Disposable test strips with integrated reagent/blood separation layer

  • US 7,112,265 B1
  • Filed: 01/11/2000
  • Issued: 09/26/2006
  • Est. Priority Date: 02/14/1996
  • Status: Expired due to Fees
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First Claim
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1. A disposable test strip for use in a test meter of the type which receives a disposable test strip and a sample of blood and performs an electrochemical analysis of the amount of a blood analyte in the sample, comprising:

  • (a) a substrate;

    (b) a first conductive element disposed on the substrate;

    (c) a second conductive element disposed on the substrate in sufficient proximity to the first conductive element to allow the completion of an electrical circuit between the first and second conductive elements when a sample of blood is placed on the test strip;

    (d) a non-conductive integrated reagent/blood separation layer disposed over the first conductive element, said integrated reagent/blood separation layer comprising reagents for the electrochemical detection of the analyte dispersed in a non-conductive matrix effective to exclude blood cells from the surface of the first conductive element while permitting access to a first conductive species by soluble electroactive species wherein the pH of said integrated reagent/blood separation layer is buffered to a level of around pH5;

    (e) contacts for making an electrical connection between the first and second conductive elements and the test meter; and

    (f) an insulation layer disposed over at least the first conductive elements, said insulation layer having a first aperture therein aligned with the first conductive element, wherein the non-conductive integrated reagent/blood separation layer contacts the first conductive element through the aperture in the insulation layer and wherein the non-conductive integrated reagent/blood separation layer is formed covering the entire first aperture, thereby leaving no portion of the first conductive element directly exposed to a sample applied to the test strip.

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