Method for continuous manufacture of diagnostic test strips

Claim 1

A method for making a test strip comprising a substrate, a layer disposed on the substrate and located adjacent the distal end of the substrate, said layer containing a chemical reagent detection system capable of detecting the presence of an analyte in a sample of biological fluid, the reagent detection system producing a detectable change in said layer in the presence of said analyte, said method comprising: providing a web comprising a length of substrate having a width substantially the dimension of a final length of the test strip being made; providing on said substrate adjacent to one edge thereof a layer of material permeable to biological fluids, said layer having a width sufficient to place thereon a drop of biological fluid; continuously applying to the layer of permeable material an aqueous solution containing reagent detection chemicals capable of providing the detectable change in the presence of the analyte, said solution being applied in an amount to substantially saturate the permeable material; drying the layer of permeable material to contain the reagent detection chemicals within said layer; and cutting the web into shorter lengths of web containing a plurality of test strips for further processing.

Claim 2

A method for making a test strip comprising a substrate, a layer disposed on the substrate and located adjacent the distal end of the substrate, said layer containing a chemical reagent detection system capable of detecting the presence of an analyte in a sample of biological fluid, the reagent detection system producing a detectable change in said layer in the presence of said analyte, said method comprising: providing a web comprising a length of substrate having a width substantially the dimension of a final length of the test strip being made; providing on said substrate adjacent to one edge thereof a layer of material permeable to biological fluids, said layer having a width sufficient to place thereon a drop of biological fluid; continuously applying to the layer of permeable material an aqueous solution containing reagent detection chemicals capable of providing the detectable change in the presence of the analyte, said solution being applied in an amount to substantially saturate the permeable material; drying the layer of permeable material to contain the reagent detection chemicals within said layer; and cutting the web into shorter lengths of web containing a plurality of test strips for further processing.

Claim 6

A method for making a test strip comprising a substrate, a layer disposed on the substrate and located adjacent the distal end of the substrate, said layer containing a chemical reagent detection system capable of detecting the presence of an analyte in a sample of biological fluid, the reagent detection system producing a detectable change in said layer in the presence of said analyte, said method comprising: providing a web comprising a length of substrate having a width substantially the dimension of a final length of the test strip being made; providing on said substrate adjacent to one edge thereof a layer of material permeable to biological fluids, said layer having a width sufficient to place thereon a drop of biological fluid; continuously applying to the layer of permeable material a first solution containing an indicator capable of providing the detectable change in the presence of the analyte, said first solution being applied in an amount to substantially saturate the permeable material; drying the layer of permeable material to contain the indicator within said layer; continuously applying to the layer of permeable material a second solution comprising an aqueous solution containing enzymes capable of reacting with the analyte to provide a response that produces the detectable change to the indicator, said second solution being applied at a rate to provide a quantity of enzymes in the permeable layer; drying the layer of permeable material to contain the enzymes within said layer; and cutting the web into shorter lengths of web containing a plurality of test strips for further processing.

Claim 7

A method for making a test strip comprising a substrate, a layer disposed on the substrate and located adjacent the distal end of the substrate, said layer containing a chemical reagent detection system capable of detecting the presence of an analyte in a sample of biological fluid, the reagent detection system producing a detectable change in said layer in the presence of said analyte, said method comprising: providing a web comprising a length of substrate having a width substantially the dimension of a final length of the test strip being made; providing on said substrate adjacent to one edge thereof a layer of material permeable to biological fluids, said layer having a width sufficient to place thereon a drop of biological fluid; continuously applying to the layer of permeable material a first solution containing an indicator capable of providing the detectable change in the presence of the analyte, said first solution being applied in an amount to substantially saturate the permeable material; drying the layer of permeable material to contain the indicator within said layer; continuously applying to the layer of permeable material a second solution comprising an aqueous solution containing enzymes capable of reacting with the analyte to provide a response that produces the detectable change to the indicator, said second solution being applied at a rate to provide a quantity of enzymes in the permeable layer; drying the layer of permeable material to contain the enzymes within said layer; and cutting the web into shorter lengths of web containing a plurality of test strips for further processing.