the detection of an analyte in a fluid test sample using a strip of a negatively charged matrix material having a zone containing mobile, labeled binding partner for the analyte and a separate zone for capturing the labeled binding partner as it is carried through this zone by the fluid test sample. The improvement involves combining the fluid test sample with a polyalkoxylated amine surfactant to control non-specific binding of the labeled binding partner to the negatively charged matrix material.

Method for the detection of an analyte by immunochromatography

Disclosed is a method for the determination of creatinine in urine which involves contacting a urine test sample with a reagent system containing Cu.sup.+2, a hydroperoxide and an oxidizible dye which provides a detectable response when oxidized in the presence of a pseudoperoxide. The reagent system also includes a buffer to maintain the urine's pH within the range of 6.6 to 8.0 and a chelating agent for the cupric ions to prevent oxidation of the dye in the absence of creatinine.

Method for the detection of creatinine

A layered device suitable for use in the analysis of blood samples which includes a first layer of a matrix material having dispersed therein a complex of copper and a polymer containing multiple pendant carboxyl groups which selectively combines with hemoglobin and bilirubin in fluid communication with a second layer which contains a reagent system which reacts with one or more predetermined analytes in the blood sample to provide a color change.

Multilayered device containing a polymer-copper complex to control

A new and improved test device and method of determining the presence or concentration of a predetermined analyte, such as glucose, cholesterol or occult blood, in a test sample are disclosed. The test device includes a test pad comprising a suitable carrier matrix incorporating an indicator reagent composition capable of interacting with the predetermined analyte to produce a detectable or measurable response. In addition, the new and improved indicator reagent composition, comprising an indicator dye, such as a redox indicator, like a benzidine indicator; a redox mediator, such as an oxidase enzyme capable of interacting with the predetermined analyte and a peroxidase enzyme; a metal ion complex; and a cooxidant selected from the group consisting of bromate ion, chlorate ion, perchlorate ion, chromate ion, an organic oxidant like a peroxide, a hydroperoxide or a N-halo compound, and combinations thereof, is incorporated into the carrier matrix to provide a more accurate, ascorbate interference-resistant assay of a test sample for the predetermined analyte.

Ascorbate interference-resistant composition, device and method of

Disclosed is a method for separating biological substances, particularly hemoglobin or bilirubin, from blood plasma or serum which involves contacting the plasma or serum with a water insoluble complex of a polymer containing multiple pendant carboxyl groups and copper.

Use of polymer-copper complex to control interference of biological

The present invention is directed to the elimination of ascorbic acid interference in assay systems, particularly assay systems based upon oxidase-peroxidase coupled reactions. When ascorbic acid is present in a sample, it can act as a reductant thereby interfering with an assay's reagent system. The present invention eliminates this inteference by quickly oxidizing any ascorbate thereby preventing ascorbate from acting as an unwanted reductant. The ascorbate is oxidized using a dual oxidant system comprising a water soluble polymer bound to Cu.sup.+2 and an organic or inorganic oxidant such as chromate, peroxide, or a N-halo derivative. This invention is surprisingly selective and generally will not itself interfere with the assay's reagent system. Furthermore, the present invention is so fast and efficient that it can be incorporated into a convenient format, such as a conventional 'dip-and-read' reagent test strip system.

Agent for reducing ascorbic acid interference in liquid or dry phase

A novel compound useful in detecting leukocytes, esterase and protease in a test sample. The compound has the structure ##STR1## in which: A is an acid residue, R is lower alkyl, aryl, carboxyl, carboxyl ester, amido or cyano, R* is H or lower alkyl, and X is O, S, or NR', in which R' is H, lower alkyl or aryl.

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Elkhart, IN, United States of America

Meitak Teresa Yip