Device for analyzing a liquid sample

Abstract

A device (1) and a method for measuring at least one component of a liquid sample (47), in particular comprising serum, plasma and / or urine, are provided, the device comprising: a first portion (24) adapted for a receiving space (7) of the sample partially delimited at a first side (40) and comprising at least one measuring area (21); a second portion (22) comprising a receiving space wall (49), the second portion (22) being connected to the first portion (24) such that the receiving space wall (49) partially delimits the receiving space (7) at a second side (50); and a sample input cup (4) delimiting a sample input area (8) fillable with the sample, wherein the sample input area (8) is in fluid communication with the receiving space (7), wherein the receiving space wall (49) is integrally formed with at least a portion of the sample input cup (4).

Description

Technical Field

[0001] This invention relates to an apparatus and method for measuring at least one component of a liquid sample (particularly including serum, plasma, and / or urine). Furthermore, this invention relates to a method for manufacturing such an apparatus. Background Technology

[0002] Document EP3139162A1 discloses a movable measuring unit for measuring at least one component of a liquid sample, comprising a first part and a second part, and a sample supply system attached to an inlet to allow the liquid sample to be supplied to a receiving space partially provided by the second part and / or the first part.

[0003] Measurement systems for measuring electrolytes in liquids are generally known. Thus, the amount of sample to be analyzed can be applied to a single device with different specific electrodes, or a specific amount of sample can be applied to multiple electrodes combined in a single device to determine the activity of various ions. However, conventional measurement devices typically use large and complex configurations to provide suitable fluid flow across multiple electrodes. Furthermore, in conventional systems, relatively large amounts of sample solution and / or complex fluid and pump systems may be required to perform accurate measurements and / or execute the necessary preparation steps.

[0004] Therefore, an apparatus for measuring the composition of liquid samples may be needed, which mitigates at least some of the aforementioned problems. In particular, a measuring apparatus that is less complex than conventionally known apparatuses and / or does not require large quantities of samples while ensuring accurate measurement of sample composition may be required. Furthermore, a corresponding manufacturing method for producing such an apparatus may be needed. Additionally, a corresponding method for measuring the composition of liquid samples may be needed, which produces accurate measurement results, particularly for small quantities of liquid samples. Summary of the Invention

[0005] This requirement can be achieved by means of embodiments of the present disclosure, which relate to an apparatus for measuring at least one component of a liquid sample, a method for measuring at least one component of a liquid sample, and a method for manufacturing the apparatus.

[0006] According to embodiments of the present invention, an apparatus is provided for measuring at least one component of a liquid sample (particularly including serum, plasma, and / or urine), the apparatus comprising: a first portion adapted to partially define a receiving space for a sample on a first side and including at least one measuring region; a second portion including a receiving space wall portion coupled to the first portion such that the receiving space wall portion partially defines the receiving space on a second side; and a sample input cup defining a sample input region that can be filled with a sample, wherein the sample input region is in fluid communication with the receiving space, wherein the receiving space wall portion is integrally formed with at least a portion of the sample input cup.

[0007] An apparatus for measuring at least one component of a liquid sample may include a measuring unit formed by a first part and a second part joined together. This apparatus (also referred to as a measuring system or device) is particularly suitable for measuring components such as K+. + Ca ++ Na + Cl - The concentration of at least one ion and / or pH and / or HCT and / or the partial pressure of O2, CO2 and / or the concentration of glucose, lactic acid, urea, creatinine, etc. For each specific analyte, at least one separate corresponding sensitive (measuring) region can be provided. When multiple sensitive regions are provided for measuring different components of a liquid, the sensitive regions can be arranged side-by-side along the longitudinal direction of the receiving space. The receiving space can also be referred to as the measuring channel.

[0008] The measurement system can be adapted to perform potential and / or current measurements and / or conductivity measurements, i.e., measurements of potential and / or current and / or impedance. As a result of the measurements, the concentrations of different analytes can be determined, and / or the partial pressures of different gases within the sample can be determined, and / or the volume of blood cells can be determined. The measurement system can also be adapted to perform optical measurements, alternatively or additionally.

[0009] The receiving space can be specifically configured to have a channel in a longitudinal direction corresponding to the flow direction during sample supply to the receiving space. The receiving space, which is surrounded (at least partially) by a portion of the first and second portions, can be formed as a channel or groove. The receiving space can be accessed after the second portion is connected to the first portion via a sample input cup and one or more additional conduit sections.

[0010] The second part can be integrally formed and may not include any conductive material. The first part can be glued to the second part or can be otherwise connected. A seal can be arranged between the interface of the first and second parts to liquid-tightly seal the receiving space.

[0011] The measuring unit, particularly the measuring unit formed by the first and second parts connected to each other, can be configured as a consumable that can be frequently replaced (e.g., after performing a predetermined number of measurements, after a predetermined time interval, or at a fixed frequency). The measuring unit can be inserted into a receiving space, such as a measuring device. The measuring device can have processing and control capabilities for processing measurement results from at least one measuring area and / or also controlling other components of the measuring device, such as a liquid delivery system including one or more pumps.

[0012] The first and second parts can be manufactured separately. Depending on the application, the first part can be configured as a basic planar plate including one or more analyte-sensitive regions, such as one or more photoelectrodes, one or more metabolite sensors, one or more electrodes, and / or one or more current sensors. The first part may include conductors electrically connected to one or more measurement regions. When coupled or inserted into the receiving space of a measurement device, these conductors may be electrically connected to processing or control equipment to allow measurement data to be acquired from at least one measurement region. The first part may include other electronic circuitry as needed.

[0013] The second part may not include any electrical conductors. When the first and second parts are connected to each other, the receiving space for the sample may be surrounded on the first side by a portion of the first part and on the second side by the receiving space wall of the second part.

[0014] Measurements can be performed once the sample is filled into the receiving space where the measurement area may come into contact with the sample. After the sample has been filled into the sample input cup, i.e., the sample input area, the sample can be filled into the receiving space. During normal operation for preparing for or performing measurements on liquid samples, the device can be oriented in a specific orientation such that the longitudinal axis of the sample input cup is oriented substantially perpendicularly. The sample input cup may laterally define the sample input area, but may allow access to the sample input area from above, particularly via the sample input port.

[0015] After the sample is fed into the sample input area within the sample input cup, for example, as described below, the sample can be transferred to the receiving space for measurement by applying or exerting negative pressure (suction) in an area downstream of the receiving space, particularly at the output port of the receiving space. The sample to be measured and / or washing solution and / or calibration solution can be filled via the sample input cup during various steps, including performing the measurement and / or maintaining the apparatus or device used for measuring the component or preparing the measurement.

[0016] When at least a portion of the sample input cup is integrally formed with the receiving space wall of the second portion, contamination issues concerning surfaces exposed to the sample and / or calibration solution and / or washing solution can be mitigated. In particular, as observed in conventional systems, the inner surface of the sample input cup can have a smooth surface, and there must be no gaps or spaces between the connected components that could potentially allow the sample and / or calibration solution and / or washing solution to penetrate, thus leading to contamination.

[0017] Embodiments of the present invention provide a highly integrated device and method for determining, particularly in the context of a clinical chemistry analyzer, at least one component of a liquid sample, typically serum, plasma, and urine. Further, embodiments of the present invention provide a method for manufacturing a highly integrated measurement unit having a rotationally symmetric widened input side that serves as a measurement channel for a sample chamber.

[0018] This device can automatically analyze the chemical composition of at least one component of other biologically important substances (referred to as analytes) in substances such as serum, plasma, urine, or bodily fluids. As part of a biochemical test, the chemical analyzer measures the concentration and / or activity of the analyte. This device can be configured as a CC-analyzer (clinical chemistry analyzer) for use in hospital laboratories.

[0019] Because electrolytes play an important physiological role in many functions of the human body, the measurement of electrolytes in body fluids (especially sodium, potassium, and chloride) is one of the most frequently performed measurements.

[0020] Embodiments of the present invention can support the analysis of clinical samples such as serum and urine in ion-selective electrode (ISE) devices, including performing multiple tests on test solutions using multiple ion-specific analytical electrodes. Typically, the analyzer electrode (an example of a measurement area) responds to the activity of specific ions on the sample components. Typically, the sample and operating solution can be placed in front of the ion-sensitive electrode, the electromotive force (EMF) is measured and processed, and the results can be reported to the user.

[0021] Embodiments of the present invention may support one of two different technologies (i.e., direct ISE and indirect ISE).

[0022] In direct ISE, the patient's serum sample comes into direct contact with the electrode surface, and the activity of relevant ions is measured in the plasma fluid of the serum. Indirect ISE, on the other hand, involves diluting the patient's serum with a buffer solution before the sample comes into contact with the ISE membrane. Using a diluted test solution reduces the required volume of test solution (i.e., sample volume) and reduces the harmful effects of components such as proteins that may be present in high concentrations in some test solutions. This method can then calculate the electrolyte concentration in the diluted sample by assuming the plasma fluid concentration of the original sample is 93%. Because electrolytes are distributed only in the aqueous phase of plasma, while dissolved solids (primarily proteins and lipids) typically comprise the remaining 7% of the patient's plasma volume, indirect ISE analyzers use this calculation. Indirect ISE can compensate for the solids (protein / lipid) present in the sample. If the sample contains more or less than 7% solids, the results calculated by the indirect ISE method may be inaccurate. Many conditions such as diabetes, liver and kidney disease, and alcoholism can increase the concentrations of proteins and lipids in the blood, leading to hyperproteinemia and hyperlipidemia, respectively. These conditions do not affect direct ISE, but due to the dilution step, indirect ISE results depend on the solids content in the sample. When the volume of plasma solids increases, this can lead to a falsely low indirect ISE value of serum electrolytes, especially sodium, a phenomenon known as pseudohyponatremia.

[0023] Therefore, embodiments of the present invention can support a reliable ISE method (i.e., direct ISE), which enables ISE readings to be performed without the risk of systematic, very limited clinical misclassification (i.e., pseudo-normal sodium, pseudo-hypernadium), while using minimal patient samples and shortening cycle time.

[0024] According to an embodiment of the invention, the sample input cup includes a sample input port located at the top, which allows insertion of a pipette, capillary, or hollow needle, and / or wherein the sample input cup is substantially rotationally symmetrical with respect to the longitudinal axis of the sample input cup.

[0025] Therefore, liquid samples can be filled from above into the sample inlet cup using conventionally used sample containers such as pipettes, capillaries, or hollow needles. The diameter or range of the sample inlet orifice can be defined or selected as needed and can be in the range of, for example, 3 mm to 10 mm. Other values ​​are also possible. The sample inlet orifice can, for example, have a circular shape. The sample inlet orifice can be the widest part of the sample inlet cup. The diameter or range of the sample inlet cup (in a cross-sectional view) can decrease from top to bottom. When the sample inlet cup is substantially rotationally symmetric (e.g., substantially cylindrically symmetric), manufacturing can be simplified, and liquid samples can be filled in a simple manner from a sample supply device having a substantially circular cross-section.

[0026] Specifically, the entire sample input cup can be integrally formed with the receiving space wall, and further includes, for example, a material defining a receiving space output conduit that can lead to the receiving space output port.

[0027] According to embodiments of the invention, the sample input cup is funnel-shaped and / or bell-shaped and / or continuously narrows and / or continuously widens and has a apex at the bottom, and / or wherein the cross-sectional area of ​​the sample input region perpendicular to the longitudinal axis decreases from the top to the bottom of the sample input cup, the sample input region is defined by the inner surface of the sample input cup, and / or wherein the cross-sectional area of ​​the sample input region near or located at the bottom of the cup is smaller than the diameter of a water droplet with a volume between 10 μl and 50 μl, such that, in particular, the inner surface of the sample input cup is wetted with water at the bottom, and / or wherein the diameter of the sample input region or the inner surface of the sample input cup increases by more than twice from the bottom to the top of the sample input cup.

[0028] When the sample input cup is formed with a apex at the bottom, it can support the measurement of small amounts of sample that may be present in the bottom region of the sample input cup. Specifically, only a very small surface area on the inner surface of the sample input cup at the bottom can be wetted by the liquid sample, limiting potential contamination. Specifically, this device can be used to measure samples with volumes, for example, between 15 μl and 40 μl. Therefore, embodiments of the invention can, in particular, support direct ISE. As described below, the cross-section of the sample input region or the diameter or range of the inner surface of the sample input cup can correspond to the diameter of the output orifice of the sample input cup.

[0029] The cross-sectional dimension or diameter of the inner surface of the sample input cup (or sample input area) can gradually decrease from the top to the bottom of the sample input cup in a continuous or stepwise manner. As will be explained below, the gradual decrease in the cross-sectional range or diameter can allow the inner surface to be recessed, for example, at least in the bottom portion, particularly in the second region.

[0030] According to an embodiment of the invention, the sample input cup includes at least one side inlet and / or at least one side outlet, particularly including a connecting tube extending in a longitudinal direction at an angle between 30° and 60° (particularly 40° and 50°) to the longitudinal direction of the sample input cup, particularly allowing the provision of a sample manifold and / or working solution inlet and / or calibration solution inlet and / or washing solution inlet and / or waste solution or overflow liquid outlet.

[0031] Furthermore, the side inlet and / or side outlet can also be integrally formed and included in the second part of the device. The side inlet and / or side outlet can protrude obliquely from the outer surface of a wall having an inner surface for defining the sample input area. Thus, washing solution and / or calibration solution can be supplied from an external container to the sample input area as needed for measurement preparation, calibration of the measuring equipment, or cleaning of components of the measuring equipment. The side outlet can, for example, be oriented to protrude substantially perpendicular to the longitudinal axis of the sample input cup. The side outlet can, for example, serve as an overflow outlet at the top of the sample input cup.

[0032] The side inlet and / or side outlet may have a connection portion to allow the connection of a (flexible) tube. For example, the flexible tube may slide above the connection portion to allow any calibration solution or washing solution to be delivered to the sample input area via the side inlet. When liquid is guided to the sample input area via the side inlet, it exits downwards from the side inlet and flows along the inner surface of the sample input cup, thereby effectively wetting the inner surface below the side inlet or the liquid communication port between the side inlet and the sample input cup. This allows for reliable cleaning of the inner surface of the sample input cup. If more than one side inlet exists, the side inlets may be tilted at the same or different angles relative to the longitudinal axis or vertical direction of the sample input cup. The tilt angle can be selected or adjusted to achieve the desired helical flow of any solution or liquid introduced via the side inlet.

[0033] According to an embodiment of the invention, at least one side inlet is oriented and positioned relative to the sample input cup such that liquid supplied by the side inlet is discharged into the sample input cup substantially tangentially to the inner surface of the sample input cup; and / or the longitudinal direction of at least one side inlet is parallel to the tangent at the inner surface of the sample input cup, and the side inlet is positioned such that liquid supplied to the sample input cup by the side inlet wets / flows at a portion of the inner surface of the sample input cup adjacent to the liquid communication opening between the side inlet and the sample input cup; and / or the liquid communication opening between the side inlet and the sample input cup is above the level of a reference amount of liquid filled into the sample input cup.

[0034] The side inlet and / or side outlet may comprise a substantially cylindrical cavity, such as one with a circular cross-sectional shape. The inner surface of the sample input cup can be effectively and thoroughly cleaned by the supplied liquid as it drains substantially tangentially from the inner surface. Furthermore, continuous flow is achieved and overflow is prevented. The side inlet may be in fluid communication with the sample input area via a liquid communication opening. The liquid communication opening may be above the liquid level reached when, for example, the sample to be measured is filled into the sample input cup. Thus, the side inlet may not interfere with any sample liquid. The sample liquid does not wet the liquid communication opening when filling the sample input cup, thereby reducing contamination.

[0035] According to an embodiment of the invention, at least one side inlet includes a first side inlet and a second side inlet arranged at different axial positions of the sample input cup and, in particular, substantially on the laterally opposite sides of the sample input cup, wherein the first side inlet and the second side inlet specifically allow liquid to be introduced into the sample input area in a spiral flow at the inner surface of the sample input cup, thereby preventing cross-contamination and / or carryover and / or spillage and / or allowing cleaning or rinsing of the inner surface of the sample input cup, and / or wherein the side outlet includes an overflow outlet arranged axially above the first side inlet and the second side inlet.

[0036] The first and second side inlets are arranged at different vertical heights of the sample input cup, for example, to avoid interference or spillage of liquid delivered in one side inlet into the other. Embodiments may also provide first and second side inlets that are not located on laterally opposite sides, but rather closer to each other circumferentially. Helical flow at the inner surface of the sample input cup can occur directly below the liquid communication opening, without needing to continue to the bottom of the sample input cup. Conversely, liquid or solution introduced by one of the side inlets can spread across at least a portion of the inner surface of the sample input cup, which is arranged below the corresponding liquid communication opening of the side inlet in question. Thus, thorough and effective cleaning of the inner surface of the sample input cup can be achieved.

[0037] The overflow outlet can be arranged vertically above any of the side inlets, particularly above the first and second side inlets. Specifically, the overflow outlet can be located at the top or upper part of the sample input cup, where its cross-sectional area is larger than that at the vertical or axial location of any side inlet. By widening the range or diameter of the sample input cup at the top and further by providing a side outlet configured as an overflow outlet, any liquid spillage from the interior of the sample input cup to the exterior can be prevented.

[0038] According to an embodiment of the invention, the sample input cup includes an output port at the bottom (particularly in the central region of the bottom), wherein a second portion comprises material located below the output port, the material being configured to circumferentially define a particularly straight input conduit (particularly an input conduit oriented substantially along the longitudinal axis of the sample input cup) thereby providing fluid communication between the sample input region and the receiving space, wherein the outer surface of the material defining the input conduit serves as an adhesive surface, and the first portion is attached (particularly glued) to the adhesive surface.

[0039] The outlet port can provide fluid or liquid communication between the sample input area (provided by the sample input cup) and the receiving space, particularly via the input conduit. In this document, the input conduit is understood as an input conduit leading to the receiving space. Consequently, the material defining the second portion of the input conduit can also be integrally formed. Therefore, the input conduit can also be integrally formed as part of the second portion, rather than being formed as a separate element or unit. Thus, as observed in conventional systems, potential contamination of the sample liquid in gaps or spaces between connecting elements can be reduced or even avoided.

[0040] The sample input conduit can be arranged, for example, such that the longitudinal central axis of the input conduit coincides with the longitudinal central axis of the sample input cup or sample input area. This simplifies manufacturing. Furthermore, when the input conduit is substantially straight, flow resistance during the delivery of any liquid contained within the sample input cup to the receiving space (for measurement) can be reduced. Additionally, sample liquid loss can be minimized.

[0041] Providing an adhesive or interface surface for the second part simplifies the connection or coupling with the first part. The connection or coupling between the first and second parts can be liquid-tight, particularly ensuring that the receiving space is liquid-tight when the first and second parts are coupled.

[0042] According to an embodiment of the invention, the first part and the second part each include a respective interface surface region (in particular a plane), the interface surface region being provided to form an adhesive surface, the first part and the second part being mounted (in particular glued) together on the adhesive surface, and / or wherein the interface surface region of the second part is laterally offset from the input conduit axis of the input conduit toward the first side, particularly due to the material defining the input conduit on the first side.

[0043] The interface surface area can be advantageously used to join the first part and the second part. The first part and the second part can be joined by one or more different connecting devices, such as bolts, one or more clips, etc., and in particular, they can be glued together so that the respective interface surface areas come into contact with each other by adhesive. When the interface surface area of ​​the second part is laterally offset from the input conduit axis toward the first side, the input conduit can be advantageously arranged to extend in a manner that its central longitudinal axis is aligned with or coincides with the longitudinal axis of the sample input cup.

[0044] According to one embodiment of the invention, the sample input cup includes at least one of the following partitions: a first partition comprising a continuously varying diameter (particularly at the bottom), wherein the inner surface of the first partition particularly comprises an angle between 10° and 60° with respect to the longitudinal axis of the sample input cup; a second partition comprising a substantially constant diameter and having one or more inlets (particularly in the middle), wherein the inner surface of the second partition particularly comprises an angle between 0° and 10° with respect to the longitudinal axis of the sample input cup; and a third partition comprising a continuously varying diameter and / or one or more stepped varying diameters (particularly at the top), wherein the inner surface of the third partition particularly comprises an angle between 40° and 60° with respect to the longitudinal axis of the sample input cup.

[0045] A partition can be understood as a division within different vertical regions of the sample input cup. In the first partition, the inner surface of the sample input cup may, for example, have a concave shape, thereby allowing an increase in diameter in the vertically upward direction. Therefore, the angle between the tangent at the inner surface (in the longitudinal section) and the longitudinal axis can vary within the first partition. In the second partition, the angle between the inner surface of the sample input cup and the longitudinal axis can be substantially constant, and in particular, can be approximately 0°. In the third partition, the diameter or extent of the input cup can, for example, increase linearly according to the vertical position. Between the second and third partitions, the angle between the inner surface of the sample input cup and the longitudinal axis of the sample input cup can change abruptly, for example, changing between 5° and 20°. Thus, a significantly increased volume in the vertical direction can be provided within the third partition, in order to particularly prevent any spillage of liquid contained within the sample input cup.

[0046] According to embodiments of the invention, the second part is integrally formed, particularly manufactured by injection molding, and further particularly using polycarbonate, polyester, polyamide and mixtures thereof, and / or the second part, particularly the downstream receiving space, further includes: a receiving space output port, which includes a tube connector, and / or wherein the measurement area includes at least one analyte-sensitive area (particularly an ion-selective electrode), and / or a device including a sample input cup is configured to support direct ion-selective electrode measurements of undiluted samples as input via the sample input cup.

[0047] Thus, the fabrication of the second part can be simplified and performed using conventionally available techniques. The receiving space output port has a tube connector, for example, that allows the connection of a flexible tube. Downstream of the tubing, a pump, particularly a suction pump or peristaltic pump, can be provided for conveying any liquid contained in the sample input cup into the receiving space and further, for example, conveying it out of the receiving space after measurement. Depending on the intended measurement needs, the measurement area may include, for example, one or more ion-selective electrodes and / or one or more photoelectrodes and / or one or more metabolic sensors and / or one or more current sensors, etc. Thus, conventionally intended measurement procedures can be supported and the sample volume can be reduced as needed for the measurement.

[0048] According to an embodiment of the invention, the device further includes at least one suction pump connected to the receiving space output port; and / or a liquid column separator connected to the suction pump to receive liquid at the input port and configured to output liquid via the output port, particularly to the waste liquid chamber, such that the continuous liquid column between the input port and the output port of the liquid column separator is interrupted.

[0049] The suction pump can be configured, for example, as a peristaltic pump. This allows for the delivery of any liquid to and from the receiving space. The liquid column separator can be configured to prevent any continuous liquid column between the upstream and downstream regions of the liquid column separator. This reduces or even eliminates electromagnetic interference caused by electromagnetic signals connected to the conductive liquid column, thereby improving the reliability of measurement results. Specifically, due to the function of the liquid column separator, the upstream liquid can be electrically disconnected from any downstream liquid.

[0050] According to an embodiment of the invention, the liquid column separator includes at least one guide member arranged substantially vertically, having a guide surface at which inflowing liquid is collected and guided to flow downward, at least one drip edge located at the bottom of the guide member; and a bottom collection region vertically spaced from and located below the drip edge, wherein the liquid column separator is specifically formed by an upper member including the guide member and by a lower member forming the bottom collection region.

[0051] Liquid can enter the liquid column separator via the inlet port and can be guided through or along the guide surface. The liquid, guided downwards at the guide surface, can then reach the drip edge and drip from there to be collected in a bottom collection region separated from and (vertically) spaced apart from the drip edge. The bottom collection region can then communicate with the liquid output port of the liquid column separator. This provides a simple construction and simplifies manufacturing.

[0052] According to embodiments of the invention, in order to guide the liquid, two parallel and spaced-apart, particularly transparent, guiding members (e.g., guide plates) are provided, allowing the liquid to flow downward between them as a continuous liquid film, and / or wherein optical measurements can be transmitted through the transparent guide plates and the liquid therebetween.

[0053] The liquid can be guided between two parallel guiding members. Specifically, the liquid can be guided between two parallel guiding members, guiding surfaces, or guiding plates, ensuring that no air bubbles exist between the guiding plates. Therefore, one or more optical measurements (in the visible and / or infrared and / or ultraviolet spectral ranges) can be enabled. For example, one or more radiation sources, such as a light source, can be provided, and measuring light can be generated and guided through the liquid flowing between the two parallel guiding members. Furthermore, one or more detectors can be provided to measure the intensity of transmitted light passing through the liquid guided between the two parallel guiding members. Thus, further analysis of the sample can be achieved.

[0054] It should be understood that features of an apparatus for measuring at least one component of a liquid sample, disclosed, described, explained, or provided alone or in any combination, may also be applied alone or in any combination to or provide a method for measuring at least one component of a liquid sample; or a method for manufacturing an apparatus for measuring at least one component of a liquid sample according to embodiments of the present invention, and vice versa.

[0055] According to embodiments of the present invention, a method for measuring at least one component of a liquid sample (particularly including serum, plasma, and / or urine) is provided, the method comprising: filling the sample into a sample input region defined by a sample input cup; partially defining a receiving space for the sample at a first side by a first portion, wherein the first portion includes at least one measurement region; partially defining a receiving space at a second side by a receiving space wall connected to the first portion; wherein the sample input region is in fluid communication with the receiving space, wherein the receiving space wall and the sample input cup are integrally formed; the method further comprising: guiding the sample into the receiving space; and measuring the sample in contact with the measurement region.

[0056] Furthermore, according to embodiments of the present invention, a method for manufacturing an apparatus for measuring at least one component of a liquid sample is provided, the method comprising: manufacturing a first portion including at least one measuring region; manufacturing a second portion including a receiving space wall and a sample input cup; connecting the second portion to the first portion such that the receiving space is defined on a first side by the first portion and on a second side by the receiving space wall; wherein the sample input cup is configured to define a sample input region that can be filled with a sample, wherein the sample input region is in fluid communication with the receiving space, and wherein at least a portion of the receiving space wall and the sample input cup are integrally formed.

[0057] According to an embodiment, the sample input cup may, in particular, protrude entirely beyond the top of the first portion. The first portion may extend below the output port but not above it. The receiving space output port may include a tube connector arranged vertically at a level higher than the measurement area.

[0058] According to embodiments of the invention, the first part comprises a polymer formed as a printed circuit board. When using conventionally available adhesives, the polymer can be effectively adhered to the second part. Furthermore, this simplifies the manufacturing of the first part. Specifically, depending on the requirements of the measurement system and the heating / temperature detection system, conventionally available printed circuit board materials can be used, and conventionally available techniques can be applied to form copper conductive traces and / or sensor areas and / or other electronic components on the polymer. The printed circuit board can be layered.

[0059] The aspects defined above and other aspects of the invention will become apparent from the examples of embodiments described below and will be illustrated with reference to examples of embodiments. The invention will now be described in more detail with reference to examples of embodiments, but the invention is not limited to these embodiments. Attached Figure Description

[0060] Embodiments of the present invention will now be described with reference to the accompanying drawings. The present invention is not limited to the drawings or the described embodiments.

[0061] Figure 1 An apparatus for measuring at least one component of a liquid sample according to an embodiment of the present invention is illustrated schematically.

[0062] Figure 2 , Figure 3 , Figure 4 , Figure 5 The second part of an apparatus for measuring the composition of a liquid sample according to an embodiment of the present invention is schematically shown in side view, top cross-sectional view, side cross-sectional view and longitudinal cross-sectional view respectively;

[0063] Figure 6A second part of an apparatus for measuring the composition of a liquid sample according to an embodiment of the present invention is schematically shown in a side cross-sectional view.

[0064] Figure 7 A longitudinal cross-sectional view schematically illustrates an apparatus for measuring at least one component of a liquid sample according to an embodiment of the present invention; and

[0065] Figure 8 , Figure 9 , Figure 10 The liquid column separator according to an embodiment of the present invention is shown in different cross-sectional views. Detailed Implementation

[0066] Figure 1 The apparatus 1 for measuring at least one component of a liquid sample, schematically illustrated according to an embodiment of the present invention, includes a measuring unit 2 comprising a first portion and a second portion (described in detail below), wherein the first and second portions are jointly labeled with reference numeral 3. The second portion includes a sample input cup 4. The first and second portions (jointly labeled with reference numeral 3) define a receiving space 7, which is in fluid communication with a sample input region 8 disposed inside the sample input cup 4. The receiving space 7 is further in fluid communication with a receiving space output port 6.

[0067] The apparatus 1 (also referred to as a measuring device) further includes a fluid delivery system 5 connected to the receiving space output port 6 of the measuring unit 2. The fluid delivery system can be configured as a peristaltic pump. The fluid delivery system 5, provided for aspirating and positioning liquid samples (e.g., patient samples) and / or working solutions and / or calibration solutions, is fluidly connected at a first end to the receiving space output port 6 of the measuring unit 3 and at a second end to a liquid column separator 9 (also referred to as a hose line separator), which will be described in detail below. Thus, the liquid column separator 9 is connected to the delivery system 5, or in particular the aspiration pump, to receive liquid at the input port 10 and is configured to output liquid via the output port 11, thereby interrupting the continuous liquid column between the input port 10 and the output port 11 of the liquid column separator. Consequently, the hose line separator or liquid column separator 9 electrically connects the measuring unit 3 to the closed conductive liquid column and / or the conductive coating on the surface of the tube (in particular the waste pipe 13) downstream of the liquid column separator 9 to avoid electrical interference. The liquid column separator 9 is in fluid communication with the fluid delivery system 5 at the input port 10 and is connected to the waste liquid pipe 13 at the output port 11. The waste liquid pipe 13 connects the liquid column separator 9 and the waste liquid chamber 14 for collecting waste liquid.

[0068] The apparatus 1 further includes additional fluid or liquid delivery systems 15 for providing the working solution and calibration solution. These additional delivery systems 15 may typically include multiple peristaltic pumps fluidly connected (via conduit 16) to a fluid chamber 17 containing the working solution and / or calibration solution, and on the other hand, include specific inlets 19 (particularly one or more inlets 19) via conduit 18 leading to the interior 8 of the sample input cup 4. Within the fluid chamber 17, one or more containers may be provided for the working solution and / or calibration solution.

[0069] The device 1 further includes a control unit 20 communicatively connected to one or more other components of the device 1 (particularly the delivery systems 5 and / or 15 and the circuitry or electrodes of the provided measurement area 21), allowing access from the receiving space 7 to at least one sensitive area of ​​the measurement area 21. The control unit 20 can be configured to acquire measurement data and can be configured to perform signal processing and / or system control and / or power supply and / or data exchange with external equipment. Specifically, the control unit 20 can be electrically connected to the measurement unit 3 (particularly the measurement area 21) and can be electrically connected to one or more of the solution or liquid delivery systems 5, 15.

[0070] The apparatus 1 is configured to support direct ISE and / or indirect ISE methods for determining multiple ion activities in liquid samples. The highly integrated measurement unit comprises a first section (described in detail below) and includes a fluid channel with a receiving space 7. The first section includes all analyte electrodes and / or reference electrodes and / or sensors for fluid control (particularly fluid and bubble detection) and / or elements for temperature control. A sample input cup 4 serves as a sample chamber and / or sample manifold, having specific inlets 19 for working solutions and / or calibration solutions.

[0071] The first part 24 can be connected to the second part 22 by gluing at the various interface portions. The first part 24 can be configured as a flat panel, and in particular as a printed circuit board.

[0072] Sample input cup 4 defines sample input area 8, into which, for example, a sample, calibration solution, or washing solution can be filled. Part 22 includes partially defined... Figure 1 The receiving space wall (49) of the receiving space 7 shown is, for example... Figure 7 (As shown in the diagram). The sample input cup 4 is integrally formed with the receiving space wall. The measuring unit 3 may include a housing and may be designed as a consumable and insertable and retractable from other components of the measuring device.

[0073] Figure 2The second part 22 is schematically shown in a side view. In this document, the longitudinal axis 26 of the sample input cup 4 is vertically oriented to perform the measurement. The sample input cup 4 includes a sample input port 27 that allows insertion of a pipette, capillary, or hollow needle at the top. Figure 2 , Figure 3 , Figure 4 , Figure 5 In the illustrated embodiment, the sample input cup 4 is substantially rotationally symmetrical with respect to its longitudinal axis 26. For example, according to Figure 2 , Figure 5 Understandably, the sample input cup is bell-shaped and has a apex at the bottom.

[0074] The sample input cup 4 includes a first side inlet 29 and a second side inlet 30 arranged at different vertical positions (and therefore axial positions of the sample input cup 4). Further, these side inlets 29, 30 are arranged laterally on opposite sides of the sample input cup 4. The sample input cup 4 further includes a side outlet 31 located vertically above the first inlet 29 and the second inlet 30. Figure 2 It can be seen that the longitudinal axis 32 of the first inlet 29 is inclined at an angle α relative to the vertical direction 26. For example, the angle α can be in the range of 30° to 60°. The second inlet 30 can be inclined at a similar angle but in the opposite direction.

[0075] Figure 3 Along Figure 2 The cross-sectional view, marked by line AA, schematically illustrates the first section 22. In this document, the sample input region 8 is defined by the inner surface 28 of the sample input cup 4. The cross-sectional dimension, or diameter, of the inner surface 28 of the sample input cup 4 increases from the bottom to the top of the sample input cup. Figure 3 The diameter D of the sample input area 8 (or the inner surface 28 of the sample input cup 4) is shown in the figure.

[0076] Figure 4 Along Figure 2 The cross-sectional view taken by the line marked BB schematically shows the second part 22.

[0077] The first inlet 29 includes a cylindrical cavity 33 arranged to extend tangentially to the inner surface 28. Therefore, liquid supplied to the sample input region 8 via the side inlet 29 will be discharged substantially tangentially to the inner surface 28 of the sample input cup 4 into the sample input cup or sample input region 8. The cavity 33 of the side inlet 29 is in fluid communication with the sample input region 8 at its end via a liquid communication opening 34. When liquid is supplied to the sample input region 8 via the first inlet 29, the liquid will wet a portion of the inner surface 28 adjacent to the liquid communication opening 34.

[0078] If possible Figure 3 and Figure 5 As can be seen, the sample input cup 4 includes an output port 35 at the bottom, which is used to direct the liquid contained in the sample input area 8 towards the sample input area 8. Figure 2 The receiving space 7 is shown as the outlet. Between the sample input area 8 and the receiving space 7, an input conduit 36 ​​is arranged (particularly oriented and arranged along the longitudinal axis 26 of the sample input cup 4). In the illustrated embodiment, the input conduit 36 ​​is a straight conduit with a cylindrical cross-section. The receiving space 7 is arranged below the input conduit. The input conduit 36 ​​is defined by material 37 included in the second part 22.

[0079] Material 37 of the input conduit 36 ​​is limited to Figure 5 As shown in the figure, Figure 5 It shows in Figure 2 The second section 22 is a cross-sectional view taken at the section line marked CC. From Figure 5 As can be seen, the side outlet 31 provides an inner cavity 38 for conveying liquid, wherein the inner cavity 38 extends perpendicular to the longitudinal direction 26 of the sample input cup. Figure 5 The diagram also shows interface surface areas 39 disposed in the second portion 22. These interface surface areas 39 provide a way to glue the first portion 24 (in) Figure 7 The adhesion surface is shown in the image. Figure 5 It can be seen that, in particular, because material 37 defines the input conduit 36 ​​at the first side 40, the interface surface region 39 of the second portion 22 is laterally offset by a distance d from the input conduit axis 26 toward the first side 40 (e.g., Figure 7 (as shown in the image).

[0080] Figure 6 The second section 22 is schematically shown in a schematic side view. Herein, the second side inlet 30 leads via a liquid communication opening 34 to the sample input region 8 provided by the sample input cup 4. The sample input port 27 of the sample input cup 4 is arranged within the third partition 41 (particularly at the top). In the third partition 41, the diameter D of the input region 8 increases linearly, thereby increasing the vertical position along the longitudinal axis 26.

[0081] Inlets (particularly first and second inlets 30) may be located in a second section 42 of the sample input cup 4, which is vertically below the third section 41. Within the second section 42, the diameter D may be substantially constant. The sample input cup 4 further includes a first section 43 in the bottom region, which may also include an outlet 35 leading to the input conduit 36. Within the first section, the diameter D may vary continuously in the vertical direction. According to embodiments of the invention, the sample input cup may include one or more of all these regions in any combination. For example, the sample input cup 4 does not necessarily include a section with a substantially constant diameter. Inlets 30 or other inlets may alternatively be connected to or located within the first and / or third sections and the outlet.

[0082] Downstream of the receiving space 7 defined by the material of the second part 22, a receiving space output port 44 is provided with a pipe connector 45, on which, for example, a flexible tube can be pulled out. The second part 22 also partially defines a region 46 that branches off from the fluid connection path of the receiving space 7 toward the receiving space output port 44.

[0083] Region 46 (an optional feature) forms a collector, which serves as a compartment for the internal electrolyte required for potential measurement.

[0084] In order to load the liquid sample 47 contained in the sample input cup 4 (e.g., having a fill level 60 below the side inlet) into the receiving space 7, according to Figure 6 The flow direction 48 shown is used to transport the liquid. The receiving space output port 44 can, for example, be directed towards the liquid column via pump 5 and liquid column separator 9. Figure 1 The waste liquid compartment 14 shown is connected.

[0085] Figure 7 With Figure 5 The measurement unit 3 is schematically shown in the cross-sectional side view corresponding to the observation direction. The measurement unit 3 includes a second part 22 (on the second side 50) and a first part 24 (on the first side 40). The second part 22 includes a receiving space wall 49 that partially defines the receiving space 7. The first part 24 includes at least one measurement area 21 and defines the receiving space 7 on the first side 40. The receiving space wall 49 of the second part 22 defines the receiving space 7 on the second side 50. Figure 7As can be seen, the first part 24 is designed or constructed as a flat plate (particularly a printed circuit board). The first part 24 and the second part 22 are connected to each other via the interface surface area 39 of the second part 22 and the interface surface area 51 of the first part 24. The interface surface areas 39 and 51 are, in particular, planar areas. The material 37 below the output hole 35 of the second part 22 circumferentially defines the input conduit 36, which provides fluid communication between the sample input area 8 and the receiving space 7. The measuring unit 3 can be inserted into the receiving opening or receiving slot of the measuring device and can be replaced periodically as a consumable.

[0086] Figure 8 , Figure 9 , Figure 10 A liquid column separator 9 according to an embodiment of the present invention is schematically shown in a cross-sectional view, which may, for example, be included in... Figure 1 In the device 1 shown. Figure 8 It is along Figure 10 A side view of the section line marked AA; Figure 9 It is along Figure 8 The cross-sectional view marked with the BB section line; Figure 10 A top view of a liquid column separator is shown. The liquid column separator 9 includes an inlet port 10 through which liquid is input. The liquid column separator 9 is configured to output liquid via an outlet port 11, such that the continuous liquid column between the inlet port 10 and the outlet port 11 is interrupted. Therefore, the liquid column separator 9 includes a guide member having a guide surface 52 at which the inflowing liquid is collected and guided downwards, i.e., downwards in a vertical direction. The liquid column separator, or particularly the guide surface 52, includes a drip edge 53 at the bottom of the guide member 52. Liquid drips from the drip edge 53 and is collected in a bottom collection region 54. The bottom collection region 54 can be filled to a level 55 below the drip edge 53, such that the liquid within the bottom collection region 54 is electrically disconnected from any liquid at or upstream of the drip edge 53.

[0087] like Figure 10 As shown, the guiding member 52 is formed by two parallel and spaced-apart guide plates 56 and 57. Liquid is guided to flow between the guide plates 56 and 57. An optical light source and detector (not shown) may be provided to allow for one or more optical measurements for additional sample analysis. Figure 1 As shown, the liquid column separator 9 can be installed between the conveying system 5 and the waste liquid chamber 14. The bottom collection area is defined by the shell wall 58.

[0088] According to embodiments of the present invention, the following features can be applied to any of the above embodiments:

[0089] The fluid channel of the measurement unit may have a rotationally symmetric widening section (as an example of a sample input cup) at the first end of the measurement channel, which can serve as a sample chamber and / or sample manifold with specific inlets for the working solution and / or calibration solution. The diameter of the inner surface of the widening section may be increased by at least twice from bottom to top.

[0090] The lower portion of the widened section can be formed such that the sample of the test solution contacts the interior of the rotationally symmetric inner surface, thus ensuring that droplets formed at the tip of the sample delivery system (especially a pipette) are fully captured by the inner surface and the channel is completely filled. This allows for the dispensing and measurement of very small volumes of sample. The upper portion of the widened section can be formed such that at least one supply line protrudes tangentially from the rotationally symmetric surface, and the distance between the supply line and the area with the minimum surface radius is chosen such that a closed liquid column does not form in the absence of active liquid flow. This disconnects the electrical connection between the sensor area and the power supply lines of the measurement unit, subsequently leading to increased immunity to interference.

[0091] A tangentially angled connection of the supply lines can create a downward-swirling spiral flow, which better cleans the inner surfaces in contact with the test solutions (particularly patient samples and calibration and / or working solutions). The sample inlet cup may include one or more supply lines. In the presence of multiple supply lines, the location of any of these supply lines or inlets can be chosen such that the distance between the lines and the direction of the spiral flow prevent cross-contamination. The upper portion of the widened section (e.g., the supply sample inlet cup) can be formed in a way that prevents spillage and / or mitigates the effects of spillage and / or leakage of the test solutions (particularly patient samples and / or calibration and / or working solutions). This can be achieved by additionally increasing the diameter of the inner surface of the widened section and / or by having a drain line protruding from the inner surface, through which liquid can be drained in a targeted manner.

[0092] The second end of the flow channel can be in fluid communication with the fluid delivery system, which can be located adjacent to the second end of the channel.

[0093] The measuring unit (particularly the flow channel) can be integrally formed, particularly manufactured by injection molding, and further, especially using polycarbonate, polyester, polyamide, and mixtures thereof. This allows for the integration of a sample chamber and / or sample manifold with specific inlets for working and / or calibration solutions into a consumable that can be replaced periodically without cost drawbacks. Furthermore, this avoids long-term effects (such as coatings and / or surface-modified coatings on biological samples, particularly biofouling) through periodic replacement and eliminates the need for frequent, extensive cleaning and / or other maintenance activities, thereby increasing system uptime and reducing user interaction.

[0094] Fluid delivery systems (e.g., in) Figure 1 The peristaltic pump (marked by reference numeral 5 in the attached diagram) is located particularly adjacent to the second end of the channel. When activated, the pump can be used to aspirate and position test solutions, particularly patient samples and / or calibration and / or working solutions. When deactivated, pump 5 can be used as a valve. Thus, unnecessary negative pressure is not generated in the higher flow rate portions of the circulation, allowing for the aspiration and / or positioning of small amounts of test solution.

[0095] The liquid column separator 5, also known as the hose separator 5, can consist of at least two hollow bodies connected in a way that allows liquid to drip, thereby interrupting the closed liquid column. The diameter of the inner surface of the lower body exceeds the diameter of the inner surface of the upper body, and the boundary of the inner surface of the upper body penetrates the internal volume of the lower body. This creates an edge that forces the liquid to drip (e.g., Figure 8 (See edge 53). This allows for the disconnection of the electrical connection of the hose lines (especially the waste liquid line and measuring unit 3), which subsequently leads to increased immunity to interference.

[0096] The body of the liquid column separator can be provided with two parallel, transparent surfaces (e.g., Figure 10 As shown in 56, 57), the two parallel transparent surfaces are spaced apart to form a cuvette for optically determining the composition of a sample. The liquid column separator 9 can be integrally formed, particularly by injection molding, and further particularly by using polycarbonate, polyester, polyamide, and mixtures thereof.

[0097] For example, the measuring unit can be replaced periodically or after a predetermined number of measurements have been performed.

[0098] It should be noted that the term "comprising" does not exclude other elements or steps, and the use of the articles "a" or "an" does not exclude multiple. Elements described in conjunction with different embodiments can also be combined. It should also be noted that the reference numerals in the claims should not be construed as limiting the scope of the claims. Furthermore, spatially relative terms such as "front" and "rear," "upper" and "lower," "left" and "right," etc., are used to describe the relationship between one element and another as shown in the figures. Therefore, spatially relative terms can be applied to orientations different from those depicted in the figures. Obviously, since the device according to embodiments of the invention can be used in orientations different from those shown in the figures, all such spatially relative terms refer only to the orientations shown in the figures for ease of description and are not necessarily limiting.

Claims

1. An apparatus (1) for measuring at least one component of a liquid sample (47), the apparatus comprising: The first part (24) is adapted to partially define the sample receiving space (7) on the first side (40) and includes at least one measurement area (21). Part Two (22) includes: A receiving space wall (49), the second portion being connected to the first portion (24), such that the receiving space wall (49) partially defines the receiving space (7) on the second side (50); and Sample input cup (4) defines the sample input area (8) that can be filled with sample. The sample input area (8) is in fluid communication with the receiving space (7). The receiving space wall (49) is integrally formed with at least a portion of the sample input cup (4); The sample input cup (4) includes an output hole (35) located in the central region of the bottom. The second portion (22) includes a material (37) below the output port (35), the material being configured to circumferentially define an input conduit (36) that provides fluid communication between the sample input region (8) and the receiving space (7). The outer surface (39) of the material defining the input conduit is used as an adhesion surface, and the first portion (24) is attached to the adhesion surface.

2. The apparatus of claim 1, wherein at least one of the following is true: The sample inlet cup (4) includes a sample inlet port (27) at the top, allowing insertion of one of a pipette, a capillary tube, and a hollow needle; and The sample input cup (4) is substantially rotationally symmetrical with respect to the longitudinal axis (26) of the sample input cup.

3. The apparatus according to claim 1, wherein at least one of the following is true: The sample input cup (4) is bell-shaped with a apex at the bottom; The cross-sectional area (D) of the sample input region (8) perpendicular to the longitudinal axis (26) decreases from the top to the bottom of the sample input cup, and the sample input region is defined by the inner surface (28) of the sample input cup; and The cross-sectional area (D) of the sample input region near or located at the bottom of the sample input cup is smaller than the diameter of a water droplet with a volume between 10 μl and 50 μl; and The diameter (D) of the sample input area (8) or the inner surface (28) of the sample input cup increases by more than twice from the bottom to the top of the sample input cup.

4. The apparatus according to claim 1, The sample input cup (4) includes at least one of at least one side inlet (29, 30) and at least one side outlet (31), wherein the longitudinal direction (32) of the at least one side inlet (29, 30) extends at an angle (α) between 30° and 60° with respect to the longitudinal direction (26) of the sample input cup (4).

5. The apparatus of claim 4, wherein at least one of the side inlet and the side outlet allows for the provision of at least one of a sample manifold and a working solution inlet and a calibration solution inlet and a washing solution inlet, and a waste solution outlet or an overflow liquid outlet.

6. The apparatus of claim 4, wherein at least one of the following is true: The at least one side inlet (29, 30) is oriented and positioned relative to the sample input cup such that liquid supplied by the side inlet is discharged substantially tangentially into the sample input cup (4) into the sample input cup; and The longitudinal direction (32) of the at least one side inlet (29) is parallel to the tangent at the inner surface (28) of the sample input cup (4); and The side inlets (29, 30) are positioned such that liquid supplied to the sample input cup from the side inlets flows at a portion of the liquid communication opening on the inner surface of the sample input cup, immediately adjacent to the liquid communication opening between the side inlets and the sample input cup; and The liquid communication opening (34) between the side inlet (30) and the sample input cup (4) is higher than the liquid level (60) of the reference volume liquid filled into the sample input cup (4).

7. The apparatus according to claim 4, The at least one side inlet includes a first side inlet (29) and a second side inlet (30) arranged at different axial positions of the sample input cup. The first and second side inlets allow liquid to be introduced into the sample input area in a spiral flow at the inner surface of the sample input cup, thereby preventing cross-contamination.

8. The apparatus according to claim 7, The side outlet (31) includes an overflow outlet axially arranged above the first side inlet (29) and the second side inlet (30).

9. The apparatus according to claim 1, The first part (24) and the second part (22) each include a corresponding interface surface area (39, 51), the interface surface area being configured to form an adhesive surface, and the first part and the second part being mounted together at the adhesive surface.

10. The apparatus according to claim 9, Wherein, due to the material (37) defining the input conduit on the first side, the interface surface region (39) of the second part is laterally offset from the input conduit axis (26) of the input conduit (36) toward the first side.

11. The apparatus of claim 1, wherein the sample input cup comprises at least one of the following partitions: The first section (43) includes a continuously varying diameter at the bottom; The second section (42) includes a substantially constant diameter in the middle and has one or more entrances; The third section (41) includes, at the top, a continuously varying diameter or one or more progressively varying diameters.

12. The apparatus of claim 11, wherein at least one of the following is true: The inner surface of the first partition forms an angle between 10° and 60° with the longitudinal axis of the sample input cup; and The inner surface of the second partition forms an angle between 0° and 10° with the longitudinal axis of the sample input cup; and The inner surface of the third partition forms an angle between 40° and 60° with the longitudinal axis of the sample input cup.

13. The apparatus according to claim 1, The second part (22) is integrally formed by injection molding using at least one of polycarbonate, polyester, polyamide and mixtures thereof.

14. The apparatus of claim 1, wherein at least one of the following is true: The second partition further includes an acceptance space output port (44) downstream of the acceptance space, the acceptance space output port (44) including a pipe connector (45); and The measurement area (21) includes at least one analyte-sensitive region, said at least one analyte-sensitive region including an ion-selective electrode; and The device, including the sample input cup (4), is configured to support direct ion-selective electrode measurements of undiluted samples as input via the sample input cup.

15. The apparatus of claim 14, further comprising at least one of the following: At least one suction pump (5) is connected to the output port of the receiving space; A liquid column separator (9) is connected to the suction pump to receive liquid at the input port (10) and is configured to output liquid via the output port (11) such that the continuous liquid column between the input port and the output port of the liquid column separator is interrupted.

16. The apparatus of claim 15, wherein the liquid column separator comprises: At least one guide member (52) has a guide surface at which the inflowing liquid is collected and guided to flow downward. At least one drip edge (53) is located at the bottom of the guide member; The bottom collection area (54) is perpendicularly spaced from the drip edge and located below the drip edge. The liquid column separator is formed by an upper member including the guide member and a lower member forming the bottom collection area.

17. The apparatus of claim 16, wherein at least one of the following is true: Two parallel and spaced-apart guide plates (56, 57) are provided to guide the liquid, allowing the liquid to flow downward as a continuous liquid film between the guide plates; and Optical measurements are performed using transparent guide plates (56, 57) and the liquid between the guide plates.

18. A method for measuring at least one component of a liquid sample (47), the method comprising: The sample is filled into the sample input area (8) defined by the sample input cup (4); The sample receiving space (7) is partially defined by a first portion (24) on the first side (40), wherein the first portion includes at least one measurement area (21). The receiving space (7) is partially defined on the second side (50) by the receiving space wall (49) connected to the second part (22) of the first part (24). The sample input area (8) is in fluid communication with the receiving space (7). The receiving space wall is integrally formed with the sample input cup; The sample input cup (4) includes an output hole (35) located in the central region of the bottom. The second portion (22) includes a material (37) below the output port (35), the material being configured to circumferentially define an input conduit (36) that provides fluid communication between the sample input region (8) and the receiving space (7). The outer surface (39) of the material defining the input conduit is used as an adhesion surface, and the first portion (24) is attached to the adhesion surface; The method further includes: Guide the liquid sample into the receiving space (7); The sample (47) in contact with the measurement area (21) is measured.

19. The method of claim 18, wherein the liquid sample (47) comprises at least one of serum, plasma, and urine.

20. A method for manufacturing an apparatus (1) for measuring at least one component of a liquid sample, the method comprising: Manufacturing a first part (24) that includes at least one measuring area; The second part (22) is manufactured, which includes the receiving space wall (49) and the sample input cup (4); Connect the second part (22) to the first part (24): This allows the receiving space (7) to be defined by the first part (24) on the first side (40), and The receiving space (7) is partially defined on the second side (50) by the receiving space wall (49); The sample input cup (4) is configured to define a sample input area (8) that can be filled with the sample. The sample input area (8) is in fluid communication with the receiving space (7). The receiving space wall (49) is integrally formed with at least a portion of the sample input cup (4); The sample input cup (4) includes an output hole (35) located in the central region of the bottom. The second portion (22) includes a material (37) below the output port (35), the material being configured to circumferentially define an input conduit (36) that provides fluid communication between the sample input region (8) and the receiving space (7). The outer surface (39) of the material defining the input conduit is used as an adhesion surface, and the first portion (24) is attached to the adhesion surface.

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