# US 2010/0167271 A1 · Method for screening blood using a preservative that may be in a substantially solid state form > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2010/0167271 A1 - Document ID: US20100167271A1 - Status: Published application - Kind: A1 - Application number: 12/646,204 - Filed: 2009-12-23 - Published: 2010-07-01 - Earliest claimed: 2008-12-30 - Assignees: Streck, Inc. - Inventors: Wayne L. Ryan - Web page: https://patentgrep.com/patent/US20100167271A1 ## CPC - G01N 33/56972: {White blood cells} - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## Abstract Methods and devices useful for screening a blood product for a transfusion, pursuant to which leukocytes in drawn whole blood are contacted with a formaldehyde releaser screening preservative so that the presence of any residual leukocytes can be screened. A substantially solid state form preservative for one or more blood components (e.g., leukocytes) and use thereof is also described. ## Claims ### Claim 1 A method for screening a blood product for a transfusion, comprising the steps of: contacting a leuko-reduced drawn blood sample with a screening preservative composition that is (i) in a substantially solid state form; and (ii) includes a formaldehyde releaser agent selected from the group consisting of diazolidinyl urea, imidazolidinyl urea, dimethoylol-5,5-dimethylhydantoin, dimethylol urea, 2-bromo-2.-nitropropane-1,3-diol, an oxazolidine, sodium hydroxymethyl glycinate, hydroxymethoxymethyl-1-1aza-3,7-dioxabicyclo [3.3.0]octane, 5-hydroxymethyl-1-1-aza-3,7dioxabicyclo [3.3.0]octane, 5-hydroxypoly[methyleneoxy]methyl-1-1aza-3,7dioxabicyclo [3.3.0]octane, quaternary adamantine and any combination thereof; and optionally, screening any residual leukocytes prior to a blood transfusion. ### Claim 2 (depends on 1) The method of claim 1, wherein (i) the formaldehyde releaser agent consists essentially of a formaldehyde releaser and is substantially free of any separately added aldehyde cross-linker at the time of contacting, (ii) the contacting is performed in the absence of applied or energized radiation, or both (i) and (ii). ### Claim 3 (depends on 1) The method of claim 1, wherein the screening preservative composition includes diazolidinyl urea, imidazolidinyl urea, or a combination thereof as the formaldehyde releaser agent. ### Claim 4 (depends on 1) The method of claim 1, wherein the screening step is performed substantially at the time when the blood is drawn, within 48 hours after any leukoreduction is performed, at least 48 hours after any leukoreduction is performed, or any combination thereof. ### Claim 5 (depends on 1) The method of claim 1, wherein the leuko-reduced blood sample contains white blood cells in a concentration of less than about 10 white blood cells/μl prior to contact with the preservative composition and maintains substantially the same white blood cell concentration at the time of screening the blood sample. ### Claim 6 (depends on 1) The method of claim 1, wherein prior to and during the contacting step the screening preservative composition is substantially free of any crystals. ### Claim 7 (depends on 1) The method of claim 1, wherein prior to the contacting step the screening preservative composition has a viscosity that renders it substantially immobile and resistant to flow for a period of time of at least 24 hours when maintained at a temperature of at least about 60° C. ### Claim 8 (depends on 2) The method of claim 2, wherein prior to and during the contacting step the screening preservative composition has a composition of about 0.5 to about 1.2% by weight of K3EDTA; about 5 to about 20% by weight of the agent; and about 0.001 to about 1 mg % of a dye. ### Claim 9 (depends on 1) The method of claim 1, wherein the screening includes analyzing for the presence of alanine aminotransferase (ALT), one or any combination of infectious diseases selected from Human T-Lymphotropic Virus (HTLV-I and/or HTLV-II), Syphilis, West Nile Virus, or any combination thereof. ### Claim 10 (depends on 4) The method of claim 4, wherein the screening includes passing a portion of the blood through an automated instrument selected from a hematology analyzer, a flow cytometer or a combination thereof, and/or wherein the screening step includes one or any combination of a step of counting residual white blood cells, immunophenotyping residual white blood cells, microscopically inspecting residual white blood cells, analyzing membrane permeability of residual white blood cells, or detecting the presence of bacteria. ### Claim 11 (depends on 1) The method of claim 1, wherein the screening step is performed at least 72 hours after the contacting step. ### Claim 12 A device comprising: a) a receptacle that receives a sample of blood and that is substantially transparent over at least a portion of its area; b) a screening preservative composition contacting the receptacle and being visible through the substantially transparent window, the screening preservative composition having a viscosity so that it remains substantially fixed in a single location prior to receiving the sample of blood, but which is of sufficient concentration so that upon contact with the sample of blood the screening preservative composition will disperse in the sample, and substantially preserve white blood cell components in the sample. ### Claim 13 (depends on 12) A method of making a device according to claim 12, comprising the steps of: a) forming an aqueous liquid mixture including a formaldehyde releaser and a dye; b) dispensing the liquid mixture into the receptacle; and c) removing at least about 70% by volume of any water in the liquid mixture to form a screening preservative composition. ### Claim 14 (depends on 13) The method of claim 13, wherein a freeze drying process is used to remove any water in the liquid mixture. ### Claim 15 (depends on 13) The method of claim 13, wherein at least 90% by volume of water is removed from the liquid mixture to form the screening preservative. ### Claim 16 (depends on 13) The method of claim 13, wherein the screening preservative composition consists essentially of diazolidinyl urea, imidazolidinyl urea, or a combination thereof. ### Claim 17 (depends on 13) The method of claim 13, wherein the screening preservative composition has a composition of about 0.5 to about 1.2% by weight of K3EDTA; about 5 to about 20% by weight of the agent; and about 0.001 to about 1 mg % of a dye. ### Claim 18 (depends on 13) The method of claim 13, wherein the removing step is sufficient so that a colored ring (e.g., a generally annular ring) is visibly defined on a base of the receptacle that substantially circumscribes the base of the receptacle. ### Claim 19 A device for screening blood comprising: a. a first end; b. an intermediate location where the cross section about the longitudinal axis of the device changes from constant to variable; c. a second end; d. a non-planar base that extends between the second end and toward or away from the intermediate location; e. a sectional volume per unit length between the second end and the intermediate location that is less than that between the first end and the intermediate location; wherein a preservative composition is supported between the first end and second end. ### Claim 20 (depends on 19) The device of claim 19, wherein the device has a volume of less than about 5 ml between the first end and the non-planar base.