Miles Laboratories, Inc.

Miles Inc.

Other

Bayer Corporation

Thomas A Magers

David L Tabb

Robert Bauer

John E Sheats

A composition, test device and method of determining the presence or concentration of ketone bodies, and specifically D-.beta.-hydroxybutyrate, 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 D-.beta.-hydroxybutyrate to produce a detectable or measurable response. In addition, a new and improved indicator reagent composition, comprising a) an indicator dye that is responsive to thiols, such as a substituted isobenzothiazolone, Ellman's reagent or a derivative of Ellman's reagent; b) D-.beta.-hydroxybutyrate dehydrogenase; c) lipoamide dehydrogenase; d) D,L-lipoamide; and e) nicotinamide adenine dinucleotide, is incorporated into the carrier matrix to provide an accurate and sensitive assay of a test sample for D-.beta.-hydroxybutyrate (DHBA) in particular, and for ketone bodies in general. The improved method and composition are especially useful in the assay of whole blood, blood serum, blood plasma and urine for ketone bodies.

Composition and method of assaying for ketone bodies

A composition, test device and method of determining the presence or concentration of ketone bodies, and specifically D-.beta.-hydroxybutyrate, 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 D-.beta.-hydroxybutyrate to produce a detectable or measurable response. In addition, a new and improved indicator reagent composition, comprising a) an indicator dye that is responsive to thiols, such as a substituted isobenzothiazolone, Ellman's reagent or a derivative of Ellman's reagent: b) D-.beta.-hydroxybutyrate dehydrogenase; c) lipoamide dehydrogenase; d) D,L-lipoamide; and e) nicotinamide adenine dinucleotide, is incorporated into the carrier matrix to provide an accurate and sensitive assay of a test sample for D-.beta.-hydroxybutyrate (DHBA) in particular, and for ketone bodies in general. The improved method and composition are especially useful in the assay of whole blood, blood serum, blood plasma and urine for ketone bodies.

Composition and method of assaying for D-.beta.-hydroxybutyrate

Composition for determining the presence or concentration of

The present invention provides a stable, convenient solid state test device for the determination of ethanol in an aqueous test sample, a method for its preparation and a method for its use. The use of carrier matrix incorporated with alcohol oxidase, a peroxidatively active substance and a suitable chromogenic indicator for the determination of ethanol in aqueous samples such as body fluid samples (e.g., serum, urine or saliva) is part of the invention. The invention provides a method of incorporating the enzyme alcohol oxidase and a peroxidatively active substance into a carrier matrix with a chromogenic indicator system capable of providing a detectable response to the presence of at least 100 mg/dL ethanol in less than about 5 minutes. The method involves either (a) the use of a specialized incorporation procedure or (b) the addition of an azide to the test device. Either method overcomes the 'false positive' problem seen when solution assay reagents are incorporated at the increased concentrations necessary to provide a test device sensitive to the at least 100 mg/dL ethanol.

Enzymatic ethanol test

An improved composition, device and method, whereby enhanced sensitivity is achieved in detecting test sample constituents such as glucose and blood. The improvement resides in the use of a broad range of compounds as enhancers for benzidine-type indicators. The enhancer tends to stabilize the blue colorform of such indicators.

Stabilization of benzidine-type indicators with various enhancers

An improved composition, device and method, whereby enhanced sensitivity is achieved in detecting test sample constituents such as glucose and blood. The improvement resides in the use of a broad range of compounds as enhancers for benzidine-type indicators. The enhancer tends to stabilize the blue color form of such indicators.

An improved composition, test device and method for detecting the presence of a sugar in a test sample are disclosed. The composition comprises a sugar oxidase, a peroxidase, a chromogen compound capable of producing a detectable response in the presence of hydrogen peroxide and peroxidase, and an enhancer compound having the structure ##STR1## in which the R substituents, same or different, are hydrogen, lower alkyl, lower alkyloxy, aryl or aryloxy; or in which two of the R substituents bound to a common atom together form a closed ring having 3 to about 6 atoms, said ring being saturated, unsaturated or aromatic. R' is hydrogen or an alkyl or alkenyl group having 1 to about 20 carbon atoms. The composition can be incorporated with a carrier matrix to form a test device. The method comprises contacting a test solution with the device and observing any detectable response.

Stabilized composition, test device, and method for detecting the

A composition, device and method for determining the presence of a component in a test sample which contains an interfering substance, such as ascorbic acid, are disclosed. The composition comprises an oxidase or other substance capable of producing peroxide in the presence of the component, a peroxidatively active substance, a chromogen capable of providing a detectable response (such as a color change) in the presence of peroxide and a peroxidatively active substance, and a complex of mercuric ion and one or more ligands wherein (a) the ligand binds covalently to the ion to form a water-soluble complex, and the ligand is not oxidizable by the complexed ion, and (b) the complex has a stability constant, K.sub.s, of at least 10.sup.7 and is substantially noninterfering with respect to the detectable response.

Ascorbate resistant composition, test device and method for detecting a

An improved composition and test device for determining the presence of a constituent in a test sample are disclosed. The composition, which contains a benzidine-type indicator is improved by additionally comprising an amine oxide compound. The device comprises a carrier matrix incorporated with the improved composition. The method comprises contacting the test sample with the composition and observing any detectable response.

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South Bend, IN, United States of America

Thomas A Magers