Test device, method of manufacturing same and method of determining a component in a sample

A method of manufacturing a test article for determining the presence of a predetermined chemical compound in a test fluid comprising:

• mixing a predetermined quantity of a reagent composition into an incompletely cured silicone polymerizable material dispersed in a removable carrier liquid to form a reagent containing matrix material;
• forming said reagent-containing matrix material into a layer on a support surface;
• and
• drying said layer and polymerizing said silicone polymerizable material on said support surface while removing said carrier liquid to form a dried matrix material layer permeable to a predetermined chemical compound and containing reagent composition capable of reaction with the predetermined chemical compound in a test fluid when the predetermined chemical compound penetrates into said dried matrix material layer;
• wherein a catalyst is added to the reagent containing matrix material, said catalyst capable of causing a reaction with the predetermined chemical compound in the test fluid to produce hydrogen peroxide;
• a substance having peroxidative activity is added to the reagent containing matrix material;
• and a compound capable of reaction to a colored form or reaction to change color in the presence of hydrogen peroxide is added to the regaent containing matrix material.

A method of measuring the concentration of a predetermined chemical compound in a test fluid comprising:

• mixing a predetermined quantity of a reagent composition into an incompletely cured silicone polymerizable material dispersed in a removable carrier liquid to form a reagent-containing matrix material permeable to a predetermined chemical compound in a test fluid;
• forming said reagent-containing matrix material into a layer;
• and
• drying said layer and polymerizing said polymerizable material while removing said carrier liquid to form a dried matrix material layer permeable to said predetermined chemical compound and containing a reagent composition capable of reaction with said predetermined chemical compound when said predetermined chemical compound penetrates into said dried matrix material layer;
• contacting a surface of said dried matrix material layer with said test fluid to cause a visibly detectable color change in said matrix material layer;
• and
• determining the concentration of said predetermined chemical compound based upon the degree of said color change.

A method of manufacturing a test device including a continuous layer of a silicone containing polymer permeable to a predetermined chemical compound while screening out hemoglobin and other coloring bodies found in whole blood comprising:

• dispersing a polymerizable silicone containing compound in removable carrier liquid to form an incompletely cured polymerizable layer forming composition, said silicone containing compound being substantially immiscible in said carrier liquid;
• adding a reagent composition to said polymerizable layer forming a composition capable of interaction with a predetermined chemical compound to produce a detectable color change in said polymerizable layer;
• applying said incompletely cured polymerizable layer forming composition containing said reagent composition onto a support surface;
• and
• polymerizing said silicone containing compound while in layer form and removing at least a portion of the carrier liquid during polymerization of the silicone containing compound in dispersed, layered form, to form a cured, continuous polymerized silicone containing compound layer permeable to said predetermined chemical compound.