CN115201159A - Portable automatic biochemical analyzer based on intelligent mobile terminal - Google Patents

Portable automatic biochemical analyzer based on intelligent mobile terminal Download PDF

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Publication number
CN115201159A
CN115201159A CN202210900561.1A CN202210900561A CN115201159A CN 115201159 A CN115201159 A CN 115201159A CN 202210900561 A CN202210900561 A CN 202210900561A CN 115201159 A CN115201159 A CN 115201159A
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CN
China
Prior art keywords
mobile terminal
intelligent mobile
detection
reaction tank
automatic biochemical
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Pending
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CN202210900561.1A
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Chinese (zh)
Inventor
郑磊
吴泽
付强强
张鹏
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Southern Hospital Southern Medical University
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Southern Hospital Southern Medical University
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Priority to CN202210900561.1A priority Critical patent/CN115201159A/en
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/59—Transmissivity
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/01—Arrangements or apparatus for facilitating the optical investigation
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/01—Arrangements or apparatus for facilitating the optical investigation
    • G01N21/03—Cuvette constructions
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N2035/1027—General features of the devices
    • G01N2035/1034—Transferring microquantities of liquid
    • G01N2035/1039—Micropipettes, e.g. microcapillary tubes

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention belongs to the technical field of biochemical detection equipment, and particularly discloses a portable automatic biochemical analyzer based on an intelligent mobile terminal, which comprises an analyzer main body and a reagent card, wherein the analyzer main body comprises a shell, a fluid driving device and a detection analysis system are arranged in the shell, and a reagent card loading groove and an intelligent mobile terminal insertion hole are formed in the analyzer main body; the detection analysis system comprises a light source, a reaction tank and an intelligent mobile terminal, wherein light emitted by the light source can be captured by an ambient light sensor of the intelligent mobile terminal after passing through the reaction tank. The invention realizes full-automatic biochemical detection and data analysis and processing through the combination of the flow control technology and the intelligent mobile terminal, and the results can be shared in real time without depending on fixed fields and unchangeable instruments carried, without the operation of professionals, thereby realizing low-cost home self-test.

Description

Portable automatic biochemical analyzer based on intelligent mobile terminal
Technical Field
The invention relates to the technical field of biochemical detection equipment, in particular to a portable automatic biochemical analyzer based on an intelligent mobile terminal.
Background
The patient has self-testing requirements in grading diagnosis and treatment, family health and disease monitoring.
Biochemical diagnosis is one of the most commonly used in vitro diagnostic methods. It is the earliest automatic detection method and is widely applied to clinical diagnosis. However, the currently used fully automatic biochemical detectors in clinical practice are expensive, bulky and require professional operation. It cannot be popularized in small clinics or remote areas, and is not suitable for household use. There are also some simple biochemical test kits on the market, but the preparation, mixing and reaction of the reagents still require manual operation, the reading depends on the test equipment, and the reading needs to be carried out in a laboratory, which is not available to untrained ordinary people, and thus is not suitable for use in a basic medical institution or home use.
Based on the above current situation, it is very important and urgent to develop a biochemical detection platform which is miniaturized, integrated in function, simple in use, low in price, and applicable to basic medical institutions or households.
Disclosure of Invention
In view of the above drawbacks of the prior art, an object of the present invention is to provide a portable automatic biochemical analyzer based on an intelligent mobile terminal, which realizes full-automatic biochemical detection and data analysis by combining a flow control technology and the intelligent mobile terminal, and provides a novel biochemical detection platform with small size, integrated functions, simple use and low cost for a patient.
In order to achieve the above objects and other related objects, the present invention provides a portable automatic biochemical analyzer based on an intelligent mobile terminal, the basic scheme is as follows: the automatic biochemical analyzer comprises an analyzer main body and a reagent card, wherein the analyzer main body comprises a shell, a fluid driving device and a detection analysis system are installed in the shell, a reagent card loading groove and an intelligent mobile terminal insertion opening are formed in the analyzer main body, the reagent card loading groove is located above the intelligent mobile terminal insertion opening, the reagent card loading groove is used for inserting the reagent card, and the intelligent mobile terminal insertion opening is used for inserting the intelligent mobile terminal; a capillary tube is arranged in the reagent card, and a detection reagent is prepackaged in the capillary tube; the detection analysis system comprises a light source, a reaction tank and an intelligent mobile terminal, wherein the reaction tank is positioned below the outlet end of the capillary tube, and the fluid driving device is used for driving a detection reagent in the capillary tube to flow into the reaction tank through the outlet end; the intelligent mobile terminal is internally provided with an ambient light sensor and a detection application program (App) for reading light intensity and carrying out data acquisition and analysis, and further comprises a display screen for displaying a detection result; the light source is positioned above the reaction tank, and light rays emitted by the light source can be captured by an ambient light sensor of the intelligent mobile terminal after passing through the reaction tank.
The working principle of the basic scheme is as follows: adding a sample to be detected into a reaction tank, inserting a reagent card into a reagent card loading slot, placing an intelligent mobile terminal into an intelligent mobile terminal insertion slot, driving a detection reagent pre-packaged in a capillary tube to be added into the reaction tank through a fluid driving device, and carrying out biochemical detection reaction; and then, emitting incident light through a light source, capturing the incident light by an ambient light sensor of the intelligent mobile terminal after the incident light passes through the reaction tank, reading the transmitted light through a detection application program built in the intelligent mobile terminal and carrying out data analysis, and finally displaying a detection result on a display screen of the intelligent mobile terminal, wherein the intensity of the transmitted light is in inverse proportion to the concentration of the object to be detected in the sample.
The technical effect of this basic scheme does: the automatic biochemical analyzer controls a detection reagent to be added into the reaction tank by utilizing a flow control technology, and can realize automatic biochemical detection; the portable intelligent mobile terminal is used for reading light and analyzing and processing data, and a large-scale professional detection equipment instrument which is inconvenient to carry and a fixed field is not required; the full-automatic biochemical detection and data analysis are realized through the combination of the flow control technology and the intelligent mobile terminal, the operation of professionals is not needed, the use mode is simple, and the low-cost and convenient home self-test can be realized.
In an embodiment of the present invention, the detection application program can directly read the light intensity value passing through the reaction cell and instantly convert the light intensity value into the concentration value of the object to be detected.
In an embodiment of the present invention, the detection reagent is a reagent for detecting clinical samples and/or clinically available biochemical detection indicators, the clinical samples include urine, serum/plasma, cerebrospinal fluid, amniotic fluid and saliva, and the biochemical detection indicators include, but are not limited to, urinary microalbumin (marb), creatinine (CRE), uric acid, cystatin-C, and apolipoprotein. When the latex enhanced immunoturbidimetry is used for detecting the urinary microalbuminum (mAB), the detection reagent comprises a sample diluent R1, an enzyme reaction reagent R2 and a washing buffer solution, and the washing buffer solution is preferably a PBST buffer solution; when the urine Creatinine (CRE) is detected by a colorimetric method (a creatinine enzyme method), the detection reagent comprises a creatininase mixed solution R1, a peroxidase mixed solution R2 and a washing buffer solution, and the washing buffer solution is preferably PBST buffer solution.
In one embodiment of the invention, the detection reagent comprises a plurality of components, and the components are segmented and are sequentially pre-packaged in the capillary along the outlet end of the capillary according to the adding sequence during detection; preferably, the volume of each detection reagent component in the capillary is controlled to be 20 to 100. Mu.L. When the detection reagent is used for detecting the urinary microalbuminuria (mALB), the components pre-packaged in the capillary tube along the outlet end of the capillary tube are as follows: sample diluent R1, enzyme reaction reagent R2, washing buffer solution and color reagent R3; when the detection reagent is used for detecting urinary Creatinine (CRE), the components pre-packaged in the capillary along the outlet end of the capillary in sequence are as follows: creatininase mixed liquor R1, peroxidase mixed liquor R2 and washing buffer solution.
In one embodiment of the present invention, each detection reagent component in the capillary is separated by physical separation selected from extrusion separation or air separation or by using an oily solution selected from a buffer including, but not limited to, PBST and TBST to avoid contact during transportation. When extrusion separation is selected, the capillary tube is a thin-wall hose, the extrusion separation mode is that the capillary tube is extruded by external pressure to be separated into a plurality of sections which are mutually independent, one section is filled with a detection reagent component to prevent the detection reagent components from contacting with each other in the transportation process, and the reagent can circulate after the external pressure is removed; the air is separated from the adjacent components by air, and preferably, the volume of the air is controlled to be 20 to 100. Mu.L.
In an embodiment of the present invention, the capillary tube is a thin-walled hose with a smooth inner wall and low absorption, and is preferably a silicone tube, an elastic plastic tube, or the like.
In one embodiment of the present invention, the reagent card is a single use design.
In one embodiment of the present invention, the reagent card includes a holder plate for holding a capillary tube and a capillary tube.
In an embodiment of the present invention, the supporting plate is provided with grooves matching with the shape of the capillaries, and the capillaries are placed in the grooves to realize fixation.
In an embodiment of the present invention, the supporting plate is provided with a sample adding hole, and the sample adding hole is opposite to the reaction tank.
In one embodiment of the present invention, the outlet end of the capillary extends out of the support plate and is disposed downward.
In an embodiment of the present invention, a reaction tank accommodating frame is disposed at the bottom of the supporting plate, a reaction tank installation groove for placing a reaction tank is disposed below the reagent card loading groove, and the reaction tank accommodating frame can be inserted into the reaction tank installation groove and covers the reaction tank. When the reagent card is inserted into the reagent card loading slot, the reaction tank is covered by the reaction tank containing frame so as to avoid the influence of external light on the detection reaction; simultaneously, set up the reaction tank mounting groove, be convenient for get and put the reaction tank.
In an embodiment of the present invention, the support plate and the reaction chamber receiving frame are integrally formed.
In an embodiment of the present invention, the reagent card further includes a cover plate, the cover plate can be covered on the supporting plate, and a groove matching with the capillary in shape is formed at the bottom of the cover plate. The cover plate is matched with the supporting plate up and down, and the capillary tube is fixed in a physical compression mode.
In an embodiment of the present invention, the cover plate is provided with a through hole opposite to the sample adding hole on the supporting plate.
In an embodiment of the invention, the reagent card further comprises an extrusion separation plate, the extrusion separation plate is positioned above the cover plate, a plurality of convex clips are arranged at the bottom of the extrusion separation plate, a plurality of insertion holes corresponding to the clips one by one are formed in the cover plate, the insertion holes all penetrate through the cover plate, the capillary tubes are flexible tubes, the clips can penetrate through the insertion holes to be inserted into grooves, used for placing the capillary tubes, in the support plate, the capillary tubes are tightly pressed, and the extrusion separation of the components of the detection reagent is performed. Through above-mentioned structure can realize the extrusion of detect reagent component and separate, the concrete mode is: firstly, placing a capillary tube into a groove of a supporting plate, and sequentially injecting each detection reagent component in sections according to sequence; then cover the lamina tecti on the layer board, will extrude the spacer plate to cover on the lamina tecti again, the checkpost passes in the jack inserts the recess, compresses tightly the hose-type capillary, divides into a plurality of sections independent each other with each detection reagent component to the reagent card is assembled to avoid contacting each other in the transportation between each detection reagent component in the capillary. When the reagent card is needed to be used, the reagent card is inserted into the reagent card loading slot after the uppermost extrusion division plate is opened. The positions of the clips and the jacks are adjusted according to the specific quantity of the components of the detection reagent and the required volume size of the components of the detection reagent.
In an embodiment of the invention, the reagent card further comprises a buckle, and the buckle is used for buckling the extrusion division plate, the cover plate and the supporting plate together when the extrusion division plate, the cover plate and the supporting plate are assembled together in sequence from top to bottom, so that the extrusion division plate, the cover plate and the supporting plate are prevented from being loosened and separated in a transportation process.
In an embodiment of the present invention, the fasteners are disposed on the extrusion separation plate, two fasteners are disposed on two sides of the extrusion separation plate, respectively, each fastener includes a body portion and a buckling portion, the body portion vertically extends downward along the left/right side walls of the extrusion separation plate and bends upward to form the buckling portion, the body portion can be attached to the cover plate and the left/right side walls of the support plate, and the buckling portion can be buckled at the bottom of the support plate. In an embodiment of the present invention, the fluid driving device is a micro peristaltic pump, and the micro peristaltic pump is connected to the other end of the capillary tube to drive the detection reagent in the capillary tube to flow into the reaction chamber through the outlet end.
In an embodiment of the present invention, a power switch is disposed on the housing of the analyzer main body, and the power switch is used for controlling the operation and stop of the automatic biochemical analyzer, including controlling the on/off of the fluid driving device and the light source; preferably, the power switch is disposed on a back portion of the analyzer main body case.
In an embodiment of the present invention, the detection and analysis system further includes a power module, and the power module is configured to provide stable and reliable power requirements for the automatic biochemical analyzer, including OTG-USB power supply and UPS standby power supply.
In an embodiment of the present invention, the power module includes a battery and a USB interface for charging the battery, the battery is a rechargeable lithium battery, the battery is mounted in the analyzer main body casing, and the USB interface is mounted at the back of the analyzer main body casing.
In one embodiment of the present invention, the light source includes, but is not limited to, an LED, a laser, a tungsten lamp, and the like.
In an embodiment of the invention, the light source can emit light with a wavelength of 350nm to 700 nm.
In an embodiment of the present invention, the automatic biochemical analyzer further includes a time control module, the time control module is configured to control the fluid driving device to operate according to a set time and a set duration through a control circuit according to a set time parameter on/off, so as to automatically and intermittently add the corresponding detection reagent in the capillary into the reaction cell according to the requirement of the biochemical detection reaction progress to perform the corresponding reaction.
In an embodiment of the invention, the time control module is installed in the analyzer main body casing and is positioned at the back of the casing.
In an embodiment of the present invention, the automatic biochemical analyzer further includes a vibration device, and the vibration device is configured to drive the reaction cell to shake, so as to better enable the detection reagent to react with the sample.
In one embodiment of the invention, the vibrating device is mounted within the analyzer body housing.
In an embodiment of the present invention, the vibration device is a micro vibration motor, and a vibration output end of the micro vibration motor is in contact with the reaction cell.
In an embodiment of the present invention, two micro vibration motors are provided, and are respectively located at the left and right sides of the reaction tank.
In an embodiment of the present invention, the vibration output end of the vibration device is provided with a protection member, and the protection member is used for protecting the reaction tank so as to prevent the vibration output end of the vibration device from directly contacting the reaction tank, thereby preventing the reaction tank from directly contacting the vibration output end and being damaged.
In an embodiment of the present invention, the protection member is a rubber block or a rubber ring.
In an embodiment of the present invention, the reaction cell is a cuvette and serves as a container for detecting a reaction, and a portion of the light signal generated by the light source is absorbed by a reacted solution in the cuvette.
In an embodiment of the present invention, the smart mobile terminal includes, but is not limited to, a commercially available smart phone for reading the transmitted light intensity and collecting, analyzing and interacting information of data.
In an embodiment of the present invention, the housing is made of a material that is opaque to light so as to avoid interference from ambient light.
The invention also provides application of the portable automatic biochemical analyzer based on the intelligent mobile terminal in biochemical detection.
In an embodiment of the present invention, the types of the samples for biochemical detection include urine, serum/plasma, cerebrospinal fluid, amniotic fluid and saliva, and the items for biochemical detection include, but are not limited to, urine microalbumin (mal), creatinine (CRE), uric acid, cystatin-C, apolipoprotein, and all currently clinically available biochemical detection indexes.
As described above, the portable automatic biochemical analyzer based on the intelligent mobile terminal of the invention has the following beneficial effects:
the portable automatic biochemical analyzer provided by the invention realizes full-automatic biochemical detection and data analysis and processing by utilizing the combination of a flow control technology and an intelligent mobile terminal, and the results can be shared in real time without depending on a fixed field and an instrument which is not changed to be carried, and without the operation of professional personnel, the low-cost home self-detection can be realized, and the portable automatic biochemical analyzer has great practical application value in the field of biochemical detection.
Drawings
Fig. 1 is a perspective view of a portable automatic biochemical analyzer based on an intelligent mobile terminal according to an embodiment of the present invention.
Fig. 2 is a perspective view of an analyzer body housing of a portable automatic biochemical analyzer based on an intelligent mobile terminal according to an embodiment of the present invention.
Fig. 3 is a schematic diagram illustrating an explosion structure of a reagent card in a portable automatic biochemical analyzer based on an intelligent mobile terminal according to an embodiment of the present invention.
FIG. 4 shows a longitudinal cross-sectional view of the reagent card of FIG. 3 when assembled.
Figure 5 shows a top view of the carrier in the reagent card of figure 3.
Figure 6 shows top and bottom views of the cover plate of the reagent card of figure 3.
Fig. 7 is a schematic diagram showing an explosion structure of a reagent card according to another embodiment of the present invention.
Fig. 8 is a schematic diagram of the exploded view of the reagent card shown in fig. 7 from another viewing angle (bottom view).
FIG. 9 is a longitudinal sectional view of the portable automated biochemical analyzer of the reagent card shown in FIG. 1.
FIG. 10 is a cross-sectional view of the portable automatic biochemical analyzer shown in FIG. 9 taken along the direction D-D.
FIG. 11 is a rear view of the portable automated biochemical analyzer of the reagent card shown in FIG. 1. FIG. 12 is a graph showing the standard curve obtained in test example 1.
FIG. 13 is a graph showing a comparison of the results of the tests performed by the portable automatic biochemical analyzer of the present invention and the conventional fully automatic biochemical analyzer in test example 1.
FIG. 14 is a graph showing the standard curve obtained in test example 2.
FIG. 15 is a graph showing a comparison of the results of the tests performed by the portable automatic biochemical analyzer of the present invention and the conventional fully automatic biochemical analyzer in test example 2.
Description of reference numerals:
the analyzer comprises an analyzer body 100, a housing 101, a reagent card loading slot 102, a smart mobile terminal insertion port 103, a reaction cell installation slot 104, a reagent card 200, a supporting plate 201, a cover plate 202, an insertion hole 2021, a capillary 203, a sample adding hole 204, a reaction cell accommodating frame 205, a pressing separation plate 206, a clamp 207, a buckle 208, a body portion 2081, a buckling portion 2082, a light source 301, a reaction cell 302, a smart mobile terminal 303, a reflector 304, a battery 305, a USB interface 306, a micro peristaltic pump 400, a time control module 500, a power switch 600, a micro vibration motor 700 and a rubber ring 800.
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention.
It should be noted that the drawings provided in this embodiment are only for schematically illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings and not drawn according to the number, shape and size of the components in actual implementation, and the form, quantity and proportion of each component in actual implementation may be arbitrarily changed, and the component layout may be more complicated. The structures, proportions, sizes, and other dimensions shown in the drawings and described in the specification are for understanding and reading the present disclosure, and are not intended to limit the scope of the present disclosure, which is defined in the claims, and are not essential to the art, and any structural modifications, changes in proportions, or adjustments in size, which do not affect the efficacy and attainment of the same are intended to fall within the scope of the present disclosure. In addition, the terms "upper", "lower", "left", "right", "middle" and "one" used in the present specification are for clarity of description, and are not intended to limit the scope of the present invention, and the relative relationship between the terms and the terms is not to be construed as a scope of the present invention.
Based on the easy-to-manipulate property of the fluid in the capillary, the precise control of the fluid movement in millimeter or even micron scale can be realized. Next milli-fluidic research mainly focuses on multi-channel feeding, real-time detection and automatic control. The flow control technology is utilized to control all reaction components to be added into the reaction vessel in sequence, and automatic biochemical detection can be realized. At present, smart phones are more and more powerful, and are super platforms integrating communication, camera shooting, data processing and network interconnection, and the application of smart mobile terminals such as smart phones in POCT is a research hotspot in recent years. The smart phone is used for reading results and analyzing data, and the smart phone does not need to depend on a fixed place and an instrument which is carried invariably. Based on the above, the invention provides the portable automatic biochemical analyzer based on the intelligent mobile terminal, and the full-automatic biochemical detection and data analysis can be hopefully realized through the combination of the flow control technology and the intelligent mobile terminal, and the result can be shared in real time.
The portable automatic biochemical analyzer based on the intelligent mobile terminal provided by the invention is further explained by specific embodiments.
As shown in fig. 1 and 2, an embodiment of the present invention provides a portable automatic biochemical analyzer based on a smart mobile terminal 303, including an analyzer main body 100 and a reagent card 200, where the analyzer main body 100 includes a casing 101, a fluid driving device and a detection and analysis system are installed in the casing 101, a reagent card loading slot 102 and a smart mobile terminal insertion slot 103 are provided on the analyzer main body 100, the reagent card loading slot 102 is located above the smart mobile terminal insertion slot 103, the reagent card loading slot 102 is used for inserting the reagent card 200, the smart mobile terminal insertion slot 103 is used for inserting the smart mobile terminal 303, and the smart mobile terminal 303 can be placed on the smart mobile terminal insertion slot 103 in a horizontal state.
In the automated biochemical analyzer of the embodiment of the present invention, the reagent card 200 is designed for one-time use. As shown in fig. 3, the reagent card 200 includes a support plate 201, a cover plate 202 and a capillary 203, wherein a detection reagent is pre-packaged in the capillary 203; the detection reagent comprises a reagent for detecting clinical samples and/or clinically available biochemical detection indexes, wherein the clinical samples comprise urine, serum/plasma, cerebrospinal fluid, amniotic fluid and saliva, and the biochemical detection indexes comprise, but are not limited to, urine microalbumin (mALB), creatinine (CRE), uric acid, cystatin-C and apolipoprotein. When the latex enhanced immunoturbidimetry is used for detecting the urinary microalbuminum (mLB), the detection reagent comprises a sample diluent R1, an enzyme reaction reagent R2 and a washing buffer solution, and the washing buffer solution is preferably a PBST buffer solution; when urine Creatinine (CRE) is detected by a colorimetric method (creatininase method), the detection reagent comprises a creatininase mixed solution R1, a peroxidase mixed solution R2 and a washing buffer solution, and the washing buffer solution is preferably PBST buffer solution.
Furthermore, the detection reagent comprises a plurality of components, each component is segmented and is pre-packaged in the capillary 203 along the outlet end of the capillary 203 in sequence according to the adding sequence during detection, and the volume of each detection reagent component in the capillary is controlled to be 20-100 mu L. When the detection reagent is used for detecting the urinary microalbuminuria (mALB), the components pre-packaged in the capillary tube along the outlet end of the capillary tube are as follows: a sample diluent R1, an enzyme reaction reagent R2, a washing buffer solution and a color reagent R3; when the detection reagent is a reagent for detecting urinary Creatinine (CRE), the components pre-packaged in the capillary in the order along the outlet end of the capillary are: creatininase mixed liquor R1, peroxidase mixed liquor R2 and washing buffer solution.
Further, each of the detection reagent components in capillary 203 are physically separated from each other during transport by a physical separation selected from the group consisting of squeeze separation or air separation or separated by an oily solution selected from the group consisting of, but not limited to, buffers such as PBST, TBST, to avoid contact with each other. When extrusion separation is selected, the capillary 203 is a thin-wall hose, and the extrusion separation mode means that the capillary 203 is extruded by external pressure to be separated into a plurality of sections which are mutually independent, one section is filled with a detection reagent component to prevent the detection reagent components from contacting with each other in the transportation process, and the reagent can be circulated after the external pressure is removed; the air is separated into adjacent components by air, and the volume of the air is preferably controlled to be 20-100 mu L.
Further, the capillary 203 is a thin-walled hose with a smooth inner wall and low adsorption, and is preferably a silicone tube, an elastic plastic tube, or the like.
Further, the capillary 203 comprises a plurality of sections of straight pipes, and two adjacent sections of straight pipes are connected together through a bent pipe.
Referring to fig. 3, 4, 5 and 6, in the automatic biochemical analyzer according to the embodiment of the present invention, a supporting plate 201 is used for fixing a capillary 203, a groove having a shape matching with that of the capillary 203 is formed on the supporting plate 201, the capillary 203 is placed in the groove to realize the fixing, and an outlet end of the capillary 203 extends out of the supporting plate 201 and is disposed downward; the supporting plate 201 is provided with a sample adding hole 204, and the sample adding hole 204 is opposite to the reaction tank 302. The cover plate 202 can cover the supporting plate 201, and the bottom of the cover plate 202 is provided with a groove matched with the shape of the capillary 203; the cover plate 202 is provided with a through hole opposite to the position of the sample adding hole 204 on the supporting plate 201. The cover plate 202 and the supporting plate 201 are matched up and down, and the capillary 203 is fixed in a physical pressing mode.
In another embodiment of the present invention, as shown in fig. 7 and 8, in the automatic biochemical analyzer according to the embodiment of the present invention, the reagent card 200 further includes a pressing separation plate 206, the pressing separation plate 206 is located above the cover plate 202, the bottom of the pressing separation plate 206 is provided with a plurality of protruding clips 207, the cover plate 202 is provided with a plurality of insertion holes 2021 corresponding to the clips 207 one by one, the insertion holes 2021 all penetrate through the cover plate 202, the capillary 203 is a flexible tube, and the clips 207 can be inserted into the grooves for placing the capillary 203 on the supporting plate 201 through the insertion holes 2021 to press the capillary 203 for pressing and separating the detection reagent components. Through above-mentioned structure can realize the extrusion of detect reagent component and separate, the concrete mode is: placing the capillary 203 into a groove of the supporting plate 201, and sequentially injecting each detection reagent component in sections according to the sequence; then the cover plate 202 is covered on the supporting plate 201, the extrusion separation plate 206 is covered on the cover plate 202, the clamp 207 is inserted into the groove through the insertion hole 2021, the hose type capillary 203 is pressed, each detection reagent component is divided into a plurality of sections which are independent from each other, so that the reagent card 200 is assembled, and the mutual contact among the detection reagent components in the capillary 203 in the transportation process is avoided. When the reagent card 200 is to be used, the uppermost pressing partition plate 206 is opened, and then the reagent card 200 is inserted into the reagent card loading slot 102. The positions of the clip 207 and the receptacle 2021 are adjusted according to the specific amounts of the components of the detection reagent and the desired volume thereof.
Further, as shown in fig. 7 and 8, the reagent card 200 further includes a snap 208, and the snap 208 is used for snapping the pressing partition plate 206, the cover plate 202 and the support plate 201 together when the pressing partition plate, the cover plate and the support plate are assembled together in sequence from top to bottom, so as to prevent the pressing partition plate, the cover plate and the support plate from being loosened during transportation. Specifically, the buckle 208 is disposed on the extrusion separation plate 206, two buckles 208 are disposed on the left side and the right side of the extrusion separation plate 206, respectively, the buckle 208 includes a body portion 2081 and a buckling portion 2082, the body portion 2081 vertically extends downward along the left/right side walls of the extrusion separation plate 206 and is bent upward to form the buckling portion 2082, the body portion 2081 can be attached to the cover plate 202 and the left/right side walls of the support plate 201, and the buckling portion 2082 can be buckled at the bottom of the support plate 201.
Referring to fig. 1, 11, and 10, in the automatic biochemical analyzer according to the embodiment of the present invention, the detection analysis system includes a light source 301, a reaction cell 302, and an intelligent mobile terminal 303. The reaction cell 302 is located below the outlet end of the capillary 203, and the outlet end of the capillary 203 is inserted into the reaction cell 302, in this embodiment, the reaction cell 302 is a cuvette and is used as a container for detecting a reaction, and a part of the optical signal generated by the light source 301 is absorbed by a solution after the reaction in the cuvette. An ambient light sensor and a detection application program (App) for reading light intensity and performing data acquisition and analysis are arranged in the intelligent mobile terminal 303, and the detection application program can directly read the light intensity value penetrating through the reaction tank and immediately convert the light intensity value into a concentration value of an object to be detected; the smart mobile terminal 303 further includes a display screen for displaying the detection result. In this embodiment, the smart mobile terminal 303 recommends using a smart phone, which can be used for reading of transmitted light intensity, data acquisition, analysis, and information interaction, but is not limited to the smart phone. The light source 301 is located above the reaction tank 302, light emitted by the light source 301 after passing through the reaction tank 302 can be captured by an ambient light sensor of the smart mobile terminal 303, and the light source 301 includes, but is not limited to, an LED, a laser, a tungsten lamp, and the like, and can emit light with a wavelength of 350nm to 700 nm.
Referring to fig. 11 and 10, in the automatic biochemical analyzer according to the embodiment of the present invention, the light source 301 is horizontally disposed, the light emitted therefrom is horizontally directed, and a reflector 304 inclined at 45 ° is disposed at the front end of the light source 301 so as to direct the light downward.
As shown in FIG. 10, in the automatic biochemical analyzer according to the embodiment of the present invention, the fluid driving device is used to drive the detection reagent in the capillary 203 to flow into the reaction cell 302 through the outlet port. The fluid driving device specifically employs a micro peristaltic pump 400, and the micro peristaltic pump 400 is installed in the casing 101 of the analyzer body 100 and above the reagent card loading well 102. A micro peristaltic pump 400 is connected to the other end of the capillary 203 (the end opposite the outlet end) to drive the detection reagent in the capillary 203 through the outlet end into the reaction cell 302.
As shown in fig. 10, in the automatic biochemical analyzer according to the embodiment of the present invention, the detection analysis system further includes a power module, and the power module is configured to provide stable and reliable power requirements for the automatic biochemical analyzer, including OTG-USB power supply and UPS standby power supply.
Further, the power module includes a battery 305 and a usbus interface 306 for charging the battery 305, the battery 305 is a rechargeable lithium battery 305, the battery 305 is installed in the casing 101 of the analyzer main body 100, and the battery 305 is also installed in the casing 101 of the analyzer main body 100, as shown in fig. 11, and the usbus interface 306 is installed at the back of the casing 101 of the analyzer main body 100.
Referring to fig. 1, 2, 3 and 4, a reaction well accommodating frame 205 is disposed at the bottom of the support plate 201, a reaction well mounting groove 104 for placing a reaction well 302 is disposed below the reagent card loading groove 102, and the reaction well accommodating frame 205 is inserted into the reaction well mounting groove 104 and covers the reaction well 302. The pallet 201 and the reaction well receiving frame 205 are preferably integrally formed. When the reagent card 200 is inserted into the reagent card loading slot 102, the reaction chamber 302 is covered by the reaction chamber accommodating frame 205 to prevent external light from affecting the detection reaction; meanwhile, the reaction tank mounting groove 104 is arranged, so that the reaction tank 302 can be conveniently taken and placed. In addition, a through hole is formed in the bottom of the reaction tank installation groove 104, and the position of the through hole corresponds to that of the ambient light sensor of the intelligent mobile terminal 303, so that the ambient light sensor of the intelligent mobile terminal 303 can capture transmitted light.
As shown in fig. 11, the automatic biochemical analyzer according to the embodiment of the present invention further includes a time control module 500, which is used for controlling the fluid driving device to operate according to the set time parameter on/off by the control circuit, so as to automatically and intermittently add the corresponding detection reagent in the capillary 203 into the reaction cell 302 according to the requirement of the biochemical detection reaction progress, so as to perform the corresponding reaction. The time control module 500 is mounted within the housing 101 of the analyzer body 100 and is located at the back of the housing 101.
As shown in fig. 11, in the automatic biochemical analyzer according to the embodiment of the present invention, a power switch 600 is disposed on the back of the casing 101 of the analyzer main body 100, and the power switch 600 is used for controlling the operation and the stop of the automatic biochemical analyzer, including controlling the on/off of the fluid driving device, the light source 301, the time control module, and the vibrating device.
As shown in fig. 11, the automatic biochemical analyzer according to the embodiment of the present invention further includes a vibration device, and the vibration device is configured to drive the reaction cell 302 to shake, so as to better enable the detection reagent to react with the sample. Specifically, the vibration device adopts a micro vibration motor 700, and is installed in the casing 101 of the analyzer main body 100, and the vibration output end of the micro vibration motor 700 extends out of the casing 101 to contact with the reaction cell 302. Preferably, two micro vibration motors 700 are provided, respectively on the left and right sides of the reaction cell 302.
Further, the vibration output end of the vibration device is provided with a protection member for protecting the reaction tank 302 so as to prevent the vibration output end of the vibration device from directly contacting the reaction tank 302, thereby preventing the reaction tank 302 from directly contacting the vibration output end and being damaged. The protector may employ a rubber block or ring 800, and as shown in fig. 1 and 11, the rubber ring 800 is provided in the reaction cell installation groove 104. As shown in fig. 1, 2 and 3, in order to install the rubber ring 800 and the micro vibration motor 700, through holes are formed at both left and right sides of the reaction cell accommodating frame 205, and the reaction cell installation groove 104 is also provided with corresponding through holes, so that the rubber ring 800 and the vibration output end of the micro vibration motor 700 are connected to each other. In use, the reaction cell 302 is placed in the rubber ring 800 to protect the reaction cell 302.
In addition, it should be noted that the housing 101 of the automated biochemical analyzer in the embodiment of the present invention is made of a material opaque to light so as to avoid interference of ambient light.
The use method of the automatic biochemical analyzer provided by the embodiment of the invention comprises the following steps: adding a sample to be detected into a reaction tank 302, then inserting a reagent card 200 into a reagent card loading slot 102, putting an intelligent mobile terminal 303 into an intelligent mobile terminal insertion slot 103, driving a detection reagent pre-packaged in a capillary 203 into the reaction tank 302 through a fluid driving device, and carrying out biochemical detection reaction; then, the incident light is emitted by the light source 301, the incident light is captured by an ambient light sensor of the intelligent mobile terminal 303 after passing through the reaction tank 302, the intensity of the transmitted light is inversely proportional to the concentration of the object to be detected in the sample, the transmitted light is read and subjected to data analysis by a detection application program built in the intelligent mobile terminal 303, and finally, the detection result is displayed on a display screen of the intelligent mobile terminal 303.
The embodiment of the invention provides an automatic biochemical analyzer for biochemical colorimetric analysis, immunoturbidimetric analysis, nano-sensing technology and the like, the detectable sample types comprise urine, serum/plasma, cerebrospinal fluid, amniotic fluid, saliva and the like, the automatic biochemical analyzer can be used for detecting all currently clinically available biochemical detection indexes such as urinary microalbumin (mALB), creatinine (CRE), uric acid, cystatin-C, apolipoprotein and the like, and the biochemical detection project can be carried out only by injecting corresponding detection reagents into a reagent card capillary.
The user only needs to take a small amount of urine by using the capillary tube to be added into the reaction tank 302, then the reagent card 200 is pushed into the reagent card loading groove 102, the device power switch 600 is turned on, and the detection result is automatically presented on the mobile phone after a few minutes without additional operation in the whole process and without depending on fields and instruments. The control module 500 regulates and controls the starting time/duration and the shutdown time/duration of the micro peristaltic pump 400 each time to drive the reaction components pre-packaged in the capillary 203 to be sequentially added into the reaction system according to the corresponding time, light is captured by the mobile phone front-end environment light sensor after passing through the reaction tank 302, and the intensity of transmitted light is in inverse proportion to the concentration of the object to be detected in the sample.
Test example 1
The portable automatic biochemical analyzer is used for detecting the microalbuminuria (mALB), and the operation process and the detection result are as follows:
1. procedure of operation
1. Detection reagent prepackaging
The method is characterized in that a latex enhanced immunoturbidimetry method is used for detecting the urinary microalbumin (mAB), and the used detection reagents comprise a sample diluent R1, an immune microsphere mixed solution R2 and a PBST buffer solution. Using a pipette, 75. Mu.L of R1, 75. Mu.L of R2, and 75. Mu.L of PBST buffer were sequentially injected into capillary 203, with 100. Mu.L of air in between each component. The prepared reagent card is stored for a long time at the temperature of 200 ℃.
2. Program setting
The on-off of the circuit is controlled within a set time by a circuit control system preset in the time control module 500, so as to control the operation time and duration of the peristaltic pump 400. For example: the setting circuit is switched on for 3s after the power switch is switched on, and the setting circuit is operated for 9s; then, starting at 18s, and operating for 18s; and off at other times.
3. Detection process
(1) Inserting the smart phone into the smart mobile terminal insertion port 103, and opening an APP on the smart phone;
(2) And (3) taking 10 mu L of sample by using a capillary sampling tube, adding the sample into the reaction tank 302, pushing the reagent card 200 into the reagent card loading groove 102, turning on a power switch for 600 min, and displaying a detection result on a mobile phone after 5 min.
4. Standard curve establishment
The serially diluted mALB standards (400 mg/L,200mg/L,100mg/L,50mg/L,25mg/L,12.5mg/L, 6.25mg/L,3.13 mg/L) were added to the reaction cell 302, and the intensity of transmitted light was read at the 2 nd time and recorded as I 0 (ii) a The intensity of transmitted light is read once at 5min and is marked as I. OD = Lg (I) 0 I). The OD value was plotted on the ordinate and the standard concentration on the abscissa, and the results are shown in FIG. 12.
2. The result of the detection
The above protocol was used to detect mALB in 562 clinical urine samples and the results were compared with those obtained with a fully automated biochemical analyzer (model AU5811, beckman) in clinical settings, as shown in FIG. 13, which showed good consistency (R) 2 ＝0.9913)。
Test example 2
The portable automatic biochemical analyzer is used for detecting the urinary Creatinine (CRE), and the operation process and the detection result are as follows:
1. procedure of operation
1. Reagent prepackaging
The urine Creatinine (CRE) is detected by a colorimetric method (a creatinine enzyme method), and the used detection reagent comprises a creatinine enzyme mixed solution R1, a peroxidase mixed solution R2 and a PBST buffer solution. Using a pipette, 50. Mu.L of R1, 50. Mu.L of R2, and 50. Mu.L of PBST buffer were sequentially injected into capillary 203, with 100. Mu.L of air between each component. The prepared reagent card is stored for a long time at the temperature of 200 ℃.
2. Program setting
The on-off of the circuit is controlled within a set time by a circuit control system preset in the time control module 500, so as to control the operation time and duration of the peristaltic pump 400. For example: the setting circuit is switched on for 3s after the power switch is switched on, and the setting circuit is operated for 9s; starting at the 5 th min, and running for 18s; and off at other times.
3. Detection process
(1) Inserting the smart phone into the smart mobile terminal insertion port 103, and opening an APP on the smart phone;
(2) And (3) taking 10 mu L of sample by using a capillary sampling tube, adding the sample into a reaction pool 302 of the reagent card, pushing the reagent card 200 into the reagent card loading groove 102, turning on a power switch 600, and displaying a detection result on a mobile phone after 10 min.
4. Standard curve establishment
A gradient of diluted CRE standards (9000. Mu. Mol/L, 4500. Mu. Mol/L, 2250. Mu. Mol/L, 1125. Mu. Mol/L, 562.5. Mu. Mol/L, 218.3. Mu. Mol/L, 140.6. Mu. Mol/L) was added to the reaction cell 302 and the transmitted light intensity, denoted as I, was read once at 5min 0 (ii) a The intensity of transmitted light was read at 10min and recorded as I. OD = Lg (I) 0 I) is used. The OD value was plotted on the ordinate and the standard concentration on the abscissa, and the results are shown in FIG. 14.
2. The result of the detection
The CRE in 192 clinical urine samples was tested using the protocol described above and compared with that of a fully automated biochemical analyzer (model AU5811, beckmann) used clinically, as shown in fig. 15, which showed good agreement (R) between them 2 ＝0.9913)。
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims (10)

1. The utility model provides a portable automatic biochemical analysis appearance based on intelligent Mobile terminal which characterized in that includes: the analyzer comprises an analyzer main body and a reagent card, wherein the analyzer main body comprises a shell, a fluid driving device and a detection analysis system are installed in the shell, a reagent card loading groove and an intelligent mobile terminal insertion opening are formed in the analyzer main body, the reagent card loading groove is positioned above the intelligent mobile terminal insertion opening, the reagent card loading groove is used for inserting the reagent card, and the intelligent mobile terminal insertion opening is used for inserting the intelligent mobile terminal; a capillary tube is arranged in the reagent card, and a detection reagent is prepackaged in the capillary tube; the detection analysis system comprises a light source, a reaction tank and an intelligent mobile terminal, wherein the reaction tank is positioned below the outlet end of the capillary tube, and the fluid driving device is used for driving a detection reagent in the capillary tube to flow into the reaction tank through the outlet end; the intelligent mobile terminal is internally provided with an ambient light sensor and a detection application program for reading light intensity and carrying out data acquisition and analysis, and further comprises a display screen for displaying a detection result; the light source is positioned above the reaction tank, and light emitted by the light source can be captured by an ambient light sensor of the intelligent mobile terminal after passing through the reaction tank.
2. The portable automatic biochemical analyzer based on intelligent mobile terminal according to claim 1, characterized in that: the detection reagent is used for detecting clinical samples and/or biochemical detection indexes which are clinically available, the clinical samples comprise urine, serum/plasma, cerebrospinal fluid, amniotic fluid and saliva, and the biochemical detection indexes comprise urine microalbumin (mALB), creatinine (CRE), uric acid, cystatin-C and apolipoprotein;
and/or the detection reagent comprises a plurality of components, and the components are segmented and are pre-packaged in the capillary tube along the outlet end of the capillary tube in sequence according to the adding sequence during detection.
3. The portable automatic biochemical analyzer based on intelligent mobile terminal according to claim 2, characterized in that: each detection reagent component in the capillary is separated by physical separation or an oily solution to avoid mutual contact in a transportation process, the physical separation is selected from extrusion separation or air separation, and the oily solution is selected from buffer solution; when extrusion separation is adopted, the capillary tube is a thin-wall hose.
4. The portable automatic biochemical analyzer based on intelligent mobile terminal according to claim 1, characterized in that: the reagent card comprises a support plate and a capillary tube, wherein the support plate is used for fixing the capillary tube.
5. The portable automatic biochemical analyzer based on intelligent mobile terminal according to claim 4, wherein: the supporting plate is provided with a groove matched with the capillary tube in shape;
and/or a sample adding hole is arranged on the supporting plate, and the sample adding hole is opposite to the reaction tank;
and/or the outlet end of the capillary tube extends out of the supporting plate and is arranged downwards;
and/or a reaction tank accommodating frame is arranged at the bottom of the supporting plate, a reaction tank mounting groove for placing a reaction tank is arranged below the reagent card loading groove, and the reaction tank accommodating frame can be inserted into the reaction tank mounting groove and covers the reaction tank; and/or the reagent card also comprises a cover plate, the cover plate can cover the supporting plate, and the bottom of the cover plate is provided with a groove matched with the shape of the capillary tube; the cover plate is provided with a through hole opposite to the sample adding hole on the supporting plate.
6. The portable automatic biochemical analyzer based on intelligent mobile terminal according to claim 1, characterized in that: a power switch is arranged on the shell of the analyzer main body and used for the operation and stop of the automatic biochemical analyzer;
and/or the detection analysis system further comprises a power supply module, and the power supply module is used for supplying power to the automatic biochemical analyzer.
7. The portable automatic biochemical analyzer based on intelligent mobile terminal according to claim 1, characterized in that: the light source is selected from any one of an LED, a laser and a tungsten lamp; the light source can emit light with the wavelength of 350 nm-700 nm.
8. The portable automatic biochemical analyzer based on intelligent mobile terminal according to claim 1, characterized in that: the automatic biochemical analyzer also comprises a time control module which is used for controlling the fluid driving device to operate according to set time and duration through a control circuit according to set time parameters of on/off.
9. The portable automatic biochemical analyzer based on intelligent mobile terminal according to claim 1, wherein: the automatic biochemical analyzer further comprises a vibrating device, and the vibrating device is used for driving the reaction tank to shake.
10. Use of the portable automatic biochemical analyzer based on the intelligent mobile terminal according to any one of claims 1 to 9 in biochemical detection.
CN202210900561.1A 2022-07-28 2022-07-28 Portable automatic biochemical analyzer based on intelligent mobile terminal Pending CN115201159A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202210900561.1A CN115201159A (en) 2022-07-28 2022-07-28 Portable automatic biochemical analyzer based on intelligent mobile terminal

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202210900561.1A CN115201159A (en) 2022-07-28 2022-07-28 Portable automatic biochemical analyzer based on intelligent mobile terminal

Publications (1)

Publication Number Publication Date
CN115201159A true CN115201159A (en) 2022-10-18

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Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (1)

Country Link
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