WO2017005122A1 - 检测系统 - Google Patents

检测系统 Download PDF

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Publication number
WO2017005122A1
WO2017005122A1 PCT/CN2016/087503 CN2016087503W WO2017005122A1 WO 2017005122 A1 WO2017005122 A1 WO 2017005122A1 CN 2016087503 W CN2016087503 W CN 2016087503W WO 2017005122 A1 WO2017005122 A1 WO 2017005122A1
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WO
WIPO (PCT)
Prior art keywords
reagent
reaction
cartridge
push rod
storage portion
Prior art date
Application number
PCT/CN2016/087503
Other languages
English (en)
French (fr)
Inventor
刘圣强
龚挺锋
何焕军
Original Assignee
艾康生物技术(杭州)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 艾康生物技术(杭州)有限公司 filed Critical 艾康生物技术(杭州)有限公司
Priority to US15/741,688 priority Critical patent/US10751718B2/en
Priority to EP16820773.6A priority patent/EP3318873A4/en
Publication of WO2017005122A1 publication Critical patent/WO2017005122A1/zh
Priority to US17/001,280 priority patent/US20200384473A1/en

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/72Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/52Containers specially adapted for storing or dispensing a reagent
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L7/00Heating or cooling apparatus; Heat insulating devices
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D15/00Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08Selective adsorption, e.g. chromatography
    • B01D15/26Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
    • B01D15/3857Reaction chromatography
    • BPERFORMING OPERATIONS; TRANSPORTING
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    • B01DSEPARATION
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
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    • B01D53/34Chemical or biological purification of waste gases
    • B01D53/74General processes for purification of waste gases; Apparatus or devices specially adapted therefor
    • B01D53/84Biological processes
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    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
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    • B01D67/0039Inorganic membrane manufacture
    • B01D67/0044Inorganic membrane manufacture by chemical reaction
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    • B01J2219/00277Apparatus
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    • B01J2219/00488Means for mixing reactants or products in the reaction vessels by rotation of the reaction vessels
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    • B01J2219/00277Apparatus
    • B01J2219/00495Means for heating or cooling the reaction vessels
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
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    • B01J2220/00Aspects relating to sorbent materials
    • B01J2220/50Aspects relating to the use of sorbent or filter aid materials
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    • B01L2300/0848Specific forms of parts of containers
    • B01L2300/0851Bottom walls
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    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0861Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0867Multiple inlets and one sample wells, e.g. mixing, dilution
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    • B01L2300/12Specific details about materials
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    • BPERFORMING OPERATIONS; TRANSPORTING
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    • B01L2300/00Additional constructional details
    • B01L2300/18Means for temperature control
    • B01L2300/1805Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
    • B01L2300/1827Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks using resistive heater
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0403Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0457Moving fluids with specific forces or mechanical means specific forces passive flow or gravitation
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/06Valves, specific forms thereof
    • B01L2400/0677Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • B01L2400/0683Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L7/00Heating or cooling apparatus; Heat insulating devices
    • B01L7/52Heating or cooling apparatus; Heat insulating devices with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B25HAND TOOLS; PORTABLE POWER-DRIVEN TOOLS; MANIPULATORS
    • B25CHAND-HELD NAILING OR STAPLING TOOLS; MANUALLY OPERATED PORTABLE STAPLING TOOLS
    • B25C1/00Hand-held nailing tools; Nail feeding devices
    • B25C1/08Hand-held nailing tools; Nail feeding devices operated by combustion pressure
    • B25C1/10Hand-held nailing tools; Nail feeding devices operated by combustion pressure generated by detonation of a cartridge
    • B25C1/105Cartridge ejecting mechanisms and latch mechanisms
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • B29C65/24Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools characterised by the means for heating the tool
    • B29C65/30Electrical means
    • B29C65/305Electrical means involving the use of cartridge heaters
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B41PRINTING; LINING MACHINES; TYPEWRITERS; STAMPS
    • B41JTYPEWRITERS; SELECTIVE PRINTING MECHANISMS, i.e. MECHANISMS PRINTING OTHERWISE THAN FROM A FORME; CORRECTION OF TYPOGRAPHICAL ERRORS
    • B41J2/00Typewriters or selective printing mechanisms characterised by the printing or marking process for which they are designed
    • B41J2/005Typewriters or selective printing mechanisms characterised by the printing or marking process for which they are designed characterised by bringing liquid or particles selectively into contact with a printing material
    • B41J2/01Ink jet
    • B41J2/17Ink jet characterised by ink handling
    • B41J2/175Ink supply systems ; Circuit parts therefor
    • B41J2/17503Ink cartridges
    • B41J2/17536Protection of cartridges or parts thereof, e.g. tape
    • B41J2/1754Protection of cartridges or parts thereof, e.g. tape with means attached to the cartridge, e.g. protective cap
    • GPHYSICS
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    • G01N15/04Investigating sedimentation of particle suspensions
    • G01N15/042Investigating sedimentation of particle suspensions by centrifuging and investigating centrifugates
    • G01N2015/045Investigating sedimentation of particle suspensions by centrifuging and investigating centrifugates by optical analysis
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    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • G01N2035/0401Sample carriers, cuvettes or reaction vessels
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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    • G01N35/02Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/04Details of the conveyor system
    • G01N2035/0401Sample carriers, cuvettes or reaction vessels
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    • G01N2035/0415Block or rack elements with a single row of samples moving in two dimensions in a horizontal plane
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    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/48785Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
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Definitions

  • the invention relates to the technical field of biological sample detection, and in particular to a detection system.
  • HbA1c glycated hemoglobin in the blood
  • Glycated hemoglobin is a product of hemoglobin and blood sugar in red blood cells in human blood.
  • the amount of HbA1c formed by the human body is relatively high.
  • the average lifespan of red blood cells in human body is 120 days.
  • the content of HbA1c in the blood will remain relatively unchanged. Therefore, the glycosylated hemoglobin test can usually reflect the blood glucose control of patients for nearly 8 to 12 weeks. The effect of elevated or decreased blood sugar.
  • US Patent No. 1,562,237 discloses a reaction cartridge comprising a reaction channel and a liquid reagent storage portion, a reaction reagent is provided with a dry reagent, and a liquid reagent storage portion is used for storing a buffer or other liquid reagent, a liquid reagent
  • the storage portion includes a storage body 30' sealed by a seal or film 32' having a distal end 33' that tears the film directly from the distal end to separate the film from the storage body, releasing the reagents in the storage body to In the reaction channel.
  • the liquid reagent When the liquid reagent is released, it is necessary to artificially separate the film 32' originally sealed on the storage body 30' and then remove the film.
  • the above method can tear the film and release the liquid reagent, it is very difficult to tear the film from the storage body 30' through an extended distal end 33'. If the force is excessively applied or the force is too light, the film is broken. The opening or tearing is incomplete, so that the liquid reagent cannot be completely released, and the liquid reagent is too small during the detection, which causes a deviation of the detection result; on the other hand, in the non-detection period, the film 32' is exposed to the air, which is prone to artificial occurrence. Or the risk of other factors being broken or destroyed.
  • US Pat. No. 5,272, 093 discloses a "reagent container and its delivery method" comprising a reagent storage chamber 12' and a seal 40' sealed on a reagent storage chamber, the seal being a two-layered folding arrangement, one The layer is used to seal the reagent storage chamber and the other layer extends outside the reagent storage chamber to form an extension 42' for tearing off the reagent in the reagent storage chamber.
  • the sealing member 40' which is originally sealed on the reagent storage chamber 12'. If the force is excessive or the force is too light, it is easy to manufacture. The film is broken or the tearing is incomplete, resulting in the liquid reagent not being completely released, so that the liquid reagent is too small during the detection, resulting in deviation of the detection result.
  • US Pat. No. 8,846,380 discloses a "reaction cartridge for detecting the concentration of glycated hemoglobin", which comprises a first zone for containing a blood sample of the kit, a second zone for containing the washing solution, and detection.
  • the zone and the reagent pack, the reagent and the wash solution in the reagent pack are stored separately and sealed with aluminum foil 120'.
  • the aluminum foil is torn by the reaction box, and the reagent and the washing solution in the reagent package are temporarily stored in the first reaction zone and the second reaction zone of the reaction cartridge, respectively, and the blood sample is sequentially rotated through the reaction cartridge.
  • a reaction occurs that solves the problem of reagent storage and distribution.
  • the release portion 130' on the artificially folded aluminum foil is required, the release portion 130' is aligned with the holder in the detection box, and the aligned reagent package is inserted into the detection box, so that the detection box is
  • the release portion can be cut off to separate the aluminum foil from the reagent pack.
  • reaction box and the reagent package are designed in a split type, and the open design of the reaction box, if improperly operated, it is easy to drop foreign matter into the reaction box, thereby affecting the accuracy of the detection result.
  • the release portion 130' is exposed to the air, which is prone to risk of tearing or breaking by human or other factors.
  • the reaction cartridge of the prior art includes a sampling needle, a reagent reservoir, a reaction portion, a detection zone, and the like.
  • the reaction cartridge detects the reaction, the reagent in the reagent reservoir is released to the reaction portion to participate in the detection reaction.
  • the reaction cartridge is small in size and compact in structure, and the reagent reservoir and the reaction panel are The distance between the wall plate and the reagent release port of the reagent reservoir is likely to generate an adsorption force to the reagent liquid, so that the reagent portion remains in the gap between the reagent release port and the wall plate.
  • the drainage tip is also designed at the position of the reagent storage reagent release port, so that the reagent passes through the reagent release port and is guided by the drainage tip, and finally enters the reaction portion under the action of gravity, and drains.
  • the tip can better conduct the flow, when the reagent is released, the tip of the drain is prone to liquid hanging, so that the reagent part remains on the tip of the drain.
  • the distance between the tip of the drain and the wall is relatively close, and some reagents are also present. Adsorbed between the tip of the drain and the wall. Part of the reaction reagent remains, so that the reaction is insufficient, resulting in a decrease in the accuracy of the test results.
  • the technical problem to be solved by the present invention is to provide a detection system for the above problems existing in the prior art.
  • a detection system includes a reagent reaction box and a detection device, wherein the reagent reaction box is packaged with a reagent storage portion and a push rod movable relative to the reagent storage portion, and the reagent storage portion is provided with at least one reagent receiving chamber and a reagent receiving chamber Sealed by a sealing member; the push rod is connected to a sealing member for cooperating with the detecting device to separate the sealing member from the reagent storage portion; the detecting device comprises a detecting box, and the detecting box is provided with a ejector rod The top rod and the push rod cooperate to separate the seal from the reagent storage portion.
  • the jack is movable relative to the test cartridge.
  • the jack is disposed on a bottom plate of the test cartridge.
  • the jack is disposed on an inner side panel of the test cartridge.
  • the reagent reaction box is provided with an opening, and the ejector rod cooperates with the push rod through the opening.
  • the inner side of the detection box is provided with a movable plate.
  • the movable panel comprises a substrate and an elastic member, and the substrate is connected to the detection box by an elastic member.
  • the substrate is a heating plate.
  • a resilient piece is disposed on one of the inner sides of the detection box.
  • the detection box is provided with a groove on an inner side surface of the movable panel.
  • a biological sample reaction cartridge wherein the reaction cartridge is packaged with a reagent storage portion and a push rod movable relative to the reagent storage portion; the reagent storage portion is provided with at least one reagent receiving chamber, and the reagent receiving chamber is sealed by a sealing member; The push rod is coupled to a seal for interfacing with an external device to separate the seal from the reagent storage portion.
  • the push rod is provided with a force receiving portion that cooperates with an external device.
  • the reaction box is provided with an opening, the force receiving portion is exposed in the opening, and the force receiving portion cooperates with the external device through the opening.
  • the force receiving portion is a back of the push rod.
  • the force receiving portion is a bottom surface of the push rod.
  • the reaction box is provided with a sliding slot, and the sliding slot is slidably coupled with the push rod.
  • the sliding slot is provided with a separating plate, and the separating plate isolates the sliding groove from the inner space of the reaction box.
  • At least one limiting protrusion is provided on at least one side of the push rod.
  • the push rod is provided with at least one hollowed groove body near the edge, and the limit protrusion is arranged On the outer side wall of the trough body, the limiting protrusions are disposed in pairs with the trough body.
  • the reaction box is provided with a limiting groove that cooperates with the limiting protrusion.
  • a reagent reservoir comprising a reagent receiving chamber for storing a solid particulate reagent or a powder particulate reagent, the reagent receiving chamber being sealed by a seal.
  • the solid particle reagent or powder particle reagent is a lyophilized solid particle reagent or a lyophilized powder particle reagent.
  • the solid particulate reagent is a latex freeze-dried sphere.
  • the reagent reservoir further comprises a reagent receiving chamber for storing a liquid reagent or a powder reagent.
  • the reagent accommodating chamber for storing the liquid reagent or the powder reagent is provided with an injection hole that communicates with the reagent accommodating chamber and the external space, and the injection hole is sealed by the sealing member.
  • the reagent reservoir comprises at least two reagent holding chambers, at least two reagent receiving chambers being distributed in an array.
  • the reagent reservoir comprises two reagent receiving chambers, and the two reagent receiving chambers are arranged side by side or vertically.
  • the reagent reservoir comprises four reagent receiving chambers, four reagent receiving chambers are arranged in two rows and four rows, each row is provided with two reagent receiving chambers, and each column is provided with one reagent receiving chamber.
  • a cavity for containing a desiccant is provided on the back of the reagent reservoir.
  • a reagent reaction cartridge includes a reagent storage portion, a reagent release portion, and a reaction portion, wherein the reagent storage portion, the reagent release portion, and the reaction portion are disposed inside the reaction cartridge;
  • the reagent storage portion includes at least one reagent storage chamber, and a reagent
  • the accommodating chamber is sealed by a sealing member;
  • the reagent releasing portion includes a push rod movable relative to the reagent storage portion, the push rod is connected to the sealing member, and the push rod is used for cooperating with the external device to separate the sealing member from the reagent storage portion;
  • the reaction portion includes at least one reaction zone that receives the reagent released by the reagent storage portion.
  • the reagent storage portion includes a plurality of reagent accommodating chambers, and the plurality of reagent accommodating chambers are distributed in an array.
  • the reagent storage portion includes at least two columns of reagent receiving chambers, each column including at least one reagent receiving chamber.
  • At least one of the reagent holding chambers is for storing solid particles or powder particle reagents.
  • the reaction portion includes a first reaction zone and a second reaction zone, a first reaction zone and a second reaction
  • the zones receive and temporarily store reagents released by different reagent holding chambers.
  • the first reaction zone is used for temporarily storing the solid particle reagent
  • the first reaction zone comprises a support portion and a blocking portion, and a gap is formed between the support portion and the barrier portion, and the maximum width of the slit is smaller than the minimum width of the solid particle reagent.
  • the support portion is a step.
  • the first reaction zone further comprises a second baffle, the second baffle is disposed obliquely, and the second baffle forms a second gap with the barrier, the minimum width of the second slit being greater than the maximum width of the solid particle reagent.
  • the blocking portion and the second baffle are baffles having an arc.
  • the second reaction zone is used for temporarily storing a liquid reagent
  • the second reaction zone is provided with a flow guiding member
  • the flow guiding member comprises a first drainage plate and a second drainage plate.
  • a reagent reaction cartridge for detecting a biological sample comprising a reagent storage portion, a reagent release portion and a reaction portion, wherein the reagent storage portion, the reagent release portion and the reaction portion are both disposed inside the reaction cartridge;
  • the reagent storage portion includes at least one reagent receiving chamber, the reagent receiving chamber is sealed by a seal;
  • the reagent releasing portion includes a push rod movable relative to the reagent storage portion, the push rod is connected to the sealing member, and the push rod is used for external equipment Interacting to separate the seal from the reagent storage portion;
  • the reaction portion includes at least one reaction zone, and the reaction zone receives the reagent released by the reagent storage portion.
  • a test box is provided with a movable plate, wherein the movable plate comprises a substrate and an elastic member, and the substrate is fixedly connected to the inner wall of the detecting box by an elastic member.
  • the substrate is a heating plate.
  • the detection box is provided with a groove on an inner side surface of the movable panel.
  • the elastic members are two.
  • a spring piece is disposed on one of the inner side surfaces of the detection box adjacent to the movable panel.
  • a ejector rod is disposed in the detection box.
  • the jack is movable relative to the test cartridge.
  • the jack is disposed on a bottom plate of the test cartridge.
  • the upper end of the jack is chamfered.
  • the jack is disposed on an inner side panel of the test cartridge.
  • a biological sample analysis kit includes a reaction portion including at least one reaction zone, wherein The at least one reaction zone is a first reaction zone, the first reaction zone is for temporarily storing the solid particle reagent, the first reaction zone comprises a support portion and a blocking portion, and a gap is formed between the support portion and the barrier portion, and the maximum width of the gap Less than the minimum width of the solid particle reagent.
  • the support portion is a step.
  • the blocking portion is a baffle, which is referred to as a first baffle.
  • the first baffle is a vertical baffle, and a bottom of the first baffle forms a gap with the support portion.
  • the first reaction zone further includes a second baffle, the second baffle is disposed obliquely, and the second baffle forms a second gap with the first baffle, and the minimum width of the second slit is greater than the maximum width of the solid particle reagent .
  • the first baffle and the second baffle are baffles having an arc.
  • a powder drying reagent is fixed in the reaction zone.
  • the reaction portion further includes a second reaction zone for temporarily storing the liquid reagent.
  • the second reaction zone is provided with a flow guiding member, and the flow guiding member comprises a first drainage plate and a second drainage plate.
  • the solid particulate reagent is a latex freeze-dried ball reagent.
  • a reagent storage unit includes at least one reagent accommodating chamber, at least one reagent accommodating chamber is provided with an injection hole, the injection hole communicates with the reagent accommodating chamber and the external space, and the reagent accommodating chamber and the injection hole are both sealed by a seal.
  • the reagent receiving chamber is for storing a powder reagent or a liquid reagent.
  • the reagent reservoir comprises a plurality of reagent receiving chambers, the plurality of reagent receiving chambers being distributed in an array.
  • the reagent reservoir comprises two reagent receiving chambers, and the two reagent receiving chambers are arranged laterally to the left and right.
  • the reagent reservoir comprises two reagent receiving chambers, and the two reagent receiving chambers are vertically arranged vertically.
  • the reagent reservoir comprises four reagent receiving chambers, four reagent receiving chambers are arranged in two rows and four rows, each row is provided with two reagent receiving chambers, and each column is provided with one reagent receiving chamber.
  • a cavity for containing a desiccant is provided on the back of the reagent reservoir.
  • a detection reaction cartridge includes a reagent storage unit installed in a reaction cartridge, and a reagent release position is disposed on the reagent storage chamber, the reaction cartridge includes a wall plate facing the reagent release position, and the guide plate has a guide rib.
  • the flow rib is in contact with the droplet on the end of the reagent release site, and the flow leader is used to direct the droplet on the end of the reagent release site.
  • the flow guiding rib is in contact with the end of the reagent release site.
  • the reaction cartridge further includes a reaction portion, and the flow guiding rib extends into the reaction portion.
  • the reaction cartridge includes a side plate, and the flow guiding rib is at an angle to the side plate.
  • the flow guiding rib is arched.
  • the flow guiding rib comprises a flow guiding surface facing the reagent release position, the flow guiding surface being a rounded curved surface.
  • the guiding rib further comprises two side guiding surfaces adjacent to the flow guiding surface, and the joint between the two side guiding surfaces and the wall plate is a smooth curved surface.
  • the reagent release site comprises a reagent release port.
  • the reagent release site further comprises a baffle attached below the reagent release port.
  • the reagent reaction cassettes referred to herein may also be referred to as reaction cassettes, biological sample reaction cassettes, biological sample analysis cassettes, and detection reaction cassettes.
  • the reagent reaction cassette of the present invention is a single unit, and the reagent storage part and the push rod are both enclosed in the reagent reaction box.
  • the reaction only the test box needs to be combined, and the reagent box is inserted into the external device in one step. In this case, the rapid release of the reagent in the reagent storage portion can be achieved.
  • the above structure reduces the artificial manual operation portion of the detection reaction to the most simplified degree, and improves the automation degree of the reaction.
  • the artificial manual operation step only includes sampling the sample to collect the sample and adding the sample to the reagent reaction box. The step of inserting the reagent reaction cartridge into an external device.
  • the reagent cartridge of the present invention contains various parts contained in the reagent reaction cartridge, in particular, the reagent storage portion and the push rod are contained inside the reagent reaction cartridge, so that the reagent storage portion and the push rod cannot be touched manually. Only when the external thrust of the detection box in the external device is inserted into the reagent reaction box can the push rod be actuated; when the unreacted, the improper operation or other factors are caused, the seal portion and the reagent storage portion are torn off, resulting in The possibility of reagent leakage in advance.
  • the gap between the opening and the components of the reagent reaction box of the invention is a gap fit, which provides a simple reaction space inside the reagent reaction box, ensures the purity of each reaction reagent, and avoids the external foreign matter being mixed into the reagent reaction box. Possibly, the accuracy of the reaction is improved.
  • the reagent reservoir of the present invention is a separate component, packaged in a reagent reaction cartridge, and a reagent storage package
  • a reagent receiving chamber for storing a solid particle reagent or a powder particle reagent.
  • the solid particle reagent or the powder particle reagent is sealed in the reagent storage, avoiding the random movement of the reagent in the reagent reaction box, avoiding the problem that the prior art needs to fix the dry reagent, and at the same time, improving the reagent in the sealed state.
  • the shelf life of the effective period at room temperature is distinguished from other reagents, and is particularly suitable for reagents that are difficult to store at room temperature.
  • the reagent storage unit of the present invention is provided with a latex freeze-dried ball, on the one hand, maximizing the protection of the reactivity of the latex antibody, and on the other hand, greatly improving the shelf life of the reagent at normal temperature.
  • the reagent reaction cartridge of the present invention can realize simultaneous release of a plurality of reagents, and multiple reagents in accordance with reaction time and sequence, by arranging the number of reagent accommodating chambers in the reagent storage portion and their arrangement, and the function of the push rod automation function. At the same time, adding and mixing drying reagents can complete the detection of various samples.
  • the detection system of the invention can quickly push the ejector action when the reagent reaction box is inserted, and at the same time, the reagent reaction box is quickly and firmly fixed in the detection box, thereby ensuring that the detection area is aligned with the light-passing hole, that is, one step operation At the same time, the functions of reagent release, reagent reaction box fixation and detection zone light are completed, which simplifies the reaction step.
  • the reaction cartridge of the present invention is provided with a flow guiding rib.
  • the flow guiding rib When the liquid reagent is released from the reagent reservoir into the reaction cartridge, the flow guiding rib is in contact with the droplet at the end of the reagent releasing end, so that the droplet follows the guiding rib.
  • the drainage direction leaves the reagent release position, avoiding the local residue of the reagent droplets, ensuring the accuracy of the reagent capacity control, and making the reaction more complete.
  • Figure 1 is a schematic view showing the structure of a reaction cartridge in the prior art.
  • FIG. 2 is a schematic view showing the structure of a reagent container in the prior art.
  • Fig. 3 is a partial schematic view showing the structure of a reaction cartridge in the prior art.
  • FIG. 4 is a schematic view of a perspective of a local structure in a detection system.
  • Fig. 5 is a schematic view showing the structure of the panel in the reagent reaction cartridge after being hidden.
  • Figure 6 is a schematic view showing the structure of the backing plate hidden in the reagent reaction cartridge.
  • Fig. 7 is a schematic view showing the connection structure of a reagent storage portion, a seal member, and a reagent releasing portion.
  • Fig. 7A is a schematic view showing the structure of the sealing member of Fig. 7 after being torn.
  • Fig. 8 is a schematic structural view of a reagent storage unit.
  • Fig. 8A is a schematic structural view of the reagent storage unit at an angle.
  • Fig. 8B is a schematic structural view of another angle of the reagent storage unit.
  • Fig. 9 is a schematic structural view showing an embodiment of a reagent storage unit.
  • Fig. 10 is a schematic structural view showing another embodiment of the reagent storage unit.
  • Fig. 11 is a view showing the connection structure of the upper cap, the reagent storage portion, and the reagent releasing portion in the reagent reaction cartridge.
  • Figure 12 is a schematic view showing the connection structure of the cartridge and the push rod in the reagent reaction cartridge.
  • Fig. 12A is a schematic view showing the structure of the pusher in the reagent reaction cartridge after sliding relative to the cartridge.
  • Figure 13 is a schematic view showing the structure of another embodiment in which the cartridge is connected to the pusher in the reagent reaction cartridge.
  • Figure 14 is a schematic view showing the axial structure of the release portion in the reagent reaction cartridge.
  • Figure 15 is a schematic enlarged view of the structure at A in Figure 6.
  • Figure 16 is a schematic view showing the axial structure of the cartridge in the reagent reaction cartridge connected to the push rod.
  • Fig. 16A is a schematic enlarged view of the structure C at Fig. 16.
  • Figure 17 is a schematic isometric view showing another embodiment of the cartridge in the reagent reaction cartridge connected to the pusher.
  • Figure 18 is a schematic enlarged view of the structure at D in Figure 5.
  • Figure 19 is a schematic isometric view of the external structure of the reagent reaction cartridge.
  • Figure 19A is a schematic rear view of the reagent reaction cartridge.
  • Figure 20 is a schematic view showing the structure of the upper cover in the reagent reaction cartridge.
  • Figure 20A is an enlarged schematic view of the structure at B in Figure 20.
  • Fig. 20B is a schematic view showing another angle structure of the upper cover in the reagent reaction cartridge.
  • Figure 21 is a schematic view showing the connection structure of the upper lid and the reagent storage portion in the reagent reaction cartridge.
  • Figure 22 is an exploded view of the reagent reaction cartridge.
  • Figure 23 is a schematic cross-sectional view of the test cartridge.
  • Figure 24 is a schematic view showing the structure of internal components in the test cartridge.
  • Figure 25 is a schematic cross-sectional view showing the pusher of the reagent reaction cartridge inserted into the test cartridge by the jack.
  • Figure 26 is a schematic view showing the structure of the elastic member in the detecting case.
  • Figure 27 is a schematic view showing the structure of the elastic piece in the detecting case.
  • Figure 28 is a schematic view showing the state of the reagent in step 0 when the reagent reaction cartridge is detected.
  • 28A-28F are schematic views of the reagent states in steps 1-6, respectively, when the reagent reaction cartridge is detected.
  • Figure 29 is a schematic view showing the structure of the flow guiding rib on the reaction cartridge.
  • Figure 30 is a schematic view showing the flow guiding structure of the back panel of the reaction cartridge after see-through.
  • Figure 30A is a schematic view showing the structure of Figure 30 in the H-H section.
  • Figure 30B is an enlarged schematic view of the structure at E in Figure 30A.
  • Figure 31 is a schematic view showing the structure of an embodiment of a flow guiding rib in a reaction cartridge.
  • Figure 32 is a schematic view showing the structure of another embodiment of the flow guiding rib in the reaction cartridge.
  • Figure 33 is a schematic view showing the structure of still another embodiment of the flow guiding rib in the reaction cartridge.
  • Figure 34 is a schematic view showing the structure of an embodiment of a flow guiding rib and a reagent reservoir in a reaction cartridge.
  • the detection system of the present invention is for rapidly detecting the concentration of an analyte in a biological sample, including a reagent reaction cartridge 100 and an external device, and the external device is a device other than the body of the reagent reaction cartridge 100, wherein the external device Also known as a detection device, an external device or detection device is provided with a detection box 200, and the reagent reaction box 100 and the detection box 200 are used together.
  • the reagent reaction cartridge 100 serves as a reaction vessel, and can realize storage of a plurality of reagents, sequential addition of a plurality of reagents, and recovery of waste liquid.
  • the detecting box 200 is used for placing the reagent reaction box 100, and the detecting box 200 is mounted on the detecting device, and the detecting device provides mechanical power and control for rotating the reagent reaction box 100, mixing the reagents in the reagent reaction box 100, releasing the reagent, and the like. Optics are also provided on the external device for detecting the concentration of the analyte in the liquid sample.
  • a reagent storage unit 102, a reagent releasing unit 150, a reaction unit, and a detection area 28 are provided in the reagent reaction cartridge 100.
  • the reagent storage unit 102 and the reagent release unit 150 are both enclosed in the reagent reaction cartridge 100.
  • a cavity is disposed in the reagent reaction cartridge 100, and the reagent storage portion 102 is housed in the cavity.
  • the reagent storage unit 120 is packaged as a separate component in the reagent reaction cartridge 100, facilitating rapid assembly of the reagent reaction cartridge.
  • the reagent storage portion 102 is for sealing and storing solid particles, powder or liquid reagents, and the reagent releasing portion 150 can quickly open the reagent storage portion 102 to release the reagents into the reaction portion of the reagent reaction cartridge 100 under the cooperation of the detection cartridge 200 in the detecting device.
  • the reaction portion is used for the temporary storage, mixing and reaction of the biological sample and the reagent, and the reaction intermediate or final product is detected through the detection zone 28.
  • the reagent storage portion 102 includes at least one reagent accommodating chamber, and the reagent storage portion 102 is sealed by the sealing member 104, that is, the reagent accommodating chamber is sealed by the sealing member 104.
  • the reagent storage unit 102 is also referred to as a reagent storage, and the reagent storage unit 102 includes a plurality of reagent storage chambers, and a plurality of reagent storage chambers are arrayed. cloth.
  • the number of reagent accommodating chambers is set according to the kind of reagents required for detecting the reaction, and the order of addition, for example, one, two or more, and the reagent accommodating chambers are independent from each other, that is, the plurality of reagent accommodating chambers are mutually With spacing, they are distributed in an array.
  • the two reagent accommodating chambers may be laterally arranged in a row, or may be longitudinally arranged in a row, or may be diagonally distributed; for example, a plurality of reagent accommodating chambers may be spaced apart from each other.
  • the capacity of the reagent holding chamber is also set according to the dose required to detect the reaction.
  • the reagent storage portion includes at least two columns of reagent receiving chambers, each column including at least one reagent receiving chamber.
  • the reagent storage portion 102 includes two reagent accommodating chambers, and the two reagent accommodating chambers are laterally arranged side by side. That is, the reagent accommodating chamber 106 and the reagent accommodating chamber 108 are distributed in a row and two columns, and the bottom of the reagent accommodating chamber is substantially on the same horizontal line. Therefore, when the seal 104 is torn open, the reagent accommodating chamber 106 and the reagent in the reagent accommodating chamber 108 can be released together into the reagent reaction cartridge 100.
  • the two reagent accommodating chambers are longitudinally arranged, that is, the reagent accommodating chamber 110 and the reagent accommodating chamber 112 are arranged in two rows and one column, and the partial tearing seal is partially opened.
  • the reagent accommodating chamber 112 located in the lower row preferentially releases the reagent, and continues to tear the sealing member 104 according to the reaction time requirement, so that the reagent accommodating chamber 110 located in the upper row releases the reagent.
  • the control seal 104 it is possible to add reagents in sequence to control the progress of the reaction.
  • the reagent receiving chamber 114 As shown in FIG. 10, as another embodiment of the reagent storage portion, four reagent receiving chambers are arranged in an array, that is, the reagent receiving chamber 114, the reagent receiving chamber 116, the reagent receiving chamber 118, and the reagent receiving chamber 120 are two. Four rows are arranged. To the extent that the control seal 104 is torn, the reagents in the lower row of reagent receiving chamber 118 and reagent receiving chamber 120 are preferentially released, followed by the release of the upper row of reagents.
  • the reagent reservoir comprises a reagent receiving chamber for storing a solid particulate reagent or a powder particulate reagent.
  • the solid particle reagent or the powder particle reagent is sealed in the reagent storage, avoiding the random movement of the reagent in the reagent reaction box, avoiding the problem that the prior art needs to fix the dry reagent, and at the same time, improving the reagent in the sealed state.
  • the shelf life of the effective period at room temperature is distinguished from other reagents, and is particularly suitable for reagents that are difficult to store at room temperature.
  • the solid particle reagent or powder particle reagent is a lyophilized solid particle reagent or a lyophilized powder particle reagent.
  • the solid particulate reagent is a latex freeze-dried sphere. The latex freeze-dried ball, on the one hand, maximizes the protection of the latex antibody reactivity, and on the other hand, greatly improves the shelf life of the reagent at room temperature.
  • the reagent reservoir further includes a reagent receiving chamber for storing the liquid reagent.
  • Test The agent accommodating chamber can be used for storing solid particles, powder particles or liquid reagents, and can be set according to the detection needs.
  • At least one reagent accommodating chamber is provided with an injection hole 130 that communicates with the reagent accommodating chamber and the external space, and the reagent accommodating chamber and the injection hole 130 are sealed by the sealing member 104.
  • the injection hole 130 is provided on a reagent accommodating chamber for storing a powder reagent or a liquid reagent.
  • the reagent accommodating chamber is sealed with the sealing member 104 and the injection hole 130 is exposed outside, and the liquid or powder reagent is injected into the reagent accommodating chamber, and then the injection is sealed.
  • the hole 130 thereby ensuring the sealing effect and reducing the difficulty of sealing the liquid or powder reagent.
  • the reagent accommodating chamber and the injection hole can be sealed step by step by the same sealing member, and can be sealed by two sealing members, such as sealing the injection hole with a sealing plug.
  • a cavity 132 for mounting a desiccant is further provided on the back of the reagent storage portion 102.
  • the desiccant is mounted in the cavity 132 by the cooperation of the cavity 132 and the inner wall of the panel 10.
  • the reagent storage portion 102 includes two reagent holding chambers for storing the solid particle reagent and the liquid reagent, respectively.
  • the reagent storage unit 102 includes two reagent accommodating chambers 106, 108 as an example.
  • the reagent accommodating chamber 106 stores the solid particle reagent and the reagent accommodating chamber 108 for storing the liquid reagent, and the injection port is provided at the upper end of the reagent accommodating chamber 108. 130.
  • the solid particle reagent is first placed in the reagent accommodating chamber 106 during sealing, the chamber opening of the reagent accommodating chamber 106 and the reagent accommodating chamber 108 is sealed with a seal 104, and the liquid reagent is injected into the reagent accommodating chamber 108, followed by sealing.
  • the piece 104 seals the injection hole 130.
  • the bottom of the reagent receiving chamber is beveled.
  • the reagent is quickly discharged, the residue of the reagent in the accommodating chamber is minimized, and the precision of the reagent capacity control is ensured.
  • the reagent storage portion 102 is sealed by the sealing member 104, that is, the reagent is sealed in the reagent accommodating chamber, and the sealing member 104 can be detached from the reagent accommodating chamber under the action of an external force, and the tearing off of the sealing member 104 can be From left to right, from bottom to top, etc., the description will be made by taking the seal from the bottom to the top as an example, as shown in Fig. 7A.
  • the seal 104 can be a seal conventionally used in the prior art such as aluminum foil, film, and the like.
  • the reaction cartridge includes a reagent reservoir 102 mounted in a reaction cartridge having a reagent release site thereon, and the reaction cartridge 100 includes a wall facing the reagent release site a guide rib 70 is disposed on the wall plate, and the guide rib 70 and the droplet on the end of the reagent release end In contact, the guide rib 70 is used to direct droplets on the end of the reagent release site.
  • the reagent release site refers to a position at which the liquid reagent flows from the reagent reservoir to a position where the reagent exits the reagent reservoir, that is, a liquid passage of the liquid reagent on the reagent reservoir.
  • the end of the reagent release site refers to the tail end of the liquid channel.
  • the wall panel is the backing plate 12 or the isolating plate 36 on the reaction cartridge 100 mentioned below.
  • the reagent releasing portion adopts a manual manual method in the prior art when the guiding is performed.
  • the reagent release portion is employed in an automated manner herein.
  • the reagent release site includes a reagent release port 140.
  • the bottom of the reagent release port 140 is the end of the reagent release site.
  • the reagent release site further includes a baffle 142 attached below the reagent release port 140.
  • the deflector 142 is used for guiding the liquid to make the liquid reagent flow more smoothly away from the reagent reservoir 102.
  • the deflector 142 has a sharp angle, and the bottom of the deflector 142 is the reagent release end.
  • the flow guiding rib 70 is in contact with the end of the reagent release site.
  • the contact surface of the droplet at the end of the reagent release site with the guide rib 70 is increased, and the droplet is drained more quickly.
  • the flow guiding rib includes a contact end 72 and a leading end 74 which are sequentially connected, and the contact end 72 is in contact with a droplet on the end of the reagent releasing end or is in contact with a reagent releasing end, the leading end 74 extends downwardly from the contact end 72.
  • the flow guiding ribs are in the form of thin strips.
  • the contact end 72 is for contacting the droplets and draining the droplets onto the leading end 74 for directing the droplets on the contact end 72 to a designated location of the reaction cartridge 100.
  • the cross-sectional area of the guiding end 74 is sequentially decreased from top to bottom, and the bottom of the guiding end forms a tip end, which facilitates the drainage of the liquid droplets and reduces the liquid hanging phenomenon at the bottom of the guiding end as much as possible.
  • the contact end is in contact with the droplet, which can quickly drain the droplet. The closer the contact end is to the end of the reagent release site, the larger the contact surface of the contact end with the droplet, and the more obvious the drainage effect of the guide rib.
  • the reaction cartridge 100 further includes a reaction portion, and the guide rib 70 extends into the reaction portion. That is, the leading end 74 of the guide rib 70 extends into the reaction portion and is in contact with the liquid reagent in the reaction portion.
  • the extension of the guide rib 70 allows the droplet to be quickly and accurately guided into the reaction section.
  • the droplets suspended on the leading end are taken away from the liquid reagent in the reaction section, and the residual of the small droplets on the guiding ribs is avoided.
  • the contact end 72 of the flow guide rib 70 extends upwardly. It facilitates the rapid introduction of liquid from the reagent reservoir into the reaction section.
  • the reaction cartridge 100 includes a side panel, and the flow guiding rib 70 is at an angle to the side panel.
  • the guide ribs 70 may be disposed obliquely or in parallel with the side plates.
  • the side panels are the left side panel 6 or the right side panel 8 on the reaction cartridge 100 mentioned below.
  • the flow guiding direction of the flow guiding rib 70 coincides with the flow direction of the liquid in the reagent reservoir.
  • the flow guiding rib When the flow direction of the reagent reservoir releasing the liquid reagent is perpendicular to the horizontal plane, the flow guiding rib is disposed at a vertical horizontal plane; when the reagent reservoir of the reaction cartridge releases the reagent, the reaction box is inclined at an angle to the horizontal plane, and the flow direction of the liquid reagent at this time Released at an oblique angle to the side plates, the guide bars are inclined, and the direction of inclination of the guide bars is the flow direction of the liquid in the reagent reservoir.
  • the direction of the flow guiding of the guide ribs is consistent with the flow direction of the liquid in the reagent reservoir, which is advantageous for reducing the resistance during the drainage process and allowing the reagent to flow down quickly.
  • the flow guiding rib is arched.
  • the longitudinal direction of the flow guiding rib is triangular.
  • the triangle is a rounded triangle.
  • the triangle is selected from the group consisting of a right triangle, an obtuse triangle, or an acute triangle.
  • the longitudinal section of the guide rib 70 has a right-angled triangular shape, and one of the right-angled sides of the right-angled triangle is fixed on the wall plate, and the portion of the guide rib 70 that can contact the liquid droplet To be the contact end 72, the portion below the contact end 72 is the leading end 74.
  • the longitudinal section of the guide rib 70 has an obtuse triangular shape, and the largest oblique side of the obtuse-angled triangle is fixed on the wall plate, and the flow guiding rib 70 can be liquid-liquid.
  • the portion of the drop contact is the contact end 72, the portion below the contact end 72 is the leading end 74, and the portion above the contact end 72 is the extension of the contact end 72.
  • the guide rib 70 includes a mounting surface 80, a flow guiding surface 82 opposite to the mounting surface, and two side flow guiding surfaces 84 adjacent to the mounting surface, the mounting surface 80 being fixed at On the siding.
  • the flow guiding surface 82 is disposed facing the reagent release position, and the flow guiding surface 82 is a rounded curved surface, and the joint between the two side flow guiding surfaces 84 and the wall plate is a rounded curved surface.
  • the design of the smooth surface makes the drainage of the guide ribs smoother and the resistance is smaller.
  • the reagent release portion 150 includes a push rod 152 that is coupled to a seal 104 that cooperates with an external device to separate the seal from the reagent storage portion.
  • the sealing member 104 is attached or fixed to the push rod 152.
  • the push rod 152 cooperates with the inner wall of the reagent reaction box 100 to generate movement relative to the reagent storage portion 102.
  • the seal 104 is moved relative to the reagent storage portion 102, that is, the seal
  • the tearing action of 104 causes the reagents in the reagent holding chamber to be released into the reagent reaction cartridge 100.
  • the movement of the push rod 152 relative to the reagent storage portion 102 can be implemented from left to right, from right to left, from bottom to top, and the like.
  • one end of the sealing member 104 seals the reagent storage portion 102, and the other end is folded and attached to the push rod 152.
  • the push rod 152 is provided with a force receiving portion that cooperates with an external device.
  • the force receiving part is used to take the thrust provided by the external device.
  • the push rods 152 are all housed inside the reagent reaction cartridge 100, and the thrust members of the external device need to protrude into the reagent reaction cartridge 100 or otherwise act on the force receiving portion of the push rod 152.
  • the push rods 152 are all housed in the reagent reaction box, and the push rods in the reagent reaction box are not touched by the human hand, and the push rod 152 cannot be actuated by the human hand.
  • the push rod 152 can be operated only by the external tool. This avoids the possibility of premature leakage of the reagent by artificially tearing or damaging the seal 104 during non-detection periods, mishandling or other reasons.
  • a chute 38 is provided in the reagent reaction cartridge 100.
  • the chute 38 embeds the push rod 152 in the slide, and on the other hand, the chute 38 is in sliding engagement with the push rod 152.
  • the chute 38 is disposed on the back plate 12.
  • the chute 38 can be designed to be composed only of the back plate 12 and the two groove sides. At this time, the side portions of the push rod 152 are received in the chute 38.
  • the chute 38 is provided with a partitioning plate 36 that isolates the chute 38 from the internal space of the reagent reaction cartridge 100.
  • the chute 38 is a columnar body having at least one end open, and the four sides of the columnar body are composed of a part of the back plate 12, both sides of the chute 38 and the isolating plate 36, that is, the chute 38 is sealed and connected.
  • the separator 36 separates the chute 38 from the internal space of the reagent reaction cartridge 100.
  • the height of the separator 36 is such that the reaction liquid does not flow outside the reagent reaction cartridge.
  • the chute 38 is designed as a separate area that isolates the push rod 152 or the outer thrust member from the reagent to prevent the push rod 152 or the outer thrust member from contacting the reagents and carrying away some of the reagent.
  • At least one of the limiting protrusions 154 is disposed on at least one side of the push rod 152.
  • the limit projection 154 allows the push rod 152 to be more stably installed inside the reagent reaction cartridge 100.
  • the number of the limiting protrusions 154 is two, which are respectively disposed on the left and right sides of the push rod 152.
  • the limiting protrusion 154 is disposed at an upper portion of the side of the push rod 152.
  • the limiting protrusion 154 on the push rod 152 is elastically deformed by the reagent reaction box 100, and the push rod 152 and the reagent reaction box are added. 100 friction, make the putter The 152 can be stably installed in the reagent reaction cartridge 100, and also increases the resistance of the push rod 152 during movement.
  • the push rod 152 is provided with at least one hollowed groove body 156 near the edge, and the limiting protrusion 154 is disposed on the outer side wall of the groove body 156, and the limiting protrusion is provided.
  • the 154 is disposed in pairs with the trough body 156.
  • the limiting protrusions 154 are two, and the two limiting protrusions 154 are respectively disposed on the left and right sides of the push rod 152.
  • the hollow groove bodies 156 are also two, respectively The left side and the right side of the push rod are disposed near the edge, that is, the outer side wall of the left side groove body 156 is the left side surface of the push rod 152, and the outer side wall of the right side side groove body 156 is the right side surface of the push rod 152. That is, the limiting protrusion 154 is disposed on the outer side wall of the groove body 156.
  • the arrangement of the hollowing trough 156 makes it easier to deform when the push rod 152 is operated, thereby avoiding the inflexibility of the push rod 152 due to excessive friction.
  • the reagent reaction box 100 is provided with a limit convex.
  • the 154 fits the limiting groove 158.
  • the chute 38 is provided with a limiting groove 158 that engages with the limiting protrusion 154.
  • the number of the limiting groove 158 is the same as that of the limiting protrusion 154.
  • the push rod is provided with a recess 162.
  • the groove 162 is disposed at the upper end of the push rod 152, and the groove 162 is an adhesive groove for attaching the sealing member 104.
  • the groove bottom of the groove 162 is slightly lower than the plane of the groove of the groove 162.
  • the seal 104 fills the groove 162 to make the pusher plane flush.
  • the peeling of the pusher 152 is caused by the seal 104 being raised.
  • the force receiving portion of the push rod 152 is the bottom surface or the back portion of the push rod.
  • an external force acts on the bottom surface of the push rod to tear the push rod 152 from the bottom to the top.
  • an external force acts on the back of the push rod, which also causes the push rod 152 to tear the seal member 104 from the bottom up.
  • the force receiving portion of the push rod 152 may also be the upper bottom surface, the left side surface or the right side surface of the push rod.
  • the push rod When the upper bottom surface is the upper bottom surface, the push rod can be pulled from the upper portion; when the left side surface is the left side, the push rod can be pushed from the left to the right side. Rod; for the right side, the pusher can be pushed from right to left.
  • the force receiving portion of the push rod 152 is magnetically connected to the external thrust member, that is, the force receiving portion of the push rod 152 and the external thrust member are magnetic components that attract each other, such as iron blocks, magnets, and the like.
  • Push rod 152 The external thrust member is separated from the reagent reaction box 100, and under the action of the magnetic force, the push rod 152 is driven by the external thrust member.
  • the reagent reaction cartridge 100 is provided with an opening, the force receiving portion is exposed in the opening, and the force receiving portion receives the external thrust through the opening. That is, the outer thrust member can protrude into the opening, contact with the push rod 152 in the reagent reaction box 100 and urge it to move, and the opening position setting is related to the force receiving portion of the push rod 152.
  • the force receiving portion of the push rod 152 is the bottom surface of the push rod, and the aforementioned opening 34 is provided on the bottom plate 4 of the reagent reaction cartridge 100.
  • the opening 34 is provided with a chamfer 40, and the push rods 152 are all housed in the chute 38 and spaced apart from the opening 34 to avoid collision during misoperation.
  • the outer thrust member is introduced from the chamfer 40 of the opening 34 and extends into the chute 38 in contact with the push rod 152 and urges the push rod 152 and the outer thrust member into sliding engagement with the chute 38.
  • the force receiving portion of the push rod 152 is the back of the push rod 152, and the opening 34 is provided on the back plate 12 of the reagent reaction cartridge 100.
  • the back of the push rod 152 is provided with a rib or recess 160, and the rib or recess 160 is a force receiving portion, and the rib or recess 160 is exposed in the opening 34.
  • the outer thrust member contacts the rib or recess 160 and urges the push rod 152 into sliding engagement with the chute 38.
  • the reaction portion includes at least one reaction zone that receives the reagent released by the reagent storage portion 102.
  • the reaction part includes a plurality of reaction zones, and the number and position setting of the reaction zones are related according to the number of reagent accommodating chambers in the reagent storage unit 102 and the reaction steps.
  • the two reagents simultaneously released may be temporarily stored in one reaction zone, or may be separately There are two separate reaction zones temporarily; if there are drying reagents in the reaction zone, other reaction zones can be separately set, and each reaction zone is connected to each other, and the reagents in each reaction zone can be mixed by rotating the reagent reaction box. .
  • a detection area 28 is disposed in the reaction portion.
  • the detection area 28 may be disposed on a flow path of any reagent of the reagent reaction cartridge 100.
  • the detection area 28 is generally made of a transparent material to transmit light emitted by the optical device. Or scattered light enters the reagent reaction cartridge 100.
  • a flow guiding member is disposed between the reagent storage portion 102 and the reaction portion. More specifically, the flow guiding member is disposed between the reagent receiving chamber and the corresponding reaction region, and the flow guiding member enables the reagent in the reagent receiving chamber to be fast and accurate. Released into the reaction zone.
  • the reaction portion includes at least one reaction zone, wherein at least one reaction zone is a first reaction zone 26, and the first reaction zone 26 is used for temporarily storing solid particle reagents,
  • a reaction zone 26 includes a support portion and a blocking portion, and a gap 47 is formed between the support portion and the blocking portion, and the slit 47
  • the maximum width is less than the minimum width of the solid particle reagent.
  • the gap between the support portion and the barrier portion serves to block the solid particle reagent in the first reaction zone from entering the other reaction zone, so that the solid particle reagent can be stably stored on the support portion.
  • the support portion is a step 46
  • the blocking portion is a baffle, which is referred to as a first baffle 48.
  • the first baffle 48 is a vertical baffle, and the bottom of the first baffle 48 forms a slit 47 with the support portion.
  • the solid particulate reagent is a latex freeze-dried ball reagent.
  • the minimum width of the latex freeze-dried ball reagent i.e., the diameter of the latex freeze-dried ball, is greater than the maximum width of the slit 47, so that the latex freeze-dried ball reagent is blocked by the slit 47.
  • the first reaction zone 26 further includes a second baffle 50, the second baffle 50 is disposed obliquely, and the second baffle 50 forms a second slit 49 with the blocking portion.
  • the minimum width of the second slit 49 is greater than the maximum width of the solid particle reagent.
  • the second baffle 50 and the barrier portion are used for drainage of the solid particulate reagent, so that the solid particulate reagent can smoothly enter the first reaction zone 26.
  • the maximum width of the latex freeze-dried ball reagent that is, the diameter of the latex freeze-dried ball is smaller than the minimum width of the second slit 49, so that the latex freeze-dried ball reagent can easily enter the first reaction zone 26.
  • the first baffle 48 and the second baffle 50 are baffles having an arc.
  • the solid particle reagent can be quickly introduced, and in consideration of the difference in the diameter of the solid particles, the solid particles are prevented from being caught between the first baffle 48 and the second baffle 50 and cannot fall onto the step 46.
  • the reaction portion further includes a second reaction zone for temporarily storing the liquid reagent.
  • the second reaction zone is provided with a flow guiding member, and the flow guiding member comprises a first drainage plate and a second drainage plate.
  • the reaction portion includes a first reaction zone 26 and a second reaction zone 25, and the first reaction zone 26 is for receiving solid particles released by the reagent accommodating chamber 106, and second.
  • the reaction zone 25 is for receiving a liquid reagent released by the reagent receiving chamber 108.
  • a flow guiding member is disposed on the second reaction zone 25, and the flow guiding member includes a first drainage plate 42 and a second drainage plate 44 to rapidly flow the liquid reagent into the second reaction zone 25.
  • the first reaction zone 26 includes a step 46 for temporarily storing reagents, a first baffle 48 and a second baffle 50 for guiding solid particles into the step 46, and simultaneously A gap 47 is formed between a baffle 48 and the step 46 which prevents solid particles from entering the second reaction zone 25 and allows liquid reagent to flow into the first reaction zone 26.
  • the reagent reaction cartridge 100 includes a top plate 2, a bottom plate 4, a left side plate 6, a right side plate 8, a panel 10, and a back plate 12.
  • the reagent reaction cartridge 100 is generally a square box-shaped body made of a plastic material.
  • one end of the left side plate 6 or the right side plate 8 of the reagent reaction cartridge 100 is a slope 22.
  • the back plate 12 of the reagent reaction cartridge 100 is provided with an extension 24 extending out to the outside of the slope 22.
  • the slope 22 is disposed at the lower left corner of the reagent reaction cartridge 100.
  • the back plate 12 has a square shape
  • the panel 10 has a pentagon shape
  • the left side plate 6 has a side surface and a sloped surface
  • the extending portion 24 has a right-angled triangular shape
  • the oblique side of the right-angled triangle is the back plate 12 and the extension. The junction of the portion 24.
  • the arrangement of the inclined surface 22 and the extending portion 24 facilitates artificially distinguishing the front and back sides of the reagent reaction box 100, avoiding the reverse insertion of the reagent reaction box 100 into the detection box 200, and on the other hand, automatically when the reagent reaction box is matched with the detection box. Identify the front and back of the reagent reaction cartridge to avoid misuse.
  • the reagent reaction cartridge 100 is provided with positioning projections 16.
  • the positioning protrusion 16 is disposed on the panel 10, and the positioning protrusion 16 has an inverted triangle shape. As shown in FIG. 20A, the positioning protrusion 16 is used for firmly positioning the reagent reaction box 100 in the corresponding groove of the detection box 200, and positioning the protrusion. The 16 is engaged with the groove limit to secure the reagent reaction cartridge 100 in the detection cartridge 200 to avoid displacement of the reagent reaction cartridge 100 relative to the detection cartridge 200 when rotating.
  • the top plate 2 of the reagent reaction cartridge 100 is provided with a handle 14 for facilitating the user to hold the handle 14 to quickly insert the reagent reaction cartridge 100 into the detection cartridge 200 after the detection is completed.
  • the reagent reaction cartridge 100 is quickly removed.
  • the back plate 12 of the reagent reaction cartridge 100 is provided with a notch 52. The provision of the notch 52 makes the injection molding of the reagent reaction cartridge 100 more convenient.
  • the reagent reaction box 100 is provided with a reagent storage unit 102, a reagent release unit 150, a reaction unit, a detection area 28, a sampling rod 30, and a liquid absorption pad. 32.
  • the reagent reaction cartridge 100, the reagent storage portion 102, the reagent releasing portion 104, and the sampling rod 30 are each made of a plastic material.
  • the sampling rod 30 is for collecting a liquid sample such as blood, urine, or the like, and adding the liquid sample to the reagent reaction cartridge 100. After the test is completed, the liquid absorption pad 32 is used to recover the waste liquid to avoid contamination by liquid leakage.
  • the reagent reaction cartridge 100 is a cavity which can be divided into a casing 18 and an upper cover 20.
  • the casing 18 includes a backing plate 12, a bottom plate 4, a left side plate 6, and a right side plate.
  • the upper cover 20 includes a top plate 2 and a panel 10, and the upper cover 20 and the case 18 are sealed and connected by welding or the like to facilitate assembly of the reagent reaction cartridge 100.
  • the liquid absorbing pad 32 is disposed at an upper portion of the inclined surface 22, the liquid absorbing pad 32 is sequentially directed to the right side plate 8 as the sampling rod 30 and the reagent storage portion 102, and the reaction portion and the reagent releasing portion 104 are both disposed at Below the reagent storage unit 102, the detection area 28 is disposed in the reaction unit.
  • the sampling rod 30 is disposed in the reagent reaction cartridge 100 through an opening, and the sampling rod 30 is fitted to the opening to prevent foreign matter from being mixed during sampling.
  • the inclined surface 22 is disposed on the left side of the sampling rod 30, which is favorable for the sample on the sampling rod 30 to be in sufficient contact with the reaction liquid to prevent the reaction liquid from being too small to contact the sample.
  • the second drainage plate 44 is connected to the upper end of the first baffle 48.
  • the upper end of the first drainage plate 42 is further connected with a sampling needle guiding plate 57, and the sampling needle guiding plate 57 is disposed in the vertical direction.
  • the casing 18 and the upper cover 20 are each provided with a sampling needle fixing member 59 for sampling the needle fixing member 59 to prevent it from shaking.
  • the reagent storage unit and the reagent reaction box are connected.
  • the reagent storage unit 102 is provided with positioning members, and each positioning member constitutes a cavity, and the cavity is used for accommodating the reagent storage unit. 102, the reagent storage portion 102 is fixedly mounted in the reagent reaction cartridge 100.
  • the cavity can also be constructed using conventional techniques in the prior art.
  • the panel 10 is provided with a positioning post 54 and a support plate 61.
  • the left positioning plate 56 and the right positioning plate 58 are a plurality of discrete positioning positions.
  • the positioning member of the reagent storage portion 102 includes a mounting hole 122, a left positioning member 124, a right positioning member 126, and a lower positioning member 128.
  • the mounting hole 122 is fastened on the positioning post 54 for fixing the upper end of the reagent storage portion 102; the left positioning member 124 and the right positioning member 126 are respectively limited to the left positioning plate 56 and the right positioning plate 58.
  • the lower positioning member 128 is placed on the support plate 61. Therefore, the reagent storage portion 102 is stably installed in the reagent reaction cartridge 100, and displacement of the reagent storage portion 102 during the movement or shaking of the reagent reaction cartridge 100 is avoided.
  • the detecting cartridge 200 is provided with a plunger 204 which is in contact with the force receiving portion through the opening 34 in the reagent reaction cartridge and provides the force of the external device.
  • the jack 204 is movable relative to the test cartridge 200.
  • the jack 204 can be fixed to the casing or can move relative to the casing.
  • the active area of the jack 204 and the position of the movement are controlled by an external device.
  • the movement of the jack 204 can be controlled by a motor, or conventional techniques in the prior art can be employed.
  • the jack 204 is disposed on the bottom plate of the detecting cartridge 200 or the jack 204 is disposed on the inner panel of the detecting cartridge 200.
  • the opening 34 is provided on the bottom plate 4 of the reagent reaction cartridge 100, and the jack 204 is disposed on the bottom plate of the detecting cartridge 200.
  • the upper end of the jack 204 is chamfered to facilitate the insertion of the jack 204 into the opening 34.
  • the detecting box 200 is provided with a movable plate including a substrate 206 and an elastic member 210, and the substrate 206 is fixedly coupled to the inner wall of the detecting case 200 by the elastic member 210.
  • the number of the elastic members 210 is two, and the elastic member 210 includes a mounting surface 212 and two elastic arms 214.
  • the mounting surface 212 is fixedly connected to the inner side surface of the detecting box 200, and the two elastic arms 214 are respectively fixedly connected to the substrate 206. .
  • the substrate 206 is a heating plate, which is referred to as a first heating plate. That is, the movable plate serves as a heating member and as an elastic fastener.
  • a spring piece 216 is provided on one of the inner side faces of the test cartridge 200 as shown in Figs.
  • the elastic piece 216 is disposed on one of the inner side faces adjacent to the movable plate.
  • the elastic piece 216 is provided with a spring arm 218.
  • One end of the elastic arm 218 is fixed to the elastic piece 216, and the other end of the elastic arm 218 has a rounded curved shape, and the elastic arm 218 is mounted facing the inner cavity of the detection box 200.
  • the elastic piece 216 is used to fit the inclined surface 22 on the reagent reaction box 100, so that the side of the reverse box 100 on which the slope is not provided is in close contact with the inner side wall of the detection box 200.
  • the elastic piece 216 Since the elastic piece 216 has a certain elasticity, if the reagent reaction box 100 is reversely inserted into the detection box 200, the reagent reaction box 100 cannot be completely inserted into the detection box 200 due to the action of the elastic piece 216, and therefore, the elastic piece 216 and the inclined surface 22 The cooperation can also serve as an identification function for the correct insertion of the reagent reaction cartridge 100.
  • a groove 202 is provided on one of the inner side faces of the detecting cartridge 200.
  • the groove 202 is disposed on the inner side of the opposite movable panel.
  • the groove 202 is used for snapping the positioning protrusion 16 on the reagent reaction box 100, so that the reagent reaction box 100 can be snapped onto the groove 202, and the movement of the reagent reaction box 100 during the rotation or vibration of the detection box 200 is avoided. Bit.
  • the detection box 200 is fixed on an external device to achieve mixing or rotation, and the detection box 200 includes a box body with an open end, and the box body is provided. There is a light-passing hole 201, and a ejector 204, a first heating plate 206 and a second heating plate 208 are disposed in the casing.
  • the first heating plate 206 is a movable plate, and the ejector 204 contacts the force receiving portion through the opening 34 and provides an external portion. Thrust, number A heating plate 206 and a second heating plate 208 are used to heat the reagents to meet the reaction temperature requirements.
  • the reagent reaction cartridge 100 presses the first heating plate 206, and the first heating plate 206 deforms the elastic member 210 under the action of pressure, and the reagent reaction cartridge The 100 can be quickly inserted and snapped into the recess 202.
  • the bevel 22 of the reagent reaction cartridge 100 compresses the elastic piece 216 to align the detection area 28 on the reagent reaction cartridge 100 with the light-passing hole 201 on the detection cartridge 200.
  • the plunger 204 extends into the opening 34 to contact the push rod 152.
  • the push rod 152 moves from bottom to top.
  • the driving seal 104 is moved from bottom to top to tear the sealing member 104 away from the reagent storage portion 102, and the releasing reagent is as shown in Fig. 7A.
  • the immunological method refers to measuring HbA1c based on the interaction of an antigen molecule and a specific antibody after erythrocyte lysis.
  • Detection of HbA1c by immunoagglutination involves the following two detection steps: detection of total hemoglobin Hb concentration and glycated hemoglobin HbA1c concentration in the sample, respectively.
  • Total hemoglobin (Hb) is detected by oxidizing ferrous ions in hemoglobin with potassium ferricyanide to form methemoglobin, methemoglobin reacts with thiocyanate to form thiocyanate, and absorbance at 531 nm is detected to obtain Hb. concentration.
  • HbA1c Glycated hemoglobin
  • immunoassay for HbA1c requires the use of a thiocyanate liquid reagent (Buffer), a latex sphere labeled with an anti-HbA1c antibody, a potassium ferricyanide drying reagent (drying), and agglutination with multiple HbA1c immunoreactive binding sites. Dry reagent (drying).
  • the thiocyanate liquid reagent 60 is stored in the reagent accommodating chamber 108
  • the latex ball 62 labeled with the anti-HbA1c antibody is stored in the reagent accommodating chamber 106
  • the potassium ferricyanide drying reagent 64 is solidified in the second reaction zone.
  • the lectin drying reagent 66 is cured in the first reaction zone 26.
  • the latex ball is a latex freeze-dried pellet, and the specific HbA1c antibody is attached to the latex pellet by covalent bonding in advance, and the latex sphere is quickly frozen into a pellet of the same volume by freeze-drying technology.
  • the concentration of HbA1C in the blood is detected using the reagent reaction cartridge of the present invention.
  • the steps of immunoassay for detecting HbA1c are as follows:
  • Step 0 As shown in Fig. 28, the sampling rod 30 with the sample was inserted into the reagent reaction cartridge.
  • Step 1 As shown in Fig. 28A, the detection box is rotated, the reagent reaction cartridge is inserted into the detection box, and the push rod 152 is moved upward by the external thrust, and the sealing member 104, the latex ball 62 and the thiocyanate 60 are pulled off. At the same time, the latex ball 62 falls into the first reaction zone 26 for temporary storage, and the thiocyanate liquid reagent 60 falls into the detection zone 28 of the second reaction zone 25.
  • Step 2 As shown in Fig. 28B, the reagent reaction cartridge was rotated, and Buffer 60 (thiocyanate), dried matter 64 (potassium ferricyanide) and a blood sample were mixed to form a mixture X.
  • Buffer 60 thiocyanate
  • dried matter 64 potential ferricyanide
  • Step 3 As shown in Fig. 28C, the reagent reaction cartridge is rotated, and the mixture X in the step 2 is rotated to the detection zone 28 to detect the content of hemoglobin (Hb) in the sample.
  • Step 4 As shown in Fig. 28D, continue to rotate the reagent reaction cartridge so that the mixture X in the step 2 enters the first reaction zone 26, and the mixture and the dried material 66 (a lectin containing multiple HbA1c immunoreactive binding sites) and Latex balls 62 (latex microspheres labeled with anti-HbA1c antibody) were mixed to form a mixture Y.
  • Step 5 As shown in Fig. 28E, the reagent reaction cartridge is rotated, and the mixture Y in the step 4 is introduced into the detection zone 28 to detect the content of glycated hemoglobin (HbA1C) in the sample.
  • HbA1C glycated hemoglobin
  • Step 6 As shown in Fig. 28F, the reagent reaction cartridge is rotated, and the mixture Y in the step 4 is introduced into the liquid absorption pad 32, so that the waste liquid after the reaction is absorbed.
  • the detection of HbA1c ends, and the detection structure is calculated by an external device and output.
  • the reagent reaction cassette of the present invention is not limited to the detection of HbA1c in the above blood sample, and can also be used for detection of other biological samples such as urine, saliva, spinal fluid, etc., and can also be used for C-reactive protein, cholesterol, blood lipids and biological samples. Concentration detection of analytes such as blood sugar.

Abstract

一种检测系统,包括试剂反应盒(100)和检测设备,所述试剂反应盒(100)内封装有试剂存储部(102)和一可相对试剂存储部运动的推杆(152),试剂存储部(102)设有至少一个试剂容纳腔,试剂容纳腔由密封件(104)密封;所述推杆与密封件(104)相连,所述推杆(152)用于与检测设备相互配合使密封件(104)与试剂存储部(102)分离;所述检测设备包括一检测盒(200),检测盒(200)内设有一顶杆(204),顶杆(204)与推杆(152)相互配合使密封件(104)与试剂存储部(102)分离。该系统在试剂反应盒插入时,能够迅速的推动顶杆动作,一步操作,同时完成了试剂释放、试剂反应盒固定和检测区对光等多个功能,简化了反应步骤。

Description

检测系统 技术领域
本发明涉及生物样本检测技术领域,尤其涉及一种检测系统。
背景技术
医学体外诊断在现今医疗行业上扮演相当重用的角色,其可以定性或定量的测量人体液体中各种生物指标的变化,以提供疾病诊断或治疗指标等咨询,例如,血液中的糖化血红蛋白(HbA1c)的检测对于糖尿病的诊断和控制至关重要。
糖化血红蛋白是人体血液中红细胞内的血红蛋白与血糖结合的产物,当血液中葡萄糖浓度较高时,人体形成的HbA1c的含量也会相对较高。人体内红细胞的平均寿命是120天,在细胞死亡之前,血液中HbA1c的含量也会保持相对不变,因此,糖化血红蛋白测试通常可以反映患者近8~12周的血糖控制情况,不受偶尔一次血糖升高或降低的影响。
现有技术中也有多种设计用于检测分析物的浓度,如:
如图1所示,US1562237公开了一种反应盒,反应盒包括反应通道和液体试剂存储部,反应通道上设有干燥的试剂,液体试剂存储部用于存放缓冲液或其它液体试剂,液体试剂存储部包括存储本体30',存储本体由密封件或薄膜32'密封,薄膜32'具有一个远端33',从远端直接撕扯薄膜使薄膜与存储本体分离,将存储本体中的试剂释放到反应通道中。
在释放液体试剂时,需要人为将原本密封在存储本体30'上的薄膜32'分离开,再将薄膜去除。虽然上述方式能够撕开薄膜,释放液体试剂,但是,通过一段延伸的远端33'从存储本体30'上撕开薄膜十分不易,如人为撕开时用力过度或是用力过轻容易造成薄膜断开或是撕离不完全,使液体试剂不能完全释放,检测时液体试剂过少,造成检测结果的偏差;另一方面,在非检测时段,薄膜32'是裸露在空气中的,易出现人为或其它因素扯开或破坏的风险。
如图2所示,US5272093公开了一种“试剂容器及其递送方法”,包括试剂存储腔12'和密封在试剂存储腔上的密封件40',密封件为折叠式的两层设置,一层用于密封试剂存储腔,另一层延伸到试剂存储腔外部形成延伸段42',延伸段42'用于撕扯释放试剂存储腔中的试剂。在释放液体试剂时,需要人为将原本密封在试剂存储腔12'上的密封件40'分离开,如果用力过度或是用力过轻极容易造 成薄膜断开或是撕离不完全,造成液体试剂不能完全释放,使检测时液体试剂过少,造成检测结果的偏差。
如图3所示,US8846380公开了一种“用于检测糖化血红蛋白浓度的反应盒”,反应盒中包括用于容纳试剂盒血液样品的第一区、用于容纳洗涤溶液的第二区、检测区和试剂包,试剂包中的试剂和洗涤溶液分开存储,并用铝箔120'封存。当试剂包插入反应盒中时,铝箔被反应盒撕开,试剂包中的试剂和洗涤溶液分别暂存在反应盒的第一反应区和第二反应区上,通过反应盒的旋转依次与血液样本发生反应,从而解决了试剂的存储和分配问题。
上述反应盒在检测时,首先,需要人为折叠铝箔上的释放部130',使释放部130'对准检测盒内的夹持器,再将对准后的试剂包插入检测盒,使得检测盒能够切除释放部,实现铝箔与试剂包的分离。这种设计相对复杂,操作步骤繁多,而且,在插接时需要人为对准,易出现插接不到位的情形而造成反复插接。另一方面,反应盒与试剂包采用分体式设计,反应盒的敞口式设计,若操作不当,极易将异物掉入反应盒中,造成影响检测结果的准确性。再者,在非检测时段,释放部130'是裸露在空气中的,易出现人为或其它因素扯开或破坏的风险。
现有技术中的反应盒包括采样针、试剂存储器、反应部、检测区等。反应盒在检测反应时,试剂存储器中的试剂被释放到反应部参与检测反应,在试剂释放到反应部的过程中,由于反应盒体积较小,结构紧凑,试剂存储器与反应盒的壁板之间的距离较近,壁板与试剂存储器的试剂释放口之间易产生对试剂液体的吸附力,使试剂部分残留在试剂释放口与壁板的间隙中。另外,为了使试剂更加顺畅的进入反应部,还会在试剂存储器试剂释放口的位置设计引流尖端,使试剂通过试剂释放口后由引流尖端导流,最后在重力的作用下进入反应部,引流尖端虽然能够更好的导流,但是,试剂释放时,引流尖端容易存在挂液现象,使反应试剂部分残留在引流尖端上,同时,引流尖端与壁板的距离较近,也存在部分试剂被吸附在引流尖端与壁板之间。反应试剂的部分残留,使反应不够充分,造成检测结果精准度的降低。
发明内容
本发明所要解决的技术问题是针对现有技术中存在的上述问题,提供了一种检测系统。
为解决上述问题,本发明的技术方案之一是:
一种检测系统,包括试剂反应盒和检测设备,所述试剂反应盒内封装有试剂存储部和一可相对试剂存储部运动的推杆,试剂存储部设有至少一个试剂容纳腔,试剂容纳腔由密封件密封;所述推杆与密封件相连,所述推杆用于与检测设备相互配合使密封件与试剂存储部分离;所述检测设备包括一检测盒,检测盒内设有一顶杆,顶杆与推杆相互配合使密封件与试剂存储部分离。
优选地,所述顶杆可相对检测盒运动。
优选地,所述顶杆设置在检测盒的底板上。
优选地,所述顶杆设置在检测盒的内侧面板上。
优选地,所述试剂反应盒上设有一开口,所述顶杆穿过开口与推杆相互配合。
优选地,所述检测盒的内侧面上设有活动板。
优选地,所述活动板包括基板和弹性件,基板通过弹性件与检测盒连接。
优选地,所述基板为加热板。
优选地,所述检测盒的其中一个内侧面上设有弹片。
优选地,所述检测盒相对活动板的内侧面上设有凹槽。
本发明的技术方案之二是:
一种生物样品反应盒,所述反应盒内封装有试剂存储部和一可相对试剂存储部运动的推杆;所述试剂存储部设有至少一个试剂容纳腔,试剂容纳腔由密封件密封;所述推杆与密封件相连,所述推杆用于与外部设备相互配合使密封件与试剂存储部分离。
优选地,所述推杆上设有与外部设备相互配合的受力部。
优选地,所述反应盒上设有一开口,受力部裸露在所述开口中,受力部通过开口与外部设备相互配合。
优选地,所述受力部为推杆的背部。
优选地,所述受力部为推杆的底面。
优选地,所述反应盒内设有滑槽,滑槽与推杆滑动配合连接。
优选地,所述滑槽上设有隔离板,隔离板隔离滑槽与反应盒的内部空间。
优选地,所述推杆的至少一个侧面上设有至少一个限位凸起。
优选地,所述推杆靠近边缘处设有至少一个镂空的槽体,所述限位凸起设置 在槽体的外侧壁上,限位凸起与槽体成对设置。
优选地,所述反应盒上设有与限位凸起配合的限位凹槽。
本发明的技术方案之三是:
一种试剂存储器,所述试剂存储器包括用于存放固体颗粒试剂或粉末颗粒试剂的试剂容纳腔,所述试剂容纳腔由密封件密封。
优选地,所述固体颗粒试剂或粉末颗粒试剂为冻干固体颗粒试剂或冻干粉末颗粒试剂。
优选地,所述固体颗粒试剂为乳胶冻干球。
优选地,所述试剂存储器还包括用于存放液体试剂或粉末试剂的试剂容纳腔。
优选地,所述用于存放液体试剂或粉末试剂的试剂容纳腔上设置有注射孔,注射孔连通试剂容纳腔与外部空间,注射孔由密封件密封。
优选地,所述试剂存储器包括至少两个试剂容纳腔,至少两个试剂容纳腔成阵列分布。
优选地,所述试剂存储器包括两个试剂容纳腔,两个试剂容纳腔左右横向排列或上下纵向排列。
优选地,所述试剂存储器包括四个试剂容纳腔,四个试剂容纳腔呈两排四列状分布,每排设有两个试剂容纳腔,每列设有一个试剂容纳腔。
优选地,所述试剂存储器的背部上设有用于容纳干燥剂的腔体。
本发明的技术方案之四是:
一种试剂反应盒,包括试剂存储部、试剂释放部和反应部,所述试剂存储部、试剂释放部和反应部均设置在反应盒内部;所述试剂存储部包括至少一个试剂容纳腔,试剂容纳腔由密封件密封;所述试剂释放部包括一可相对试剂存储部运动的推杆,推杆与密封件相连,推杆用于与外部设备相互配合使密封件与试剂存储部分离;所述反应部包括至少一个反应区,反应区接收试剂存储部释放的试剂。
优选地,所述试剂存储部包括多个试剂容纳腔,多个试剂容纳腔成阵列分布。
优选地,所述试剂存储部包括至少两列试剂容纳腔,每列包括至少一个试剂容纳腔。
优选地,所述试剂容纳腔中至少一个用于存放固体颗粒或粉末颗粒试剂。
优选地,所述反应部包括第一反应区和第二反应区,第一反应区和第二反应 区分别接收并暂存不同试剂容纳腔释放的试剂。
优选地,所述第一反应区用于暂存固体颗粒试剂,第一反应区包括支撑部和阻挡部,支撑部与阻挡部之间形成一缝隙,缝隙的最大宽度小于固体颗粒试剂的最小宽度,所述支撑部为一台阶。
优选地,所述第一反应区还包括第二挡板,第二挡板倾斜设置,第二挡板与阻挡部形成第二缝隙,第二缝隙的最小宽度大于固体颗粒试剂的最大宽度。
优选地,所述阻挡部和第二挡板为具有弧度的挡板。
优选地,所述第二反应区用于暂存液体试剂,第二反应区上设有导流件,导流件包括第一引流板和第二引流板。
本发明的技术方案之五是:
一种试剂反应盒在生物样品检测中的应用,所述试剂反应盒包括试剂存储部、试剂释放部和反应部,所述试剂存储部、试剂释放部和反应部均设置在反应盒内部;所述试剂存储部包括至少一个试剂容纳腔,试剂容纳腔由密封件密封;所述试剂释放部包括一可相对试剂存储部运动的推杆,推杆与密封件相连,推杆用于与外部设备相互配合使密封件与试剂存储部分离;所述反应部包括至少一个反应区,反应区接收试剂存储部释放的试剂。
本发明的技术方案之六是:
一种检测盒,所述检测盒内设有一活动板,活动板包括基板和弹性件,基板通过弹性件固定连接在检测盒的内壁上。
优选地,所述基板为加热板。
优选地,所述检测盒相对活动板的内侧面上设有凹槽。
优选地,所述弹性件为两个。
优选地,所述检测盒内与活动板相邻的其中一个内侧面上设有弹片。
优选地,所述检测盒内设有一顶杆。
优选地,所述顶杆可相对检测盒运动。
优选地,所述顶杆设置在检测盒的底板上。
优选地,所述顶杆的上端部设有倒角。
优选地,所述顶杆设置在检测盒的内侧面板上。
本发明的技术方案之七是:
一种生物样品分析盒,包括反应部,所述反应部包括至少一个反应区,其中 至少一个反应区为第一反应区,所述第一反应区用于暂存固体颗粒试剂,第一反应区包括支撑部和阻挡部,支撑部与阻挡部之间形成一缝隙,缝隙的最大宽度小于固体颗粒试剂的最小宽度。
优选地,所述支撑部为一台阶。
优选地,所述阻挡部为一挡板,记为第一挡板。
优选地,所述第一挡板为竖直的挡板,第一挡板的底部与支撑部形成缝隙。
优选地,所述第一反应区还包括第二挡板,第二挡板倾斜设置,第二挡板与第一挡板形成第二缝隙,第二缝隙的最小宽度大于固体颗粒试剂的最大宽度。
优选地,所述第一挡板和第二挡板为具有弧度的挡板。
优选地,所述反应区内固设有粉末干燥试剂。
优选地,所述反应部还包括第二反应区,第二反应区用于暂存液体试剂。
优选地,所述第二反应区上设有导流件,导流件包括第一引流板和第二引流板。
优选地,所述固体颗粒试剂为乳胶冻干球试剂。
本发明的技术方案之八是:
一种试剂存储器,所述试剂存储器包括至少一个试剂容纳腔,至少一个试剂容纳腔上设有注射孔,注射孔连通试剂容纳腔与外部空间,试剂容纳腔和注射孔均由密封件密封。
优选地,所述试剂容纳腔用于存储粉末试剂或液体试剂。
优选地,所述试剂存储器包括多个试剂容纳腔,多个试剂容纳腔成阵列分布。
优选地,所述试剂存储器包括两个试剂容纳腔,两个试剂容纳腔左右横向排列。
优选地,所述试剂存储器包括两个试剂容纳腔,两个试剂容纳腔上下纵向排列。
优选地,所述试剂存储器包括四个试剂容纳腔,四个试剂容纳腔呈两排四列状分布,每排设有两个试剂容纳腔,每列设有一个试剂容纳腔。
优选地,所述试剂存储器的背部上设有用于容纳干燥剂的腔体。
本发明的技术方案之九是:
一种检测反应盒,包括安装在反应盒中的试剂存储器,试剂存储器上设有试剂释放位,所述反应盒包括面向试剂释放位的壁板,所述壁板上设有导流筋,导 流筋与试剂释放位末端上的液滴接触,导流筋用于导流试剂释放位末端上的液滴。
优选地,所述导流筋与试剂释放位末端接触。
优选地,所述反应盒还包括反应部,导流筋伸到反应部中。
优选地,所述反应盒包括一侧板,所述导流筋与侧板呈一定角度。
优选地,所述导流筋呈拱形。
优选地,所述导流筋包括面向试剂释放位的导流面,所述导流面为圆滑曲面。
优选地,所述导流筋还包括与导流面相邻的两个侧部导流面,两个侧部导流面与壁板的连接处为圆滑曲面。
优选地,所述试剂释放位包括试剂释放口。
优选地,所述试剂释放位还包括连接在试剂释放口下方的导流板。
本文中提及的试剂反应盒也可称为反应盒、生物样品反应盒、生物样品分析盒和检测反应盒。
相比较于现有技术,本发明的有益效果是:
1.本发明的试剂反应盒为一个单独的整体,试剂存储部和推杆均封装在试剂反应盒内部,在反应时,仅需与检测盒配合,一步操作,即将试剂反应盒插入到外部设备中,即可实现试剂存储部中试剂的快速释放。上述结构将检测反应中的人为手动操作部分缩减到最简化的程度,提升了反应的自动化程度,在反应时,人为手动的操作步骤仅包括取样棒采集样品及将样品添加到试剂反应盒中和试剂反应盒插入外部设备的步骤。
2.本发明的试剂反应盒所包含的各个部分均收容在试剂反应盒内部,尤其是试剂存储部和推杆包含在试剂反应盒内部,使得人为手动均不能触碰到试剂存储部和推杆,只有借助外部设备中检测盒的外部推力伸入试剂反应盒中时才能促使推杆动作;杜绝了未反应时,因人为操作不当或其它因素,使密封件部分与试剂存储部撕离,造成试剂提前漏出的可能。
3.本发明的试剂反应盒上的开口与各部件之间均是缝隙配合,提供了试剂反应盒内部单纯的反应空间,保证了各反应试剂的纯度,避免了外部异物混入试剂反应盒中的可能,提高了反应的精准度。
4.本发明的试剂存储器为独立部件,封装在试剂反应盒中,试剂存储器包 括用于存放固体颗粒试剂或粉末颗粒试剂的试剂容纳腔。固体颗粒试剂或粉末颗粒试剂密封在试剂存储器中,避免了试剂在试剂反应盒中的随意移动,避免现有技术中需要对干燥试剂进行固定的问题,同时,密封状态下,也提高了该试剂常温下的有效期保存期,使其与其它试剂区别开来,特别适用常温下比较难保存的试剂。
5.本发明的试剂存储部设有乳胶冻干球,一方面实现了对乳胶抗体反应活性保护的最大化,另一方面,大大的提高了试剂常温下有效期保存期。
6.本发明的试剂反应盒通过配置试剂存储部中试剂容纳腔的个数及其排列,与推杆自动化功能的配合,可以实现多个试剂同时释放、多个试剂按照反应时间和顺序依次或同时添加及配合烘干试剂,完成各种样品检测的可能。
7.本发明的检测系统在试剂反应盒插入时,能够迅速的推动顶杆动作,同时,将试剂反应盒快速稳固的固定在检测盒中,保证了检测区对准通光孔,即一步操作,同时完成了试剂释放、试剂反应盒固定和检测区对光等多个功能,最简化了反应步骤。
8.本发明的反应盒上设置了导流筋,在液体试剂从试剂存储器中释放到反应盒中时,通过导流筋与试剂释放位末端的液滴接触,使液滴顺着导流筋的引流方向离开试剂释放位,避免了试剂液滴的局部残留,保证了试剂容量控制的精准度,使反应更加充分。
附图说明
图1是现有技术中反应盒的结构示意图。
图2是现有技术中试剂容器的结构示意图。
图3是现有技术中反应盒的局部结构示意图。
图4是检测系统中局部结构的轴测示意图。
图5是试剂反应盒中面板隐藏后的结构示意图。
图6是试剂反应盒中背板隐藏后的结构示意图。
图7是试剂存储部、密封件与试剂释放部的连接结构示意图。
图7A是图7中密封件撕开后的结构示意图。
图8是试剂存储部的结构示意图。
图8A是试剂存储部一个角度的结构示意图。
图8B是试剂存储部另一个角度的结构示意图。
图9是试剂存储部一种实施方式的结构示意图。
图10是试剂存储部另一种实施方式的结构示意图。
图11是试剂反应盒中上盖、试剂存储部与试剂释放部的连接结构示意图。
图12是试剂反应盒中盒体与推杆的连接结构示意图。
图12A是试剂反应盒中推杆相对盒体滑动后的结构示意图。
图13是试剂反应盒中盒体与推杆连接另一种实施方式的结构示意图。
图14是试剂反应盒中释放部的轴测结构示意图。
图15是图6中A处的放大结构示意图。
图16是试剂反应盒中盒体与推杆相连的轴测结构示意图。
图16A是图16中C处的放大结构示意图。
图17是试剂反应盒中盒体与推杆相连的另一种实施方式的轴测结构示意图。
图18是图5中D处的放大结构示意图。
图19是试剂反应盒外部结构的轴测示意图。
图19A是试剂反应盒的后视结构示意图。
图20是试剂反应盒中上盖的结构示意图。
图20A是图20中B处的放大结构示意图。
图20B是试剂反应盒中上盖的另一个角度结构示意图。
图21是试剂反应盒中上盖与试剂存储部的连接结构示意图。
图22是试剂反应盒的爆炸图。
图23是检测盒的剖面结构示意图。
图24是检测盒中内部部件的结构示意图。
图25是试剂反应盒插入检测盒中推杆被顶杆顶起的剖面结构示意图。
图26是检测盒中弹性件的结构示意图。
图27是检测盒中弹片的结构示意图。
图28是试剂反应盒检测时处于步骤0的试剂状态示意图。
图28A-28F分别是试剂反应盒检测时处于步骤1-6的试剂状态示意图。
图29是反应盒上导流筋的结构示意图。
图30是反应盒上背板透视后的导流结构示意图。
图30A是图30在H-H剖面的结构示意图。
图30B是图30A中E处的放大结构示意图。
图31是反应盒中导流筋的一种实施方式的结构示意图。
图32是反应盒中导流筋的另一种实施方式的结构示意图。
图33是反应盒中导流筋的再一种实施方式的结构示意图。
图34是反应盒中导流筋和试剂存储器的一种实施方式的结构示意图。
具体实施方式
下面结合附图和实施例进一步详细说明本发明,但本发明的保护范围并不限于此。
如图4所示,本发明的检测系统用于快速检测生物样品中被分析物的浓度,包括试剂反应盒100和外部设备,外部设备为除试剂反应盒100本体以外的设备,其中,外部设备也称为检测设备,外部设备或检测设备上设有一检测盒200,试剂反应盒100和检测盒200配套使用。试剂反应盒100作为反应的容器,可以实现多种试剂的存储、多种试剂的顺序添加和废液回收等功能。检测盒200用于放置试剂反应盒100,检测盒200安装在检测设备上,并由检测设备提供试剂反应盒100旋转、试剂反应盒100内试剂混匀、试剂释放等的机械动力及控制,同时外部设备上还设有光学器件,光学器件用于检测液体样品内检测物的浓度。
如图5和图6所示,试剂反应盒100内设有试剂存储部102、试剂释放部150、反应部和检测区28。试剂存储部102和试剂释放部150均封装在试剂反应盒100中。优选地,所述试剂反应盒100内设有一腔体,所述试剂存储部102收容在腔体中。试剂存储部120为独立部件封装在试剂反应盒100中,有利于试剂反应盒的快速组装。试剂存储部102用于密封贮存固体颗粒、粉末或液体试剂,试剂释放部150在检测设备中检测盒200的配合下可以快速打开试剂存储部102释放试剂到试剂反应盒100的反应部中。反应部用于生物样品与试剂的暂存、混合及反应,并通过检测区28对反应的中间产物或最终产物进行检测。
如图7和图8所示,试剂存储部102包括至少一个试剂容纳腔,试剂存储部102由密封件104密封,即试剂容纳腔由密封件104密封。试剂存储部102也称为试剂存储器,试剂存储部102包括多个试剂容纳腔,多个试剂容纳腔成阵列分 布。试剂容纳腔的数量根据检测反应所需要的试剂种类、添加的顺序进行设定,例如一个,两个或是多个,试剂容纳腔彼此之间是独立的,即多个试剂容纳腔彼此之间设有间距,成阵列式分布。例如,两个试剂容纳腔可以是横向成排状,也可以是纵向成列状,亦可以是对角分布;再如,多个试剂容纳腔可以间隔插空分布。试剂容纳腔的容量也是根据检测反应所需要的剂量进行设定。
作为一种优选,所述试剂存储部包括至少两列试剂容纳腔,每列包括至少一个试剂容纳腔。优选地,如图8所示,试剂存储部102包括两个试剂容纳腔,两个试剂容纳腔左右横向排列。即试剂容纳腔106和试剂容纳腔108呈一排两列左右分布,试剂容纳腔的底部大致在同一水平线上。因此,在撕开密封件104时,试剂容纳腔106和试剂容纳腔108中的试剂可以一同释放到试剂反应盒100内。
如图9所示,作为试剂存储部102的一种实施方式,两个试剂容纳腔纵向排列的情形,即试剂容纳腔110和试剂容纳腔112呈两排一列上下分布,在部分撕开密封件104时,位于下排的试剂容纳腔112优先释放试剂,根据反应时间的要求,继续撕开密封件104,使位于上排的试剂容纳腔110释放试剂。在控制密封件104撕开的程度下,就可以依次加入试剂,控制反应的进行。
如图10所示,作为试剂存储部的另一种实施方式,四个试剂容纳腔呈阵列排列的情形,即试剂容纳腔114、试剂容纳腔116、试剂容纳腔118和试剂容纳腔120呈两排四列状分布。在控制密封件104撕开的程度下,下排的试剂容纳腔118和试剂容纳腔120中的试剂优先释放,接着释放上排的试剂。
作为一种优选,所述试剂存储器包括用于存放固体颗粒试剂或粉末颗粒试剂的试剂容纳腔。固体颗粒试剂或粉末颗粒试剂密封在试剂存储器中,避免了试剂在试剂反应盒中的随意移动,避免现有技术中需要对干燥试剂进行固定的问题,同时,密封状态下,也提高了该试剂常温下的有效期保存期,使其与其它试剂区别开来,特别适用常温下比较难保存的试剂。
优选地,所述固体颗粒试剂或粉末颗粒试剂为冻干固体颗粒试剂或冻干粉末颗粒试剂。优选地,所述固体颗粒试剂为乳胶冻干球。乳胶冻干球,一方面实现了对乳胶抗体反应活性保护的最大化,另一方面,大大的提高了试剂常温下有效期保存期。
作为一种优选,所述试剂存储器还包括用于存放液体试剂的试剂容纳腔。试 剂容纳腔可以用于存放固体颗粒、粉末颗粒或是液体试剂,可以根据检测需要进行设定。
作为一种优选,如图8A所示,至少一个试剂容纳腔上设有注射孔130,注射孔130连通试剂容纳腔与外部空间,试剂容纳腔和注射孔130均由密封件104密封。优选地,注射孔130设于用于存放粉末试剂或液体试剂的试剂容纳腔上。为了更加简易的密封液体试剂或粉末试剂,在密封时,先用密封件104密封试剂容纳腔并将注射孔130裸露在外面,再将液体或粉末试剂注入到试剂容纳腔中,接着再密封注射孔130,以此保证了密封的效果,并降低了密封液体或粉末试剂的难度。试剂容纳腔和注射孔可由同一密封件分时分步密封,可由两个密封件分别密封,如使用密封塞子密封注射孔等。
作为一种优选,如图8B所示,试剂存储部102的背部上还设有用于安装干燥剂的腔体132。试剂存储部102安装在试剂反应盒100中时,由腔体132和面板10内壁的配合,干燥剂安装在腔体132中。
作为一种优选,试剂存储部102包括两个试剂容纳腔,两个试剂容纳腔分别用于存储固体颗粒试剂和液体试剂。本实施例以试剂存储部102包括两个试剂容纳腔106,108为例进行详细说明,试剂容纳腔106存储固体颗粒试剂和试剂容纳腔108存储液体试剂,并在试剂容纳腔108的上端设有注射孔130。在密封时先将固体颗粒试剂放置在试剂容纳腔106中,用密封件104密封试剂容纳腔106和试剂容纳腔108的腔体开口,再将液体试剂注入到试剂容纳腔108中,接着利用密封件104密封注射孔130。
作为一种优选,试剂容纳腔的底部设计呈斜面状。在释放试剂时,方便试剂快速流出,尽量减少了试剂在容纳腔内的残留,保证了试剂容量控制的精准度。
如图7所示,试剂存储部102由密封件104密封,即将试剂密封在试剂容纳腔中,密封件104在外力的作用下,可以与试剂容纳腔撕离,密封件104的撕离可以是由左往右、由下往上等方式,本文以密封件由下往上撕离为例进行说明,如图7A所示。密封件104可以为铝箔、薄膜等现有技术中常规使用的密封件。
如图29、30、30A和30B所示,所述反应盒包括安装在反应盒中的试剂存储器102,所述试剂存储器102上设有试剂释放位,反应盒100包括面向试剂释放位的壁板,所述壁板上设有导流筋70,导流筋70与试剂释放位末端上的液滴 接触,导流筋70用于导流试剂释放位末端上的液滴。所述试剂释放位是指液体试剂从试剂存储器中流出到试剂离开试剂存储器的位置,即液体试剂在试剂存储器上的液体通道。相对应的,试剂释放位末端是指液体通道的尾端。所述壁板为下文提及的反应盒100上的背板12或隔离板36,当导流筋70安装在背板12时,试剂释放部采用现有技术中的人工手动方式,当导流筋70安装在隔离板36时,试剂释放部采用本文中自动方式。液体试剂从试剂存储器中释放到反应盒中时,部分液滴易残留在试剂释放位末端上或是吸附在试剂释放位末端与壁板之间,通过导流筋与试剂释放位末端的液滴接触,使液滴顺着导流筋的引流方向离开试剂释放位,避免了试剂液滴的局部残留,保证了试剂容量控制的精准度,使反应更加充分。
如图34所示的实施方式中,所述试剂释放位包括试剂释放口140。试剂释放口140的底部即为试剂释放位的末端。如图30‐33所示的实施方式中,所述试剂释放位还包括连接在试剂释放口140下方的导流板142。导流板142用于液体的导流,使液体试剂更加顺畅的离开试剂存储器102,导流板142呈尖角状,导流板142的底部即为试剂释放位末端。
作为优选,所述导流筋70与试剂释放位末端接触。使试剂释放位末端的液滴与导流筋70的接触面增加,更加快速的引流液滴。如图30B所示,所述导流筋包括依次相连的接触端72和引导端74,所述接触端72与试剂释放位末端上的液滴接触或与试剂释放位末端接触,所述引导端74由接触端72向下延伸。作为优选,所述导流筋呈细条状。接触端72用于接触液滴并将液滴引流到引导端74上,引导端74用于将接触端72上的液滴引导到反应盒100的指定位置。所述引导端74横截面的面积从上到下依次减小,引导端的底部形成尖端,有利于液滴的引流,尽可能的减小了引导端底部的挂液现象。接触端与液滴接触,能快速引流液滴。接触端越接近试剂释放位末端,接触端与液滴的接触面就越大,导流筋的引流作用就越明显。
如图31‐33所示,所述反应盒100还包括反应部,导流筋70伸到反应部中。即导流筋70的引导端74延伸到反应部中,并与反应部中的液体试剂接触。导流筋70的延伸设计,使液滴可以快速准确的引导到反应部中。同时,附着在试剂释放位末端的大液滴经导流筋引流后,可能存在极小的液点悬挂在导流筋引导端 底部,引导端上悬挂的液滴与反应部中的液体试剂接触后被带走,避免了小液滴在导流筋上的残留。如图32所示的实施方式中,导流筋70的接触端72向上延伸。有利于快速引导试剂存储器的液体进入反应部。
如图29‐34所示的实施方式中,所述反应盒100包括一侧板,所述导流筋70与侧板呈一定角度。导流筋70倾斜设置或与侧板平行设置均可。所述侧板为下文提及的反应盒100上的左侧板6或右侧板8。优选地,所述导流筋70的导流方向与试剂存储器中液体的流动方向一致。当试剂储存器释放液体试剂的流动方向与水平面垂直时,导流筋垂直水平面设置;反应盒的试剂储存器在释放试剂时,反应盒与水平面呈一定角度的倾斜,此时液体试剂的流动方向与侧板成倾斜角度释放,导流筋倾斜设置,导流筋的倾斜方向即为试剂存储器中液体的流动方向。导流筋的导流方向与试剂存储器中液体的流动方向一致,有利于减小引流过程中的阻力,使试剂快速流下。作为优选,所述导流筋呈拱形。优选地,所述导流筋的纵截面呈三角形状。所述三角形为圆角三角形。所述三角形选自:直角三角形、钝角三角形或锐角三角形。如图33所示的实施方式中,所述导流筋70的纵截面呈直角三角形状,直角三角形的其中一个直角边固设在壁板上,导流筋70上能与液滴接触的部分为接触端72,接触端72以下的部分为引导端74。如图30A、31和32所示的实施方式中,所述导流筋70的纵截面呈钝角三角形状,钝角三角形状的最大斜边固设在壁板上,导流筋70上能与液滴接触的部分为接触端72,接触端72以下的部分为引导端74,接触端72以上的部分为接触端72的延伸部分。
如图30B所示,所述导流筋70包括安装面80、与安装面相对的导流面82和与安装面相邻的两个侧部导流面84,所述安装面80固设在壁板上。导流面82面向试剂释放位设置,所述导流面82为圆滑曲面,两个侧部导流面84与壁板的连接处为圆滑曲面。圆滑曲面的设计,使导流筋的引流更加顺畅,阻力更小。
如图11和图12所示,试剂释放部150包括推杆152,推杆152与密封件104相连,所述推杆152用于与外部设备相互配合使密封件与试剂存储部分离。如图7A所示,即密封件104粘贴或固定在推杆152上,当外界设备作用于推杆152时,推杆152与试剂反应盒100的内壁配合产生相对于试剂存储部102的运动,在推杆152运动的同时,带动密封件104相对试剂存储部102运动,即密封件 104撕离的动作,使得试剂容纳腔中的试剂释放到试剂反应盒100中。推杆152相对试剂存储部102的运动可以为由左往右、由右往左、由下往上等方式实现。
作为一种优选,如图7所示,密封件104的一端密封试剂存储部102,另一端折叠后粘贴在推杆152上。
作为一种优选,所述推杆152上设有与外部设备相互配合的受力部。受力部用于承接外部设备提供的推力。
作为一种优选,推杆152全部收容在试剂反应盒100内部,外部设备的推力件需要伸入到试剂反应盒100内部或通过其他方式作用于推杆152的受力部。推杆152全部收容在试剂反应盒内,人手接触不到试剂反应盒中的推杆,人为徒手也不能促使推杆152动作,只有在借助外部工具后才能使推杆152动作。这样就避免了在非检测时段,误操作或其它原因人为撕开或破坏密封件104造成试剂提前泄漏的可能。
作为一种优选,如图13所示,试剂反应盒100内设有滑槽38。一方面,滑槽38将推杆152嵌在滑道中,另一方面,滑槽38与推杆152滑动配合。作为一个实施方式,滑槽38设置在背板12上,滑槽38可以设计为仅有背板12和两槽边组成,此时,推杆152两侧边部分收容在滑槽38中。
作为一种优选,如图12和图12A所示,所述滑槽38上设有隔离板36,隔离板36隔离滑槽38与试剂反应盒100的内部空间。作为一种实施方式,滑槽38为至少一端开口的柱状体,柱状体的四个侧面由部分背板12、滑槽38两侧边和隔离板36组成,也就是说,滑槽38密封连接隔离板36,隔离板36隔开滑槽38与试剂反应盒100的内部空间,隔离板36高度以反应液不会流到试剂反应盒外为设计要求。滑槽38设计成一个独立的区域,将推杆152或外部推力件与试剂隔离开,可以避免推杆152或外部推力件与反应试剂的接触而带走部分试剂。
作为一种优选,如图14所示,所述推杆152的至少一个侧面上设有至少一个限位凸起154。限位凸起154可以使推杆152更加稳定的安装在试剂反应盒100的内部。优选地,限位凸起154的数量为两个,分别设置在推杆152的左右侧面上。优选地,所述限位凸起154设置在推杆152侧面的上部。当推杆152安装在试剂反应盒100内时,推杆152上的限位凸起154在试剂反应盒100的挤压下,使推杆152产生弹性形变,增加了推杆152与试剂反应盒100的摩擦力,使推杆 152可以稳定的安装在试剂反应盒100内,也增加推杆152运动时的阻力。
作为一种优选,如图14所示,所述推杆152靠近边缘处设有至少一个镂空的槽体156,所述限位凸起154设置在槽体156的外侧壁上,限位凸起154与槽体156成对设置。作为一个具体实施例,限位凸起154为两个,两个限位凸起154分别设置在推杆152的左右侧面上,与之相对应的,镂空的槽体156也为两个,分别设置在推杆左侧和右侧靠近边缘处,即左侧边槽体156的外侧壁为推杆152的左侧面,右侧边槽体156的外侧壁为推杆152的右侧面,也就是说,限位凸起154设置在槽体156的外侧壁上。镂空槽体156的设置,使推杆152动作时更易产生形变,避免了因摩擦过大而造成推杆152滑动不灵活。
若推杆152长期处于形变状态就容易损失一定的弹性,而使紧固效果不佳,为解决上述问题,作为一种优选,如图15所示,试剂反应盒100上设有与限位凸起154配合的限位凹槽158。优选地,滑槽38上设有与所述限位凸起154卡合的限位凹槽158,限位凹槽158的数量与限位凸起154相同。推杆152在初始状态即常态下时,限位凹槽158与限位凸起154卡合,此时,推杆152未发生形变;当推杆152在外力的推动下滑动时,推杆152在限位凸起154处产生形变并离开限位凹槽158。
作为一种优选,如图14所示,所述推杆上设有一凹槽162。凹槽162设置在推杆152的上端,凹槽162为粘贴槽,粘贴槽用于粘贴密封件104。在未粘贴密封件前,凹槽162的槽底所在平面略低于凹槽162槽口所在平面,当粘贴密封件104后,密封件104填平凹槽162,使推杆平面平齐。避免推杆152推动时,因密封件104高出推杆152表面而造成剥离的可能。
作为一种优选,推杆152的受力部为推杆的底面或背部,当受力部为推杆的底部时,外力作用于推杆的底面,使推杆152由下往上撕开密封件104,当受力部为推杆的背部时,外力作用于推杆的背部,同样促使推杆152由下往上撕开密封件104。推杆152的受力部还可以为推杆的上底面、左侧面或是右侧面,为上底面时,可以从上部拉动推杆;为左侧面时,可以从左往右推动推杆;为右侧面时,可以从右往左推动推杆。
作为另一种实施方式,推杆152的受力部与外界推力件磁性连接,即推杆152的受力部、外界推力件为相互吸引的磁性组件,如铁块、磁铁等。推杆152 和外界推力件由试剂反应盒100隔离,在磁性作用下,由外界推力件带动推杆152动作。
作为一种优选,试剂反应盒100上设有一开口,受力部裸露在所述开口中,受力部通过开口接收外部推力。即外部推力件可以伸入开口中,与试剂反应盒100内的推杆152接触并促使其动作,开口位置设置与推杆152的受力部设置相关。
作为一种实施方式,如图16所示,推杆152的受力部为推杆的底面,前述的开口34设置在试剂反应盒100的底板4上。优选地,如图16A所示,开口34上设有倒角40,推杆152全部收容在滑槽38中并距离开口34有一定的间隔,以避免误操作时的碰撞。外部推力件由开口34的倒角40处引入并伸入滑槽38,与推杆152接触,并促使推杆152和外部推力件与滑槽38滑动配合。
作为另一种实施方式,如图17所示,推杆152的受力部为推杆152的背部,前述开口34则设置在试剂反应盒100的背板12上。优选地,推杆152的背部上设有凸棱或凹部160,凸棱或凹部160为受力部,凸棱或凹部160裸露在开口34中。外部推力件与凸棱或凹部160接触,并促使推杆152与滑槽38滑动配合。
所述反应部包括至少一个反应区,反应区接收试剂存储部102释放的试剂。反应部包括多个反应区,反应区的数量及位置设定根据试剂存储部102中试剂容纳腔的数量及反应步骤相关,如同时释放的两种试剂可以暂存在一个反应区内,也可以分别暂存在两各个独立的反应区内;若反应区内还有烘干试剂,也可单独设置其它反应区,各个反应区之间相互连通,可以通过旋转试剂反应盒实现各个反应区内试剂的混合。
如图5和图6所示,反应部内设置有检测区28,检测区28可以设置在试剂反应盒100的任意试剂的流通通道上,检测区28一般采用透明材料,使光学器件发出的透射光或散射光进入试剂反应盒100。试剂存储部102与反应部之间设有导流件,更为具体的是,导流件设置在试剂容纳腔与相应的反应区之间,导流件使试剂容纳腔内的试剂快速准确的释放到反应区内。
作为一种优选,如图5和图18所示,反应部包括至少一个反应区,其中至少一个反应区为第一反应区26,所述第一反应区26用于暂存固体颗粒试剂,第一反应区26包括支撑部和阻挡部,支撑部与阻挡部之间形成一缝隙47,缝隙47 的最大宽度小于固体颗粒试剂的最小宽度。支撑部与阻挡部之间的缝隙用于阻挡第一反应区内的固体颗粒试剂进入其它反应区,使固体颗粒试剂可以稳定的暂存在支撑部上。作为一种实施方式,支撑部为一台阶46,阻挡部为一挡板,记为第一挡板48。第一挡板48为竖直的挡板,第一挡板48的底部与支撑部形成缝隙47。优选地,所述固体颗粒试剂为乳胶冻干球试剂。乳胶冻干球试剂的最小宽度即乳胶冻干球的直径大于缝隙47的最大宽度,使乳胶冻干球试剂被缝隙47阻挡。
作为一种优选,如图5和图18所示,第一反应区26还包括第二挡板50,第二挡板50倾斜设置,第二挡板50与阻挡部形成第二缝隙49,第二缝隙49的最小宽度大于固体颗粒试剂的最大宽度。第二挡板50与阻挡部用于固体颗粒试剂引流,使固体颗粒试剂能够顺利的进入到第一反应区26中。作为一个具体实施方式,乳胶冻干球试剂的最大宽度即乳胶冻干球的直径小于第二缝隙49的最小宽度,使乳胶冻干球试剂方便进入第一反应区26中。
作为一种优选,第一挡板48和第二挡板50为具有弧度的挡板。一方面使固体颗粒试剂可以快速进入,考虑到固体颗粒直径上的差异,避免固体颗粒卡在第一挡板48和第二挡板50之间而无法落到台阶46上。
作为一种优选,所述反应部还包括第二反应区,第二反应区用于暂存液体试剂。优选地,第二反应区上设有导流件,导流件包括第一引流板和第二引流板。
作为一种具体实施方式,如图5和图6所示,反应部包括第一反应区26和第二反应区25,第一反应区26用于接收试剂容纳腔106释放的固体颗粒,第二反应区25用于接收试剂容纳腔108释放的液体试剂。第二反应区25上设有导流件,导流件包括第一引流板42和第二引流板44,使液体试剂快速流入第二反应区25中。第一反应区26包括用于暂存试剂的台阶46、第一挡板48和第二挡板50,第一挡板48和第二挡板50用于引导固体颗粒进入台阶46,同时,第一挡板48与台阶46之间形成缝隙47,该缝隙47可以阻止固体颗粒进入第二反应区25,并允许液体试剂流入第一反应区26中。
如图19和图19A所示,试剂反应盒100包括顶板2、底板4、左侧板6、右侧板8、面板10和背板12。试剂反应盒100大致呈方形盒状体,由塑料材料制成,
作为一种优选,如图19所示,所述试剂反应盒100的左侧板6或右侧板8的一端为一斜面22。优选地,试剂反应盒100的背板12上设有一延伸部24,延伸部24延伸出至斜面22的外部。优选地,斜面22设置在试剂反应盒100的左下角。在一种实施方式中,背板12呈方形,面板10为五边形,左侧板6具有一侧面和一斜面,延伸部24呈直角三角形状,直角三角形的斜边为背板12与延伸部24的连接处。斜面22和延伸部24的设置,便于人为区分试剂反应盒100的正反面,避免试剂反应盒100反向插入到检测盒200中,另一方面,在试剂反应盒与检测盒配合时,可以自动识别试剂反应盒的正反面,避免误操作。
作为一种优选,如图20所示,试剂反应盒100上设有定位凸起16。定位凸起16设置在面板10上,定位凸起16呈倒三角形状,如图20A,定位凸起16用于将试剂反应盒100牢固定位在检测盒200相对应的凹槽中,定位凸起16与凹槽限位卡合,使试剂反应盒100紧固在检测盒200内,避免旋转时,试剂反应盒100相对检测盒200的移位。
作为一种优选,如图19A所示,试剂反应盒100的顶板2上设有手柄14,在检测时,方便用户握住手柄14快速将试剂反应盒100插入检测盒200中,在检测完成后,又快速将试剂反应盒100拔出。作为一种优选,试剂反应盒100的背板12上设有槽口52,槽口52的设置使试剂反应盒100的注塑成型更为方便。
作为一种具体实施方式,如图5、图6和图22所示,试剂反应盒100内设有试剂存储部102、试剂释放部150、反应部、检测区28、取样棒30和液体吸收垫32,试剂反应盒100、试剂存储部102、试剂释放部104和取样棒30均由塑料材料制成。取样棒30用于采集液体样品如血液、尿液等,并将液体样品加入到试剂反应盒100内。在检测完成后,液体吸收垫32用于回收废液,避免液体泄漏造成污染。
如图5、图6和图22所示,试剂反应盒100为一空腔,可分为盒体18和上盖20,盒体18包括背板12、底板4、左侧板6和右侧板8,上盖20包括顶板2和面板10,上盖20与盒体18通过焊接等方式密封连接,方便试剂反应盒100的组装。所述液体吸收垫32设置在斜面22的上部,液体吸收垫32依次往右侧板8的方向为取样棒30和试剂存储部102,反应部和试剂释放部104均设置在 试剂存储部102的下方,检测区28设置在反应部内。取样棒30通过一开口设置在试剂反应盒100中,取样棒30与该开口间隙配合,避免取样时,异物的混入。斜面22设置在取样棒30左侧,有利于取样棒30上的样品与反应液充分接触,避免反应液过少而接触不到样本。液体吸收垫32、试剂存储部102、取样棒30、反应部和试剂释放部104的格局布置不限于上方式。优选地,第二引流板44和第一挡板48上端相连,第一引流板42的上端还连接有采样针导向板57,采样针导向板57竖直方向设置。如图12和图20B所示,盒体18和上盖20均设有采样针固定件59,用于采样针固定件59,避免其晃动。
作为一种具体实施方式,试剂存储部与试剂反应盒连接方式,如图8A所示,试剂存储部102上设有定位件,各定位件组成了腔体,该腔体用于收容试剂存储部102,使得试剂存储部102固定安装在试剂反应盒100中。所述腔体也可以采用现有技术中的常规技术手段。作为一个具体实施例,如图12和12A、图20和图20B所示,面板10上设有定位柱54和支撑板61,左侧定位板56和右侧定位板58为多个分散的定位件,分散设置在盒体18和上盖20上,上述定位件用于固定连接试剂存储部102。如图8A和图8B所示,试剂存储部102的定位件包括安装孔122、左定位件124、右定位件126和下定位件128。如图21所示,安装孔122扣在定位柱54上,用于固定试剂存储部102的上端;左定位件124和右定位件126分别与左侧定位板56和右侧定位板58限位连接,下定位件128放置在支撑板61上。因此,试剂存储部102稳固的安装在试剂反应盒100内,避免了试剂存储部102在试剂反应盒100移动或摇晃过程中的移位。
上述的各个优选和实施方式之间可以根据需要进行任意选配和组合,以实现最终快速样品浓度检测的目的。
如图23和图24所示,检测盒200内设有一顶杆204,顶杆204通过试剂反应盒上的所述开口34与受力部接触并提供外部设备的作用力。
作为一种优选,所述顶杆204可相对检测盒200运动。顶杆204可以固定安在盒体上,也可以与盒体相对运动。顶杆204活动时,由外部设备控制顶杆204的活动区域及移动的位置,例如可以用电机控制顶杆204的移动,也可采用现有技术中的常规技术。若顶杆204固定在盒体上,试剂反应盒100插入外部设备的检测盒200时,借助插入力,将顶杆204与推杆152配合,使推杆152动作。
作为一种优选,所述顶杆204设置在检测盒200的底板上或所述顶杆204设置在检测盒200的内侧面板上。如图25所示,检测盒200与受力部为推杆152的底面配合时,开口34设置在试剂反应盒100的底板4上,顶杆204设置在检测盒200的底板上。优选地,顶杆204的上端部设有倒角,方便顶杆204伸入开口34。检测盒200与受力部为推杆152的背部配合时,开口34则设置在试剂反应盒100的背板12上,顶杆204设置在检测盒200的内侧面板上。
作为一种优选,如图24和图26所示,检测盒200内设有一活动板,活动板包括基板206和弹性件210,基板206通过弹性件210固定连接在检测盒200的内壁上。优选地,弹性件210的数量为两个,弹性件210包括安装面212和两个弹臂214,安装面212与检测盒200的内侧面固定连接,两个弹臂214分别与基板206固定连接。
作为一种优选,所述基板206为加热板,记为第一加热板。即活动板即作为加热件同时又作为弹性紧固件。
作为一种优选,如图23‐27所示所述检测盒200的其中一个内侧面上设有弹片216。优选地,弹片216设置在与活动板相邻的其中一个内侧面上。弹片216设有一弹臂218,弹臂218一端与弹片216固定,弹臂218的另一端呈圆滑曲面状,弹臂218面向检测盒200内部空腔安装。弹片216用以配合试剂反应盒100上的斜面22,使反向盒100上未设置斜面的一侧紧贴着检测盒200的内侧壁。由于弹片216具有一定的弹性,若是试剂反应盒100反向插入到检测盒200中时,由于弹片216的作用,试剂反应盒100无法完全插合在检测盒200内,因此,弹片216和斜面22的配合又能起到试剂反应盒100正确插入的识别作用。
作为一种优选,如图23所示,所述检测盒200的其中一个内侧面上设有凹槽202。优选地,凹槽202设置在相对活动板的内侧面上。凹槽202用于卡接试剂反应盒100上的定位凸起16,使试剂反应盒100可以卡接在凹槽202上,避免了检测盒200在旋转或振动过程中,试剂反应盒100的移位。
作为一种具体实施方式,如图4、图23和图24所示,检测盒200固定在外部设备上,以实现混匀或旋转,检测盒200包括一端敞口的盒体,盒体上设有通光孔201,盒体内设有顶杆204、第一加热板206和第二加热板208,第一加热板206为活动板,顶杆204通过上述开口34与受力部接触并提供外部推力,第 一加热板206和第二加热板208用于加热试剂,以满足反应温度的要求。
如图25所示,当试剂反应盒100插入到检测盒200中时,试剂反应盒100按压第一加热板206,第一加热板206在压力作用下,使弹性件210发生形变,试剂反应盒100即能快速插入并将定位凸起16扣合到凹槽202中。同时,试剂反应盒100的斜面22压缩弹片216,使试剂反应盒100上的检测区28对准检测盒200上的通光孔201。在试剂反应盒100插入到检测盒200的过程中,顶杆204伸入开口34与推杆152接触,随着试剂反应盒100由上往下的过程中,推杆152由下往上动作,带动密封件104由下往上动作,使密封件104与试剂存储部102撕离,释放试剂如图7A所示。
目前市场面上糖化血红蛋白检测方法很多,其中常用的检测方法有离子交换层析、亲和层析、高压液相、免疫法、离子捕获法、电泳法等。免疫法是指红细胞溶解之后,基于抗原分子和特殊抗体的相互作用来测量HbA1c。
用免疫凝集法检测HbA1c包括以下两个检测步骤:分别检测样品中的总血红蛋白Hb浓度和糖化血红蛋白HbA1c浓度。总血红蛋白(Hb)的检测通过使用铁氰化钾氧化血红蛋白中的亚铁离子,生成高铁血红蛋白,高铁血红蛋白与硫氰酸盐反应生成硫氰酸高铁血红蛋白,检测在531nm下的吸光值,得到Hb的浓度。糖化血红蛋白(HbA1c)与含有多个HbA1c免疫反应结合位点的凝集素与血液中的HbA1c竞争结合标记在乳胶微球上的抗HbA1c抗体,前者的结合会引起反应液浊度的变化,通过检测531nm的吸光值变化可以得到血液中HbA1c的浓度。血液中HbA1c的浓度也高,浊度越低,吸光值越小,吸光值与HbA1c浓度的变化通过校准曲线获得。
因此,免疫法检测HbA1c需要使用硫氰酸盐液体试剂(Buffer)、标记了抗HbA1c抗体的乳胶球、铁氰化钾干燥试剂(烘干物)和含有多个HbA1c免疫反应结合位点的凝集素干燥试剂(烘干物)。如图28所示,硫氰酸盐液体试剂60存储在试剂容纳腔108,标记了抗HbA1c抗体的乳胶球62存储在试剂容纳腔106中,铁氰化钾干燥试剂64固化在第二反应区25上,凝集素干燥试剂66固化第一反应区26中。
其中,乳胶球为乳胶冻干小球,预先将乳胶小球上通过共价结合的方法连接上特异性HbA1c抗体,再采用冻干技术将乳胶球速冻为体积相同的小球,实现 了对乳胶抗体反应活性保护的最大化,同时,大大的提高了常温下有效期保存期。
利用本发明的试剂反应盒检测血液中HbA1C的浓度。免疫法检测HbA1c的步骤如下:
步骤0:如图28所示,将带有样品的取样棒30插入到试剂反应盒中。
步骤1:如图28A所示,旋转检测盒,将试剂反应盒插入到检测盒中,推杆152在外部推力的作用下向上运动,扯掉密封件104,乳胶球62和硫氰酸盐60同时释放,乳胶球62落下进入第一反应区26中暂存,硫氰酸盐液体试剂60落下进入第二反应区25中检测区28中。
步骤2:如图28B所示,旋转试剂反应盒,将Buffer60(硫氰酸盐)、烘干物64(铁氰化钾)和血液样本混合,形成混合物X。
步骤3:如图28C所示,旋转试剂反应盒,将步骤2中的混合物X旋转至检测区28,检测样品中血红蛋白(Hb)的含量。
步骤4:如图28D所示,继续旋转试剂反应盒,使步骤2中的混合物X进入第一反应区26,混合物与烘干物66(含有多个HbA1c免疫反应结合位点的凝集素)和乳胶球62(标记了抗HbA1c抗体的乳胶微球)混合,形成混合物Y。
步骤5:如图28E所示,旋转试剂反应盒,使步骤4中的混合物Y进入检测区28,检测样品中糖化血红蛋白(HbA1C)的含量。
步骤6:如图28F所示,旋转试剂反应盒,使步骤4中的混合物Y进入液体吸收垫32,使反应后的废液被吸收。
HbA1c检测结束,由外部设备计算检测结构并输出。
本发明的试剂反应盒不限于上述血液样本中HbA1c的检测,也可以用于其他生物样本如尿液、唾液、脊液等的检测,也可用于生物样本中C-反应蛋白、胆固醇、血脂和血糖等分析物的浓度检测。
上述说明中,凡未加特别说明的,均采用现有技术中的常规技术手段。

Claims (10)

  1. 一种检测系统,包括试剂反应盒和检测设备,其特征在于,
    所述试剂反应盒内封装有试剂存储部和一可相对试剂存储部运动的推杆,试剂存储部设有至少一个试剂容纳腔,试剂容纳腔由密封件密封;
    所述推杆与密封件相连,所述推杆用于与检测设备相互配合使密封件与试剂存储部分离;
    所述检测设备包括一检测盒,检测盒内设有一顶杆,顶杆与推杆相互配合使密封件与试剂存储部分离。
  2. 根据权利要求1所述的检测系统,其特征在于,所述顶杆可相对检测盒运动。
  3. 根据权利要求1所述的检测系统,其特征在于,所述顶杆设置在检测盒的底板上。
  4. 根据权利要求1所述的检测系统,其特征在于,所述顶杆设置在检测盒的内侧面板上。
  5. 根据权利要求1所述的检测系统,其特征在于,所述试剂反应盒上设有一开口,所述顶杆穿过开口与推杆相互配合。
  6. 根据权利要求1所述的检测系统,其特征在于,所述检测盒的内侧面上设有活动板。
  7. 根据权利要求6所述的检测系统,其特征在于,所述活动板包括基板和弹性件,基板通过弹性件与检测盒连接。
  8. 根据权利要求7所述的检测系统,其特征在于,所述基板为加热板。
  9. 根据权利要求1所述的检测系统,其特征在于,所述检测盒的其中一个内侧面上设有弹片。
  10. 根据权利要求6所述的检测系统,其特征在于,所述检测盒相对活动板的内侧面上设有凹槽。
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