IP Library Granted Patent US 10,914,657
Granted Patent B2
US 10,914,657 · App. 13/795,444 · Granted Feb 9, 2021

Fixative and staining solutions

Inventors: Daniel Lapen (Lancaster, MA); Kerri Horton (Boston, MA)
Assignee: Roche Diagnostics Hematology, Inc.
G01N1/30Y10T436/10Y10T436/101666Y10T436/108331Y10T436/25
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Quick Facts
Patent No.
US 10,914,657
App. No.
13/795,444
Granted
Feb 9, 2021
Kind
B2
Abstract

The formulations, systems, and methods disclosed herein permit automated preparation of specimens (e.g., biological specimens) for examination. The disclosed formulations, systems, and methods provide fast, efficient, and highly uniform specimen processing using minimal quantities of fluids. The methods include at least a fixing phase for fixing a specimen to a substrate such as a microscope slide, a staining phase for staining the specimen, and a rinsing phase for rinsing the specimen. One or more of the fixing, staining, and rinsing phases include one or more agitation phases for distributing reagents evenly and uniformly across the specimen. The systems can be implemented as a standalone device or as a component in a larger system for preparing and examining specimens.

Claims (17)

1. A cytological staining solution consisting of

about 0.5 g/L to about 5.0 g/L of Eosin Y;

about 5 mM to about 250 mM bis-tris buffer;

about 0.5 mL/L to about 2.0 mL/L polysorbate 20;

about one g/L to about 20 g/L sodium chloride;

about five mL/L to about 50 mL/L ethylene glycol;

about 0.2 ppm to about 50 ppm of an antimicrobial agent;

acetic acid; and

water,

wherein the solution has a pH of from 5.8 to 6.2.

2. The cytological staining solution of claim 1 , wherein the antimicrobial agent is selected from the group consisting of benzalkonium chloride, 5-chloro-2-methyl-4-isothiazolin-3-one, 2-methyl-4-isothiazolin-3-one, azides, merthiolates, antibiotics, and any combination thereof.

3. The cytological staining solution of claim 2 , wherein the antimicrobial agent comprises 5-chloro-2-methyl-4-isothiazolin-3-one, 2-methyl-4-isothiazolin-3-one, or a combination thereof.

4. The cytological staining solution of claim 1 , wherein a 1:500 dilution of the solution in water has a UV absorbance of from about 0.1 to about one at a peak wavelength of from about 510 to about 530 nm.

5. The cytological staining solution of claim 1 , wherein the Eosin Y is present at a concentration of about 0.75 g/L to about 1.25 g/L.

6. The cytological staining solution of claim 1 , wherein the polysorbate 20 is present at about 0.8 mL/L to about 1.2 mL/L.

7. The cytological staining solution of claim 1 , wherein the sodium chloride is present at about 4 g/L.

8. The cytological staining solution of claim 1 , wherein the ethylene glycol is present at about 9 mL/L to about 11 mL/L.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 13, 2014
From: CONSTITUTION MEDICAL, INC.
To: ROCHE DIAGNOSTICS HEMATOLOGY, INC.
Reel/Frame 031972/0675 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 25, 2013
From: LAPEN, DANIEL; LICARI, KERRI
To: CONSTITUTION MEDICAL, INC.
Reel/Frame 030077/0133 →
Continuity (5)
Continuation 13526164 · Jun 18, 2012
Provisional Application 61498159 · Jun 17, 2011
Provisional Application 61505011 · Jul 6, 2011
Provisional Application 61510180 · Jul 21, 2011
Related Publication 20130252279A1 · Sep 26, 2013