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...

AI Technical Summary

Benefits of technology

[0010] The present invention overcomes the above and other problems by providing a manufacturing process and manufacturing apparati in which the chemical and other variables within a test strip can be more easily controlled, thus resulting in a more accurate test strip.

[0017] The invention not only provides a more accurate test strip, but also reduces waste of impregnated membrane. Further, the invention provides a more efficient manufacturing process. These and other objects and benefits of the invention will become apparent from the following written description and accompanying figures.

Problems solved by technology

It is evident from FIG. 2 that a lot of the test strip is wasted.

The bigger problem is that the space 213 between adjacent used areas greatly increases the distance between the first used area and the last used area on a roll of test strip.

This discrepancy between the chemical content for areas near the beginning of the test strip roll 110 and areas near the end of the test strip roll 110 results in a manufacturing variation giving rise to inaccuracies in testing with the dry test strip.

Images