IP Library Granted Patent US 11,506,655
Granted Patent B2
US 11,506,655 · App. 16/321,747 · Granted Nov 22, 2022

Suspension composition for hematology analysis control

Inventors: Brad Hunsley (Papillion, NE); John W. Scholl (Omaha, NE)
Assignee: STRECK, INC.
G01N33/5094C12N5/0634C12N2501/90C12N2501/999
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 11,506,655
App. No.
16/321,747
Granted
Nov 22, 2022
Kind
B2
Abstract

A suspension composition for a hematology analysis control particularly useful for preserving relevant detectable characteristics of blood cells for a prolong stability period. The suspension may include at least one polysaccharide, which may include or derive from chitosan and/or chitin, as a stabilizing agent.

Claims (21)

1. A suspension composition comprising:

one or more simulated blood components;

a buffered aqueous solution; and

at least one stabilizing agent, wherein the at least one stabilizing agent includes one or any combination of chitin, a salt of chitin, a derivative of chitin, a chitosan, a salt of a chitosan, or a derivative of a chitosan, and wherein the one or more simulated blood components are derived from blood cells processed to preserve characteristics detectable by a hematology analyzer.

2. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount sufficient for preserving stability of detectable morphological characteristics of the one or more simulated blood components for a period of at least 30 days, after being stored during such period at about 2 to about 10° C., upon suspending the blood components; wherein the one or more simulated blood components include nucleated blood cells, and wherein the detectable morphological characteristics that are preserved include size, a nucleus morphology and morphology of other native nuclear cytoplasm granules.

3. The suspension composition of claim 1 , wherein the aqueous buffered solution includes at least one buffering agent, and at least one antimicrobial.

4. The suspension composition of claim 1 , wherein the aqueous buffered solution includes at least one dispersion agent for reducing aggregation of the one or more simulated blood components as compared with the aqueous buffered solution without the dispersion agent.

5. The suspension composition of claim 1 , wherein the suspension composition has a pH ranging from about 6 to about 8.

6. The suspension composition of claim 1 , wherein the at least one stabilizing agent is selected from chitosan acetate, chitosan lactate, chitosan oligosaccharide, carboxyl methyl chitosan, or any combination thereof.

7. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount up to about ten percent (10%) (weight/volume) of the suspension composition.

8. The suspension composition of claim 1 , wherein the one or more simulated blood components includes simulated nucleated leukocytes, nucleated red blood cells or both.

9. The suspension composition of claim 1 , wherein the suspension composition and any resulting control composition employing the suspension composition is substantially free of any added lipoprotein.

10. A method of using the suspension composition of claim 1 , comprising dispensing the suspension composition onto a substrate, and at least partially evaporating water from the aqueous buffered suspension composition.

11. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount up to about seven percent (7%) (weight/volume) of the suspension composition.

12. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount of about five percent (5%) (weight/volume) of the suspension composition.

13. The suspension composition of claim 1 , wherein the one or more simulated blood components comprises one or any combination of components for simulating a platelet, a reticulated platelet, a red blood cell, reticulocyte, an immature reticulocyte, a nucleated red blood cell, or a simulated leukocyte population or sub-population.

14. The suspension composition of claim 1 , wherein the amount of the one or more simulated blood components is a known amount for simulating a normal amount in whole blood.

15. The method of claim 10 , further comprising creating and analyzing an image of the suspension composition in a digital imaging hematology instrument.

16. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount sufficient for preserving stability of detectable morphological characteristics of the one or more simulated blood components for a period of at least 3 days, after being stored during such period at about 1 to about 10° C., upon suspending the one or more simulated blood components.

17. The suspension composition of claim 1 , wherein the one or more simulated blood components comprises neutrophils, lymphocytes, and monocytes.

18. The suspension composition of claim 1 , wherein the one or more simulated blood components comprises neutrophils, eosinophils, basophils, lymphocytes, and monocytes.

Assignments (4)
SECURITY INTEREST Recorded Feb 21, 2023
From: STRECK LLC
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 062819/0851 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 16, 2023
From: STRECK, INC.
To: STRECK LLC
Reel/Frame 062766/0015 →
SECURITY INTEREST Recorded Apr 23, 2021
From: STRECK, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 056016/0124 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 4, 2019
From: HUNSLEY, BRAD; SCHOLL, JOHN W.
To: STRECK, INC.
Reel/Frame 048798/0138 →
Continuity (3)
Provisional Application 62454224 · Feb 3, 2017
Provisional Application 62368676 · Jul 29, 2016
Related Publication 20190178876A1 · Jun 13, 2019
Cited By (10)
US 12,196,661 US 12,228,492 US 12,276,659 US 12,312,595 US 12,332,241 US 12,352,679 US 12,379,387 US 12,429,478 US 12,461,007 US 12,669,427