Method and kit for detecting an analyte

Chemistry: analytical and immunological testing – Involving an insoluble carrier for immobilizing immunochemicals

Reexamination Certificate

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C436S501000, C436S514000, C436S530000, C436S533000, C436S535000, C436S536000, C436S541000, C436S529000, C436S179000, C436S808000, C436S827000, C435S002000, C435S004000, C435S005000, C435S006120, C435S007100

Reexamination Certificate

active

06271044

ABSTRACT:

TECHNICAL FIELD OF THE INVENTION
The present invention relates to a method of detecting and measuring the concentration of an analyte.
BACKGROUND OF THE INVENTION
In many applications (e.g., medical diagnostic procedures, chemical analysis, etc.), it is desirable to detect the presence of and measure the concentration of a given analyte in a solution containing an unknown amount of the analyte. Depending upon the nature of the analyte, several protocols exist for acquiring such measurements. For example, where the analyte is immunogenic or comprises epitopes to extant antisera, immunological methods can be employed. Thus, for example, the techniques of immunoprecipitation, immunoconcentration, affinity column separation chromatography using antibodies, etc., can quantify the concentration of a given analyte within a solution.
More recently, a phenomenon for exploiting differential viscosity to measure analyte concentration was proposed (see, e.g., Ballerstadt et al.,
Biosensors & Biolectronics,
9, 557-67 (1994)). To exploit this viscometric affinity assay, several devices and concepts of miniaturized sensor systems have been developed (Id.; see also published German Patent application DE 19501159 Al). Additionally, there are hand-held devices for measuring the concentrations of certain analytes (e.g., glucose).
Many of the methods for measuring analyte concentration require relatively sophisticated equipment (e.g., centrifuges, affinity columns, cold storage facilities, etc.) or reagents (e.g., preparations of protein H, characterized monoclonal antibodies, etc.). Moreover, many of the devices available for measuring analyte concentration are relatively sophisticated electronic devices and are, therefore, too expensive for widespread application in many developing nations or otherwise unsuited for use under field conditions. Thus, despite these advances, there remains a need for simpler and more straightforward methods of detecting and measuring the concentration of such analytes. The present invention provides such a method.
BRIEF SUMMARY OF THE INVENTION
The present invention provides a viscometric method of detecting the presence or absence of an analyte in a solution. The method utilizes a dispersion of a conjugate and a receptor. The conjugate functions as an analog of the analyte, and the receptor can interact with both the analyte and the conjugate to change the viscosity of the dispersion. The test solution is introduced into an aliquot of the dispersion. Equivalent spots of the dispersion and the aliquot containing the analyte within the dispersion are then placed on a substrate such that the spots can spread upon the substrate. The presence of analyte in the test solution is detected by noting a change in the viscosity of the dispersion through a comparison of the spots. To facilitate the method, the invention provides a test kit comprising a conjugate comprising an analog of the analyte, a receptor binding the analog and the analyte, and a substrate upon which spots of liquid can spread.
The invention can best be understood with reference to the accompanying drawings and in the following detailed description of the preferred embodiments.


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