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1. WO2019055622 - ADHESIVE-POLYMER CONTAINING MEMBRANES FOR IN VITRO DIAGNOSTIC DEVICES

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[ EN ]

What is claimed is:

1. A membrane for an in vitro diagnostic sensor for detecting the presence and/or concentration of a target analyte in a fluidic biological sample, the membrane comprising: a polymer matrix comprising a polymer that has been modified to contain at least one surface adhesion functional group, wherein the at least one surface adhesion functional group enables attachment of the membrane to a substrate of the in vitro diagnostic sensor.

2. The membrane of claim 1, wherein the at least one surface adhesion functional group comprises a catecholic functional group (1,2-dihydroxybenzene).

3. The membrane of claim 1 or 2, wherein the polymer is polyvinyl chloride, carboxylated-polyvinyl chloride, and/or aminated-polyvinyl chloride.

4. The membrane of any one of claims 1-3, wherein the surface adhesion functional group comprises DOPA (3,4-dihydroxyphenylalanine) and/or dopamine (3,4-dihydroxyphenethylamine).

5. The membrane of any one of claims 1-4, wherein the surface adhesion functional group comprises from about 1 to about 99 weight percent of the membrane.

6. The membrane of any one of claims 1-5, further comprising a plasticizer.

7. The membrane of any one of claims 1-6, further defined as an ion-sensing membrane selected from the group consisting of a magnesium, sodium, potassium, calcium, chloride, or pH sensing membrane.

8. An in vitro diagnostic sensor for detecting the presence and/or concentration of a target analyte in a fluidic biological sample, comprising:

a substrate having at least one suitable functional group disposed on at least a portion of a surface thereof; and

the membrane of any one of claims 1-7, wherein the surface adhesion functional group interacts with the at least one suitable functional group disposed on the surface of the substrate to attach the membrane to the substrate.

9. The in vitro diagnostic sensor of claim 8, wherein the at least one suitable functional group disposed on at least a portion of the surface of the substrate comprises a nucleophilic functional group.

10. The in vitro diagnostic sensor of claim 8 or 9, further defined as a potentiometric, amperometric, impedi metric, or conductometric sensor.

11. The in vitro diagnostic sensor of any one of claims 8-10, further defined as a biosensor that detects a target analyte selected from the group comprising blood urea nitrogen (BU N), glucose, glutamate, lactate, ethanol, ascorbic acid, choline acetylcholine, creatinine, cholesterol, pyruvate, and bilirubin.

12. The in vitro diagnostic sensor of claim 11, further defined as comprising an enzyme selected from the group comprising urease, glucose oxidase, glutamate oxidase, lactate oxidase, pyruvate oxidase, sarcosine oxidase, creatinine amidohydrolase, creatine amidinohydrolase, ascorbate oxidase, alcohol oxidase, cholesterol oxidase, choline oxidase, bilirubin oxidase, laccase, tyrosinase, alcohol dehydrogenase, glucose dehydrogenase, glutamate dehydrogenase, lactate dehydrogenase, and pyruvate dehydrogenase.

13. The in vitro diagnostic sensor of any one of claims 8-12, wherein the substrate is an electrode.

14. The in vitro diagnostic sensor of claim 13, further defined as an ion selective electrode that detects a target analyte selected from the group comprising magnesium, sodium, potassium, calcium, and chloride.

15. The in vitro diagnostic sensor of any one of claims 8-14, further defined as a multi-use diagnostic sensor having at least a 14 day use-life.

16. A method of producing the in vitro diagnostic sensor of any one of claims 8-15, the method comprising the step of:

disposing a membrane on a substrate, the membrane comprising a polymer matrix comprising a polymer that has been modified to contain at least one surface adhesion functional group, wherein the substrate has at least one suitable functional group disposed on at least a portion of a surface thereof, and wherein the surface adhesion functional group interacts with the at least one suitable functional group disposed on the surface of the substrate to attach the membrane to the substrate.

A diagnostic sensor array assembly, comprising:

a plurality of in vitro diagnostic sensors, at least two of the plurality of in vitro diagnostic sensors being an in vitro diagnostic sensor of any one of claims 8- 16, and wherein the membranes of at least two of the sensors is attached to the same substrate.

18. A method of producing a diagnostic sensor array assembly, the method comprising the step of:

forming a plurality of diagnostic sensors on at least one surface of a substrate, wherein each of the plurality of diagnostic sensors are spatially positioned on the at least one surface of the substrate, and wherein at least one of the plurality of diagnostic sensors is formed by the method of claim 16.

A method for detecting the presence and/or concentration of a plurality of target :es in a fluidic biological sample, the method comprising the steps of:

(a) inserting a fluidic biological sample into a blood gas, electrolyte, and/or metabolite instrument containing the diagnostic sensor array assembly of claim 17; and

(b) measuring the presence and/or concentration of each of the plurality of target analytes captured by the individual diagnostic sensors of the array assembly.

20. The method of claim 19, wherein the fluidic biological sample is selected from the group comprising blood, plasma, serum, urine, saliva, sputum, cerebrospinal fluid (CSF), skin, intestinal fluid, intraperitoneal fluid, cystic fluid, sweat, interstitial fluid, extracellular fluid, tears, mucus, bladder wash, semen, fecal, pleural fluid, nasopharyngeal fluid, and combinations thereof.