CN112625890B

CN112625890B - Nucleic acid POCT detection device and detection method thereof

Info

Publication number: CN112625890B
Application number: CN202011544888.7A
Authority: CN
Inventors: 陈华云; 陈成龙; 邹天桥; 刘淑园; 黎秋华; 杨迎宾
Original assignee: Guangzhou Heas Biotech Co ltd
Current assignee: Guangzhou Heas Biotech Co ltd
Priority date: 2020-12-23
Filing date: 2020-12-23
Publication date: 2021-08-31
Anticipated expiration: 2040-12-23
Also published as: WO2022134153A1; CN112625890A

Abstract

The invention provides a nucleic acid POCT detection device and a detection method thereof, wherein the nucleic acid POCT detection device comprises a shell assembly, a consumable fixing module, a motion module and a light path module are integrated in the shell assembly, and the motion module and the light path module are arranged on one side of the consumable fixing module after being vertically stacked; the consumable fixing module is provided with a heating baffle, the disposable consumable comprises a detection bag and an amplification cabin, the central area of the detection bag is a nucleic acid extraction area, and the nucleic acid extraction area and the amplification cabin are in a semi-closed state. The invention integrates the steps of sample pretreatment, sample amplification, detection and the like of nucleic acid detection into one detection flow, and the sample to be detected completes the whole detection process in a relatively closed environment, thereby solving the problems of integration and full sealing of nucleic acid detection, adapting to the requirements of various nucleic acid POCT detection and the like.

Description

Nucleic acid POCT detection device and detection method thereof

Technical Field

The invention belongs to the technical field of nucleic acid detection, and relates to a nucleic acid POCT detection device and a detection method thereof.

Background

In the traditional nucleic acid detection, sample pretreatment, nucleic acid extraction and nucleic acid detection need to be independently completed step by step, each link needs to be operated by combining specific equipment or instruments, the steps are complex, and the operation needs to be carried out in a specific professional detection laboratory. Most of nucleic acid POCTs in the field of molecular diagnostics are designed by using the principles of microfluidics, electrophoresis and the like, so that the preparation process of the device is complex and the cost is high. Therefore, there is an urgent need to develop a molecular nucleic acid POCT device, i.e., an instant detection device, which realizes an integrated detection of "sample in and result out" and further performs a qualitative judgment on the amplification result through indexes such as turbidity and color of the amplification solution. Not only can meet the detection requirements of epidemic situation in special period, but also can be popularized and used in basic level, such as: respiratory tract infection, genital secretion, bacteria detection, food safety detection, pet virus detection, zoonosis and other fields, and provides a convenient and fast way for on-site instant detection.

POCT is a new method that is used for analyzing immediately on a sampling site, upgrading and improving the complex processing process and program of various biological samples in laboratory test by technology, and under the premise of not influencing the final test result, the whole test process is simple, and no or few equipment is needed, so that the test result can be obtained quickly. The POCT equipment technical professional committee of the China medical equipment Association defines it as: the method is a detection mode which is carried out on a sampling site and can quickly obtain a detection result by utilizing a portable analytical instrument and a matched reagent.

POCT is one of the most important research directions in the biomedical field at present. In recent years, based on the rapid development of semiconductor technology and the rapid progress of medical science, the POCT with miniaturized experimental apparatus, simplified operation and immediate report result is more and more favored by people due to the practical requirements of efficient and fast-paced working modes and experimental sites. At present, the mainstream POCT products in domestic and foreign markets are basically based on immunology and developed by a colloidal gold technology or a chemiluminescence technology, the POCT products aiming at nucleic acid detection are all research hotspots in the global scope, and few foreign in-vitro diagnostic reagents with core technology mastered are provided for commercial application at home and abroad.

Nucleic acid detection plays a very important role in clinical medicine, forensic identification, genetic inspection, epidemiological investigation, infectious disease prevention and control, biological terrorism and other aspects, and is widely applied to the fields of biological medicine and the like. The current methods mainly adopt PCR technology, sequencing technology, hybridization technology and the like, and have advantages and disadvantages due to different application purposes,

CN111704993A discloses an integrated molecular nucleic acid POCT device, which comprises a reagent cartridge and a cartridge bracket; different interconnected cavities are arranged in the reagent card box, and each cavity is provided with a valve switch for controlling the on-off of liquid correspondingly. The card box support provides functions such as switch break-make, piston motion, heating temperature measurement, judgement card box have for the reagent card box to play the support positioning action. The integrated device allows the direct addition of samples such as nasopharyngeal swabs, genital tract swabs, sputum, blood and the like without other processing, thereby realizing the integrated detection of 'sample in and result out'.

CN110186742A discloses a sample mixing device, the sample is sent into the reaction chamber of arranging step by step, reaction liquid has all been preset in every reaction chamber, the sample is at every reaction intracavity and its interior reaction liquid through mixing device intensive mixing, set up liquid extraction device between the two-stage reaction chamber, send into the sequent reaction chamber through the sample after pressure extraction structure preorder mixing processing, connect the reaction tube on the end reaction chamber, the sample is after each reaction intracavity reaction liquid is handled, send into the reaction tube and carry out the nucleic acid amplification reaction, handle the sample step by step through setting up a plurality of reaction chambers, carry out the transport of sample between different reaction chambers through the liquid extraction device of pressure extraction between every reaction chamber, send into the reaction tube finally and carry out the nucleic acid amplification reaction.

However, in general, the pretreatment of a sample is complicated and tedious, the amplification and detection processes are time-consuming, the detection process also needs to be precise, a large-scale, complex, precise and expensive instrument is needed, the problems of biological cross-contamination and biological safety are easily caused, the requirements on personnel, environment and instruments are high, and the method is not suitable for rapid diagnosis beside a basic bed, on site and in the field.

Disclosure of Invention

Aiming at the defects in the prior art, the invention aims to provide a nucleic acid POCT detection device and a detection method thereof, the steps of sample pretreatment, sample amplification, detection and the like in nucleic acid detection are integrated into one detection flow, and the whole detection process is completed in a relatively closed environment after a sample to be detected is added, so that the problems of integration and full sealing of nucleic acid detection are solved.

In order to achieve the purpose, the invention adopts the following technical scheme:

in a first aspect, the invention provides a nucleic acid POCT detection device, which comprises a housing assembly, wherein a consumable fixing module, a motion module and an optical path module are integrally arranged in the housing assembly, and the motion module and the optical path module are arranged on one side of the consumable fixing module after being vertically stacked.

The fixed module of consumptive material on be provided with the heating baffle, the fixed module of consumptive material be used for fixed and heating disposable consumptive material, disposable consumptive material including detecting package and amplification cabin, the detection contain nucleic acid and draw the district, before the detection begins, to adding the sample that awaits measuring in the nucleic acid extraction district, nucleic acid extraction district and amplification cabin be half a state.

The motion module include drive module and extrusion module, drive module drive extrusion module extrude the nucleic acid and draw the district for nucleic acid extraction reagent and the sample misce bene that awaits measuring.

The light path module emits exciting light to the amplification cabin and receives reflected light.

The invention integrates the steps of sample pretreatment, sample amplification, detection and the like of nucleic acid detection into a detection flow, and the whole detection process is completed in a relatively closed environment after a sample to be detected is added, so that the problems of integration and full sealing of nucleic acid detection are solved, the problems of miniaturization, quick detection, portability and the like of equipment are solved by combining the frontiers of the current electronic technology and optical technology, and the characteristics of low requirement on reaction temperature, low-purity tolerance and the like of a constant-temperature amplification technology are utilized, so that the detection system can realize quick and full-sealing integrated automatic detection of the sample nucleic acid, and can effectively prevent the problems of biological safety, cross contamination among samples, product pollution and the like in the detection process. Meanwhile, the detection device disclosed by the invention is small in size, convenient to carry, simple to train, capable of being operated, low in requirement on personnel and suitable for the requirements of various nucleic acid POCT detections. Specifically, the main advantages of the nucleic acid POCT detection device provided by the present invention are:

(1) the nucleic acid POCT detection device integrates all links (sample treatment, nucleic acid amplification and result determination) of a nucleic acid detection process, simplifies the flow of molecular diagnosis, reduces the technical threshold of integrated molecular diagnosis, has simple structure and low cost, has low professional requirement on operators, and greatly expands the application scene.

(2) According to the nucleic acid POCT detection device, each reaction chamber is independently sealed, mutual interference of each detection link is avoided, interference of an external environment on a detection process can be prevented, and high accuracy of results is ensured.

(3) The operator only needs to add the sample into the nucleic acid extraction area, and the subsequent processes are automatically completed by a nucleic acid POCT detection system, so that the automation of the nucleic acid detection process is realized.

(4) The nucleic acid POCT detection device provided by the invention adopts disposable consumables, and different extraction reagents and reaction reagents are contained in reagent cavities of different detection devices, so that the detection devices can be selected in a targeted manner according to samples to be analyzed, and different samples can be analyzed quickly. The amplification and detection analysis can be completed in the amplification detection chamber, and the operation is simple.

As a preferred technical solution of the present invention, the housing assembly includes a main housing, a top housing and a bottom housing, the top housing is detachably mounted on the top of the main housing, and the bottom housing is detachably mounted on the bottom of the main housing.

Preferably, the top shell is provided with a sample insertion opening, the top shell is provided with a flip, and the flip covers the sample insertion opening after being closed.

Preferably, a touch screen fixing shell is arranged on one side face of the main case, a touch screen is arranged on the touch screen fixing shell, and the touch screen is used for manual interaction and result display.

Preferably, a touch screen cover plate is further arranged on the outer side of the touch screen and used for protecting the touch screen.

Preferably, a code scanner electrically connected with the touch screen is arranged below the touch screen, and the code scanner is used for reading and identifying basic information of the disposable consumables.

In the invention, the two-dimensional code on the disposable consumable is scanned to identify the corresponding program of the disposable consumable and the detection device, the two-dimensional code information (such as information of consumable date and batch) is displayed on the touch screen after passing, and if the two-dimensional code does not pass, the touch screen of the instrument prompts that the two-dimensional code is invalid or the code is scanned again, so that whether the disposable consumable is used or not is judged.

Preferably, a code scanning baffle is further arranged on the outer side of the code scanner and used for protecting the code scanner.

Preferably, the inner surface of the shell assembly is sprayed with conductive paint.

Preferably, a bottom plate is fixed on the bottom surface inside the shell assembly, and the bottom plate is used for fixing the module inside the shell assembly.

As a preferable technical scheme, the disposable consumable comprises a first consumable support, a detection bag and a second consumable support which are sequentially laminated and fixed, and the detection bag is fixed after the first consumable support and the second consumable support are relatively buckled.

Preferably, a plastic nozzle and an amplification cabin are respectively fixed at two ends of the detection bag.

Preferably, one end of the detection bag is fixed with the plastic nozzle in a heat sealing mode.

Preferably, the other end of the detection bag is fixed with the amplification cabin in a heat sealing mode.

Preferably, the central area of the detection packet is a nucleic acid extraction area, two ends of the nucleic acid extraction area are respectively communicated with the plastic nozzle and the amplification cabin, a sample to be detected is added into the nucleic acid extraction area through the plastic nozzle, and a nucleic acid extraction reagent in the nucleic acid extraction area and a reagent mixture obtained after the reaction of the sample to be detected are fed into the amplification cabin.

Preferably, a plastic nozzle cover is arranged at the nozzle of the plastic nozzle and used for plugging the nozzle of the plastic nozzle.

Preferably, the plastic mouth cover and the plastic mouth are fixed in a plug-in or threaded manner.

Preferably, the plastic mouth cover is screwed into the mouth of the plastic mouth, the sample to be detected is added to the nucleic acid extraction area through the plastic mouth after the plastic mouth cover is unscrewed, and the plastic mouth cover is screwed after the sample addition is finished.

Preferably, the fixed area of the detection packet and the amplification cabin is a cavity structure, a filter element is arranged in the cavity structure, and a reagent mixture obtained by reaction in the detection packet enters the amplification cabin after being filtered by the filter element.

In the invention, the filter element has two main functions, one is used for preventing the amplification system dry powder in the amplification detection area from transferring to the detection packet due to the negative pressure generated by the restoration when the amplification detection area and the nucleic acid extraction area are restored, so that the amplification reaction can not be detected; secondly, the nucleic acid sample extracted from the nucleic acid extraction area is filtered when entering the amplification detection area, so that the purification effect on the nucleic acid of the pretreatment sample is achieved.

Preferably, one side of the nucleic acid extraction area, which is close to the plastic nozzle, is marked as a compaction area, and the driving module drives the fixing module to compact the compaction area for isolating the plastic nozzle from the nucleic acid extraction area.

Preferably, one side of the nucleic acid extraction area close to the amplification cabin is marked as a semi-sealed area, and the driving module drives the fixing module to press the semi-sealed area for isolating the nucleic acid extraction area from the amplification cabin.

Preferably, the amplification cabin in be provided with the amplification detection zone of transparent shell, after the nucleic acid extraction reaction, open the nucleic acid and draw the area and amplify the semi-enclosed region between the cabin, reagent mixture gets into the amplification detection zone under the extrusion of extrusion module, the exciting light that the light path module sent sees through the transparent shell of amplification detection zone and shines to reagent mixture, the reverberation passes the transparent shell of amplification detection zone and is received by the light path module.

Preferably, the amplification detection area is divided into at least one detection subarea which are mutually independent, and freeze-dried powder is filled in the detection subarea.

The invention divides the amplification detection area into a plurality of detection subareas, and can carry out different detections on the same sample to be detected.

As a preferred technical scheme, the consumable fixing module comprises a consumable fixing plate and a heat insulation plate, a guide cavity is formed between the consumable fixing plate and the heat insulation plate, the disposable consumable is inserted into the guide cavity, and the disposable consumable is fixed after the consumable fixing plate and the heat insulation plate are relatively attached.

Preferably, one side of the consumable fixing plate close to the heat insulation plate is marked as a binding face, three side edges of the binding face of the consumable fixing plate are provided with U-shaped protruding guide rails, and after the consumable fixing plate and the heat insulation plate are relatively bound, the protruding guide rails are in contact with the heat insulation plate to form the guide cavity between the consumable fixing plate and the heat insulation plate.

Preferably, the nucleic acid POCT detection device is in a normal working state, the consumable fixing module is vertically fixed on the bottom plate, and the disposable consumable is vertically inserted into the guide cavity from the top of the consumable fixing module.

Preferably, the bottom of the guide cavity is provided with a travel limit switch clamping groove, a travel limit switch is arranged in the travel limit switch clamping groove, the disposable consumables are completely inserted into the guide cavity and then touch the travel limit switch, and the nucleic acid POCT detection device responds to confirm that the disposable consumables are successfully inserted.

Preferably, the central area of the consumable fixing plate is provided with a rectangular through groove, and after the disposable consumable is inserted into the guide cavity, the detection bag is exposed outside through the rectangular through groove.

Preferably, one side surface, away from the heat insulation plate, of the consumable fixing plate is marked as a back-off surface, an annular step groove is formed in the back-off surface of the consumable fixing plate and comprises two layers of annular steps, and a biconvex lens is embedded in the annular step of the inner layer.

Preferably, a lens pressing ring is arranged in the annular step of the outer layer, and the lens pressing ring is used for fixing the biconvex lens at the annular step of the inner layer.

Preferably, the binding surface of the consumable fixing plate is provided with a rectangular groove, and the rectangular groove and the circular stepped groove are corresponding in position and are communicated with each other; the reaction device pressing block is embedded in the rectangular groove and used for pressing the amplification cabin, and excitation light emitted by the light path module penetrates through the reaction device pressing block to irradiate the amplification cabin after being converged and enhanced by the biconvex lens.

Preferably, one side face, away from the consumable fixing plate, of the heat insulation plate is marked as a back-off face, a first fan square groove and a second fan square groove are formed in the back-off face of the heat insulation plate, a group of fans are arranged in the first fan square groove and the second fan square groove respectively, and air flow generated by the fans penetrates through the heat insulation plate to blow to the guide cavity for cooling disposable consumables in the guide cavity.

Preferably, one side face, close to the consumable fixing plate, of the heat insulation plate is marked as a binding face, and the binding face of the heat insulation plate is provided with a first square groove and a second square groove.

Preferably, the first square groove corresponds to and is communicated with the first fan square groove, and the second square groove corresponds to and is communicated with the second fan square groove.

Preferably, the contour dimension of the second square groove is smaller than that of the second fan square groove.

Preferably, the second square groove corresponds to and is communicated with the central area of the second fan square groove.

Preferably, a heating baffle is embedded in the first square groove, and a heating plate of the reaction device is embedded in the second square groove.

Preferably, the surface of the reaction device heating plate is further provided with a reaction device pressing block, and the reaction device pressing block is used for fixing the reaction device heating plate in the second square groove.

Preferably, the consumable fixing module further comprises a supporting block, wherein the supporting block is located on one side of the width of the bottom of the consumable fixing plate and the bottom of the heat insulation plate and is used for fixing the consumable fixing plate and the heat insulation plate on the bottom plate.

Preferably, the movement module and the light path module are arranged in an up-down stacked manner and then are positioned on one side of the consumable fixing plate.

As a preferred technical solution of the present invention, the motion module includes a main module and control modules located on two opposite sides of the main module.

Preferably, the master module group include drive module, two fixed modules and at least one extrusion module, fixed module and extrusion module transversely arrange side by side in vertical direction, the extrusion module be located between two fixed modules, transversely arrange fixed module and extrusion module side by side and the disposable consumptive material cooperation of vertical arrangement, the realization is to nucleic acid extraction reagent in the disposable consumptive material and the sample that awaits measuring extrude and mix.

Preferably, the two fixing modules are respectively and correspondingly arranged in the compressing area and the semi-sealing area of the disposable consumable, and the driving module respectively drives the two fixing modules to move and fix the two fixing modules to the compressing area and the semi-sealing area, so that the nucleic acid extracting area between the compressing area and the semi-sealing area forms a closed space.

Preferably, the extrusion module set up in the nucleic acid extraction district of disposable consumptive material correspondingly, the drive module be used for driving the extrusion module and make reciprocating motion in the horizontal direction, extrude nucleic acid extraction reagent and the sample that awaits measuring in the nucleic acid extraction district.

Preferably, the reciprocating directions of two adjacent extrusion modules are opposite, while one extrusion module retracts to separate from the nucleic acid extraction area, the other extrusion module pushes out the extrusion nucleic acid extraction area, so that the nucleic acid extraction reagent and the sample to be detected are uniformly mixed.

Preferably, the driving module comprises at least three groups of driving assemblies arranged side by side in the vertical direction, and each group of driving assemblies is in independent transmission connection with the extrusion module or the fixing module respectively.

Preferably, the driving assembly in transmission connection with the fixed module comprises a motor, a gear and a trapezoidal screw rod which are in transmission connection in sequence, the motor drives the trapezoidal screw rod to rotate through the gear, and the trapezoidal screw rod drives the corresponding fixed module to move and be fixed to the semi-sealing area or the pressing area.

Preferably, the driving assembly in transmission connection with the extrusion module comprises a motor in transmission connection and a motor guide shaft, the motor is in transmission connection with the corresponding extrusion module through the motor guide shaft, and the extrusion module reciprocates in the horizontal direction along the motor guide shaft to extrude the nucleic acid extraction zone.

Preferably, the fixed module comprises a fixed push plate guide block, a fixed push plate connecting block and a consumable pressing sheet which are sequentially connected, the fixed push plate guide block is in transmission connection with the trapezoidal screw rod, and the consumable pressing sheet is in direct contact with the semi-sealing area or the pressing area.

Preferably, the fixed push plate guide block is connected with the fixed push plate connecting block through a snap spring shaft, a spring is sleeved on the periphery of the snap spring shaft, and a snap spring is arranged at the connecting end of the snap spring shaft and the fixed push plate guide block.

Preferably, the extrusion module connect even piece and consumptive material push pedal including the extrusion push pedal guide block, the extrusion push pedal that connect gradually, the extrusion push pedal guide block be connected with the motor guiding axle transmission, consumptive material push pedal and nucleic acid extraction district direct contact.

Preferably, the extrusion push pedal guide block pass through jump ring hub connection extrusion push pedal connecting block, the periphery cover of jump ring axle be equipped with the spring, the jump ring axle is provided with the jump ring with the link of extrusion push pedal guide block.

Preferably, the contact surface of the consumable push plate and the nucleic acid extraction area is provided with a heating film, and the heating film heats the nucleic acid extraction area.

Preferably, the moving module further comprises a bearing mounting plate, the bearing mounting plate is of a groove structure, and the fixing module and the extrusion module are arranged in a groove of the bearing mounting plate.

Preferably, a motor guide shaft pressing plate is arranged at the opening of the groove of the bearing mounting plate and used for fixing the fixing module and the extrusion module in the groove of the bearing mounting plate.

Preferably, the motion module still include the motor mounting panel, the motor mounting panel be groove structure, the motor set up in the recess of motor mounting panel.

Preferably, the groove opening of the motor mounting plate is provided with a motor pressing block, and the motor pressing block is used for fixing the motor in the groove of the motor mounting plate.

Preferably, the control module group including set up respectively in the spacing PCB board of main module group motor and the master control PCB board of the relative both sides face of main module group, spacing PCB board of motor and motor electric connection for the motion stroke of control motor, the master control PCB board be used for nucleic acid POCT detection device's whole operation control.

As a preferred technical scheme of the invention, the nucleic acid POCT detection device also comprises a limiting module, wherein the limiting module is positioned below the top shell and is used for fixing the consumable fixing module and sensing whether the turnover cover is completely closed or not.

The limiting module comprises a limiting plate located right below the plastic top shell, the limiting plate is of a square structure, two opposite sides are marked as guiding sides, and the other two sides are respectively marked as limiting sides and transmission sides.

Preferably, the transmission side of the limiting plate is in transmission connection with one side of the rotating shaft of the flip through a connecting rod shaft.

Preferably, one end of the connecting rod shaft connected with the turnover cover is provided with a snap spring pin.

Preferably, the guiding edge of limiting plate both sides is provided with the cylinder guide shaft respectively, cylinder guide shaft periphery cover be equipped with spacing deflector, spacing deflector be fixed in the both sides of top shell below, along with flip opens and shuts, slide along the spacing deflector of both sides by connecting rod axle drive limiting plate.

Preferably, the limiting guide plate is provided with a marble fixing hole, a marble spring is embedded into the marble fixing hole, a marble is placed into the marble spring, and the rotation angle of the flip cover is controlled through the degree of tightness of the marble and the marble spring.

Preferably, a square notch is formed in the limiting edge of the limiting plate, and a limiting switch is embedded in the square notch; flip is at closed in-process, and flip promotes the limiting plate through the connecting rod axle and removes to the fixed module direction of consumptive material, supports to the fixed module of consumptive material until square notch.

As a preferable technical scheme, the nucleic acid POCT detection device further comprises a fan module, and the fan module is used for cooling the disposable consumables in an air cooling mode.

Preferably, the fan module is disposed on one side of the whole formed by stacking the motion module and the light path module.

Preferably, the fan module and the consumable fixing module are respectively located at two adjacent sides of the whole body formed by the up-down stacked arrangement of the moving module and the light path module.

In a second aspect, the present invention provides a nucleic acid POCT detection method for performing nucleic acid POCT detection using the nucleic acid POCT detection apparatus according to the first aspect, the detection method comprising:

sample adding: before the detection starts, adding a sample to be detected into the nucleic acid extraction area, inserting the disposable consumable after the sample addition into the consumable fixed module, and starting the operation of the detection device;

(II) extraction: the heating baffle and the extrusion module heat the nucleic acid extraction area, the driving module drives the extrusion module to extrude the nucleic acid extraction area, and the nucleic acid extraction reagent and the sample to be detected are uniformly mixed to complete the nucleic acid extraction reaction;

(III) detection: and the reagent mixture obtained by the nucleic acid extraction reaction is pushed into the amplification chamber under the extrusion of the motion module to carry out the nucleic acid amplification reaction, the light path module emits exciting light to the expansion chamber and receives reflected light, and the test result is displayed after data processing.

As a preferred technical scheme of the invention, the step (I) specifically comprises the following steps:

(1) adding a sample to be detected into the nucleic acid extraction area through a plastic nozzle, and screwing down a plastic nozzle cover;

(2) starting a power supply of the detection device, scanning the two-dimensional code on the disposable consumable through the code scanner, and identifying and reading basic information of the disposable consumable;

(3) opening the turnover cover, inserting the disposable consumables into the guide cavity along the raised guide rail in the consumable fixing plate until the travel limit switch at the bottom of the guide cavity is triggered, and starting the detection device when the detection device is judged that the disposable consumables are successfully inserted; otherwise, the detection device is regarded as not inserting the disposable consumable, the detection device can not be started normally, the disposable consumable is inserted again until triggering the travel limit switch, and then the flip cover is closed;

(4) in the process of closing the flip cover, the flip cover pushes the limiting plate to move towards the consumable fixing module through the connecting rod shaft until the square notch of the limiting plate abuts against the consumable fixing module, and when the limiting switch is tightly contacted and attached with the top shell, the detection device senses that the flip cover is completely closed and starts; when the limit switch is not tightly contacted with the top shell, the detection device judges that the flip cover is not completely closed, and the flip cover is closed again until the limit switch is tightly contacted with the top shell.

As a preferred technical solution of the present invention, the step (ii) specifically comprises:

(a) the heating baffle on the consumable fixing module and the heating film arranged on the extrusion module heat the nucleic acid extraction area, extraction reaction starts in the nucleic acid extraction area, and the movement module starts to work at the same time;

(b) the motor respectively and independently drives the two consumable pressing sheets to respectively press the semi-sealing area and the pressing area of the detection package, so that a relatively sealed cavity is formed in the nucleic acid extraction area;

(c) the motor drives the consumable push plates to do reciprocating motion in the horizontal direction in the nucleic acid extraction area, the nucleic acid extraction area is extruded in a single direction, the motion directions of two adjacent consumable push plates are opposite, a nucleic acid extraction reagent in the nucleic acid extraction area is mixed with a sample to be detected, and the nucleic acid extraction area is heated through a heating film in the nucleic acid extraction process;

(d) after the extraction reaction is finished, the consumable material pressing sheet of the compaction semi-sealing area is reset, and the fan module is used for cooling the nucleic acid extraction area by air; fall to and predetermine the temperature after the fan module and close, motor drive extrusion module releases in the horizontal direction, thereby each extrusion module extrudes the nucleic acid extraction district by the reagent mixture of plastics mouth in to the amplification cabin direction in proper order with the nucleic acid detection area, extrudees into the amplification cabin.

As a preferred technical solution of the present invention, the step (iii) specifically includes:

after the reagent mixture enters the amplification cabin, heating the amplification cabin by a heating plate of the reaction device to perform nucleic acid amplification reaction;

(ii) the light path module emits exciting light to the expansion cabin and receives reflected light, and simultaneously performs data processing on the reflected light received by the light path module and transmits the obtained detection result to the display screen;

(iii) after the amplification reaction is finished, cooling the amplification cabin by the fan module, and resetting the extrusion module and the fixing module.

The system refers to an equipment system, or a production equipment.

Compared with the prior art, the invention has the beneficial effects that:

Drawings

FIG. 1 is an exploded view of a detection device according to an embodiment of the present invention;

FIG. 2 is an exploded view of a housing assembly according to one embodiment of the present invention;

FIG. 3 is an exploded view of a consumable fixing module according to an embodiment of the present invention;

FIG. 4(a) is a schematic structural diagram of a bonding surface of a consumable fixing plate according to an embodiment of the present invention;

FIG. 4(b) is a schematic structural diagram of the back side of the consumable fixing plate according to one embodiment of the present invention;

FIG. 5(a) is a schematic structural view of a bonding surface of a heat shield according to an embodiment of the present invention;

FIG. 5(b) is a schematic structural view of the back side of the thermal insulation panel according to an embodiment of the present invention;

FIG. 6 is an exploded view of a motion module according to an embodiment of the present invention;

FIG. 7 is a schematic structural diagram of a fixing module according to an embodiment of the present invention;

FIG. 8 is a schematic structural diagram of an extrusion die set according to an embodiment of the present invention;

FIG. 9 is a diagram illustrating an assembly relationship between a position limiting module and a top housing according to an embodiment of the present invention;

fig. 10 is a schematic disassembled structural view of a limiting module according to an embodiment of the present invention;

FIG. 11(a) is a schematic view of the assembly of a first consumable rack and a second consumable rack according to one embodiment of the present invention;

fig. 11(b) is a schematic structural diagram of a detection packet according to an embodiment of the present invention.

Wherein, 1-a housing assembly; 2-a touch screen; 3-a code scanner; 4-consumable fixing module; 5-a motion module; 6-an optical path module; 7-a fan module; 8-a limiting module; 9-a bottom plate; 10-disposable consumables; 11-a flip cover; 12-a top shell; 13-main chassis; 14-a touch screen fixed shell; 15-touch the membrane screen cover plate; 16-a code-scanning baffle; 17-a bottom shell; 18-consumable fixing plate; 19-a lenticular lens; 20-a lens press ring; 21-briquetting of the reaction device; 22-reaction unit heating plate; 23-a heating baffle; 24-a travel limit switch; 25-a heat insulation plate; 26-a fan; 27-a support block; 28-motor briquetting; 29-a motor; 30-a motor mounting plate; 31-a gear; 32-trapezoidal lead screw; 33-bearing mounting plate; 34-an extrusion die set; 35-a fixed module; 36-motor guide shaft; 37-motor guide shaft pressure plate; 38-motor limit PCB board; 39-master control PCB board; 40-extruding the push plate guide block; 41-circlip shaft; 42-a clamp spring; 43-a spring; 44-extruding the push plate to connect the connecting block; 45-consumable push plate; 46-connecting the fixed push plate with the connecting block; 47-consumable tabletting; 48-connecting rod shaft; 49-circlip pin; 50-a limiting plate; 51-a limit guide plate; 52-a marble; 53-limit switches; 54-a first consumable rack; 55-a second consumable support; 56-detection packet; 57-plastic spout cover; 58-plastic spout; 59-a filter element; 60-an amplification chamber; 61-fixing the push plate guide block; 181-raised rail; 182-rectangular groove; 183-limit switch card slot; 184-annular stepped groove; 185-rectangular through slot; 251-a first square groove; 252-a second square groove; 253-first fan square groove; 254-second fan square groove; 501-cylindrical guide shaft; 502-square notch; 511-marble fixing holes; 561-a compression zone; 562-nucleic acid extraction zone; 563-semi-enclosed region; 601-amplifying the detection zone.

Detailed Description

It is to be understood that in the description of the present invention, the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be taken as limiting the present invention. Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

It should be noted that, in the description of the present invention, unless otherwise explicitly specified or limited, the terms "disposed," "connected" and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

The technical scheme of the invention is further explained by the specific implementation mode in combination with the attached drawings.

In one embodiment, the invention provides a nucleic acid POCT detection apparatus, as shown in fig. 1, the nucleic acid POCT detection apparatus includes a housing assembly 1, a consumable fixing module 4, a moving module 5 and an optical path module 6 are integrally disposed in the housing assembly 1, and the moving module 5 and the optical path module 6 are disposed on one side of the consumable fixing module 4 after being stacked up and down. The consumable fixing module 4 is provided with a heating baffle 23, and the consumable fixing module 4 is used for fixing and heating the disposable consumable 10. As shown in FIG. 11(b), the disposable consumable 10 comprises a detection packet 56 and an amplification chamber 60, wherein the central region of the detection packet 56 is a nucleic acid extraction region 562, a sample to be tested is added into the nucleic acid extraction region 562 before the detection is started, and the nucleic acid extraction region 562 and the amplification chamber 60 are in a half-sealed state. The motion module 5 comprises a driving module and an extrusion module 34, wherein the driving module drives the extrusion module 34 to extrude the nucleic acid extraction area 562, so that the nucleic acid extraction reagent and the sample to be detected are uniformly mixed. The light path block 6 emits the excitation light to the amplification chamber 60 and receives the reflected light.

As shown in fig. 2, the housing assembly 1 includes a main chassis 13, a top chassis 12 and a bottom chassis 17, wherein the top chassis 12 is detachably mounted on the top of the main chassis 13, and the bottom chassis 17 is detachably mounted on the bottom of the main chassis 13. A sample insertion opening is formed in the top shell 12, a flip 11 is arranged on the top shell 12, and the flip 11 covers the sample insertion opening after being closed. A touch screen fixing shell 14 is arranged on one side face of the main case 13, a touch screen 2 is arranged on the touch screen fixing shell 14, and the touch screen 2 is used for manual interaction and result display. The outer side of the touch screen 2 is also provided with a touch screen cover plate 15, and the touch screen cover plate 15 is used for protecting the touch screen 2. A code scanner 3 electrically connected with the touch screen 2 is arranged below the touch screen 2, and the code scanner 3 is used for reading and identifying basic information of the disposable consumable 10. A code scanning baffle 16 is further arranged outside the code scanner 3, and the code scanning baffle 16 is used for protecting the code scanner 3. The inner surface of the shell assembly 1 is sprayed with conductive paint, a bottom plate 9 is fixed on the bottom surface inside the shell assembly 1, and the bottom plate 9 is used for fixing modules inside the shell assembly 1.

As shown in fig. 11(a) and 11(b), the disposable consumable 10 includes a first consumable support 54, a detection pack 56 and a second consumable support 55, which are sequentially stacked and fixed, and the detection pack 56 is fixed after the first consumable support 54 and the second consumable support 55 are relatively buckled. As shown in FIG. 11(b), a plastic nozzle 58 and an amplification chamber 60 are fixed to both ends of the detection pack 56, respectively, one end of the detection pack 56 is heat-sealed and fixed to the plastic nozzle 58, and the other end of the detection pack 56 is heat-sealed and fixed to the amplification chamber 60. The central area of the detection packet 56 is a nucleic acid extraction area 562, two ends of the nucleic acid extraction area 562 are respectively communicated with the plastic nozzle 58 and the amplification cabin 60, a sample to be detected is added into the nucleic acid extraction area 562 through the plastic nozzle 58, and a nucleic acid extraction reagent in the nucleic acid extraction area 562 and a reagent mixture obtained after the reaction of the sample to be detected enter the amplification cabin 60.

As shown in fig. 11(b), a plastic nozzle cover 57 is provided at the nozzle of the plastic nozzle 58, and the plastic nozzle cover 57 is used for sealing the nozzle of the plastic nozzle 58; furthermore, the plastic nozzle cover 57 and the plastic nozzle 58 are fixed in a plug-in or threaded manner; furthermore, the plastic nozzle cover 57 is screwed into the nozzle of the plastic nozzle 58, the sample to be tested is added to the nucleic acid extraction region 562 through the plastic nozzle 58 after the plastic nozzle cover 57 is unscrewed, and the plastic nozzle cover 57 is screwed after the sample injection is completed. The fixed area of the detection packet 56 and the amplification chamber 60 is a cavity structure, a filter element 59 is arranged in the cavity structure, and a reagent mixture obtained by reaction in the detection packet 56 enters the amplification chamber 60 after being filtered by the filter element 59.

As shown in FIG. 11(b), the side of the nucleic acid extracting region 562 near the plastic nozzle 58 is marked as a compacting region 561, and the driving module drives the fixing module 35 to be fixed in the compacting region 561 for isolating the plastic nozzle 58 from the nucleic acid extracting region 562; one side of the nucleic acid extraction region 562 close to the amplification chamber 60 is marked as a semi-sealed region 563, and the driving module drives the fixing module 35 to compress the semi-sealed region 563 for isolating the nucleic acid extraction region 562 from the amplification chamber 60. An amplification detection area 601 with a transparent shell is arranged in the amplification cabin 60, freeze-dried powder is filled in the amplification detection area 601, and the freeze-dried powder is used for nucleic acid amplification. After the nucleic acid extraction reaction is finished, the semi-sealed region 563 between the nucleic acid extraction region 562 and the amplification chamber 60 is opened, the reagent mixture enters the amplification detection region 601 under the extrusion of the extrusion module 34, the exciting light emitted by the light path module 6 irradiates to the reagent mixture through the transparent shell of the amplification detection region 601, and the reflected light passes through the transparent shell of the amplification detection region 601 and is received by the light path module 6. The amplification detection area 601 is divided into at least one detection subarea which are mutually independent, and freeze-dried powder is filled in the detection subarea.

As shown in fig. 3, the consumable fixing module 4 comprises a consumable fixing plate 18 and a thermal insulation plate 25, and one side of the consumable fixing plate 18 close to the thermal insulation plate 25 is marked as an attaching surface. Three side edges along the binding face of consumable fixing plate 18 are provided with protruding guide rail 181 of U-shaped (see fig. 4 (a)), and after consumable fixing plate 18 and heat insulating board 25 laminated relatively, protruding guide rail 181 contacted with heat insulating board 25 thereby formed the direction cavity between consumable fixing plate 18 and heat insulating board 25, and disposable consumptive material 10 inserts the direction cavity, and consumable fixing plate 18 and heat insulating board 25 laminated relatively after-fixing disposable consumptive material 10. Under normal operating condition, the nucleic acid POCT detection device is vertically fixed on the bottom plate 9 by the consumable fixing module 4, and the disposable consumable 10 is vertically inserted into the guide cavity from the top of the consumable fixing module 4. The bottom of the guide cavity is provided with a stroke limit switch clamping groove 183, the stroke limit switch 24 is arranged in the stroke limit switch clamping groove 183, the disposable consumable 10 is completely inserted into the guide cavity and then touches the stroke limit switch 24, and the nucleic acid POCT detection device senses and confirms that the disposable consumable 10 is successfully inserted. The central area of the consumable fixing plate 18 is provided with a rectangular through slot 185, and after the disposable consumable 10 is inserted into the guide cavity, the detection bag 56 is exposed through the rectangular through slot 185.

One side face, away from the heat insulation plate 25, of the consumable fixing plate 18 is marked as a back-off face, an annular step groove 184 is formed in the back-off face of the consumable fixing plate 18, the annular step groove 184 comprises two layers of annular steps (see fig. 4 (b)), the annular step of the inner layer is embedded into the double-convex lens 19, a lens pressing ring 20 is arranged in the annular step of the outer layer, and the lens pressing ring 20 is used for fixing the double-convex lens 19 to the annular step of the inner layer. The bonding surface of the consumable fixing plate 18 is provided with a rectangular groove 182, the rectangular groove 182 corresponds to the circular stepped groove in position and is communicated with the circular stepped groove, a reaction device pressing block 21 is embedded in the rectangular groove 182, the reaction device pressing block 21 is used for pressing the amplification chamber 60, and excitation light emitted by the light path module 6 is converged and enhanced by the biconvex lens 19 and then passes through the reaction device pressing block 21 to irradiate the amplification chamber 60.

As shown in fig. 5(a) and 5(b), one side surface of the heat insulation board 25 away from the consumable fixing plate 18 is referred to as a back-off surface, a first fan square groove 253 and a first fan square groove 254 are formed on the back-off surface of the heat insulation board 25, a set of fans 26 are respectively arranged in the first fan square groove 253 and the first fan square groove 254, and air flow generated by the fans 26 passes through the heat insulation board 25 and is blown to the guide cavity for cooling the disposable consumable 10 in the guide cavity (see fig. 5 (b)). One side surface of the heat insulation plate 25 close to the consumable fixing plate 18 is marked as an attaching surface, and the attaching surface of the heat insulation plate 25 is provided with a first square groove 251 and a second square groove 252. The first square groove 251 corresponds to and communicates with the first fan square groove 253, the second square groove 252 has a smaller contour dimension than the first fan square groove 254, and the second square groove 252 corresponds to and communicates with the center region of the first fan square groove 254. The heating baffle 23 is embedded in the first square groove 251, the heating plate 22 of the reaction device is embedded in the second square groove 252, and the reaction device pressing block 21 is further disposed on the surface of the heating plate 22 of the reaction device, and the reaction device pressing block 21 is used for fixing the heating plate 22 of the reaction device in the second square groove 252 (see fig. 5 (a)).

As shown in FIG. 3, the consumable fixing module 4 further comprises a supporting block 27, and the supporting block 27 is located at one side of the bottom width of the consumable fixing plate 18 and the thermal shield 25, and is used for fixing the consumable fixing plate 18 and the thermal shield 25 on the bottom plate 9. The moving module 5 and the light path module 6 are arranged in an up-and-down stacked manner and then are positioned on one side of the consumable fixing plate 18.

As shown in fig. 6, the motion module 5 includes the master module and the control module that is located the relative both sides face of master module, the master module includes the drive module, two fixed modules 35 and at least one extrusion module 34, fixed module 35 and extrusion module 34 transversely arrange side by side in vertical direction, extrusion module 34 is located between two fixed modules 35, transversely arrange side by side fixed module 35 and extrusion module 34 cooperate with the disposable consumptive material 10 of vertical arrangement, the realization is to nucleic acid extraction reagent in the disposable consumptive material 10 and the sample that awaits measuring extrude and mix.

Two fixed modules 35 correspond respectively and set up in the district 561 and half a district 563 of compressing tightly of disposable consumptive material 10, and the drive module drives two fixed modules 35 respectively and removes and fix to compressing tightly district 561 and half a district 563 for compress tightly the nucleic acid extraction district 562 between district 561 and the half a district 563 and form the enclosure space. The extrusion module 34 is correspondingly disposed in the nucleic acid extraction area 562 of the disposable consumable 10, and the driving module is used for driving the extrusion module 34 to reciprocate in the horizontal direction, so as to extrude the nucleic acid extraction reagent and the sample to be detected in the nucleic acid extraction area 562. The reciprocating directions of the two adjacent extrusion modules 34 are opposite, and when one extrusion module 34 is withdrawn and separated from the nucleic acid extraction area 562, the other adjacent extrusion module 34 pushes out the extrusion nucleic acid extraction area 562, so that the nucleic acid extraction reagent and the sample to be detected are uniformly mixed.

The driving module comprises at least three groups of driving components which are arranged side by side in the vertical direction, and each group of driving components is in independent transmission connection with the extrusion module 34 or the fixed module 35 respectively. The driving assembly in transmission connection with the fixed module 35 comprises a motor 29, a gear 31 and a trapezoidal screw 32 which are in transmission connection in sequence, the motor 29 drives the trapezoidal screw 32 to rotate through the gear 31, and the trapezoidal screw 32 drives the corresponding fixed module 35 to move and be fixed to the semi-sealing area 563 or the pressing area 561. The driving component in transmission connection with the extrusion module 34 comprises a motor 29 and a motor guide shaft 36 in transmission connection, the motor 29 is in transmission connection with the corresponding extrusion module 34 through the motor guide shaft 36, and the extrusion module 34 reciprocates in the horizontal direction along the motor guide shaft 36 to extrude the nucleic acid extraction zone 562.

As shown in fig. 7, the fixing module 35 includes a fixing push plate guide block 61, a fixing push plate connecting block 46 and a consumable tablet 47, which are connected in sequence, the fixing push plate guide block 61 is in transmission connection with the trapezoidal screw 32, and the consumable tablet 47 is in direct contact with the semi-sealed region 563 or the compacting region 561. The fixed push plate guide block 61 is connected with the fixed push plate connecting block through a clamp spring shaft 41, a spring 43 is sleeved on the periphery of the clamp spring shaft 41, and a clamp spring 42 is arranged at the connecting end of the clamp spring shaft 41 and the fixed push plate guide block 61. As shown in FIG. 8, the extrusion module 34 comprises an extrusion push plate guide block 40, an extrusion push plate connection block 44 and a consumable push plate 45 which are connected in sequence, the extrusion push plate guide block 40 is in transmission connection with the motor guide shaft 36, and the consumable push plate 45 is in direct contact with the nucleic acid extraction region 562. The extrusion push plate guide block 40 is connected with the extrusion push plate connecting block through a clamp spring shaft 41, a spring 43 is sleeved on the periphery of the clamp spring shaft 41, and a clamp spring 42 is arranged at the connecting end of the clamp spring shaft 41 and the extrusion push plate guide block 40. The contact surface of the consumable push plate 45 and the nucleic acid extraction area 562 is provided with a heating film which heats the nucleic acid extraction area 562.

As shown in fig. 6, the moving module 5 further includes a bearing mounting plate 33 and a motor mounting plate 30, the bearing mounting plate 33 is a groove structure, and the fixing module 35 and the extruding module 34 are disposed in the groove of the bearing mounting plate 33. A motor guide shaft pressing plate 37 is arranged at the opening of the groove of the bearing mounting plate 33, and the motor guide shaft pressing plate 37 is used for fixing the fixing module 35 and the extrusion module 34 in the groove of the bearing mounting plate 33. The motor mounting plate 30 is a groove structure, and the motor 29 is arranged in the groove of the motor mounting plate 30. A motor 29 pressing block 28 is arranged at the opening of the groove of the motor mounting plate 30, and the motor 29 pressing block 28 is used for fixing the motor 29 in the groove of the motor mounting plate 30.

As shown in fig. 6, the control module comprises a main module motor limiting PCB 38 and a main control PCB 39 respectively disposed on two opposite sides of the main module, the motor limiting PCB 38 is electrically connected to the motor 29 for controlling the movement stroke of the motor 29, and the main control PCB 39 is used for controlling the overall operation of the nucleic acid POCT detection apparatus.

As shown in fig. 9 and 10, the nucleic acid POCT detection device further includes a limiting module 8, the limiting module 8 is located below the top case 12, and the limiting module 8 is used for fixing the consumable fixing module 4 and sensing whether the flip cover 11 is completely closed. The limiting module 8 comprises a limiting plate 50 located right below the plastic top shell 12, the limiting plate 50 is of a square structure, wherein two opposite sides are marked as guiding sides, and the other two sides are marked as limiting sides and transmission sides respectively. The transmission edge of the limit plate 50 is in transmission connection with one edge of the rotating shaft of the flip 11 through a connecting rod shaft 48, and one end of the connecting rod shaft 48 connected with the flip 11 is provided with a snap spring pin 49. As shown in fig. 10, the guiding edges at two sides of the limiting plate 50 are respectively provided with a cylindrical guiding shaft 501, the outer circumference of the cylindrical guiding shaft 501 is sleeved with a limiting guiding plate 51, the limiting guiding plate 51 is fixed at two sides below the top shell 12, and the limiting plate 50 is driven by the connecting rod shaft 48 to slide along the limiting guiding plates 51 at two sides along with the opening and closing of the flip 11. The limiting guide plate 51 is provided with a marble fixing hole 511, a marble spring is embedded into the marble fixing hole 511, a marble 52 is placed into the marble spring, and the rotation angle of the flip cover 11 is controlled through the degree of tightness of matching between the marble 52 and the marble spring. Square notch 502 has been seted up to limiting plate 50's spacing limit, and square notch 502 department imbeds limit switch 53, and flip 11 is at closed in-process, and flip 11 promotes limiting plate 50 through connecting rod shaft 48 and removes to the fixed module 4 direction of consumptive material, and until square notch 502 supports to the fixed module 4 of consumptive material.

Nucleic acid POCT detection device still includes fan module 7, and fan module 7 is used for carrying out the forced air cooling to disposable consumptive material 10, and the whole one side that forms after motion module 5 and the upper and lower range upon range of arrangement of light path module 6 is provided with fan module 7. The fan module 7 and the consumable fixing module 4 are respectively positioned at two adjacent sides of the whole formed by the up-down stacking arrangement of the moving module 5 and the light path module 6.

In another embodiment, the present invention provides a nucleic acid POCT detection method for detecting nucleic acid POCT using the nucleic acid POCT detection device according to one embodiment, the detection method comprising:

(1) adding a sample to be detected into the nucleic acid extraction area 562 through the plastic nozzle 58, and screwing the plastic nozzle cover 57;

(2) starting a power supply of the detection device, scanning the two-dimensional code on the disposable consumable 10 through the code scanner 3, and identifying and reading basic information of the disposable consumable 10;

(3) opening the flip cover 11, inserting the disposable consumable 10 into the guide cavity along the raised guide rail 181 in the consumable fixing plate 18 until the travel limit switch 24 at the bottom of the guide cavity is triggered, and starting the detection device when the detection device is deemed to be successfully inserted into the disposable consumable 10; otherwise, the detection device is regarded as not inserting the disposable consumable 10, the detection device can not be started normally, the disposable consumable 10 is inserted again until triggering the travel limit switch 24, and then the flip cover 11 is closed;

(4) in the closing process of the flip cover 11, the flip cover 11 pushes the limiting plate 50 to move towards the consumable fixing module 4 through the connecting rod shaft 48 until the square notch 502 of the limiting plate 50 abuts against the consumable fixing module 4, when the limiting switch 53 is tightly contacted with the top shell 12, the detection device senses that the flip cover 11 is completely closed, and the detection device is started; when the limit switch 53 is not in contact with and close to the top shell 12, the detection device judges that the flip cover 11 is not completely closed, and the flip cover 11 is closed again until the limit switch 53 is in contact with and close to the top shell 12;

(5) the heating baffle 23 on the consumable fixing module 4 and the heating film arranged on the extrusion module 34 heat the nucleic acid extraction area 562, the extraction reaction starts in the nucleic acid extraction area 562, and the motion module 5 starts to work at the same time;

(6) the motor 29 respectively and independently drives the two consumable pressing sheets 47 to respectively press the semi-sealed area 563 and the pressing area 561 of the detection packet 56, so that a relatively sealed cavity is formed in the nucleic acid extraction area 562;

(7) the motor 29 drives the consumable push plates 45 to reciprocate horizontally in the nucleic acid extraction area 562 to extrude the nucleic acid extraction area 562 unidirectionally, the moving directions of the two adjacent consumable push plates 45 are opposite, nucleic acid extraction reagents in the nucleic acid extraction area 562 are mixed with a sample to be detected, and the nucleic acid extraction area 562 is heated by a heating film in the nucleic acid extraction process;

(8) after the extraction reaction is finished, the consumable material pressing sheet 47 of the compaction semi-sealed area 563 is reset, and the fan module 7 carries out air cooling and temperature reduction on the nucleic acid extraction area 562; after the temperature is reduced to the preset temperature, the fan module 7 is turned off, the motor 29 drives the extrusion modules 34 to push out in the horizontal direction, and each extrusion module 34 sequentially extrudes the nucleic acid detection region from the plastic nozzle 58 to the direction of the amplification cabin 60 so as to extrude the reagent mixture in the nucleic acid detection region out of the nucleic acid extraction region 562 and into the amplification cabin 60;

(9) after the reagent mixture enters the amplification chamber 60, the heating plate 22 of the reaction device heats the amplification chamber 60 to perform nucleic acid amplification reaction;

(10) the light path module 6 emits exciting light to the expansion cabin and receives reflected light, meanwhile, data processing is carried out on the reflected light received by the light path module 6, and the obtained detection result is transmitted to the display screen;

(11) after the amplification reaction is finished, the fan module 7 cools the amplification cabin 60, and the extrusion module 34 and the fixing module 35 are reset.

The applicant declares that the above description is only a specific embodiment of the present invention, but the scope of the present invention is not limited thereto, and it should be understood by those skilled in the art that any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are within the scope and disclosure of the present invention.

Claims

1. A nucleic acid POCT detection device is characterized by comprising a shell assembly, wherein a consumable fixing module, a motion module and an optical path module are integrated in the shell assembly, and the motion module and the optical path module are arranged on one side of the consumable fixing module after being vertically stacked;

the consumable fixing module is provided with a heating baffle and is used for fixing and heating disposable consumables, the disposable consumables comprise a detection bag and an amplification cabin, the detection comprises a nucleic acid extraction area, a sample to be detected is added into the nucleic acid extraction area before the detection is started, and the nucleic acid extraction area and the amplification cabin are in a semi-sealed state;

the motion module comprises a driving module and an extrusion module, and the driving module drives the extrusion module to extrude the nucleic acid extraction area, so that the nucleic acid extraction reagent and the sample to be detected are uniformly mixed;

the light path module emits exciting light to the amplification cabin and receives reflected light;

the detection bag is characterized in that a plastic nozzle and an amplification cabin are respectively fixed at two ends of the detection bag, a plastic nozzle cover is arranged at a nozzle of the plastic nozzle, and the plastic nozzle cover is used for plugging the nozzle of the plastic nozzle.

2. The apparatus according to claim 1, wherein the housing assembly comprises a main housing, a top housing and a bottom housing, the top housing is detachably mounted on the top of the main housing, and the bottom housing is detachably mounted on the bottom of the main housing.

3. The apparatus for detecting nucleic acid POCT according to claim 2, wherein the top case has a sample insertion opening, and the top case has a lid that covers the sample insertion opening when the lid is closed.

4. The nucleic acid POCT detection device of claim 2, wherein a touch screen fixing shell is arranged on one side surface of the main machine shell, a touch screen is arranged on the touch screen fixing shell, and the touch screen is used for manual interaction and result display.

5. The nucleic acid POCT detection device according to claim 4, wherein a touch screen cover plate is further arranged on the outer side of the touch screen, and the touch screen cover plate is used for protecting the touch screen.

6. The nucleic acid POCT detection device of claim 4, wherein a code scanner is arranged below the touch screen and electrically connected with the touch screen, and the code scanner is used for reading and identifying basic information of the disposable consumables.

7. The nucleic acid POCT detection device of claim 6, wherein a code scanning baffle is further disposed outside the code scanner, and the code scanning baffle is used for protecting the code scanner.

8. The nucleic acid POCT detection device of claim 1, wherein the inner surface of the housing assembly is coated with a conductive paint.

9. The apparatus for detecting nucleic acid POCT according to claim 1, wherein a bottom plate is fixed to the bottom surface inside the housing assembly, and the bottom plate is used for fixing a module inside the housing assembly.

10. The nucleic acid POCT detection device of claim 1, wherein the disposable consumable comprises a first consumable support, a detection bag and a second consumable support which are sequentially stacked and fixed, and the first consumable support and the second consumable support are relatively buckled and then fix the detection bag.

11. The nucleic acid POCT detection device of claim 1, wherein one end of the detection bag is heat sealed and fixed to the plastic nozzle.

12. The nucleic acid POCT detection device according to claim 1, wherein the other end of the detection pack is heat-sealed and fixed to the amplification chamber.

13. The nucleic acid POCT detection device according to claim 1, wherein the central region of the detection packet is a nucleic acid extraction region, two ends of the nucleic acid extraction region are respectively communicated with the plastic nozzle and the amplification chamber, a sample to be detected is added into the nucleic acid extraction region through the plastic nozzle, and a nucleic acid extraction reagent in the nucleic acid extraction region and a reagent mixture obtained after reaction of the sample to be detected enter the amplification chamber.

14. The nucleic acid POCT detection device of claim 1, wherein the plastic nozzle cover and the plastic nozzle are fixed by a plug-in or screw-thread manner.

15. The nucleic acid POCT detection device according to claim 1, wherein the plastic nozzle cover is screwed into the nozzle of the plastic nozzle, a sample to be detected is added to the nucleic acid extraction region through the plastic nozzle after the plastic nozzle cover is unscrewed, and the plastic nozzle cover is screwed after the sample injection is completed.

16. The nucleic acid POCT detection device of claim 1, wherein the fixing region of the detection pack and the amplification chamber is a cavity structure, a filter element is arranged in the cavity structure, and a reagent mixture obtained by reaction in the detection pack enters the amplification chamber after being filtered by the filter element.

17. The apparatus for detecting nucleic acid POCT according to claim 1, wherein the side of the nucleic acid extraction region near the plastic nozzle is marked as a compression region, and the driving module drives the fixing module to compress the compression region for isolating the plastic nozzle from the nucleic acid extraction region.

18. The apparatus for detecting nucleic acid POCT according to claim 1, wherein the side of the nucleic acid extraction region near the amplification chamber is labeled as a semi-sealed region, and the driving module drives the fixing module to compress the semi-sealed region for isolating the nucleic acid extraction region from the amplification chamber.

19. The nucleic acid POCT detection device according to claim 1, wherein an amplification detection zone with a transparent shell is arranged in the amplification chamber, after the nucleic acid extraction reaction is finished, a semi-sealed zone between the nucleic acid extraction zone and the amplification chamber is opened, the reagent mixture enters the amplification detection zone under the extrusion of the extrusion module, the excitation light emitted by the light path module irradiates the reagent mixture through the transparent shell of the amplification detection zone, and the reflected light passes through the transparent shell of the amplification detection zone and is received by the light path module.

20. The apparatus for detecting nucleic acid POCT according to claim 19, wherein the amplification detection region is partitioned into at least one detection partition independent from each other, and the detection partition is filled with a lyophilized powder.

21. The apparatus according to claim 1, wherein the consumable fixing module comprises a consumable fixing plate and a heat insulation plate, a guide cavity is formed between the consumable fixing plate and the heat insulation plate, the disposable consumable is inserted into the guide cavity, and the disposable consumable is fixed after the consumable fixing plate and the heat insulation plate are relatively attached.

22. The nucleic acid POCT detection device of claim 21, wherein one side of the consumable fixing plate close to the thermal insulation plate is marked as a bonding surface, U-shaped protruding guide rails are arranged along three side edges of the bonding surface of the consumable fixing plate, and after the consumable fixing plate and the thermal insulation plate are bonded relatively, the protruding guide rails contact the thermal insulation plate to form the guide cavity between the consumable fixing plate and the thermal insulation plate.

23. The apparatus of claim 1, wherein the consumable fixing module is vertically fixed on the bottom plate under normal operation of the apparatus, and the disposable consumable is vertically inserted into the guiding cavity from the top of the consumable fixing module.

24. The nucleic acid POCT detection device of claim 21, wherein a travel limit switch slot is arranged at the bottom of the guide cavity, a travel limit switch is arranged in the travel limit switch slot, the disposable consumable is fully inserted into the guide cavity and then touches the travel limit switch, and the nucleic acid POCT detection device senses and confirms that the disposable consumable is successfully inserted.

25. The apparatus of claim 1, wherein the consumable fixing plate has a rectangular through slot in a central region thereof, and the disposable consumable is inserted into the guide cavity such that the detection bag is exposed through the rectangular through slot.

26. The nucleic acid POCT detection device of claim 1, wherein a side surface of the consumable fixing plate away from the thermal insulation plate is marked as a back surface, an annular step groove is formed in the back surface of the consumable fixing plate, the annular step groove comprises two annular steps, and a biconvex lens is embedded in the annular step of the inner layer.

27. The nucleic acid POCT detection device according to claim 1, wherein a lens holding ring is provided in the annular step of the outer layer, and the lens holding ring is used to fix the biconvex lens to the annular step of the inner layer.

28. The apparatus for detecting nucleic acid POCT according to claim 1, wherein the bonding surface of the consumable fixing plate is provided with a rectangular groove corresponding to the circular stepped groove in position and communicating with the circular stepped groove; the reaction device pressing block is embedded in the rectangular groove and used for pressing the amplification cabin, and excitation light emitted by the light path module penetrates through the reaction device pressing block to irradiate the amplification cabin after being converged and enhanced by the biconvex lens.

29. The nucleic acid POCT detection device of claim 21, wherein a side of the thermal insulation plate away from the consumable fixing plate is designated as a back-off surface, the back-off surface of the thermal insulation plate is provided with a first fan square groove and a second fan square groove, a set of fans are respectively arranged in the first fan square groove and the second fan square groove, and an air flow generated by the fans passes through the thermal insulation plate and is blown to the guide cavity for cooling the disposable consumables in the guide cavity.

30. The nucleic acid POCT detection device of claim 21, wherein one side surface of the thermal insulation plate close to the consumable fixing plate is denoted as a bonding surface, and the bonding surface of the thermal insulation plate is provided with a first square groove and a second square groove.

31. The nucleic acid POCT detection device of claim 30, wherein the first square groove corresponds to and communicates with a first fan square groove, and the second square groove corresponds to and communicates with a second fan square groove.

32. The nucleic acid POCT detection device of claim 30, wherein the second square groove has a profile dimension smaller than a profile dimension of the second fan square groove.

33. The nucleic acid POCT detection device of claim 30, wherein the second square groove is positioned corresponding to and in communication with a central region of the second fan square groove.

34. The nucleic acid POCT detecting device according to claim 30, wherein a heating baffle is fitted in the first square groove, and a heating plate of the reaction device is fitted in the second square groove.

35. The apparatus for detecting nucleic acid POCT according to claim 34, wherein a reaction device pressing block is further provided on the surface of the reaction device heating plate, and the reaction device pressing block is used to fix the reaction device heating plate in the second square groove.

36. The apparatus for detecting nucleic acid POCT according to claim 1, wherein the consumable fixing module further comprises a support block, the support block is located on one side of the width of the bottom of the consumable fixing plate and the thermal insulation plate, and is used for fixing the consumable fixing plate and the thermal insulation plate on the bottom plate.

37. The apparatus of claim 1, wherein the movement module and the optical path module are stacked up and down and then located on one side of the consumable fixing plate.

38. The apparatus for detecting nucleic acid POCT according to claim 1, wherein the motion module comprises a main module and a control module disposed on opposite sides of the main module.

39. The apparatus according to claim 38, wherein the main module comprises a driving module, two fixing modules and at least one extruding module, the fixing modules and the extruding module are arranged side by side in a vertical direction, the extruding module is located between the two fixing modules, and the fixing modules and the extruding module are matched with the disposable consumables arranged vertically to realize the extrusion and mixing of the nucleic acid extraction reagent and the sample to be tested in the disposable consumables.

40. The apparatus of claim 1, wherein the two fixing modules are disposed in the compacting area and the semi-sealing area of the disposable consumable respectively, and the driving module drives the two fixing modules to move and fix to the compacting area and the semi-sealing area respectively, such that the nucleic acid extracting area between the compacting area and the semi-sealing area forms a closed space.

41. The nucleic acid POCT detection device of claim 1, wherein the extrusion module is correspondingly disposed in a nucleic acid extraction area of the disposable consumable, and the driving module is configured to drive the extrusion module to reciprocate in a horizontal direction to extrude the nucleic acid extraction reagent and the sample to be detected in the nucleic acid extraction area.

42. The nucleic acid POCT detection device according to claim 1, wherein the reciprocating directions of two adjacent extrusion modules are opposite, and when one extrusion module retracts to separate from the nucleic acid extraction region, the other adjacent extrusion module pushes out the extruded nucleic acid extraction region, thereby realizing uniform mixing of the nucleic acid extraction reagent and the sample to be detected.

43. The apparatus of claim 1, wherein the driving module comprises at least three sets of driving units laterally arranged side by side in a vertical direction, and each set of driving units is independently connected to the pressing module or the fixing module in a driving manner.

44. The nucleic acid POCT detection device according to claim 1, wherein the driving component in transmission connection with the fixing module comprises a motor, a gear and a trapezoidal lead screw which are in transmission connection in sequence, the motor drives the trapezoidal lead screw to rotate through the gear, and the trapezoidal lead screw drives the corresponding fixing module to move and be fixed to the semi-sealing area or the pressing area.

45. The POCT detection device for nucleic acid according to claim 1, wherein the driving assembly in transmission connection with the extrusion module comprises a motor in transmission connection and a motor guide shaft, the motor is in transmission connection with the corresponding extrusion module through the motor guide shaft, and the extrusion module reciprocates in the horizontal direction along the motor guide shaft to extrude the nucleic acid extraction region.

46. The apparatus of claim 44, wherein the fixing module comprises a fixing push plate guide block, a fixing push plate connecting block and a consumable pressing sheet, which are connected in sequence, the fixing push plate guide block is in transmission connection with the trapezoidal screw rod, and the consumable pressing sheet is in direct contact with the semi-sealed region or the pressing region.

47. The apparatus for detecting nucleic acid POCT according to claim 46, wherein the fixed push plate guide block is connected with the fixed push plate connecting block through a snap spring shaft, a spring is sleeved on the periphery of the snap spring shaft, and a snap spring is arranged at the connecting end of the snap spring shaft and the fixed push plate guide block.

48. The nucleic acid POCT detection device of claim 1, wherein the extrusion module comprises an extrusion push plate guide block, an extrusion push plate connection block and a consumable push plate which are connected in sequence, the extrusion push plate guide block is in transmission connection with a motor guide shaft, and the consumable push plate is in direct contact with the nucleic acid extraction area.

49. The apparatus for detecting nucleic acid POCT according to claim 48, wherein the extrusion push plate guide block is connected with the extrusion push plate connection block through a snap spring shaft, a spring is sleeved on the periphery of the snap spring shaft, and a snap spring is arranged at the connection end of the snap spring shaft and the extrusion push plate guide block.

50. The apparatus for detecting nucleic acid POCT according to claim 48, wherein a heating film is disposed on the contact surface of the consumable pusher and the nucleic acid extraction region, and the heating film heats the nucleic acid extraction region.

51. The nucleic acid POCT detection device of claim 1, wherein the motion module further comprises a bearing mounting plate, the bearing mounting plate is of a groove structure, and the fixing module and the extrusion module are arranged in the groove of the bearing mounting plate.

52. The apparatus for detecting the POCT of nucleic acid according to claim 51, wherein a motor-driven guide shaft pressing plate is disposed at the opening of the groove of the bearing-mounting plate, and the motor-driven guide shaft pressing plate is used for fixing the fixing module and the pressing module in the groove of the bearing-mounting plate.

53. The apparatus for detecting nucleic acid POCT according to claim 41, wherein the motion module further comprises a motor mounting plate, the motor mounting plate has a groove structure, and the motor is disposed in the groove of the motor mounting plate.

54. The apparatus for detecting nucleic acid POCT according to claim 53, wherein a motor pressing block is disposed at the opening of the groove of the motor mounting plate, and the motor pressing block is used for fixing the motor in the groove of the motor mounting plate.

55. The apparatus of claim 38, wherein the control module comprises a motor-limiting PCB and a main-control PCB respectively disposed on opposite sides of the main module, the motor-limiting PCB is electrically connected to the motor for controlling the movement of the motor, and the main-control PCB is used for controlling the overall operation of the apparatus.

56. The nucleic acid POCT detection device of claim 1, further comprising a limiting module, wherein the limiting module is located below the top shell and is used for fixing the consumable fixing module and sensing whether the flip cover is completely closed;

57. The apparatus for detecting nucleic acid POCT according to claim 56, wherein the driving side of the position-limiting plate is drivingly connected to the side of the rotating shaft of the lid through a link shaft.

58. The apparatus for detecting nucleic acid POCT according to claim 57, wherein a circlip pin is provided at an end of the link shaft connected to the lid.

59. The apparatus for detecting nucleic acid POCT according to claim 56, wherein the guide edges at two sides of the position-limiting plate are respectively provided with a cylindrical guide shaft, the cylindrical guide shafts are sleeved with position-limiting guide plates, the position-limiting guide plates are fixed at two sides below the top shell, and the position-limiting plates are driven by the connecting rod shaft to slide along the position-limiting guide plates at two sides along with the opening and closing of the flip cover.

60. The apparatus of claim 59, wherein the position-limiting guide plate has a ball fixing hole, a ball spring is inserted into the ball fixing hole, and the rotation angle of the lid is controlled by the degree of tightness of the ball spring.

61. The nucleic acid POCT detection device of claim 56, wherein the limit edge of the limit plate is provided with a square notch, and a limit switch is embedded in the square notch; flip is at closed in-process, and flip promotes the limiting plate through the connecting rod axle and removes to the fixed module direction of consumptive material, supports to the fixed module of consumptive material until square notch.

62. The nucleic acid POCT detection device of claim 1, further comprising a fan module for cooling the disposable consumable by air cooling.

63. The apparatus for detecting nucleic acid POCT according to claim 62, wherein the fan module is provided on one side of the whole of the movement module and the optical path module which are arranged in a vertically stacked manner.

64. The apparatus of claim 62, wherein the fan module and the consumable fixing module are respectively located at two adjacent sides of a whole formed by the moving module and the optical path module stacked up and down.

65. The nucleic acid POCT detection device according to claim 62, wherein the detection method of the nucleic acid POCT detection device comprises:

66. The nucleic acid POCT detection device according to claim 65, wherein the step (I) specifically comprises:

67. The nucleic acid POCT detection device according to claim 65, wherein the step (II) specifically comprises:

68. The nucleic acid POCT detection device according to claim 65, wherein the step (III) specifically comprises: