Granted Patent
B2
US 12,429,478 · App. 17/973,220 · Granted Sep 30, 2025
Suspension composition for hematology analysis control
Assignee:
STRECK LLC
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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 (24)
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 processed blood cells.
2. The suspension composition of claim 1 , wherein the suspension composition is adapted for use in digital imaging hematology instrument that creates and analyzes an image by a computer implemented technique of a sample that has been dispensed onto a substrate.
3. The suspension composition of claim 1 , wherein the suspension composition is adapted, upon mixing with the one or more simulated blood components, for dispensing through a nozzle for delivery by printing to a transparent substrate and subsequent analysis by a digital imaging hematology analyzer.
4. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount sufficient for preserving stability of the 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.
5. The suspension composition of claim 1 , wherein the aqueous buffered solution includes at least one buffering agent, and at least one antimicrobial.
6. 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.
7. The suspension composition of claim 1 , wherein the suspension composition has a pH ranging from about 6 to about 8.
8. 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.
9. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount up to about ten percent (10%) of the suspension composition.
10. The suspension composition of claim 1 , wherein the one or more simulated blood components include simulated nucleated leukocytes, nucleated red blood cells or both.
11. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount up to about ten percent (10%) of a resulting control composition admixture including the suspension composition and the simulated blood cells.
12. 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.
13. A method of using the suspension composition of claim 2 , comprising a step of dispensing the suspension composition onto a substrate, and at least partially evaporating water from the aqueous buffered suspension composition.
14. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount up to about seven percent (7%) of the suspension composition.
15. The suspension composition of claim 1 , wherein the at least one stabilizing agent is present in an amount of about five percent (5%) of the suspension composition.
16. 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.
17. 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.
18. The method of claim 13 , further comprising creating and analyzing an image of the suspension composition in a digital imaging hematology instrument.
19. 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 2 to about 10° C., upon suspending the one or more simulated blood components.
20. The suspension composition of claim 1 , wherein the one or more simulated blood components comprises neutrophils, lymphocytes, and monocytes.
21. The suspension composition of claim 1 , wherein the one or more simulated blood components comprises neutrophils, eosinophils, basophils, lymphocytes, and monocytes.
Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 28, 2025
From: HUNSLEY, BRAD; SCHOLL, JOHN W.
To: STRECK, INC.
Reel/Frame 071233/0052 →
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 →
Continuity (4)
Continuation
16321747
Provisional Application
62454224
· Feb 3, 2017
Provisional Application
62368676
· Jul 29, 2016
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