Cartridge for multiplexed analysis of analytes and methods of using the cartridge

Abstract

Aspects of the present disclosure provide an assay cartridge that allows for the analysis of multiple chemical constituents of a sample, such as blood. In certain embodiments, the assay cartridge includes a chemical analysis module for analyzing multiple analytes. The chemical analysis module includes a top plate and a bottom plate and a plurality of channels disposed between the top plate and the bottom plate, wherein one or more of the plurality of channels contains one or more reagents that generate a detectable signal in each such channel indicative of an analyte concentration. The chemical analysis module can have a sample port to deliver a sample to the plurality of channels and one or more sensors to detect the signals generated in the channels. Also provided herein are methods of analyzing a sample, such as a plasma, serum, or blood sample, in the assay cartridges provided herein.

Description

[0001] Cross-references to related applications This application claims the benefit of U.S. Provisional Patent Application No. 63 / 612,216, filed December 19, 2023, which is incorporated herein by reference in its entirety. Background Technology

[0002] Analysis of biological samples (e.g., blood samples) typically involves testing for multiple chemical components, such as metabolites and proteins. The analysis of these biological samples is often limited by sample availability. Therefore, it is desirable to perform multiplex analysis of biological samples (especially their chemical components) using only trace amounts of the sample. Summary of the Invention

[0003] In some respects, this disclosure provides an analysis kit that includes multiple channels that allow for multiple analysis of chemical components in a sample, particularly a biological sample such as blood, serum, or plasma.

[0004] In some aspects, this disclosure provides an analysis cartridge including a chemical analysis module for multiplexing analytes in a sample. In some cases, the chemical analysis module includes a top plate and a bottom plate, and a plurality of channels disposed between the top plate and the bottom plate. In some cases, the top plate and the bottom plate have a plurality of vertical walls disposed between the top plate and the bottom plate, thereby creating the plurality of channels. The plurality of channels can extend from a proximal end to a distal end of the top plate and the bottom plate.

[0005] In some cases, one or more of the plurality of channels contain one or more reagents that generate a detectable signal in each such channel indicating the concentration of the analyte. The chemical analysis module may have a sample port at its proximal end that delivers a sample to the plurality of channels. The chemical analysis module may have one or more sensors that detect the detectable signal generated in one or more of the plurality of channels.

[0006] In some embodiments, the sample is serum or plasma. The separation of plasma from blood can be performed using plasma separation membranes or by digital microfluidics (e.g., by using agglutination or magnetic beads to separate blood cells from plasma). In some cases, the sample may be whole blood.

[0007] In some cases, the analysis kit also includes a sample delivery module configured to deliver a sample to a sample port, thereby allowing the sample to fill the channels of the chemical analysis module.

[0008] In some embodiments, the chemical analysis module includes one or more channels within the plurality of channels, each channel being configured to detect analytes such as glucose, calcium, blood urea nitrogen (BUN), creatinine, sodium, potassium, chloride ions, carbon dioxide (CO2), total serum protein (TP), serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0009] In some aspects, this disclosure also provides a chemical analysis module that allows for multiplex analysis of chemical components in samples, particularly biological samples such as blood, serum, or plasma. In some cases, the chemical analysis module includes a top plate and a bottom plate, and a plurality of channels disposed between the top plate and the bottom plate. In some cases, the top plate and the bottom plate have a plurality of vertical walls disposed between the top plate and the bottom plate, thereby creating the plurality of channels. The plurality of channels can extend from a proximal end to a distal end of the top plate and the bottom plate.

[0010] This article also provides methods for analyzing samples (such as plasma, serum, or blood samples) in the analytical kits provided herein. Attached Figure Description

[0011] Figure 1 An example of a chemical analysis module with multiple amperometric sensors is depicted.

[0012] Figure 2 An example of a chemical analysis module with a combination of amperometric and optical sensors is depicted.

[0013] Figure 3 An example of a sample delivery module including a sample drainage section is depicted.

[0014] Figure 4 An example of a sample delivery module is depicted.

[0015] Figure 5 An example of a sample delivery module including a digital microfluidic (DMF) chip is depicted. Detailed Implementation

[0016] This disclosure relates to U.S. Provisional Patent Application No. 63 / 605,046, filed December 1, 2023, the contents of which are incorporated herein by reference in their entirety.

[0017] Certain aspects of this disclosure provide analytical kits that allow for the analysis of the chemical composition of samples, such as blood samples. The analytical kits described herein can allow for comprehensive metabolic panel (CMP) analysis of blood samples.

[0018] In some cases, the chemical analysis module includes a top plate and a bottom plate, as well as multiple channels disposed between the top and bottom plates. These channels can extend from the proximal end to the distal end of the top and bottom plates.

[0019] The "proximal end" of a chemical analysis module is the location of the sample port. The "distal end" of a chemical analysis module is the opposite of the proximal end. In some cases, one or more sensors may be located at or near the distal end in one or more channels of a multi-channel system.

[0020] One or more of the multiple channels can be open to air at the distal end, allowing the sample to be loaded into the channels, for example, via capillary forces. Furthermore, the dimensions of the top plate, the bottom plate, the distance between the top and bottom plates, and the dimensions of the channels within the multiple channels ensure that the surface tension of the sample prevents it from overflowing from the distal end, thus keeping the sample within the channels.

[0021] In some cases, the top and bottom plates have multiple vertical walls disposed between them, thereby creating multiple channels. Alternatively, the top and / or bottom plates have recesses or grooves that engage with another plate to form multiple channels. For example, the top and bottom plates may have semi-circular recesses that, when joined together, form channels with a circular cross-section.

[0022] In some cases, dents or grooves may be present only on the top plate or only on the bottom plate. In such embodiments, the plate without dents or grooves may be substantially flat. When the top and bottom plates are joined together with or without adhesive, multiple channels may subsequently be formed. The channels thus formed will have the shape of dents or grooves.

[0023] The indentation or groove can be any other suitable shape to create a channel having a rectangular, square, oval, circular, elliptical, irregular cross-section, or a combination thereof. Channels with any other suitable cross-section can be used, and such embodiments are within the scope of this disclosure.

[0024] In some cases, one or more channels within a plurality of channels contain one or more reagents, which in each such channel generate a detectable signal indicating the concentration of the analyte.

[0025] In some cases, one or more channels contain one or more reagents that generate a detectable signal in each such channel indicating the concentration of the analyte, while one or more channels of a plurality of channels may have one or more reagents for detecting the analyte in addition to the reagents that generate the detectable signal. Such channels can be used as reference channels or blank channels for the corresponding analyte.

[0026] The chemical analysis module may have a sample port at the proximal end for delivering samples to multiple channels.

[0027] The chemical analysis module may have one or more sensors that detect detectable signals generated in one or more of a plurality of channels.

[0028] In some cases, the analysis kit also includes a sample delivery module configured to deliver a sample to a sample port, thereby allowing the sample to fill multiple channels of the chemical analysis module.

[0029] This article also provides methods for analyzing samples (such as plasma, serum, or blood samples) in the analytical kits provided herein.

[0030] Before describing the device and method in more detail, it should be understood that this disclosure is not limited to the specific embodiments described, as such embodiments can vary. It should also be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting.

[0031] Where a numerical range is provided, it should be understood that, unless the context explicitly specifies otherwise, every intermediate value between the upper and lower limits of the range (to one-tenth of the lower limit unit), as well as any other value or intermediate value within the range, is encompassed within the device and method. The upper and lower limits of these smaller ranges may be independently included in the smaller range and are also encompassed within the device and method, but are subject to any explicitly excluded limitations within the range. Where the range includes one or two limits, the range excluding one or both of those included limits is also included within the device and method.

[0032] Certain ranges are presented herein with numerical values ​​preceded by the term "about". The term "about" is used herein to provide literal support for the exact number it modifies and for numbers that are close to or approximate to the number it modifies. In determining whether a number is close to or approximate to a specifically stated number, a close to or approximate unstated number may be a number that provides a substantially equivalent number to the specifically stated number in the context in which it is presented.

[0033] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In the event of conflict, this document (including the definitions) shall prevail. Preferred methods and materials are described below, although similar or equivalent methods and materials may be used in practice or testing of this disclosure. All publications, patent applications, patents, and other references mentioned herein are incorporated herein by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and are not intended to be limiting.

[0034] This disclosure can be more readily understood by referring to the following detailed description of the desired embodiments and the examples included therein. In the following description and claims, reference will be made to several terms, which should be defined as having the following meanings.

[0035] As used herein, the terms “comprising,” “including,” “having,” “having,” “may,” “containing,” and variations thereof are intended as open-ended transitional phrases, terms, or words that do not exclude the possibility of additional actions or structures. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” include plural references. This disclosure also covers other embodiments that “comprising” the embodiments or elements presented herein, “consisting of… (an embodiment or element),” and “consisting substantially of… (an embodiment or element),” whether or not they are explicitly stated. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” include plural references.

[0036] This document uses the term "comprising" to require the presence of the listed components and permits the presence of other components. The term "comprising" should be interpreted as including the terms "substantially composed of" and "composed of". "Substantially composed of" permits the presence of the listed components as well as other components that do not alter the function / structure of the listed components. "composed of" permits the presence of the listed components as well as any adhesives or other bonding means used to attach the listed components.

[0037] The numerical value should be understood to include the same numerical value when reduced to the same number of significant digits, and a numerical value whose difference from the value is less than the experimental error of conventional measurement techniques of the type described in this application used to determine the value.

[0038] For the statements of numerical ranges in this paper, each intermediate value with the same precision is explicitly considered. For example, for the range 6–9, the numbers 7 and 8 are considered in addition to 6 and 9, and for the range 6.0–7.0, the numbers 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, and 7.0 are explicitly considered.

[0039] All ranges disclosed herein include the stated endpoints and are independently combinable (e.g., the range “from 2 grams to 10 grams” includes the endpoints 2 grams and 10 grams, as well as all intermediate values). The endpoints of the ranges and any values ​​disclosed herein are not limited to precise ranges or values; they are precise enough to include values ​​that approximate these ranges and / or values.

[0040] The modifier “about” used with quantity includes the stated value and has a meaning determined by the context. When used in the context of a range, the modifier “about” should also be considered to disclose a range defined by the absolute values ​​of the two endpoints. For example, a range of “from about 2 to about 10” also discloses a range of “from 2 to 10”. The term “about” can refer to plus or minus 10% of the indicated number. For example, “about 10%” can indicate a range of 9% to 11%, and “about 1” can mean 0.9 to 1.1.

[0041] It should be noted that many of the terms used in this document are relative terms. For example, the terms “upper” and “lower” are relative to each other in position, that is, in a given orientation, the upper component is located at a higher height than the lower component, but these terms may change if the components are flipped. The terms “inlet” and “outlet” are relative to the fluid flowing through them and to a given structure; for example, fluid flows into the structure through an inlet and flows out of the structure through an outlet.

[0042] The terms “horizontal” and “vertical” are used to indicate directions relative to an absolute frame of reference (i.e., the ground plane). However, these terms should not be interpreted as requiring structures to be absolutely parallel or absolutely perpendicular to each other. For example, the first vertical structure and the second vertical structure are not necessarily parallel to each other. The terms “top” and “bottom” are used to refer to surfaces where the top is always higher than the bottom relative to an absolute frame of reference (i.e., the Earth’s surface). The terms “upward” and “downward” are also relative to an absolute reference; upward always goes against Earth’s gravity, while downward always goes towards Earth’s gravity.

[0043] The term “parallel” should be interpreted in its common sense (two surfaces that maintain a roughly constant distance between them) rather than in its strict mathematical sense (these surfaces never intersect when extended to infinity).

[0044] All publications and patents referenced in this specification are incorporated herein by reference as if each individual publication or patent were specifically and individually indicated to be incorporated by reference, and are incorporated herein by reference to disclose and describe methods and / or materials relating to the referenced publications. References to any publication refer to its disclosure prior to its filing date and should not be construed as an admission that the invention is not entitled to a prior art invention prior to that publication. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0045] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. It should also be noted that claims can be drafted to exclude any optional elements. Therefore, this statement is intended as a prior basis for the use of exclusive terms such as “alone,” “only,” etc., in relation to the statement or “negative” limitation of claim elements.

[0046] As will be apparent to those skilled in the art upon reading this disclosure, each individual embodiment described and illustrated herein has discrete components and features that can be readily separated from or combined with features of any of the other embodiments without departing from the scope or spirit of the apparatus and method. Any stated method may be performed in the order of the stated events or in any other logically possible order.

[0047] equipment As summarized above, certain aspects of this disclosure provide analytical kits for analyzing the chemical composition of biological samples, such as blood, plasma, or serum samples. Furthermore, certain aspects of this disclosure provide analytical kits that allow for the analysis of small-volume samples.

[0048] Suitable samples for analysis in the analytical kits disclosed herein may include blood, urine, saliva, sweat, sputum, semen, mucus, tears, lymph, amniotic fluid, interstitial fluid, bronchoalveolar lavage fluid, cerebrospinal fluid, feces, etc. Samples may also include extracts obtained by immersing swabs in a suitable buffer solution. For example, nasal or pharyngeal swabs may be immersed in a buffer solution (such as saline) to prepare a sample that can be analyzed in the analytical kits disclosed herein. Samples may also be tissue lysates produced in a suitable buffer solution. Additional samples that can even be analyzed in the analytical kits disclosed herein are readily identifiable by those skilled in the art, and such embodiments are within the scope of this disclosure.

[0049] Certain biological samples that will be analyzed in the analytical kits disclosed herein include venous blood, capillary blood, serum, or plasma.

[0050] As used herein, “subject” refers to any vertebrate, including but not limited to mammals (e.g., cattle, pigs, camels, alpacas, horses, goats, rabbits, sheep, hamsters, guinea pigs, cats, dogs, rats and mice, non-human primates (e.g., monkeys, such as cynomolgus monkeys or rhesus monkeys, chimpanzees, etc.) and humans). In some embodiments, the subject may be human or non-human. In some embodiments, the subject is human. The subject or patient may be receiving other forms of treatment.

[0051] In some embodiments, the analysis kit includes a chemical analysis module. In some cases, the chemical analysis module allows for multiplex analysis of analytes in the sample.

[0052] In some embodiments, the chemical analysis module includes a top plate and a bottom plate, and a plurality of channels disposed between the top plate and the bottom plate. The plurality of channels can extend from the proximal end to the distal end of the top plate and the bottom plate.

[0053] In some cases, the top and bottom plates have multiple vertical walls disposed between them, thereby creating multiple channels. Alternatively, the top and / or bottom plates have recesses or grooves that engage with another plate to form multiple channels. For example, the top and bottom plates may have semi-circular recesses or grooves that, when joined together, form channels with a circular cross-section. The recesses or grooves can be any other suitable shape to create channels with rectangular, square, oval, circular, or elliptical cross-sections. Channels with any suitable cross-section can be used, and such embodiments are within the scope of this disclosure. In some cases, the recesses or grooves may be present only on the top plate or only on the bottom plate. In such embodiments, the plate without recesses or grooves may be substantially flat. When the top and bottom plates are joined together with or without adhesive, multiple channels can subsequently be formed. The channels thus formed will have the shape of recesses or grooves.

[0054] The top and bottom plates can be made of any suitable material, such as polyethylene terephthalate (PET). Alternatively, the top and / or bottom plates may comprise laser-ablated gold or platinum electrodes on a PET sheet. The top and bottom plates can be made of flexible or rigid plastic. The top and bottom plates can be transparent, translucent, or opaque independently of each other. In some cases, the top plate has a different level of transparency than the bottom plate.

[0055] In some cases, the multiple vertical walls between the top and bottom plates are made of adhesive. For example, adhesive lines of a suitable pattern can be applied to the top and / or bottom plates. The top and bottom plates can then be brought into contact with each other, for example, by pressing them together, such that the adhesive lines facilitate the bonding of the top and bottom plates, thereby also forming a channel that includes the top and bottom plates and the vertical walls of adhesive.

[0056] In some cases, the adhesive applied to the top and / or bottom plates is a pressure-sensitive adhesive. Some examples of such adhesives include acrylic adhesives or silicone adhesives. In some cases, the adhesive is a medical-grade adhesive.

[0057] In some cases, roll-to-roll manufacturing is used to bring the top and bottom plates, including the adhesive lines, into contact to create a chemical analysis module that includes multiple channels.

[0058] In some cases, the top plate includes columns extending downward into the channels. Such columns facilitate sample filling of the channels because they induce capillary action. For example, a sample introduced at the sample port can be filled into multiple channels of the chemical analysis module via capillary action or wicking, which can be facilitated by columns extending downward from the top plate into the multiple channels.

[0059] In some cases, the distance between the top and bottom plates of the chemical analysis module is between 10µm and 100µm, such as 10µm, 15µm, 20µm, 15µm, 30µm, 35µm, 40µm, 45µm, 50µm, 55µm, 60µm, 65µm, 70µm, 75µm, 80µm, 85µm, 90µm, 95µm, or 100µm.

[0060] In some cases, one or more channels of a plurality of channels contain one or more reagents that generate a detectable signal in each such channel indicating the concentration of the analyte. In other cases, in addition to the reagents that generate the detectable signal, one or more channels have one or more reagents for detecting the analyte. Such channels can be used as reference channels or blank channels for the corresponding analyte.

[0061] The chemical analysis module may include a sample port at the proximal end for delivering samples to multiple channels.

[0062] In some cases, the chemical analysis module may have one or more sensors that detect detectable signals generated in one or more of a plurality of channels.

[0063] In some cases, the sensor is located within or near a channel of multiple channels and detects detectable signals generated within the channel. The sensor can also be located at any suitable location within the channel, such as in the middle of the channel or at the far end of the channel.

[0064] The term "located within the channel" indicates that the sensor is completely or partially enclosed within the channel, such as in any suitable location, such as the middle or far end of the channel.

[0065] The term "(located) near the channel" indicates that the sensor is at a certain distance from the channel but can detect signals generated in the channel.

[0066] Sensors located within or near channels can detect electrochemical signals, such as current or charge generated within the channel. For example, an amperometric sensor can detect current generated within a channel. Similarly, a potentiometric sensor can detect charge generated within a channel.

[0067] Sensors located within or near the channel can also detect chemical signals, such as oxygen generated within the channel. Coulomb sensors can detect oxygen generated within the channel.

[0068] In some cases, the sensor is pointed at the channel and detects the detectable signal generated in the channel.

[0069] The term "sensor pointing at a channel" means that a sensor may be physically located within or near a channel, or it may not be located within or near a channel, but rather in a suitable position to detect detectable signals generated within the channel. For example, an optical sensor may be positioned to detect optical signals generated within a channel. Therefore, in some cases, a chemical analysis module includes one or more optical sensors that are pointed at one or more channels to detect optical signals generated within those channels.

[0070] In one or more channels within a chemical analysis module, an appropriate sensor detects the generated signal, depending on the signal being generated. For example, to detect a current generated in a channel, the channel may include an amperometric sensor. To detect oxygen, the channel may include a coulometric sensor. To detect charge, the sensor may include a potential sensor. To detect optical signals, an optical sensor may be pointed at the channel. The optical sensor may be a CCD (charge-coupled device) sensor or a CMOS (complementary metal-oxide-semiconductor) sensor.

[0071] The chemical analysis module may have only an ampere sensor, only a potential sensor, only a coulometric sensor, only an optical sensor, or a combination thereof.

[0072] For example, the detectable signal generated in one or more channels in the first group of multiple channels can be an electrochemical signal, and the corresponding sensor can be an amperometric sensor or a potentiometric sensor; the detectable signal generated in one or more channels in the second group of multiple channels can be an optical signal, and the corresponding sensor can be an optical sensor; and the detectable signal generated in one or more channels in the third group of multiple channels can be oxygen, and the corresponding sensor can be a coulometric sensor. Therefore, in multiple channels, a combination of amperometric sensors, potentiometric sensors, coulometric sensors, and optical sensors can be used to detect the signals generated in the corresponding channels.

[0073] The electrochemical signals generated in two or more channels of a multi-channel system can be different from each other, for example, as different ions or different chemical substances that can be detected. Therefore, different sensors can be implemented in different channels of a multi-channel system.

[0074] Similarly, the optical signals generated in two or more channels of a multi-channel system can be different from each other, for example, different wavelengths of the optical signals can be detected. Therefore, different optical sensors can be implemented to detect signals from different channels of a multi-channel system.

[0075] Additional detectable signals for determining chemical substance concentrations and corresponding sensors can be generated, as are known in the art, and such embodiments are within the scope of this disclosure.

[0076] In some exemplary embodiments, the analysis box includes two or more channels of a plurality of channels, said two or more channels including the following combinations of sensors: One or more electrochemical sensors and one or more optical sensors; One or more electrochemical sensors and one or more chemical sensors; One or more optical sensors and one or more chemical sensors; One or more ampere sensors and one or more potential sensors; One or more ampere sensors and one or more coulomb sensors; One or more ampere sensors and one or more optical sensors; One or more potential sensors and one or more optical sensors; One or more potential sensors and one or more coulomb sensors.

[0077] In some cases, the channel width is between 0.1 mm and 1 mm, such as 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, or 1 mm. The widths of different channels within multiple channels in a chemical analysis module can differ from each other.

[0078] In some embodiments, the channel length is between 5 mm and 100 mm, such as 5 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, 60 mm, 65 mm, 70 mm, 75 mm, 80 mm, 85 mm, 90 mm, 95 mm, or 100 mm. The lengths of different channels within the multiple channels of the chemical analysis module can differ from each other.

[0079] Depending on the distance between the top and bottom plates, the width of the channel, and the length of the channel, the channel volume can be between 5 µl and 10 µl. In some embodiments, the distance between the top and bottom plates, the width of the channel, and the length of the channel are selected such that the channel volume is between 0.01 µl and 1 µl, such as 0.01 µl, 0.05 µl, 0.1 µl, 0.2 µl, 0.3 µl, 0.4 µl, 0.5 µl, 0.6 µl, 0.7 µl, 0.8 µl, 0.9 µl, or 1.0 µl.

[0080] The reagents provided in the channels within the multi-channel system are designed to detect analytes and provide detectable signals indicating analyte concentrations. Analytes detected in different channels of the multi-channel system may include glucose, calcium, BUN, creatinine, sodium, potassium, chloride, CO2, TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0081] Various methods for detecting each of the above analytes are known in the art. Various reagents for detecting each of the above analytes are also known in the art. Therefore, channels comprising specific reagents designed to detect one or more of the above analytes are within the scope of this disclosure. Furthermore, reagents and methods for detecting additional analytes are known in the art, and apparatus comprising such reagents for detecting such additional analytes is within the scope of this disclosure.

[0082] In some cases, channels in multiple channels are configured to analyze analytes selected from the following: glucose, calcium, BUN, creatinine, sodium, potassium, chloride, CO2, TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0083] In some embodiments, two or more of the multiple channels are configured to analyze two or more analytes selected from: glucose, calcium, BUN, creatinine, sodium, potassium, chloride, CO2, TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0084] For example, the chemical analysis module may have 17 channels, each configured to analyze one analyte selected from the following: glucose, calcium, BUN, creatinine, sodium, potassium, chloride, CO2, TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipase. Therefore, the chemical analysis module can analyze all of the following analytes: glucose, calcium, BUN, creatinine, sodium, potassium, chloride, CO2, TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipase. In addition to these 17 channels, additional control / reference / blank channels may be included within the multiple channels.

[0085] In some cases, multiple channels of the chemical analysis module are designed to provide CMP for blood samples. In such cases, the chemical analysis module may have multiple channels configured to analyze a combination of the following analytes: glucose, calcium, sodium, potassium, carbon dioxide, chloride, albumin, TP, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, BUN, and creatinine.

[0086] In some cases, the kit includes a module for separating plasma from blood cells in a blood sample. The separated plasma can then be delivered to the sample port.

[0087] The plasma separation module may include a filter for separating plasma from blood cells in a blood sample.

[0088] The plasma separation module may also include a DMF chip for separating plasma from blood cells in a blood sample. Typically, the DMF chip includes: a first substrate; a second substrate; a gap separating the first and second substrates; and a plurality of electrodes that generate an electrically driven force on a droplet comprising blood and one or more reagents to transport the droplet between the first and second substrates. One or more reagents in the DMF for separating plasma from blood may include one or more agglutinants or magnetic beads. The agglutinants or magnetic beads can adhere to blood cells, which can selectively move away from the liquid portion of the blood (i.e., plasma) via the DMF electrodes.

[0089] An exemplary DMF-based plasma separation microfluidic device is described in Dixon et al. (2020), Lab on a Chip, 20, 1845, which is incorporated herein by reference in its entirety.

[0090] exist Figure 1-2 An exemplary embodiment of an analysis kit including a chemical analysis module is provided.

[0091] Figure 1The exemplary embodiment shown includes an analysis cartridge 100, which includes a chemical analysis module 101, the chemical analysis module including a sample port 103 at its proximal end. The sample port 103 can receive a sample from a sample delivery module. The sample may be plasma, serum, or blood. Any other suitable sample may also be loaded into the chemical analysis module, and such embodiments are within the scope of this disclosure.

[0092] The chemical analysis module 101 may include a top plate and a bottom plate, wherein the top plate and the bottom plate are in Figure 1 The perspective view shown is not clear. The top panel can be transparent, opaque, or translucent. Figure 1 In this configuration, the top plate can be transparent, opaque, or translucent, but is not shown to make the lower channels in the chemical analysis module visible. The bottom plate lies below the channels and can also be transparent, opaque, or translucent.

[0093] Different channels 102 are formed by a top plate, a bottom plate, and a vertical wall 105. The channels 102 are open to air at their distal ends, thereby facilitating the filling of the channels via capillary forces.

[0094] Multiple ampere sensors 104 are located at the distal end of the chemical analysis module. In this embodiment, all channels include ampere sensors.

[0095] exist Figure 2 Another exemplary embodiment of the analysis cartridge is shown in the figure. In this figure, the analysis cartridge 200 includes a chemical analysis module 201, which includes a sample port 203 at its proximal end. A sample delivery module (not shown) can deliver a sample to the sample port 203. The sample can be plasma, serum, or blood. Any other suitable sample can also be loaded into the chemical analysis module, and such embodiments are within the scope of the invention.

[0096] The chemical analysis module 201 may include a top plate and a bottom plate, wherein the top plate and the bottom plate are in Figure 2 The perspective view shown is not clear. The top panel can be transparent, opaque, or translucent. Figure 2 In this configuration, the top plate can be transparent, opaque, or translucent, but is not shown to make the channels below visible in the chemical analysis module. The bottom plate lies below the channels and can also be transparent, opaque, or translucent. The top plate can have a different level of transparency than the bottom plate.

[0097] Multiple channels 202 are formed by a top plate, a bottom plate, and a vertical wall 206. The distal ends of the channels 202 are open to air, thereby facilitating the filling of the channels via capillary forces.

[0098] Channel 204 is designed to generate electrochemical current signals. These electrochemical current signals are detected by amperometric sensor 207. Although Figure 2 A number of channels 204 are shown together to generate an electrochemical current signal and have an ampere sensor 207, but such channels and sensors can exist in any of the one or more channels.

[0099] exist Figure 2 In this configuration, channel 205 is designed to generate an optical signal indicated by oval 208. One or more optical sensors (not shown) can be pointed at channel 205 to detect the optical signal 208.

[0100] Therefore, in Figure 2 In the embodiments shown, some channels generate electrochemical signals, and some channels generate optical signals. Corresponding sensors are placed or configured accordingly.

[0101] In some cases, the sample delivery module is configured to deliver samples to the sample port. In some cases, samples between 100 nmol and 200 µl are delivered. In some embodiments, the sample delivery module is configured to deliver samples with volumes between 2 µl and 50 µl to the sample port, such as 2 µl, 5 µl, 10 µl, 15 µl, 20 µl, 25 µl, 30 µl, 35 µl, 40 µl, 45 µl, 50 µl, 55 µl, 60 µl, 65 µl, 70 µl, 75 µl, 80 µl, 85 µl, 90 µl, or 100 µl. The samples delivered to the sample port are filled in different channels. Depending on the geometry of the different channels, different volumes of samples can be filled in different channels.

[0102] In some cases, the sample delivery module includes a sample chamber, a sample drainage section, and a sample filling component.

[0103] In some cases, the sample loading mechanism can load the sample into the sample chamber. Any suitable fluid motion mechanism can be used to load the sample into the sample chamber. For example, appropriate positive or negative pressure can be applied to the sample to introduce it from other parts of the analyzer into the sample chamber. For example, the sample can be moved into the sample chamber via diffusion, convection, pumping, pressure application, gravity-driven flow, density gradient, temperature gradient, chemical gradient, pressure gradient (positive or negative), pneumatic pressure, gas-generating chemical reaction, centrifugal flow, capillary pressure, wicking, electric field-mediated, electrode-mediated, electrophoresis, dielectrophoresis, magnetophoresis, magnetic field, magnetically driven flow, optical force, chemotaxis, phototaxis, surface tension gradient driven flow, Marangoni stress, thermocapillary convection, surface energy gradient, sonication, surface acoustic waves, electroosmosis, thermophoresis, electrowetting, photowetting, pipettes, peristaltic pumps, syringe pumps, pressure-driven flow-controlled pumps, etc.

[0104] The sample chamber is fluidly connected to the sample port, and the sample added to the sample chamber is delivered to the sample port. At the sample port, the delivered sample fills the channels of the chemical analysis module.

[0105] In some cases, the sample chamber is also fluidly connected to a sample drain. When the sample arrives at the sample port, it fills the channels of the chemical analysis module. Capillary action can facilitate this filling of the channels. In some cases, when the chemical analysis module is substantially filled with sample, back pressure from the sample prevents further movement of the sample into the channels. Excess fluid is then drained from the sample chamber to the fluidly connected sample drain.

[0106] Various parameters of the sample drainage section can be adjusted. For example, the depth of the sample drainage section can be between 0.1 mm and 1 mm, such as 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, or 1.0 mm. Furthermore, the length of the sample drainage section can be between 10 mm and 100 mm, such as 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, or 100 mm. The width of the sample drainage section can be between 0.5mm and 1.5mm, such as 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.05, 1.1, 1.15, 1.2, 1.25, 1.3, 1.35, 1.4, 1.45 or 1.5mm.

[0107] Figure 3 An embodiment of an analysis cartridge including a sample delivery module is shown, which delivers a sample to a sample port and includes a sample drainage section. The analysis cartridge 300 includes a chemical analysis module 301 and a sample delivery module 303.

[0108] The sample delivery module 303 includes a sample chamber 307. A sample filling member (not shown) delivers a sample into the sample chamber 307, which is fluidly connected to and thus delivers the sample to the sample port 302. The sample delivered to the sample port can be capillarily filled into a channel 306. At the distal end of the chemical analysis module, the channel has a sensor 305 for detecting a detectable signal generated in the respective channel. Although Figure 3 The sensor shown is an ampere sensor, but any other sensor or combination of sensors can be used.

[0109] The sample chamber 307 is fluidly connected to the sample drainage section 304. For example... Figure 3 As shown, the sample drainage section 304 includes two channels, each of which is fluidly connected to the sample chamber.

[0110] In some cases, the sample delivery module includes a sample chamber fluidly connected to a sample port of the chemical analysis module. This fluid connection to the sample port can be used to deliver samples to the chemical analysis module. Figure 4 An exemplary analysis box for this embodiment is provided. Figure 4 In this process, the sample chamber 403 can be filled with a sample using a sample filling component (not shown).

[0111] The chemical analysis module 401 includes multiple channels 406 and a sensor 407. The multiple channels 406 are open to air. Once a sufficient amount of sample is added to the sample chamber 403, the sample is delivered to the sample port 404. The sample can then enter the channels of the chemical analysis module, for example, via capillary action. As the sample fills the chemical analysis module, it expels air until the channel is completely filled. The dimensions of the chemical analysis module / channel are designed such that the surface tension of the sample at the edges of the open channels prevents the sample from overflowing from the far ends of the channels. The surface tension also provides sufficient back pressure to prevent further sample from entering the channels.

[0112] In some cases, the sample delivery module includes a DMF chip for delivering a sample to sample port 404. As is known in the art, the DMF chip includes: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrical driving force on a sample droplet between the first substrate and the second substrate to transport the sample droplet.

[0113] In some embodiments, the DMF chip includes a first substrate and a second substrate, wherein the second substrate is positioned above the first substrate and separated from it by a gap. The first or second substrate may include a plurality of DMF electrodes. The plurality of DMF electrodes may be an electrode array or a series of electrodes, which are individually controllable for activation and deactivation. The plurality of DMF electrodes may be covered with an insulating material to electrically isolate the DMF electrodes. In some embodiments, the space / gap between the first and second substrates may be filled with air or an inert fluid, such as oil. In an exemplary embodiment, a series of DMF electrodes may be disposed on the first substrate, and a single electrode may be disposed on the second substrate in a face-to-face configuration with the series of electrodes on the first substrate. The series of electrodes and the single electrode may be covered with an insulating layer. In other cases, the series or plurality of electrodes on the first substrate may be configured as coplanar electrodes, and the second substrate may not include electrodes. Various configurations of DMF electrodes are known in the art and are described, for example, in U.S. Patent No. 11,016,053, which is incorporated herein in its entirety. Any of these configurations of DMF electrodes may be present in the analytical cassettes disclosed herein.

[0114] Figure 5 An exemplary analysis cartridge 500 is provided, which includes a DMF chip 501 for transferring a sample into a chemical analysis module 504. The sample can be supplied from a sample chamber 502 to the DMF chip. The DMF chip moves the sample from the sample chamber to a sample port 505 of the chemical analysis module 504. An optional wicking pad 503 can absorb excess sample that does not enter the chemical analysis module 504.

[0115] In some cases, the DMF chip includes one or more drying agents that facilitate sample movement above the DMF electrode. The DMF electrode may be coated with a surfactant, namely ethylenediaminetetra(ethoxylate-block-propoxylate)tetraol (90r4 or Tetronic 904). TM Compared to electrodes without it, Tetronic 904 TM To promote better droplet movement, any suitable surfactant can be used. In some cases, the electrodes include EDTA, which prevents blood samples from clotting when operating in a DMF chip.

[0116] Chemical Analysis Module Certain aspects of this disclosure provide a chemical analysis module for performing multiplex analysis of analytes in a sample.

[0117] In some cases, the chemical analysis module includes: A top plate and a bottom plate, and a plurality of channels disposed between the top plate and the bottom plate, wherein one or more of the plurality of channels contain one or more reagents, the one or more reagents generating a detectable signal in each such channel indicating the concentration of an analyte; Delivering the sample to the sample ports of the plurality of channels; and One or more sensors that detect the detectable signal generated in one or more of the plurality of channels.

[0118] Certain details of the chemical analysis modules described elsewhere in this disclosure regarding the analytical kits of this disclosure also apply to the chemical analysis modules disclosed herein. Such details are incorporated herein by reference in their entirety.

[0119] The plurality of channels can extend from the proximal end to the distal end of the top plate and the bottom plate.

[0120] The multiple channels can be formed using the top plate and / or the bottom plate, which have indentations or grooves forming the multiple channels. The cross-section of each of the multiple channels can be rectangular, square, oval, circular, elliptical, or irregular in shape.

[0121] In some cases, the multiple channels are formed via multiple vertical walls disposed between the top plate and the bottom plate. In some cases, the multiple vertical walls disposed between the top plate and the bottom plate include an adhesive.

[0122] In certain cases, within the chemical analysis module, one or more sensors are located within or adjacent to a channel and detect the detectable signal generated within the channel. For example, the sensor may be located in the middle of the channel or at the distal end of the channel.

[0123] In some cases, the sensor may be an amperometric sensor that detects the current generated in the channel. The sensor may also be a potential sensor that detects the charge generated in the channel. Alternatively, the sensor may be a coulometric sensor that detects the oxygen generated in the channel.

[0124] In some cases, one or more of the sensors are pointed at the channel and detect the detectable signal generated in the channel. Such a sensor may be an optical sensor that detects an optical signal generated in the channel. The optical sensor may be a CCD sensor or a CMOS sensor.

[0125] In some cases, within the multiple channels of the chemical analysis module, the detectable signal generated in one or more channels of a first group is an electrochemical signal, and the corresponding sensor is an amperometric sensor and / or a potentiometric sensor. Similarly, within the multiple channels of the chemical analysis module, the detectable signal generated in one or more channels of a second group is an optical signal, and the corresponding sensor is an optical sensor. Furthermore, within the multiple channels of the chemical analysis module, the detectable signal generated in one or more channels of a third group is oxygen, and the corresponding sensor is a coulometric sensor.

[0126] In some cases, two or more of the multiple channels comprise the following combinations of sensors: One or more electrochemical sensors and one or more optical sensors; One or more electrochemical sensors and one or more chemical sensors; One or more optical sensors and one or more chemical sensors; One or more ampere sensors and one or more potential sensors; One or more ampere sensors and one or more coulomb sensors; One or more ampere sensors and one or more optical sensors; One or more potential sensors and one or more optical sensors; One or more potential sensors and one or more coulomb sensors.

[0127] For example, the detectable signal generated in one or more channels in the first group of the plurality of channels is an electrochemical signal, and the corresponding sensor is an amperometric sensor and / or a potentiometric sensor; the detectable signal generated in one or more channels in the second group of the plurality of channels is an optical signal, and the corresponding sensor is an optical sensor; and the detectable signal generated in one or more channels in the third group of the plurality of channels is oxygen, and the corresponding sensor is a coulometric sensor.

[0128] In some cases, the top plate includes a column extending downward into the channel. Such a column facilitates the filling of the channel with samples via capillary action.

[0129] In some cases, the distance between the top plate and the bottom plate is between 10µm and 100µm. The longest dimension in the cross-section of the channel can be between 0.1mm and 1mm. Furthermore, the length of the channel can be between 5mm and 100mm. In some cases, the volume of one or more channels within the plurality of channels is between 0.01µl and 1µl.

[0130] In some cases, channels of the chemical analysis module disclosed herein are configured to detect analytes selected from: glucose, calcium, blood urea nitrogen (BUN), creatinine, sodium, potassium, chloride ions, carbon dioxide (CO2), total serum protein (TP), serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0131] In some cases, multiple channels are configured to detect two or more analytes selected from the following: glucose, calcium, BUN, creatinine, sodium, potassium, chloride, carbon dioxide (CO2), TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0132] In even more advanced cases, multiple channels are configured to detect two or more analytes selected from the following: glucose, calcium, sodium, potassium, carbon dioxide, chlorine, albumin, TP, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, BUN, and creatinine.

[0133] Certain aspects of this disclosure provide analytical kits that include the chemical analysis modules disclosed herein.

[0134] In addition to the chemical analysis module, the analysis kit may also include a plasma separation module for separating plasma from blood cells in a blood sample.

[0135] The plasma separation module may include a filter for separating plasma from blood cells in the blood sample.

[0136] The plasma separation module may further include a first digital microfluidic (DMF) chip for separating plasma from blood cells in the blood sample, the first DMF chip including: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrical driving force on a droplet containing the blood and one or more reagents to transport the droplet between the first substrate and the second substrate.

[0137] In some cases, in addition to the chemical analysis module, the analysis kit also includes a sample delivery module that delivers the sample to a sample port, which in turn delivers the sample to the chemical analysis module.

[0138] In some cases, the sample delivery module includes a sample chamber, a sample filling member for delivering the sample into the sample chamber, and a sample drain fluidly connected to the sample chamber, wherein the sample drain receives excess sample beyond the sample filled into the chemical analysis module.

[0139] The sample drainage section includes two or more channels fluidly connected to the sample chamber.

[0140] The sample delivery module may further include a DMF chip for delivering the sample to the sample port, wherein the DMF chip includes: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrical driving force on a droplet of the sample between the first substrate and the second substrate to transport the droplet.

[0141] In some cases, the sample delivery module includes a sample chamber and a sample filling component that fills the sample into the sample chamber.

[0142] method The analytical kits or chemical analysis modules disclosed herein can be used to analyze the chemical composition of samples (e.g., blood, serum, or plasma samples).

[0143] Any suitable sample analyzed in the methods disclosed herein can be blood, urine, saliva, sweat, sputum, semen, mucus, tears, lymph, amniotic fluid, interstitial fluid, bronchoalveolar lavage fluid, cerebrospinal fluid, feces, etc. In some cases, the methods include CMP of the subject's blood. Those skilled in the art will readily identify additional samples that can be analyzed by the methods disclosed herein, and such embodiments are within the scope of this disclosure.

[0144] Any structural elements of the analytical cartridges or chemical analysis modules described elsewhere in this disclosure (e.g., those described above under “Apparatus”) are applicable to the methods disclosed herein. For example, the structure of a chemical analysis module as discussed above is also applicable to the methods disclosed herein.

[0145] Certain aspects of this disclosure provide methods for analyzing samples (e.g., blood, plasma, or serum samples) in the analytical cartridges disclosed herein. In some cases, the method includes delivering a small volume of sample to a chemical analysis module, for example, a sample with a volume between 100 nmol and 200 µl. In some embodiments, the method includes delivering a sample with a volume between 2 µl and 50 µl to a sample port, such as 2 µl, 5 µl, 10 µl, 15 µl, 20 µl, 25 µl, 30 µl, 35 µl, 40 µl, 45 µl, 50 µl, 55 µl, 60 µl, 65 µl, 70 µl, 75 µl, 80 µl, 85 µl, 90 µl, or 100 µl.

[0146] Samples (such as blood, serum, or plasma samples) loaded into a chemical analysis module can be analyzed to obtain, store, and process the concentrations of one or more analytes in the sample. Such information can be used to determine the chemical composition of the sample. For example, depending on the detection of a specific type and concentration of a chemical substance detected in the chemical analysis module, the method includes providing the CMP value of the blood sample.

[0147] In some cases, the method includes using a DMF chip to load the sample into the chemical analysis module of the analysis kit.

[0148] In some cases, the method includes using a sample chamber and a sample dispensing member to load a sample into the chemical analysis module of the analysis cartridge. In some cases, using a sample chamber and a sample dispensing member to load a sample into the chemical analysis module of the analysis cartridge further includes using a sample drain to receive excess sample beyond the sample filled into the chemical analysis module.

[0149] Therefore, under certain circumstances, this disclosure provides a method for analyzing a sample in an analytical cartridge, the analytical cartridge including a sample delivery module, the sample delivery module including a sample chamber, a sample dispensing member for delivering the sample into the sample chamber, and a sample drain fluidly connected to the sample chamber, wherein excess sample beyond the sample filled into the chemical analysis module is received in the sample drain fluidly connected to the sample chamber. In some cases, excess sample beyond the sample filled into the chemical analysis module is received in two or more channels of the sample drain, such as one, two, three, four, five, or six channels fluidly connected to the sample chamber.

[0150] Similarly, in some cases, this disclosure provides a method for analyzing a sample in an analysis cartridge, the analysis cartridge including a sample delivery module, the sample delivery module including a DMF chip for delivering a sample to a sample port, wherein the DMF chip includes: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrical driving force on a sample droplet between the first substrate and the second substrate to transport the liquid droplet.

[0151] Furthermore, in some cases, this disclosure provides a method for analyzing a sample in an analysis kit, the analysis kit including a sample delivery module, the sample delivery module including a sample chamber and a sample dispensing member for dispensing the sample into the sample chamber.

[0152] In some cases, it may be desirable to analyze control samples. Control samples can be analyzed simultaneously with samples from subjects as described above. Results obtained from subject samples can be compared with results obtained from control samples. A standard curve can be provided, and the sample measurements can be compared to the standard curve. Using samples from multiple donors, a standard curve can be provided for reference levels in normal healthy subjects.

[0153] Therefore, in view of the above, a method is provided for determining the presence, amount, or concentration (quantity) of an analyte in a test sample. The method includes: measuring the target analyte in the test sample and comparing it with a control. The calibrator is optionally and preferably part of a series of calibrators, wherein each calibrator in the series is distinguished from the others in the series by the concentration of the analyte.

[0154] For the sake of completeness, various aspects of the present invention are set forth in the following numbered clauses: Clause 1. An analytical kit comprising a chemical analysis module for performing multiplex analysis of analytes in a sample. The chemical analysis module includes: A top plate and a bottom plate, and a plurality of channels disposed between the top plate and the bottom plate, wherein one or more of the plurality of channels contain one or more reagents, the one or more reagents generating a detectable signal in each such channel indicating the concentration of an analyte; Sample port, which delivers the sample to the plurality of channels; and One or more sensors that detect the detectable signal generated in one or more of the plurality of channels.

[0155] Clause 2. The analysis box according to Clause 1, wherein the plurality of channels extend from the proximal end of the top plate and the distal end of the bottom plate.

[0156] Clause 3. The analysis box according to Clause 1 or 2, wherein the top plate and / or the bottom plate have indentations or grooves forming the plurality of channels.

[0157] Clause 4. The analysis box according to any one of Clauses 1 to 3, wherein the cross-section of the channel is rectangular, square, oval, circular, elliptical or irregular in shape.

[0158] Clause 5. The analysis box according to Clause 1 or 2, wherein the top plate and the bottom plate have a plurality of vertical walls disposed between the top plate and the bottom plate, thereby creating the plurality of channels.

[0159] Clause 6. The analysis box according to Clause 5, wherein the plurality of vertical walls disposed between the top plate and the bottom plate comprise an adhesive.

[0160] Clause 7. An analysis box according to any one of Clauses 1 to 6, wherein one of the one or more sensors is located within or adjacent to the channel and detects the detectable signal generated in the channel.

[0161] Clause 8. The analysis box according to Clause 7, wherein the sensor is located in the middle of the channel or at the far end of the channel.

[0162] Clause 9. The analysis box according to Clause 6 or 7, wherein the sensor is an ampere sensor that detects the current generated in the channel.

[0163] Clause 10. The analysis box according to Clause 6 or 7, wherein the sensor is a potential sensor that detects the charge generated in the channel.

[0164] Clause 11. The analysis kit according to Clause 6 or 7, wherein the sensor is a coulomb sensor that detects oxygen generated in the channel.

[0165] Clause 12. An analysis box according to any one of Clauses 1 to 6, wherein a sensor of the one or more sensors points to a channel and detects the detectable signal generated in the channel.

[0166] Clause 13. The analysis box according to Clause 12, wherein the sensor is an optical sensor that detects an optical signal generated in the channel.

[0167] Clause 14. The analytical kit according to any one of Clauses 1 to 13, wherein the detectable signal generated in one or more channels of the first group is an electrochemical signal, and the corresponding sensor is an amperometric sensor and / or a potentiometric sensor.

[0168] Clause 15. The analysis box according to any one of Clauses 1 to 14, wherein the detectable signal generated in one or more channels of the second group is an optical signal, and the corresponding sensor is an optical sensor.

[0169] Clause 16. The analytical kit according to any one of Clauses 1 to 15, wherein the detectable signal generated in one or more channels of the third group is oxygen, and the corresponding sensor is a coulomb sensor.

[0170] Clause 17. The analysis box according to any one of Clauses 1 to 8, wherein two or more of the plurality of channels comprise the following combinations of sensors: One or more electrochemical sensors and one or more optical sensors; One or more electrochemical sensors and one or more chemical sensors; One or more optical sensors and one or more chemical sensors; One or more ampere sensors and one or more potential sensors; One or more ampere sensors and one or more coulomb sensors; One or more ampere sensors and one or more optical sensors; One or more potential sensors and one or more optical sensors; One or more potential sensors and one or more coulomb sensors.

[0171] Clause 18. The analytical kit according to any one of Clauses 14 to 17, wherein the detectable signal generated in one or more channels of the first group is an electrochemical signal and the corresponding sensor is an amperometric sensor and / or a potentiometric sensor; the detectable signal generated in one or more channels of the second group is an optical signal and the corresponding sensor is an optical sensor; and the detectable signal generated in one or more channels of the third group is oxygen and the corresponding sensor is a coulometric sensor.

[0172] Clause 19. The analysis box according to any one of Clauses 1 to 18, wherein the top plate includes a column extending downward into the channel.

[0173] Clause 20. The analysis box according to any one of Clauses 1 to 19, wherein the distance between the top plate and the bottom plate is between 10 µm and 100 µm.

[0174] Clause 21. The analytical cassette according to any one of Clauses 1 to 20, wherein the longest dimension in the cross-section of the channel is between 0.1 mm and 1 mm.

[0175] Clause 22. The analysis box according to any one of Clauses 1 to 21, wherein the length of the channel is between 5 mm and 100 mm.

[0176] Clause 23. The analysis box according to any one of Clauses 1 to 22, wherein the volume of one or more channels within the plurality of channels is between 0.01 µl and 1 µl.

[0177] Clause 24. The analytical kit according to any one of Clauses 1 to 23, wherein one of the plurality of channels is configured to detect an analyte selected from: glucose, calcium, blood urea nitrogen (BUN), creatinine, sodium, potassium, chloride ions, carbon dioxide (CO2), total serum protein (TP), serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0178] Clause 25. The analytical kit according to any one of Clauses 1 to 24, wherein the plurality of channels are configured to detect two or more analytes selected from: glucose, calcium, BUN, creatinine, sodium, potassium, chloride, carbon dioxide (CO2), TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0179] Clause 26. The analytical kit according to any one of Clauses 1 to 25, wherein the plurality of channels are configured to detect two or more analytes selected from: glucose, calcium, sodium, potassium, carbon dioxide, chlorine, albumin, TP, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, BUN, and creatinine.

[0180] Clause 27. The analysis kit according to any one of Clauses 1 to 26, wherein the analysis kit further comprises a plasma separation module for separating plasma from blood cells in a blood sample.

[0181] Clause 28. The analytical kit according to Clause 27, wherein the plasma separation module includes a filter for separating plasma from blood cells in the blood sample.

[0182] Clause 29. The analysis kit according to Clause 27, wherein the plasma separation module includes a first digital microfluidic (DMF) chip for separating plasma from blood cells in the blood sample, the first DMF chip including: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrodynamic force on a droplet containing the blood and one or more reagents to transport the droplet between the first substrate and the second substrate.

[0183] Clause 30. The analytical kit according to any one of Clauses 1 to 29, the analytical kit further comprising a sample delivery module that delivers the sample to a sample port, the sample port delivering the sample to the chemical analysis module.

[0184] Clause 31. The analytical cartridge according to Clause 30, wherein the sample delivery module includes a sample chamber, a sample filling member for delivering the sample into the sample chamber, and a sample drain fluidly connected to the sample chamber, wherein the sample drain receives excess sample beyond the sample filled into the chemical analysis module.

[0185] Clause 32. The analytical cartridge according to Clause 31, wherein the sample drainage portion includes two or more channels fluidly connected to the sample chamber.

[0186] Clause 33. The analysis kit according to Clause 30, wherein the sample delivery module includes a second DMF chip for delivering the sample to the sample port, wherein the second DMF chip includes: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrical driving force on a droplet of the sample between the first substrate and the second substrate to transport the droplet.

[0187] Clause 34. The analytical kit according to Clause 30, wherein the sample delivery module includes a sample chamber and a sample dispensing member for dispensing the sample into the sample chamber.

[0188] Clause 35. A method for analyzing a sample, the method comprising: filling the sample into an analytical cassette according to any one of Clauses 1 to 34, and analyzing the sample.

[0189] Clause 36. The method according to Clause 35, the method comprising analyzing the sample in one or more of the plurality of channels in a range of 0.1 µl to 2 µl.

[0190] Clause 37. The method according to Clause 35 or 36, wherein the sample is: blood, plasma, urine, saliva, sweat, sputum, semen, mucus, tears, lymph, amniotic fluid, interstitial fluid, pulmonary lavage fluid, cerebrospinal fluid, feces, nasal swabs soaked in buffer solution, or pharyngeal swabs soaked in buffer solution.

[0191] Clause 38. The method described in accordance with Clause 37, wherein the blood is venous blood or capillary blood.

[0192] Clause 39. A method of manufacturing an analytical kit according to any one of Clauses 1 to 34, said method comprising: Provide a roof plate with specific characteristics; Provide a base plate with specific characteristics; Apply adhesive lines to the top plate and / or the bottom plate; The two plates are joined together to create a chemical analysis module that includes multiple channels.

[0193] Clause 40. The method according to Clause 39, wherein the top plate and the bottom plate comprise PET film.

[0194] Clause 41. A chemical analysis module for performing multiplex analysis of analytes in a sample, the chemical analysis module comprising: A top plate and a bottom plate, and a plurality of channels disposed between the top plate and the bottom plate, wherein one or more of the plurality of channels contain one or more reagents, the one or more reagents generating a detectable signal in each such channel indicating the concentration of an analyte; Delivering the sample to the sample ports of the plurality of channels; and One or more sensors that detect the detectable signal generated in one or more of the plurality of channels.

[0195] Clause 42. The chemical analysis module according to Clause 41, wherein the plurality of channels extend from the proximal end of the top plate and the distal end of the bottom plate.

[0196] Clause 43. The chemical analysis module according to Clause 41 or 42, wherein the top plate and / or the bottom plate have recesses or grooves forming the plurality of channels.

[0197] Clause 44. A chemical analysis module according to any one of Clauses 41 to 43, wherein the cross-section of the channel is rectangular, square, oval, circular, elliptical, or irregular in shape.

[0198] Clause 45. The chemical analysis module according to Clause 41 or 42, wherein the top plate and the bottom plate have a plurality of vertical walls disposed between the top plate and the bottom plate, thereby creating the plurality of channels.

[0199] Clause 46. The chemical analysis module according to Clause 45, wherein the plurality of vertical walls disposed between the top plate and the bottom plate comprise an adhesive.

[0200] Clause 47. A chemical analysis module according to any one of Clauses 41 to 46, wherein one of the one or more sensors is located within or adjacent to the channel and detects the detectable signal generated in the channel.

[0201] Clause 48. The chemical analysis module according to Clause 47, wherein the sensor is located in the middle of the channel or at the distal end of the channel.

[0202] Clause 49. The chemical analysis module according to Clause 46 or 47, wherein the sensor is an amperometric sensor that detects the current generated in the channel.

[0203] Clause 50. A chemical analysis module according to Clause 46 or 47, wherein the sensor is a potential sensor that detects the charge generated in the channel.

[0204] Clause 51. A chemical analysis module according to Clause 46 or 47, wherein the sensor is a coulometric sensor that detects oxygen generated in the channel.

[0205] Clause 52. A chemical analysis module according to any one of Clauses 41 to 46, wherein a sensor of the one or more sensors points to a channel and detects the detectable signal generated in the channel.

[0206] Clause 53. The chemical analysis module according to Clause 52, wherein the sensor is an optical sensor that detects an optical signal generated in the channel.

[0207] Clause 54. A chemical analysis module according to any one of Clauses 41 to 53, wherein the detectable signal generated in one or more channels of a first group is an electrochemical signal, and the corresponding sensor is an amperometric sensor and / or a potentiometric sensor.

[0208] Clause 55. A chemical analysis module according to any one of Clauses 41 to 54, wherein the detectable signal generated in one or more channels of a second group is an optical signal, and the corresponding sensor is an optical sensor.

[0209] Clause 56. A chemical analysis module according to any one of Clauses 41 to 55, wherein the detectable signal generated in one or more channels of the third group is oxygen, and the corresponding sensor is a coulometric sensor.

[0210] Clause 57. A chemical analysis module according to any one of Clauses 41 to 48, wherein two or more of the plurality of channels comprise the following combinations of sensors: One or more electrochemical sensors and one or more optical sensors; One or more electrochemical sensors and one or more chemical sensors; One or more optical sensors and one or more chemical sensors; One or more ampere sensors and one or more potential sensors; One or more ampere sensors and one or more coulomb sensors; One or more ampere sensors and one or more optical sensors; One or more potential sensors and one or more optical sensors; One or more potential sensors and one or more coulomb sensors.

[0211] Clause 58. A chemical analysis module according to any one of Clauses 54 to 57, wherein the detectable signal generated in one or more channels of the first group is an electrochemical signal and the corresponding sensor is an amperometric sensor and / or a potentiometric sensor; the detectable signal generated in one or more channels of the second group is an optical signal and the corresponding sensor is an optical sensor; and the detectable signal generated in one or more channels of the third group is oxygen and the corresponding sensor is a coulometric sensor.

[0212] Clause 59. A chemical analysis module according to any one of Clauses 41 to 58, wherein the top plate includes a column extending downward into the channel.

[0213] Clause 60. The chemical analysis module according to any one of Clauses 41 to 59, wherein the distance between the top plate and the bottom plate is between 10 µm and 100 µm.

[0214] Clause 61. A chemical analysis module according to any one of Clauses 41 to 60, wherein the longest dimension in the cross-section of the channel is between 0.1 mm and 1 mm.

[0215] Clause 62. A chemical analysis module according to any one of Clauses 41 to 61, wherein the length of the channel is between 5 mm and 100 mm.

[0216] Clause 63. The chemical analysis module according to any one of Clauses 41 to 62, wherein the volume of one or more channels within the plurality of channels is between 0.01 µl and 1 µl.

[0217] Clause 64. A chemical analysis module according to any one of Clauses 41 to 63, wherein one of the plurality of channels is configured to detect analytes selected from: glucose, calcium, blood urea nitrogen (BUN), creatinine, sodium, potassium, chloride ions, carbon dioxide (CO2), total serum protein (TP), serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0218] Clause 65. A chemical analysis module according to any one of Clauses 41 to 64, wherein the plurality of channels are configured to detect two or more analytes selected from: glucose, calcium, BUN, creatinine, sodium, potassium, chlorine, carbon dioxide (CO2), TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

[0219] Clause 66. A chemical analysis module according to any one of Clauses 41 to 65, wherein the plurality of channels are configured to detect two or more analytes selected from: glucose, calcium, sodium, potassium, carbon dioxide, chlorine, albumin, TP, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, BUN, and creatinine.

[0220] Clause 67. An analytical kit comprising a chemical analysis module according to any one of Clauses 41 to 66.

[0221] Clause 68. The analysis kit according to Clause 67 further includes a plasma separation module for separating plasma from blood cells in a blood sample.

[0222] Clause 69. The analytical kit according to Clause 68, wherein the plasma separation module includes a filter for separating plasma from blood cells in the blood sample.

[0223] Clause 70. The analysis kit according to Clause 68, wherein the plasma separation module includes a first digital microfluidic (DMF) chip for separating plasma from blood cells in the blood sample, the first DMF chip including: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrodynamic force on a droplet containing the blood and one or more reagents to transport the droplet between the first substrate and the second substrate.

[0224] Clause 71. The analytical kit according to any one of Clauses 67 to 70, the analytical kit further comprising a sample delivery module that delivers the sample to a sample port, the sample port delivering the sample to the chemical analysis module.

[0225] Clause 72. The analytical cartridge according to Clause 71, wherein the sample delivery module includes a sample chamber, a sample filling member for delivering the sample into the sample chamber, and a sample drain fluidly connected to the sample chamber, wherein the sample drain receives excess sample beyond the sample filled into the chemical analysis module.

[0226] Clause 73. The analytical cartridge according to Clause 72, wherein the sample drainage portion includes two or more channels fluidly connected to the sample chamber.

[0227] Clause 74. The analysis kit according to Clause 71, wherein the sample delivery module includes a second DMF chip for delivering the sample to the sample port, wherein the second DMF chip includes: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrical driving force on a droplet of the sample between the first substrate and the second substrate to transport the droplet.

[0228] Clause 75. The analytical kit according to Clause 71, wherein the sample delivery module includes a sample chamber and a sample dispensing member for dispensing the sample into the sample chamber.

[0229] Clause 76. A method for analyzing a sample, the method comprising: loading the sample into a chemical analysis module according to any one of Clauses 31 to 66 or into an analysis kit according to any one of Clauses 67 to 75, and analyzing the sample.

[0230] Clause 77. The method according to Clause 76, the method comprising: analyzing the sample in one or more of the plurality of channels in a range of 0.1 µl to 2 µl.

[0231] Clause 78. The method according to Clause 76 or 77, wherein the top plate and the bottom plate comprise PET film.

[0232] Clause 79. The method according to any one of Clauses 76 to 78, wherein the sample is: blood, urine, saliva, sweat, sputum, semen, mucus, tears, lymph, amniotic fluid, interstitial fluid, pulmonary lavage fluid, cerebrospinal fluid, feces, nasal swabs soaked in buffer solution, or pharyngeal swabs soaked in buffer solution.

[0233] Clause 80. The method described in accordance with Clause 79, wherein the blood is venous blood or capillary blood.

[0234] Clause 81. A method for manufacturing a chemical analysis module according to any one of Clauses 41 to 66, the method comprising: Provide a roof plate with specific characteristics; Provide a base plate with specific characteristics; Apply adhesive lines to the top plate and / or the bottom plate; The two plates are joined together to create a chemical analysis module that includes multiple channels.

[0235] The foregoing only illustrates the principles of this disclosure. It should be understood that those skilled in the art will be able to design various devices that, while not explicitly described or shown herein, embody the principles of the invention and are included within its spirit and scope. Furthermore, all examples and conditional language set forth herein are primarily intended to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to advance the field, and should be interpreted as not being limited to such specific examples and conditions. Moreover, all statements herein that set forth the principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to cover both structural and functional equivalents. Additionally, it is intended that such equivalents include both currently known equivalents and those to be developed in the future, i.e., any element developed that performs the same function regardless of its structure. Therefore, the scope of the invention is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of the invention are embodied in the appended claims.

Claims

1. An analytical kit, the analytical kit comprising a chemical analysis module for performing multiplex analysis of analytes in a sample, the chemical analysis module being used to perform multiplex analysis of analytes in a sample. The chemical analysis module includes: A top plate and a bottom plate, and a plurality of channels disposed between the top plate and the bottom plate, wherein one or more of the plurality of channels contain one or more reagents, the one or more reagents generating a detectable signal in each such channel indicating the concentration of an analyte; Sample port, which delivers the sample to the plurality of channels; and One or more sensors that detect the detectable signal generated in one or more of the plurality of channels.

2. The cartridge of claim 1, wherein, The plurality of channels extend from the proximal end of the top plate and the distal end of the bottom plate.

3. The cartridge of claim 1 or 2, wherein, The top plate and / or the bottom plate have indentations or grooves forming the plurality of channels.

4. The cartridge of any one of claims 1 to 3, wherein, The cross-section of the channel is rectangular, square, oval, circular, elliptical, or irregular in shape.

5. The cartridge of claim 1 or 2, wherein, The top plate and the bottom plate have multiple vertical walls disposed between the top plate and the bottom plate, thereby creating the multiple channels.

6. The cartridge of claim 5, wherein, The plurality of vertical walls disposed between the top plate and the bottom plate include an adhesive.

7. The cartridge of any one of claims 1 to 6, wherein, One of the sensors is located within or near the channel and detects the detectable signal generated in the channel.

8. The cartridge of claim 7, wherein, The sensor is located in the middle of the channel or at the far end of the channel.

9. The cartridge of claim 6 or 7, wherein, The sensor is an ampere sensor, which detects the current generated in the channel.

10. The cartridge of claim 6 or 7, wherein, The sensor is a potential sensor that detects the charge generated in the channel.

11. The cartridge of claim 6 or 7, wherein, The sensor is a coulomb sensor, which detects oxygen generated in the channel.

12. The cartridge of any one of claims 1 to 6, wherein, One of the sensors points to the channel and detects the detectable signal generated in the channel.

13. The cartridge of claim 12, wherein, The sensor is an optical sensor that detects optical signals generated in the channel.

14. The cartridge of any one of claims 1 to 13, wherein, The detectable signal generated in one or more channels of the first group is an electrochemical signal, and the corresponding sensor is an amperometric sensor and / or a potentiometric sensor.

15. The cartridge of any one of claims 1 to 14, wherein, The detectable signal generated in one or more channels of the second group is an optical signal, and the corresponding sensor is an optical sensor.

16. The analytical kit according to any one of claims 1 to 15, wherein, The detectable signal generated in one or more channels of the third group is oxygen, and the corresponding sensor is a coulomb sensor.

17. The analytical kit according to any one of claims 1 to 8, wherein, Two or more of the multiple channels comprise the following combinations of sensors: One or more electrochemical sensors and one or more optical sensors; One or more electrochemical sensors and one or more chemical sensors; One or more optical sensors and one or more chemical sensors; One or more ampere sensors and one or more potential sensors; One or more ampere sensors and one or more coulomb sensors; One or more ampere sensors and one or more optical sensors; One or more potential sensors and one or more optical sensors; One or more potential sensors and one or more coulomb sensors.

18. The analytical kit according to any one of claims 14 to 17, wherein, The detectable signal generated in one or more channels of the first group is an electrochemical signal, and the corresponding sensor is an amperometric sensor and / or a potentiometric sensor; The detectable signal generated in one or more channels of the second group is an optical signal, and the corresponding sensor is an optical sensor; The detectable signal generated in one or more channels of the third group is oxygen, and the corresponding sensor is a coulomb sensor.

19. The analytical kit according to any one of claims 1 to 18, wherein, The top plate includes columns that extend downward into the channel.

20. The analytical kit according to any one of claims 1 to 19, wherein, The distance between the top plate and the bottom plate is between 10µm and 100µm.

21. The analytical kit according to any one of claims 1 to 20, wherein, The longest dimension in the cross-section of the channel is between 0.1 mm and 1 mm.

22. The analytical kit according to any one of claims 1 to 21, wherein, The length of the channel is between 5mm and 100mm.

23. The analytical kit according to any one of claims 1 to 22, wherein, The volume of one or more channels within the plurality of channels is between 0.01 µl and 1 µl.

24. The analytical kit according to any one of claims 1 to 23, wherein, One of the multiple channels is configured to detect analytes selected from the following: glucose, calcium, blood urea nitrogen (BUN), creatinine, sodium, potassium, chloride ions, carbon dioxide (CO2), total serum protein (TP), serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

25. The analytical kit according to any one of claims 1 to 24, wherein, The multiple channels are configured to detect two or more analytes selected from the following: glucose, calcium, BUN, creatinine, sodium, potassium, chloride, carbon dioxide (CO2), TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

26. The analytical kit according to any one of claims 1 to 25, wherein, The multiple channels are configured to detect two or more analytes selected from the following: glucose, calcium, sodium, potassium, carbon dioxide, chlorine, albumin, TP, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, BUN, and creatinine.

27. The analytical kit according to any one of claims 1 to 26, wherein, The analysis kit also includes a plasma separation module for separating plasma from blood cells in a blood sample.

28. The analytical kit according to claim 27, wherein, The plasma separation module includes a filter for separating plasma from blood cells in the blood sample.

29. The analysis kit according to claim 27, wherein, The plasma separation module includes a first digital microfluidic (DMF) chip for separating plasma from blood cells in the blood sample. The first DMF chip includes: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrodynamic force on a droplet containing the blood and one or more reagents to transport the droplet between the first substrate and the second substrate.

30. The analytical kit according to any one of claims 1 to 29, further comprising a sample delivery module that delivers the sample to a sample port, the sample port delivering the sample to the chemical analysis module.

31. The analysis kit according to claim 30, wherein, The sample delivery module includes a sample chamber, a sample filling member for delivering the sample into the sample chamber, and a sample drain fluidly connected to the sample chamber, wherein the sample drain receives excess sample beyond the sample filled into the chemical analysis module.

32. The analysis box according to claim 31, wherein, The sample drainage section includes two or more channels fluidly connected to the sample chamber.

33. The analysis kit according to claim 30, wherein, The sample delivery module includes a second DMF chip for delivering the sample to the sample port, wherein the second DMF chip includes: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrical driving force on a droplet of the sample between the first substrate and the second substrate to transport the droplet.

34. The analysis kit according to claim 30, wherein, The sample delivery module includes a sample chamber and a sample filling component for filling the sample into the sample chamber.

35. A method for analyzing a sample, the method comprising: The sample is loaded into the analysis kit according to any one of claims 1 to 34, and the sample is analyzed.

36. The method according to claim 35, wherein the method comprises: The sample was analyzed in one or more of the plurality of channels at a concentration between 0.1 µl and 2 µl.

37. The method according to claim 35 or 36, wherein, The samples are: blood, plasma, urine, saliva, sweat, sputum, semen, mucus, tears, lymph, amniotic fluid, interstitial fluid, pulmonary lavage fluid, cerebrospinal fluid, feces, nasal swabs soaked in buffer solution, or pharyngeal swabs soaked in buffer solution.

38. The method according to claim 37, wherein, The blood in question is venous blood or capillary blood.

39. A method for manufacturing an analytical cartridge according to any one of claims 1 to 34, the method comprising: Provide a top plate with specific characteristics; Provide a base plate with specific characteristics; Apply adhesive lines to the top plate and / or the bottom plate; The two plates are joined together to create a chemical analysis module that includes multiple channels.

40. The method according to claim 39, wherein, The top plate and the bottom plate comprise PET film.

41. A chemical analysis module for performing multiplex analysis of analytes in a sample, the chemical analysis module comprising: A top plate and a bottom plate, and a plurality of channels disposed between the top plate and the bottom plate, wherein one or more of the plurality of channels contain one or more reagents, the one or more reagents generating a detectable signal in each such channel indicating the concentration of an analyte; Sample port, which delivers the sample to the plurality of channels; and One or more sensors that detect the detectable signal generated in one or more of the plurality of channels.

42. The chemical analysis module according to claim 41, wherein, The plurality of channels extend from the proximal end of the top plate and the distal end of the bottom plate.

43. The chemical analysis module according to claim 41 or 42, wherein, The top plate and / or the bottom plate have indentations or grooves forming the plurality of channels.

44. The chemical analysis module according to any one of claims 41 to 43, wherein, The cross-section of the channel is rectangular, square, oval, circular, elliptical, or irregular in shape.

45. The chemical analysis module according to claim 41 or 42, wherein, The top plate and the bottom plate have multiple vertical walls disposed between the top plate and the bottom plate, thereby creating the multiple channels.

46. ​​The chemical analysis module according to claim 45, wherein, The plurality of vertical walls disposed between the top plate and the bottom plate include an adhesive.

47. The chemical analysis module according to any one of claims 41 to 46, wherein, One of the sensors is located within or near the channel and detects the detectable signal generated in the channel.

48. The chemical analysis module according to claim 47, wherein, The sensor is located in the middle of the channel or at the far end of the channel.

49. The chemical analysis module according to claim 46 or 47, wherein, The sensor is an ampere sensor, which detects the current generated in the channel.

50. The chemical analysis module according to claim 46 or 47, wherein, The sensor is a potential sensor that detects the charge generated in the channel.

51. The chemical analysis module according to claim 46 or 47, wherein, The sensor is a coulomb sensor, which detects oxygen generated in the channel.

52. The chemical analysis module according to any one of claims 41 to 46, wherein, One of the sensors points to the channel and detects the detectable signal generated in the channel.

53. The chemical analysis module according to claim 52, wherein, The sensor is an optical sensor that detects optical signals generated in the channel.

54. The chemical analysis module according to any one of claims 41 to 53, wherein, The detectable signal generated in one or more channels of the first group is an electrochemical signal, and the corresponding sensor is an amperometric and / or potentiometric sensor.

55. The chemical analysis module according to any one of claims 41 to 54, wherein, The detectable signal generated in one or more channels of the second group is an optical signal, and the corresponding sensor is an optical sensor.

56. The chemical analysis module according to any one of claims 41 to 55, wherein, The detectable signal generated in one or more channels of the third group is oxygen, and the corresponding sensor is a coulomb sensor.

57. The chemical analysis module according to any one of claims 41 to 48, wherein, Two or more of the multiple channels comprise the following combinations of sensors: One or more electrochemical sensors and one or more optical sensors; One or more electrochemical sensors and one or more chemical sensors; One or more optical sensors and one or more chemical sensors; One or more ampere sensors and one or more potential sensors; One or more ampere sensors and one or more coulomb sensors; One or more ampere sensors and one or more optical sensors; One or more potential sensors and one or more optical sensors; One or more potential sensors and one or more coulomb sensors.

58. The chemical analysis module according to any one of claims 54 to 57, wherein, The detectable signal generated in one or more channels of the first group is an electrochemical signal, and the corresponding sensor is an amperometric sensor and / or a potentiometric sensor; The detectable signal generated in one or more channels of the second group is an optical signal, and the corresponding sensor is an optical sensor; Furthermore, the detectable signal generated in one or more channels of the third group is oxygen, and the corresponding sensor is a coulomb sensor.

59. The chemical analysis module according to any one of claims 41 to 58, wherein, The top plate includes columns that extend downward into the channel.

60. The chemical analysis module according to any one of claims 41 to 59, wherein, The distance between the top plate and the bottom plate is between 10µm and 100µm.

61. The chemical analysis module according to any one of claims 41 to 60, wherein, The longest dimension in the cross-section of the channel is between 0.1 mm and 1 mm.

62. The chemical analysis module according to any one of claims 41 to 61, wherein, The length of the channel is between 5mm and 100mm.

63. The chemical analysis module according to any one of claims 41 to 62, wherein, The volume of one or more channels within the plurality of channels is between 0.01 µl and 1 µl.

64. The chemical analysis module according to any one of claims 41 to 63, wherein, One of the multiple channels is configured to detect analytes selected from the following: glucose, calcium, blood urea nitrogen (BUN), creatinine, sodium, potassium, chloride ions, carbon dioxide (CO2), total serum protein (TP), serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

65. The chemical analysis module according to any one of claims 41 to 64, wherein, The multiple channels are configured to detect two or more analytes selected from the following: glucose, calcium, BUN, creatinine, sodium, potassium, chloride, carbon dioxide (CO2), TP, serum albumin, lactate, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, lipids, and lipases.

66. The chemical analysis module according to any one of claims 41 to 65, wherein, The multiple channels are configured to detect two or more analytes selected from the following: glucose, calcium, sodium, potassium, carbon dioxide, chlorine, albumin, TP, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, BUN, and creatinine.

67. An analysis kit comprising a chemical analysis module according to any one of claims 41 to 66.

68. The analysis kit according to claim 67, further comprising a plasma separation module for separating plasma from blood cells in a blood sample.

69. The analysis kit according to claim 68, wherein, The plasma separation module includes a filter for separating plasma from blood cells in the blood sample.

70. The analytical kit according to claim 68, wherein, The plasma separation module includes a first digital microfluidic (DMF) chip for separating plasma from blood cells in the blood sample. The first DMF chip includes: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrodynamic force on a droplet containing the blood and one or more reagents to transport the droplet between the first substrate and the second substrate.

71. The analytical kit according to any one of claims 67 to 70, the analytical kit further comprising a sample delivery module, the sample delivery module delivering the sample to a sample port, the sample port delivering the sample to the chemical analysis module.

72. The analysis kit according to claim 71, wherein, The sample delivery module includes a sample chamber, a sample filling member for delivering the sample into the sample chamber, and a sample drain fluidly connected to the sample chamber, wherein the sample drain receives excess sample beyond the sample filled into the chemical analysis module.

73. The analysis kit according to claim 72, wherein, The sample drainage section includes two or more channels fluidly connected to the sample chamber.

74. The analysis kit according to claim 71, wherein, The sample delivery module includes a second DMF chip, which delivers the sample to the sample port. The second DMF chip includes: a first substrate; a second substrate; a gap separating the first substrate and the second substrate; and a plurality of electrodes that generate an electrical driving force on a droplet of the sample between the first substrate and the second substrate to transport the droplet.

75. The analytical kit according to claim 71, wherein, The sample delivery module includes a sample chamber and a sample filling component for filling the sample into the sample chamber.

76. A method for analyzing a sample, the method comprising: The sample is loaded into the chemical analysis module according to any one of claims 31 to 66 or into the analysis kit according to any one of claims 67 to 75, and the sample is analyzed.

77. The method of claim 76, wherein the method comprises analyzing 0.1 µl to 2 µl of the sample in one or more of the plurality of channels.

78. The method according to claim 76 or 77, wherein, The top plate and the bottom plate comprise PET film.

79. The method according to any one of claims 76 to 78, wherein, The samples are: blood, urine, saliva, sweat, sputum, semen, mucus, tears, lymph, amniotic fluid, interstitial fluid, pulmonary lavage fluid, cerebrospinal fluid, feces, nasal swabs soaked in buffer solution, or pharyngeal swabs soaked in buffer solution.

80. The method according to claim 79, wherein, The blood in question is venous blood or capillary blood.

81. A method for manufacturing a chemical analysis module according to any one of claims 41 to 66, the method comprising: Provide a top plate with specific characteristics; Provide a base plate with specific characteristics; Apply adhesive lines to the top plate and / or the bottom plate; The two plates are joined together to create a chemical analysis module that includes multiple channels.

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