# US 10,371,697 B2 · Method of manufacturing Uni- and No-code test stripes > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,371,697 B2 - Document ID: US10371697B2 - Status: Granted - Kind: B2 - Application number: 15/216,765 - Filed: 2016-07-22 - Published: 2016-11-10 - Granted: 2019-08-06 - Earliest claimed: 2014-01-24 - Assignees: Roche Diabetes Care, Inc. - Applicants: Roche Diabetes Care, Inc. - Inventors: Alexander Ibach; Yilmaz Isgoeren - Web page: https://patentgrep.com/patent/US10371697B2 ## CPC - G01N 33/526: {the element being adapted for a specific analyte} - C12Q 1/006: {for glucose} - G01N 21/78: producing a change of colour - G01N 21/8483: {Investigating reagent band (test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04)} - G01N 33/66: involving blood sugars, e.g. galactose - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES ## Abstract The present invention pertains to the field of manufacture of diagnostic test elements. Specifically, the invention relates to a diagnostic test element for determining an analyte comprised in a body fluid sample, said test element comprising at least one test field with at least one detection layer and at least one separation layer, wherein said at least one separation layer comprises dispersed SiO2 in an amount of about 1.0 to 1.6 g/m2. The invention also relates to a coating composition being capable of forming a separation layer on a diagnostic test element of the present invention described above. Moreover, provided is a method for the manufacture of the diagnostic test element as well as the use of the diagnostic test element for determining the amount of an analyte, preferably, glucose, in a sample of a subject. ## Claims ### Claim 1 A diagnostic test element for determining an analyte comprised in a body fluid sample, said test element comprising at least one test field with at least one detection layer and at least one separation layer, wherein said at least one separation layer comprises SiO2 in an amount of 1.0 to 1.6 g/m2 and dispersion-saturated solid components, wherein said dispersion-saturated solid components have been obtained by dispersing the solid components in a coating composition forming the separation layer until a maximum is reached such that no further increase in the amount of dispersed solid components can be observed (plateau stage). ### Claim 2 (depends on 1) The diagnostic test element of claim 1, wherein said at least one separation layer further comprises TiO2. ### Claim 3 (depends on 2) The diagnostic test element of claim 2, wherein said TiO2 is present in an amount of 5.5 to 9.0 g/m2. ### Claim 4 (depends on 2) The diagnostic test element of claim 2, wherein said TiO2 is present in an amount forming a ratio of SiO2 to TiO2 of 0.11 to 0.29. ### Claim 5 (depends on 1) The diagnostic test element of claim 1, wherein said detection layer and separation layer are essentially free of iron-containing oxidizing agents. ### Claim 6 (depends on 5) The diagnostic test element of claim 5, wherein said iron-containing oxidizing agent is potassium ferricyanide (III). ### Claim 7 (depends on 1) A coating composition being capable of forming a separation layer on a diagnostic test element as described in claim 1. ### Claim 8 (depends on 7) The coating composition of claim 7, wherein said composition comprises silicic acid in an amount of 2.0 g to 3.5 g per 100 g coating composition. ### Claim 9 (depends on 7) The coating composition of claim 7, wherein said composition further comprises TiO2 in an amount of 11.0 g to 18.0 g per 100 g coating composition. ### Claim 10 (depends on 1) A method for the manufacture of a diagnostic test element according to claim 1 comprising dispersing solid components for the separation layer in a coating composition until a maximum is reached such that no further increase in dispersed solid components occurs (plateau stage), wherein said coating composition comprises silicic acid in an amount of 2.0 g to 3.5 g per 100 g coating composition. ### Claim 11 (depends on 10) The method of claim 10, wherein said method further comprises adding phosphoromolybdic acid as indicator to the coating composition. ### Claim 12 (depends on 11) The method of claim 11, wherein said phosphoromolybdic acid is added less than 2 days, less than 1 day, less than 6 hours, less than 3 hours, less than 2 hours or less than 1 hour prior to applying the coating composition to the test field of the diagnostic test element. ### Claim 13 (depends on 11) The method of claim 11, wherein said phosphoromolybdic acid is added after pH adjustment of the coating composition.