Boehringer Mannheim Gmbh

Roche Diagnostics Operations, Inc.

Roche Diagnostics Gmbh

Joachim Steinbiss

Reiner Schlipfenbacher

Rolf Lerch

Dieter Mangold

Heinz-Friedrich Trasch

Andreas Rauscher

Herbert Harttig

Michael Fritz

Anselm Rothe

Helmut Freitag

Hans-Erich Wilk

Volker Gerstle

Juergen Schwab

Volker Keller

A system for simple nucleic acid analysis is described in which the amplification space contains at least a part of the binding space. An additional improvement is achieved by the design of the binding or/and amplification space which is optionally surrounded by a heatable metal layer.

System for simple nucleic acid analysis

The present invention concerns a method for the detection of nucleic acids on an analytical element which contains a sample application zone and a detection zone, the analytical element enabling liquid transport from the sample application zone to the detection zone, wherein a sample is applied to the sample application zone of the analytical element and the nucleic acids contained in the sample are denatured and can be detected qualitatively in the detection zone by hybridization with a detection probe and also quantitatively, preferably by means of marker groups. In addition new analytical elements and reagent kits for the detection of nucleic acids are provided.

Analytical element for species-specific detection of nucleic acids

A carrier matrix of polyvinyl alcohol-coated glass is dissolvably impregnated with reagent. The matrix is manufactured by slurrying glass fibers in an excess of water and polyvinyl alcohol and forming a layer, which is then dried and impregnated with reagent.

Carrier matrix with dissolvably impregnated reagent

A test carrier for the analytical determination of a component of a liquid sample, especially for the diagnosis of diseases, in which a reaction sequence taking place on a test carrier having a base layer, a liquid transport path which extends from a sample application region to an evaluation region and a signal formation layer in which, on the basis of a signal formation reaction, with the help of a signal formation reagent system, an optically determinable change characteristic for the component to be determined takes place. At least one signal formation reagent is present in the signal formation layer. In the evaluation region, there is provided a liquid transport layer which is an absorbent material which is in fluid contact with the liquid transport path. The signal formation layer runs parallel to the liquid transport layer, the signal formation layer is in liquid contact via a liquid exchange surface with the liquid transport layer perpendicularly to the plane of the base layer and the speed of liquid transport of the liquid transport layer and the chronological commencement of the signal formation reaction in the signal forming layer are adapted to one another in such a manner that the liquid first spreads out in the liquid transport layer and the signal formation reaction takes place substantially thereafter.

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

The present invention provides a test kit and a process thereof for the determination of an analyte in a pasty sample, especially in faeces, containing a sample application region which has a sample layer with a sample field for the application of a sample. An analysis device with reagents is provided which reacts with the analyte and includes a component producing a detection signal. The sample layer includes a material which is capillary-active so that a liquid is transported therein by capillary action.

Test kit and process for the determination of an analyte in a pasty

Test kit 10 for determining an analyte in a pasty sample, in particular in stool. It contains a capillary-active fluid transport section 11 which leads from an eluant application zone 12 via a sample application zone 14 to an eluate reception zone 15, together with analysis section containing reagents which react with the analyte and include a component producing a test signal. Improved reliability of the analysis with simplicity of manufacture and ease of handling is achieved by the fact that the fluid transport path 11 between the eluant feed zone 12 and the sample field 23 is formed as a delay section 13. The sample application zone 14 is provided with a sample layer 16a with a sample field 23 for the application of the sample.

Test kit for determining an analyte in a pasty sample

Test carrier for analysis of a sample liquid with the help of a specific binding reaction of two bioaffine binding partners, one of which is contained in the sample and one in the reagent system of the test carrier, with several capillary-active test zones (11-16; 21-25) arranged substantially next to one another on a base layer (2). The test zones are in liquid contact with one another so that they form a liquid transport path (20, 30) along which a liquid flows, driven by capillary forces, from a start zone (11, 21), a reaction thereby taking place between the first binding partner and the reagent system containing the second reaction partner, which reaction leads to a labelled species characteristic for the desired analysis. A third binding partner specific for the first binding partner sets as capturing reagent which is so arranged in a zone of the liquid transport path (20, 30) and is so measured with regard to the amount used that it binds a part of the first binding partner and thereby removes it from the reaction leading to the characteristic labelled species. A process for the analysis of a liquid sample with the above test carrier is also provided.

Test carrier utilizing reaction of two bioaffine binding partners

A test carrier for the analytical determination of a component of a liquid sample, especially for the diagnosis of diseases, by means of a reaction sequence taking place on the test carrier with several test layers, which, in the initial state, are dry and, in the case of using the sample liquid, are wetted, comprising a base layer on which are present next to one another a sample application region and an evaluation region, a liquid transport path which extends from the sample application region into the evaluation region and a color-forming layer in which, on the basis of a color-formation reaction with the help of a color-forming reagent system, at least one color-forming reagent of which is present in the color-forming layer, there takes place an optically detectable change characteristic for the component to be determined. In the evaluation region above the surface of the color-forming layer facing away from the base layer, there is arranged an absorbent covering layer which, in the initial state of the test carrier, is so non-transparent that the color of the color-forming layer is not visible. The covering layer is in fluid contact with the liquid transport path and the covering layer and the color-forming layer are formed in such a manner that the color of the color-forming reagent becomes visible when both layers are wetted by the sample liquid.

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.

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Lorsch, Germany

Joachim Steinbiss