Sheet-like diagnostic device

Details Sheet-like diagnostic device Sheet-like diagnostic device

1995-10-18

2001-11-06

Chin, Christopher L. (Department: 1641)

Chemistry: analytical and immunological testing

Involving diffusion or migration of antigen or antibody

C435S007920, C435S007930, C435S007950, C435S805000, C435S806000, C435S969000, C435S970000, C435S971000, C435S974000, C436S518000, C436S528000, C436S541000, C436S810000, C436S814000, C436S818000

Reissue Patent

active

RE037437

ABSTRACT:

The invention relates to a solid diagnostic device which comprises several functional sectors and is used for the detection and quantitative determination of substances or analytes in biological fluids. The invention also relates to a process using this device in which, after the device has come into contact with the fluid, the analytes react with specific combination partners having biological affinity and am detected by means of labelling reagents.
In methods of diagnosis, the ability to identify and estimate specific compounds has made it possible to monitor the administration of medicaments, the quantification of physiologically active compounds or secondary products thereof and the diagnosis of infections. In this respect, the immunoassay methods (RIA,
ELSIA

ELISA
and the agglutination test) are of particular importance. The specific combination reactions utilized in the tests are not limited to immunological interactions, such as antigen-antibody or hapten-antibody interactions, but also utilize interactions having biological affinity, such as lectin-sugar or active compound-receptor.
Although the existing tests are sensitive and specific, they do not constitute convenient application forms, because of the long duration of the test (in most cases several hours or even days) and the frequent test steps, such as immune reaction, washing steps and enzymatic reaction. The long test times are not compatible with use in emergency methods of diagnosis.
Integrated dry chemical test elements, such as are described in the present invention, simplify the performance of the tests and shorten the test times.
No sheet-like test element, in which all the components of the immune reaction of a heterogeneous immunoassay using solid phase detection, and the functional performance and the “bound-free” separation, are integrated has been described so far.
Whereas in the test strip assembly the immune reaction steps and the separation of bound and free phases are operated in the heterogeneous test by directed streams of liquid, in test element assemblies operating by means of thin layers laminated over one another (film technology), processes controlled by diffusion and directed by the concentration gradient are possible driving forces. A fluorescence labelling is used in German Offenlegungsschrift No. 3,329,728 (Japanese Patent No. P144,341/82) and EP A No. 0,097,952 (Japanese Patent No. 114,359/82). The labelling has a low molecular weight and hence promotes processes controlled by diffusion. However, the test has to be carried out at an elevated temperature. In the first of these two cases both the free phase and also the bound phase are evaluated. In film technology the absorption of solvent is effected either by hydrating swellable components or by filling capillary cavities. In the case Of assemblies having layers laminated over one another only the top layer and the bottom layer are accessible to detection without major difficulties.
After the reaction steps have taken place it is difficult to react reagents with components in intermediately placed layers. In the test strip assembly having zones situated one behind another, such as is used in the present invention, in principle each zone is readily accessible both from above and also from below, for a determination and also for the addition of reagents which may perhaps be required.
The invention relates to a sheet-like diagnostic device which contains all the reagent components and which contains not only all the components required for the functional sequence, but also the functional sequences themselves in an integrated form, and by means of which it is possible to detect an analyte having properties of biological affinity, in such a way that a solution of the analyte is brought into contact with a functional region of the device designed for this purpose, and the analyte as detected via a signal-producing system in a single functional region, a solid phase zone.
A second analyte, or further analytes, as constituents of the same solution can be detected at the same time by means of the device, if these analytes possess properties of biological affinity different from the hit analyte. They are also detected in the same manner as the first analyte in a single functional region, a solid phase zone appropriate for them. The functional regions for the detection of the second or further analytes are situated on the sheet-like device in front of or behind the functional region for the detection of the first analyte. The device can also contain several solid phase zones which are appropriate for an analyte and different measurement ranges of this analyte. The device contains all reactants and reagents in a dehydrated form.


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