IP Library › Granted Patent US 10,921,223
Granted Patent B2
US 10,921,223 · App. 16/597,930 · Granted Feb 16, 2021

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
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Quick Facts
Patent No.
US 10,921,223
App. No.
16/597,930
Granted
Feb 16, 2021
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 (49)

1. A slide, comprising:

a detection area configured to hold a sample comprising a tissue section or loose cells; and

a control area 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 the stained tissue or cells.

2. The slide of claim 1 , further comprises an adhesive coating configured to bind with moieties, wherein the adhesive coating comprises at least one end group selected from the group consisting of —ROH, —R(C═O)OH, —RNH 3 , —R(C═O)NH 2 , and —RNH 2 .

3. The slide of claim 1 , wherein the control area comprises a primary target array, the primary target array comprises one or more primary target loading dots, each primary target loading dot of the one or more primary target loading dots comprises a protein site including a protein reactive to a host FcyRI peptide on the 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 onto the slide.

4. The slide of claim 3 , 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.

5. The slide of claim 4 , wherein the primary target array 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.

6. The slide of claim 4 , wherein the primary target array 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.

7. The slide of claim 1 , wherein the control area comprises a primary target array, the primary target array 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.

8. The slide of claim 1 , wherein the control area comprises a primary target array, the primary target array 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.

9. The slide of claim 1 , wherein the control area comprises a secondary target array, the secondary target array 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.

10. The slide of claim 9 , wherein the control area comprises a plurality of secondary target arrays, each of the plurality of secondary target arrays in a same secondary target array comprises a same host protein, and each of the plurality of secondary target arrays in different secondary target arrays comprises different host proteins.

11. The slide of claim 1 , wherein the control area further comprises an antigen retrieval monitor loading dot configured to monitor a degree of antigen retrieval in the immunohistochemical or the immunochemical detection process.

12. The slide of claim 11 , 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.

13. The slide of claim 1 , wherein the control area is covered with a paraffin coating.

14. The slide of claim 1 , further comprises at least one of:

a marking identifying a slide type;

a code for identifying an antigen supported by the control area; or

a lot number.

15. A slide, comprising:

a detection area configured to hold a sample comprising a tissue section or loose cells; and

a control area 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 the stained tissue or cells, wherein the control area further comprises an imaging reference loading dot.

16. The slide as claimed in claim 15 , 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.

17. The slide of claim 15 , 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.

18. A method for immunohistochemical staining using a slide, the method comprising:

removing a portion of a fixation, wherein the portion is sufficient to expose antigen sites in a tissue section and expose control targets;

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

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

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

assessing a quality of the staining process, wherein the assessing comprises assessing staining results of the control targets or an antigen retrieval monitor located in a control area separate from the tissue section.

19. The method of claim 18 , further comprising removing a paraffin protection layer from the control targets, wherein removing the paraffin protection layer comprises:

warming the slide to a temperature ranging between 65 and 75° C. for 3-10 minutes to obtain a semi-liquefied paraffin over the control area and tissue section;

liquefying the semi-liquefied paraffin with an organic solvent;

rehydrating the control and detection areas using a stepped sequence of anhydrous ethanol to at most 60% ethanol concentration; and

rehydrating the control targets in a buffer solution.

20. The method of claim 19 , wherein the organic solvent comprises at least one selected from the group consisting of an aliphatic solvent, xylene, and xylol, and the buffer solution is a salt-based buffer solution.

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 Dec 11, 2020
From: SUNSTONE SCIENTIFIC LTD.
To: SHENZHEN PRS LIMITED
Reel/Frame 054613/0054 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 10, 2019
From: HUSHER, FREDERICK KNUTE; SHUM, JEE JONG
To: SUNSTONE SCIENTIFIC LTD.
Reel/Frame 050674/0856 →
Continuity (2)
Provisional Application 62745074 · Oct 12, 2018
Related Publication 20200116601A1 · Apr 16, 2020
Cited By (2)
US 12,553,909 US 12,730,037