IP Library › Granted Patent US 11,300,485
Granted Patent B2
US 11,300,485 · App. 17/147,139 · Granted Apr 12, 2022

Process record slide for staining and method of using the same

Inventors: Frederick Knute Husher (Melbourne Beach, FL); Jee Jong Shum (Miami, FL)
Assignee: SHENZHEN PRS LIMITED
G01N1/30G01N33/54393G01N2001/2893
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,300,485
App. No.
17/147,139
Granted
Apr 12, 2022
Kind
B2
Abstract

Described herein is a process record slide for staining. The process record slide includes a detection area for mounting a sample and a control area including one or more control targets. Also described herein is a method of using the process record slide in an immunohistochemical (IHC) or an immunochemistry (ICC) staining process.

Claims (41)

1. A control target array comprising:

a first plurality of control targets, wherein each of the first plurality of control targets has a similar chemical or biochemical property, and the control target array is configured to:

indicate an error and performance measure of intermediate steps during an immunohistochemical or an immunochemical detection process, and

provide a reference for qualitatively or quantitatively determining a color and antigen density of stained tissue or cells.

2. The control target array of claim 1 , further comprising a second plurality of control targets, wherein each of the second plurality of control targets has a similar chemical or biochemical property different from the chemical or biochemical property of the first plurality of control targets.

3. The control target array of claim 2 , wherein the second plurality of control targets comprises a secondary target loading dot, the secondary target loading dot comprises a plurality of secondary targets, and each of the plurality of secondary targets comprises:

a host protein of a primary antibody used in the immunohistochemical or the immunochemical detection process; and

a dummy protein.

4. The control target array of claim 3 , wherein each of the second plurality of control targets comprises a same host protein, and each of the first plurality of control targets comprises different host proteins.

5. The control target array of claim 1 , wherein the first plurality of control targets comprises:

a plurality of target loading dots, wherein each primary target loading dot of the plurality target loading dots comprises a protein site including a protein reactive to a host FcyRI peptide on a primary antibody, the protein is reactive to a singular or plurality of primary antibody hosts, and each protein site immobilizes a single primary antibody protein.

6. The control target array of claim 5 , wherein the FcyRI peptide is coupled to a carrier protein, and the carrier protein comprises a non-reactive protein, the non-reactive protein is non-reactive to a secondary stain reagent used in the immunohistochemical or the immunochemical detection process.

7. The control target array of claim 1 , wherein the first plurality of control targets comprises a plurality of primary target loading dots, each primary target loading dot of the plurality of primary target loading dots comprises a same reactive FcyRI peptide, each primary target loading dot of the plurality of primary target loading dots has a different concentration of the reactive FcyRI peptide from each other primary target loading dot of the plurality of primary target loading dots.

8. The control target array of claim 1 , wherein the first plurality of control targets comprises a plurality of primary target loading dots, each primary target loading dot of the plurality of primary target loading dots comprises a different reactive peptide, each primary target loading dot of the plurality of primary target loading dots has a different concentration of the reactive peptide from each other primary target loading dot of the plurality of primary target loading dots.

9. The control target array of claim 1 , wherein the first plurality of control targets comprises a primary target loading dot, the primary target loading dot comprises a plurality of primary targets, and each of the plurality of primary target comprises an antibody against a host protein of the primary antibody used in the immunohistochemical or the immunochemical detection process.

10. The control target array of claim 1 , wherein the first plurality of control targets comprises a primary loading dot, the primary target loading dot comprises a plurality of primary targets, and each of the plurality of primary target comprises Protein A, Protein G, Protein A/G, or Protein L against the host protein of the primary antibody used in the immunohistochemical or the immunochemical detection process.

11. The control target array of claim 1 , further comprising an imaging reference loading dot.

12. The control target array of claim 11 , wherein the imaging reference loading dot comprises at least one:

a black reference target comprising carbon dust;

a white reference target, wherein the white reference target comprises a metal oxide or a metal sulfate; or

a clear reference target, wherein the clear reference target comprises a non-reactive protein to any immunohistochemical or immunochemical reagents.

13. The control target array of claim 11 , wherein the imaging reference loading dot comprises:

an anhydride-based epoxy for a white reference target and a black reference target; and

a protein from the equine family of mammals for a clear reference target.

14. The control target array of claim 1 , further comprising an antigen retrieval monitor loading dot configured to monitor a degree of antigen retrieval in the immunohistochemical or the immunochemical detection process.

15. The control target array of claim 14 , wherein the antigen retrieval monitor loading dot comprises a carrier protein or submicron bead comprising:

host proteins covalently attached for defining a 3D particle; and

a fixative under or over the host proteins.

16. The control target array of claim 1 , further comprising a paraffin coating over the first plurality of control targets.

17. A method for immunohistochemical staining, the method comprising:

subjecting a slide and a control target array to a same fixation removal process to expose antigen sites in a tissue section on the slide and to expose control targets on the control target array;

staining the tissue section and the control targets, wherein the staining comprising: applying a primary antibody to the slide, applying a secondary antibody conjugated with a moiety to the slide; and applying stain reagents that produce color in a presence of the moiety to indicate a presence of a targeted antigen.

18. The method according to claim 17 , wherein the control target array is on the slide.

19. The method according to claim 17 , wherein the control target array is configured to:

indicate an error and performance measure of intermediate steps during the immunohistochemical staining process, and

provide a reference for qualitatively or quantitatively determining a color and antigen density of the stained tissue or cells.

20. A method for immunohistochemical staining, the method comprising:

subjecting a slide and a control target array to a same fixation removal process to expose antigen sites in a tissue section on the slide and to expose control targets on the control target array;

staining the tissue section and the control targets, wherein the staining comprising:

applying one or more primary antibodies conjugated with a moiety to the slide; and

applying stain reagents that produce color in a presence of the moiety to indicate a presence of a targeted antigen.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 10, 2026
From: SHENZHEN PRS LIMITED
To: PROCESS RECORD SLIDE LIMITED
Reel/Frame 075963/0786 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 12, 2021
From: HUSHER, FREDERICK KNUTE; SHUM, JEE JONG
To: SUNSTONE SCIENTIFIC LTD.
Reel/Frame 054895/0167 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 12, 2021
From: SUNSTONE SCIENTIFIC LTD.
To: SHENZHEN PRS LIMITED
Reel/Frame 054895/0376 →
Continuity (3)
Continuation 16597930 · Oct 10, 2019
Provisional Application 62745074 · Oct 12, 2018
Related Publication 20210131927A1 · May 6, 2021
Cited By (3)
US 12,313,834 US 12,553,909 US 12,730,037