Disposable test strips with integrated reagent/blood separation layer
DCFirst Claim
1. A disposable test strip for use in a test meter 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 the first conductive element by soluble electroactive species; and
(e) contacts for making an electrical connection between the first and second conductive elements and the test meter.
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Abstract
An improved disposable glucose test strip for use in a test meter of the type which receives a disposable test strip and a sample of blood from a patient and performs an electrochemical analysis is made using a non-conductive integrated reagent/blood separation layer containing a filler, an enzyme effective to oxidize glucose, e.g., glucose oxidase, and a mediator effective to transfer electrons from the enzyme. The integrated layer formulation is printed over a conductive carbon element to form a working electrode. The filler, for example a silica filler, is selected to have a balance of hydrophobicity and hydrophilicity such that one drying it forms a two-dimensional network on the surface of the conductive element. The response of this test strip is essentially temperature independent over relevant temperature ranges and is substantially insensitive to the hematocrit of the patient.
655 Citations
34 Claims
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1. A disposable test strip for use in a test meter 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:
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(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 the first conductive element by soluble electroactive species; and
(e) contacts for making an electrical connection between the first and second conductive elements and the test meter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A method for forming a disposable test strip for use in a test meter 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:
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(a) forming first and second conductive elements on a substrate;
(b) forming a layer of insulation covering the first conductive element, said layer of insulation having a first aperture therein aligned with a portion of the first conductive element in a sample application region; and
(c) forming a integrated reagent/blood separation layer layer disposed on the insulation layer and making contact with the first conductive element through the first aperture in the insulation layer, said integrated reagent/blood separation layer comprising reagents for the electrochemical detection of glucose dispersed in a non-conductive matrix effective to exclude blood cells from the surface of the first conductive element while permitting access to the first conductive species by soluble electroactive species, whereby the first conductive element is isolated from direct contact with a sample placed on the test strip. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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Specification