WO2022052364A1 - 生化分析仪 - Google Patents

生化分析仪 Download PDF

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Publication number
WO2022052364A1
WO2022052364A1 PCT/CN2020/138008 CN2020138008W WO2022052364A1 WO 2022052364 A1 WO2022052364 A1 WO 2022052364A1 CN 2020138008 W CN2020138008 W CN 2020138008W WO 2022052364 A1 WO2022052364 A1 WO 2022052364A1
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WO
WIPO (PCT)
Prior art keywords
assembly
heating
test paper
biochemical analyzer
temperature
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PCT/CN2020/138008
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English (en)
French (fr)
Inventor
赖远强
朱海科
吴岸峰
景振辉
Original Assignee
广州万孚生物技术股份有限公司
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Publication of WO2022052364A1 publication Critical patent/WO2022052364A1/zh

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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
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • 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
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour

Definitions

  • the present application relates to the technical field of analysis and testing, and in particular, to a biochemical analyzer.
  • Biochemical analyzer also known as biochemical analyzer, is a biochemical inspection and detection device used to realize the detection and feedback of multiple samples or multiple items.
  • the detection principle of the biochemical analyzer is to detect a certain characteristic chemical composition in the sample based on the principle of photoelectric colorimetry. Due to the advantages of fast detection speed, high accuracy and low consumption of biochemical instruments, biochemical instruments have been widely used in hospitals, epidemic prevention stations and quarantine stations.
  • the current biochemical instrument mainly includes a sample adding system and a software system.
  • the test results of the biochemical meters on the market are usually greatly affected by the ambient temperature.
  • the main purpose of the present application is to provide a biochemical analyzer whose test results are less affected by ambient temperature.
  • the embodiments of the present application provide a biochemical analyzer.
  • the biochemical analyzer is used to analyze and test the sample to be tested on the test paper.
  • the biochemical analyzer includes:
  • the optical path assembly includes a light source assembly for emitting light to illuminate the test paper;
  • the first heating assembly includes a tray body and a first heating element, the tray body is used for placing the test paper, and the first heating element is used for heating the lower surface of the test paper;
  • the second heating assembly comprising a second heating element for heating the upper surface of the test strip
  • a housing assembly in which the optical path assembly is located.
  • the biochemical analyzer in this embodiment heats the upper and lower surfaces of the test paper, which can heat the test paper to the required working temperature, thereby reducing the influence of the ambient temperature on the test results.
  • the first heating assembly has a first temperature sensing element and a first over-temperature protection switch electrically connected to the first temperature sensing element
  • the second heating assembly has a second temperature A sensing element and a second over-temperature protection switch electrically connected to the second temperature sensing element
  • the first temperature sensing element is used to detect the temperature of the lower surface of the test paper
  • the second temperature sensing element The element is used to detect the temperature of the upper surface of the test strip.
  • the temperature sensing element detects that the temperature of the upper and lower surfaces of the test paper exceeds the required working temperature, and the temperature protection switch can stop the work of the heating element, thereby ensuring that the working temperature of the test paper is basically at a constant temperature.
  • the first temperature sensing element is mounted on the tray body through thermally conductive silica gel; the second heating assembly further includes a heating element fixing bracket, and the second temperature sensing element is made of thermally conductive silica gel Installed on the heating element fixing bracket.
  • Thermally conductive silicone can speed up the transfer of heat.
  • the tray body further has a storage structure for accommodating a calibration object, and the calibration object is used for light intensity calibration of the light source assembly.
  • the tray assembly stores the designed calibration objects.
  • the storage structure includes a first fixing slot and a first fixing cover, the first fixing slot is used for accommodating the calibration object, and the first fixing cover is detachably and fixedly connected to the the top of the first fixing groove.
  • the detachable connection mode of the fixing groove and the fixing cover makes the storage of the calibrator more reliable and facilitates the taking and placing of the calibrator.
  • the test paper assembly further includes a first support element and a second support element arranged up and down, the test paper is located between the first support element and the second support element, the first support element and the second support element.
  • the support element has a first through hole
  • the second support element has a second through hole.
  • the first support element and the second support element are respectively located above and below the test paper body, and clamp the test paper body. The user can hold the entire test strip assembly through the two supporting elements, and the structure is simple, the cost is low, and the use is convenient.
  • the test paper has a reagent membrane layer and a permeable membrane layer, the permeable membrane layer is located between the reagent membrane layer and the first support element, and the reagent membrane layer is coated with a chemical reagent .
  • the chemical reagent enables incident light to be partially absorbed after passing through the reagent film layer.
  • the permeable membrane layer is used to permeate the sample to be tested in liquid form to the next layer from top to bottom.
  • the biochemical analyzer further includes a scanning component and a control unit
  • the test paper has coded information
  • the scanning component is configured to scan the coded information to identify the type of the test paper and transmit it to the test paper.
  • the control unit is used to control the on-off state of the light source assembly. 1D, 2D, and 3D codes can all be read by the machine to identify the type of test strip.
  • the light source assembly includes a first LED lamp assembly having a wavelength of 405 nm, a second LED lamp assembly having a wavelength of 550 nm, and a third LED lamp assembly having a wavelength of 610 nm.
  • the biochemical analyzer in this embodiment includes three different wavelengths, which enriches the testable objects of the biochemical analyzer.
  • the housing assembly is a closed structure.
  • the casing assembly of the closed structure provides installation positions for each component inside the casing assembly, and isolates the external light to avoid the influence of the external light on the optical path assembly.
  • FIG. 1 is a schematic structural diagram of a housing assembly in an embodiment of the application
  • FIG. 2 is a schematic diagram of the assembly structure of the cabin entry and exit components in the embodiment of the application;
  • FIG. 3 is a schematic diagram of the exploded structure of the cabin entry and exit assembly in the embodiment of the application;
  • FIG. 4 is a schematic structural diagram of a scanning assembly in an embodiment of the present application.
  • FIG. 5 is a schematic diagram of an assembly structure of an optical path assembly in an embodiment of the present application.
  • FIG. 6 is a schematic diagram of an exploded structure of an optical path assembly in an embodiment of the present application.
  • FIG. 7 is a cross-sectional view of an optical path assembly in an embodiment of the application.
  • FIG. 8 is a schematic diagram of the assembly structure of the tray assembly in the embodiment of the application.
  • FIG. 9 is a schematic diagram of an exploded structure of a tray assembly in an embodiment of the application.
  • FIG. 10 is a schematic diagram of the assembly structure of the pressing block assembly in the embodiment of the application.
  • FIG. 11 is a cross-sectional view of a pressure block assembly in an embodiment of the application.
  • FIG. 12 is a schematic diagram of the exploded structure of the housing assembly in the embodiment of the application.
  • FIG. 13 is a schematic diagram of the exploded structure of the test paper assembly in the embodiment of the application.
  • FIG. 14 is a schematic diagram of the assembly structure of the test strip assembly in the embodiment of the present application.
  • 300-scanning assembly 310-scanner, 320-scanner holder;
  • 400-optical path assembly 410-first LED lamp assembly, 411-first LED lamp, 412-first sleeve, 413-first convex mirror, 414-first PCBA board, 415-first convex mirror fixing cover; 420-second LED lamp assembly; 430-third LED lamp assembly; 440-third heating element; 461-first fixing seat; 470-photodiode;
  • 500-tray assembly 510-tray body, 511-tray upper cover, 512-tray lower cover, 513-test strip assembly fixing groove; 520-first heating element, 521-first temperature sensing element; 522-first pass Temperature protection switch; 530-calibrator, 531-calibrator storage tank, 532-calibrator fixing cover; 541-insulation pad;
  • 600-pressing block assembly 600-actuating mechanism; 611-first bracket, 6111-first bracket upper fixing cover, 6112-first bracket lower fixing cover; 612-second bracket; 613-electromagnet; 614-guide Shaft, 6141-lead shaft thread head; 615-linear bearing, 6151-bearing fixing cover, 6152-bearing buffer ring; 616-compression spring; 617-electromagnet connecting element; 618-pressing block body; 620-heating mechanism; 621-second heating element; 622-second over-temperature protection switch; 623-second temperature sensing element;
  • 700-test strip assembly 710-first support element, 711-first through hole; 720-second support element, 721-second through hole; 730-permeable membrane layer; 740-reagent membrane layer; 750-identification code layer .
  • connection should be understood in a broad sense, for example, it may be a fixed connection and a movable connection, or a detachable connection and a non-detachable connection. , or integrally connected; it may be a mechanical connection, an electrical connection or a mutual communication.
  • fixed connection includes detachable connection, non-detachable connection and integral connection.
  • the embodiment of the present application provides a biochemical analyzer 10 .
  • the biochemical analyzer 10 is used for analyzing and testing the sample to be tested on the test strip.
  • the biochemical analyzer 10 includes an optical path assembly 400 , a first heating assembly, a second heating assembly, and a housing assembly 100 .
  • the light path assembly 400 includes a light source assembly for emitting light to illuminate the test paper.
  • the first heating assembly includes a tray body 510 and a first heating element 520.
  • the tray body 510 is used for placing the test paper, and the first heating element 520 is used for heating the lower surface of the test paper.
  • the first heating assembly is a tray assembly 500 .
  • the second heating assembly includes a second heating element 621, and the second heating element 621 is used to heat the upper surface of the test paper.
  • the second heating assembly is a pressing block assembly 600 .
  • the optical path assembly 400 is located within the housing assembly 100 .
  • the housing assembly 100 is a box structure.
  • the housing assembly 100 includes a bottom plate, an upper sealing plate, a right sealing plate and a left sealing plate (the left sealing plate is also used as a left motor bracket, namely the third bracket 210 in FIG. 2 to FIG. 3 ). Stroke closed case.
  • FIG. 1 also shows that the first lead screw portion 221 extends out of the housing assembly 100 .
  • the biochemical analyzer in this embodiment heats the upper and lower surfaces of the test paper, which can heat the test paper to the required working temperature, thereby reducing the influence of the ambient temperature on the test results.
  • the first heating assembly has a first temperature sensing element 521 and a first over-temperature protection switch 522 electrically connected to the first temperature sensing element 521
  • the second heating element The assembly has a second temperature sensing element 623 and a second over-temperature protection switch 622 electrically connected to the second temperature sensing element 623.
  • the first temperature sensing element 521 is used to detect the temperature of the lower surface of the test paper
  • the second temperature sensing element 521 is used to detect the temperature of the lower surface of the test paper.
  • the sensing element 623 is used to detect the temperature of the upper surface of the test paper.
  • the temperature sensing element detects that the temperature of the upper and lower surfaces of the test paper exceeds the required working temperature, and the temperature protection switch can stop the work of the heating element, thereby ensuring that the working temperature of the test paper is basically at a constant temperature.
  • the first temperature sensing element 521 is mounted on the tray body 510 through thermal conductive silica gel (not shown in the figure); the second heating assembly further includes a heating element fixing bracket, and the second temperature sensing element 623 passes through Thermally conductive silica gel (not shown in the figure) is mounted on the heating element fixing bracket.
  • Thermally conductive silica gel has good thermal conductivity and good electrical insulation, and also has a wide operating temperature. Thermally conductive silicone can speed up the transfer of heat.
  • the first heating assembly is a tray assembly 500 ; as shown in FIGS. 10 to 12 , the second heating assembly is a pressing block assembly 600 , and the heating element fixing bracket is a first bracket 611 .
  • the tray body 500 further has a storage structure for accommodating a calibration object 530 , and the calibration object 530 is used for light intensity calibration of the light source assembly.
  • the tray assembly stores the designed calibration objects.
  • the storage structure includes a first fixing slot and a first fixing cover
  • the first fixing slot is used for accommodating the calibration object 530
  • the first fixing cover is detachably fixedly connected on the top of the first fixing groove.
  • the first fixing groove is the calibrator storage groove 531
  • the first fixing cover is the calibrator fixing cover 532 .
  • the matching method of the fixing groove and the fixing cover makes the storage of the calibrator more reliable; the detachable connection method is convenient for taking and placing the calibrator.
  • the first heating component in the biochemical analyzer 10 is the tray component 500 .
  • the tray assembly 500 includes a tray body 510 , a tray upper cover 511 , a tray lower cover 512 , a scaler fixing cover 532 , a first temperature sensing element 521 , a first over-temperature protection switch 522 , a first heating element 520 and a heat insulation pad 541.
  • the tray body 510 is provided with a test paper assembly fixing groove 513 and a calibration object storage groove 531 .
  • the calibrator 530 is stored in the calibrator storage tank 531 .
  • the assembly process of the tray assembly 500 by means of the screw connection element, the calibrator fixing cover 532 fixes the calibrator 530 into the calibrator storage groove 531 of the tray body 510; the first temperature sensing element 521, the first overtemperature The protection switch 522 and the first heating element 520 are all coated with thermally conductive silica gel and are respectively assembled to the corresponding positions of the tray body 510; the tray upper cover 511 and the tray lower cover 512 are fixed to the tray body 510 by screw connection elements, and both The outer surface of the tray body 510 is completely wrapped, and only the test strip assembly fixing groove 513 is exposed, so as to reduce heat loss; the tray assembly 500 is fixed to the access cabin assembly 200 by a threaded connection element (specifically, it is fixed to the tray turntable through a threaded connection element.
  • a threaded connection element specifically, it is fixed to the tray turntable through a threaded connection element.
  • a thermal insulation pad 541 is arranged between the tray body 510 and the tray adapter element 230, so that the tray body 510 and the tray adapter element 230 are effectively thermally isolated, thereby achieving effective thermal isolation. Reduce heat loss.
  • the function of the tray assembly 500 is to fix and heat the lower surface of the test strip assembly 700 (through the cooperative action of the first heating element 520 and the first temperature sensing element 521 to heat the tray body 510 to the design temperature, and to pass the test paper of the tray body 510 )
  • the assembly fixing groove 513 transfers heat to the lower surface of the test strip assembly 700 );
  • the second heating component in the biochemical analyzer 10 is the pressing block component 600 .
  • the pressing block assembly 600 can be roughly divided into a heating mechanism 620 , an actuating mechanism 610 , a pressing block body 618 and a second bracket 612 .
  • the heating mechanism 620 generally includes a first bracket 611, a second temperature sensing element 623, a second heating element 621, a second over-temperature protection switch 622, an upper fixing cover 6111 of the first bracket, a lower fixing cover 6112 of the first bracket, and an electromagnet Connection element 617 .
  • the second temperature sensing element 623 may use a temperature probe.
  • the first bracket 611 is provided with a pressing block body 618 .
  • the actuating mechanism 610 includes a compression spring 616 , a bearing buffer ring 6152 , a linear bearing 615 , a bearing fixing cover 6151 , an electromagnet 613 and a guide shaft 614 .
  • the guide shaft 614 includes a guide shaft threaded head 6141 .
  • the assembly process of the pressing block assembly 600 can be briefly described as follows: (1).
  • the heating mechanism 620: the second temperature sensing element 623, the second heating element 621 and the second over-temperature protection switch 622 are assembled to the The corresponding position of the first bracket 611; the upper fixing cover 6111 of the first bracket, the lower fixing cover 6112 of the first bracket and the electromagnet connecting element 617 are made of plastic material, and the three are fixed to the first bracket 611 by the screw connection element, Plays the role of wrapping the heating element and insulating the heat to prevent heat dissipation.
  • Actuating mechanism 610 the electromagnet 613 is assembled with the slot of the electromagnet connecting element 617; the bearing fixing cover 6151 fixes the bearing buffer ring 6152 and the linear bearing 615 to the second bracket 612 through the threaded connecting element; the guide shaft 614 passes through the linear bearing 615 and the compression spring 616, and the guide shaft 614 is locked to the screw hole of the first bracket 611 through the guide shaft threaded head 6141, so as to realize the conduction between the guide shaft 614 and the actuating mechanism 610, and play the role of guiding and Elastic compression.
  • the function of the pressing block assembly 600 is as follows: when the entire biochemical analyzer is working, the upper surface of the test paper is heated, and the pressing block assembly 600 is automatically lifted when the entering and exiting chamber assembly 200 is working, so as to avoid damage to the tray assembly 500 .
  • the test strip assembly 700 further includes a first support member 710 and a second support member 720 arranged up and down, and the test strip is located between the first support member 710 and the second support member 720 , the first support element 710 has a first through hole 711 , and the second support element 720 has a second through hole 721 .
  • the first support element and the second support element are respectively located above and below the test paper body, and clamp the test paper body.
  • the user can hold the entire test strip assembly through the two supporting elements, and the structure is simple, the cost is low, and the use is convenient.
  • the test paper has a reagent membrane layer 740 and a permeable membrane layer 730 , the permeable membrane layer 730 is located between the reagent membrane layer 740 and the first support element 720 , and the reagent membrane layer 740 is coated with Covered with chemical reagents.
  • the chemical reagent can partially absorb the incident light after passing through the reagent film layer, while the unabsorbed light reaches the permeable film layer and generates diffuse reflection, and the light reflects out of the test paper assembly.
  • the permeable membrane layer is used to permeate the sample to be tested in liquid form to the next layer from top to bottom.
  • the permeable membrane layer can be made of hydrophilic materials, so as to facilitate the permeation and diffusion of the sample to be tested.
  • the test strip assembly 700 includes a second support element 720 , a reagent membrane layer 740 , a permeable membrane layer 730 , a first support element 710 and an identification code layer 750 .
  • the test strip assembly 700 is a layered structure, and includes a first support element 710 , a permeable membrane layer 730 , a reagent membrane layer 740 and a second support element 720 in order from top to bottom.
  • the first support element 710 has a first through hole 711, and the first through hole 711 is used for sample injection; the second support element 720 has a second through hole 721, and the second through hole 721 is used to allow the light emitted by the optical path assembly to pass and return .
  • the surface of the second supporting element 720 can be divided into a first area and a second area, wherein the first area is coincident with the first supporting element 710 , in addition, the second supporting element 720 also has a second supporting element 710 that exceeds the first supporting element 710 and cannot be overlapped. Second area.
  • the identification code layer 750 is attached to the second area. Specifically, the identification code layer 750 may be a bar code label layer.
  • the reagent film layer 740 is coated with different chemical reagents, and the chemical reagent causes the incident light to be partially absorbed through the reagent film layer 740 , and the unabsorbed incident light reaches the lower surface of the permeable film layer 730 and is reflected out of the test paper assembly.
  • An identification code layer 750 is designed on the test paper to distinguish different test papers.
  • the biochemical analyzer 10 calculates the parameter value of the corresponding parameter of the sample to be tested by the absorbance.
  • the biochemical analyzer 10 further includes a scanning component 300 and a control unit (not shown in the figure), the test paper has coded information, and the scanning component 300 is used to scan the coded information to identify the test paper
  • the type of the light source is sent to the control unit, and the control unit is used to control the on-off state of the light source assembly.
  • the scanning assembly 300 includes a scanner 310 and a scanner holder 320 .
  • the scanner 310 is fixed to the scanner fixing base 320 through the screw connection element, and the scanner fixing base 320 is fixed to the upper cover plate of the housing assembly 100 through the screw connection element.
  • the scanner 310 scans the encoded information (such as a one-dimensional code) on the test strip, thereby identifying the parameter type of the test strip and transmitting it to the control unit (such as a CPU) of the biochemical analyzer, so as to control the on-off of the LED light. off state.
  • the control unit such as a CPU
  • the encoding includes at least one of a one-dimensional code, a two-dimensional code, and a three-dimensional code.
  • the 3D code is a set of arrays that can be interpretable by specific rules through a specific algorithm and combined with the overall color content of the picture, to encode a string of binary numbers and image information compiled from text. 1D, 2D, and 3D codes can all be read by the machine to identify the type of test strip. Specifically, a one-dimensional code or a two-dimensional code may be used for encoding.
  • the housing assembly 100 is a closed structure.
  • the casing assembly of the closed structure provides installation positions for each component inside the casing assembly, and isolates the external light to avoid the influence of the external light on the optical path assembly. It should be pointed out that the closed structure of the casing assembly does not mean that all the working components of the biochemical analyzer are completely located inside the casing assembly, and some components are located outside the casing assembly, which can still meet the requirements of isolating external light.
  • the biochemical analyzer 10 further has an optical path assembly 400 .
  • the optical path assembly 400 is used to test the test paper based on the principle of photoelectric colorimetry.
  • the optical path assembly 400 includes a first LED lamp assembly 410 (wavelength is 405nm), a second LED lamp assembly 420 (wavelength is 550nm), a third LED lamp assembly 430 (wavelength is 610nm), Three heating elements 440, a photodiode 470, and a first fixing seat 461 (aluminum base material).
  • the biochemical analyzer in the embodiment of the present application includes three different wavelengths, which enriches the testable objects of the biochemical analyzer.
  • the first LED lamp assembly 410 includes a first LED lamp 411 , a first sleeve 412 , a first convex mirror 413 , a first convex mirror fixing cover 415 and a first PCBA board 414 .
  • the first sleeve 412 is made of an aluminum base material, and the first sleeve 412 is provided with a light-transmitting hole.
  • the light source assembly includes a first LED lamp assembly with a wavelength of 405 nm, a second LED lamp assembly with a wavelength of 550 nm, and a third LED lamp assembly with a wavelength of 610 nm.
  • Different sample components to be tested each have a specific wavelength, and the absorbance at the specific wavelength is usually positively correlated with the concentration of the component. Therefore, different wavelengths need to be used to test and analyze the concentrations of multiple components.
  • the working process of the optical path assembly 400 can be briefly described as follows: After the biochemical analyzer 10 identifies the type of the test strip through the scanning assembly 300, it controls the corresponding LED lamp to energize and work. As shown in FIG. 7 , taking the first LED lamp assembly 410 as an example, the light generated by the LED lamp irradiates the surface of the first convex mirror 413 through the light-transmitting hole of the first sleeve 412 and is refracted along the first convex mirror 413 produces parallel beams. In FIG. 7, the direction of the arrow indicates the direction of the optical path. As shown in FIG. 7 , the parallel light beam irradiates the test paper reagent film layer 740 on the tray body 510 , and the reagent film layer 740 absorbs part of the light; the remaining light is reflected to the photodiode 470 .
  • the biochemical analyzer 10 converts the corresponding parameter values of the sample to be tested, thereby completing the test to be tested. sample testing.
  • a third heating element 440 is also designed in the optical path assembly 400 of the biochemical analyzer 10 in the embodiment of the present application.
  • the third heating element 440 is made of an aluminum base material, and the third heating element 440 is provided with a heating circuit and a third temperature sensing element (not shown in the figure).
  • the third temperature sensing element may employ a temperature probe.
  • the back of the third heating element 440 is coated with thermally conductive silica gel, and the third heating element 440 is fixed to the upper surface of the first fixing seat 461 through a screw connection element.
  • the third heating element 440 After the third heating element 440 is powered on, the third heating element 440 heats the first fixing seat 461 and transfers the heat to the sleeve and the LED lamp, so that the working temperature of the optical path assembly 400 is stabilized at a desired temperature (eg 37 °C) or so, thereby reducing the influence of the external ambient temperature on the light intensity of the LED lamp.
  • a desired temperature eg 37 °C
  • the biochemical analyzer 10 also has an access chamber assembly 200 .
  • the function of the cabin entry and exit assembly 200 is to connect the tray assembly 500 to realize the actions of the tray assembly 500 automatically exiting the cabin and automatically entering the cabin.
  • the access cabin assembly 200 includes a stepping motor 220 , a tray adapter element 230 , an optical coupler 250 , a guide rail 240 and a bearing 260 .
  • the number of optocouplers 250 is two.
  • the stepping motor 220 , the two optocouplers 250 and the guide rail 240 are fixed to the left sealing plate (ie, the third bracket 210 ) of the housing assembly 100 through screw connection elements.
  • the stepping motor 220 is provided with a fixed flange seat 223 , the stepping motor 220 is further connected with a first screw part 221 and a second screw part 222 , and the first screw part 221 and the second screw part 222 are coaxial.
  • the guide rail 240 is provided with a guide rail mounting seat 241 , the three mutually perpendicular surfaces of the tray adapter element 230 are mounting surfaces, and the tray adapter element 230 is further provided with an optocoupler blocking piece 270 .
  • the tray adapter element 230 is designed with three mounting surfaces. The first mounting surface is fixed to the guide rail mounting seat 241 through the threaded connection element, the second mounting surface is fixedly connected to the fixed flange seat 223 through the threaded connection element, and the second mounting surface is Fixed connection with the tray assembly 500 .
  • the biochemical analyzer 10 includes the housing assembly 100 , the access chamber assembly 200 , the scanning assembly 300 , the optical path assembly 400 , the tray assembly 500 , the pressing block assembly 600 and the test strip assembly 700 described in the previous embodiments.
  • the structures and compositions of the above components are not described again.
  • test strip assembly 700 may be a separate component independent of the biochemical analyzer 10 , that is, in some embodiments, the biochemical analyzer 10 may also not include the test strip assembly 700 .
  • the tray assembly 500 is automatically extended: the electromagnet 613 in the pressing block assembly 600 is energized to work, driving the heating mechanism 620 to rise, so that the pressing block body 618 is separated from the surface of the tray assembly 500; the stepping motor of the entry and exit cabin assembly 200 220 works to drive the tray assembly 500 to extend to the design position (the optocoupler 250 is used to detect the movement position of the tray assembly 500);
  • the third heating element 440 is energized to work, so that the overall temperature of the optical path assembly 400 is maintained at about 37°C; the first LED lamp assembly 410, the second LED lamp assembly 420 and the third LED lamp assembly 430 are respectively Lights on, and the emitted light passes through the test strip assembly 700 and is reflected to the photodiode 470, so that the light intensity of each group of LED lights can be calibrated.
  • test paper assembly 700 Placement and sample injection process of the test paper assembly 700: The test paper assembly 700 is placed in the test paper assembly fixing groove 513 of the tray assembly 500, and the liquid of the sample to be tested is dropped into the test paper assembly 700 by using a syringe or a pipette or other tool. In the first through hole 711 , the liquid of the sample to be tested will automatically diffuse to the entire permeable membrane layer 730 .
  • the tray assembly 500 is automatically retracted: the stepping motor 220 of the entry and exit cabin assembly 200 works to drive the tray assembly 500 to retract to the design position (the optocoupler 250 is used to detect the movement position of the tray assembly 500); the pressing block assembly
  • the electromagnet 613 in 600 is powered off, and the heating mechanism 620 descends under the action of the elastic force of the compression spring 616 and its own gravity, so that the pressing block body 618 presses the upper surface of the test strip assembly 700 .
  • Heating process the first heating element 520 of the tray assembly 500 is energized and operated to heat the tray body 510; the second temperature sensing element 623 detects the temperature of the tray body 510, and the control unit controls the power of the first heating element 520 to make The temperature of the tray body 510 is maintained at about 37° C.; the heat is transferred to the lower surface of the test strip assembly 700 through the test strip assembly fixing groove 513 of the tray body 510 .
  • the first over-temperature protection switch 522 automatically powers off the first heating element 520 to avoid damage to the tray assembly 500; 611 ; under the cooperative action of the second temperature sensing element 623 and the second over-temperature protection switch 622 , the temperature of the first bracket 611 is maintained at about 37° C., thereby heating the upper surface of the test strip assembly 700 .
  • the test strip assembly 700 can be heated and the temperature can be maintained at about 37° C., thereby reducing the influence of the ambient temperature on the test results.
  • the scanner 310 After the tray assembly 500 is retracted to the designed position (the optical coupler 250 is used to detect the moving position of the tray assembly 500 ), the scanner 310 is powered on and works. The scanner 310 scans the encoded information (eg, one-dimensional code) on the test strip assembly 700 and transmits it to the control unit. The control unit identifies the type of the test strip assembly 700 to be tested through the coded information, and controls the corresponding LED lights to work with electricity.
  • the encoded information eg, one-dimensional code
  • the light emitted by the LED lamp assembly in the optical path assembly is partially absorbed after passing through the reagent film layer 740, and the remaining light is reflected in the diffuse reflection layer; the reflected light is absorbed by the photodiode after passing through the reagent film layer 740.
  • the biochemical analyzer 10 calculates the parameter value of the corresponding parameter of the sample to be tested by the absorbance.
  • the biochemical analyzer 10 of this embodiment has at least the following technical effects:
  • test paper assembly 700 The upper and lower surfaces of the test paper assembly 700 are heated to achieve rapid heating of the test paper and a constant temperature of about 37°C;
  • the rear end of the tray assembly 500 is equipped with a calibration object 530. During the process of placing the test strip assembly 700 and injecting the sample, the light intensity of each group of LED lights of the light source assembly 400 can be calibrated at the same time;
  • the third heating element 440 in the optical path assembly 400 can heat the LED lamp assembly, etc., so that the LED lamp assembly is kept at a constant temperature of about 37°C, thereby reducing the influence of changes in ambient temperature on the test results;
  • the structure of the biochemical analyzer 10 is simple, the test results are relatively reliable, the test time is short, and the cost is low.
  • the entire biochemical analyzer 10 needs neither a complicated liquid circuit structure nor a complicated heat preservation structure. Not only that, the testing process is highly automated—the user only needs to put in the test strip and complete the sample injection, and the subsequent testing work can be automatically completed by the biochemical analyzer 10 .
  • the optical path component of the biochemical analyzer in the embodiment of the present application has three LED lamps with different wavelengths and a photodiode, and adopts the photoelectric colorimetric principle based on the Lambert Beer absorption theory to measure body fluids (containing trace amounts of whole blood, plasma, serum, etc.) or urine, etc.) GLU (glucose), TP (total protein), AST (aspartate aminotransferase), GGT (glutamyl aminotransferase), CHE (cholinesterase) and CREA (creatinine) ) and other different parameters.
  • GLU glucose
  • TP total protein
  • AST aspartate aminotransferase
  • GGT glutyl aminotransferase
  • CHE cholinesterase
  • CREA creatinine

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Abstract

一种生化分析仪（10），用于对试纸上的待测样品进行分析测试，包括光路组件（400）、第一加热组件（500）、第二加热组件（600）以及壳体组件（100）。试纸组件（700）包括试纸；光路组件（400）包括光源组件，光源组件用于发出光线而照射试纸；第一加热组件（500）包括托盘本体（510）以及第一加热元件（520），托盘本体（510）用于放置试纸，第一加热元件（520）用于加热试纸的下表面；第二加热组件（600）包括第二加热元件（621），第二加热元件（621）用于加热试纸的上表面；光路组件（400）位于壳体组件（100）内。这种生化分析仪能够降低环境温度对于测试结果的影响。

Description

生化分析仪
本申请要求在2020年09月09日提交中国专利局、申请号为202010938594.6的中国专利申请的优先权，该申请的全部内容通过引用结合在本申请中。
技术领域
本申请涉及分析测试技术领域，尤其涉及一种生化分析仪。
背景技术
生化分析仪又称生化仪，是用于实现多个样品或多个项目的检测及反馈的生化检验检测装置。生化仪的检测原理是基于光电比色原理检测样品中的某种特征化学成分。由于生化仪具有检测速度快、准确性高以及消耗剂量少等优点，现已在医院、防疫站以及检疫站等场所广泛应用。
目前的生化仪主要包括加样系统以及软件系统等。然而，现有市场上的生化仪的测试结果通常受环境温度的影响较大。
发明内容
本申请的主要目的在于提供一种生化分析仪，使其测试结果较少受环境温度的影响。
本申请实施例提供了一种生化分析仪。所述生化分析仪用于对试纸上的待测样品进行分析测试。所述生化分析仪包括：
光路组件，所述光路组件包括光源组件，所述光源组件用于发出光线而照射所述试纸；
第一加热组件，所述第一加热组件包括托盘本体以及第一加热元件，所述托盘本体用于放置所述试纸，所述第一加热元件用于加热所述试纸的下表面；
第二加热组件，所述第二加热组件包括第二加热元件，所述第二加热元件用于加热所述试纸的上表面；以及
壳体组件，所述光路组件位于所述壳体组件内。
本实施例中的生化分析仪对试纸的上下两表面加热，能够将试纸加热到所需的工作温度，从而降低环境温度对于测试结果的影响。
在一些具体实施例中，所述第一加热组件具有第一温度传感元件以及与所述第一温度传感元件电连接的第一过温保护开关，所述第二加热组件具有第二 温度传感元件以及与所述第二温度传感元件电连接的第二过温保护开关，所述第一温度传感元件用于检测所述试纸的下表面的温度，所述第二温度传感元件用于检测所述试纸的上表面的温度。温度传感元件检测到试纸上下表面的温度超出所需工作温度，温度保护开关可中止加热元件的工作，从而确保试纸的工作温度基本处于恒温状态。
在一些具体实施例中，所述第一温度传感元件通过导热硅胶安装于所述托盘本体上；所述第二加热组件还包括加热元件固定支架，所述第二温度传感元件通过导热硅胶安装于所述加热元件固定支架上。导热硅胶能够加快热量的传递。
在一些具体实施例中，所述托盘本体还具有用于容纳定标物的储存结构，所述定标物用于所述光源组件的光强校准。托盘组件储存了设计了定标物，在放置试纸组件及将待测样品进样的同时，即可对光源组件的每组LED灯进行光强校准，从而缩短测试时间并提高测试可靠性。
在一些具体实施例中，所述储存结构包括第一固定槽以及第一固定盖，所述第一固定槽用于容纳所述定标物，所述第一固定盖可拆卸地固定连接于所述第一固定槽的顶部。固定槽与固定盖的可拆卸地连接方式，使得定标物的储存更加可靠，并且方便定标物的取放。
在一些具体实施例中，所述试纸组件还包括上下布置的第一支撑元件以及第二支撑元件，所述试纸位于所述第一支撑元件以及所述第二支撑元件之间，所述第一支撑元件具有第一通孔，所述第二支撑元件具有第二通孔。第一支撑元件与第二支撑元件分别位于试纸本体的上方和下方，并夹紧试纸本体。用户通过两个支撑元件可夹持整个试纸组件，结构简单、成本较低且使用方便。
在一些具体实施例中，所述试纸具有试剂膜层以及渗透膜层，所述渗透膜层位于所述试剂膜层与所述第一支撑元件之间，所述试剂膜层涂覆有化学试剂。该化学试剂能够使得入射光经过试剂膜层后被部分地吸收。渗透膜层用于将液体形式的待测样品由上至下渗透至下一层。
在一些具体实施例中，所述生化分析仪还包括扫描组件以及控制单元，所述试纸上具有编码信息，所述扫描组件用于扫描所述编码信息以识别所述试纸的类型并传送至所述控制单元，所述控制单元用于控制所述光源组件的通断状态。一维码、二维码以及三维码都可由机器设备读取，从而能够识别试纸的类型。
在一些具体实施例中，所述光源组件包括波长为405nm的第一LED灯组件、波长为550nm的第二LED灯组件以及波长为610nm的第三LED灯组件。本实 施例中的生化分析仪包括三种不同的波长，丰富了该生化分析仪的可测试对象。
在一些具体实施例中，所述壳体组件为封闭的结构。封闭结构的壳体组件为壳体组件内部的各组件提供安装位置，并隔离外界光线以避免外界光线对光路组件造成的影响。
附图说明
图1为本申请实施例中的壳体组件的结构示意图；
图2为本申请实施例中的进出舱组件的组装结构示意图；
图3为本申请实施例中的进出舱组件的分解结构示意图；
图4为本申请实施例中的扫描组件的结构示意图；
图5为本申请实施例中的光路组件的组装结构示意图；
图6为本申请实施例中的光路组件的分解结构示意图；
图7为本申请实施例中的光路组件的剖视图；
图8为本申请实施例中的托盘组件的组装结构示意图；
图9为本申请实施例中的托盘组件的分解结构示意图；
图10为本申请实施例中的压块组件的组装结构示意图；
图11为本申请实施例中的压块组件的剖视图；
图12为本申请实施例中的壳体组件的分解结构示意图；
图13为本申请实施例中的试纸组件的分解结构示意图；
图14为本申请实施例中的试纸组件的组装结构示意图。
附图标记：
10-生化分析仪；
100-壳体组件；
200-进出舱组件；210-第三支架；220-步进电机；221-第一丝杆部，222-第二丝杆部，223-固定法兰座；230-托盘转接元件；240-导轨，241-导轨安装座；250-光耦；260-轴承；270-光耦挡片；
300-扫描组件，310-扫描仪，320-扫描仪固定座；
400-光路组件；410-第一LED灯组件，411-第一LED灯，412-第一套筒，413-第一凸镜，414-第一PCBA板，415-第一凸镜固定盖；420-第二LED灯组件；430-第三LED灯组件；440-第三加热元件；461-第一固定座；470-光电二极管；
500-托盘组件；510-托盘本体，511-托盘上盖，512-托盘下盖，513-试纸组件固定槽；520-第一加热元件，521-第一温度传感元件；522-第一过温保护开关；530-定标物，531-定标物储存槽，532-定标物固定盖；541-隔热垫；
600-压块组件；610-致动机构；611-第一支架，6111-第一支架上固定盖，6112-第一支架下固定盖；612-第二支架；613-电磁铁；614-导轴，6141-导轴螺纹头部；615-直线轴承，6151-轴承固定盖，6152-轴承缓冲圈；616-压缩弹簧；617-电磁铁连接元件；618-压块本体；620-加热机构；621-第二加热元件；622-第二过温保护开关；623-第二温度传感元件；
700-试纸组件；710-第一支撑元件，711-第一通孔；720-第二支撑元件，721-第二通孔；730-渗透膜层；740-试剂膜层；750-标识码层。
具体实施方式
下面详细描述本申请的实施方式，实施方式的示例在附图中示出，其中自始至终相同或类似的标号表示相同或类似的元件或具有相同或类似功能的元件。下面通过参考附图描述的实施方式是示例性的，仅用于解释本申请，而不能理解为对本申请的限制。本申请各实施例之间的技术方案可以相互结合，但是应当以本领域普通技术人员能够实现为基础。
在本申请的描述中，需要理解的是，术语“上”、“下”、“前”、“后”以及“左”、“右”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
在本申请的描述中，需要说明的是，除非另有明确的规定和限定，术语“连接”应做广义理解，例如，可以是固定连接和活动连接，也可以是可拆卸连接和不可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接或可以是相互间的通讯。而“固定连接”包括可拆卸连接、不可拆卸连接以及一体地连接等。
在本申请中，涉及类似“第一”或“第二”等用语仅用于描述目的，不能理解为指示或暗示其相对重要性或者隐含指明所指示的技术特征的数量。在本申请中，涉及类似“竖直”以及“水平”并非仅指绝对竖直以及绝对水平，也包括在本领域可接受的大致竖直以及大致水平。
本申请实施例提供了一种生化分析仪10。请参阅图1至图14，生化分析仪10用于对试纸上的待测样品进行分析测试。生化分析仪10包括光路组件400、 第一加热组件、第二加热组件以及壳体组件100。
光路组件400包括光源组件，该光源组件用于发出光线而照射试纸。
第一加热组件包括托盘本体510以及第一加热元件520，托盘本体510用于放置试纸，第一加热元件520用于加热试纸的下表面。具体地，如图8至图9所示，第一加热组件为托盘组件500。
第二加热组件包括第二加热元件621，第二加热元件621用于加热试纸的上表面。具体地，如图10至图12所示，第二加热组件为压块组件600。
光路组件400位于壳体组件100内。
具体地，请参阅图1，壳体组件100为箱体结构。壳体组件100包括底板、上封板、右封板以及左封板(左封板也作为左电机支架，即图2至图3中的第三支架210)，上述各板件通过螺纹连接元件行程封闭的箱体。图1还示出，第一丝杆部221伸出壳体组件100之外。
本实施例中的生化分析仪对试纸的上下两表面加热，能够将试纸加热到所需的工作温度，从而降低环境温度对于测试结果的影响。
在一些具体实施例中，请参阅图8至图12，第一加热组件具有第一温度传感元件521以及与第一温度传感元件521电连接的第一过温保护开关522，第二加热组件具有第二温度传感元件623以及与第二温度传感元件623电连接的第二过温保护开关622，第一温度传感元件521用于检测试纸的下表面的温度，第二温度传感元件623用于检测试纸的上表面的温度。温度传感元件检测到试纸上下表面的温度超出所需工作温度，温度保护开关可中止加热元件的工作，从而确保试纸的工作温度基本处于恒温状态。
在一些具体实施例中，第一温度传感元件521通过导热硅胶(图中未示出)安装于托盘本体510上；第二加热组件还包括加热元件固定支架，第二温度传感元件623通过导热硅胶(图中未示出)安装于该加热元件固定支架上。导热硅胶具有较好的导热性以及良好的电绝缘性，并且还具有较宽的使用温度。导热硅胶能够加快热量的传递。
具体地，如图8至图9所示，第一加热组件为托盘组件500；如图10至图12所示，第二加热组件为压块组件600，加热元件固定支架为第一支架611。
在一些具体实施例中，请参阅图8至图9，托盘本体500还具有用于容纳定标物530的储存结构，定标物530用于光源组件的光强校准。托盘组件储存了设计了定标物，在放置试纸组件及将待测样品进样的同时，即可对光源组件的每组LED灯进行光强校准，从而缩短测试时间并提高测试可靠性。
在一些具体实施例中，请参阅图8至图9，该储存结构包括第一固定槽以及第一固定盖，第一固定槽用于容纳定标物530，第一固定盖可拆卸地固定连接于第一固定槽的顶部。具体地，第一固定槽为定标物储存槽531，第一固定盖为定标物固定盖532。固定槽与固定盖的配合方式，使得定标物的储存更加可靠；可拆卸地连接方式，方便于定标物的取放。
在一些具体实施例中，请参阅图8至图9，生化分析仪10中的第一加热组件即为托盘组件500。托盘组件500包括托盘本体510、托盘上盖511、托盘下盖512、定标物固定盖532、第一温度传感元件521、第一过温保护开关522、第一加热元件520以及隔热垫541。托盘本体510内设置有试纸组件固定槽513以及定标物储存槽531。定标物储存槽531内储存有定标物530。
托盘组件500的装配过程：借助于螺纹连接元件，定标物固定盖532将定标物530固定至托盘本体510的定标物储存槽531内；第一温度传感元件521、第一过温保护开关522以及第一加热元件520三者均涂有导热硅胶并分别装配至托盘本体510的相应位置；托盘上盖511以及托盘下盖512通过螺纹连接元件固定至托盘本体510上，且两者整体包裹托盘本体510的外表面,仅将试纸组件固定槽513裸露，以便减少热量损失；托盘组件500通过螺纹连接元件固定至进出舱组件200上(具体而言，通过螺纹连接元件固定至托盘转接元件230的第三安装面)，在托盘本体510与托盘转接元件230两者之间设置了隔热垫541，使得托盘本体510与托盘转接元件230两者实现有效的热隔绝，从而减少热量损失。
托盘组件500的作用在于：固定并加热试纸组件700的下表面(通过第一加热元件520以及第一温度传感元件521的协同作用，加热托盘本体510至设计温度，并通过托盘本体510的试纸组件固定槽513将热量传递至试纸组件700的下表面)；储存定标物530，用于生化分析仪10的光路定标。
在一些具体实施例中，请参阅图10至图12，生化分析仪10中的第二加热组件即为压块组件600。如图10至图12所示，压块组件600大致可分为加热机构620、致动机构610、压块本体618以及第二支架612。加热机构620大致包括第一支架611、第二温度传感元件623、第二加热元件621、第二过温保护开关622、第一支架上固定盖6111、第一支架下固定盖6112以及电磁铁连接元件617。第二温度传感元件623可采用温度探头。第一支架611上设置有压块本体618。致动机构610包括压缩弹簧616、轴承缓冲圈6152、直线轴承615、轴承固定盖6151、电磁铁613以及导轴614。导轴614包括导轴螺纹头部6141。
压块组件600的装配过程可简要描述如下：(1).加热机构620：第二温度传感元件623、第二加热元件621以及第二过温保护开关622三者通过涂覆导热 硅胶装配至第一支架611相应的位置；第一支架上固定盖6111、第一支架下固定盖6112以及电磁铁连接元件617三者采用塑料材质，并且三者通过螺纹连接元件固定至第一支架611上，起到包裹加热元件以及隔热的作用，防止热量散发。
(2).致动机构610：电磁铁613与电磁铁连接元件617的卡槽装配；轴承固定盖6151通过螺纹连接元件将轴承缓冲圈6152以及直线轴承615固定至第二支架612上；导轴614穿过直线轴承615以及压缩弹簧616，且导轴614通过导轴螺纹头部6141锁紧至第一支架611的螺孔，实现导轴614与致动机构610的导通，起到导向及弹性压紧的作用。
压块组件600作用如下：整个生化分析仪工作时对试纸的上表面加热，且在进出舱组件200工作时压块组件600自动抬起，以免损伤托盘组件500。
在一些具体实施例中，请参阅图13至图14，试纸组件700还包括上下布置的第一支撑元件710以及第二支撑元件720，试纸位于第一支撑元件710以及第二支撑元件720之间，第一支撑元件710具有第一通孔711，第二支撑元件720具有第二通孔721。
第一支撑元件与第二支撑元件分别位于试纸本体的上方和下方，并夹紧试纸本体。用户通过两个支撑元件可夹持整个试纸组件，结构简单、成本较低且使用方便。
在一些具体实施例中，请参阅图13至图14，试纸具有试剂膜层740以及渗透膜层730，渗透膜层730位于试剂膜层740与第一支撑元件720之间，试剂膜层740涂覆有化学试剂。该化学试剂能够入射光经过试剂膜层后被部分地吸收，而未被吸收的光线到达渗透膜层后产生漫反射，光线反射出试纸组件。渗透膜层用于将液体形式的待测样品由上至下渗透至下一层。渗透膜层可选用亲水性材料，从而有利于待测样品的渗透扩散。
具体地，请参阅图13至图14，试纸组件700包括第二支撑元件720、试剂膜层740、渗透膜层730、第一支撑元件710以及标识码层750。试纸组件700为层叠结构，由上至下依次为第一支撑元件710、渗透膜层730、试剂膜层740以及第二支撑元件720。第一支撑元件710具有第一通孔711，第一通孔711用于进样；第二支撑元件720具有第二通孔721，第二通孔721用于使得光路组件发出的光线通过并返回。
第二支撑元件720的表面可划分为第一区域以及第二区域，其中第一区域与第一支撑元件710相重合，此外第二支撑元件720还具有超出第一支撑元件710而无法重合的第二区域。标识码层750贴附于第二区域。具体地，标识码层 750可以是条码标贴层。
试剂膜层740涂覆有不同的化学试剂，该化学试剂使入射光经过试剂膜层740被部分吸收，未被吸收的入射光到达渗透膜层730的下表面后反射出试纸组件。在试纸上设计了标识码层750，用于区分不同的试纸。
试纸组件700的工作过程可简要描述如下：待测样品从第一支撑元件710的第一通孔711滴入后，待测样品通过渗透膜层730扩散渗透到整个膜层，并在渗透膜层730的下表面形成漫反射层；光路组件中的LED灯组件发出的光线经试剂膜层740后被部分地吸收，剩余的光线则在漫反射层中被反射；被反射光线透过试剂膜层740后则被光电二极管吸收。光吸收的程度以吸光度来衡量，相关公式为：吸光度＝-lg(反射光/入射光)，生化分析仪10通过吸光度计算出待测样品的相应参数的参数值。
在一些具体实施例中，请参阅图4，生化分析仪10还包括扫描组件300以及控制单元(图中未示出)，试纸上具有编码信息，扫描组件300用于扫描该编码信息以识别试纸的类型并传送至控制单元，控制单元用于控制所述光源组件的通断状态。
具体地，如图4所示，扫描组件300包括扫描仪310以及扫描仪固定座320。扫描仪310通过螺纹连接元件固定至扫描仪固定座320上，而扫描仪固定座320通过螺纹连接元件固定至壳体组件100的上封板。生化分析仪工作时，扫描仪310对试纸上的编码信息(例如一维码)进行扫描，从而识别试纸的参数类型并传送到生化分析仪的控制单元(例如CPU)，以便控制LED灯的通断状态。
编码包括一维码、二维码以及三维码中的至少一种。三维码是通过特定的算法并结合图片整体的色彩内容，将由文本编译而得的二进制数字串与图像信息编码为一组可通过特定规则解读的阵列。一维码、二维码以及三维码都可由机器设备读取，从而能够识别试纸的类型。具体地，编码可选用一维码或二维码。
在一些具体实施例中，请参阅图1，壳体组件100为封闭的结构。封闭结构的壳体组件为壳体组件内部的各组件提供安装位置，并隔离外界光线以避免外界光线对光路组件造成的影响。应当指出，封闭结构的壳体组件并不意味着生化分析仪全部的工作组件都完全位于壳体组件内部，部分元件位于壳体组件之外，仍然能够满足隔离外界光线的要求。
在一些具体实施例中，请参阅图5至图7，生化分析仪10还具有光路组件400。光路组件400作为生化分析仪10的核心部件，用于基于光电比色原理实现试纸的测试。如图5至图7所示，光路组件400包括第一LED灯组件410(波 长为405nm)、第二LED灯组件420(波长为550nm)、第三LED灯组件430(波长为610nm)、第三加热元件440、光电二极管470以及第一固定座461(铝基材材质)。
不同的待测样品成分各自有其特定的波长，在该特定的波长处的吸光度通常与该成分的浓度正相关，因而测试分析多种成分的浓度，需要采用不同的波长。本申请实施例中的生化分析仪包括三种不同的波长，丰富了该生化分析仪的可测试对象。
光路组件400的每个元件均通过螺纹连接元件固定至第一固定座461上。第一LED灯组件410、第二LED灯组件420以及第三LED灯组件430的结构相同。以第一LED灯组件410为例，第一LED灯组件410均包括第一LED灯411、第一套筒412、第一凸镜413、第一凸镜固定盖415以及第一PCBA板414。第一套筒412由铝基材材质制成，第一套筒412内设有透光孔。
光源组件包括波长为405nm的第一LED灯组件、波长为550nm的第二LED灯组件以及波长为610nm的第三LED灯组件。不同的待测样品成分各自有其特定的波长，在该特定的波长处的吸光度通常与该成分的浓度正相关，因而测试分析多种成分的浓度，需要采用不同的波长。
光路组件400的工作过程可简要描述如下：生化分析仪10通过扫描组件300识别试纸的类型后，控制相应的LED灯通电工作。如图7所示，以第一LED灯组件410为例，LED灯产生的光线透过第一套筒412的透光孔照射到第一凸镜413的表面，并沿第一凸镜413折射产生平行光束。图7中，箭头的方向表示光路的方向。如图7所示，平行光束照射到托盘本体510上的试纸试剂膜层740上，试剂膜层740吸收部分光线；剩余的光线反射到光电二极管470。
通过比较作为光源的LED灯发出的光束的光强与光电二极管470吸收的光束的光强的差异，基于光电比色原理，生化分析仪10换算出待测样品的相应参数值，从而完成待测样品的测试。
研究发现，在不同的环境温度下，LED灯在同等的电流下产生的光束的光强也会不同。为解决该问题，本申请的实施例中的生化分析仪10的光路组件400还设计了第三加热元件440。第三加热元件440由铝基材材质制成，第三加热元件440内设加热电路以及第三温度传感元件(图中未示出)。第三温度传感元件可采用温度探头。第三加热元件440的背面涂覆有导热硅胶，第三加热元件440通过螺纹连接元件固定至第一固定座461的上表面。当第三加热元件440通电工作后，第三加热元件440加热第一固定座461，并将热量传递至套筒以及LED灯上，从而使光路组件400的工作温度稳定在所需温度(例如37℃)左右，从而降低外界环境温度对LED灯的光强影响。
在一些具体实施例中，请参阅图2至图3，生化分析仪10还具有进出舱组件200。进出舱组件200的作用在于连接托盘组件500，实现托盘组件500自动地出舱以及自动地进舱的动作。如图2至图3所示，进出舱组件200包括步进电机220、托盘转接元件230、光耦250、导轨240以及轴承260。光耦250的数目为两个。步进电机220、两个光耦250以及导轨240通过螺纹连接元件固定至壳体组件100的左封板(也即第三支架210)上。步进电机220上设置有固定法兰座223，步进电机220还连接有第一丝杆部221及第二丝杆部222，第一丝杆部221及第二丝杆部222同轴。导轨240设有导轨安装座241，托盘转接元件230的三个相互垂直的表面为安装面，托盘转接元件230上还设有光耦挡片270。托盘转接元件230上设计有三个安装面，第一安装面通过螺纹连接元件固定至导轨安装座241上，第二安装面通过螺纹连接元件与固定法兰座223固定连接，第二安装面则与托盘组件500固定连接。
在一些实施例中，生化分析仪10包括前述实施例中描述的壳体组件100、进出舱组件200、扫描组件300、光路组件400、托盘组件500、压块组件600以及试纸组件700。上述各组件的结构及组成不再赘述。
可以理解的是，试纸组件700可以作为独立于生化分析仪10的单独部件，即在一些实施例中，生化分析仪10也可以不包括试纸组件700。
以下文字将描述具有上述各组件的生化分析仪10的工作过程：
(1).托盘组件500自动地伸出：压块组件600中的电磁铁613通电工作，带动加热机构620上升，使得压块本体618脱离托盘组件500的表面；进出舱组件200的步进电机220工作，带动托盘组件500伸出至设计位置(光耦250用于检测托盘组件500的运动位置)；
(2).定标过程：第三加热元件440通电工作，使得光路组件400的整体温度保持在37℃左右；第一LED灯组件410、第二LED灯组件420以及第三LED灯组件430分别点亮，发出的光线通过试纸组件700后反射至光电二极管470，从而可对每组LED灯进行光强校准。
(3).试纸组件700的放置以及进样过程：试纸组件700放置至托盘组件500的试纸组件固定槽513内，采用注射器或移液枪等工具将待测样品的液体滴入试纸组件700的第一通孔711内，待测样品的液体将自动扩散至整个渗透膜层730。
(4).托盘组件500自动地缩回：进出舱组件200的步进电机220工作，带动托盘组件500缩回至设计位置(光耦250用于检测托盘组件500的运动位置)；压块组件600中的电磁铁613断电，加热机构620在压缩弹簧616的弹 力及自身重力的作用下下降，使得压块本体618压紧试纸组件700的上表面。
(5).加热过程：托盘组件500的第一加热元件520通电工作，加热托盘本体510；第二温度传感元件623检测托盘本体510的温度，控制单元控制第一加热元件520的功率，使托盘本体510的温度保持在37℃左右；通过托盘本体510的试纸组件固定槽513，将热量传递至试纸组件700的下表面。
当托盘本体510的温度过高时，第一过温保护开关522自动对第一加热元件520断电，以免损坏托盘组件500；压块组件600的第二加热元件621通电工作，加热第一支架611；在第二温度传感元件623以及第二过温保护开关622的协同作用下，第一支架611的温度保持在37℃左右，从而加热试纸组件700的上表面。
通过上下表面双面加热的方式，试纸组件700可以能够被加热且温度保持在37℃左右，从而减小环境温度对于测试结果的影响。
(6).测试过程：托盘组件500缩回至设计位置后(光耦250用于检测托盘组件500的运动位置)，扫描仪310通电工作。扫描仪310对试纸组件700上的编码信息(例如一维码)进行扫描并传送至控制单元。控制单元通过编码信息识别待测的试纸组件700的类型，并控制相应的LED灯通电工作。
光路组件中的LED灯组件发出的光线经试剂膜层740后被部分地吸收，剩余的光线则在漫反射层中被反射；被反射光线透过试剂膜层740后则被光电二极管吸收。光吸收的程度以吸光度来衡量，相关公式为：吸光度＝-lg(反射光/入射光)，生化分析仪10通过吸光度计算出待测样品的相应参数的参数值。
本实施例的生化分析仪10至少具有如下技术效果：
(1).试纸组件700上下两表面被加热，实现试纸快速加热并恒温至37℃左右；
(2).托盘组件500的后端配备了定标物530，在放置试纸组件700及进样的过程中，同时可对光源组件400的每组LED灯进行光强校准；
(3).光路组件400中的第三加热元件440能够加热LED灯组件等，使LED灯组件恒温至37℃左右，从而减小环境温度的变化对测试结果的影响；
(4).生化分析仪10的结构简单，测试结果较为可靠，测试时间较短，成本较低。整个生化分析仪10既无需复杂的液路结构，也无需复杂的保温结构。不仅如此，测试过程具有高度的自动化——使用者只需放入试纸及完成进样，后续的测试工作即可由生化分析仪10自动完成。
本申请实施例中的生化分析仪的光路组件中具有三种不同波长的LED灯及 一个光电二极管，采用基于朗伯比尔吸收理论的光电比色原理来测量体液(含有微量全血、血浆、血清或尿液等)中的GLU(葡萄糖)、TP(总蛋白)、AST(天门冬氨酸氨基转移酶)、GGT(谷氨酰氨基转移酶)、CHE(胆碱酯酶)以及CREA(肌酐)等不同参数。

Claims (10)

  1. 一种生化分析仪，所述生化分析仪用于对试纸上的待测样品进行分析测试，其中，所述生化分析仪包括：
    光路组件，所述光路组件包括光源组件，所述光源组件用于发出光线而照射所述试纸；
    第一加热组件，所述第一加热组件包括托盘本体以及第一加热元件，所述托盘本体用于放置所述试纸，所述第一加热元件用于加热所述试纸的下表面；
    第二加热组件，所述第二加热组件包括第二加热元件，所述第二加热元件用于加热所述试纸的上表面；以及
    壳体组件，所述光路组件位于所述壳体组件内。
  2. 根据权利要求1所述的生化分析仪，其中，所述第一加热组件具有第一温度传感元件以及与所述第一温度传感元件电连接的第一过温保护开关，所述第二加热组件具有第二温度传感元件以及与所述第二温度传感元件电连接的第二过温保护开关，所述第一温度传感元件用于检测所述试纸的下表面的温度，所述第二温度传感元件用于检测所述试纸的上表面的温度。
  3. 根据权利要求2所述的生化分析仪，其中，所述第一温度传感元件通过导热硅胶安装于所述托盘本体上；所述第二加热组件还包括加热元件固定支架，所述第二温度传感元件通过导热硅胶安装于所述加热元件固定支架上。
  4. 根据权利要求1所述的生化分析仪，其中，所述托盘本体还具有用于容纳定标物的储存结构，所述定标物用于所述光源组件的光强校准。
  5. 根据权利要求4所述的生化分析仪，其中，所述储存结构包括第一固定槽以及第一固定盖，所述第一固定槽用于容纳所述定标物，所述第一固定盖可拆卸地固定连接于所述第一固定槽的顶部。
  6. 根据权利要求1所述的生化分析仪，其中，所述试纸组件还包括上下布置的第一支撑元件以及第二支撑元件，所述试纸位于所述第一支撑元件以及所述第二支撑元件之间，所述第一支撑元件具有第一通孔，所述第二支撑元件具有第二通孔。
  7. 根据权利要求6所述的生化分析仪，其中，所述试纸具有试剂膜层以及渗透膜层，所述渗透膜层位于所述试剂膜层与所述第一支撑元件之间，所述试剂膜层涂覆有化学试剂。
  8. 根据权利要求1所述的生化分析仪，其中，所述生化分析仪还包括扫描组件以及控制单元，所述试纸上具有编码信息，所述扫描组件用于扫描所述编码信息以识别所述试纸的类型并传送至所述控制单元，所述控制单元用于控制所 述光源组件的通断状态。
  9. 根据权利要求1所述的生化分析仪，其中，所述光源组件包括波长为405nm的第一LED灯组件、波长为550nm的第二LED灯组件以及波长为610nm的第三LED灯组件。
  10. 根据权利要求1至9中任一项所述的生化分析仪，其中，所述壳体组件为封闭的结构。
PCT/CN2020/138008 2020-09-09 2020-12-21 生化分析仪 WO2022052364A1 (zh)

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