Assay modules having assay reagents and methods of making and using same

Patent metadata

Field	Value
Publication number	US-11065615-B2
Application number	US-201815882914-A
Country	US
Kind code	B2
Filing date	Jan 29, 2018
Priority date	Dec 21, 2005
Publication date	Jul 20, 2021
Grant date	Jul 20, 2021

Abstract

We describe assay modules (e.g., assay plates, cartridges, multi-well assay plates, reaction vessels, etc.), processes for their preparation, and method of their use for conducting assays. Reagents may be present in free form or supported on solid phases including the surfaces of compartments (e.g., chambers, channels, flow cells, wells, etc.) in the assay modules or the surface of colloids, beads, or other particulate supports. In particular, dry reagents can be incorporated into the compartments of these assay modules and reconstituted prior to their use in accordance with the assay methods. A desiccant material may be used to maintain and stabilize these reagents in a dry state.

First claim

We claim:

1. A multi-well assay plate comprising a plate body with a plurality of wells defined therein comprising:
(a) a plurality of detection wells, wherein each detection well comprises a binding surface having a capture reagent immobilized thereon and
(b) a plurality of reagent reconstitution wells, wherein each reagent reconstitution well comprises a reconstitutable labeled detection reagent,
wherein at least one detection well and one reagent reconstitution well comprises matched capture and detection reagents for measuring an analyte of interest, and wherein said capture reagent and said reconstitutable labeled detection reagent are not in the same well.

2. A multi-well assay plate comprising a plate body with a plurality of wells defined therein comprising:
(a) a plurality of detection wells, wherein said detection wells
(i) having well floors and well walls, wherein said well walls have inner wall surfaces and outer wall surfaces,
(ii) are arranged in a regular two dimensional pattern, and
(iii) comprise, on an inner surface of each of said detection wells, a binding surface having capture reagent immobilized thereon an array; and

(b) a plurality of reagent reconstitution wells, wherein said reagent reconstitution wells
(i) have well floors and well walls, wherein said well walls are defined by outer wall surfaces of said detection wells and by rib elements connecting the outer wall surface of adjacent detection wells and
(ii) comprise, in each reagent reconstitution well, a reconstitutable dry labeled detection reagent;

wherein at least one detection well and one reagent reconstitution well comprise matched capture and detection reagents for measuring an analyte of interest, and wherein said capture reagent and said reconstitutable dry labeled detection reagent are not in the same well.

3. The multi-well assay plate of claim 2 , wherein said detection wells have well opening perimeters with no reentrant angles or curves and said reagent reconstitution wells have well opening perimeters with reentrant curves or angles.

4. The multi-well assay plate of claim 2 , wherein said detection wells have well opening perimeters that are round.

5. The multi-well assay plate of any one of claims 2 , wherein said detection and reagent reconstitution wells can be grouped into a plurality of assay sets consisting of one or more detection wells and one reagent reconstitution well, and said detection well(s) and reagent reconstitution well within a set comprise matched capture and detection reagents for measuring an analyte of interest.

6. The multi-well assay plate of claim 5 , wherein said sets consist of one detection well and one reagent reconstitution well.

7. The multi-well assay plate of any one of claims 2 , wherein said detection well(s) or said reagent reconstitution well further comprises a reconstitutable dry assay control analyte.

8. The multi-well assay plate of any one of claims 2 further comprising one or more additional immobilized capture reagents, wherein said capture reagent and additional capture reagents form a patterned array of binding domains on said binding surface, and said binding domains differ in specificity or affinity for binding partners.

9. The multi-well assay plate of claim 8 , wherein said reconstitutable dry reagent further comprises one or more additional labeled detection reagents, and said detection reagent and additional detection reagents differ in specificity or affinity for binding partners.

10. The multi-well assay plate of claim 2 , wherein said binding surface is an electrode for use in an electrochemiluminescence assay.

11. A multi-well plate comprising a plate body with a plurality of wells defined therein comprising:
(a) a plurality of first reagent wells holding a reconstitutable first dry reagent and
(b) a plurality of second reagent wells holding a second dry reagent,
wherein said first and second reagents are matched reagents for conducting an assay, and wherein said reconstitutable first dry reagent and second dry reagent are not in the same well.

12. The multi-well assay plate of claim 11 , wherein
said first reagent wells are arranged in a regular two dimensional pattern and said first reagent wells have well floors and well walls, said well walls having inner wall surfaces and outer wall surfaces and
said second reagent wells have well floors and well walls, said well walls being defined by outer wall surfaces of said detection wells and by rib elements connecting the outer wall surfaces of adjacent detection wells.

13. The multi-well assay plate of claim 12 , wherein said detection wells are arranged in an 8×12 array.

14. The multi-well assay plate of claim 12 , wherein said first reagent wells have well opening perimeters that are round.

Assignees

• Meso Scale Technologies Llc

Inventors

• Glezer Eli N
• Jeffrey-Coker Bandele
• Debad Jeffery D
• Kumar Sudeep M
• Sigal George B
• Spieles Gisbert
• Tsionsky Michael
• Warnock Michael

Classifications

• C08F8/30 Primary

  Introducing nitrogen atoms or nitrogen-containing groups · CPC title

• G01N33/48

  Biological material, e.g. blood, urine (G01N33/02, G01N33/26, G01N33/44, G01N33/46 take precedence); Haemocytometers (counting blood corpuscules distributed over a surface by scanning the surface G06M11/02) · CPC title

• G01N33/53

  Immunoassay; Biospecific binding assay; Materials therefor · CPC title

• B01L2300/105

  using desiccants · CPC title

• B01L2300/0829

  Multi-well plates; Microtitration plates · CPC title