IP Library › Granted Patent US 12,730,037
Granted Patent B2
US 12,730,037 · App. 17/921,846 · Granted Sep 8, 2026

Test slides and methods of production in stain assessment

Inventors: David Brettle (Leeds, GB); Darren Treanor (Leeds, GB); Catriona Marie Dunn (Leeds, GB)
Assignees: LEEDS TEACHING HOSPITALS NHS TRUST; UNIVERSITY OF LEEDS
G01N1/312
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Quick Facts
Patent No.
US 12,730,037
App. No.
17/921,846
Granted
Sep 8, 2026
Kind
B2
Abstract

A QA test slide for use in a stain QA method for a stain and method of making QA test slides are described. The QA test slide comprises: a transparent substrate; a piece of biopolymer material mounted on the transparent substrate; and a sticker defining an aperture and adhered to the transparent substrate over the piece of biopolymer material and with a portion of the piece of biopolymer material exposed by the aperture and wherein a machine readable code is borne by the sticker and the machine readable code encodes a unique identifier for the QA test slide.

Claims (50)

1 . A quality assurance (QA) test slide for use in a stain QA method for a stain, the QA test slide comprising:

a transparent substrate;

a piece of biopolymer material disposed on the transparent substrate; and

a sticker defining an aperture and adhered to the transparent substrate over the piece of biopolymer material so that the sticker secures the piece of biopolymer material to the transparent substrate, a portion of the piece of biopolymer material being exposed by the aperture with the sticker completely encircling the portion of the piece of biopolymer material that is exposed, and wherein a machine readable code is borne by the sticker and the machine readable code encodes a unique identifier for the QA test slide.

2 . The QA test slide as claimed in claim 1 , wherein the transparent substrate is a microscope slide.

3 . The QA test slide as claimed in claim 1 , wherein the sticker further bears a first, a second and a third reference colour patch, and wherein each reference colour patch is a different colour.

4 . The QA test slide as claimed in claim 1 , wherein the sticker further bears a traceability code.

5 . The QA test slide as claimed in claim 1 , wherein the machine readable code is a QR code.

6 . The QA test slide as claimed in claim 1 , wherein the biopolymer material has a thickness in the range of 1 to 40 microns.

7 . The QA test slide as claimed in claim 1 , wherein the biopolymer material is cellulose.

8 . The QA test slide as claimed in claim 1 , wherein the aperture has a dimension of between 2 cm and 0.5 cm.

9 . The QA test slide as claimed in claim 1 , wherein the stain is haematoxylin and eosin (H&E) and the piece of biopolymer material is responsive to H&E.

10 . The QA test slide as claimed in claim 1 , and further comprising:

a further piece of biopolymer material mounted on the transparent substrate, wherein the sticker defines a further aperture and is adhered to the transparent substrate over the further piece of biopolymer material and with a portion of the further piece of biopolymer material exposed by the further aperture and wherein the piece of biopolymer material is responsive to a first stain and the further piece of biopolymer material is responsive to a second stain.

11 . The QA test slide as claimed in claim 10 , wherein the piece of biopolymer material is responsive to Haematoxylin and the further piece of biopolymer material is responsive to Eosin.

12 . The QA test slide as claimed in claim 10 , wherein the aperture and the further aperture each has a dimension between 1.5 cm and 0.5 cm.

13 . The QA test slide as claimed in claim 10 , wherein the piece of biopolymer material and the further piece of biopolymer material has a dimension of between 2 cm and 0.5 cm.

14 . The QA test slide as claimed in claim 1 , wherein the piece of biopolymer material has been stained by the stain which is being, or is going to be, used to stain sample slides.

15 . A method of making QA test slides for use in a stain QA method for a stain, the method comprising:

cutting a plurality of pieces of biopolymer material from a sheet of biopolymer material;

fixing a test piece of the plurality of pieces of biopolymer material to a microscope slide;

staining said test piece using a freshly made batch of the stain;

determining whether a colour of the stained test piece is sufficiently similar to a reference colour;

fixing those of the plurality of pieces of biopolymer material cut from a region of the sheet associated with the test piece to a transparent substrate of a respective microscope slide when the colour of the stained test piece is sufficiently similar to the reference colour to form a plurality of QA test slides;

assigning a unique reference to each of the plurality of QA test slides; and

adhering a respective sticker, defining an aperture therein, to the transparent substrate of each corresponding respective microscope slide and over the piece of biopolymer material fixed to the transparent substrate of the corresponding respective microscope slide so that the sticker secures the piece of biopolymer material to the transparent substrate, a portion of the piece of biopolymer material being exposed by the aperture with the sticker completely encircling the portion of the piece of biopolymer material that is exposed, and wherein a machine readable code is borne by the sticker and the machine readable code encodes the assigned unique reference for each QA test slide.

16 . The method of claim 15 , further comprising:

storing each QA test slide in a respective container.

17 . The method of claim 16 , wherein each container is an opaque container.

18 . The method of claim 16 , wherein each container includes a desiccant.

19 . The method of claim 16 , wherein the container includes an external traceability label.

20 . The method of claim 15 , wherein a spectrophotometer is used to determine whether the colour of the stained test piece is sufficiently similar to a reference colour.

21 . The method of claim 15 , further comprising:

cutting the sheet of biopolymer material from a production line piece of biopolymer material.

22 . The method of claim 15 , wherein the plurality of pieces of biopolymer material comprises a plurality of groups of pieces, and wherein:

a test piece from each group is fixed to a respective microscope slide;

each of said test pieces is stained using the freshly made batch of the stain;

whether the colour of each of the stained test pieces is sufficiently similar to a reference colour is determined; and

the rest of the pieces of the group are fixed to a respective microscope slide if the colour of the stained test piece from the group is sufficiently similar to the reference colour, for each of the plurality of groups.

23 . The method of claim 22 , wherein each group of pieces comprises a plurality of pieces that have been cut from a different position within a row of positions of the sheet.

24 . The method of claim 23 , wherein each different position is a different column.

25 . The method of claim 15 , wherein the stain is H&E.

26 . The method of claim 15 , wherein the biopolymer material has a thickness in the range of 1 to 40 microns.

27 . The method of claim 15 , wherein the biopolymer material is cellulose.

28 . The method of claim 15 , wherein determining whether the colour of the stained test piece is sufficiently similar to a reference colour includes:

measuring the colour of the stained test piece; and

calculating a value for ΔE from the measured colour of the stained test piece and the reference colour.

29 . The method of claim 28 , wherein the colour of the stained test piece is determined to be sufficiently similar to a reference colour if the value for ΔE is not greater than one.

30 . The QA test slide as claimed in claim 1 , wherein the sticker defines a further aperture arranged to permit the transmission of white light through the QA test slide.

31 . The QA test slide as claimed in claim 1 , wherein the piece of biopolymer material has an outer perimeter edge and the sticker extends outwardly beyond the outer perimeter edge so that the sticker completely encircles the outer perimeter edge.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 1, 2023
From: BRETTLE, DAVID; TREANOR, DARREN; DUNN, CATRIONA MARIE
To: LEEDS TEACHING HOSPITALS NHS TRUST; UNIVERSITY OF LEEDS
Reel/Frame 063821/0159 →
Priority Claims (1)
GB 2006257 · Apr 28, 2020 · national
Continuity (1)
Related Publication 20230175935A1 · Jun 8, 2023
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