Compositions and methods for performing assay measurements
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- MESO SCALE TECH LLC
- Filing Date
- 2026-01-13
- Publication Date
- 2026-06-16
Smart Images
Figure 2026097790000005 
Figure 2026097790000006 
Figure 2026097790000007
Abstract
Claims
1. (a) (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, (ii) pH buffering component, and (iii) ionic component, (b) (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, pH buffering component, (iii) ionic component, and (iv) surfactant, (c) (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, (ii) pH buffering component, (iii) ionic component, and (iv) liquid diluent, (d) A composition comprising (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, a pH buffering component, (iii) an ionic component, (iv) a surfactant, and (v) a liquid diluent.
2. (a) (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, (ii) pH buffering component, and (iii) ionic component, (b) (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, pH buffering component, (iii) ionic component, and (iv) surfactant, (c) (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, (ii) pH buffering component, (iii) ionic component, and (iv) liquid diluent, (d) A composition essentially comprising (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, a pH buffering component, (iii) an ionic component, (iv) a surfactant, and (v) a liquid diluent.
3. (a) (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, (ii) pH buffering component, and (iii) ionic component, (b) (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, pH buffering component, (iii) ionic component, and (iv) surfactant, (c) (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, (ii) pH buffering component, (iii) ionic component, and (iv) liquid diluent, (d) A composition comprising (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, a pH buffering component, (iii) an ionic component, (iv) a surfactant, and (v) a liquid diluent.
4. The composition according to claim 1, further comprising at least one of the following: ECL labeling, binding reagents for binding assays, preservatives, biocides, defoamers, perchlorate compounds, colorants, tracer chemicals, solid supports, or combinations thereof.
5. The composition according to any one of claims 1 to 4, wherein the pH buffering component is tris(hydroxymethyl)aminomethane (tris).
6. The composition according to any one of claims 1 to 5, wherein the pH buffering component is Tris, and the composition comprises a surfactant.
7. The composition according to claim 6, wherein the surfactant comprises a phenol ether.
8. The composition according to claim 7, wherein the surfactant is TRITON X-100.
9. The composition according to claim 6, wherein the surfactant does not contain phenol ether.
10. The composition according to claim 9, wherein the composition does not destroy the lipid bilayer membrane.
11. The composition according to claim 10, wherein the surfactant is KOLLIPHOR P-407, PLURONIC P-123, PLURONIC L-121, PLURONIC 31R1, TETRONIC 701, 2,4,7,9-tetramethyl-d-decine-4,7-diol ethoxylate, PEG(18) tridecyl ether, BRIJ L4, BRIJ 58, or TWEEN 20.
12. The composition according to claim 11, wherein the surfactant is TWEEN-20.
13. The composition according to claim 11, wherein the surfactant is PEG(18) tridecyl ether.
14. A composition according to any one of claims 1 to 4, comprising a surfactant that does not contain phenol ether.
15. The composition according to claim 14, wherein the composition does not destroy the lipid bilayer membrane.
16. The composition according to claim 15, wherein the surfactant is KOLLIPHOR P-407, PLURONIC P-123, PLURONIC L-121, PLURONIC 31R1, Tetronic701, 2,4,7,9-tetramethyl-d-decine-4,7-diol ethoxylate, PEG(18) tridecyl ether, BRIJ L4, BRIJ58, or TWEEN20.
17. The composition according to claim 16, wherein the surfactant is TWEEN20.
18. The composition according to claim 16, wherein the surfactant is PEG(18) tridecyl ether.
19. The composition according to any one of claims 14 to 18, wherein the pH buffering component is a phosphate, HEPES, glycylglycine, borate, acetate, or citrate.
20. The composition according to any one of claims 1 to 19, wherein the composition comprises BDEA.
21. The composition according to any one of claims 1 to 20, wherein the composition comprises DBAE.
22. The composition according to any one of claims 1 to 21, wherein the ECL generated by ECL labeling in the presence of the composition changes by less than 1% per degree Celsius on average over a temperature range of 18°C to 30°C.
23. The composition according to claim 22, wherein the ECL is produced from an electrochemiluminescent ruthenium organometallic complex in close proximity to a carbon-based electrode.
24. The composition according to any one of claims 1 to 23, wherein the pH is approximately 6 to approximately 9.
25. The composition according to claim 24, wherein the pH is approximately 7 to approximately 8.
26. The composition according to claim 25, wherein the pH is approximately 7.6 to approximately 7.
9.
27. The composition according to claim 26, wherein the pH is approximately 7.
8.
28. The composition according to any one of claims 1 to 27, wherein the slope of the change in ECL at pH of the ECL produced by ECL labeling in the presence of the composition is less than 10% per unit of pH.
29. The composition according to claim 28, wherein the ECL is produced from an electrochemiluminescent ruthenium organometallic complex in close proximity to a carbon-based electrode.
30. The composition according to any one of claims 1 to 29, wherein the ionic component includes chloride ions.
31. The composition according to claim 30, wherein the ionic component comprises any two or any three combinations of NaCl, KCl, LiCl, or the salts thereof.
32. The composition according to claim 31, wherein the ionic component comprises NaCl.
33. The composition according to claim 31, wherein the ionic component comprises KCl.
34. A composition according to any one of claims 1 to 33, comprising a liquid diluent.
35. The composition according to claim 34, wherein the liquid diluent is water, and the composition is substantially aqueous.
36. The composition according to any one of claims 1 to 35, wherein the concentration of BDEA or DBAE is about 10 mM to about 800 mM.
37. The composition according to claim 36, wherein the concentration of BDEA or DBAE is about 75 mM to about 300 mM.
38. The composition according to claim 37, wherein the concentration of BDEA or DBAE is about 100 mM to about 150 mM.
39. The composition according to any one of claims 1 to 38, wherein a change in the concentration of BDEA or DBAE to 0.8 to 1.2 times the nominal value provides a change of less than 10% in the ECL produced by ECL labeling in the presence of the composition.
40. The composition according to claim 39, wherein the ECL is produced from an electrochemiluminescent ruthenium organometallic complex in close proximity to a carbon-based electrode.
41. The composition according to any one of claims 1 to 40, wherein the concentration of the pH buffering component is about 10 mM to about 800 mM.
42. The composition according to claim 41, wherein the concentration of the pH buffering component is about 100 mM to about 300 mM.
43. The composition according to claim 42, wherein the concentration of the pH buffering component is about 150 mM to about 250 mM.
44. The composition according to any one of claims 1 to 43, wherein the composition has an ionic strength greater than about 0.3 M.
45. The composition according to claim 44, wherein the composition has an ionic strength greater than approximately 0.5 M.
46. The composition according to claim 45, wherein the composition has an ionic strength greater than approximately 0.8 M.
47. The composition according to claim 46, wherein the composition has an ionic strength greater than about 1.0 M.
48. The composition according to any one of claims 1 to 47, wherein the composition contains chloride ions, and the concentration of the chloride ions is greater than about 0.25 M.
49. The composition according to any one of claims 1 to 48, wherein the composition contains chloride ions, and the concentration of the chloride ions is greater than about 0.5 M.
50. The composition according to any one of claims 1 to 49, wherein the composition contains chloride ions, and the concentration of the chloride ions is greater than about 0.75 M.
51. The composition according to any one of claims 1 to 50, wherein the composition contains chloride ions, and the concentration of the chloride ions is greater than about 1.0 M.
52. The composition according to any one of claims 1 to 51, wherein the pH buffering component is not a phosphate, and the composition provides at least a 20% increase in ECL generated by ECL labeling and / or at least a 20% decrease in background ECL generated in the absence of ECL labeling, compared to the same composition containing a phosphate as the pH buffering component.
53. The composition according to claim 52, wherein the ECL from the ECL label is generated from an electrochemiluminescent ruthenium organometallic complex in close proximity to the carbon-based electrode, and / or the ECL in the absence of the ECL label is generated at the carbon-based electrode.
54. The composition according to any one of claims 1 to 53, wherein the nonspecific binding (NSB) in an immunoassay using the composition containing the ionic component is lower compared to the same composition that does not contain the ionic component.
55. The composition according to any one of claims 1 to 33, wherein the composition does not contain a liquid diluent and the composition is provided in a dry form.
56. In one or more containers, add the following ingredients: (a) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, (b) pH buffering components and (c) A kit containing ionic components.
57. The kit according to claim 56, wherein one or more of the aforementioned materials are in a dried state.
58. The kit according to claim 57, wherein the kit further comprises a liquid diluent.
59. The kit according to claim 56 or 57, wherein the kit does not contain a surfactant or a liquid diluent.
60. The kit according to claim 56 or 57, wherein the kit further comprises a surfactant.
61. A method for producing a composition, (i) N-butyldiethanolamine (BDEA) or 2-dibutylaminoethanol (DBAE), or both, (ii) pH buffering components and (iii) A method comprising combining an ionic component with a method.
62. The method according to claim 61, wherein one or more of the materials are in a dried state.
63. A composition according to any one of claims 1 to 55, (a) Assay equipment, (b) Assay consumables, (c) Additional assay reagents, (d) Assay sample, A kit that includes a combination of these.
64. A kit component according to any one of claims 56 to 60, (a) Assay equipment, (b) Assay consumables, (c) Additional assay reagents, (d) Assay sample, A kit that includes a combination of these.
65. The kit according to any one of claims 63 and 64, comprising assay equipment, wherein the assay equipment is configured to perform an ECL assay.
66. A kit according to any one of claims 63 to 65, further comprising assay consumables and an electrode configured for use in an ECL assay.
67. The kit according to claim 66, wherein the electrode is a carbon-based electrode.
68. The kit according to claim 67, wherein the electrode is a screen-printed carbon ink electrode.
69. The kit according to any one of claims 63 to 68, comprising an additional assay reagent, wherein the additional assay reagent is a binding reagent.
70. The kit according to claim 69, wherein the binding reagent is labeled with ECL labeling.
71. The kit according to claim 70, wherein the label is an organometallic ruthenium complex.
72. The kit according to any one of claims 66 to 68, comprising an additional assay reagent, wherein the additional assay reagent is a binding reagent, and the additional assay reagent is immobilized on the electrode.
73. The kit according to any one of claims 66 to 68, comprising an additional assay reagent, wherein the additional assay reagent is a plurality of binding reagents immobilized as an array on the electrode.
74. The kit according to any one of claims 66 to 68, comprising an additional assay reagent, wherein the additional assay reagent is a binding reagent immobilized on particles.
75. The kit according to claim 74, wherein the particles can be collected by magnetism.
76. A kit according to any one of claims 64 to 75, comprising at least one assay sample, wherein the at least one assay sample comprises an assay calibration sample and / or an assay control sample.
77. A method for generating ECL, (a) The electrodes, (i) The composition according to any one of claims 1 to 56, and (ii) Contact with the ECL label, (b) Applying a voltage to the electrode, (c) A method comprising generating an ECL.
78. (d) The method according to claim 77, further comprising measuring the ECL.
79. A method for measuring the amount of ECL labeling, (a) The electrodes, (i) The composition according to any one of claims 1 to 55, and (ii) bringing the ECL sign into contact with the ECL sign, (b) Applying a voltage to the electrode, (c) To generate ECL, (d) Measuring the ECL and (e) A method comprising determining the amount of the label from the measured ECL.
80. A method for measuring the amount of a bound complex containing a binding reagent linked to an ECL label, (a) Contacting a binding reagent immobilized on an electrode with a labeled binding reagent containing an ECL label, (b) Forming a binding complex on the electrode containing the immobilized binding reagent and the labeled binding reagent, (c) Contacting the bonded complex on the electrode with the composition according to any one of claims 1 to 55, (d) Applying a voltage to the electrode in the presence of the composition, (e) To generate ECL, (f) A method comprising measuring the ECL to determine the amount of the binding complex on the electrode.
81. The method according to claim 80, further comprising cleaning the electrode after the formation of the binding complex and before and / or during contact with the composition.
82. A method for measuring the amount of a bound complex containing a binding reagent linked to an ECL label, (a) Contact the binding reagent immobilized on the particle with the labeled binding reagent containing the ECL label. To make them do, (b) Forming a binding complex on the particles containing the immobilized binding reagent and the labeled binding reagent, (c) Contacting the bound complex on the particles with the composition according to any one of claims 1 to 55, (d) Collecting the particles on the electrode, (e) Applying a voltage to the electrode in the presence of the composition, (f) To generate ECL, (g) A method comprising measuring the ECL to determine the amount of the binding complex on the electrode.
83. The method according to claim 82, wherein the particles are magnetically collectible particles, and the particles are collected on the electrode using a magnetic field.
84. The method according to claim 82 or 83, further comprising washing the particles after the formation of the binding complex and before and / or during contact with the composition.
85. The method according to any one of claims 80 to 84, wherein the immobilized binding reagent and the labeled binding reagent bind directly to each other.
86. The method according to any one of claims 80 to 84, wherein the immobilized binding reagent and the labeled binding reagent are indirectly bound to each other through other binding species.
87. A method for measuring the amount of an analyte, (a) Contacting a binding reagent immobilized on an electrode with a labeled binding reagent containing an ECL label and the analyte (or a sample containing the analyte), (b) Forming a binding complex on the electrode containing the immobilized binding reagent and the labeled binding reagent, (c) Contacting the bonded complex on the electrode with the composition according to any one of claims 1 to 55, (d) Applying a voltage to the electrode in the presence of the composition, (e) To generate ECL, (f) A method comprising measuring the ECL to determine the amount of the analyte.
88. The method according to claim 87, further comprising cleaning the electrode after the formation of the binding complex and before and / or during contact with the composition.
89. The method according to claim 87 or 88, wherein the method is configured to perform multiple measurements of a plurality of analytes, and the electrode has an array of immobilized binding reagents for the plurality of analytes immobilized thereon.
90. A method for measuring the amount of an analyte, (a) Contacting a binding reagent immobilized on a particle with a labeled binding reagent including an ECL label and an analyte (or a sample containing the analyte), (b) Forming a binding complex on the particles containing the immobilized binding reagent and the labeled binding reagent, (c) Contacting the bound complex on the particles with the composition according to any one of claims 1 to 55, (d) Collecting the particles on the electrode, (e) Applying a voltage to the electrode in the presence of the composition, (f) To generate ECL, (g) A method comprising measuring the ECL to determine the amount of the analyte.
91. The method according to claim 90, wherein the particles are magnetically collectible particles, and the particles are collected on the electrode using a magnetic field.
92. The method according to claim 90 or 91, further comprising washing the particles after the formation of the binding complex and before and / or during contact with the composition.
93. The method according to any one of claims 80 to 86, wherein the immobilized binding reagent and the labeled binding reagent include (i) a binding partner of the analyte of interest, (ii) the analyte of interest, or its analogues and / or competitors, or (iii) a reactive component capable of binding to species (i) or (ii).
94. The method according to any one of claims 87 to 92, wherein the immobilized binding reagent and the labeled binding reagent include (i) a binding partner for the analyte, (ii) the analyte or its analogs and / or competitors, or (iii) a reactive component capable of binding to species (i) or (ii).
95. The method according to any one of claims 77 to 94, wherein the electrode is a carbon-based electrode.
96. The method according to claim 95, wherein the electrode is a screen-printed carbon ink electrode.
97. The method according to any one of claims 77 to 96, wherein the ECL is imaged using a camera.
98. The method according to any one of claims 77 to 97, wherein the ECL is measured using a photodiode.
99. The method according to any one of claims 77 to 98, wherein the electrode is located in a multiwell plate assay consumable.
100. The method according to any one of claims 77 to 98, wherein the electrode is located in a flow cell.
101. The method according to any one of claims 77 to 98, wherein the electrode is platinum.
102. The composition according to any one of claims 1 to 55, wherein the concentration of the surfactant is about 0.2 mM to about 10 mM.
103. The composition according to claim 102, wherein the concentration of the surfactant is about 0.5 mM to about 8 mM.
104. The composition according to claim 103, wherein the concentration of the surfactant is about 1.0 mM to about 5 mM.
105. The claim is that the concentration of the surfactant is greater than the critical micelle concentration (cmc) of the surfactant. A composition according to any one of items 1 to 55.
106. The kit according to any one of claims 60 or 63 to 76, wherein the concentration of the surfactant is about 0.2 mM to about 10 mM.
107. The kit according to claim 106, wherein the concentration of the surfactant is approximately 0.5 mM to approximately 8 mM.
108. The kit according to claim 107, wherein the concentration of the surfactant is about 1.0 mM to about 5 mM.
109. The kit according to any one of claims 60 or 63 to 76, wherein the concentration of the surfactant is greater than the critical micelle concentration (cmc) of the surfactant.
110. The method according to any one of claims 77 to 101, wherein the concentration of the surfactant is about 0.2 mM to about 10 mM.
111. The method according to claim 110, wherein the concentration of the surfactant is about 0.5 mM to about 8 mM.
112. The method according to claim 111, wherein the concentration of the surfactant is about 1.0 mM to about 5 mM.
113. The method according to any one of claims 77 to 101, wherein the concentration of the surfactant is greater than the critical micelle concentration (cmc) of the surfactant.