Importance

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Abstract

A device, method of use and method of manufacturing of said device for detecting an analyte in a biological fluid. The device comprises an immunochromatographic test strip with a raised, arcuate sample receiving zone. The test strip comprises a bibulous strip positioned above the base wherein the bibulous strip defines a developer receiving zone, a sample application zone and an indicator zone and wherein the zones are in capillary contact with each other permitting a developing fluid to wick from the developer receiving zone, through the sample application zone to the indicator zone. Further, a mobilizable detector agent attached to a marker for binding to an analyte of interest in a sample is positioned downstream from the sample application zone and upstream from an immobilized indicator agent, which is attached within the indicator zone. The developing fluid transports the analyte of interest to a detector agent wherein the analyte is bound to the detector agent and is the complex is then transported to the indicator agent where it is bound again such that it produces a detectable signal. The sample application zone comprises of the invention an elevated region relative to the developer receiving zone and the indicator zone wherein the elevated region of the sample application zone can contain an observationally controllable volume of sample. The elevated sample application zone is arcuate in side profile and comprises lesser elevated regions contiguous with opaque borders residing both upstream and downstream from the elevated region.

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First Claim