Apparatus and method of manufacturing bodily fluid test strip

Abstract

There is a dry test strip holder having a test port and a retainer defining a well about the test port, and a sheet of test strip material. A test element that is 50% or less greater than the size of the test port is cut from the sheet using a die and punch. The punch drives the test element through a channel in the die while the cone-shaped outer surface of the die spreads the retainer, allowing the test element to drop into the well. A cap is snapped over the retainer to capture the test element.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 60 / 602,210 filed Aug. 17, 2004, which application is hereby incorporated by reference to the same extent as though fully contained herein.BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The invention in general relates to disposable dry test strips for testing bodily fluids, and more particularly to a method and apparatus for manufacturing such test strips.

[0004] 2. Statement of the Problem

[0005] The level of certain analytes in blood and other body fluids is often used to diagnose disease, determine disease risk factors, monitor the course of a therapy, or determine the presence of illicit drugs. In recent years, analytes carried in blood have been evaluated to determine various cholesterol and triglyceride levels as a significant indicator of risk of coronary heart disease. Physicians commonly order what is referred to in the art as a “full l...

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