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WO2025172513A1 - Système de support de test - Google Patents

Système de support de test

Info

Publication number
WO2025172513A1
WO2025172513A1 PCT/EP2025/053998 EP2025053998W WO2025172513A1 WO 2025172513 A1 WO2025172513 A1 WO 2025172513A1 EP 2025053998 W EP2025053998 W EP 2025053998W WO 2025172513 A1 WO2025172513 A1 WO 2025172513A1
Authority
WO
WIPO (PCT)
Prior art keywords
sample
processing unit
carrier system
test carrier
specifically
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/EP2025/053998
Other languages
English (en)
Inventor
Andreas ARISTOW
Christoph Boehm
Thorsten Brueckner
Christoph FAIGLE
Juergen Klepp
Eloisa Lopez-Calle
Ludwig POLLICH
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 WO2025172513A1 publication Critical patent/WO2025172513A1/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
    • 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
    • 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
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/025—Align devices or objects to ensure defined positions relative to each other
    • 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
    • B01L2200/16—Reagents, handling or storing thereof
    • 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
    • B01L2300/0672—Integrated piercing tool
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0457—Moving fluids with specific forces or mechanical means specific forces passive flow or gravitation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber

Definitions

  • Wet analysis systems which essentially use liquid reagents to perform an analysis via a number of required steps, which may exemplarily include conveying a sample and liquid reagent into a reaction and measurement vessel, mixing the sample and the liquid reagent together in the reaction and measurement vessel and analyzing the mixed solution to measure a desired analyte.
  • Dry chemical analysis systems commonly use dry reagents to perform an analysis, which are typically integrated into a test strip for example.
  • the liquid sample is applied on the test strip and dissolves the reagents, and the reaction between the sample and the reagents produces typically a colorimetric change, which can be analyzed optically such as via reflectometry.
  • it can be further differentiated between dry chemical analysis sys- tems which further integrate a passive separation, for example lateral flow tests, of the cellular components of the blood sample via various filtration methods, for example fiberglass sheets.
  • the cellular components mainly the red blood cells, may be held back by the filtration part of the test strip and may allow only the plasma to pass through. Passive separation commonly relates to the fact that these systems are driven by capillary pressure only.
  • wet and dry reagent analysis systems commonly use a combination of liquid reagents and dry reagents to realize a test protocol to measure an analyte.
  • the sample is conveyed with a liquid reagent into a reaction and measurement vessel, mixing the sample and the liquid reagent in the reaction and measurement vessel.
  • a dry reagent is added to the sample and the liquid reagent into the reaction and measurement vessels are consequently mixed to perform a subsequent measurement of the desired analyte.
  • US 5 286 454 A describes a cuvette for taking up a fluid and mixing the fluid with a reagent for analyzing the mixture which consists of a body of glass or polymeric material having a first cavity in which the fluid can be taken up, preferably by capillary action, through an inlet, and at least one further cavity exerting capillary force on fluid which is transported from the first cavity into a reception cavity by subjecting the cuvette to centrifugal force.
  • the further cavity preferably exerts capillary force through a wick which does not extend as far as the bottom of the reception cavity, and a capillary channel.
  • each such cavity communicates with a further reception cavity into which the fluid can be transported from the cavity by the exertion of centrifugal force.
  • the cuvette may also have cavities for receiving washing or diluting liquid, which are connected in series or in parallel with the cavity.
  • WO 2007/008137 Al describes a cuvette for taking up a body fluid sample and for providing the body fluid sample to an analysis which comprises an inlet cavity for receiving a body fluid sample to be analyzed, a centrifugation reception cavity, which is arranged in communication with the inlet cavity such that spontaneous flow from the inlet cavity to the centrifugation reception cavity is prevented and such that body fluid from the inlet cavity may be forced into the centrifugation reception cavity by applying a centrifugation force on the cuvette, an analysis sample reception cavity, which is arranged in capillary connection with at least part of the centrifugation reception cavity for providing a sample transport by capillary action from the centrifugation reception cavity to the analysis sample reception cavity.
  • the analysis sample reception cavity has an opening through an outer wall of the cuvette, said opening extending over the entire width of the analysis sample reception cavity.
  • test carrier system and a method for detecting at least one analyte in a sample which at least partially address the above-mentioned technical challenges.
  • a highly efficient and precise as well as a cost-effective in-vitro diagnostic test shall be provided.
  • the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present.
  • the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.
  • the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element.
  • the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.
  • a test carrier system comprising at least one reaction and measurement cup.
  • the reaction and measurement cup is configured for receiving at least one buffer solution, specifically at least one washing buffer solution.
  • 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 enables optical analysis of the buffer solution.
  • the test carrier system comprises at least one sample processing unit.
  • the sample processing unit is attachable to the reaction and measurement cup.
  • the sample processing unit comprises at least one sample application area.
  • the sample application area is configured for receiving at least one sample.
  • the sample application area comprises at least one capillary which opens into an interior space of the sample processing unit.
  • the sample processing unit comprises at least one chemical reagent.
  • the chemical reagent is received within the interior space of the sample processing unit or within the reaction and measurement cup.
  • the chemical reagent may be received within a compartment or a sidewall of the reaction and measurement cup.
  • the test carrier system is configured to be rotatable around a rotation axis of the test carrier system whereby the buffer solution is alternatively transportable to the sample application area or to the chemical reagent depending on at least one of a direction of rotation and a degree of rotation of the test carrier system around the rotation axis of the test carrier system.
  • the test carrier system may be configured to be rotatable around a rotation axis of the test carrier system whereby the buffer solution is subsequently transportable or transported to the sample application area and to the chemical reagent.
  • the sample may specifically be a biological sample.
  • biological sample may refer to a clinical specimen, e.g. materials taken from humans or animals.
  • the biological sample may specifically be selected from the group consisting of blood, specifically venous blood, specifically capillary blood.
  • blood may refer to body fluid in humans or animals that delivers necessary substances such as nutrients and oxygen to cells and transports metabolic waste products away from the cells.
  • the blood may comprise blood cells and plasma, also referred to as blood plasma.
  • the blood cells may be suspended in the plasma.
  • plasma may refer to a component of blood which is freed from blood cells.
  • the plasma may comprise water and compounds such as proteins, glucose, clotting factors, electrolytes, hormones, carbon dioxide and oxygen. Examples for proteins may be serum albumin, globulin and fibrinogen.
  • the plasma may comprise at least one analyte of interest.
  • analyte 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 element, component or compound which may be present in the sample and the presence and/or the concentration of which may be of interest.
  • the at least one analyte may be one constituent of the plasma such as a protein, glucose, a clotting factor, an electrolyte, an hormone, carbon dioxide or oxygen. Additionally or alternatively, however, other types of analytes may be used and/or any combination of the analytes may be determined.
  • system 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 group of at least two elements which may interact with each other in order to fulfill at least one common function. The at least two components may be handled independently or may be coupled, connectable or integratable in order to form a common component.
  • test carrier system 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.
  • test carrier system may be configured for receiving the sample. Further, specifically, the test carrier system may be configured for providing a metered volume of the sample. Further, specifically, the test carrier system may be configured for one or more chemicals, specifically reagent chemicals, for further preparing the sample for conducting the at least one analytical measurement. Further details may be given below in more detail.
  • the test carrier system comprises the at least one reaction and measurement cup.
  • 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 element creating a partially enclosed space that may be usable to contain, store and/or to transport objects or materials.
  • the enclosed space may also be referred to as interior space.
  • the cup may particularly be made of a durable and/or of an at least partly rigid material such as thermoformed plastic.
  • the cup may be manufactured by injection molding.
  • 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.
  • reaction and measurement cup may refer to an arbitrary cup which is configured for receiving and holding at least one substance, specifically at least one liquid substance, and for enabling a reaction within the cup, such as within at least one interior space of the cup.
  • the at least one substance, specifically the at least one liquid substance may be configured for undergoing a chemical reaction with at least one further substance.
  • the reaction and measurement cup may be configured for receiving the sample or at least one constituent of the sample as will further be described below in more detail.
  • the reaction and measurement cup may be configured for receiving one or more chemical reagents which may undergo a chemical reaction with the sample or with the at least one constituent of the sample within the interior space of the reaction and measurement cup as will further be described below in more detail.
  • the reaction and measurement cup comprises the at least one wall.
  • wall 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 structure, specifically a structural material, which is configured to at least partially surround an object thereby defining physical limits of the object.
  • the wall may be configured to protect a volume at least partially enclosed by the wall.
  • the at least one optical window is received in the wall of the reaction and measurement cup.
  • optical window 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 section within a wall of an arbitrary cup or container being made of at least one optically transparent material such as of at least one optically transparent plastic material or of at least one optically transparent glass.
  • the term “being received” may generally refer to a condition of an object of being located or inserted into a receptacle or into an opening of another element.
  • the optical window may be inserted into a receptacle or a groove within the wall of the reaction and measurement cup.
  • the reaction and measurement cup may be configured for performance of an optical analysis in transmission.
  • the reaction and measurement cup may comprise at least two optical windows, specifically two optical windows.
  • the reaction and measurement cup may comprise at least one first optical window and at least one second optical window. The first optical window and the second optical window respectively may be received in opposing side walls of the reaction and measurement cup, specifically such that an optical analysis in transmission of an analyte received in the buffer solution is feasible.
  • the optical window enables an optical analysis of the buffer solution, specifically of at least one analyte being dissolved in the buffer solution.
  • optical analysis 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 analytical examination including a process of determining a presence and/or a quantity and/or a concentration of at least one analyte or to a process of determining a parameter of the at least one analyte which is characteristic of the properties of the analyte based on an optical detection principle.
  • the optical analysis may be performed via at least one measurement device.
  • 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.
  • 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 specifi- cally be filled with the buffer solution such that the at least one optical window is completely covered with the buffer solution.
  • buffer solution 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 solution which is an acid or a base aqueous solution comprising a mixture of a weak acid and its conjugate base, or vice versa. Its pH value may change little when a small amount of strong acid or base is added to it.
  • the buffer solution may be configured for being used as means of keeping the pH value at a nearly constant value in a wide variety of chemical applications.
  • the buffer solution may also be referred to as a PH buffer solution.
  • the buffer solution may specifically be a washing 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 contamina- - lo tions.
  • 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 which may specifically be a reversible attachment.
  • an irreversible attachment may also be feasible.
  • the stepper motor may be a brushless DC electric motor that divides a full rotation into a number of equal steps.
  • a motor's position can be commanded to move and hold at one of these steps without any position sensor for feedback.
  • An electronic may control the direction and angel of rotation.
  • said electrical motor is an electrical motor in combination with a photoelectric sensor for rotation detection, e.g. a full-circle optical rotary sensor, and an electronics controlling the direction and angle of rotation.
  • the sample processing unit may specifically be attachable to the reaction and measurement cup such that the sample processing unit opening faces a reaction and measurement cup opening of the reaction and measurement cup.
  • the reaction and measurement cup may be fluidically connected to the sample processing unit via the sample processing unit opening and the reaction and measurement cup opening.
  • the sample processing unit comprises the sample application area.
  • sample application area 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 area or section of the sample processing unit configured for receiving, accepting or making contact to the sample.
  • the sample application area is configured for receiving at least one sample.
  • the sample application area may comprise at least one receptacle forming at least one sample port.
  • the receptacle may specifically be an open receptacle having at least one opening. The sample may be applied via the opening of the receptacle.
  • the receptacle may specifically be a cavity within the sample processing unit housing.
  • the sample processing unit may comprise at least one filter element.
  • the at least one filter element may be received in the receptacle.
  • filter element 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 element which may have an essentially flat shape and which may be configured for separating one component of a sample, specifically of a fluid sample, from other components of the sample.
  • the filter element may specifically be a plasma separation membrane.
  • separation may generally refer to an arbitrary process of eliminating specific components of a sample or may as well refer to an arbitrary process of removing at least one part of the sample from an original residence.
  • the removed part of the sample and the residual part of the sample may have a different chemical composition, respectively.
  • plasma separation membrane 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 membrane which is configured for eliminating plasma, for removing plasma from the biological sample which may specifically be blood or for separating plasma from the cellular compounds of the biological sample.
  • the plasma separation membrane may be a semi-permeable membrane which is permeable for plasma but which is non- permeable for the cellular compounds of the biological sample.
  • the plasma separation membrane may specifically have at least one microporous structure.
  • the filter element may specifically have a sample application side facing the sample application area and a plasma side opposing the sample application side.
  • 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 limi- tation, 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 sample processing unit. When the sample is applied to the sample processing unit, the sample may get into contact with the sample application side of the filter element. Thus, the sample may cover a surface of the sample application side of the filter element at least partially.
  • the plasma separation membrane may be a semi-permeable membrane which 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 may have a thickness of 50 pm to 1000 pm, preferably of 75 pm to 750 pm, most preferably of 100 pm to 500 pm. However, also other thicknesses may be feasible.
  • the filter element may have an arbitrary shape. However, preferably, the filter element may have a round shape.
  • the filter element may have a diameter of 1 mm to 50 mm, preferably of 5 mm to 20 mm, most preferably of 6 mm to 10 mm. However, also other dimensions may be feasible.
  • the filter element may be at least partially made of asymmetric polysulfone. Further, additionally or alternatively, the filter element may be made at least partially of fibers selected from the group consisting of natural fibers; synthetic fibers, specifically glass fibers; or mixtures thereof. However, also other materials may be feasible.
  • the filter element may be received in 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 filter element to the surface of the receptacle may be feasible.
  • the sample application area further comprises the at least one 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 intermolecular forces between the fluidic medium and a surface of the capillary facing the fluidic medium.
  • the capillary may specifically be a plasma metering capillary.
  • 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 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 elongate 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. Instead, a flow of a fluid medium or an insertion of another object from one end of the element to a further end through the lumen may be feasible.
  • 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 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.
  • the capillary may have an inner diameter in the range 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 capillary may refer to a diameter of the channel.
  • the channel may specifically at least partially have a round cross-section. Still, other shapes are also possible.
  • the capillary may have an outer diameter in the range 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 capillary may have a length in the range 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 channel of the capillary may be at least partially enclosed by a capillary wall of the capillary.
  • the term “capillary wall” may generally refer to an arbitrary structure, specifically a structural material, which is configured to at least partially surround a channel of a capillary thereby defining physical limits of the channel.
  • the capillary wall may circumferentially enclose the channel of the capillary.
  • the term “circumferentially enclosing” may generally refer to a property of an arbitrary object or volume of being fully enclosed by another object in at least two dimensions.
  • the channel of capillary may be at least partially enclosed by the capillary wall in directions perpendicular to a longitudinal axis of the capillary.
  • the capillary opens into the interior space of the sample processing unit.
  • the capillary may extend from the sample processing unit housing, specifically from a wall of the sample processing unit housing.
  • the capillary may be arranged such that the longitudinal axis of the capillary is oriented transverse, specifically perpendicular, to a longitudinal axis of the filter element.
  • the capillary may comprise an application end and an opposing outlet end.
  • application end and “outlet end” 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 ends of the capillary.
  • the application end may be fluidically connected to the receptacle. Specifically, the application end may face the filter element, specifically the plasma side of the filter element.
  • the application end of the capillary may be at least partially received within the sample processing unit housing.
  • the outlet end may open into the interior space of the sample processing unit.
  • the sample may migrate through the channel of the capillary from the application end to the outlet end by capillary action.
  • the outlet end may be configured for eluting the sample, specifically the compounds of the sample, specifically the plasma, from the capillary, specifically from the channel of the capillary.
  • fluidically 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 spe- cial or customized meaning.
  • the term specifically may refer, without limitation, to property of two or more elements, wherein the two or more elements are connected such that a transfer of an arbitrary fluid medium from one of the two elements to the other one of the two elements or vice versa is provided.
  • the capillary may be arranged directly underneath the filter element.
  • the filter element and the 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 capillary.
  • the receptacle may comprise at least one funnel compartment arranged adjacent to the application end of the capillary, specifically above the application end of the 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.
  • the filter element may be received in the receptacle of the sample processing unit housing such that the funnel compartment is covered at least partially, preferably fully, by the filter element.
  • the funnel compartment may be configured for collecting the sample, specifically the compounds of the sample, specifically the plasma, specifically after the sample, specifically the compounds of the sample, specifically the plasma, has passed through the filter element.
  • the funnel compartment may open into the capillary, specifically into the application end of the capillary.
  • the funnel compartment may be configured for guiding the sample, specifically the compounds of the sample, specifically the plasma, into the application end of the capillary.
  • 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.
  • 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 sample processing unit may further comprise at least one further filter element arranged between the filter element and the capillary.
  • At least one surface of the further filter element may comprise at least one surface profiling.
  • 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.
  • 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 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 extend from the outlet end of the 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 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 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 capillary and the sample processing unit housing may form an integral unit.
  • the capillary and the sample processing unit housing may be designed integrally.
  • the term “integrally” may refer to a state wherein two or more components permanently built into at least another one of the two or more components.
  • the capillary may be fixedly attached to the sample processing unit housing.
  • the capillary and the sample processing unit housing may form a single piece.
  • the sample application area comprising the receptacle, the capillary and the filter element may specifically form a plasma separation and metering unit.
  • 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 plasma from the biological sample which may specifically be blood. Further, the term may refer to an arbitrary unit which is configured for providing a metered volume of plasma.
  • the sample processing unit further comprises the at least one chemical reagent.
  • chemical reagent 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 substance which may be configured for undergoing a chemical reaction with at least one further substance.
  • the chemical reagent may specifically be configured for performing at least one optically detectable detection reaction.
  • the term “optically detectable detection reaction” refers to a detection of an optically detectable property of the analyte itself or an auxiliary compound which is produced or converted with a detection reaction depending on the presence and/or concentration of the analyte in the sample, such as a color change and/or a change in remissive properties.
  • the optically detectable detection reaction may be analyte specific. Further, the optically detectable detection reaction may be a qualitative and/or a quantitative detection.
  • 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 dry chemical reagent may be attached to the wall of the sample processing unit by at least one adhesive material.
  • the dry chemical reagent may be dissolvable or soluble in the buffer solution. Thus, when the dry chemical reagent may get in direct contact with the buffer solution the dry chemical reagent may be dissolved.
  • the sample processing unit may comprise at least two of the dry chemical reagents.
  • 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 sample application area and the at least two chemical reagents may be arranged adjacent to each other, specifically on the top part of the sample processing unit.
  • the at least two dry chemical reagents may be separated from each other by at least one separation wall.
  • the separation wall may be located in the interior space of the sample processing unit.
  • the separation wall may be oriented transverse, specifically perpendicular, to the top part of the sample processing unit.
  • the separation wall may extend from the at least one wall of the sample processing unit, specifically from at least one all of the top part of the sample processing unit into the interior space of the sample processing unit.
  • the chemical reagent may be a liquid chemical reagent.
  • the term “liquid” may refer to a property of a material of being a nearly incompressible fluid which may specifically be conform to a shape of a container where the material is received. Further, the term may refer to a property of a material of retaining an essentially constant volume independent of pressure.
  • the liquid chemical reagent may be located or arranged on the top part of the sample processing unit. Further, specifically, the liquid chemical reagent may be received in the interior space of the sample processing unit.
  • the sample processing unit may comprise at least one chamber and the liquid chemical reagent may be received in the chamber. The chamber may be arranged at the wall 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 reaction and measurement cup may comprise at least one opening mechanism which is configured for opening the chamber sealing foil, specifically during movement of the sample processing unit to the reaction and measurement cup.
  • the opening mechanism may specifically comprise at least one sharp-shaped element which is configured for piercing the chamber sealing foil.
  • the sharp-shaped element may specifically be located in the interior space of the reaction and measurement cup.
  • the sharpshaped element may extend from a wall, specifically from an interior wall of the reaction and measurement cup.
  • the sharp-shaped element may extend parallel to a longitudinal axis of the reaction and measurement cup.
  • the sharp-shaped element In an assembled state of the reaction and measurement cup and the sample processing unit, the sharp-shaped element may be placed underneath the chamber, specifically underneath the chamber sealing foil.
  • the chamber sealing foil may be arranged transverse, specifically perpendicular, to the sharpshaped element.
  • 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 reaction and measurement cup may be receivable at least partially into the interior space of the sample processing unit.
  • the at least one side wall of the sample processing unit may enclose the at least one side wall of the reaction and measurement cup at least partially.
  • the reaction and measurement cup may be configured for sliding into the sample processing unit, specifically, into the interior space of the sample processing unit. The sliding movement may be performed by pressing the sample processing unit towards the reaction and measurement cup, specifically manually such as by a user or a patient.
  • the side wall of the sample processing unit may comprise at least one sliding guide rail and the side wall of the reaction and measurement cup, specifically an outer surface of the reaction and measurement cup, may comprise at least one sliding receptacle, or vice versa.
  • the sliding guide rail may be receivable in the sliding receptacle and may be configured for moving within the sliding receptacle.
  • 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 rotation of the test carrier system may specifically refer to a two-dimensional rotation.
  • the test carrier system may be configured to be rotatable around the rotation axis in at least two possible directions.
  • One of the two directions may refer to a clockwise motion.
  • the clockwise motion may correspond to a direction of hands of an arbitrary clock, specifically from the top to the right, then down and then to the left, and back up to the top.
  • another one of the two directions may refer to a counterclockwise or anticlockwise motion.
  • the anticlockwise motion may correspond to an opposite sense of rotation.
  • the test carrier system may be configured to be rotatable around the rotation axis of the test carrier system whereby the washing is transported subsequently to the sample application area and to the chemical reagent.
  • the test carrier system may configured to be firstly rotatable around the rotation axis of the test carrier system whereby the buffer solution is transported to the sample application area by a clockwise motion of the test carrier system and to be secondly rotatable around the rotation axis of the test carrier system whereby the buffer solution is transported to the chemical reagent by a counterclockwise motion of the test carrier system, or vice versa.
  • the test carrier system may be configured to be firstly rotatable around the rotation axis of the test carrier system whereby the buffer solution is transported to the sample application area by a counterclockwise motion of the test carrier system and to be secondly rotatable around the rotation axis of the test carrier system whereby the buffer solution is transported to the chemical reagent by a clockwise motion of the test carrier system.
  • a 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 sample application area, the sample processing unit, specifically the capillary of the sample processing unit, is flooded with the buffer solution and the chemical reagent is not flooded with the buffer solution.
  • 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 sample processing unit may comprise two of the chemical reagents.
  • the test carrier system may be configured to be firstly rotatable around the rotation axis of the test carrier system whereby the buffer solution is transported to the sample application area and to a first one of the two chemical reagents such as by a counterclockwise motion of the test carrier system and to be secondly rotatable around the rotation axis of the test carrier system whereby the buffer solution is transported to a second one of the chemical reagents such as by a clockwise motion of the test carrier system.
  • a 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 sample application area and to the first one of the two chemical reagents, the sample processing unit, specifically the capillary of the sample processing unit, and the first one of the two chemical reagents are flooded with the buffer solution and the second one of the chemical reagents is not flooded with the buffer solution.
  • 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 second one of the chemical reagent, the second one of the chemical reagent, is flooded with the buffer solution and the sample processing unit, specifically the capillary of the sample processing unit, and the first one of the two chemical reagents are not flooded with the buffer solution.
  • a method for detecting at least one analyte of a sample is disclosed. The method comprises using the test carrier system as described above or as will further be described below in more detail.
  • the method comprises the following steps which specifically may be performed in the given order. It shall be noted, however, that a different order is also possible. Further, it is also possible to perform one or more of the method steps once or repeatedly. Further, it is possible to perform two or more of the method steps simultaneously or in a timely overlapping fashion. The method may comprise further method steps which are not listed.
  • the method comprises the following steps: a) attaching the sample processing unit to the reaction and measurement cup, wherein the buffer solution is received in the reaction and measurement cup; b) applying at least one sample to the sample application area, wherein the sample or one or more compounds of the sample are at least partially drawn into the capillary; c) rotating the test carrier around the rotation axis such that the buffer solution is transported to the sample application area whereby the sample or one or more compounds of the sample are at least partially released from the capillary; d) rotating the test carrier around the rotation axis such that the buffer solution comprising the sample or one or more compounds of the sample are transported to the chemical reagent; and e) rotating the test carrier into a measurement position, specifically into a vertical position, and performing at least one analyte measurement, specifically by placing the optical window of the reaction and measurement cup in front of the optical measurement device.
  • the buffer solution is received in the reaction and measurement cup.
  • the buffer solution may be provided in the factory. Thus, a user may receive a prefilled reaction and measurement cup wherein the buffer solution is already received. Alternatively, the user may fill the buffer solution into the reaction and measurement cup before conducting step a).
  • the reaction and measurement cup may be sealed with at least one sealing foil, and, during step a), the sealing foil may be pierced.
  • a volume of the sample may be the range of 10 pl to 200pl, preferably in the range of 20 pl to lOOpl.
  • the sample may be a biological sample.
  • the biological sample may be blood, specifically venous blood, specifically capillary blood. For further details on the sample, reference may be made to the description above.
  • Step c) may comprise a counterclockwise rotation of the test carrier around the rotation axis and step d) may comprise a clockwise rotation of the test carrier around the rotation axis, or vice versa.
  • step d) may comprise a counterclockwise rotation of the test carrier around the rotation axis and step c) may comprise a clockwise rotation of the test carrier around the rotation axis,
  • the buffer solution may comprise the sample or one or more compounds of the sample.
  • the steps c) and d) may respectively be repeated at least two times.
  • the test carrier may be rotated around the rotation axis in the clockwise rotation or in the counterclockwise direction at least two times.
  • the test carrier may be brought into the vertical position or may be rotated such that a degree of rotation in one direction is diminished.
  • the test carrier system may be rotated back and forth at least two times.
  • the test carrier Before step d) is performed, the test carrier may be brought into the vertical position and at least one reference measurement may be performed, specifically by placing the optical window of the reaction and measurement cup in front of an optical measurement device, specifically at least one photometric optical measurement device.
  • the buffer solution may comprise the sample or one or more compounds of the sample and the dissolved chemical reagent.
  • the sample processing unit may comprise the at least one first dry chemical reagent and the at least one second dry chemical reagent.
  • the buffer solu- tion may comprise the sample or one or more compounds of the sample, the first dissolved dry chemical reagent and the second dissolved dry chemical reagent.
  • the chemical reagent may be the liquid chemical reagent received in the chamber of the sample processing unit.
  • the method may further comprise a piercing of the chamber sealing foil of the chamber.
  • an interior space of the chamber may be fluidi- cally connected to the reaction and measurement cup.
  • the piercing of the chamber sealing foil of the chamber may specifically be performed after step c) is performed.
  • the piercing of the chamber sealing foil of the chamber may include a movement of the sample processing unit to the reaction and measurement cup.
  • the methods and devices according to the present invention provide a large number of advantages over known methods and devices. Specifically, cellular components such as red blood cells may be separated from the sample and a known volume of compounds of the sample may be provided.
  • the test carrier system may provide all chemicals which are required for the method for detecting at least one analyte of a sample.
  • the method for detecting at least one analyte of a sample may be performed in an easy and reproducible manner.
  • Embodiment 1 A test carrier system, wherein the test carrier system comprises:
  • reaction and measurement cup • at least one reaction and measurement cup, wherein the reaction and measurement cup is configured for receiving at least one buffer solution, specifically at least one washing 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;
  • the sample processing unit is attachable to the reaction and measurement cup
  • the sample processing unit comprises: o 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 capillary which opens into an interior space of the sample processing unit, wherein the sample application area comprises at least one receptacle forming at least one sample port, wherein the receptacle is an open receptacle having at least one opening, wherein the biological sample may be applied via the opening of the receptacle, wherein the opening is configured to allow insertion of a sealing cap into the opening of the receptacle; and o at least one chemical reagent, wherein the chemical reagent is received within the interior space of the sample processing unit; wherein the test carrier system is configured to be rotatable around a 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.
  • Embodiment 2 The test carrier system according to the preceding embodiment, wherein the reaction and measurement cup is filled with the buffer solution, wherein the reaction and measurement cup is sealed with at least one sealing foil.
  • Embodiment 3 The test carrier system according to any one of the preceding embodiments, wherein at least one filter element, specifically at least one plasma separation membrane, is received in the receptacle.
  • Embodiment 4 The test carrier system according to any one of the preceding embodiments, wherein the capillary comprises at least one outlet end and at least one application end, wherein the application end is fluidically connected to the receptacle, wherein the outlet end opens into the interior space of the sample processing unit.
  • Embodiment 5 The test carrier system according to the preceding embodiment, wherein the outlet end comprises at least one outlet opening, and wherein the capillary further comprises at least one lateral opening in a capillary wall, the lateral opening being located adjacent to the outlet end.
  • Embodiment 6 The test carrier system according to the preceding embodiment, wherein the lateral opening comprises at least one slot extending along a longitudinal axis of the capillary.
  • Embodiment 7 The test carrier system according to the preceding embodiment, wherein the slot extends from the outlet end of the capillary.
  • Embodiment 8 The test carrier system according to any one of the two preceding embodiments, wherein the slot comprises longitudinal side walls being formed in the capillary wall, wherein the longitudinal side walls extend along the longitudinal axis of the capillary.
  • Embodiment 9 The test carrier system according to the preceding embodiment, wherein, in a top view of the outlet end of the capillary, the longitudinal side walls, with respect to the longitudinal axis as vertex, are arranged at an angle of 5° to 90°.
  • Embodiment 10 The test carrier system according to any one of the two preceding embodiments, wherein in a top view of the outlet end of the capillary the longitudinal side walls, with respect to the longitudinal axis as vertex, are arranged at an angle of essentially 180°.
  • Embodiment 11 The test carrier system according any one of the six preceding embodiments, wherein the capillary comprises at least two of the lateral openings, wherein the lateral openings are, in a top view of the outlet end of the capillary, arranged opposite to each other.
  • Embodiment 12 The test carrier system according any one of the seven preceding embodiments, wherein the lateral opening has a length of 0.5 mm to 20 mm.
  • Embodiment 13 The test carrier system according to any one of the preceding embodiments, wherein the capillary is a plasma metering capillary.
  • Embodiment 14 The test carrier system according to any one of the preceding embodiments, wherein the chemical reagent is a dry chemical reagent, wherein the dry chemical reagent is attached to a wall of the sample processing unit facing the interior space of the sample processing unit.
  • the chemical reagent is a dry chemical reagent
  • the dry chemical reagent is attached to a wall of the sample processing unit facing the interior space of the sample processing unit.
  • Embodiment 15 The test carrier system according to the preceding embodiment, wherein the sample processing unit comprises at least two of the dry chemical reagents, wherein the at least two dry chemical reagents are arranged adjacent to each other.
  • Embodiment 16 The test carrier system according to the preceding embodiment, wherein the at least two dry chemical reagents are separated from each other by at least one separation wall extending from the at least one wall of the sample processing unit into an interior space of the sample processing unit.
  • Embodiment 17 The test carrier system according to any one of the three preceding embodiments, wherein the sample application area and the dry- chemical reagent are respectively arranged on a top part of the sample processing unit, wherein the sample application area and the dry chemical reagent are arranged adjacent to each other.
  • Embodiment 18 The test carrier system according to any one of the preceding embodiments 1 to 13, wherein the chemical reagent is a liquid chemical reagent, wherein the sample processing unit comprises at least one chamber, wherein the liquid chemical reagent is received in the camber.
  • Embodiment 19 The test carrier system according to the preceding embodiment, wherein the chamber is sealed with at least one chamber sealing foil.
  • Embodiment 20 The test carrier system according to the preceding embodiment, wherein the reaction and measurement cup comprises at least one opening mechanism which is configured for opening the chamber sealing foil, specifically during movement of the sample processing unit to the reaction and measurement cup.
  • Embodiment 22 A method for detecting at least one analyte of a sample, wherein the method comprises using the test carrier system according to any one of the preceding embodiments, wherein the method comprises the following steps: a) attaching the sample processing unit to the reaction and measurement cup, wherein the buffer solution is received in the reaction and measurement cup; b) applying at least one sample to the sample application area, wherein the sample or one or more compounds of the sample are at least partially drawn into the capillary; c) rotating the test carrier system around the rotation axis such that the buffer solution is transported to the sample application area whereby the sample or one or more compounds of the sample are at least partially released from the capillary; d) rotating the test carrier system around the rotation axis such that the buffer solution comprising the sample or one or more compounds of the sample are transported to the chemical reagent; and e) bringing the test carrier system into a vertical position and performing at least one analyte measurement, specifically by placing the optical window of the reaction and measurement cup in front of the optical measurement
  • Embodiment 23 The method according to the preceding embodiment, wherein, before step d) is performed, the test carrier system is brought into the vertical position and at least one reference measurement is performed, specifically by placing the optical window of the reaction and measurement cup in front of an optical measurement device, specifically at least one photometric optical measurement device;
  • Embodiment 24 The method according to any one of the two preceding embodiments, wherein the reaction and measurement cup is sealed with at least one sealing foil, wherein, during step a), the sealing foil is pierced.
  • Embodiment 25 The method according to any one of the three preceding embodiments, wherein a volume of the sample is in the range of 10 pl to 200pl, preferably in the range of 20 pl to lOOpl.
  • Embodiment 26 The method according to any one of the four preceding embodiments, wherein the sample is blood, specifically venous blood, specifically capillary blood.
  • Embodiment 27 The method according to any one of the seven preceding embodiments, wherein step c) is repeated at least two times.
  • Embodiment 28 The method according to any one of the eight preceding embodiments, wherein step c) comprises a counterclockwise rotation of the test carrier system around the rotation axis and wherein step d) comprises a clockwise rotation of the test carrier system around the rotation axis, or vice versa.
  • Embodiment 29 The method according to any one of the nine preceding embodiments, wherein the sample processing unit comprises at least one first dry chemical reagent and at least one second dry chemical reagent, wherein during step c) the test carrier system is rotated around the rotation axis such that, additionally, the buffer solution is transported to the first dry chemical reagent.
  • Embodiment 30 The method according to the preceding embodiment, wherein in step d), the buffer solution additionally comprises the dissolved first dry chemical reagent.
  • Embodiment 31 The method according to the preceding embodiment, wherein in step d) the buffer solution comprising the sample or one or more compounds of the sample and the dissolved first dry chemical reagent are transported to the second dry chemical reagent.
  • Figure 1 shows an exemplary embodiment of a section of a sample processing unit of a test carrier system in a cross-sectional view according to the present invention
  • Figures 2 A to 2C show an exemplary embodiment of a capillary of a sample application area of a sample processing unit according to the present invention in a perspective view (Figure 2A), in a top view ( Figure 2B) and in a side view (Figure 2C);
  • Figures 3 A to 3C show a further exemplary embodiment of a capillary of a sample application area of a sample processing unit according to the present invention in a perspective view (Figure 3A), in a top view ( Figure 3B) and in a side view (Figure 3C);
  • Figures 4 A to 4C show a further exemplary embodiment of a capillary of a sample application area of a sample processing unit to the present invention in a perspective view (Figure 4A), in a top view ( Figure 4B) and in a side view (Figure 4C);
  • Figure 5 shows an exemplary surface profiling of a sample processing unit housing of a sample processing unit according to the present invention in a top view
  • Figures 6 A to 6D show an exemplary method for sample processing, wherein a section of a sample processing unit is depicted in a cross-sectional view, respectively;
  • Figures 7A to 7B show details of an exemplary method for sample processing, wherein a section of a sample processing unit is depicted in a cross-sectional view, respectively;
  • FIGS. 8 A to 8B show details of an exemplary method for sample processing, wherein a section of a sample processing unit is depicted in a cross-sectional view, respectively;
  • Figure 9 shows several pictures depicted a plasma separation and metering in a capillary over time
  • Figure 10 shows experimental data showing a plasma separation efficiency over time until a plasma metering capillary of a plasma separation and metering unit according to the present invention is fully filled;
  • Figure 14 A to 14C a schematic representation of a further embodiment of a test carrier system with only liquid reagents stored in blister;
  • Figure 15 A to 151 a schematic representation of a test carrier system during operation
  • Figure 16A to 16C a schematic representation of a further embodiment of a test carrier system with solely liquid reagents for the detection of a given analyte using a blister to store one liquid reagent; and
  • Figure 17A to 17H a schematic representation of a test carrier during operation.
  • Figure 1 shows an exemplary embodiment of a section 108 of a sample processing unit 110 of a test carrier system in a cross-sectional view according to the present invention
  • the sample processing unit 110 comprises at least one sample application area 112.
  • the sample application area is configured for receiving at least one sample.
  • the sample application area comprises at least one capillary 114 which opens into an interior space 116 of the sample processing unit 110.
  • the sample processing unit 110 may comprise at least one filter element 118.
  • the plasma separation membrane 118 may be received in the receptacle 115.
  • the plasma separation membrane 118 may comprise a sample application side 120 facing the sample port
  • the filter element 117 117 and a plasma side 122 opposing the sample application side 120.
  • the filter element 118 may be attached to at least one surface 134 of the receptacle 114 by at least one adhesive 136, specifically by at least one double-sided adhesive 138.
  • the filter element 118 may have at least one microporous structure. Further, the filter element 118 may exemplarily be made of asymetric polysulfone. Further, the filter element 118 may have a thickness t of 100 pm to 500 pm and may have a diameter d, specifically an outer diameter, of 6 mm to 10 mm.
  • the capillary 114 may comprise at least one capillary channel 140.
  • An application end 126 of the capillary 114 may be fluidically connected to the plasma side 122 of the filter element 118.
  • An outlet end 128 opposing the application end 126 of the capillary 114 may comprise an outlet opening 130.
  • the capillary 114 may specifically be a micro-capillary 142.
  • the capillary 114 may be located underneath the filter element 118.
  • the capillary 114 may have an outer diameter d o of 1 mm to 3 mm and an inner diameter d, of 0.5 mm to 1.3 mm.
  • a length /, specifically an overall length, of the plasma metering capillary 124 may be in the range between 1 mm to 10 mm.
  • the receptacle 115 may comprise at least one funnel compartment 144 arranged adjacent to an application end 126 of the capillary 114, specifically at least one conically tapered compartment 132, configured for guiding the sample or compounds of the sample into the application end 126.
  • the filter element 118 may be received in the receptacle 115 such that the funnel compartment 144 is covered at least partially, preferably fully, by the filter element 118.
  • Figures 2A to 2C show an exemplary embodiment of a capillary 114 of a sample application area 112 of a sample processing unit 110 according to the present invention in a perspective view (Figure 2A), in a top view ( Figure 2B) and in a side view ( Figure 2C).
  • the capillary 114 may correspond, at least partially, to the capillary 114 of the sample application area 112 according to Figure 1.
  • the capillary 114 may comprise the outlet opening 130.
  • the capillary 114 may further comprise at least one lateral opening 148 in a capillary wall 124, the lateral opening 148 being located adjacent to the outlet end 128, specifically adjacent to the outlet opening 130.
  • the capillary 114 as illustrated in Figures 2A to 2C may comprise one single lateral opening 148.
  • the lateral opening 148 may comprise at least one slot 150 extending along a longitudinal axis 152 of the capillary 114.
  • the slot 150 may extend from the outlet end 128 of the capillary 114.
  • the slot 150 may be formed by a groove 154 within the at least one capillary wall 124 of the capillary 114.
  • the slot 150 may comprise longitudinal side walls 158 being formed in the capillary wall 124, wherein the longitudinal side walls 158 extend along the longitudinal axis 152 of the capillary 114.
  • the lateral opening 148 may be oriented essentially 90° from the longitudinal axis 152.
  • the longitudinal axis 152 may also be referred to as horizontal axis.
  • the longitudinal side walls 158 In a top view of the outlet end 128 of the capillary 114, as illustrated in Figure 2B, the longitudinal side walls 158, with respect to the longitudinal axis 152 as vertex, may be arranged at an angle a of 15° to 65°.
  • the lateral opening 148 may have a length l c of 1 mm to 10 mm, as illustrated in Figure 2C.
  • Figures 3 A to 3C show a further exemplary embodiment of a capillary 114 of a sample application area 112 of a sample processing unit 110 according to the present invention in a perspective view (Figure 3A), in a top view ( Figure 3B) and in a side view ( Figure 3C).
  • the capillary 114 may correspond, at least partially, to the capillary 114 according to Figure 1.
  • Figure 1 the capillary 114 may correspond, at least partially, to the capillary 114 according to Figures 2 A to 2C.
  • Figures 2A to 2C above.
  • the longitudinal side walls 158 in a top view of the outlet end 128 of the capillary 114 the longitudinal side walls 158, with respect to the longitudinal axis 152 as vertex, may be arranged at an angle a of essentially 180°. Further, as specifically illustrated in Figure 3C, the lateral opening 148 may have a length l c of 1 mm to 10 mm.
  • Figure 5 shows an exemplary surface profiling 160 of a sample processing unit housing 156 of a sample processing unit 110 according to the present invention in a top view.
  • the housing 112 may correspond, at least partially, to the sample processing unit housing 156 of the sample processing unit 110 according to Figure 1.
  • plasma 174 may be generated by passive separation of cellular contents and plasma, specifically due to the microporous structure of the filter element 118 and thus generated capillary forces.
  • the plasma 174 may be drawn into the capillary 114 which may gradually fill over time. After the plasma 174 has reached the outlet end 128 of the capillary 114, a flow of plasma 174 may come to an automatic halt.
  • the process of sample processing may be actively enhanced by applying an overpressure, specifically a defined overpressure, on the sample application area 112.
  • the defined overpressure may be generated via a syringe piston or by a pneumatic system as illustrated schematically in Figure 7B with arrows 176.
  • the overpressure may range between 10 mbar and 1000 mbar and may be kept either constant during over an entire separation and metering time or may be varied at distinct time points of the process.
  • Figures 8A to 8B show details of an exemplary method for sample processing, wherein a section of a sample processing unit 110 is depicted in a cross-sectional view, respectively.
  • the section of a sample processing unit 110 may correspond, at least partially, to the section of the sample processing unit 110 according to Figure 1.
  • the method may correspond, at least partially, to the method as illustrated in Figures 6 A to 6B.
  • Figures 6A to 6B above.
  • a blood sample may be applied and the method for sample processing may correspond to a method for plasma separation and metering.
  • an operator may insert the flexible sealing cap 180 manually into the receptacle 115 or the flexible sealing cap 180 may be inserted into the sample port 116 by an automatized process which is applying a constant displacement of an outer surface 182 of the flexible sealing cap 180 thus resulting in a controlled generation of overpressure onto the clinical sample 170.
  • Figure 9 shows several pictures depicting a plasma separation and metering in a capillary 114 of a sample processing unit 110 over time.
  • the capillary 114 unit may correspond, at least partially, to the capillary 113 of the sample processing unit 110 according to Figure 1.
  • the method may correspond, at least partially, to the method as illustrated in Figures 6A to 6B.
  • Figures 6A to 6B reference is made to the description of Figures 6A to 6B above.
  • the plasma separation and metering in the capillary 114 is exemplarily shown over a time period of 75 s.
  • the plasma 174 may be located at the application end 126. Thereafter, the plasma 174 may gradually travel towards the outlet end 128 and may reach the outlet end 128 at 75 s.
  • Figure 11 shows an exemplary embodiment of a test carrier system 182 in a cross-sectional view according to the present invention.
  • the test carrier system comprises at least one reaction and measurement cup 184.
  • the reaction and measurement cup 184 is configured for receiving at least one buffer solution 186, specifically at least one washing buffer solution 188.
  • the reaction and measurement cup 184 comprises at least one optical window 190 which is received in at least one wall 192 of the reaction and measurement cup 184.
  • the optical window 190 enables optical analysis of the buffer solution 186.
  • the test carrier system 182 comprises the at least one sample processing unit 110.
  • the sample processing unit 110 may correspond, at least partially, to the sample processing unit 110 according to Figure 1. Thus, reference is made to the description of Figure 1 above.
  • the sample processing unit 110 is attachable to the reaction and measurement cup 184.
  • the sample processing unit 110 comprises at least one chemical reagent 194.
  • the chemical reagent 194 may specifically be a dry chemical reagent 198.
  • the sample processing unit 110 may comprise two of the chemical reagents 194, specifically of the dry chemical reagents 198.
  • the dry chemical reagents 198 may be attached to a wall 200 of the sample processing unit 110.
  • the two dry chemical reagents 198 may be applied on a top part 202 of the sample pro- cessing unit 110.
  • the two dry chemical reagents 198 may be separated from each other by a separation wall 204.
  • the separation wall 204 may extend from the wall 200 of the sample processing unit 110 into the interior space 116 of the sample processing unit 110.
  • the separation wall 204 may be configured for avoiding spillage and intermixing during operation of the test carrier system 182 as will further be described below in more detail.
  • the test carrier system 182 is configured to be rotatable around a rotation axis 196 of the test carrier system 182 whereby the buffer solution 186 is transported to the sample application area 112 and to the chemical reagent 194, specifically subsequently, as will further be described below in more detail.
  • the sample processing unit 110 is attached to the reaction and measurement cup 184, as schematically illustrated with arrows 208.
  • the buffer solution 186 is received in the reaction and measurement cup 184.
  • the reaction and measurement cup 184 may be sealed with at least one sealing foil 206, specifically to avoid spilling, evaporation or degradation of the buffer solution 186.
  • the sample processing unit 110 may be placed on top of the reaction and measurement cup 184. While placing and/or pressing the sample processing unit 110 on top of the reaction and measurement cup 184, the sealing foil 206 may be pierced, specifically by using a detected opening mechanism 208 exposing the buffer solution 186.
  • the at least one biological sample 168 is applied to the sample application area 112, wherein the biological sample 168 is at least partially drawn into the capillary 114.
  • the biological sample 168 may also be referred to as clinical sample 170.
  • the clinical sample 170 may specifically be whole blood such as venous blood or capillary blood. Consequently, the plasma 174may be separated from the cellular constituents via the filter element 180 and the plasma 174 may be subsequently drawn into the capillary 114.
  • the sample application area 112 may be sealed with at least one cover element 210, as schematically illustrated with arrows 212.
  • the cover element 201 may be configured for avoiding spillage of the clinical sample 170.
  • the test carrier system 182 is rotated around the rotation axis 196 such that the buffer solution 186 is transported to the sample application area 112 whereby the biological sample 168 is at least partially released from the capillary 114.
  • the plasma 174 may be conveyed into the buffer solution 186.
  • the test carrier system 182 may be rotated counterclockwise around the rotation axis 196 as schematically illustrated with arrow 214. This step may also be referred to as incubation step.
  • the test carrier system 182 may be rotated back and forth multiple times to release the plasma 174 from the capillary 114. Further, the test carrier system 182 may be rotated around the rotation axis 196 such that, additionally, the buffer solution 186 is transported to a first dry chemical reagent 216 of the two dry chemical reagents 198. Thus, the first dry chemical reagent 216 may be dissolved.
  • the test carrier system 182 may be brought into a vertical position and at least one reference measurement may be performed, specifically by placing the optical window 192 of the reaction and measurement cup 184 in front of an optical measurement device 218, specifically at least one photometric optical measurement device 220.
  • the vertical re-orientation of the test carrier system 182 may be conducted by rotating the test carrier system 182 clockwise around its rotation axis 196 such as schematically illustrated in Figure 12E with arrow 226.
  • the photometric optical measurement device 220 may specifically comprise at least one light source 222 and at least one detector 224.
  • the reference measurement may also be referred to as blank measurement.
  • the blank measurement may be conducted with the buffer solution 186, the plasma 174 and the dissolved first dry chemical reagent 216.
  • the test carrier system 182 may be rotated around the rotation axis 196 such that the buffer solution 186 comprising the plasma 174 is transported to a second dry- chemical reagent 228 of the dry chemical reagents 198.
  • the test carrier system 182 may be rotated clockwise around the rotation axis 196 to move the buffer solution 186, the plasma 174 and the dissolved first dry chemical reagent 216 to the sample processing unit 110 to dissolve the second dry chemical reagent 228.
  • the clockwise rotation is in Figure 12H schematically illustrated with arrow 230. This step may also be referred to as incubation step.
  • the test carrier system 182 is brought into the vertical position and at least one analyte measurement is performed, specifically by placing the optical window of the reaction and measurement cup 184 in front of the optical measurement device 218, again. Specifically, the test carrier system 182 may be rotated back to an upright position by rotating the test carrier system 182 counterclockwise around the rotation axis 196.
  • the reaction and measurement cup may comprise now the buffer solution 186, the plasma 174 and the dissolved first dry chemical reagent and the dissolved second dry chemical reagent 228.
  • Figure 13 shows a further exemplary embodiment of a test carrier system 182 in a cross- sectional view according to the present invention.
  • the test carrier system 182 may correspond, at least partially, to the test carrier system 182 according to Figure 11.
  • the chemical reagent 194 may be a liquid chemical reagent 232.
  • the sample processing unit 110 may comprise at least one chamber 234 and the liquid chemical reagent 232 may be received in the chamber 234.
  • the chamber 234 may be sealed with at least one chamber sealing foil 236 and the reaction and measurement cup 184 may comprise at least one opening mechanism 238 configured for opening the chamber sealing foil 236 during attachment of the sample processing unit 110 onto the reaction and measurement cup 184.
  • the test carrier system 182 may comprise at least one further chemical reagent 240, specifically at least one further liquid chemical reagent 242.
  • the further chemical reagent 240 may be received in the reaction and measurement cup 184.
  • Figures 14A to 14C show a schematic representation of a further embodiment of a test carrier system 182 with only liquid reagents stored in blister.
  • Figure 14 A a perspective vies is illustrated.
  • Figure 14B a partially disassembled view is illustrated.
  • Figure 14C a cross-sectional view is illustrated.
  • the test carrier system 182 may feature solely liquid reagents for the detection of a given analyte stored in blisters.
  • the sample processing unit 110 comprises a plasma separation and metering unit 244.
  • the plasma separation and metering unit 244 may comprise the sample application area 112 having the receptacle 115 as well as the filter element 118.
  • the sample processing unit 110 comprises a first liquid reagent storage blister 246 and second liquid reagent storage blister 248 respectively having chemical reagents 194.
  • the first liquid reagent storage blister 246 may be openable via piercing needles 250.
  • the piercing needles 250 may be configured for releasing chemical reagent 194 into the sample processing unit 110 via an opening 252 into a first mixing zone 254.
  • the second liquid reagent storage blister 248 may be openable via piercing needles 256 to release the chemical reagent 194 into the sample processing unit 110 via an opening 258 towards a second mixing zone 260 separated to the first mixing zone 254 via a barrier 262.
  • the sample processing unit 110 is permanently joined to the reaction and measurement cup 184.
  • the first liquid reagent storage blister 246 and/or the second liquid reagent storage blister 248 are adhesively connected to the test carrier system 110 or to the plasma separation and metering unit 244 using an adhesive film specifically to bond the first liquid reagent storage blister 246 and/or the second liquid reagent storage blister 248 at connection areas 400, 401 together. It is generally important to select an adhesive that is suitable for the specific type of material of the blisters and test carrier system and does not interfere with the reagents.
  • Figures 15A to 15J show a schematic representation of a test carrier system 110 during operation.
  • the test carrier system 110 according to Figures 15A to 15J corresponds to the test carrier system 110 according to Figure 14A to 14C.
  • Figures 14A to 14C See Figures 15A to 15J above.
  • the test carrier system 182 is placed into measurement system prior starting the measurement.
  • a sample 264 e.g. whole blood is applied to the sample processing unit 110 via e.g. pipetting the sample 264 onto the filter element 118 which may be a plasma separation membrane 266.
  • the sample 264 is actively or passively driven through the plasma separation membrane 266 and generated plasma 268 from the sample 264 is metered in the capillary 114.
  • the first liquid reagent storage blister 246 is opened, via piercing needles 250 to release a first liquid reagent 270 into the sample processing unit 110 via the opening 252 into the first mixing zone 254.
  • test carrier system 182 is tilted clockwise to elute the metered plasma 268 from the sample 264 into the first liquid reagent 270 via the first mixing zone 254. Subsequently, the test carrier system 182 is tilted back in upright position to drive the mixed plasma sample 268 and first reagent liquid 270 into the reaction and measurement cup 184. Subsequently, the second liquid reagent storage blister 248 is opened, via piercing needles 256, to release the second liquid reagent 272 into the sample processing unit 110 via the opening 258 towards the second mixing zone 260 separated from the first mixing zone 254 via a barrier 262.
  • test carrier system 182 is rotated counter clockwise to mix the plasma sample 268 and first reagent liquid 270 with the second reagent liquid 272 via the second mixing zone 260. Subsequently, the test carrier system 110 is rotated back to an upright position to drive the mixed plasma sample 268, first reagent liquid 270 and second reagent liquid 272 into the reaction and measurement cup 184 for detection of the analyte.
  • Figures 16A to 16C show a schematic representation of a further embodiment of a test carrier system 182with solely liquid reagents for the detection of a given analyte using a blister to store one liquid reagent.
  • a perspective vies is illustrated.
  • Figure 16B a partially disassembled view is illustrated.
  • Figure 16C a cross-sectional view is illustrated.
  • the test carrier system 182 features solely liquid reagents for the detection of a given analyte using a blister to store one liquid reagent.
  • the sample processing unit 110 comprises a plasma separation and metering unit 244.
  • the plasma separation and metering unit 244 may comprise the sample application area 112 having the receptacle 115 as well as the filter element 118.
  • the sample processing unit 110 comprises a liquid reagent storage blister 274.
  • an opening mechanism 276 for a sealing foil 278 is integrated.
  • a first liquid reagent 280 is located in the reaction and measurement cup 184 sealed by the sealing foil 278. The sealing foil 278 is opened by moving the sample processing unit 110 towards the reaction and measurement cup 184.
  • Figures 17A to 17H show a schematic representation of a test carrier system 110 during operation.
  • the test carrier system 110 according to Figures 17A to 17H corresponds to the test carrier system 110 according to Figure 16A to 16C.
  • Figures 16A to 16C See Figures 17A to 16C above.
  • the test carrier system 182 is placed into measurement system prior starting the measurement. Subsequently, a sample 282 e.g. whole blood is applied to the sample processing unit 110 via e.g. pipetting the sample 282 onto the plasma separation membrane 266. Subsequently, the sample 282 is actively or passively driven through the plasma separation membrane 266 and the generated plasma 268 from the sample 282 is metered in the capillary 114, 142. Subsequently, the reaction and measurement cup 184 is opened, via piercing the sealing foil 278 of the reaction and measurement cup 184 while moving the sample processing unit 110 from a first position 294 to a second position 296 via a snap fit connection 298 via the instrument.
  • a sample 282 e.g. whole blood is applied to the sample processing unit 110 via e.g. pipetting the sample 282 onto the plasma separation membrane 266.
  • the sample 282 is actively or passively driven through the plasma separation membrane 266 and the generated plasma 268 from the sample 282 is metered in the
  • test carrier system 182 is tilted clockwise to elute the metered plasma 268 from the sample 264 into the first liquid reagent 280 via a first mixing zone 284. Subsequently, the test carrier system 182 is tilted back in upright position to drive the mixed sample 286 into the reaction and measurement cup 184.
  • the second liquid reagent storage blister 274 is opened to release the second liquid reagent 288 into the sample processing unit 110 towards a second mixing zone 290 separated to the first mixing zone 284 via a barrier 292.
  • the test carrier system 182 is rotated counter clockwise to mix the plasma sample 268 and first reagent liquid 280 with the second reagent liquid 288 via the second mixing zone 290.
  • the test carrier system 182 is rotated back to an upright position to drive the mixed plasma sample 268, the first reagent liquid 280 and second reagent liquid 288 into the reaction and measurement cup 184 for detection of the analyte.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

Est divulgué un système de support de test (182). Le système de support de test (182) comprend : au moins une coupelle de réaction et de mesure (184), la coupelle de réaction et de mesure (184) étant conçue pour recevoir au moins une solution tampon (186), la coupelle de réaction et de mesure (184) comprenant au moins une fenêtre optique (190) qui est reçue dans au moins une paroi (192) de la coupelle de réaction et de mesure (184), la fenêtre optique (192) permettant une analyse optique de la solution tampon (186) ; et au moins une unité de traitement d'échantillon (110), l'unité de traitement d'échantillon (110) pouvant être fixée à la coupelle de réaction et de mesure (184), l'unité de traitement d'échantillon (110) comprenant : au moins une zone d'application d'échantillon (112), la zone d'application d'échantillon (112) étant conçue pour recevoir au moins un échantillon, la zone d'application d'échantillon (112) comprenant au moins un capillaire (114) qui s'ouvre dans un espace intérieur (116) de l'unité de traitement d'échantillon (110) ; et au moins un réactif chimique (194), le réactif chimique étant reçu à l'intérieur de l'espace intérieur (116) de l'unité de traitement d'échantillon (110) ou à l'intérieur de la coupelle de réaction et de mesure (184) ; le système de support de test (182) étant conçu pour pouvoir tourner autour d'un axe de rotation (196) du système de support de test (182), la solution tampon (186) pouvant être transportée de façon alternée jusqu'à la zone d'application d'échantillon (112) ou au réactif chimique (194) en fonction d'une direction de rotation et/ou d'un degré de rotation du système de support de test (182) autour de l'axe de rotation (196) du système de support de test (182).
PCT/EP2025/053998 2024-02-16 2025-02-14 Système de support de test Pending WO2025172513A1 (fr)

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EP24158152 2024-02-16

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5286454A (en) 1989-04-26 1994-02-15 Nilsson Sven Erik Cuvette
US5833630A (en) * 1994-11-03 1998-11-10 Kloth; Bernd Sample collection device
WO2007008137A1 (fr) 2005-07-08 2007-01-18 Hemocue Ab Cuvette et procédé et outil de conformage pour la fabrication de celle-ci
US20120045826A1 (en) * 2008-09-24 2012-02-23 Greg Yantz Kits and devices for detecting analytes
US20180207638A1 (en) * 2015-07-21 2018-07-26 Michael Ryan McNeely Automatic plasma separation and metering
US20190240667A1 (en) * 2016-07-18 2019-08-08 Siemens Healthcare Diagnostics Inc. Liquid analytical reagent dispensing apparatus and analytical kits and methods of use related thereto

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5286454A (en) 1989-04-26 1994-02-15 Nilsson Sven Erik Cuvette
US5833630A (en) * 1994-11-03 1998-11-10 Kloth; Bernd Sample collection device
WO2007008137A1 (fr) 2005-07-08 2007-01-18 Hemocue Ab Cuvette et procédé et outil de conformage pour la fabrication de celle-ci
US20120045826A1 (en) * 2008-09-24 2012-02-23 Greg Yantz Kits and devices for detecting analytes
US20180207638A1 (en) * 2015-07-21 2018-07-26 Michael Ryan McNeely Automatic plasma separation and metering
US20190240667A1 (en) * 2016-07-18 2019-08-08 Siemens Healthcare Diagnostics Inc. Liquid analytical reagent dispensing apparatus and analytical kits and methods of use related thereto

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