IP Library Patent Application 18491674
Patent Application
App. No. 18/491,674

DEVICES AND KITS FOR DETECTING ANALYTES OF INTEREST AND METHODS OF USING THE SAME

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Patent No.
US None
App. No.
18/491,674
Abstract

Disclosed are various embodiments of a device comprising a synthetic polymeric substrate having a high quality finish upper surface, the upper surface having at least a bilayer coating comprising a first, reflective layer and a second, transparent layer. Also disclosed are kits containing embodiments of the disclosed device and detectable particles. Also disclosed are various embodiments of a method of using the disclosed device and various embodiments of a method of using the disclosed kit.

Claims (41)

1 . A device, comprising:

a synthetic polymeric substrate having an upper surface;

a coating on at least a portion of the upper surface, wherein the coating comprises a first layer comprised of a material that reflects electromagnetic radiation and a second layer comprised of a material that is a dielectric and is transparent.

2 . The device of claim 1 , wherein the first coating layer is selected from the group consisting of aluminum, silver, gold, chromium, silicon, and dielectric materials.

3 . The device of claim 1 , wherein the first coating layer has a thickness of between about 10-1000 nm or between 10-500 nm or between 10-250 nm or between 10-200 nm or between 50-150 nm or between 75-125 nm.

4 . The device of claim 1 , wherein the second coating layer is a metalloid, an oxide of a metalloid, or a synthetic polymer.

5 . The device of claim 4 , wherein the metalloid or metalloid oxide is boron, silicon, germanium, arsenic, antimony, tellurium, polonium, or an oxide thereof.

6 . The device of claim 1 , wherein the second layer has a thickness of between about 10-500 nm or between 20-200 nm or between 20-100 nm or between 50-100 nm or between 75-100 nm or between 70-90 nm.

7 . The device of claim 1 , wherein the second layer comprises silicon dioxide.

8 . The device of claim 1 , wherein the first layer is at least as thick as the second layer.

9 . The device of claim 8 , wherein the first layer is aluminum and the second layer is silicon dioxide.

10 . The device of claim 9 , wherein the first layer and the second layer have a thickness within about 30%, 25%, 20%, 15%, or 10% of each other.

11 . The device of claim 1 , wherein an overcoating is applied with 3-glycidyloxypropyl)trimethoxysilane (GPTMS), 3-aminopropyltrimethoxysilane (APTMS), or 3-aminopropyltriethoxysilane (APTES).

12 . The device of claim 1 , wherein the substrate has a surface roughness before or after coating, essentially equivalent to a silicon wafer suitable for semiconductor production.

13 . The device of claim 1 , wherein the substrate has a thickness of less than 1 mm, less than 0.5 mm, less than 0.3 mm, less than 0.25 mm, less than 0.2 mm, less than 0.1 mm.

14 . The device of claim 1 , wherein the substrate consists of cyclic olefin copolymer or a cyclic olefin polymer.

15 . The device of claim 1 , wherein the substrate comprises a thermoplastic material.

16 . The device of claim 1 , wherein the upper surface of the substrate has a flatness of less than about 100 μm.

17 . A device, comprising:

a composite, solid support member comprised a synthetic polymeric substrate with an upper surface and a lower surface, the upper surface comprising at least a bilayer coating comprised of a reflective layer deposited on the upper surface and a dielectric, transparent layer deposited on the reflective layer; and

a plurality of binding members immobilized to the composite, solid support member.

18 . The device of claim 17 , wherein the plurality of binding members comprises a first binding member for a first analyte and a second binding member for a second analyte.

19 . The device of claim 17 , wherein the plurality of binding members comprises a haloalkane dehalogenase binding tag.

20 . The device of claim 17 , wherein the plurality of binding members comprises a protein, an antibody or a peptide.

21 . The device of claim 17 , wherein the plurality of binding members comprises a ligand with specific binding for a binding tag that is part of a fusion protein comprising an antibody or antibody fragment that binds an analyte of interest.

22 . The device of claim 21 , wherein the binding tag is a haloalkane dehalogenase or a biotin ligase binding site.

23 . The device of claim 21 , wherein the ligand is a synthetic organic compound.

24 . The device of claim 23 , wherein the compound comprises a chloroalkane linker.

25 . The device of claim 21 , wherein the ligand is biotin.

26 . A kit for detecting a biological analyte of interest in a test sample, comprising:

an assay comprising a detection zone, the detection zone comprising the device of claim 1 and a plurality of binding members immobilized to the device;

a container comprising a population of detectable particles; and

instructions for use.

27 . The kit according to claim 26 , wherein the detectable particles comprise a magnetic core and a shell, wherein the shell consists essentially of a metal selected from the group consisting of gold, silver, platinum, palladium, iridium, osmium, rhodium, ruthenium.

28 . The kit according to claim 26 , wherein the detectable particles consist essentially of a metal selected from the group consisting of gold, silver, platinum, palladium, iridium, osmium, rhodium, ruthenium, or wherein the detectable particles do not have a core-shell structure.

29 . The kit according to claim 26 , wherein the detectable particles have an average diameter ranging from about 1 nm to about 1500 nm, or from about 25 nm to about 500 nm, or from about 50 nm to about 250 nm, or from 100-180 nm.

30 . The kit according to claim 27 , wherein the magnetic core has a diameter ranging from about 5 nm to about 150 nm and the shell has a thickness ranging from about 10 nm to about 50 nm.

31 . The kit according to claim 27 , wherein the detectable particles further comprise an intermediate layer provided between the core and the shell.

32 . A method for the detection of a biological analyte in a fluid sample, comprising:

contacting a device according to claim 1 with a fluid sample suspected of comprising the biological analyte of interest and with a detectable particle associated with a binding species for the analyte of interest, where the device comprises an immobilized member with binding for the binding species; and

analyzing the device with an optical instrument for presence or absence of the detectable particle.

Assignments (2)
SECURITY AGREEMENT Recorded Aug 22, 2025
From: CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; QUIDEL CARDIOVASCULAR INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 072526/0643 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 15, 2024
From: QUIDEL CORPORATION
To: ORTHO-CLINICAL DIAGNOSTICS, INC.
Reel/Frame 068657/0827 →