IP Library Granted Patent US 11,187,702
Granted Patent B2
US 11,187,702 · App. 17/081,220 · Granted Nov 30, 2021

Enzyme quantification

Inventors: Darren R. Link (Lexington, MA); Michael L. Samuels (Windham, NH)
Assignee: Bio-Rad Laboratories, Inc.
G01N33/573B01F3/0807B01F5/0646B01F5/0653B01F13/0062B01J19/0046B01L3/502761C12Q1/25C12Q1/6804C12Q1/6818C12Q1/6827C12Q1/6851C40B40/04C40B50/08C40B60/10G01N33/5008G01N33/542G01N33/582B01J2219/0059B01J2219/0065B01J2219/0072B01J2219/0074B01J2219/00286B01J2219/00351B01J2219/00418B01J2219/00479B01J2219/00576B01J2219/00585B01J2219/00592B01J2219/00599B01J2219/00657B01J2219/00664B01J2219/00702B01J2219/00722B01J2219/00743B01L7/52B01L2200/027B01L2300/0636B01L2300/0645B01L2300/0654B01L2300/0681B01L2300/0864B01L2300/0867B01L2400/0415B01L2400/0487G01N21/6428G01N21/6445G01N2500/00
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Quick Facts
Patent No.
US 11,187,702
App. No.
17/081,220
Granted
Nov 30, 2021
Kind
B2
Abstract

The invention generally relates to methods for quantifying an amount of enzyme molecules. Systems and methods of the invention are provided for measuring an amount of target by forming a plurality of fluid partitions, a subset of which include the target, performing an enzyme-catalyzed reaction in the subset, and detecting the number of partitions in the subset. The amount of target can be determined based on the detected number.

Claims (15)

1. A method of performing a digital ELISA assay in droplets, the method comprising:

providing reagent droplets comprising reporter antibodies and second antibodies bound to magnetic beads into a channel of a microfluidic device;

introducing test droplets comprising a test fluid into the microfluidic device;

combining the reagent droplets with the test droplets in the microfluidic device to form ELISA sandwiches, each ELISA sandwich comprising one bead-bound antibody, a target analyte from the test fluid, and one reporter antibody;

adding, via the microfluidic device, a fluorogenic substrate into droplets that contain one of the ELISA sandwiches; and

detecting fluorescence indicating presence of the target analyte, wherein the detecting step provides a digital count of a number of molecules of analyte per volume of the test fluid.

2. The method of claim 1 , wherein the reporter antibodies are provided as biotinylated antibodies.

3. The method of claim 2 , further comprising introducing a streptavidin-linked enzyme for use in forming the ELISA sandwiches.

4. The method of claim 3 , wherein streptavidin-linked enzyme comprises streptavidin beta-galactosidase.

5. The method of claim 1 , wherein the fluorogenic substrate comprises fluorescein di-beta-D-galactopyranoside (FDG).

6. The method of claim 1 , wherein the target analyte comprises a protein, the detecting step yields a digital count of individual molecules of the protein per volume, and the method further comprises quantifying the protein in the test fluid from the digital count.

7. The method of claim 1 , wherein the detecting step comprises reading a first optical signal indicating the bead type and the fluorescence signal indicating the presence of the target analyte.

8. The method of claim 1 , wherein after the ELISA sandwiches are formed, the method includes retaining the magnetic beads by a magnetic field while removing unbound non-target proteins and free antibodies, prior to adding the fluorogenic substrate.

9. The method of claim 1 wherein the droplets containing the one ELISA sandwich are formed and—after the droplets containing the one ELISA sandwich are formed—the fluorogenic substrate is added.

10. The method of claim 1 , further comprising—after forming the droplets—sorting droplets and discarding droplets with no beads or with more than one bead.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2021
From: SAMUELS, MICHAEL L.; LINK, DARREN R.
To: RAINDANCE TECHNOLOGIES, INC.
Reel/Frame 055988/0549 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2021
From: RAINDANCE TECHNOLOGIES, INC.
To: BIO-RAD LABORATORIES, INC.
Reel/Frame 055988/0633 →
Continuity (6)
Continuation 16733132 · Jan 2, 2020
Continuation 13487030 · Jun 1, 2012
Continuation In Part 10389130 · Mar 14, 2003
Continuation 12504764 · Jul 17, 2009
Provisional Application 61081930 · Jul 18, 2008
Related Publication 20210088519A1 · Mar 25, 2021
Cited By (8)
US 12,235,267 US 12,311,373 US 12,337,287 US 12,350,673 US 12,454,718 US 12,529,097 US 12,540,950 US 12,571,803