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WO2025172518A1 - Élément de filtre sanguin à base de film - Google Patents

Élément de filtre sanguin à base de film

Info

Publication number
WO2025172518A1
WO2025172518A1 PCT/EP2025/054004 EP2025054004W WO2025172518A1 WO 2025172518 A1 WO2025172518 A1 WO 2025172518A1 EP 2025054004 W EP2025054004 W EP 2025054004W WO 2025172518 A1 WO2025172518 A1 WO 2025172518A1
Authority
WO
WIPO (PCT)
Prior art keywords
filter element
plasma
sample
specifically
film
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/054004
Other languages
English (en)
Inventor
Thomas Fischer
Wilhelm Leichner
Eloisa Lopez-Calle
Emanuel PEPLAU
Christopher Probst
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Roche Diagnostics Operations Inc
Original Assignee
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Roche Diagnostics Operations Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG, Roche Diagnostics GmbH, Roche Diagnostics Operations Inc filed Critical F Hoffmann La Roche AG
Publication of WO2025172518A1 publication Critical patent/WO2025172518A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D39/00—Filtering material for liquid or gaseous fluids
    • B01D39/14—Other self-supporting filtering material ; Other filtering material
    • B01D39/16—Other self-supporting filtering material ; Other filtering material of organic material, e.g. synthetic fibres
    • B01D39/1692—Other shaped material, e.g. perforated or porous sheets
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D67/00—Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
    • B01D67/0002—Organic membrane manufacture
    • B01D67/0009—Organic membrane manufacture by phase separation, sol-gel transition, evaporation or solvent quenching
    • B01D67/0011—Casting solutions therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B01D71/48—Polyesters
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/521—Single-layer analytical elements
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
    • B01D2239/04—Additives and treatments of the filtering material
    • B01D2239/0471—Surface coating material
    • B01D2239/0478—Surface coating material on a layer of the filter
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
    • B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
    • B01D2239/065—More than one layer present in the filtering material
    • B01D2239/0654—Support layers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
    • B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
    • B01D2239/065—More than one layer present in the filtering material
    • B01D2239/0681—The layers being joined by gluing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0605—Metering of fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0681—Filter

Definitions

  • the invention in a first aspect, relates to a filter element, preferably a blood filter element, comprising (A) a porous film, wherein the porous film comprises at least one film forming polymer and at least one film opener and is free of reactive agents; and (B) a porous support.
  • a second aspect of the invention is directed to a process for preparing a filter element according to the first aspect.
  • the invention relates to a filter assembly, comprising (I) the filter element of the first aspect; and (II) a spreading member (C).
  • a fourth aspect of the invention is directed to the filter element of the first aspect or the filter assembly of the third aspect, being prepared in the form of a sheet or stripe, preferably cutable and/or punchable sheet or stripe, from which the filter element or the filter assembly is cut and/or punched in required dimensions, wherein the sheet or stripe has larger dimensions regarding length and width than the filter element or the filter assembly, allowing to cut and/or punch out at least one filter element or filter assembly, wherein in case of a filter assembly, the remaining part of spreading member (C) is optionally removed after cutting and/or punching.
  • a fifth aspect of the invention is related to a method for preparing a filter element of the first aspect or the filter assembly of the third aspect.
  • a sixth aspect of the invention relates to a test carrier system comprising the filter element of the first aspect, and a seventh aspect of the invention is related to a plasma separation and metering unit comprising the filter element of the first aspect.
  • An eight aspect of the invention is directed to the use of the filter element of the first aspect or the plasma separation and metering unit of the seventh aspect for separation of blood plasma from whole blood.
  • the invention thus relates in a first aspect to a filter element, preferably a blood filter element, comprising (A) a porous film, wherein the porous film comprises at least one film forming polymer and at least one film opener and is free of reactive agents; and
  • the adhesive is selected from the group consisting of acrylate styrene copolymer (Alberdingk AS6002, Alberdingk SC4400, Alberdingk AS6800, Alberdingk H595), acrylic-urethane hybrid polymer (Hybridur 875 polymer dispersion), polyurethane (Baycusan C1000), urethane modified acrylic copolymer (Additol VXL 6212 N)vinyl propionate (Propiofan) and mixtures of two or more thereof.
  • the defoamer is tertamyl alcohol.
  • film forming polymer and pigment are present in the porous film in a weight-based ratio film forming polymer : pigment in the range of from 1 :5 to 1 :20, preferably in the range of from 2: 1 to 1 : 10, more preferably in the range of from 1 : 1 to 1 :2.
  • the porous film (A) has a thickness of less thanl mm.
  • the porous support has an average pore size that permits the passage of at least some, e.g., at least about 25% or about 40%, or substantially all, e.g., at least about 50.1%, at least about 65%, or at least about 80% of platelets by number (count) in a whole blood sample applied to the porous support in the absence of the porous film.
  • the porous support has an average pore size that permits the passage of at least some, e.g., at least about 25% or about 40%, or substantially all, e.g., at least about 50.1%, at least about 65%, or at least about 80% of erythrocytes by number (count) in a whole blood sample applied to the porous support in the absence of the porous film.
  • Such retention may be determined at standard temperature of 20 °C, without applying pressure to the applied whole blood, e.g., with the applied whole blood and porous support at a pressure of 100 kPa, and without subjecting the whole blood and porous support to artificial acceleration forces, e.g., centrifugation.
  • a second aspect of the invention relates to a process for preparing a filter element according to the first aspect comprising
  • the invention in a third aspect, relates to a filter assembly, comprising (I) the filter element of the first aspect of the invention;
  • the filter element i.e. the filter element
  • the filter element of the filter assembly is prepared or preparable by a process of the second aspect of the invention.
  • porous film of (A) or (Al), (A2), porous substrate (B) and spreading member (C) are arranged so that the porous substrate (B) is positioned between porous film (A) or one of (Al), (A2) and spreading member (C).
  • porous film of (A) or (Al), (A2), porous substrate (B) and spreading member (C) are arranged so that porous film (A) or one of (Al), (A2) is positioned between porous substrate (B) and spreading member (C).
  • the cup may be made of at least one material selected from the group consisting of polycarbonate (PC), polymethyl methacrylate (PMMA), cyclic olefin copolymer (COC/COP).
  • PC polycarbonate
  • PMMA polymethyl methacrylate
  • COC/COP cyclic olefin copolymer
  • other materials may be possible.
  • the cup may also be referred to as container or vessel.
  • reaction and measurement cup as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an arbitrary cup being configured for conducting at least one measurement, specifically at least one analytical measurement, specifically at least one optical measurement of one or more analytes of interest.
  • the one or more analytes of interest may be received in the reaction and measurement cup.
  • the one or more analytes of interest may be dissolved or may be dissolvable in at least one fluid medium which is received in the reaction and measurement cup.
  • the term “measurement device” may refer to an arbitrary device, preferably an electronic device, which is configured to detect at least one signal.
  • the signal may be an optical signal.
  • the measurement device may further comprise at least one evaluation device for evaluating at least one measurement performed with the measurement device, specifically at least one processor.
  • the measurement device may specifically comprise at least one detector, specifically at least one optical detector.
  • the term “detector” may refer to an arbitrary device which is configured to detect events or changes in its environment and to provide a corresponding output.
  • the term “optical detector” may generally refer to an arbitrary optical instrument configured for receiving electromagnetic radiation, preferably light in the infrared and/or visible and/or ultraviolet spectral range. Thus, the optical detector may be configured for recording images, which may be stored locally, transmitted to another location or both. Further, the measurement device may comprise at least one light source.
  • the reaction and measurement cup is configured for receiving the at least one buffer solution.
  • the reaction and measurement cup may be provided as being filled with the at least one buffer solution.
  • the reaction and measurement cup may be filled with the buffer solution and the reaction and measurement cup may be sealed with at least one sealing foil.
  • at least one opening of the reaction and measurement cup may be sealing with the at least one sealing foil.
  • the sealing foil may be removed from the reaction and measurement cup before the sample processing unit is attached to the reaction and measurement cup.
  • the sealing foil may be opened during attachment of the sample processing unit to the reaction and measurement cup.
  • the sealing foil may be pierced during attachment of the sample processing unit to the reaction and measurement cup.
  • the sample processing unit and the reaction and measurement cup may be fluidically connected.
  • the reaction and measurement cup may be provided empty and the reaction and measurement cup may be filled with the buffer solution in a separate step.
  • the reaction and measurement cup may specifically be filled with the buffer solution such that the at least one optical window is completely covered with the buffer solution.
  • the washing buffer solution may be configured for washing or eluting the sample or compounds of the sample from the capillary of the sample application area.
  • sample processing unit as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an arbitrary unit which is configured for receiving at least one sample and for transferring the sample from one component of the sample processing unit to another component of the sample processing unit.
  • the sample processing unit may be configured for performing at least one sample preparation procedure. During the sample preparation procedure, the sample may be prepared for performing an analyte measurement as will further be described below in more detail.
  • the sample preparation procedure may include separating compounds of the sample from other compounds of the sample as will further be described below in more detail.
  • the sample processing unit may be configured for providing a metered volume of the sample, specifically of one or more compounds of the sample as will further be described below in more detail.
  • the sample processing unit may specifically comprise at least one sample processing unit housing having at least one sample processing unit opening.
  • sample processing unit housing as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an element or component of the sample processing unit having at least one interior space and at least one wall partially surrounding the at least one interior space and providing protection to the interior space, such as one or more of a mechanical protection or a protection against environmental influences such as one or more of moisture, oxygen or microbial contaminations.
  • the sample processing unit housing may also provide a basis for attachment and/or holding the chemical reagents as will further be described below in more detail.
  • the term “interior space” may refer to a space which is partially enclosed by the walls of the sample processing unit housing.
  • the interior space of the sample processing unit specifically of the sample processing unit housing, may be accessible via the sample processing unit opening.
  • the interior space of the sample processing unit may face the reaction and measurement cup which is configured for receiving the at least one buffer solution of the sample processing unit to the reaction and measurement cup may specifically be a reversible attachment.
  • an irreversible attachment may also be feasible.
  • the sample processing unit may specifically be attachable to the reaction and measurement cup such that a leakage of fluids such as the buffer solution and/or the chemical reagent and/or the sample is prevented.
  • the sample processing unit is attachable to the reaction and measurement cup via at least one mechanism selected from the group consisting of a turning mechanism, a rotation mechanism, a gasket or tight fit between the respective surfaces of the sample processing unit and the reaction and measurement cup.
  • the turning mechanism or rotation is driven by an electrical motor.
  • said electrical motor is a stepper motor.
  • the stepper motor may also be referred to as step motor or stepping motor.
  • the stepper motor may be an electrical motor that rotates in a series of small angular steps. Stepper motors may be digital controlled electromagnetic actuators.
  • the stepper motor may be a brushless DC electric motor that divides a full rotation into a number of equal steps.
  • plasma metering capillary is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a capillary which is configured for providing a metered amount of plasma.
  • the plasma metering capillary may be configured for metering the amount of plasma to an exact volume.
  • the void volume may specifically have a precise geometry of a known volume.
  • the plasma metering capillary may be configured for being filled accurately and repeatably with the known volume leading to the plasma being metered to the known volume prior to eluting the plasma from the plasma metering capillary.
  • the channel may specifically be a straight channel.
  • the term “straight” may refer to a continuous extension of the channel in one direction without a bend, angle or curve. Consequently, the channel may essentially extend in one dimension. However, small aberrations of the channel from the extension in one dimension may be existent specifically due to slight inaccuracies during manufacturing of the capillary.
  • the capillary may specifically be a micro capillary.
  • the term “micro capillary” may refer to a capillary having a channel with dimensions at a small, typically sub-millimeter scale.
  • At least one surface of the sample processing unit housing may comprise at least one surface profiling.
  • the surface may be a surface of the funnel compartment.
  • the surface profiling may comprise a plurality of microstructures.
  • the surface profiling may be a micro-profiling.
  • the term “microprofiling” may generally refer to an arbitrary surface profiling in which elevations and/or depressions of the surface have dimensions in the range of 1 or more micrometers, i.e. of 1 pm to 1000 pm, preferably of 10 pm to 500 pm.
  • the dimensions may specifically refer to a height, a width and/or a depth of the elevations or the depressions.
  • the surface profiling may comprise an at least partially periodically arrangement of at least one element selected from the group consisting of a rectangle, a square, a pillar.
  • the surface profiling may comprise a plurality of pillars having a diameter of 10 pm to 500 pm, a height of 10 pm to 500 pm and a distance between individual pillars (edge-to-edge) of 10 pm to 1000 pm.
  • other types of elements may be feasible.
  • the surface profiling may specifically have a large number of the elements.
  • the elements may be designed as an elevation on the surface. Specifically, the elements may be isolated elements which are arranged at a distance from adjacent elements. The elements may be designed to be free of contact with one another. Alternatively, the elements may at least partially touch each other.
  • the elements may extend from the surface of the housing, in particular the elements may extend transversely, preferably perpendicularly, to the surface of the housing.
  • the surface profiling may be a periodic surface profiling.
  • periodic surface profiling may generally refer to a profiling of any free surface, which occurs repetitively in a recurring sequence.
  • the surface profiling may comprise the arrangement of elevations and depressions which occur repeatedly in a recurring sequence on the free surface.
  • the arrangement of elevations and depressions may form a unit and several of the units may be arranged on the free surface.
  • the capillary may comprise an outlet opening.
  • outlet opening as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an opening located at the outlet end of the capillary.
  • the outlet opening may be located at a front side of the capillary.
  • the channel may open into the outlet opening.
  • the capillary may comprise at least one lateral opening in the capillary wall.
  • lateral opening as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an opening located at the outlet end of the capillary.
  • the lateral opening may be located at a longitudinal side of the capillary.
  • the lateral opening may be an opening within the capillary wall.
  • the lateral opening may be located on a shell surface of the capillary wall.
  • the lateral opening may refer to an opening which is different from the outlet opening.
  • the lateral opening and the outlet opening may refer to two different openings of the capillary.
  • the lateral opening may be a through hole within the capillary wall.
  • the lateral opening may comprise at least one slot extending along a longitudinal axis of the capillary.
  • the term “slot” may generally refer to an opening, specifically a passage opening, a slit or to a notch in the capillary wall of the capillary. Specifically, the slot may extend from the outlet end of the capillary.
  • the lateral opening may be located adjacent to the outlet opening.
  • the outlet opening may be located at the front side of the capillary and the lateral opening may be located on the longitudinal side of the capillary.
  • the outlet opening and the lateral opening may be arranged in a distance to each other.
  • the lateral opening may be a through hole within the capillary wall and the outlet opening and the lateral opening may be separated from each other by at least one section of the capillary wall.
  • the outlet opening may be located at the front side of the capillary and the lateral opening may be located on the longitudinal side of the capillary and, thereby, the outlet opening and the lateral opening may be in direct contact with each other.
  • the lateral opening may specifically be the slot and the slot may comprise longitudinal side walls being formed in the capillary wall.
  • the longitudinal side walls may extend along the longitudinal axis of the capillary.
  • the side walls, with respect to the longitudinal axis as vertex may be arranged at an angle of 5° to 90°, preferably of 10° to 80°, most preferably of 15° to 65°.
  • the top view of the outlet end of the capillary may correspond to a view on the front side of the capillary.
  • the longitudinal side walls, with respect to the longitudinal axis as vertex may be arranged at an angle of essentially 180°.
  • the term “essentially” is to be understood as meaning that deviations from the angle of 180° may be present.
  • the longitudinal side walls, with respect to the longitudinal axis as vertex may be arranged at an angle which is 0.01% to 0.5% larger or smaller than the angle of 180°.
  • the capillary may comprise one single slot wherein in the top view of the outlet end of the capillary the longitudinal side walls, with respect to the longitudinal axis as vertex, may be arranged at an angle of essentially 180°.
  • the chemical reagent may specifically be configured for changing at least one detectable property in the presence of the analyte.
  • this property may be an optically detectable property, such as a color change and/or a change in remissive properties.
  • the chemical reagent may be a highly selective chemical reagent, which only changes the property if the analyte is present in the sample, whereas no change occurs if the analyte is not present. More preferably, the degree or change of the property may be dependent on the concentration of the analyte, in order to allow for a quantitative detection of the analyte.
  • the chemical reagent may be a dry chemical reagent.
  • the term “dry” may refer to a property of an arbitrary chemical of being at least to a large extend free from moisture.
  • the dry chemical reagent may be in the solid aggregate state. Molecules in a solid aggregate state may be closely packed together and may comprise a least amount of kinetic energy.
  • a solid may be characterized by a structural rigidity and a resistance to a force applied to a surface of the solid.
  • the dry chemical reagent may specifically be provided as a pellet.
  • the dry chemical reagent, specifically the pellet may be attached to a wall of the sample processing unit facing the interior space of the sample processing unit.
  • the at least two dry chemical reagents may be arranged adjacent to each other.
  • adjacent as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a property of an arbitrary element of being in proximity of another element.
  • adjacent may also be referred to as “contiguous”, “adjoint”, “besides” or further related terms. Consequently, the element and the other element may be arranged in a neighboring fashion with respect to each other.
  • the sample processing unit may, as outlined above, comprise the sample processing unit housing having the at least one sample processing unit opening.
  • the sample processing unit housing may specifically be formed by a top part and one or more side walls.
  • the top part may extend in a horizontal plane and the side walls may extend transverse, specifically perpendicular, to the top part.
  • the interior space may be enclosed by the top part and the side walls.
  • the sample processing unit and the chemical reagent specifically the at least two dry chemical reagents, may be arranged on the top part of the sample processing unit. Further, specifically, the sample application area and the chemical reagent, specifically the dry chemical reagent, may be arranged adjacent to each other, specifically on the top part of the sample processing unit.
  • the chamber may be formed by a section of the wall of the sample processing unit, specifically by a section of a wall of the top part of the sample processing unit, and by at least one side wall extending from the wall of the sample processing unit.
  • the chamber may be arranged adjacent to the sample application area.
  • the chamber may be sealed with at least one chamber sealing foil.
  • at least one chamber opening of the chamber may be sealing with the chamber sealing foil.
  • the chamber opening may be formed by the one side wall extending from the wall of the sample processing unit.
  • the chamber sealing foil may specifically extend in a horizontal plane. The chamber sealing foil may face the opening of the reaction and measurement cup.
  • the chemical reagent may exemplarily be selected from an ALT/GPT (Alanine Aminotransferase acc. to IFCC without pyridoxal phosphate activation) assay, e.g. Material- Nos.: 05850797188, 05850797190, 05850797214, or from an CREP2 (Creatinine plus ver.2) assay, e.g. Material-Nos.: 05168589214, 05401470190, 08057524190.
  • the materials are available from Roche Diagnostics GmbH. However, also other materials may be applied.
  • the sample processing unit may be moveable with respect to the reaction and measurement cup.
  • the sample processing unit may comprise two of the chemical reagents.
  • One of the chemical reagents may be dissolved within the buffer solution.
  • the sample processing unit may comprise two of the chemical reagents.
  • the two chemical reagents may respectively be liquid chemical reagents.
  • One of the two chemical reagents may be received in the chamber and the other one of the two chemical reagents may be dissolved within the buffer solution.
  • the test carrier system is configured to be rotatable around the rotation axis of the test carrier system whereby the buffer solution is transported to the sample application area and to the chemical reagent, specifically subsequently.
  • rotation axis as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to a straight line that describes a rotation of an arbitrary object.
  • transporting may generally refer to an active transfer of an arbitrary material from one location to another location.
  • the degree of rotation may be chosen such that, during rotation of the test carrier system around the rotation axis whereby the buffer solution is transported to the chemical reagent, the chemical reagent, is flooded with the buffer solution and the sample processing unit, specifically the capillary of the sample processing unit, is not flooded with the buffer solution.
  • the filter element of the filter assembly is prepared or preparable by a process of the second aspect of the invention.
  • the housing comprises at least one receptacle forming at least one sample port for receiving at least one biological sample comprising plasma, specifically a blood sample;
  • the filter element is received in the receptacle of the housing, wherein the filter element comprises a sample application side facing the sample port and a plasma side opposing the sample application side;
  • the plasma metering capillary • at least one plasma metering capillary extending from the housing, wherein an application end of the plasma metering capillary is fluidically connected to the plasma side of the filter element and is configured for receiving the plasma separated from the biological sample by the filter element, wherein an outlet end opposing the application end of the plasma metering capillary comprises an outlet opening, and wherein the plasma metering capillary further comprises a lateral opening in a capillary wall, the lateral opening being located adjacent to the outlet end; wherein the sample application side of the filter element is preferably on a porous film (A) or at least one of first porous film (Al), second porous film (A2) of the filter element and the plasma side of the filter element is preferably on the porous support (B) of the filter element.
  • A porous film
  • Al first porous film
  • A2 second porous film
  • B porous support
  • the plasma separation and metering unit comprises at least one housing.
  • the housing comprises at least one receptacle forming at least one sample port for receiving at least one biological sample comprising plasma, specifically at least one blood sample.
  • the plasma separation and metering unit comprises at least one filter element.
  • the filter element is fluidically connected to the receptacle of the housing. Specifically, the filter element may be received in the receptacle of the housing. Further, there may be intermediate structure between the filter element and the receptacle of the housing such as a transport channel.
  • the filter element comprises a sample application side facing the sample port and a plasma side opposing the sample application side.
  • the plasma separation and metering unit comprises at least one plasma metering capillary extending from the housing.
  • An application end of the plasma metering capillary is fluidically connected to the plasma side of the filter element and is configured for receiving the plasma separated from the biological sample by the filter element.
  • An outlet end opposing the application end of the plasma metering capillary comprises an outlet opening.
  • the plasma metering capillary further comprises a lateral opening in a capillary wall, the lateral opening being located adjacent to the outlet end.
  • plasma separation and metering unit as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an arbitrary unit which is configured for separating a component of the biological sample from other components of the biological sample.
  • the plasma separation and metering unit may be configured for separating plasma from the biological sample which may specifically be blood.
  • the plasma separation and metering unit comprises the filter element which is further described herein in the section related to the first aspect of the invention in more detail.
  • the term “plasma separation and metering unit” may refer to an arbitrary unit which is configured for providing a metered volume of the biological sample, specifically of a component of the biological sample, specifically of plasma.
  • the plasma separation and metering unit comprises the plasma metering capillary which will further be described below in more detail.
  • the plasma separation and metering unit may comprise the filter element and the plasma metering capillary and these may interact with each other in order to fulfill at least one common function as will further be described below in more detail.
  • the housing comprises the at least one receptacle.
  • the receptacle may specifically be an open receptacle having at least one opening.
  • the biological sample may be applied via the opening of the receptacle.
  • the receptacle may have an arbitrary shape. Specifically, the receptacle may have a cross-section having a shape which corresponds to a shape of the filter element. As outlined above, the receptacle forms the sample port for receiving the biological sample.
  • sample port as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically specifically may refer, without limitation, to an arbitrary unit or subunit of the plasma separation and metering unit configured for receiving, accepting or making contact to the biological sample to be separated into different components by the filter element.
  • the sample port may specifically be a cavity within the housing of the plasma separation and metering unit.
  • the housing may be manufactured by injection molding.
  • the housing may be made of at least one material selected from the group consisting of polycarbonate (PC), polymethyl methacrylate (PMMA), cyclic olefin copolymer (COC/COP).
  • PC polycarbonate
  • PMMA polymethyl methacrylate
  • COC/COP cyclic olefin copolymer
  • sample application side and “plasma side” as used herein are broad terms and are to be given its ordinary and customary meaning to a person of ordinary skill in the art and are not to be limited to a special or customized meaning.
  • the terms specifically may refer, without limitation, to opposing sides of the filter element, specifically to two opposing longitudinal sides of the filter element.
  • the sample application side may face an outer environment of the plasma separation and metering unit.
  • the biological sample When the biological sample is applied to the plasma separation and metering unit, the biological sample may get into contact with the sample application side of the filter element.
  • the biological sample may cover a surface of the sample application side of the filter element at least partially.
  • the filter element is permeable for plasma.
  • the plasma may be transferred from the sample application side to the opposing plasma side. Underneath the plasma side, the plasma may be collected.
  • the filter element is fluidically connected to the receptacle of the housing.
  • the filter element may be attached to at least one surface of the receptacle by at least one adhesive, specifically by at least one double-sided adhesive.
  • the adhesive may be a circumferential adhesive element.
  • the circumferential adhesive element may be configured for adhering an outer rim of the filter element to the surface of the receptacle.
  • the filter element may be irreversibly attached to the at least one surface of the receptacle by at least one method selected from the group consisting of thermobonding; ultrasonic welder; laser welding; adhesive bonding. Also other embodiments for attaching the plasma separation membrance to the surface of the receptacle may be feasible.
  • the plasma separation and metering unit comprises the plasma metering capillary.
  • capillary as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an arbitrary small, elongate void volume such as a small tube.
  • the capillary may comprise dimensions in the millimeter or sub-millimeter range.
  • a fluidic medium may migrate through the capillary by capillary action wherein the fluidic medium may flow in narrow spaces of the capillary without an assistance of external forces like gravity due to intermol ecul ar forces between the fluidic medium and a surface of the capillary facing the fluidic medium.
  • the term “plasma metering capillary” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically specifically may refer, without limitation, to a capillary which is configured for providing a metered amount of plasma.
  • the plasma metering capillary may be configured for metering the amount of plasma to an exact volume.
  • the void volume may specifically have a precise geometry of a known volume.
  • the plasma metering capillary may be configured for being filled accurately and repeatably with the known volume leading to the plasma being metered to the known volume prior to eluting the plasma from the plasma metering capillary.
  • the capillary may specifically have at least one channel.
  • the void volume as described above may be formed by the channel.
  • the term “channel” may generally refer to an arbitrary element which may have an elongated shape and which may provide a free volume or lumen and which enables a flow of a fluid medium there through. Consequently, the channel may be configured to receive a fluid medium and/or to provide a transfer of the fluid medium from one end of the channel to the other end of the channel.
  • the term “lumen” generally refers to an interior volume of an arbitrary element. The interior volume may specifically be an open interior volume. Thus, the interior volume may not be fully enclosed or surrounded by a wall of the element.
  • the channel may specifically be a straight channel.
  • straight may refer to a continuous extension of the channel in one direction without a bend, angle or curve. Consequently, the channel may essentially extend in one dimension. However, small aberrations of the channel from the extension in one dimension may be existent specifically due to slight inaccuracies during manufacturing of the plasma metering capillary.
  • the plasma metering capillary may specifically be a micro capillary.
  • the term “micro capillary” may refer to a capillary having a channel with dimensions at a small, typically sub-millimeter scale.
  • the plasma metering capillary may have an inner diameter of 0.1 mm to 3 mm, preferably of 0.25 mm to 2 mm, most preferably of 0.5 mm to 1.3 mm.
  • the inner diameter of the plasma metering capillary may refer to a diameter of the channel.
  • the channel may specifically at least partially have a round crosssection. Still, other shapes are also possible.
  • the plasma metering capillary may have an outer diameter of 0.5 mm to 5 mm, preferably of 0.75 mm to 4 mm, most preferably of 1 mm to 3 mm. Further, the plasma metering capillary may have a of 0.5 mm to 20 mm, preferably of 0.75 mm to 15 mm, most preferably of 1 mm to 10 mm. Also other dimensions may be feasible.
  • the plasma metering capillary may be arranged directly underneath the filter element.
  • the filter element and the plasma metering capillary may be spaced apart from each other, e.g. in a distance to each other.
  • at least one void volume may be formed between the filter element and the plasma metering capillary.
  • the receptacle may comprise at least one funnel compartment arranged adjacent to the application end of the plasma metering capillary, specifically above the application end of the plasma metering capillary.
  • the funnel compartment may specifically refer to a conically tapered compartment. A diameter of the funnel compartment may gradually decrease, specifically along a direction perpendicular to a direction of extension of the filter element.
  • At least one surface of the housing may comprise at least one surface profiling.
  • the surface may be a surface of the funnel compartment.
  • the surface profiling may comprise a plurality of microstructures.
  • the surface profiling may be a micro-profiling.
  • the term “microprofiling” may generally refer to an arbitrary surface profiling in which elevations and/or depressions of the surface have dimensions in the range of 1 or more micrometers, i.e. of 1 pm to 1000 pm, preferably of 10 pm to 500 pm.
  • the dimensions may specifically refer to a height, a width and/or a depth of the elevations or the depressions.
  • the surface profiling may comprise an at least partially periodical arrangement of at least one element selected from the group consisting of: a rectangle, a square, a pillar.
  • the surface profiling may comprise a plurality of pillars having a diameter of 10 pm to 500 pm, a height of 10 pm to 500 pm and a distance between individual pillars (edge-to-edge) of 10 pm to 1000 pm.
  • other types of elements may be feasible.
  • the surface profiling may specifically have a large number of the elements.
  • the elements may be designed as an elevation on the surface. Specifically, the elements may be isolated elements which are arranged at a distance from adjacent elements. The elements may be designed to be free of contact with one another. Alternatively, the elements may at least partially touch each other.
  • the elements may extend from the surface of the housing, in particular the elements may extend transversely, preferably perpendicularly, to the surface of the housing.
  • the surface profiling may be a periodic surface profiling.
  • periodic surface profiling may generally refer to a profiling of any surface, which occurs repetitively in a recurring sequence.
  • the surface profiling may comprise the arrangement of elevations and depressions which occur repeatedly in a recurring sequence on the surface.
  • the arrangement of elevations and depressions may form a unit and several of the units may be arranged on the surface.
  • the plasma metering capillary comprises the lateral opening in the capillary wall.
  • the term “lateral opening” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning.
  • the term specifically may refer, without limitation, to an opening located at the outlet end of the plasma metering capillary.
  • the lateral opening may be located at a longitudinal side of the plasma metering capillary.
  • the lateral opening may be an opening within the capillary wall.
  • the lateral opening may be located on a shell surface of the capillary wall.
  • the lateral opening may refer to an opening which is different from the outlet opening.
  • the lateral opening and the outlet opening may refer to two different openings of the plasma metering capillary.
  • the lateral opening may be a through hole within the capillary wall.
  • the lateral opening may comprise at least one slot extending along a longitudinal axis of the plasma metering capillary.
  • the term “slot” may generally refer to an opening, specifically a passage opening, a slit or to a notch in the capillary wall of the plasma metering capillary. Specifically, the slot may extend from the outlet end of the plasma metering capillary.
  • the lateral opening is located adjacent to the outlet opening.
  • adjacent as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a property of an arbitrary element of being in proximity of another element.
  • adjacent may also be referred to as “contiguous”, “adjoint”, “besides” or further related terms. Consequently, the element and the other element may be arranged in a neighboring fashion with respect to each other.
  • the outlet opening may be located at the front side of the plasma metering capillary and the lateral opening may be located on the longitudinal side of the plasma metering capillary.
  • the outlet opening and the lateral opening may be arranged in a distance to each other.
  • the lateral opening may be a through hole within the capillary wall and the outlet opening and the lateral opening may be separated from each other by at least one section of the capillary wall.
  • the outlet opening may be located at the front side of the plasma metering capillary and the lateral opening may be located on the longitudinal side of the plasma metering capillary and, thereby, the outlet opening and the lateral opening may be in direct contact with each other.
  • the lateral opening may extend from the outlet end of the plasma metering capillary.
  • the lateral opening may be a slot extending from the outlet end and may form a recess within the outlet opening.
  • the lateral opening may have a length of 0.5 mm to 20 mm, preferably of 0.75 mm to 15 mm, most preferably of 1 mm to 10 mm. However, also other lengths may be feasible.
  • the term “length” as further used herein may be viewed in a direction along the longitudinal axis of the plasma metering capillary.
  • the lateral opening may specifically be the slot and the slot may comprise longitudinal side walls being formed in the capillary wall.
  • the longitudinal side walls may extend along the longitudinal axis of the plasma metering capillary.
  • the side walls, with respect to the longitudinal axis as vertex may be arranged at an angle of 5° to 90°, preferably of 10° to 80°, most preferably of 15° to 65°.
  • the top view of the outlet end of the plasma metering capillary may correspond to a view on the front side of the plasma metering capillary.
  • the longitudinal side walls in the top view of the outlet end of the plasma metering capillary the longitudinal side walls, with respect to the longitudinal axis as vertex, may be arranged at an angle of essentially 180°.
  • the term “essentially” is to be understood as meaning that deviations from the angle of 180° may be present.
  • the longitudinal side walls, with respect to the longitudinal axis as vertex may be arranged at an angle which is 0.01% to 0.5% larger or smaller than the angle of 180°.
  • the plasma metering capillary may comprise one single slot wherein the in the top view of the outlet end of the plasma metering capillary the longitudinal side walls, with respect to the longitudinal axis as vertex, may be arranged at an angle of essentially 180°.
  • the plasma metering capillary may comprise at least two of the lateral openings, specifically of the slots.
  • the longitudinal side walls of at least two of the lateral openings may, in the top view of the outlet end of the plasma metering capillary, with respect to the longitudinal axis as vertex, be arranged at an angle of 15° to 45°.
  • the angle of the at least two lateral openings may be identical.
  • the lateral openings may be, in the top view of the outlet end of the plasma metering capillary, arranged opposite to each other.
  • the plasma metering capillary and the housing may form an integral unit.
  • the plasma metering capillary and the housing may be designed integrally.
  • the term “integrally” may refer to a state wherein two or more components may be permanently built into at least another one of the two or more components.
  • the plasma metering capillary may be fixedly attached to the housing.
  • the plasma metering capillary and the housing may form a single piece.
  • the eight aspect of the invention also comprises a method for or separating blood plasma from whole blood.
  • Embodiment 2 The filter element of embodiment 1, wherein the porous support has, in the absence of the porous film, a pore size insufficiently small to substantially retain one or more of platelets, erythrocytes, and leukocytes present in whole blood applied to the porous support.
  • Embodiment 5 The filter element of any of embodiments 1 to 4, wherein the porous support has, in the absence of the porous film, an average pore size of at least about 1 pm, at least about 2 pm, at least about 3 pm, at least about 5 pm, at least about 15 pm, at least about 25 pm, or at least about 50 pm.
  • Embodiment 6 The filter element of any of embodiments 1 to 5, wherein the porous support has, in the absence of the porous film, an average pore size of about 300 pm or less, about 200 pm or less, about 150 pm or less, or about 100 pm or less.
  • Embodiment 7 The filter element of any of embodiments 1 to 6, wherein the porous support has, in the absence of the porous film, an average pore size of at least about 5 pm, e.g., an average pore size of about 5 pm.
  • Embodiment 8 The filter element of any of embodiments 1 to 7, wherein less than 1 weight- % of the porous film of (A) are reactive agent based on the total weight of the film being 100 weight-%.
  • Embodiment 9 The filter element of embodiment 1 to 8, wherein a reactive agent is a reagent for determining a diagnostic parameter, preferably an assay reagent.
  • Embodiment 10 The filter element of any one of embodiments 1 to 9, wherein the porous film of (A) comprises at least one film forming polymer, at least one film opener and at least one pigment.
  • Embodiment 11 The filter element of embodiment 10, wherein at least 90 weight-%, preferably at least 92 weight-%, of the porous film of (A) consists of at least one film forming polymer, at least one film opener and at least one pigment, based on the total weight of all solids of the porous film being 100 weight-%.
  • Embodiment 12 The filter element of embodiment 10 or 11, wherein in the range of from 40 to 80 weight-% of the porous film of (A) consists of the at least one pigment and of at least one film forming polymer, based on the total weight of all solids of the porous film being 100 weight-%.
  • Embodiment 13 The filter element of any one of embodiments 1 to 12, wherein in the range of from 0.1 to 10 weight-% of the porous film of (A) consists of the at least one film opener, based on the total weight of all solids of the porous film being 100 weight-%.
  • Embodiment 14 The filter element of any one of embodiments 1 to 13, wherein the porous film of (A) comprises less than 1 weight-% of water, based on the total weight of the porous film being 100 weight-%.
  • Embodiment 15 The filter element of any one of embodiments 10 to 14, wherein less than 10 weight-%, preferably less than 8 weight-%, of the porous film of (A) consists of one or more component s) selected from the group consisting of dispersant, thickener, wetting agent, adhesive, precipitant, defoamer, and agglutination agent, based on the total weight of the porous film being 100 weight-% wherein, if agglutination agent is present, less than 5 weight-%, of the porous film of (A) consists of agglutination agent, based on the total weight of the porous film being 100 weight-%.
  • Embodiment 16 The filter element of any one of embodiments 10 to 15, wherein the sum of film forming polymer, at least one film opener, at least one pigment, water and one or more component(s) selected from the group consisting of dispersant, thickener, wetting agent, adhesive, precipitant, defoamer, and agglutination agent amounts to 100 weight-%, based on the total weight of the porous film being 100 weight-%.
  • Embodiment 17 The filter element of any one of embodiments 1 to 16, wherein the porous film of (A) comprises, preferably consists to at least 99 weigh-% of, at least one film forming polymer, at least one film opener, at least one pigment, water and one or more component(s) selected from the group consisting of dispersant, thickener, wetting agent, adhesive, precipitant, defoamer, and agglutination agent based on the based on the total weight of the porous film being 100 weight-%.
  • the porous film of (A) comprises, preferably consists to at least 99 weigh-% of, at least one film forming polymer, at least one film opener, at least one pigment, water and one or more component(s) selected from the group consisting of dispersant, thickener, wetting agent, adhesive, precipitant, defoamer, and agglutination agent based on the based on the total weight of the porous film being 100 weight-%.
  • Embodiment 18 The filter element of any one of embodiments 1 to 17, wherein the at least one film forming polymer is selected from the group of polyvinyl ester, preferably polyvinylacetate and/or polyvinyl propionate; polyacrylic ester; poly(methylacrylic acid); polyvinylamide; polyamide; polystyrene; copolymer of butadiene, styrene and/or maleic acid alkyl ester; polyvinylpyrrolidone; and mixtures of two or more of these polymers.
  • polyvinyl ester preferably polyvinylacetate and/or polyvinyl propionate
  • polyacrylic ester poly(methylacrylic acid); polyvinylamide; polyamide; polystyrene; copolymer of butadiene, styrene and/or maleic acid alkyl ester; polyvinylpyrrolidone; and mixtures of two or more of these polymers.
  • Embodiment 19 The filter element of any one of embodiments 1 to 18, wherein the at least one film forming polymer comprises at least polyvinyl propionate and/or polyvinylpyrrolidone.
  • Embodiment 20 The filter element of any one of embodiments 1 to 19, wherein the at least one film opener is selected from the group consisting of silicone dioxide, silicate, aluminum silicate and mixtures of two or three of these components.
  • Embodiment 21 The filter element of any one of embodiments 10 to 20, wherein the at least one pigment is a white pigment, preferably titanium dioxide (TiCh), zirconium dioxide (ZrCh) or a mixture of TiCh and ZrCh, more preferably TiCh.
  • TiCh titanium dioxide
  • ZrCh zirconium dioxide
  • Embodiment 22 The filter element of any one of embodiments 15 to 21, wherein the dispersant is selected from the group consisting of phosphate, citric acid, sodium salt of poly acrylic acid, alkylolammonium salt of a copolymer with acidic groups (BYK 180) and mixtures of two or more thereof.
  • the dispersant is selected from the group consisting of phosphate, citric acid, sodium salt of poly acrylic acid, alkylolammonium salt of a copolymer with acidic groups (BYK 180) and mixtures of two or more thereof.
  • Embodiment 23 The filter element of any one of embodiments 15 to 22, wherein the thickener is selected from the group consisting of alginate, copolymers of methacrylic acid and methyl methacrylate (Eudragit), copolymers of monoalkyl esters of poly (methyl vinyl ether/maleic acid) (Gantrez), xanthan gum (Keltrol), poly (vinylalkohol) (Mowiol), hydroxy ethyl cellulose (Natrosol), and mixtures of two or more thereof.
  • the thickener is selected from the group consisting of alginate, copolymers of methacrylic acid and methyl methacrylate (Eudragit), copolymers of monoalkyl esters of poly (methyl vinyl ether/maleic acid) (Gantrez), xanthan gum (Keltrol), poly (vinylalkohol) (Mowiol), hydroxy ethyl cellulose (Natrosol),
  • Embodiment 24 The filter element of any one of embodiments 15 to 23, wherein the wetting agent is selected from the group consisting of sulfosuccinate (Geropon T77) N-octanoyl-N- methyl glucamide (Mega-8) and mixtures thereof
  • Embodiment 25 The filter element of any one of embodiments 15 to 24, wherein the adhesive is selected from the group consisting of acrylate styrene copolymer (Alberdingk AS6002, Alberdingk SC4400, Alberdingk AS6800, Alberdingk EI595), aery lic-ur ethane hybrid polymer (Elybridur 875 polymer dispersion), polyurethane (Baycusan Cl 000), urethane modified acrylic copolymer (Additol VXL 6212 N)vinyl propionate (Propiofan) and mixtures of two or more thereof
  • the adhesive is selected from the group consisting of acrylate styrene copolymer (Alberdingk AS6002, Alberdingk SC4400, Alberdingk AS6800, Alberdingk EI595), aery lic-ur ethane hybrid polymer (Elybridur 875 polymer dispersion), polyure
  • Embodiment 26 The filter element of any one of embodiments 15 to 25, wherein the defoamer is tert-amyl alcohol.
  • Embodiment 27 The filter element of any one of embodiments 15 to 26, wherein the agglutination agent is an agent that reacts with blood cells and thereby improves filtering capacity of the filter element, preferably a lectin (which causes agglutination via hemagglutination).
  • the agglutination agent is an agent that reacts with blood cells and thereby improves filtering capacity of the filter element, preferably a lectin (which causes agglutination via hemagglutination).
  • Embodiment 28 The filter element of any one of embodiments 1 to 27, wherein film forming polymer and film opener are present in the porous film in a weight-based ratio film forming polymer : film opener in the range of from 1 : 10 to 10: 1
  • Embodiment 29 The filter element of any one of embodiments 10 to 28, wherein film forming polymer and pigment are present in the porous film in a weight-based ratio film forming polymer : pigment in the range of from 1 :5 to 1 :20, preferably in the range of from2: 1 to 1 :10, more preferably in the range of from 1 : 1 to 1 :2.
  • Embodiment 30 The filter element of any one of embodiments 1 to 29, wherein the porous film (A) has a thickness of less thanl mm.
  • Embodiment 31 The filter element of any one of embodiments 7 to 30, wherein the porous support of (B) is a porous membrane, preferably a microporous membrane, having an average pore size of less than 1 pm, preferably in the range of from 0.1 to 0.9 pm.
  • Embodiment 32 The filter element of embodiment 31, wherein the porous membrane comprises a polymer selected from the group consisting of polyethylene terephthalate (PET), polycarbonate (PC), polyethersulfone and mixtures of two or more of these polymers.
  • PET polyethylene terephthalate
  • PC polycarbonate
  • polyethersulfone polyethersulfone
  • Embodiment 33 The filter element of any one of embodiments 1 to 32, wherein the porous support of (B) has a thickness in the range of from 0.02 to 1 mm, preferably in the range of from 0.03 to 0.1 mm.
  • Embodiment 34 The filter element of any one of embodiments 1 to 30, wherein the porous support of (B) is a porous membrane, preferably a microporous membrane, having an average pore size of at least about 1 pm, at least about 2 pm, at least about 3 pm, at least about 5 pm, at least about 15 pm, at least about 25 pm, or at least about 50 pm and/or an average pore size of about 300 pm or less, about 200 pm or less, about 150 pm or less, or about 100 pm or less.
  • the porous support of (B) is a porous membrane, preferably a microporous membrane, having an average pore size of at least about 1 pm, at least about 2 pm, at least about 3 pm, at least about 5 pm, at least about 15 pm, at least about 25 pm, or at least about 50 pm and/or an average pore size of about 300 pm or less, about 200 pm or less, about 150 pm or less, or about 100 pm or less.
  • Embodiment 35 The filter element of embodiment 34, wherein the porous membrane comprises a polymer selected from the group consisting of polyethylene terephthalate (PET), polycarbonate (PC), polyethersulfone and mixtures of two or more of these polymers.
  • PET polyethylene terephthalate
  • PC polycarbonate
  • polyethersulfone polyethersulfone
  • Embodiment 36 The filter element of embodiment 35, wherein the porous support of (B) has a thickness in the range of from 0.02 to 1 mm, preferably in the range of from 0.03 to 0.25 mm, e.g., in the range of from about 0.03 to about 1 mm.
  • Embodiment 37 The filter element of any one of embodiments 1 to 36, comprising a first porous film (Al) and a second porous film (A2), wherein the porous support (B) is positioned between (Al) and (A2).
  • Embodiment 38 A process for preparing a filter element according to any one of embodiments 1 to 38, comprising:
  • Embodiment 40 A filter assembly, comprising
  • Embodiment 41 The filter assembly of embodiment 40, wherein porous film of (A) or (Al), (A2), porous substrate (B) and spreading member (C) are arranged so that the porous substrate (B) is positioned between porous film (A) or one of (Al), (A2) and spreading member (C).
  • Embodiment 42 The filter assembly of embodiment 41, wherein porous film of (A) or (Al), (A2), porous substrate (B) and spreading member (C) are directly connected to each other in that a surface of the porous film (A) or a surface of one of (Al), (A2) is in direct contact with a first surface of the porous substrate (B) and a second surface of the porous substrate (B), which is opposite to the first surface of the porous substrate (B), is in direct contact with a surface of the spreading member (C).
  • Embodiment 44 The filter assembly of embodiment 40, wherein porous film of (A) or (Al), (A2), porous substrate (B) and spreading member (C) are arranged so that porous film (A) or one of (Al), (A2) is positioned between porous substrate (B) and spreading member (C).
  • Embodiment 45 The filter assembly of any one of embodiments 40 to 44, wherein the spreading member (C) has a length which is larger than the extension of (A) or (Al), (A2) and/or the extension of (B) in the direction parallel to the length of (C).
  • Embodiment 46 The filter assembly of any one of embodiments 40 to 45, wherein the spreading member (C) comprises, preferably consists of, a track etched polymeric membrane (made from e.g. polyethylenterephthalat (PET), polycarbonate (PC), or a symmetric or asymmetric polyethersulfone (PES).
  • PET polyethylenterephthalat
  • PC polycarbonate
  • PES polyethersulfone
  • Embodiment 47 The filter assembly of any one of embodiments 40 to 46, wherein the spreading member (C) has a thickness in the range of from 5 to 50 pm, preferably in the range of from 8 to 36 pm.
  • Embodiment 48 The filter element of any one of embodiments 1 to 37 or the filter assembly of any one of embodiments 40 to 47, being prepared in the form of a sheet or stripe, preferably cutable and/or punchable sheet or stripe, from which the filter element or the filter assembly is cut and/or punched in required dimensions, wherein the sheet or stripe has larger dimensions regarding length and width than the filter element or the filter assembly, allowing to cut and/or punch out at least one filter element or filter assembly, wherein in case of a filter assembly, the remaining part of spreading member (C) is optionally removed after cutting and/or punching.
  • Embodiment 49 A method for preparing a filter element of any one of embodiments 1 to 39 or a filter assembly of any one of embodiments 40 to 47 comprising
  • Embodiment 50 A test carrier system comprising the filter element of any one of embodiments 1 to 39.
  • Embodiment 51 The test carrier system of embodiment 50 comprising
  • the reaction and measurement cup is configured for receiving at least one buffer solution, wherein the reaction and measurement cup comprises at least one optical window which is received in at least one wall of the reaction and measurement cup, the optical window enabling optical analysis of the buffer solution; and • at least one sample processing unit, wherein the sample processing unit is attachable to the reaction and measurement cup, wherein the sample processing unit comprises: at least one sample application area, wherein the sample application area is configured for receiving at least one sample, wherein the sample application area comprises at least one hollow element which opens into an interior space of the sample processing unit; and at least one chemical reagent, wherein the chemical reagent is received within the interior space of the sample processing unit or within the reaction and measurement cup; wherein the sample application area comprises at least one receptacle forming at least one sample port, wherein the filter element of any one of embodiments 1 to 28 is received or receivable in the receptacle.
  • Embodiment 52 A plasma separation and metering unit comprising the filter element of any one of embodiments 1 to 39.
  • Embodiment 53 The plasma separation and metering unit of embodiment 52 comprising:
  • the housing comprises at least one receptacle forming at least one sample port for receiving at least one biological sample comprising plasma, specifically a blood sample;
  • Embodiment 55 A method for separating blood plasma from whole blood, comprising
  • the present invention is further illustrated by the following reference examples, comparative examples, and examples.
  • the resulting aqueous mixture having a weight of 250 g was applied onto a given porous support material made of polyethersulfone (Supor 5000) having about the dimensions of a DIN A4 paper sheet, which was preferably saturated with water, wherein the application was done by knife coating/table coating/slot die coating at room temperature (in the range of from 20 to 25 °C). Afterwards, the resulting polymer containing film was dried at a temperature range from 80 - 120 °C - the composition of the resulting dry film is indicated in Table 1. Dried polymer containing film and porous support material together were considered as blood filter element.
  • FIG. 1 shows the side of the blood filter element with view onto the polymer containing film
  • Fig. IB shows the opposite side of the filter element, i.e. the surface of the carrier substrate facing away from the polymer containing film.
  • Fig. 1 shows the filter element of Example 2, wherein Fig. 1 A shows the remaining dark red (here black) spot after application of a whole blood sample (supplemented with colorant), indicating that the erythrocytes were retained on the application side, while Fig. IB shows a blue (here in grey) spot indicating that the plasma had passed through the filter element.
  • Fig. 2A shows a filter element (100) with a porous film (101) and a porous support (102).
  • Fig. 2B shows a filter element (200) with a first porous film (201), a second porous film (201) and a porous support (202) between first and second porous film.
  • Fig. 3A shows a filter element (100) comprising a porous film (101) arranged on top of a porous substrate (102), which in turn is arranged on top of a spreading member (300), together with a schematic drop of whole blood (400).
  • Fig. 3B shows a filter element (100) comprising a porous substrate (102) arranged on top of a porous film (101), which in turn is arranged on top of a spreading member (300), together with a schematic drop of whole blood (400).
  • Fig. 3C shows a filter element (200) with a first porous film (201), a second porous film (201) and a porous support (202) between first and second porous film, the filter element (200) being arranged on top of a spreading member (300), together with a schematic drop of whole blood (400).

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
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  • Analytical Chemistry (AREA)
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  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
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  • Pathology (AREA)
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  • Clinical Laboratory Science (AREA)
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  • Manufacturing & Machinery (AREA)
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Abstract

Selon un premier aspect, l'invention concerne un élément de filtre, de préférence un élément de filtre sanguin, comprenant (A) un film poreux, le film poreux comprenant au moins un polymère filmogène et au moins un agent d'ouverture de film et étant exempt d'agents réactifs ; et (B) un support poreux. Un second aspect de l'invention concerne un procédé de préparation d'un élément de filtre selon le premier aspect. Selon un troisième aspect, l'invention concerne un ensemble filtre, comprenant (I) l'élément de filtre du premier aspect ; et (II) un élément d'étalement (C). Un quatrième aspect de l'invention concerne l'élément de filtre du premier aspect ou de l'ensemble filtre du troisième aspect, préparé sous la forme d'une feuille ou d'une bande, de préférence une feuille ou une bande pouvant être découpée et/ou perforée, à partir de laquelle l'élément de filtre ou l'ensemble filtre est découpé et/ou perforé aux dimensions requises, la feuille ou la bande présentant des dimensions plus grandes en termes de longueur et de largeur que l'élément filtrant ou l'ensemble filtre, permettant de découper et/ou de perforer au moins un élément filtrant ou un ensemble filtre, dans le cas d'un ensemble filtre, la partie restante de l'élément d'étalement (C) étant éventuellement retirée après la découpe et/ou la perforation. Un cinquième aspect de l'invention concerne un procédé de préparation d'un élément de filtre du premier aspect ou de l'ensemble filtre du troisième aspect. Un sixième aspect de l'invention concerne un système de support de test comprenant l'élément de filtre du premier aspect, et un septième aspect de l'invention concerne une unité de séparation et de dosage de plasma comprenant l'élément de filtre du premier aspect. Un aspect de l'invention concerne l'utilisation de l'élément de filtre du premier aspect ou de l'unité de séparation et de dosage de plasma du septième aspect pour la séparation du plasma sanguin à partir du sang total.
PCT/EP2025/054004 2024-02-16 2025-02-14 Élément de filtre sanguin à base de film Pending WO2025172518A1 (fr)

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EP24158143.8 2024-02-16
EP24158143 2024-02-16

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WO2025172518A1 true WO2025172518A1 (fr) 2025-08-21

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3922495A1 (de) * 1989-07-08 1991-01-17 Miles Inc Analyseverfahren fuer substanzen aus biologischen fluessigkeiten, insbesondere vollblut
EP0575364A1 (fr) 1991-02-28 1993-12-29 Boehringer Mannheim Gmbh Support de test poour la determination d'un echantillon de sang total a analyser.
EP0821234A2 (fr) * 1996-07-23 1998-01-28 Roche Diagnostics GmbH Moyen diagnostique avec champ d'épreuve multicouche et méthode de détermination d'analytes l'utilisant
US20030031592A1 (en) * 1998-10-23 2003-02-13 Wolfgang-Reinhold Knappe Spreading layers, wetting agents for their production and their use in test strips
EP1522343A1 (fr) 2003-10-07 2005-04-13 Roche Diagnostics GmbH Dispositif de test analytique comprenant une matrice pour établir un canal capillaire
US20110194980A1 (en) * 2004-12-07 2011-08-11 Roche Diagnostics Operations, Inc. Process For Hydrophilizing Surfaces Of Fluidic Components And Systems
US20160327547A1 (en) * 2014-01-24 2016-11-10 Roche Diabetes Care, Inc. Method of manufacturing uni- and no-code test stripes

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3922495A1 (de) * 1989-07-08 1991-01-17 Miles Inc Analyseverfahren fuer substanzen aus biologischen fluessigkeiten, insbesondere vollblut
EP0575364A1 (fr) 1991-02-28 1993-12-29 Boehringer Mannheim Gmbh Support de test poour la determination d'un echantillon de sang total a analyser.
EP0821234A2 (fr) * 1996-07-23 1998-01-28 Roche Diagnostics GmbH Moyen diagnostique avec champ d'épreuve multicouche et méthode de détermination d'analytes l'utilisant
US20030031592A1 (en) * 1998-10-23 2003-02-13 Wolfgang-Reinhold Knappe Spreading layers, wetting agents for their production and their use in test strips
EP1522343A1 (fr) 2003-10-07 2005-04-13 Roche Diagnostics GmbH Dispositif de test analytique comprenant une matrice pour établir un canal capillaire
US20110194980A1 (en) * 2004-12-07 2011-08-11 Roche Diagnostics Operations, Inc. Process For Hydrophilizing Surfaces Of Fluidic Components And Systems
EP1824586B1 (fr) 2004-12-07 2011-11-16 Roche Diagnostics GmbH Procede pour enduire des membranes
US8202490B2 (en) 2004-12-07 2012-06-19 Roche Diagnostics Operations, Inc. Membranes and methods for coating membranes
US20160327547A1 (en) * 2014-01-24 2016-11-10 Roche Diabetes Care, Inc. Method of manufacturing uni- and no-code test stripes

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