CN220467971U - Nucleic acid detection system - Google Patents

Abstract

The utility model provides a nucleic acid detection system which helps sampling personnel to complete nucleic acid collection under the condition of no need of manual participation, and is low in cost and capable of remarkably shortening time spent from sampling to detection. Including the sampling portion that samples the sampling personnel and the detection portion that detects the sample of gathering, the sampling portion includes: an identity recognition unit that acquires identity information; a sampling rod output unit that supplies a sampling rod to a sampling person; and a sample collection unit that collects the sampling rod and the preservation liquid as a sample liquid, the detection unit including: a microfluidic tube that aspirates a predetermined amount of sample fluid from the sample collection unit; an extraction unit that extracts nucleic acid from the sample liquid in the microchannel while the sample liquid is in the microchannel; a system configuration unit for preparing a detection solution by supplying a reaction solution to the nucleic acid in the microtube; and a nucleic acid detection unit that detects a detection liquid in the microtube.

Description

Nucleic acid detection system

Technical Field

The present utility model relates to a nucleic acid detecting system, and more particularly, to a nucleic acid detecting system for confirming an infectious disease of the respiratory tract, which has an acquisition unit and a detection section, does not require manual intervention, and can rapidly give a detection result.

Background

Confirmation of respiratory infectious diseases requires nucleic acid detection, which is probably comprised of the following two steps, step 1: collecting a sample; step 2: and (5) detecting by a detection center. Both of these steps currently require human involvement.

In the sample collection stage of step 1, including sample registration and sample collection, the sample collection is currently mainly performed manually by a pipeline. Typically, one sampling point has 3-4 people, one for identity card scanning, one for sampling, and others for order maintenance and emergency. 300-500 persons can be completed per hour. In the sample collection process, a hand-held sampling rod is needed to sample a collector in a short distance, and even if three-level protection (wearing protective clothing, wearing goggles and wearing gloves) is carried out, the risk of cross infection is high. Meanwhile, medical staff needs to wear comprehensive protective equipment for a long time, and the working time and the working strength are long. Moreover, the collection quality is easy to be different due to various factors such as the level difference of medical staff at different levels, psychological fear, fatigue of the medical staff and the like, and false negative is easy to occur.

In the detection center detection stage of step 2, before performing nucleic acid detection, nucleic acid extraction needs to be performed through a sample reaction, and the sample reaction comprises the steps of sample extraction, cleavage, washing, nucleic acid extraction and the like. In the above steps, different tools are required, and the samples are also required to be split or transferred in different tools or devices, so that a great variety of special tools and devices are usually required in the process of extracting nucleic acid, and the technical requirements on experimenters are high. The nucleic acid is detected after the nucleic acid is extracted, and in the process of detecting the nucleic acid, the environment of the detection equipment is extremely high, and very specialized personnel are required to operate.

Furthermore, the process of handing over the sample to the detection center after the sample collection is completed also takes time, which is accompanied not only by a risk of sample damage but also by a later time for the sampling personnel to obtain the nucleic acid results.

In the prior art, patent document 1 provides an artificial intelligence throat swab nucleic acid automatic sampler capable of reducing the involvement of manpower by rotating a telescopic arm for nucleic acid collection. In patent document 2, there is provided a nucleic acid extraction amplification detection integrated machine in which improvement of nucleic acid detection efficiency is expected by using a microfluidic chip.

Prior art literature

Patent literature

Patent document 1: CN114711829A

Patent document 2: CN214694197U

Disclosure of Invention

Problems to be solved by the utility model

However, in patent document 1, even if the nucleic acid collection can be performed by rotating the telescopic arm, the manual intervention is still required after the completion of the sampling, and therefore, there is still a great room for improvement in shortening the time for the sampling person to acquire the detection result.

In addition, in patent document 2, the detection time can be shortened only to a certain extent, and the time required for the whole nucleic acid detection system cannot be shortened even though the human participation is unavoidable for the whole nucleic acid detection system, and the microfluidic chip itself has a relatively complex structure, includes a circuit, and has a problem of high cost.

The present utility model provides a novel nucleic acid detection system capable of automatically collecting a sample without manual intervention and automatically detecting the sample, and capable of shortening the time taken from sampling to detecting the result and having a low cost.

Solution for solving the problem

One aspect of the present utility model provides a nucleic acid detecting system including a sampling unit for sampling a sample by a sampling person and a detecting unit for detecting a sample collected by the sampling unit, the sampling unit including: an identity recognition unit which acquires identity information of the sampling personnel; a sampling wand output unit that provides individually packaged sampling wand to the sampling person; and a sample collection unit that stores a storage liquid in advance and collects the sampled sampling rod and the storage liquid as a sample liquid, wherein the detection unit includes: a microfluidic tube through which a predetermined amount of the sample liquid is aspirated from the sample collection unit; an extraction unit for extracting nucleic acid from the sample liquid in the micro flow tube in a state where the sample liquid is located in the micro flow tube; a system configuration unit for providing a reaction solution to the nucleic acid in the microtube to prepare a detection solution; and a nucleic acid detecting unit for detecting the detection liquid in the micro flow tube.

Preferably, the sampling part further comprises an image acquisition unit, the image acquisition unit captures an acquisition action image comprising the face of the sampling person and the sampling rod, the nucleic acid detection system stores a standard action image meeting the sampling requirement in advance, and whether the acquisition action image meets the sampling requirement is judged based on the standard action image.

Preferably, in the detection section, the microtubes extend continuously from the extraction unit to the nucleic acid detection unit, the system configuration unit is located on a downstream side of the extraction unit in an extending direction of the microtubes, and the nucleic acid detection unit is located on a downstream side of the system configuration unit.

Preferably, the extraction unit includes: a 1 st supply member connected to the micro flow tube, the 1 st supply member being configured to draw the sample liquid from the sample collection unit through the micro flow tube; a 2 nd supply means for supplying a lysate into the microchannel tube; a 3 rd supply means for supplying a cleaning liquid into the micro flow tube; a 4 th supply means for supplying an eluent into the microchannel tube; a magnetic bead supply means for injecting magnetic beads into the micro flow tube; a thrust force supply member for supplying thrust force to the magnetic beads and the liquid; a gas supply means for supplying a gas for drying the magnetic beads; an exhaust valve connected to the micro flow pipe for exhausting; and an electromagnet arranged on the outer wall of the micro-flow tube, and the magnetic beads are attracted on the tube wall of the micro-flow tube by electrifying.

Preferably, the system configuration unit stores a reaction reagent for preparing the reaction liquid based on the reaction reagent and supplying the reaction liquid to the micro flow tube, and has a temperature control unit capable of controlling the temperature of the reaction reagent and the reaction liquid, respectively.

Preferably, the nucleic acid detecting unit has a heating device that heats the micro flow tube, the heating device has a plurality of heating bodies each having a different temperature, the micro flow tube passes through the plurality of heating bodies in turn in a cyclic manner, or the heating device has one heating body having portions having different temperatures so as to constitute at least one temperature increasing region and at least one temperature decreasing region, and the micro flow tube passes through the temperature increasing region and the temperature decreasing region in turn in a cyclic manner.

Preferably, the plurality of heaters or the one heater is configured as a columnar body, the micro-flow tube is spirally fixed to the plurality of heaters or the one heater around the plurality of heaters or the one heater, or the plurality of heaters or the one heater is configured to have a heating surface, and the micro-flow tube is fixed to the plurality of heaters or the one heater along the heating surface of the plurality of heaters or the one heater in a meandering shape.

Preferably, the inner diameter of the microfluidic tube is 1-8 mm.

Preferably, the sampling unit is configured as either one of the following structure one and structure two, structure one: the sampling section further includes: a manipulator unit having a grip for gripping the sampling rod and having a predetermined movable range; the face positioning unit is used for positioning the face in the moving range of the manipulator unit by the sampling personnel, and the structure II is that: the sampling section further includes: a manipulator unit having a grip for gripping the sampling rod and being movable; and an image acquisition unit capturing the relative positions of the face of the sampling person and the sampling rod, the nucleic acid detection system controlling the movement of the manipulator unit based on the relative positions of the face and the sampling rod.

Preferably, the sampling part further comprises at least one of the following units, and a reminding unit reminds the sampling personnel through voice or images; the display unit displays the identity information acquired by the identity recognition unit and/or the acquisition action image captured by the image acquisition unit; and a sterilizing unit sterilizing an area contacted by the sampling person.

Preferably, the nucleic acid detecting system includes a mixing and oscillating unit for oscillating the sample collecting unit so that the sample collected by the sampling rod and the preservation solution are sufficiently mixed.

Preferably, the nucleic acid detecting system includes a waste liquid treatment unit for collecting waste liquid generated in the extraction unit and the nucleic acid detecting unit; and/or the nucleic acid detection system further comprises a detection result output unit, wherein the detection result output unit is used for outputting detection results to the sampling personnel and/or terminal equipment.

ADVANTAGEOUS EFFECTS OF INVENTION

According to the nucleic acid detection system provided by the utility model, the sampling personnel can be automatically assisted to complete nucleic acid collection in a satisfactory manner without manually participating in the nucleic acid detection system, the nucleic acid sample is not required to be transported, the nucleic acid detection is automatically carried out, the time from sampling to detecting the whole result is obviously shortened, and the cost is low.

Drawings

FIG. 1 is a block diagram showing the structure of a nucleic acid detecting system according to the present utility model.

Fig. 2 is a block diagram of the structure of the detection unit of the present utility model.

Fig. 3 is a block diagram of the structure of the extraction unit of the present utility model.

Fig. 4 is a block diagram of the architecture configuration unit of the present utility model.

FIG. 5 is a block diagram showing the structure of a nucleic acid detecting unit of the present utility model.

FIGS. 6a to 6d are schematic views of a heating device included in the nucleic acid detecting unit of the present utility model.

FIG. 7 is a flow chart of a nucleic acid detection system employing the present utility model.

Description of the reference numerals

1. The device comprises a nucleic acid detection system, 10, a sampling part, 100, an identity recognition unit, 101, an image acquisition unit, 102, a sampling rod output unit, 103, a reminding unit, 104, a display unit, 105, a sample collection unit, 106, a disinfection unit, 20, a detection part, 200, a micro-flow tube, 201, an extraction unit, 202, a system configuration unit, 203, a nucleic acid detection unit, 30, a control part, 40, a waste liquid treatment unit, 50, a mixed oscillation unit, 60, a detection result output unit, H, a heating device, H1-H6, a heating body, A1, a heating region, A2 and a cooling region.

Detailed Description

The embodiments disclosed herein are to be considered in all respects as illustrative and not restrictive. Unless specifically stated otherwise, it should be understood as a non-essential structure.

As shown in fig. 1, the nucleic acid detecting system 1 of the present embodiment includes a sampling unit 10, a detecting unit 20, a control unit 30, a waste liquid treatment unit 40, a mixing and oscillating unit 50, and a detection result output unit 60. The sampling unit 10, the detecting unit 20, the waste liquid treatment unit 40, the mixing and oscillating unit 50, and the detection result output unit 60 are connected to the control unit 30, respectively, and the above units perform their respective operations under the control of the control unit 30.

The sampling unit 10 and the detecting unit 20 are described in detail below.

< sampling portion >

The sampling unit 10 samples a sampling person, and has an identification unit 100, an image acquisition unit 101, a sampling rod output unit 102, a sample collection unit 105, a display unit 104, a reminder unit 103, and a sterilization unit 106.

The identity recognition unit 100 obtains identity information of the sampling person, which may be, for example, an identity card scanning device, including a reading device, an illumination device, and a disinfection device. When the sampling personnel performs identity recognition, the identity card is placed on a scanning area of the reading device, the illumination device illuminates the scanning area, after the reading device scans the identity card, the name of the sampling personnel is displayed through the display unit 104 for the sampling personnel to confirm, and correct information is prevented from being input after detection. Further, in order to be convenient for sample personnel fixed identification card, identification card scanning device still includes: the support device and the support device are convenient for supporting the identity card, and the reading device can read the identity card information through the opening of the support device.

After the sampling personnel take out the identity card, the sterilizing device performs ultraviolet sterilization and disinfection in the bracket device for placing the identity card.

As for the identification unit, in addition to the identification card scanning device, a fingerprint acquisition device based on spectral identification can be used, or by scanning a two-dimensional code with personal information. The two-dimension code scanning mode does not need a sampling person to contact the identity recognition unit, and identity recognition can be completed only by aligning a personal terminal device (such as a mobile phone) or a card for displaying the two-dimension code with a reading device by the sampling person, so that the two-dimension code scanning mode is preferable.

After the identification is completed, the sampling rod output unit 102 outputs the individually packaged sampling rods for the sampling personnel to take out.

The image acquisition unit 101 of the nucleic acid detecting system 1 starts image acquisition for a sampling person while the sampling rod output unit 102 supplies a sampling rod. The image acquisition unit 101 is provided with a camera, the control part 30 is provided with a storage device and a judging device, the image acquisition unit 101 captures the acquisition action image comprising the face of a sampling person and a sampling rod in real time through the camera, and the image can be video or photo. The control unit 30 retrieves the video stream of the camera and displays the video stream on the display unit 104, and the storage device stores in advance a standard motion image that meets the sampling requirement, and determines whether the acquired motion image meets the sampling requirement based on the standard motion image. The standard motion image may be, for example, an image of at least three times wiping of any one of the three parts of the left tonsil, the right tonsil, and the posterior pharyngeal wall, or an image of at least three times wiping of two parts of the left tonsil and the right tonsil, or an image of at least three times wiping of each of the three parts of the left tonsil, the right tonsil, and the posterior pharyngeal wall.

In addition, the reminding unit 103 reminds the sampling person through voice or image, for example, the reminding unit 103 can remind the person to be sampled how to sample through voice, or can display dynamic indication indicating that the sampling person opens the mouth and samples in the display unit 104, the sampling person performs the action of opening the mouth and sampling according to the dynamic indication, and the image acquisition unit 101 performs the acquisition for the action of the sampling person. The judgment device of the control unit 30 can extract the sampling rod, the left tonsil, the right tonsil, and the posterior pharyngeal wall as target objects, and further extract the centers of the sampling rod, the left tonsil, the right tonsil, and the posterior pharyngeal wall as key points for labeling, and therefore, the judgment device can classify the images acquired by the image acquisition unit 101 based on the standard motion images, and the classification is as follows: the sampling rod touches the left tonsil, the sampling rod touches the right tonsil, the sampling rod touches the back pharyngeal wall, and the sampling rod does not touch the target wiping position.

In the above process of identifying the image acquired by the image acquisition unit 101, the extraction of the target object and the labeling of the key points can be completed through artificial intelligence. As an example, the living body detection model and the nucleic acid collection motion detection model may be obtained by artificial intelligence, coordinates of the face feature points may be output based on the living body detection model, and a bounding box or a center point of the sampling rod may be output based on the nucleic acid collection motion detection model. Of course, the present utility model is not limited to this, and any means may be used as long as the standard image acquisition operation can be realized.

In addition, in the judgment of the collecting action, besides the collecting action, the effective blink times are recorded, so that the life body is further ensured to perform self-service operation. The image acquisition unit 101 can also perform face verification and comparison through an image intelligent recognition technology, so that identity confirmation can be performed more reliably, and acquisition by a real person is ensured. And judge the key position of nucleic acid sampling through the intelligent recognition technology of image, ensure the standardization of self-service nucleic acid collection action, from this, when not needing medical personnel, still guaranteed the validity of sample collection.

When the judging means judges that the target wiping position (left tonsil, right tonsil, posterior pharyngeal wall) is touched by the sampling rod at least three times in the image acquired by the image acquisition unit 101, the judging means of the control section 30 judges that the sampling personnel performs the acquisition action meeting the sampling requirement, and of course, the judging criterion for whether the acquisition action meets the sampling requirement is not limited to a judging mode, for example, the sampling requirement can be judged when the wiping for the target wiping position occurs twice or once, and the sampling personnel is not required to wipe for all the target wiping positions, or only any one target wiping position or any two target wiping positions in the sampling personnel can be wiped. When it is determined that the collection operation meeting the sampling requirement is performed, the reminding unit 103 reminds the sampling personnel to collect the sampling rod in the sample collection unit 105, and meanwhile, the sample collection unit 105 conveys the sampling rod to the sampling personnel through the conveying device. As an example of the sample collection unit 105, a test tube may be used, or other container capable of storing a sample may be used.

The sample collection unit 105 contains a storage liquid in advance, and the sampling rod is collected in the storage liquid in the sample collection unit 105, and the storage liquid and the sample on the sampling rod are mixed to form a sample liquid.

The sampling person may break the head of the sampling rod and collect the head in the sample collection unit 105, or may directly put the entire sampling rod into the collection tube without breaking the head. The sample collection unit 105 may specifically include: test tube etc. can wait that sampling personnel oneself breaks and puts in the test tube, gathers the back, wait that sampling personnel leaves the back, can disinfect and disinfect the sampling area. The sampling may be a sample, a test tube, or a mixed test.

After the sample is collected in the sample collection unit 105, the nucleic acid detecting system 1 controls the sterilizing unit 106 to sterilize the detection area, specifically, to sterilize all units (devices or areas) that the sampling person can contact, and before the sampling by the next sampling person starts after the sampling by the current sampling person is completed.

The sampling part 10 of the utility model can perform self-service sampling under the condition that staff does not participate, compared with the condition that staff participates, the utility model not only can shorten the time spent in sampling and lighten the pressure of staff, but also can utilize the image captured by the image acquisition unit 101 in real time to improve the accuracy of the acquisition action and avoid the condition that the sample acquisition is unqualified caused by various factors such as the difference of the level of medical staff, mental fear, fatigue and the like.

< detection part >

The detection unit 20 of the present utility model detects a sample collected by the sampling unit 10, and includes a micro-flow tube 200, an extraction unit 201, a system configuration unit 202, and a nucleic acid detection unit 203. The nucleic acid detecting system 1 transfers the sample collection unit 105 containing the sample to the inside of the nucleic acid detecting system 1 by an internal transfer device, so that one end of the micro flow tube 200 extends to a position below the liquid surface of the sample liquid (see fig. 2), and a predetermined amount of sample liquid is sucked from the sample collection unit 105. The inner diameter (diameter) of the micro flow tube 200 may be 1 to 8mm, preferably 2 to 5mm.

As shown in fig. 2, one end of the micro flow tube 200 protrudes below the liquid surface of the sample liquid, thereby ensuring that the sample liquid sucked to the micro flow tube 200 can be reliably sucked, and the sample liquid sequentially passes through the extraction unit 201, the system arrangement unit 202, and the nucleic acid detection unit 203 along the micro flow tube 200, that is, in the extending direction of the micro flow tube 200, the system arrangement unit 202 is located at the downstream side of the extraction unit 201, and the nucleic acid detection unit 203 is located at the downstream side of the system arrangement unit 202. Preferably, the micro-flow tube 200 extends continuously from the extraction unit 201 to the nucleic acid detection unit 203. Accordingly, by providing the valve member on the micro flow tube 200 and closing the valve member, the liquid can be retained in the corresponding region in the micro flow tube 200, and the extraction unit 201, the system arrangement unit 202, and the nucleic acid detection unit 203 can perform respective operations on the liquid in the micro flow tube 200. By opening the valve member, the liquid can be caused to flow into the next unit along the microfluidic tube 200, for example, from the extraction unit 201 into the system arrangement unit 202, or from the system arrangement unit 202 into the nucleic acid detection unit 203.

The extraction unit 201 extracts nucleic acid from the sample liquid in the micro flow tube 200 in a state where the sample liquid is located in the micro flow tube 200. The extraction of nucleic acids can be accomplished, for example, by the magnetic bead method. Specifically, as shown in fig. 3, the extraction unit 201 has a magnetic bead supply means MF1 for injecting magnetic beads, a 1 st supply means P1 for alternately extracting a preserving liquid (sample liquid) and a sterilizing liquid for immersing the oversampling bar, a 2 nd supply means P2 for extracting a lysing liquid, a 3 rd supply means P3 for extracting a cleaning liquid, a 4 th supply means P4 for extracting an eluting liquid, a gas supply means G for supplying a gas (for example, nitrogen gas) for drying the magnetic beads, a thrust supply means MF2 for providing thrust for mixing the magnetic beads with various liquids by extracting an injection cycle mode, an evacuation valve connected to the micro flow tube 200 and for exhausting air, an electromagnet provided on an outer wall of the micro flow tube and capable of attracting the magnetic beads to a tube wall of the micro flow tube 200 by energization, and a waste liquid treatment flow path for collecting waste liquid. The waste liquid treatment flow path communicates to the waste liquid treatment unit 40. The 1 st to 4 th supply members P1 to P4 and the magnetic bead supply member MF1 supply various liquids and magnetic beads to the micro flow tube 200.

The number and positions of the communication points between the 1 st supply member P1, the 2 nd supply member P2, the 3 rd supply member P3, the 4 th supply member P4, the gas supply member G, and the bead supply member MF1 and the micro flow tube may be set as needed, and for example, the communication points may be one, and communication interaction may be achieved by an eight-way valve.

As shown in fig. 3, the 1 st supply means P1 is connected to the micro flow tube 200, and when nucleic acid is extracted, the 1 st supply means P1 is used as power to suck the sample liquid from the sample collection unit 105 through the micro flow tube 200, and similarly, the magnetic beads and the lysis liquid are sequentially supplied from the magnetic bead supply means MF1 and the 2 nd supply means P2 to the micro flow tube 200, and then nitrogen is introduced to push the liquid supplied through the 1 st supply means P1 and the 2 nd supply means P2 and the magnetic beads to the vicinity of the electromagnet EM, the evacuation valve is opened, the thrust supply means MF2 repeatedly pumps and inflates the magnetic beads and the liquid, the magnetic beads are uniformly dispersed in the liquid section, the evacuation valve is closed, the electromagnet EM is energized, the magnetic beads are attracted to the tube wall by the magnetic force, and the nitrogen is introduced again to push the waste liquid so that the waste liquid is discharged to the waste liquid treatment flow path. Thereby, the nucleic acid is adsorbed on the magnetic beads.

The 3 rd supply member P3 supplies the cleaning liquid to the micro flow tube 200, at this time, the evacuation valve is closed, nitrogen is supplied, the liquid is pushed to the vicinity of the electromagnet EM, the electromagnet EM is powered off, the evacuation valve is opened, the thrust supply member MF2 repeatedly pumps/pumps, the magnetic beads are uniformly dispersed in the liquid interval, the evacuation valve is closed, the electromagnet EM is powered on, the magnetic beads are attracted to the tube wall by magnetic force, nitrogen is supplied again, and the nitrogen pushes the waste liquid so that the waste liquid is discharged to the waste liquid treatment flow path. Thereby, the nucleic acid adsorbed on the magnetic beads is washed.

The electromagnet EM is kept electrified, nitrogen is blown, and liquid on the magnetic beads is blown dry. Also in the case of keeping the electromagnet EM energized, the 4 th supply member P4 supplies the eluent to the micro-flow tube 200, nitrogen is supplied slowly, the liquid is pushed to the vicinity of the electromagnet EM, the electromagnet EM is deenergized, the evacuation valve is opened, the thrust supply member MF2 repeatedly pumps/pumps, the magnetic beads are uniformly dispersed in the liquid space, the evacuation valve is closed, the electromagnet EM is energized, the magnetic beads are attracted to the tube wall by the magnetic force, nitrogen is supplied again, and the nitrogen pushes the eluent to flow to the following system configuration unit 202. Thereby, the nucleic acid is desorbed from the magnetic beads and collected. Thereafter, the sterilizing liquid is introduced from the 1 st supply member P1 in a similar manner to sterilize the micro flow tube and the magnetic beads, and the remaining sterilizing liquid in the micro flow tube and on the magnetic beads is washed with clean water.

As shown in fig. 2, a branch pipe branches from the micro flow pipe 200 on the upstream side of the extraction unit 201 and on the downstream side of the sample collection unit 105, and a part of the sample liquid can be extracted from the branch pipe and stored as a sample. As shown in fig. 3, a filter device is provided in the micro flow tube 200 on the downstream side of the extraction unit 201 and on the upstream side of the system arrangement unit 202, and the magnetic beads are prevented from entering the system arrangement unit 202 by the filter device.

As shown in fig. 4, the system configuration unit 202 stores a reaction reagent for preparing a reaction solution based on the reaction reagent and supplies the reaction solution to the micro flow tube, thereby supplying the reaction solution to the nucleic acid in the micro flow tube 200 to prepare a detection solution, and specifically, the system configuration unit 202 includes at least two tube reagents of primer Mix and enzyme Mix and supplies the detection solution in a stock solution form. The system configuration unit 202 has a temperature control unit, a mixing unit, and an early warning unit. The mixing unit and the temperature control unit respectively perform mixing and temperature control on the primer and the enzyme. By using the temperature control unit, the cold storage can be performed without affecting the activity of the enzyme. The temperature control unit can store the primer, the enzyme, and the reaction solution in a predetermined temperature range for a short period (for example, 1 to 2 days) as needed. That is, the temperature control unit can control the temperature of the reaction reagent and the temperature of the reaction solution, respectively.

In use, the primer and the enzyme are mixed in a predetermined ratio to prepare a reaction solution, and the primer and the enzyme (for example, reverse transcriptase) can be sufficiently mixed by the mixing unit to reliably obtain the reaction solution. And (3) preserving the prepared reaction solution by using a reagent. The mixing unit and the temperature control unit are used for uniformly mixing and controlling the temperature of the reaction liquid stored as the reagent, at the moment, the early warning unit performs the lowest stock early warning, and when the amount of the reaction liquid is lower than the preset lowest stock, the early warning unit performs the early warning.

After the nucleic acid is supplied to the system arrangement unit 202 in the microchannel 200, the system arrangement unit 202 supplies the reaction solution to the microchannel 200, and the reaction solution is mixed with the nucleic acid extraction solution in the microchannel 200 to form a nucleic acid detection solution. The dispensing and dispensing in the system configuration unit 202 may be accomplished by a pipette or pipetting arm.

As shown in fig. 5, the nucleic acid detecting unit 203 is used for detecting the detection solution in the micro-flow tube 200, for example, a fluorescent quantitative PCR platform, which is used for performing a fluorescent quantitative PCR reaction process, and includes the following steps:

1. reverse transcription

Reverse transcription procedure: the reverse transcription is performed at 50℃for 15 to 20 minutes, and the time for the reverse transcription is not limited to this, but may be about 5 minutes depending on the efficiency of the reverse transcriptase.

The sample is reverse transcribed into a template by a reverse transcription procedure, and a subsequent PCR reaction is performed.

2. Pre-denaturation: super-spiral opening

Pre-denaturation procedure: the reaction is carried out at 95 ℃ for about 10 min.

The double strand of the entangled higher structure in the template obtained in the reverse transcription procedure is completely opened by the pre-denaturation procedure, and at the same time, the reverse transcriptase is inactivated.

PCR cycle

And (5) entering a main cycle, and carrying out 40-45 cycles. Each cycle includes three steps of denaturation, annealing and extension, and fluorescence acquisition.

1) Denaturation: at 95 ℃ for 5-10 s, opening the double chain;

2) Annealing and extension: carrying out the process for 20 to 30 seconds at the temperature of 60 ℃;

the primer, probe and template anneal to form an amplified complex with the enzyme, and extension begins. That is, extension has also begun at the same time that annealing occurs. Annealing and extension are combined into one step, known as two-step PCR. Primer: binding to template, guided amplification, probe: fluorescence is emitted for product quantification, and meanwhile, the fluorescence is matched with a primer to improve reaction specificity, and the probe comprises a fluorescent group and a quenching group. When the fluorescent group is closer to the quenching group (before and during probe binding), no fluorescence is emitted, and when the amplification reaction occurs, the probe bound to the template is chopped by the DNA polymerase, the fluorescent group is separated from the quenching group, and the fluorescent signal can be collected. Because only the primer and the probe are combined with the target at the same time, a fluorescent signal is generated, and the specificity of the fluorescent quantitative PCR reaction is greatly improved by using the probe.

Conventionally, heating for nucleic acid amplification has been achieved by placing a container containing nucleic acid in an incubator and adjusting the temperature of the incubator. Such heating efficiency is low. In the present utility model, since the heating is performed in the micro flow tube 200, the heating can be performed rapidly, and the efficiency of the entire nucleic acid detecting system 1 can be further improved. The heating device H may have, for example, a plurality of heating bodies each having a different temperature, and the micro-flow tube 200 into which the detection liquid flows may be cyclically and reciprocally passed through the plurality of heating bodies in turn, and for example, the micro-flow tube 200 may be spirally fixed to the plurality of heating bodies around the plurality of heating bodies. Alternatively, the heating device H may have a heating body having portions with different temperatures, thereby constituting at least one temperature increasing region and at least one temperature decreasing region, and the micro flow tube 200 into which the detection liquid flows is cyclically and reciprocally passed through the temperature increasing region and the temperature decreasing region in the one heating body in turn, for example, the micro flow tube 200 is spirally fixed to the one heating body around the one heating body. Therefore, isothermal change processes such as temperature reduction, temperature rising and temperature reduction are realized. In this case, the nucleic acid amplification can be realized in a short time by the nucleic acid detecting system, and the integrated operation can be facilitated, so that the system can be made more compact.

Specifically, as shown in fig. 6a, the heating device H may be two columnar bodies (e.g., cylindrical bodies) H1, H2, and the micro flow tube 200 is wound around and fixed to the outer circumferential surfaces of the two heating bodies H1, H2 so as to pass through the heating bodies H1, H2 in turn in a cyclic manner, for example, the micro flow tube 200 is fixed to the heating bodies H1 and H2 in a spiral manner around the heating bodies H1 and H2. The portion of the micro flow tube 200 passing through the heating body h1 and the heating body h2 in this order and returning to the heating body h1 constitutes one polymerase chain reaction cycle. The heating body h1 heats the detection liquid in the micro flow tube 200 to 95 ℃, the heating body h2 heats the detection liquid in the micro flow tube 200 to 60 ℃, and the outer diameter of the heating body h1 and the outer diameter of the heating body h2 can be appropriately selected, so long as the time of the detection liquid in the micro flow tube 200 flowing through the area of the heating body h1 is 5-10 s, and the time of the detection liquid flowing through the area of the heating body h2 is 20-30 s. In the configuration shown in fig. 6a, the region of the heating body h1 becomes a temperature increasing region, and the region of the heating body h2 becomes a temperature decreasing region.

As shown in fig. 6b, the heating device H may be a columnar heating body H3, the micro-tube 200 is spirally wound around and fixed to the outer peripheral surface of the heating body H3, and the temperatures of different portions of the heating body H3 are different, for example, in fig. 6b, the temperature of the lower portion of the heating body H3 is relatively high, the temperature of the upper portion of the heating body H3 becomes a temperature raising region A1, and the temperature of the upper portion of the heating body H3 becomes a temperature lowering region A2, whereby the micro-tube 200 is cyclically and reciprocally passed through the temperature raising region A1 and the temperature lowering region A2 in order to heat the detection liquid in the micro-tube 200 at 95 ℃ for 5 to 10s, thereby performing denaturation, and the temperature lowering region A2 is used to heat the detection liquid in the micro-tube 200 at 60 ℃ for 20 to 30s, thereby performing the annealing and the extension.

The heating device H may be configured as a plurality of heaters having heating surfaces. As shown in fig. 6c, the heating device H may be heating bodies H4, H5 having heating surfaces. The temperatures of the heating bodies h4 and h5 are different, and the micro-flow tube 200 into which the detection liquid flows is fixed to the heating bodies h4 and h5 in a meandering shape along the heating surfaces of the heating bodies h4 and h5, and passes through the heating bodies h4 and h5 in turn in a cyclic manner. The heating body h4 heats the detection liquid in the micro flow tube 200 to 95 ℃, the heating body h5 heats the detection liquid in the micro flow tube 200 to 60 ℃, and the shape and the size of the heating surfaces of the heating body h4 and the heating body h5 can be properly selected, so long as the time of the detection liquid in the micro flow tube 200 flowing through the area of the heating body h4 is 5-10 s, and the time of the detection liquid flowing through the area of the heating body h5 is 20-30 s. In the configuration shown in fig. 6c, the region of the heating body h4 becomes the temperature increasing region A1, and the region of the heating body h5 becomes the temperature decreasing region A2.

Further, the heating device H may be configured as a single heating body having a heating surface. As shown in fig. 6d, the heating device H may be a heating body H6 having a heating surface. The temperatures of the different portions of the heating body h6 are different, and for example, in fig. 6d, the upper portion of the heating body h6 has a relatively high temperature and becomes a temperature raising region A1, and the lower portion of the heating body h6 has a relatively low temperature and becomes a temperature lowering region A2. The micro-flow tube 200 into which the detection liquid flows is fixed to the heating body h6 along the heating surface of the heating body h6 in a meandering manner, and is repeatedly passed through the temperature increasing region A1 and the temperature decreasing region A2 in this order. The temperature of the detection liquid in the micro flow tube 200 is increased by the temperature increasing region A1 at 95℃for 5 to 10 seconds to denature the detection liquid, and the temperature of the detection liquid in the micro flow tube 200 is decreased by the temperature decreasing region A2 at 60℃for 20 to 30 seconds to anneal and extend the detection liquid.

The fixation of the micro-flow tube 200 to the heating bodies h1 to h6 may be in any manner, for example, for the columnar heating bodies h1 to h3, grooves may be formed in the outer walls of the columnar heating bodies h1 to h3, and the micro-flow tube 200 may be embedded in the grooves. Similarly, the heating surfaces of the heating bodies h4 to h6 having the heating surfaces may be grooved for embedding the micro flow tube 200. And the embedded micro-flow pipe can be further covered with an insulating layer to realize heat preservation and limit. Further, the case where there are two heating bodies is exemplified above for the case of a plurality of heating bodies, but the case of a plurality of heating bodies is certainly not limited to the case of two heating bodies, but three heating bodies or more may be used.

By cyclically passing the micro flow tube 200 through the temperature raising region A1 and the temperature lowering region A2 in this order as described above, denaturation, annealing, and extension can be cyclically performed.

3) Fluorescence collection. The fluorescence signal may be collected after each cycle is completed, or the signal collection for the first 10 to 12 cycles may be abandoned and the fluorescence signal may be collected from 13 cycles in order to save time. The control unit 30 may draw an amplification curve based on the collected fluorescent signals and upload the data for subsequent study and analysis.

The detection unit 20 of the present utility model, in cooperation with the collection unit 10, can automatically detect a nucleic acid sample without participation of a worker, and can further reduce the time and improve the detection efficiency compared with a case of detecting a nucleic acid sample after collection in a laboratory.

In addition, compared with the case of performing different steps in the detection process by pipetting between the test tubes, the utility model sucks samples based on the micro-flow tube 200, and performs extraction, system configuration and nucleic acid detection of nucleic acid in the micro-flow tube 200, thereby avoiding efficiency reduction caused by pipetting between the test tubes, further shortening the time for obtaining the nucleic acid result, and in addition, compared with the structure using a micro-fluidic chip, the utility model can reduce the cost.

< other units >

As shown in FIG. 1, the nucleic acid detecting system 1 further has a waste liquid treatment unit 40, a mixing and oscillating unit 50, and a detection result output unit 60.

The waste liquid treatment unit 40 is connected to the extraction unit 201 and the nucleic acid detection unit 203, and serves to collect waste liquid generated in the extraction unit 201 and the nucleic acid detection unit 203.

The mixing and oscillating unit 50 is used for oscillating the sample collection unit 105, so that the sample collected by the sampling rod and the preserving fluid are fully mixed into a sample fluid.

The detection result output unit 60 is capable of outputting a detection result to a sampling person, for example, outputting a paper detection report by printing, or outputting an electronic detection result to a terminal device. The user can view and display the nucleic acid detection result through the terminal equipment.

< procedure of nucleic acid detection System >

The flow of the nucleic acid detecting system 1 according to the present utility model will be described below.

As shown in fig. 7, when a sampling person uses the nucleic acid detecting system 1 of the present utility model, an identification card is placed at a reader, and the identity of the sampling person is recognized by the identity recognizing unit 100 (S1), and at this time, personal information of the sampling person, that is, identity information acquired by the identity recognizing unit 100 is displayed in the display unit 104. After the sample person confirms by operating the confirm button or the like, the sample bar is output by the sample bar output unit 102 (S2), then the image of the face and the sample bar is captured in real time by the image capturing unit 101 (S3), and the captured action image captured in real time by the image capturing unit 101 is displayed by the display unit 104 (S4), and when the control unit 30 determines that the sample person has performed the standard action image meeting the sampling requirement, the conveying device inside the nucleic acid detecting system 1 conveys the sample collecting unit 105 to the exposed position to the outside, and the sample bar is collected by the sample collecting unit 105 (S5), so far, the action of capturing is completed.

After the sample collection unit 105 collects the sample, the sample is conveyed back into the nucleic acid detection system 1 by the conveying device, the sample and the preservation solution are mixed and homogenized by the mixing and oscillating unit 50, so that the sample and the preservation solution are mixed and mixed fully into a sample solution, then the conveying device conveys the sample collection unit 105 to one end of the micro-flow tube 200, one end of the micro-flow tube 200 stretches into a position below the liquid surface of the sample solution, the sample solution is sucked from the sample collection unit 105 through the micro-flow tube 200 (S6), the sample solution sucked through the micro-flow tube 200 flows through the micro-flow tube 200 to the extraction unit 201, the nucleic acid in the micro-flow tube 200 is extracted by the extraction unit 201 (S7), the extracted nucleic acid further flows through the micro-flow tube 200 to the system configuration unit 202 according to a preset proportion, the system configuration unit 202 mixes and configures a reaction solution (S8), the nucleic acid in the micro-flow tube 200 is added with the reaction solution to form a detection solution (S9), the detection solution further flows into the nucleic acid detection unit 203 in the micro-flow tube 200, the detection solution is detected by the nucleic acid detection unit 203 (S10), after the detection is completed, the detection is processed by the nucleic acid detection unit 203, and the detected waste solution is processed (S11). Thus, the detection operation is completed.

The above-described flow is not always the flow for applying the nucleic acid detecting system 1, and may include a step of outputting the detection result by the detection result output unit 60, and is not always the flow necessary for applying the nucleic acid detecting system 1, and a part of the flow may be omitted appropriately.

< modification >

In the above-described embodiment, the sampling rod is gripped by the sampling person to collect nucleic acid, but the sampling rod may be gripped by a robot unit instead of the sampling person, and in this case, two configurations may be adopted,

structure one: the sampling section 10 further includes a robot arm unit and a face positioning unit.

The manipulator unit has a grip portion for gripping the sample rod, and a predetermined movement range is set for the manipulator unit, that is, the manipulator can move only between predetermined positions. The face positioning unit can position the face within a predetermined movement range of the manipulator unit, and can properly hold the sampling rod to perform standard operation conforming to the sampling requirement only by moving the manipulator.

The face positioning unit may be a mechanical structure, such as a mask, or a disposable bite, such as a mouthpiece. Positioning of the face is simply accomplished by the sampling person resting the face within the mask or opening the mouth to bite into the disposable bite. Alternatively, the face positioning unit may be a face contour image displayed on the display unit 104, and the sampling person may move while observing the display unit 104, and the image capturing unit 101 captures the face image in real time, and the control unit 30 determines that the face positioning is completed when the face image captured by the image capturing unit 101 is largely overlapped with the face contour image. After the positioning based on the face positioning unit is completed, the manipulator unit is utilized to move within a preset range, so that sample collection can be completed.

And (2) a structure II: the sampling section 10 further includes a robot arm unit.

The manipulator unit has a grip portion for gripping the sampling rod, and is movable without being limited to a predetermined range. The image acquisition unit captures the relative position between the face of the sampling person and the sampling rod in real time, for example, acquires coordinates of the face and the sampling rod, and the control unit 30 controls the movement of the manipulator unit based on the relative position between the face and the sampling rod to perform sample acquisition. As a method for acquiring the relative positions of the face and the sampling rod, for example, a stereo sensor may be used to acquire a plurality of images of an object (face, sampling rod), and parallax of the object may be acquired based on the plurality of images, thereby further obtaining the relative positions between the objects.

The above manipulator unit can also cut the sample rod in cooperation with the cutting unit.

The waste liquid generated in the extraction unit 201 and the nucleic acid detecting unit 203 may be collected and processed by the whole waste liquid treatment unit 40, or may be separated waste liquid treatment units may be provided for the extraction unit 201 and the nucleic acid detecting unit 203, and these waste liquid treatment units are collectively referred to as the waste liquid treatment unit 40.

The detection part 20 adopts the micro-flow tube 200, so that the cost is reduced compared with the structure using the micro-flow control chip, and the micro-flow tube can be reused.

The nucleic acid detecting system of the present application may be, for example, a single housing, and the sampling unit and the detecting unit may be disposed in the single housing. The box includes: the component accommodation area and the detection area where the detection person enters, such as the identification unit 100, the image acquisition unit 101, the display unit 104, are located on the outer wall of the component accommodation area, and the sampling rod output unit 102, the sample collection unit 105 can be moved between the inside and the outside of the component accommodation area by the conveying means, thereby outputting the sampling rod and the test tube. The detection unit 20, the control unit 30, the waste liquid treatment unit 40, the mixing and oscillating unit 50, the detection result output unit 60, and other units that do not need to be in contact with a person are located inside the component accommodation area. In addition, the nucleic acid detecting system may be integrated in one cabin, and the cabin may be sterilized at regular time in addition to the sterilization performed by the sterilizing unit of the nucleic acid detecting system itself.

Industrial applicability

The utility model has great advantages in improving the overall efficiency of the nucleic acid detection system.

Claims (12)

1. A nucleic acid detecting system, characterized in that,

the nucleic acid detecting system includes a sampling portion that samples a sampling person and a detecting portion that detects a sample collected by the sampling portion,

the sampling section includes:

an identity recognition unit which acquires identity information of the sampling personnel;

a sampling wand output unit that provides individually packaged sampling wand to the sampling person; and

a sample collection unit that stores a storage liquid in advance and collects the sampled sampling rod and the storage liquid as a sample liquid,

the detection unit includes:

a microfluidic tube through which a predetermined amount of the sample liquid is aspirated from the sample collection unit;

an extraction unit for extracting nucleic acid from the sample liquid in the micro flow tube in a state where the sample liquid is located in the micro flow tube;

a system configuration unit for providing a reaction solution to the nucleic acid in the microtube to prepare a detection solution; and

and the nucleic acid detection unit is used for detecting the detection liquid in the micro-flow tube.

2. The nucleic acid detection system of claim 1, wherein the nucleic acid detection system comprises a plurality of nucleic acid probes,

The sampling part also comprises an image acquisition unit which captures an acquisition action image comprising the face of the sampling person and the sampling rod,

the nucleic acid detection system is pre-stored with standard action images meeting the sampling requirements, and whether the acquired action images meet the sampling requirements is judged based on the standard action images.

3. The nucleic acid detection system of claim 1, wherein the nucleic acid detection system comprises a plurality of nucleic acid probes,

in the detection section, the microtubes extend continuously from the extraction unit to the nucleic acid detection unit,

the system configuration unit is located on the downstream side of the extraction unit in the extending direction of the microtube, and the nucleic acid detection unit is located on the downstream side of the system configuration unit.

4. The nucleic acid detection system of claim 1, wherein the nucleic acid detection system comprises a plurality of nucleic acid probes,

the extraction unit includes:

a 1 st supply member connected to the micro flow tube, the 1 st supply member being configured to draw the sample liquid from the sample collection unit through the micro flow tube;

a 2 nd supply means for supplying a lysate into the microchannel tube;

a 3 rd supply means for supplying a cleaning liquid into the micro flow tube;

A 4 th supply means for supplying an eluent into the microchannel tube;

a magnetic bead supply means for injecting magnetic beads into the micro flow tube;

a thrust force supply member for supplying thrust force to the magnetic beads and the liquid;

a gas supply means for supplying a gas for drying the magnetic beads;

an exhaust valve connected to the micro flow pipe for exhausting; and

and the electromagnet is arranged on the outer wall of the micro-flow tube, and the magnetic beads are attracted to the tube wall of the micro-flow tube by electrifying.

5. The nucleic acid detection system of claim 1, wherein the nucleic acid detection system comprises a plurality of nucleic acid probes,

the system configuration unit stores a reaction reagent for preparing the reaction liquid based on the reaction reagent and supplying the reaction liquid to the micro flow tube,

the system configuration unit is provided with a temperature control unit which can respectively control the temperature of the reaction reagent and the temperature of the reaction liquid.

6. The nucleic acid detection system of claim 1, wherein the nucleic acid detection system comprises a plurality of nucleic acid probes,

the nucleic acid detecting unit has a heating device for heating the microtube,

the heating device is provided with a plurality of heating bodies, the respective temperatures of the plurality of heating bodies are different, and the micro-flow pipe circularly and reciprocally passes through the plurality of heating bodies in turn, or,

The heating device is provided with a heating body, the heating body is provided with parts with different temperatures, so that at least one heating area and at least one cooling area are formed, and the micro-flow pipe circularly and reciprocally passes through the heating area and the cooling area in sequence.

7. The nucleic acid detecting system according to claim 6, wherein,

the plurality of heating bodies or the one heating body is formed into a columnar body, the micro-flow tube is spirally fixed on the plurality of heating bodies or the one heating body around the plurality of heating bodies or the one heating body, or,

the plurality of heating bodies or the one heating body is configured to have a heating surface, and the micro flow tube is fixed to the plurality of heating bodies or the one heating body in a meandering manner along the heating surface of the plurality of heating bodies or the one heating body.

8. The nucleic acid detection system of claim 1, wherein the nucleic acid detection system comprises a plurality of nucleic acid probes,

the inner diameter of the micro-flow tube is 1-8 mm.

9. The nucleic acid detection system of claim 1, wherein the nucleic acid detection system comprises a plurality of nucleic acid probes,

the sampling portion is configured in either one of the following structures one and two,

structure one:

The sampling section further includes:

a manipulator unit having a grip for gripping the sampling rod and having a predetermined movable range; and

a face positioning unit for positioning the face of the sampling person in the movable range of the manipulator unit,

and (2) a structure II:

the sampling section further includes:

a manipulator unit having a grip for gripping the sampling rod and being movable; and

an image acquisition unit which captures the relative positions of the face of the sampling person and the sampling rod,

the nucleic acid detection system controls the movement of the robotic unit based on the relative positions of the face and the sampling wand.

10. The nucleic acid detecting system according to claim 2, wherein,

the sampling part further comprises at least one of the following units,

the reminding unit reminds the sampling personnel through voice or images;

the display unit displays the identity information acquired by the identity recognition unit and/or the acquisition action image captured by the image acquisition unit; and

And the disinfection unit disinfects the area contacted by the sampling personnel.

11. The nucleic acid detecting system according to any one of claims 1 to 10, wherein,

the nucleic acid detection system comprises a mixing oscillation unit for oscillating the sample collection unit so that the sample collected by the sampling rod and the preservation solution are fully mixed.

12. The nucleic acid detecting system according to any one of claims 1 to 10, wherein,

the nucleic acid detecting system includes a waste liquid treatment unit for collecting waste liquid generated in the extraction unit and the nucleic acid detecting unit; and/or the number of the groups of groups,

the nucleic acid detection system further comprises a detection result output unit, wherein the detection result output unit is used for outputting detection results to the sampling personnel and/or the terminal equipment.