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WO2022160998A1 - Plate-forme de diagnostic moléculaire - Google Patents

Plate-forme de diagnostic moléculaire Download PDF

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Publication number
WO2022160998A1
WO2022160998A1 PCT/CN2021/138615 CN2021138615W WO2022160998A1 WO 2022160998 A1 WO2022160998 A1 WO 2022160998A1 CN 2021138615 W CN2021138615 W CN 2021138615W WO 2022160998 A1 WO2022160998 A1 WO 2022160998A1
Authority
WO
WIPO (PCT)
Prior art keywords
sample
assembly
tank
module
valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2021/138615
Other languages
English (en)
Chinese (zh)
Inventor
张涛
李晓峰
黄宏坤
刘建知
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Guangdong Runpon Bioscience Co Ltd
Original Assignee
Guangdong Runpon Bioscience Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202110129513.2A external-priority patent/CN114813665B/zh
Priority claimed from CN202110126913.8A external-priority patent/CN114763513A/zh
Priority claimed from CN202110129518.5A external-priority patent/CN113559955B/zh
Priority claimed from CN202110129275.5A external-priority patent/CN113567224B/zh
Application filed by Guangdong Runpon Bioscience Co Ltd filed Critical Guangdong Runpon Bioscience Co Ltd
Publication of WO2022160998A1 publication Critical patent/WO2022160998A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/34—Measuring or testing with condition measuring or sensing means, e.g. colony counters
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/36—Apparatus for enzymology or microbiology including condition or time responsive control, e.g. automatically controlled fermentors
    • C12M1/38—Temperature-responsive control

Definitions

  • FIG. 2 is a schematic structural diagram of the molecular diagnostic platform provided by the embodiment of the present application from a second perspective;
  • FIG. 9 is a schematic structural diagram of a heating device provided by an embodiment of the present application.
  • FIG. 15 is a schematic structural diagram of the heating device provided by another embodiment of the present application from a first perspective during practical application;
  • FIG. 18 is a schematic structural diagram of a to-be-heated member from a second viewing angle according to another embodiment of the present application.
  • FIG. 19 is a schematic structural diagram of a heating device provided by yet another embodiment of the application.
  • FIG. 20 is a schematic structural diagram of a clamping mechanism provided in an embodiment of the application.
  • FIG. 25 is a schematic structural diagram of a to-be-clamped member provided in other embodiments of the present application.
  • the terms “installed”, “connected” and “connected” should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • installed should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection Connection, or integral connection; can be mechanical connection, can also be electrical connection; can be directly connected, can also be indirectly connected through an intermediate medium, can be internal communication between two elements.
  • the test tube rack 23 is detachably mounted on the cartridge body, and a plurality of capillaries 24 can be installed on the test tube rack 23, and the plurality of capillaries 24 contain primers and probes for specific targets stored in freeze-dried or spot-dried form.
  • the sample processing module 3 can be configured to operate the main mechanical valve 21 and the auxiliary mechanical valve 22 of the cartridge 2 to realize the automatic operation of the main mechanical valve 21 and the auxiliary mechanical valve 22 to improve the detection efficiency and avoid manual transfer of reagents Errors that may exist in the process improve detection accuracy.
  • the sample processing module 3 may include a cassette operation unit; as shown in FIG. 2 , the cassette operation unit may include a valve body rotating assembly 31 , a main valve stem lifting assembly 32 and a secondary valve Rod lifting assembly 33, wherein the valve body rotating assembly 31 can act on the valve body of the main mechanical valve 21 and the valve body of the auxiliary mechanical valve 22, and can independently drive the valve body of the main mechanical valve 21 and the valve body of the auxiliary mechanical valve 22 to rotate , so that the main mechanical valve 21 is communicated with a plurality of chambers respectively, and the auxiliary mechanical valve 22 is communicated with the reconstitution chamber and a plurality of capillary tubes 24 .
  • the cassette operation unit may include a valve body rotating assembly 31 , a main valve stem lifting assembly 32 and a secondary valve Rod lifting assembly 33, wherein the valve body rotating assembly 31 can act on the valve body of the main mechanical valve 21 and the valve body of the auxiliary mechanical valve 22, and can independently drive the valve body of the main mechanical valve 21 and the valve body of the auxiliary mechanical valve 22 to rotate
  • the main valve stem lifting assembly 32 and the auxiliary valve stem lifting assembly 33 have the same structure.
  • the main valve stem lifting assembly 32 may include a second lifting device and a plug-board telescopic device
  • the plug-in expansion device can be installed on the second lifting device, and the second lifting device can drive the plug-in expansion device to move to the valve stem of the main mechanical valve 21;
  • the plug-in expansion device can include a plug-in plate and a driving device, and the driving device can Drive the plug-in board to extend toward the valve stem, so that the plug-in board and the valve rod are plugged together; then the plug-in board telescopic device and the valve rod of the main mechanical valve 21 can be driven to rise and fall through the second lifting device, so that the main mechanical The valve stem of the valve 21 performs piston movement in the valve body.
  • the sample processing module 3 may further include a physical processing unit 34 , and the physical processing unit 34 is used to provide suitable reaction conditions for the samples in the sample chamber.
  • the physical processing unit 34 may be disposed below the cartridge 2, and the physical processing unit 34 may include a lift drive device, a translation drive device, a magnetic attraction component and an ultrasonic heating component.
  • the drive end of the translation drive device can be formed with a support platform, and the lift drive device is installed on the support platform of the translation drive device; the drive end of the lift drive device can also be formed with a support platform, and the magnetic attraction component and the ultrasonic heating component are arranged at intervals on the lift drive device. on the support platform of the device.
  • the ultrasonic heating component can heat the samples and reagents in the sample chamber and provide sonic treatment, so that the samples and reagents can be mixed more uniformly, and provide a suitable reaction temperature for the reaction of samples and reagents, so that the reaction between samples and reagents can be more efficient. full.
  • the sample transfer module 4 and the thermal cycle module 5 can also be arranged on the rack 1, and the sample transfer module 4 can be located between the sample processing module 3 and the thermal cycle module 5.
  • the test tube rack 23 is transferred to the thermal cycler module 5 through the sample transfer module 4 , so that the sample is subjected to PCR reaction at the thermal cycler module 5 .
  • the thermal cycle module 5 may include four independent thermal tanks, which are a photodetection tank 52 , a reverse transcription tank 53 , a low temperature tank 54 and a high temperature tank 55 , respectively.
  • the four heat sinks can be arranged side by side on the rack 1 at intervals, and temperature control elements can be respectively arranged on the four heat sinks to independently control the temperature of the four heat sinks.
  • the support plate In the initial state, the support plate is located near one end of the sample transfer module 4, and the second sliding mechanism moves the support plate to a position of an appropriate height, so that the sample transfer module 4 turns the test tube rack 23 over to the position facing the thermal cycle module 5.
  • the capillary tube 24 can be placed on the support plate through the test tube rack 23 to complete the transfer of the capillary tube 24 between the sample processing module 3 and the thermal cycle module 5 .
  • the first sliding mechanism drives the capillary 24 to move to the top of the reverse transcription tank 53, the high temperature tank 55, the low temperature tank 54 and the photodetection tank 52 in turn, and put the capillary 24 into the reverse transcription tank 53, the high temperature tank 55, and the low temperature tank 54.
  • the optical module 6 is used to perform quantitative fluorescence detection on the capillary 24 in the optical detection tank 52.
  • the optical module 6 may include a light source assembly 61, an imaging assembly 62 and Optical fiber bundles; the optical fiber bundles are three-port optical fiber bundles, and the number of optical fiber bundles is multiple, and the multiple optical fiber bundles are in one-to-one correspondence with the multiple capillaries 24; the first ports of the multiple optical fiber bundles converge into a single access light source assembly 61, The second ports of the multiple optical fiber bundles are respectively connected to the multiple optical fiber fixing holes 522 of the optical fiber fixing plate 521 , and the third ports of the multiple optical fiber bundles are aggregated and connected to the imaging assembly 62 .
  • the second port of the beam emits and irradiates the corresponding plurality of capillaries 24 to excite the fluorescent substances in the capillaries 24 to emit fluorescence in corresponding wavelength bands.
  • the fluorescence excited by the plurality of capillaries 24 then enters the second port of the corresponding optical fiber bundle, and then irradiates into the imaging assembly 62 from the third port; After the film and the camera lens enter the camera, the fluorescence is collected by the camera and the fluorescence imaging photo is taken.
  • the filter wheels of the light source assembly 61 and the imaging assembly 62 may include a plurality of filters and correspond one-to-one, one filter of the light source assembly 61 and one filter of the corresponding imaging assembly 62 are a group, Thus, a plurality of filter sets are formed; in the process of performing fluorescence quantitative detection on the capillary 24, the plurality of filter sets can be rotated to a position that allows light to pass through, so that the capillary 24 can be subjected to excitation light of different wavelength bands. Illuminate and form corresponding fluorescence imaging pictures.
  • the fluorescence quantitative detection device of the present application is used to perform fluorescence quantitative detection on the sample in the capillary; as shown in FIG. 4 , the fluorescence quantitative detection device may include a first rack 11 , a light source assembly 61 , a first filter The optical component 13 , the second optical filter component 14 , the imaging component 62 , the optical fiber bundle and the optical detection slot 52 .
  • the optical detection tank 52 can be placed on the first rack 11, and the optical detection tank 52 can be used to fix the capillary tube containing the sample to be detected.
  • the number of capillaries may be multiple, and the multiple capillaries may be arranged side by side in the photodetection groove 52 at intervals.
  • the light source assembly 61 can provide a white light source, the light source assembly 61 and the first filter assembly 13 can be disposed opposite to the first frame 11, and the white light source emitted by the light source assembly 61 can illuminate the first filter assembly 13, and then pass through the first filter assembly 13.
  • a filter component 13 filters the white light source, so that monochromatic light of a predetermined wavelength band passes through the first filter component 13 to form incident light with a predetermined wavelength band for illuminating the capillary.
  • the fiber bundle may be a three-port fiber bundle, including a first port, a second port and a third port, an incident fiber may be formed between the first port and the second port, and an exit fiber may be formed between the second port and the third port .
  • the number of optical fiber bundles can be multiple, and multiple optical fiber bundles can be in one-to-one correspondence with multiple capillaries.
  • the formed incident light can enter into the plurality of incident optical fibers uniformly through the plurality of first ports.
  • the second filter assembly 14 can be disposed on the first rack 11, and the third ports of the multiple fiber bundles can be converged into a single bundle to be connected to the second filter assembly 14, so that the fluorescence of the corresponding wavelength band emitted by the multiple capillaries can be irradiated on the On the second filter component 14; the imaging component 62 can be disposed opposite to the second filter component 14, the fluorescence can be irradiated on the imaging component 62 through the second filter component 14, and the stray light can be removed by the second filter component 14, thereby
  • the fluorescence imaging photos of multiple capillaries are conveniently and quickly obtained through the imaging component 62 to analyze the concentration of the sample and improve the efficiency of fluorescence quantitative detection of the sample.
  • the white light source emitted by the light source assembly 61 can be irradiated on the filter 132 located between the light inlet and the light outlet through the light inlet, and then the white light source is filtered by the filter 132, so that the monochromatic light of the corresponding wavelength band passes through.
  • the filter 132 is emitted through the light outlet to form incident light with a predetermined wavelength band for irradiating the capillary.
  • the first sleeve 161 can be fixedly arranged on the first frame 11, and the first sleeve 161 can be arranged coaxially with the light outlet of the first filter assembly 13; one end of the first sleeve 161 can pass the first filter
  • the light outlet of the assembly 13 extends into the light shield 134 of the first filter assembly 13 and extends to the filter wheel 131, and the other end of the first sleeve 161 can be connected to the first optical fiber fixing member 163; a plurality of optical fibers After the first ports of the bundle are converged, they can be inserted into the first sleeve 161 through the first optical fiber fixing member 163, the first focusing lens 162 can be installed in the first sleeve 161, and the first port of the optical fiber bundle can be inserted into the first sleeve 161.
  • the fluorescent light is irradiated on the second lens 172; the second lens 172 is used for correcting the fluorescent light to obtain a parallel fluorescent light beam, so that the parallel fluorescent light beam is irradiated on the filter of the second filter assembly 14 , to filter the fluorescent light beam through the filter of the second filter component 14, so that the fluorescent light beam of a predetermined wavelength band is irradiated into the imaging component 62, so as to obtain a fluorescent imaging photo.
  • the second ports of the plurality of optical fiber bundles can be respectively inserted into the plurality of optical fiber fixing holes 522, and a second focusing lens can be arranged between each group of light-passing holes 523 and the optical fiber fixing holes 522, so that the second focusing lens of the optical fiber bundles is second.
  • the incident light emitted from the port is focused by the corresponding second focusing lens and then irradiated on the corresponding capillary tube, so as to excite the fluorescent substance in the capillary tube to emit fluorescence.
  • the heating device may further include a first driving assembly 1080 , and the driving end of the first driving assembly 1080 may be connected to the heating assembly through a supporting member 1090 , so The first driving assembly 1080 can drive the heating assembly to move along the first direction 1100, specifically, the first direction 1100 is the vertical direction when the heating device is in normal use; so that the heating assembly can be inserted or pulled out in the heating chamber 1010 .
  • the heating device may further include a second drive assembly 1130; wherein, the second drive assembly 1130 may include a second drive member 1140 and a second lead screw 1150;
  • the driving member 1140 is preferably a second motor, the output shaft of the second motor can be connected with the second lead screw 1150, and the guide block 1180 can be sleeved on the second lead screw 1150 and connected with the second lead screw 1150. Lead screw 1150 threaded connection.
  • a magnetic attraction member 1220 may be disposed on the second support plate 1190 , and the magnetic attraction member 1220 may include a magnetic attraction member 1220 disposed on the second support plate 1190 .
  • the support rod 1300 on the plate 1190 and the magnet 1290 disposed on the support rod 1300, the support rod 1300 can extend along the first direction 1100, so that the magnet 1290 and the heating assembly in the static state are located on the same horizontal plane .
  • the magnet 1290 can absorb the magnetic beads of the solution in the cartridge 2.
  • the magnet 1290 can be set on the second support through the support rod 1300.
  • the magnet 1290 can move left and right along the bottom of the sample storage compartment, which can fully adsorb the magnetic beads in the solution, and can put the magnetic beads in the solution. The magnetic beads move to a position where they are not easily washed away by the liquid.
  • the clamping mechanism may further include a first drive assembly, and the first drive assembly may include a fixed cylinder 1115, a first drive member 1116 and a lead screw 1117, preferably,
  • the first driving member 1116 can be a first motor, the output shaft of the first motor is connected with the lead screw 1117 , the fixing cylinder 1115 is provided with a threaded hole, and the fixing cylinder 1115 is sleeved on the lead screw 1117 , and is threadedly connected with the lead screw 1117;
  • the fixing cylinder 1115 is provided with a first clamping jaw 110 and a second clamping jaw 111 at intervals along the first direction 1109, and a first supporting plate is arranged below the first clamping jaw 110 , a second supporting plate is arranged below the second clamping jaw 111 .
  • the first drive assembly may include a fixed cylinder 1115, a first drive member 1116, a first support frame 1112, and a second support frame 1113 disposed inside the first support frame 1112.
  • the clamping mechanism further includes a limiting member; when the clamping jaws 1104 and the support plate 1106 clamp the When the piece is to be clamped, the limiting member can prevent the fixing cylinder 1115 from rotating.
  • the transfer device can realize the transfer of the test tube racks 23 , which overcomes the manual hand-held transfer method in the prior art. On the one hand, the work efficiency is improved; on the other hand, the test tube racks 23 are not polluted.
  • the fixing cylinder 1115 is fixed on the second support frame 1113, the space on the upper part of the fixing cylinder 1115 is limited, preferably, the fixing cylinder 1115 can rotate counterclockwise during the rotation process, that is, the second driving member 1131 drives the fixing cylinder 1115 to rotate.
  • the barrel 1115 rotates in a counterclockwise direction.
  • the preset angle may be 180°.
  • the fixed cylinder 1115 can be rotated by the predetermined angle.
  • the transfer member may further include a buffer 1132, so One end of the buffer member 1132 can abut on the first support frame 1112, and the other end can abut on the second driving member 1131; preferably, the buffer member 1132 can be a spring, which is activated by a spring to shock absorption.
  • the test tube rack is transferred to the thermal cycler module through the sample transfer module, so that the sample is subjected to PCR reaction at the thermal cycler module, and the capillary tube that has completed the PCR reaction is passed through the optical module.
  • Fluorescence quantitative detection is performed on the samples inside to collect fluorescence signals and obtain fluorescence imaging photos. Therefore, in the whole detection process, the operator only needs to place the cassette containing the samples and various reagents on the rack, and the subsequent operations can be completed automatically and efficiently through each module.

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Health & Medical Sciences (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Microbiology (AREA)
  • Sustainable Development (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Analytical Chemistry (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

Plate-forme de diagnostic moléculaire, comprenant les éléments suivants : un support ; une cartouche ; et un module de traitement d'échantillon, un module de transfert d'échantillon, un module de cycle thermique et un module optique prévus sur le support. La cartouche est conçue pour être utilisée afin de conditionner un échantillon à tester et divers réactifs, et un opérateur place la cartouche sur un ensemble de déplacement de cartouche du rack de manière à transporter la cartouche vers le module de traitement d'échantillon ; le module de traitement d'échantillon est conçu pour être utilisé afin de faire fonctionner la cartouche, de sorte que les réactifs dans la cartouche réagissent successivement avec l'échantillon, et une solution d'échantillon obtenue après la réaction est enfermée dans un tube capillaire sur un rack de tubes à essai ; et le module de transfert d'échantillon est conçu pour être utilisé pour transférer le rack de tubes à essai vers le module de cyclage thermique, de sorte que l'échantillon est soumis à une réaction PCR, et l'acquisition du signal par fluorescence est effectuée sur l'échantillon au moyen du module optique pour obtenir une image par fluorescence.
PCT/CN2021/138615 2021-01-29 2021-12-16 Plate-forme de diagnostic moléculaire Ceased WO2022160998A1 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
CN202110129518.5 2021-01-29
CN202110129513.2 2021-01-29
CN202110129275.5 2021-01-29
CN202110129513.2A CN114813665B (zh) 2021-01-29 2021-01-29 多通道荧光定量检测装置及分子诊断平台
CN202110126913.8A CN114763513A (zh) 2021-01-29 2021-01-29 分子诊断平台
CN202110129518.5A CN113559955B (zh) 2021-01-29 2021-01-29 夹持机构以及转移装置
CN202110126913.8 2021-01-29
CN202110129275.5A CN113567224B (zh) 2021-01-29 2021-01-29 加热装置以及待加热件

Publications (1)

Publication Number Publication Date
WO2022160998A1 true WO2022160998A1 (fr) 2022-08-04

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PCT/CN2021/138615 Ceased WO2022160998A1 (fr) 2021-01-29 2021-12-16 Plate-forme de diagnostic moléculaire

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WO (1) WO2022160998A1 (fr)

Cited By (5)

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Publication number Priority date Publication date Assignee Title
CN115612600A (zh) * 2022-10-11 2023-01-17 合肥中科易康达生物医学有限公司 一种自动化全流程的核酸检测系统和方法
CN115747025A (zh) * 2022-10-14 2023-03-07 北京卓诚惠生生物科技股份有限公司 一种全自动核酸提取与pcr检测一体机
CN115747031A (zh) * 2022-11-17 2023-03-07 北京昌平实验室 病原体核酸分析设备
CN116164235A (zh) * 2022-12-15 2023-05-26 江苏格诺生物科技有限公司 一种核酸检测卡盒
WO2025066469A1 (fr) * 2023-09-25 2025-04-03 广东润鹏生物技术有限公司 Cartouche de réactifs et appareil d'analyse d'échantillons

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CN212532946U (zh) * 2020-04-16 2021-02-12 广东润鹏生物技术有限公司 样品检测机构及分子检测设备
CN113528289A (zh) * 2020-04-16 2021-10-22 广东润鹏生物技术有限公司 样品检测机构及分子检测设备
CN215050255U (zh) * 2021-01-29 2021-12-07 广东润鹏生物技术有限公司 分子诊断平台

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US20090317806A1 (en) * 2008-06-23 2009-12-24 Canon U.S. Life Sciences, Inc. Systems and methods for monitoring the amplification of dna
CN102803147A (zh) * 2009-06-05 2012-11-28 尹特根埃克斯有限公司 通用样品准备系统以及在一体化分析系统中的用途
CN103409317A (zh) * 2013-07-23 2013-11-27 广州市第一人民医院 一种毛细管生物分析系统及其分析方法与应用
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CN215050255U (zh) * 2021-01-29 2021-12-07 广东润鹏生物技术有限公司 分子诊断平台

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115612600A (zh) * 2022-10-11 2023-01-17 合肥中科易康达生物医学有限公司 一种自动化全流程的核酸检测系统和方法
CN115747025A (zh) * 2022-10-14 2023-03-07 北京卓诚惠生生物科技股份有限公司 一种全自动核酸提取与pcr检测一体机
CN115747025B (zh) * 2022-10-14 2023-09-22 北京卓诚惠生生物科技股份有限公司 一种全自动核酸提取与pcr检测一体机
CN115747031A (zh) * 2022-11-17 2023-03-07 北京昌平实验室 病原体核酸分析设备
CN116164235A (zh) * 2022-12-15 2023-05-26 江苏格诺生物科技有限公司 一种核酸检测卡盒
WO2025066469A1 (fr) * 2023-09-25 2025-04-03 广东润鹏生物技术有限公司 Cartouche de réactifs et appareil d'analyse d'échantillons

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