In-vitro analytical diagnostic test device and optical detection module

Abstract

The present application relates to a kind of in-vitro analysis diagnosis detection device and optical detection module, optical detection module includes: first support, multiple optical detection monomers and moving mechanism. Multiple optical detection monomers are sequentially spaced on the first support, and optical detection monomer is used to carry out fluorescence detection to sample liquid in PCR chamber. Moving mechanism is connected with the first support, and moving mechanism is used to drive the first support to move, so that multiple optical detection monomers sequentially move to the position opposite to PCR chamber. Relative to the conventional optical detection structure, on the one hand, drive multiple optical detection monomers to sequentially move to the position opposite to PCR chamber along vertical direction or horizontal direction and carry out fluorescence detection, the switching speed is faster, more convenient, can improve fluorescence detection efficiency;On the other hand, the overall structure of optical detection module is relatively simple, and multiple optical detection monomers are independent of each other, can facilitate maintenance work, and service life is longer.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of in vitro analysis and diagnosis, in particular to an in vitro analysis and diagnosis detection device and an optical detection module. BACKGROUND

[0002] The POCT (point-of-care testing) integrated instrument system for fast detection of pathogens based on PCR (polymerase chain reaction) technology is suitable for analyzing sample types such as nasopharyngeal swabs, sputum, urine, feces, cervical / vaginal swabs, blood, cerebrospinal fluid, skin, wound swabs, etc. The body fluid sample is added to a disposable reagent cartridge, the cartridge is placed into the instrument system, and after nucleic acid amplification, detection, calculation and result printing output, the entire analysis process is fully automated, and personnel without professional training can easily use it and obtain reliable and accurate detection results. The instrument and reagent are suitable for single or multiple detection of pathogen DNA or RNA that infects the human body.

[0003] In the field of biotechnology, nucleic acid extraction using a centrifugal column method or a magnetic bead method generally requires four steps of lysis, binding, washing, and elution, plus subsequent steps of nucleic acid molecule hybridization, polymerase chain reaction, and molecular detection. Molecular detection technology is developing towards accuracy, convenience, sensitivity, automation and integration. However, due to the complexity of molecular detection technology itself, there are few fully automated instrument platforms from sample to result, the structure for optical detection of samples in the PCR chamber is relatively complex, and the detection efficiency is low. SUMMARY

[0004] Therefore, it is necessary to overcome the defects of the prior art and provide an in vitro analysis and diagnosis detection device and an optical detection module, which can simplify the structure and improve the detection efficiency.

[0005] The technical scheme is as follows: an optical detection module, comprising: a first support, a plurality of optical detection monomers, a plurality of the optical detection monomers are sequentially and spacedly arranged on the first support, the optical detection monomers are used for fluorescence detection of sample liquid in a PCR chamber; a moving mechanism connected with the first support, the moving mechanism is used for driving the first support to move, so that a plurality of the optical detection monomers are sequentially moved to a position opposite to the PCR chamber.

[0006] The optical detection module described above, when the PCR chamber needs to be detected by fluorescence, the first support is driven to move by the moving mechanism, so that the plurality of optical detection monomers are sequentially moved to the position opposite to the PCR chamber, and the PCR chamber is sequentially detected by fluorescence. Compared with the traditional optical detection structure, on the one hand, the way of driving the plurality of optical detection monomers to move along the vertical direction or the horizontal direction to the position opposite to the PCR chamber for fluorescence detection has faster switching speed, is more convenient, and can improve the fluorescence detection efficiency; on the other hand, the overall structure of the optical detection module is relatively simple, and the plurality of optical detection monomers are independent of each other, so that the maintenance work can be facilitated, and the service life is longer.

[0007] In one of the embodiments, the plurality of optical detection monomers are sequentially and spacedly arranged on the first support along a first direction, and the moving mechanism is used to drive the first support to move along the first direction; the first direction is a vertical direction, a horizontal direction or a direction having an included angle with the vertical direction.

[0008] In one of the embodiments, the moving mechanism comprises a second support, a first motor, a first driving wheel, a second driving wheel and a transmission element connecting the first driving wheel and the second driving wheel; the first motor, the first driving wheel and the second driving wheel are arranged on the second support; the rotating shaft of the first motor is connected with the first driving wheel, and is used to drive the first driving wheel to rotate; the transmission element is also connected with the first support; and the first support is slidingly arranged on the second support.

[0009] In one of the embodiments, the optical detection module further comprises a first sensor and a first trigger matched with the first sensor; the first sensor is arranged on the first support, and the first trigger is arranged on the second support.

[0010] In one of the embodiments, the plurality of optical detection monomers each comprise a light source, and the light sources of the plurality of optical detection monomers are light sources of different wave bands.

[0011] In one of the embodiments, the first support is provided with a plurality of light collecting channels corresponding to the plurality of optical detection units, and the optical detection units are arranged in the light collecting channels correspondingly; the light collecting channels include a first channel and a second channel, the second channel is vertically communicated with the middle part of the first channel, and the light source is arranged on the end of the second channel away from the first channel; the optical detection unit further includes a first lens, a dichroic mirror, a second lens, a third lens and a fluorescence detector, the first lens is arranged on the inner wall of the second channel, the dichroic mirror is arranged obliquely on the middle part of the first channel, the second lens, the dichroic mirror, the third lens and the fluorescence detector are arranged on the inner wall of the first channel in sequence, the second lens is located at one end of the first channel close to the PCR chamber, and the fluorescence detector is located at one end of the first channel away from the PCR chamber.

[0012] In one of the embodiments, the optical detection unit further includes a first filter and a second filter, the first filter is arranged on the inner wall of the second channel, and the first filter is located between the first lens and the dichroic mirror; the second filter is arranged on the inner wall of the first channel, and the second filter is located between the second lens and the dichroic mirror.

[0013] An in vitro analysis and diagnosis detection device, comprising the optical detection module.

[0014] The in vitro analysis and diagnosis detection device described above, when the fluorescence detection of the PCR chamber is needed, the first support is driven to move by the moving mechanism, so that the plurality of optical detection units are moved to the positions opposite to the PCR chamber in sequence, and the fluorescence detection of the PCR chamber is performed in sequence. Compared with the traditional optical detection structure, on the one hand, the mode of driving the plurality of optical detection units to move to the positions opposite to the PCR chamber in sequence along the vertical direction or the horizontal direction for fluorescence detection has a faster switching speed and is more convenient, and the fluorescence detection efficiency can be improved; on the other hand, the overall structure of the optical detection module is relatively simple, and the plurality of optical detection units are independent of each other, so that the maintenance work can be facilitated, and the service life is longer.

[0015] In one of the embodiments, the in-vitro analysis and diagnosis detection device further comprises a third bracket, a temperature rising and falling assembly, and a window assembly; the third bracket is used for installing a reagent cartridge; the temperature rising and falling assembly comprises a substrate arranged on the third bracket, a semiconductor refrigerator arranged on the substrate, and a heat conduction plate arranged on the semiconductor refrigerator, the heat conduction plate is used for tightly abutting one side of the PCR chamber of the reagent cartridge; the window assembly comprises an optical window arranged opposite to the optical detection unit, the optical window is provided with at least one transparent plate, and the transparent plate is used for tightly abutting the other side of the PCR chamber.

[0016] In one of the embodiments, the temperature rising and falling assembly further comprises a heat dissipation member connected with the substrate; the heat dissipation member comprises a heat dissipation plate stacked on the substrate, and a plurality of heat dissipation fins connected with the heat dissipation plate.

[0017] In one of the embodiments, the in-vitro analysis and diagnosis detection device further comprises a pressing assembly; the pressing assembly comprises a second driving mechanism and a mounting plate; the second driving mechanism is arranged on the third bracket, the second driving mechanism is connected with the mounting plate, and is used for driving the mounting plate to move towards or away from the reagent cartridge; the window assembly is arranged on the mounting plate.

[0018] In one of the embodiments, the window assembly further comprises a first elastic member; the optical window is connected with the mounting plate through the first elastic member.

[0019] In one of the embodiments, the window assembly further comprises a first carrier plate arranged between the first elastic member and the optical window, the optical window is arranged on the first carrier plate, and the first carrier plate is connected with the mounting plate through the first elastic member.

[0020] In one of the embodiments, the mounting plate is provided with a first recess, the first elastic member and the first carrier plate are arranged in the first recess; the mounting plate is provided with a first limiting plate on the plate surface, the first limiting plate abuts and cooperates with the first carrier plate, and the first limiting plate is arranged circumferentially around the outer edge of the optical window.

[0021] In one of the embodiments, the pressing assembly further comprises at least one pressing member; at least one of the pressing members is arranged on the mounting plate.

[0022] In one of the embodiments, the pressing assembly further comprises at least one second elastic member arranged on the mounting plate, at least one of the pressing members and at least one of the second elastic members are arranged one by one, and the pressing member is connected with the mounting plate through the second elastic member.

[0023] In one embodiment, the mounting plate has a receiving chamber and a guide hole communicating with the receiving chamber. The second elastic member is disposed in the receiving chamber. One end of the clamping member is located inside the receiving chamber and is connected to the second elastic member. The clamping member is movably disposed in the guide hole. The other end of the clamping member extends out of the guide hole and is used to clamp or release the valve of the reagent cartridge.

[0024] In one embodiment, the in vitro analysis and diagnostic testing device further includes a second sensor and a second trigger that engages with the second sensor; the second sensor is mounted on the third bracket, and the second trigger is mounted on the mounting plate. Attached Figure Description

[0025] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an improper limitation of the invention.

[0026] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This is a schematic diagram of the structure of an in vitro analytical diagnostic testing device according to an embodiment of the present invention from one perspective;

[0028] Figure 2 for Figure 1 A schematic diagram of one viewpoint structure of the hidden window component and optical detection module;

[0029] Figure 3 for Figure 1 Another structural diagram showing the hidden window components and optical detection module;

[0030] Figure 4 This is a schematic diagram of the optical detection module from one perspective according to an embodiment of the present invention;

[0031] Figure 5 for Figure 4 Another perspective structural diagram;

[0032] Figure 6 for Figure 4 The structural diagram of one perspective of the moving mechanism is hidden in the middle;

[0033] Figure 7 for Figure 4Another perspective view of the moving mechanism hidden from view;

[0034] Figure 8 For Figure 7 Cross-sectional view at A-A;

[0035] Figure 9 One perspective view of the moving mechanism of an embodiment of the present application;

[0036] Figure 10 Another perspective view of the moving mechanism of an embodiment of the present application;

[0037] Figure 11 Schematic view of the reagent cartridge of an embodiment of the present application;

[0038] Figure 12 One perspective view of the temperature raising and lowering assembly of an embodiment of the present application;

[0039] Figure 13 Another perspective view of the temperature raising and lowering assembly of an embodiment of the present application;

[0040] Figure 14 For Figure 13 Schematic view of the cross-section at B-B;

[0041] Figure 15 One perspective view of the window assembly of an embodiment of the present application mounted on the mounting plate;

[0042] Figure 16 Another perspective view of the window assembly of an embodiment of the present application mounted on the mounting plate;

[0043] Figure 17 For Figure 16 Schematic view of the enlarged structure at C;

[0044] Figure 18 For Figure 17 Schematic view of the cross-section at D-D;

[0045] 100, optical detection module; 110, first support; 111, slide rail; 112, light channel; 1121, first channel; 1122, second channel; 120, optical detection unit; 121, light source; 122, first lens; 123, dichroic mirror; 124, second lens; 125, third lens; 126, fluorescence detector; 127, first filter; 128, second filter; 130, moving mechanism; 131, second support; 1311, slide block; 132, first motor; 133, first drive wheel; 134, second drive wheel; 135, transmission element; 141, first sensor; 142, first trigger;

[0046] 210, third support; 211, support plate; 2111, second recess; 2112, inlet and outlet; 212, guide plate; 220, temperature rising and falling assembly; 221, base plate; 222, semiconductor refrigerator; 223, heat conduction plate; 224, heat dissipation piece; 225, first positioning plate; 230, window assembly; 231, optical window; 2311, transparent plate; 2312, PC plate; 232, first elastic piece; 233, first carrier plate; 234, hollowed-out opening; 240, reagent cartridge; 241, valve; 242, sample chamber; 243, pretreatment chamber; 244, mixing chamber; 245, PCR chamber; 250, pressing assembly; 251, second driving mechanism; 252, pressing piece; 253, mounting plate; 2531, first recess; 254, first limiting plate; 261, second sensor; 262, second triggering piece; 270, thermal lysis assembly; 280, magnetic mixing assembly. DETAILED DESCRIPTION

[0047] In order to make the above objectives, features and advantages of the present application more apparent, specific embodiments of the present application will be described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in many different ways from those described and can be practiced in other ways apparent to those skilled in the art without departing from the spirit and scope of the present application, and it is therefore intended that all such alternatives fall within the scope of the present application. It should be noted that the following detailed description merely sets forth some exemplary embodiments of the present application, however, it is not intended to cause limitation of the present application.

[0048] Referring to Figures 1 to 5 , Figure 11 , Figure 1 Fig. 1 shows a perspective view of an in-vitro diagnostic testing device according to an embodiment of the present application, Figure 2 and Figure 3 Fig. 2 shows two different perspective views of the in-vitro diagnostic testing device according to an embodiment of the present application, Figure 1 and Figure 4 Fig. 3 shows two different perspective views of an optical detection module according to an embodiment of the present application, Figure 5 and Figure 11A schematic diagram of a reagent cartridge 240 according to an embodiment of the present invention is shown. In one embodiment, an in vitro analytical diagnostic detection device includes an optical detection module 100. Specifically, the optical detection module 100 includes a first support 110, a plurality of optical detection units 120, and a moving mechanism 130. The plurality of optical detection units 120 are sequentially and spaced apart on the first support 110, and the optical detection units 120 are used to perform fluorescence detection on the sample liquid in the PCR chamber 245. The moving mechanism 130 is connected to the first support 110, and the moving mechanism 130 is used to drive the first support 110 to move, so that the plurality of optical detection units 120 are sequentially moved to a position opposite to the PCR chamber 245.

[0049] The aforementioned in vitro analytical diagnostic detection device and optical detection module 100, when fluorescence detection of the PCR chamber 245 is required, drives the first support 110 to move via the moving mechanism 130, causing multiple optical detection monomers 120 to sequentially move to positions opposite to the PCR chamber 245, and sequentially perform fluorescence detection on the PCR chamber 245. Compared to traditional optical detection structures, on the one hand, the method of driving multiple optical detection monomers 120 to sequentially move along the vertical or horizontal direction to positions opposite to the PCR chamber 245 for fluorescence detection is faster and more convenient, improving fluorescence detection efficiency; on the other hand, the overall structure of the optical detection module 100 is relatively simple, and the multiple optical detection monomers 120 are independent of each other, facilitating maintenance and extending service life.

[0050] See Figures 4 to 7 , Figure 6 and Figure 7 They are shown respectively Figure 4 The following diagrams conceal two different viewpoints of the moving mechanism 130. In one embodiment, multiple optical detection units 120 are sequentially and spaced apart on the first support 110 along a first direction, and the moving mechanism 130 drives the first support 110 to move along the first direction. The first direction can be a vertical direction, a horizontal direction, or a direction that forms an angle with the vertical direction. For example, the first direction can be... Figure 5 As shown in S in the diagram. It should be noted that the first direction is the direction that forms an angle with the vertical direction, that is, the direction that is tilted relative to the vertical direction.

[0051] Please see Figure 9 and Figure 10 , Figure 9 and Figure 10Two different perspective structural diagrams of an embodiment of the moving mechanism 130 are shown respectively. In one embodiment, the moving mechanism 130 includes a second support 131, a first motor 132, a first driving wheel 133, a second driving wheel 134, and a transmission element 135 connecting the first driving wheel 133 and the second driving wheel 134. The first motor 132, the first driving wheel 133, and the second driving wheel 134 are all arranged on the second support 131, and the rotating shaft of the first motor 132 is connected with the first driving wheel 133 for driving the first driving wheel 133 to rotate. The transmission element 135 is also connected with the first support 110. The connection between the transmission element 135 and the first support 110 includes but is not limited to clamping connection, adhesive connection, or connection by screws, pins, ropes, etc., so that the transmission element 135 can drive the first support 110 to move when the transmission element 135 moves. The first support 110 is slidingly arranged on the second support 131. The first driving wheel 133 and the second driving wheel 134 are specifically, for example, gears, chain wheels, belt wheels, etc., and the transmission element 135 is arranged correspondingly with the first driving wheel 133 and the second driving wheel 134. In this way, when the first motor 132 works, the first driving wheel 133 drives the transmission element 135 to move, and the transmission element 135 drives the first support 110 to run when the transmission element 135 moves, so as to drive different optical detection units 120 to move to the position opposite to the PCR chamber 245. In addition, since the first support 110 is slidingly arranged on the second support 131, i.e., the first support 110 slides along the second support 131 when the first support 110 runs, the running effect is relatively stable and reliable. As an example, the first support 110 is provided with a sliding rail 111, and the second support 131 is provided with a sliding block 1311 slidingly matched with the sliding rail 111.

[0052] As an example, the moving mechanism 130 is not limited to the combination of the first motor 132, the first driving wheel 133, the second driving wheel 134, and the transmission element 135 described above, but can also be, for example, a motor screw drive structure, an oil cylinder driving mechanism, an electric cylinder driving mechanism, a gas cylinder driving mechanism, etc., which are not limited herein.

[0053] Please refer to Figure 8 and Figure 11 , Figure 8 shown Figure 7 A cross-sectional view at A-A is shown. In one embodiment, the optical detection module 100 further includes a first sensor 141 (such as a light sensor, a temperature sensor, etc.) arranged on the first support 110. Figure 4The first sensor 141 is arranged on the first support 110, and the first trigger 142 is arranged on the second support 131. In this way, the first sensor 141 can sense the moving position of the first trigger 142, and the moving position information of the first support 110 can be obtained according to the sensing signal of the first trigger 142, so that the plurality of optical detection units 120 can be controlled to move to the position opposite to the PCR chamber 245 more accurately.

[0054] Specifically, the first sensor 141 is a photoelectric switch, a proximity switch, a reflection sensor, or other types of sensors, as long as it can sense the moving position of the first trigger 142 and timely feedback the moving position signal of the first trigger 142.

[0055] Please refer back to Figure 8 And Figure 11 In an embodiment, the plurality of optical detection units 120 each includes a light source 121. The light sources 121 of the plurality of optical detection units 120 are light sources 121 of different wavebands. In this way, the waveband of the fluorescence generated by the optical detection unit 120 is determined according to the waveband of the light source 121, and the plurality of light sources 121 of different wavebands correspond to a plurality of fluorescences of different wavebands, that is, different waveband fluorescences can be provided to perform fluorescence detection on the sample liquid in the PCR chamber 245, to ensure the fluorescence detection effect and efficiency, and to meet the needs of different detection items. In this embodiment, the optical detection unit 120 is specifically, for example, 5, and correspondingly generates 5 fluorescences of different wavebands. The specific waveband size of the 5 fluorescences is set according to actual needs, which is not limited here. In addition, the optical detection unit 120 can also be other quantities, such as 3, 4, 6, 8, etc., which are not limited here.

[0056] As an optional solution, among the plurality of optical detection units 120, the wavebands of the light sources 121 provided by two, three or other quantities of the optical detection units 120 can be the same. Of course, the light sources 121 of the plurality of optical detection units 120 can also be completely different wavebands.

[0057] Please refer back to Figure 8 And Figure 11In one embodiment, the first support 110 is provided with a plurality of light collection channels 112 corresponding to the plurality of optical detection units 120. The optical detection unit 120 is arranged in the light collection channel 112. The light collection channel 112 includes a first channel 1121 and a second channel 1122. The second channel 1122 is vertically communicated with the middle part of the first channel 1121, and the light source 121 is arranged on the end of the second channel 1122 away from the first channel 1121. The optical detection unit 120 further includes a first lens 122, a dichroic mirror 123, a second lens 124, a third lens 125 and a fluorescence detector 126. The first lens 122 is arranged on the inner wall of the second channel 1122, the dichroic mirror 123 is arranged on the middle part of the first channel 1121, the second lens 124, the dichroic mirror 123, the third lens 125 and the fluorescence detector 126 are arranged on the inner wall of the first channel 1121 in sequence, the second lens 124 is located at one end of the first channel 1121 close to the PCR chamber 245, and the fluorescence detector 126 is located at one end of the first channel 1121 away from the PCR chamber 245. Specifically, the light source 121 is specifically an LED lamp. In addition, the fluorescence detector 126 is specifically a photodiode detector.

[0058] In one embodiment, the optical detection unit 120 further includes a first filter 127 and a second filter 128. The first filter 127 is arranged on the inner wall of the second channel 1122, and the first filter 127 is located between the first lens 122 and the dichroic mirror 123. The second filter 128 is arranged on the inner wall of the first channel 1121, and the second filter 128 is located between the second lens 124 and the dichroic mirror 123.

[0059] Please refer to Figure 8 and Figure 11 The working method of the optical detection unit 120 is described by taking one of the optical detection units 120 as an example. The light source 121 generates excitation light, the excitation light is collimated by the first lens 122, the collimated excitation light is filtered by the first filter 127 to remove stray light, the excitation light filtered to remove stray light is reflected by the dichroic mirror 123 into the second lens 124, and the excitation light is converged by the second lens 124 to irradiate the sample liquid in the PCR chamber of the reagent cartridge 240. The sample liquid at a certain temperature state generates fluorescence, the fluorescence is collected by the second lens 124, and enters the second filter 128 through the dichroic mirror 123. The fluorescence is filtered by the second filter 128, enters the third lens 125, and is converged by the third lens 125 to the fluorescence detector 126 for fluorescence signal detection.

[0060] Please refer to Figures 1 to 3 , Figures 11 to 18, further, the in-vitro analysis diagnosis detection device further comprises a third bracket 210, a temperature rising and falling assembly 220 and a window assembly 230. The third bracket 210 is used for installing a reagent cartridge 240. The temperature rising and falling assembly 220 comprises a base plate 221 arranged on the third bracket 210, a semiconductor refrigerator 222 arranged on the base plate 221, and a heat conduction plate 223 arranged on the semiconductor refrigerator 222. The heat conduction plate 223 is used for tightly abutting one side of a PCR chamber 245 of the reagent cartridge 240. The window assembly 230 comprises an optical window 231 arranged opposite to the optical detection unit 120. The optical window 231 is provided with at least one transparent plate 2311. The transparent plate 2311 is used for tightly abutting the other side of the PCR chamber 245.

[0061] In this way, the reagent cartridge 240 is installed on the third bracket 210, so that the heat conduction plate 223 tightly abuts one side of the PCR chamber 245, and the transparent plate 2311 tightly abuts the other side of the PCR chamber 245. Then the semiconductor refrigerator 222 performs cyclic temperature rising and falling actions. When the temperature rises, heat is transferred to the PCR chamber 245 through the heat conduction plate 223. When the temperature falls, cold is transferred to the PCR chamber 245 through the heat conduction plate 223. At the same time, the excitation light of the optical detection module 100 passes through the transparent plate 2311 of the optical window 231 and enters the sample liquid in the PCR chamber 245, the sample liquid generates fluorescence and reflects back to the optical detection module 100 for optical detection, so that the number of sample amplification in each thermal cycle can be quantitatively detected. Since the PCR chamber 245 of the reagent cartridge 240 is slightly inflated due to a certain pressure and is compressed by the optical window 231, the other side of the PCR chamber 245 has good contact with the heat conduction plate 223, thereby greatly reducing the heat conduction loss between the material interfaces, greatly increasing the heat conduction efficiency of the thermal cycle control of the PCR chamber 245, accurately controlling the temperature of the PCR chamber 245, and obviously improving the temperature rising and falling effect. In addition, the overall structure of the optical detection module 100 is relatively simple.

[0062] Please refer to Figure 11 It should be noted that the reagent cartridge 240 in the embodiment is provided with at least two chambers. The at least two chambers are, for example, a sample chamber 242, a pretreatment chamber 243, a mixing chamber 244 and a PCR chamber 245, and of course can also be other functional chambers. The specific number of the sample chamber 242, the pretreatment chamber 243, the mixing chamber 244 and the PCR chamber 245 is not limited and can be set according to actual needs. In the embodiment, the sample chamber 242 is one and is used for installing sample liquid; the pretreatment chamber 243 is one and is used for heating and cracking treatment of the sample liquid; the mixing chamber 244 is, for example, two and is used for mixing treatment of the sample liquid and freeze-dried reagents; and the PCR chamber 245 is, for example, two and is used for polymerase chain reaction and molecular detection treatment of the sample liquid.

[0063] It should be noted that the number of transparent plates 2311 of the optical window 231 can be one, two, three or other numbers, which is not limited herein, and is set according to the PCR chamber 245 of the reagent cartridge 240, and is set one-to-one with the PCR chamber 245.

[0064] In addition, the optical window 231 includes a PC plate 2312, and the transparent plate 2311 is fixed on the PC plate 2312 by, for example, screwing, gluing, ultrasonic welding or laser welding, etc. It should be noted that the transparent plate 2311 is specifically selected from an optical material, which can be the same as or different from the material of the PC plate 2312, which is not limited herein.

[0065] Please refer to Figures 12 to 14 , Figure 12 and Figure 13 respectively show two different perspective views of the temperature rising and falling assembly 220 of an embodiment, Figure 14 showing Figure 13 a cross-sectional structure schematic view at B-B. In an embodiment, the temperature rising and falling assembly 220 further includes a heat dissipation piece 224. The heat dissipation piece 224 is connected with the base plate 221. The heat dissipation piece 224 includes a heat dissipation plate stacked on the base plate 221, and a plurality of heat dissipation fins connected with the heat dissipation plate. In this way, when the semiconductor refrigerator 222 is used to heat and rise the temperature of the PCR chamber 245, the heat dissipation piece 224 can better dissipate the coldness outward through the base plate 221; when the semiconductor refrigerator 222 is used to cool the PCR chamber 245, the heat dissipation piece 224 can better dissipate the heat outward through the base plate 221.

[0066] In addition, in order to improve the heat dissipation efficiency of the heat dissipation piece 224, the optical detection module 100 can also be provided with a fan or a water cooling structure, so that the fan blows air to the heat dissipation piece 224 to quickly take away the heat of the heat dissipation piece 224, or the water cooling structure contacts the heat dissipation piece 224 to quickly take away the heat of the heat dissipation piece 224. In addition, in order to stably set the semiconductor refrigerator 222 and the heat conduction plate 223 on the base plate 221, the temperature rising and falling assembly 220 further includes a first positioning plate 225, which is fixedly installed on the base plate 221 by at least one mounting piece. The first positioning plate 225 is provided with a first opening, and the semiconductor refrigerator 222 and the heat conduction plate 223 are arranged in the first opening. The edge of the first opening is connected with the outer edge of the heat conduction plate 223 by clamping connection, adhesive connection or mounting piece.

[0067] Please refer to Figure 3 , Figures 15 to 18In one embodiment, the in-vitro analysis and diagnosis detection device further comprises a pressing assembly 250. The pressing assembly 250 comprises a second driving mechanism 251 and a mounting plate 253. The second driving mechanism 251 is arranged on the third support 210, and the second driving mechanism 251 is connected with the mounting plate 253, and is used to drive the mounting plate 253 to move towards or away from the reagent cartridge 240. The window assembly 230 is arranged on the mounting plate 253. Thus, the second driving mechanism 251 drives the mounting plate 253 to move towards or away from the reagent cartridge 240, and the mounting plate 253 drives the window assembly 230 to move when the mounting plate 253 moves, so that the transparent plate 2311 of the window assembly 230 can tightly contact or release the other side of the PCR chamber 245. That is, when the reagent cartridge 240 is disassembled or assembled on the third support 210, the transparent plate 2311 is driven by the second driving mechanism 251 to move away from the other side of the PCR chamber 245, so as to avoid interference with the reagent cartridge 240; when the reagent cartridge 240 is assembled in place on the third support 210, the transparent plate 2311 is driven by the second driving mechanism 251 to tightly contact the other side of the PCR chamber 245.

[0068] It should be noted that the second driving mechanism 251 is, for example, a motor-screw driving structure, a cylinder driving structure, a hydraulic cylinder driving structure, an electric cylinder driving structure, a cam driving structure, etc., which is not limited here and can be set according to actual needs.

[0069] Please refer to Figure 3 , Figures 15 to 18 In one embodiment, the window assembly 230 further comprises a first elastic member 232. The optical window 231 is connected with the mounting plate 253 through the first elastic member 232. Thus, when the transparent plate 2311 of the optical window 231 contacts the side of the PCR chamber 245, the first elastic member 232 plays a buffering role, which ensures that the transparent plate 2311 tightly contacts the side of the PCR chamber 245 while avoiding damage to the PCR chamber 245.

[0070] Please refer to Figure 3 , Figures 15 to 18In an embodiment, the window assembly 230 further comprises a first carrier plate 233 arranged between the first elastic member 232 and the optical window 231. The optical window 231 is arranged on the first carrier plate 233, and the first carrier plate 233 is connected to the mounting plate 253 through the first elastic member 232. Specifically, the first carrier plate 233 is made of a hard material such as aluminum alloy, which can strengthen the structural strength of the optical window 231 and is not prone to damage. In addition, the number of the first elastic member 232 is not limited herein, for example, it can be one, two, three, four or other numbers, which can be set according to actual needs. In addition, it should be noted that in order to let the fluorescence of the optical detection unit 120 pass through the transparent plate 2311 of the optical window 231, the PC board 2312 of the mounting plate 253, the first carrier plate 233 and the optical window 231 are provided with a hollow opening 234 corresponding to the position of the transparent plate 2311, which can let the fluorescence of the optical detection unit 120 pass through.

[0071] Please refer to Figure 3 、 Figures 15 to 18 In an embodiment, the mounting plate 253 is provided with a first recess 2531, and the first elastic member 232 and the first carrier plate 233 are arranged in the first recess 2531. The mounting plate 253 is provided with a first limiting plate 254 on the plate surface, the first limiting plate 254 is in abutting fit with the first carrier plate 233, and the first limiting plate 254 is arranged circumferentially around the outer edge of the optical window 231. In this way, on the one hand, during the process that the transparent plate 2311 abuts against the side of the PCR chamber 245, the first carrier plate 233 will move in the first recess 2531 under the pushing force, and the operation stability is good; on the other hand, the first limiting plate 254 plays a limiting role on the first carrier plate 233, which can avoid the first carrier plate 233 and the first elastic member 232 from being separated from the first recess 2531.

[0072] In an embodiment, the pressing assembly 250 further comprises at least one pressing member 252. The at least one pressing member 252 is arranged on the mounting plate 253. Specifically, the pressing member 252 is, for example, a thimble, a top rod or the like, as long as it can push the valve 241 to make the valve 241 close, or loosen the valve 241 to make the valve 241 open. The size of the abutting end face of the pressing member 252 is correspondingly arranged with the size of the valve 241.

[0073] In an embodiment, the number of the pressing member 252 arranged on the mounting plate 253 is not less than the number of the valve 241 of the reagent card box 240. In this way, when the mounting plate 253 is driven to move by the second driving mechanism 251, all the valves 241 of the reagent card box 240 can be opened or closed. For example, the number of the pressing member 252 in the embodiment is, for example, four, and the four pressing members 252 are arranged one by one corresponding to the four valves 241 of the reagent card box 240.

[0074] Specifically, the mounting plate 253 is made of, for example, aluminum, copper, iron, stainless steel, wood, plastic, etc., which is not limited herein and can be set according to actual needs.

[0075] Please refer to Figure 3 , Figures 15 to 18 In one embodiment, the in-vitro analysis and diagnosis detection device further comprises a second sensor 261 and a second trigger 262 in sensing cooperation with the second sensor 261. The second sensor 261 is arranged on the support plate 211, and the second trigger 262 is arranged on the mounting plate 253 or the second connecting plate. In this way, the second sensor 261 can sense the moving position of the second trigger 262, and the moving position information of the mounting plate 253 can be obtained according to the sensing signal of the second trigger 262, so as to correspondingly control the movement stroke of the pressing member 252 within the preset range. The second sensor 261 is similar to the first sensor 141, which will not be described herein.

[0076] In one embodiment, the pressing assembly 250 further comprises at least one second elastic member arranged on the mounting plate 253, and the at least one pressing member 252 is arranged in one-to-one correspondence with the at least one second elastic member. The pressing member 252 is connected with the mounting plate 253 through the second elastic member. In this way, under the buffering action of the second elastic member, the pressing member 252 can avoid damaging the reagent card 240 during contacting the valve 241.

[0077] In one embodiment, the mounting plate 253 is internally provided with a containing chamber (not shown in the figure) and a guide through hole (not shown in the figure) in communication with the containing chamber. The second elastic member is arranged in the containing chamber. One end of the pressing member 252 is located inside the containing chamber and connected with the second elastic member, the pressing member 252 is movably arranged in the guide through hole, and the other end of the pressing member 252 extends to the outside of the guide through hole and is used for pressing or loosening the valve 241 of the reagent card 240.

[0078] Specifically, the first elastic member 232 and the second elastic member are, for example, springs, elastic blocks, etc., which are not limited herein and can be set according to actual needs.

[0079] Further, the third support 210 comprises a support plate 211 and a guide plate 212. The support plate 211 is provided with a second recess 2111 on one side thereof, which is used to accommodate the reagent cartridge 240. The guide plate 212 is arranged on one side of the support plate 211 and is used to abut against the side of the reagent cartridge 240 loaded into the second recess 2111. One side wall of the second recess 2111 is provided with an inlet and outlet 2112. In this way, when the reagent cartridge 240 needs to be tested, the reagent cartridge 240 is guided by the guide plate 212 to enter the second recess 2111 through the inlet and outlet 2112, i.e., the guide plate 212 plays a guiding role for the reagent cartridge 240, and the reagent cartridge 240 is relatively stable in position under the action of the guide plate 212 and the support plate 211 after entering the second recess 2111.

[0080] In one embodiment, the in-vitro analysis and diagnosis detection device further comprises a thermal lysis assembly 270. The thermal lysis assembly 270 is arranged on the support plate 211 and is used to perform a heating lysis treatment on the liquid in the pre-treatment chamber 243 of the reagent cartridge 240. In addition, the in-vitro analysis and diagnosis detection device further comprises a magnetic mixing assembly arranged on the support plate 211 and used to make the magnetic beads in the mixing chamber 244 of the reagent cartridge 240 move up and down, so that the liquid in the mixing chamber 244 is fully mixed to obtain the required mixed liquid.

[0081] In one embodiment, the in-vitro analysis and diagnosis detection device further comprises a temperature sensor (not shown in the figure). The temperature sensor is used to acquire temperature information of the heat conduction plate 223. In this way, the temperature information of the heat conduction plate 223 can be sensed in real time by the temperature sensor, so that the temperature of the heat conduction plate 223 can be accurately grasped, and the semiconductor refrigerator 222 can be controlled to work according to the detected temperature information.

[0082] Generally, a temperature sensor is installed on a heating body to monitor the temperature of the heating body. Due to the reliability of the performance of the temperature sensor and the reliability of the production and installation process, there is a certain temperature difference between the actual temperature and the set temperature, which affects the reliability of the test results of the sample liquid.

[0083] Further, the temperature sensor is two, and both of the two temperature sensors are connected with the heat conduction plate 223. The wires of the two temperature sensors are also used to be electrically connected with a controller (not shown in the figure). In this way, the semiconductor refrigerator 222 can synchronously compare the temperature values returned by the two temperature sensors during the temperature control and adjustment of the heat conduction plate 223, and an error can be reported if the two detected temperature values are out of tolerance, so as to ensure that the temperature sensor is not failed. In addition, the temperature of the heat conduction plate 223 can be controlled by, for example, a PID algorithm, to ensure the accuracy and reliability of the temperature of the heat conduction plate 223.

[0084] Please refer to Figure 3 ,Figure 4 、 Figure 7 、 Figure 8 、 Figure 11 、 Figure 14 With Figure 18 In one embodiment, the optical detection method of the PCR chamber 245 is described in detail, taking the PCR chamber 245 of the reagent cartridge 240 as two and the optical detection monomer 120 as five as an example, which specifically includes the following steps:

[0085] Step S10, after the sample liquid flows from the mixing chamber 244 to the two PCR chambers 245, the second driving mechanism 251 drives the mounting plate 253 to move towards the reagent cartridge 240 under a certain pressure, so that the pressing part 252 is pressed on the valve 241 of the reagent cartridge 240, and the PCR chamber 245 of the reagent cartridge 240 is slightly bulged. The optical window 231 is also pressed on the front of the PCR chamber 245. Because the PCR chamber 245 is slightly bulged due to a certain pressure, after it is compressed by the optical window 231, the back of the PCR chamber 245 has good contact with the heat conduction plate 223, reducing the heat conduction loss between the material interfaces and greatly increasing the heat conduction efficiency of the thermal cycle control of the PCR chamber 245.

[0086] Step S20, the temperature rising and falling assembly 220 starts to perform thermal cycle work, for example, first makes the sample liquid of the PCR chamber 245 rise to a first preset temperature, and then makes the sample liquid of the PCR chamber 245 fall to a second preset temperature, and continuously cycles according to the set program. The first preset temperature and the second preset temperature are set according to the actual situation, which is not limited here.

[0087] Step S30, while the temperature rising and falling assembly 220 performs thermal cycle on the sample liquid of the PCR chamber 245, the five optical detection monomers 120 (recorded as the first optical detection monomer, the second optical detection monomer, the third optical detection monomer, the fourth optical detection monomer, and the fifth optical detection monomer in turn) perform up-down reciprocating motion under the control of the moving mechanism 130, and stay at 6 positions during the process. Different optical detection monomers 120 at each stop position will be aligned with the upper and lower two PCR chambers of the reagent cartridge 240 in turn. At the same time, the light source 121 on the LED circuit board of the optical detection monomer 120 is turned on in turn during the stay of each position, and the fluorescence detector 126 performs optical signal acquisition. The optical module acquisition timing is as follows: the first optical detection monomer aligns with the upper PCR chamber 245 The second optical detection monomer aligns with the upper PCR chamber 245, the first optical detection monomer aligns with the lower PCR chamber 245 The third optical detection monomer aligns with the upper PCR chamber 245, the second optical detection monomer aligns with the lower PCR chamber 245 The fourth optical detection monomer aligns with the upper PCR chamber 245, and the third optical detection monomer aligns with the lower PCR chamber 245 The fifth optical detection monomer aligns with the upper PCR chamber 245, and the fourth optical detection monomer aligns with the lower PCR chamber 245 The fifth optical detection monomer aligns with the lower PCR chamber 245. This process is one cycle. After one cycle, the optical detection module 100 returns to the initial position, i.e., the first optical detection monomer aligns with the upper PCR chamber 245, and enters the second cycle. This is repeated, so that the sample amplification quantity of each thermal cycle is quantitatively detected.

[0088] After the step S40, the thermal cycle and the optical sampling are completed, the optical detection module 100 returns to the initial position, and the second driving mechanism 251 drives the mounting plate 253 to move away from the third support 210, so as to take out the reagent cartridge 240 from the third support 210, and complete the amplification and detection of the nucleic acid.

[0089] The technical features of the above embodiments can be combined in any manner. In order to make the description simple, all possible combinations of the technical features in the above embodiments are not described, but as long as the combinations of the technical features do not contradict, they should be considered as the scope of the description.

[0090] The above embodiments only express several implementation manners of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the patent. It should be pointed out that for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

[0091] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0092] In addition, the terms "first", "second", etc. are used herein only to describe different instances, and are not used to denote or imply relative importance or a number of indications of the technical features indicated. Thus, the technical features defined with "first", "second", etc. can explicitly or implicitly include at least one of the technical features. In the description of the present application, the meaning of "a plurality of" is at least two, such as two, three, etc., unless otherwise explicitly specified and limited.

[0093] In the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting", "fixing" and the like should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise explicitly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0094] In the present application, unless otherwise explicitly specified and limited, the first feature is "on" or "under" the second feature, which can be direct contact between the first and second features, or indirect contact between the first and second features through an intermediate medium. Moreover, the first feature "above", "over" and "on" the second feature can be directly above or obliquely above the first feature, or only indicate that the horizontal height of the first feature is higher than that of the second feature. The first feature "below", "under" and "under" the second feature can be directly below or obliquely below the first feature, or only indicate that the horizontal height of the first feature is less than that of the second feature.

[0095] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it can be directly on another element or there can be a middle element. When an element is considered to be "connected" to another element, it can be directly connected to another element or there can be a middle element. The terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used herein are only for illustrative purposes, and do not represent the only embodiment.

Claims

1. An in-vitro analytical diagnostic test device, characterized in that, The optical detection module comprises: The optical detection module comprises: The first support, a plurality of optical detection monomers, a plurality of optical detection monomers are sequentially and spacedly arranged on the first support, and the optical detection monomer is used for fluorescence detection of sample liquid in the PCR chamber; The moving mechanism is connected with the first support, and the moving mechanism is used for driving the first support to move, so that a plurality of optical detection monomers are sequentially moved to a position opposite to the PCR chamber; The in-vitro analysis and diagnosis detection device further comprises a third support and a temperature rising and falling assembly; the third support is used for installing a reagent cartridge; the temperature rising and falling assembly comprises a substrate provided on the third support, a semiconductor refrigerator provided on the substrate, and a heat-conducting plate provided on the semiconductor refrigerator, and the heat-conducting plate is used for tightly abutting one side of the PCR chamber of the reagent cartridge; The in-vitro analysis and diagnosis detection device further comprises a window assembly; the window assembly comprises an optical window arranged opposite to the optical detection monomer, and the optical window is provided with at least one transparent plate, and the transparent plate is used for tightly abutting the other side of the PCR chamber; The in-vitro analysis and diagnosis detection device further comprises a pressing assembly; the pressing assembly comprises a second driving mechanism and a mounting plate; the second driving mechanism is provided on the third support, and the second driving mechanism is connected with the mounting plate and used for driving the mounting plate to move towards or away from the reagent cartridge; and the window assembly is provided on the mounting plate.

2. The in-vitro analytical diagnostic testing device according to claim 1, characterized in that, A plurality of optical detection monomers are sequentially and spacedly arranged on the first support along a first direction, the moving mechanism is used for driving the first support to move along the first direction; the first direction is a vertical direction, a horizontal direction or a direction having an included angle with the vertical direction.

3. The in-vitro analytical diagnostic testing device according to claim 2, characterized in that, The moving mechanism comprises a second support, a first motor, a first driving wheel, a second driving wheel, and a transmission element connecting the first driving wheel and the second driving wheel; the first motor, the first driving wheel and the second driving wheel are all provided on the second support; the rotating shaft of the first motor is connected with the first driving wheel and used for driving the first driving wheel to rotate; the transmission element is also connected with the first support; and the first support is slidingly arranged on the second support.

4. The in-vitro analytical diagnostic testing device according to claim 3, characterized in that, The optical detection module further comprises a first sensor and a first trigger matched with the first sensor; the first sensor is installed on the first support, and the first trigger is installed on the second support.

5. The in-vitro analytical diagnostic testing device according to claim 1, characterized in that, A plurality of optical detection monomers all comprise light sources, and the light sources of a plurality of optical detection monomers are light sources of different wave bands.

6. The in-vitro analytical diagnostic device according to claim 5, characterized in that The first support is provided with a plurality of light collecting channels corresponding to a plurality of optical detection units, the optical detection units are arranged in the light collecting channels correspondingly; the light collecting channel comprises a first channel and a second channel, the second channel is vertically communicated with the middle part of the first channel, the light source is arranged on the end of the second channel away from the first channel; the optical detection unit further comprises a first lens, a dichroic mirror, a second lens, a third lens and a fluorescence detector, the first lens is arranged on the inner wall of the second channel, the dichroic mirror is arranged on the middle part of the first channel, the second lens, the dichroic mirror, the third lens and the fluorescence detector are arranged on the inner wall of the first channel in sequence, the second lens is located at one end of the first channel close to the PCR chamber, and the fluorescence detector is located at one end of the first channel away from the PCR chamber.

7. The in-vitro analytical diagnostic device according to claim 6, characterized in that The optical detection unit further comprises a first filter and a second filter, the first filter is arranged on the inner wall of the second channel, and the first filter is located between the first lens and the dichroic mirror; the second filter is arranged on the inner wall of the first channel, and the second filter is located between the second lens and the dichroic mirror.

8. The in-vitro analytical diagnostic testing device according to claim 1, characterized in that, The temperature rising and falling assembly further comprises a heat dissipation piece connected with the substrate; the heat dissipation piece comprises a heat dissipation plate stacked on the substrate, and a plurality of heat dissipation fins connected with the heat dissipation plate.

9. The in-vitro analytical diagnostic testing device according to claim 1, characterized in that, The window assembly further comprises a first elastic piece; the optical window is connected with the mounting plate through the first elastic piece.

10. The in-vitro analytical diagnostic device according to claim 9, characterized in that, The window assembly further comprises a first carrier plate arranged between the first elastic piece and the optical window, the optical window is arranged on the first carrier plate, and the first carrier plate is connected with the mounting plate through the first elastic piece.

11. The in-vitro analytical diagnostic device according to claim 10, characterized in that The mounting plate is provided with a first recess, the first elastic piece and the first carrier plate are arranged in the first recess; a first limiting plate is arranged on the surface of the mounting plate, the first limiting plate is in abutting fit with the first carrier plate, and the first limiting plate is arranged in the circumferential direction around the outer edge of the optical window.

12. The in-vitro analytical diagnostic testing device according to claim 1, characterized in that, The pressing assembly further comprises at least one pressing piece; at least one pressing piece is arranged on the mounting plate.

13. The in-vitro analytical diagnostic device according to claim 12, characterized in that The pressing assembly further comprises at least one second elastic piece arranged on the mounting plate, at least one pressing piece and at least one second elastic piece are arranged correspondingly, and the pressing piece is connected with the mounting plate through the second elastic piece.

14. The in-vitro analytical diagnostic device according to claim 13, characterized in that The mounting plate is internally provided with a containing chamber and a guide through hole in communication with the containing chamber, the second elastic piece is arranged in the containing chamber, one end of the pressing piece is located in the containing chamber and connected with the second elastic piece, the pressing piece is movably arranged in the guide through hole, and the other end of the pressing piece extends to the outside of the guide through hole and is used for pressing or loosening the valve of the reagent card box.

15. The in-vitro analytical diagnostic device according to claim 8, characterized in that, The in-vitro analytical diagnostic detection device further comprises a second sensor and a second trigger matched with the second sensor; the second sensor is arranged on the third support, and the second trigger is arranged on the mounting plate.

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