Boehringer Mannheim Gmbh

Helmut Freitag

Anselm Rothe

Hans-Erich Wilk

Klaus Pollmann

Heino Eikmeier

Christopher Douglas Wilsey

Wolfgang-Reinhold Knappe

Ulfert Deneke

Hans Wielinger

Rolf Nagel

Joachim Steinbiss

Johann Berger

Wolfgang Weckerle

Karin Munter

Johannes Winkle

Josef Burg

Henio Eikmeier

A new reagent and methods for measuring the concentration of (or detecting the presence of) an analyte in a sample. The reagent includes a phenazine-containing compound and an enzyme. The phenazine-containing compound must be of sufficient type to form a semiquinoid (the color indicator) by reaction involving the enzyme, analyte, and phenazine-containing compound. Importantly, the phenazine-containing compound must be in sufficient amount to correlate the concentration of semiquinoid to the concentration of analyte in the sample or to detect the presence of the analyte in the sample. The reagent may further include a buffer and a surfactant. The reagent may be incorporated into a film and may be provided in kit form. The methods for measuring the amount of (or detecting the presence of) an analyte in a sample importantly include spectrophotometric measurement (or detection) of the semiquinoid indicator at wavelengths greater than about 580 nanometers, which reduces interferences due to the presence of hemoglobin, bilirubin, and turbidity. Further, these assay methods importantly involve short incubation periods of less than about one minute for test samples measuring (or detecting) spectrophotometric absorbance (assays performed on solutions) and less than about 1.5 minutes for test samples measuring (or detecting) spectrophotometric reflectance or transmittance (assays performed on films).

Reagent and assay methods including a phenazine-containing indicator

The present invention concerns compounds having the general formula I ##STR1## in which R.sup.1 denotes hydrogen or hydroxy,

Diphenylmethane derivatives, process for their production and their use

Subject matter of the invention is a new method of detecting a substance with hydrolase activity in a sample, characterized in that the sample is brought into contact with an indicator enzyme, which is covalently bound to an insoluble carrier material and can be rendered soluble by the hydrolase activity, in that the cleaved off indicator is separated and in that its enzymatic activity is determined and test means for its implementation.

Devices for determining hydrolase activity through its hydrolytic

The present invention provides a test carrier for the analytical determination of a component of a liquid sample, especially of a body fluid, with a carrier layer, which is partly covered by a liquid-absorbing layer which contains a sample application zone and a transport zone, and a reagent layer which is in contact with the liquid-absorbing layer, wherein the reagent layer in contact with the liquid-absorbing layer is so arranged that it does not overlap with the sample application zone and is full-facedly in contact with the liquid-absorbing layer.

Test carrier for the analytical determination of a component of a liquid

The present invention provides a test carrier for the analysis of a sample liquid with a test layer which contains a ligand fixed to to carrier particles, which ligand reacts with a component of the sample liquid, the test layer having a three-dimensional open structure which is so porous that the sample liquid with the component can penetrate into it, the carrier particles being arranged in the layer in such a manner that the ligand, upon pentration of the sample liquid, comes into contact with the component of the sample, wherein the carrier particles consist of an inorganic material, on the surface of which reactive organic groups are covalently bound as coupling groups, and the ligand is covalently bound to the coupling groups. The present invention also provides processes for the production of such a test carrier and a method for using it.

Test carrier for analysis of a liquid sample

The present invention provides a test carrier for the analysis of a sample liquid and especially of a body fluid, having a porous test layer (8, 13) which contains a solid component (9, 17), wherein the solid component (9, 17) is coated with a protein which is insoluble in the sample liquid under the test conditions. A process for the production of this test layer is also disclosed, wherein the protein is dissolved in a solvent under conditions under which the solubility of the protein is sufficiently high in order to dissolve a certain minimum amount of the protein, the solid component of the test layer is contracted with the solution and the solubility is reduced to such an extent that the component is coated by the precipitating protein.

Test carrier for the analysis of a sample liquid

The present invention provides a process for the determination of an analyte in a body fluid, in which there are used two binding components capable of specifically binding with one another, one of the binding components being enzyme-labelled and not carrier-fixed and the other binding component being carrier-fixed. The process contains a step in which the binding components are incubated with one another so that binding reaction takes place. The amount of enzyme-labelled binding component not bound to the carrier-fixed binding component is a measure of the concentration of the analyte which is determined by allowing the labelling enzyme to act upon a substrate producing a detection signal. During the specific binding reaction, incubation is carried out simultaneously with a non-fixed substrate of the labelling enzyume which does not produce a detection signal and with a carrier-fixed substrate of the labelling enzyme which produces a detection signal, the substrate not producing a detection signal being so chosen with regard to the amount used and affinity to the labelling enzyme in relation to the amount of the substrate producing a detection signal and its affinity to the labelling enzyme and in relation to the total activity of the labelling enzyme that the enzyme-catalyzed reaction of the substrate producing a detection signal is delayed until the specific binding reaction between the binding components has substantially taken place.

Process and test carrier for the determination of an analyte

The present invention provides a process for the detection of an analyte, wherein a sample containing the analyte is incubated either with a labelled binding partner and the immobilized analyte or an immobilized analyte analogue or with the labelled analyte or analyte analogue and an immobilized binding partner, the binding partner displaying towards the immobilized or labelled analyte or analyte analogue a higher affinity than towards the free analyte, and the labelled binding partner or the labelled analyte or the labelled analyte analogue is present in insufficiency compared with the concentration of the analyte to be detected. The present invention also provides an agent for carrying out this process, wherein it contains either the immobilized analyte or an immobilized analyte analogue and a labelled binding partner or the labelled analyte or a labelled analyte analogue and an immobilized binding partner, as well as optionally an appropriate buffer system and further conventionally used adjuvants, the binding partner displaying towards the immobilized or labelled analyte or analyte analogue a higher affinity than towards the free analyte.

Process for determination of an analyte and reagent therefor

A composition useful in determining analytes, such as glucose or cholesterol, is disclosed. The composition contains an enzyme which specifically reacts with the analyte to be determined, a soluble ferricyanide compound which is reducible to form a ferrocyanide, a soluble ferric compound which provides ferric ions for reacting with ferrocyanide to form a reaction product, and a buffer which does not prevent formation of this reaction product. The composition has a pH of from about 3.0 to about 6.0.

Method and reagent for determination of an analyte via enzymatic means

The present invention provides a multi-layer test carrier (1) for the analytical determination of a component in a liquid sample, especially in a body fluid, having a first carrier layer (2) and a second carrier layer (10), at least one of which is transparent, a liquid-absorbing layer (3) being applied to the first carrier layer (2) and a reagent layer (11) containing at least one reagent being applied to the second carrier layer (10), the carrier layers being so arranged and fixed that the surfaces (3a, 11a) of the absorbing layer and of the reagent layer facing away from the carrier layer can be brought into contact with one another and can be pressed against one another, wherein the reagent layer (11) is soluble substantially without residue in the sample liquid and the take-up ability of the liquid-absorbing layer (3) for the sample liquid is so great that an amount of liquid absorbed therein suffices in order to dissolve the reagent layer free of residues so that substances contained in the reagent layer (11) pass over from the reagent layer (11) into the liquid-absorbing layer (3) when the two layers are pressed against one another.

Multilayer test strip device with a dissolvable reagent layer

The present invention provides a test carrier (1) for the analytical determination of a component of a body fluid with a base layer (2) and at least two planar test layers which, in the initial state of the test carrier, before carrying out the determination, are separate from one another but can be brought into contact with one another by external manipulation, wherein a first test layer (8) and a second test layer (10) are arranged on the base layer essentially next to one another but separated in the initial state by a gap, a contact element (11, 17, 18, 20) being provided which consists of a capillary-active material which is so dimensioned that it can bridge the gap (12) and which is so mounted and arranged that, in a first position, it cannot contact at least one of the test layers (8, 10) but, by external pressure, it can be brought into a second position in which it contacts both test layers in such a manner that a liquid exchange between the test layers is possible.

Test carrier and method for the analytical determination of a component

Hydrophilic glass fibers which have bonded to their surfaces a layer of silane molecules of the formula ##STR1## are useful for the separation of plasma from blood for haemostasiological testing. In the formula: the molecule is bonded at its end oxygen to a surface of a glass fibre; R.sub.1 is C.sub.2 -C.sub.6 alkylene; X is OH, C.sub.1 -C.sub.6 alkoxy, having n carbon atoms and up to (n-1) OH groups in which n is 1-6, or an amino acid or peptide residue; and each of R'.sub.3 and R'.sub.3 is C.sub.1 -C.sub.6 alkyl, an oxygen bridge to the silicon atom of another silane molecule or an oxygen bridge to the glass surface. The fibres have an average diameter of from 0.2 to 5 microns and a density of 0.1 to 0.5 g/cm.sup.3.

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Indianapolis, IN, United States of America

Helmut Freitag