CN219930089U

CN219930089U - Detecting consumable and detecting device

Info

Publication number: CN219930089U
Application number: CN202320406453.9U
Authority: CN
Inventors: 李小锋; 李晨阳; 杜逸穹; 李彬健; 黄钦炎
Original assignee: Guangdong Hexin Health Technology Co ltd
Current assignee: Guangdong Hexin Health Technology Co ltd
Priority date: 2022-03-10
Filing date: 2023-03-06
Publication date: 2023-10-31
Anticipated expiration: 2033-03-06
Also published as: CN116694446A; WO2023169375A1

Abstract

The utility model discloses a detection consumable and a detection device. The detection consumable comprises a transfer treatment area, a cracking area, a cleaning area, an elution area and an amplification area; a swab container is arranged in the upstream pipeline of the cracking zone; the lysis zone is connected with the transfer treatment zone and is used for carrying out lysis on the sample of the swab container by adopting the lysis solution of the lysis zone and storing the lysed nucleic acid into the transfer treatment zone; the intermediate transfer treatment area is connected with the cleaning area and is used for cleaning the nucleic acid stored in the intermediate transfer treatment area by adopting the cleaning solution of the cleaning area; the transfer treatment area is connected with the elution area; the elution region is connected with the amplification region and is used for amplifying the eluted nucleic acid. The detection consumable has the advantages of low cost, high detection efficiency and convenient operation.

Description

Detecting consumable and detecting device

The present utility model claims priority from chinese patent application CN2022205357068, with application date 2022, 3 and 10. The present utility model incorporates the entirety of the above-mentioned chinese patent application.

Technical Field

The utility model is used in the technical field of molecular detection, and particularly relates to a detection consumable and a detection device.

Background

At present, in the molecular diagnosis technology, the steps of sample storage, transportation, nucleic acid extraction, nucleic acid amplification and the like are required to be realized separately by the traditional technology, different contents are required to be separated, different storage devices are required to be packaged by the traditional technology, and when the traditional technology is used, different storage devices are required to be opened in different areas according to different steps, so that cross contamination is prevented, the traditional Polymerase Chain Reaction (PCR) laboratory is large in investment, complex in operation and high in cross contamination probability, and the skill requirement on operators is high, so that the traditional detection mode has extremely high cost on each link and matched consumable material requirement of detection, and is very inconvenient to operate and low in detection efficiency.

Disclosure of Invention

The utility model aims to at least solve one of the technical problems in the prior art and provides a detection consumable and a detection device, wherein the detection consumable has the advantages of low cost, high detection efficiency and convenient operation.

The technical scheme adopted for solving the technical problems is as follows:

the utility model provides a detect consumptive material, includes the first hose that is used for storing the sample, the second hose that is used for storing the lysate, the third hose that is used for storing the washing liquid, the fourth pipe that is used for collecting nucleic acid, the fifth hose and the flexible passageway that are used for storing eluent and reaction liquid, the flexible passageway will first hose the second hose the third hose the fourth pipe with the fifth hose is linked together, the one end of first hose is the introduction end, the other end of first hose with the flexible passageway is linked together, the second hose the third hose with all be equipped with the barrier film that can seal reagent in the fifth hose, the barrier film can break through the extrusion hose, be equipped with in the fourth pipe and be used for adsorbing the collection device of nucleic acid, be equipped with in the fourth pipe and be used for promoting the liquid to flow through collection device's piston.

Preferably, one end of the second hose is a closed end, the other end of the second hose is communicated with the flexible channel, one end of the third hose is a closed end, the other end of the third hose is communicated with the flexible channel, one end of the fourth hose is closed by a piston, the other end of the fourth hose is communicated with the flexible channel, one end of the fifth hose is a closed end, and the other end of the fifth hose is communicated with the flexible channel.

Preferably, the flexible channel is formed by sealing two layers of films, the films are in sealing connection with the first hose, the second hose, the third hose, the fourth hose and the fifth hose, and a channel communicated with the first hose, the second hose, the third hose, the fourth hose and the fifth hose is formed between the two layers of films.

Preferably, the device further comprises a support frame, wherein the first hose, the second hose, the third hose, the fourth hose and the fifth hose are arranged in parallel in the support frame, one ends of the first hose, the second hose, the third hose, the fourth hose and the fifth hose are connected with the support frame, and the other ends of the first hose, the second hose, the third hose, the fourth hose and the fifth hose are fixedly connected with the support frame through the thin film.

Preferably, the support frame is provided with a feeding nozzle, one end of the feeding nozzle is fixedly connected with the sample feeding end of the first hose, and the other end of the feeding nozzle is provided with a sealing cover.

Preferably, the support frame is provided with a plurality of joints, the closed end of the second hose, the closed end of the third hose and the closed end of the fifth hose are fixedly connected with the support frame sequentially through the joints, and the fourth hose and the support frame are integrally formed.

Preferably, the collection device includes a nucleic acid adsorbing membrane disposed along a radial direction of the fourth tube.

Preferably, a filter element is arranged at one end, connected with the flexible channel, of the fourth pipe, a limiting ring used for limiting the movement range of the nucleic acid adsorption membrane is arranged in the fourth pipe, and the nucleic acid adsorption membrane is positioned between the limiting ring and the filter element.

The utility model also provides a detection device comprising a pressing plate for pressing a hose, a baffle for closing the hose and the flexible channel, and the detection consumable according to any one of the above.

Preferably, the detecting device comprises a first heating device and a second heating device, the first heating device is arranged in the fifth hose, and the second heating device is positioned at the opposite position of the baffle.

One of the above technical solutions has at least one of the following advantages or beneficial effects: this detect consumable separates all reagents that need store through the barrier film in the hose of detecting the consumable, and need not to open the detection consumable when using and can mix the reagent of depositing each separation according to the operation requirement, and the piston has improved collection device's nucleic acid collection effect, and this detect consumable is with low costs, convenient to use has both taken into account the requirement of each reagent separation storage, has promoted the convenience of unifying the use again, makes the detection can accomplish under the closed state, can not cause the pollution to the external world.

Additional aspects and advantages of the utility model will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the utility model.

The utility model also provides a detection consumable, which comprises a transfer treatment area, a cracking area, a cleaning area, an elution area and an amplification area; a swab container is arranged in an upstream pipeline of the cracking zone;

the lysis zone is connected with the transfer treatment zone and is used for carrying out lysis on the sample of the swab container by adopting the lysis solution of the lysis zone and storing the lysed nucleic acid into the transfer treatment zone;

The transfer treatment area is connected with the cleaning area and is used for washing the nucleic acid stored in the transfer treatment area by adopting the washing liquid of the cleaning area;

the transit treatment area is connected with the elution area and is used for introducing the eluent of the elution area to elute the washed nucleic acid and introducing the eluted nucleic acid into the elution area;

the elution region is coupled to the amplification region for amplifying the eluted nucleic acid.

The utility model also provides a detection consumable, which comprises a transfer treatment area, a cracking area, a cleaning area, an elution area and an amplification area;

the cracking zone is connected with the transfer treatment zone and is used for cracking the sample by adopting the cracking liquid of the cracking zone and storing the cracked nucleic acid into the transfer treatment zone;

The elution region is connected with the amplification region and is used for amplifying the eluted nucleic acid;

the transfer treatment area is internally provided with a piston for pushing liquid to flow into or flow out of the transfer treatment area.

In the present utility model, preferably, a swab container is disposed in the upstream pipeline of the lysing area.

In the present utility model, preferably, the detecting consumable further includes a liquid storage area, and the liquid storage area is disposed upstream of the cracking area.

In the present utility model, preferably, the lysis zone, the intermediate treatment zone, the washing zone, the elution zone, and the amplification zone are provided in at least one pipe.

In the present utility model, preferably, the lysis zone, the transfer treatment zone, the washing zone, the elution zone and the amplification zone are mutually communicated through a flow channel, and the other end which is not connected with the flow channel is a closed end.

In some preferred embodiments of the utility model, the storage zone, the lysis zone, the staging zone, the washing zone, the elution zone and the amplification zone are disposed within at least one conduit.

In some preferred embodiments of the utility model, one end of the reservoir is engaged with the flow channel, thereby providing communication between the reservoir and the lysis zone, the staging zone, the washing zone, the elution zone and the amplification zone.

In some preferred embodiments of the utility model, the flow channels are formed by a membrane integrally formed at one end of each of the hoses.

In some preferred embodiments of the utility model, the conduit is a flexible hose; preferably, a plurality of isolating layers are arranged in each flexible hose along the axis perpendicular to the flexible hose; more preferably, the blocking layer is a unsealable sealing layer integrally formed in the pipeline, and the unsealable sealing layer is used for temporarily sealing the reagent in the pipeline.

In some preferred embodiments of the present utility model, a nucleic acid collector is disposed near one end of the transfer processing region where the flow channel is connected, and a piston rod is disposed at the other end of the transfer processing region, such that a piston cavity is formed from the piston rod to the nucleic acid collector; a protruding rubber plug is arranged below the piston rod; the nucleic acid collector is stuck with a compression ring with a concave structure with a wide upper part and a narrow lower part, and the convex rubber plug is matched with the compression ring with the concave structure.

In some preferred embodiments of the present utility model, one end of the liquid storage area is connected with the flow channel, and the other end is a feeding end; the swab container is arranged in the liquid storage area.

In the utility model, preferably, the number and the positions of the washing areas in the washing area can be flexibly adjusted according to actual requirements.

In some preferred embodiments of the utility model, the cleaning zone comprises a first cleaning zone and a second cleaning zone, the first cleaning zone being a portion proximate the flow path and the second cleaning zone being a portion proximate the closed end.

In some embodiments of the utility model, the reservoir is disposed in the first hose.

In some embodiments of the utility model, the lysing area and the cleaning area are disposed in a second hose and a third hose.

In some embodiments of the utility model, the transfer processing area is disposed in the fourth hose.

In some specific embodiments of the utility model, the elution zone and the amplification zone are disposed in a fifth hose, the elution zone is disposed in a portion proximate to the flow channel, and the amplification zone is a portion proximate to the closed end.

In some specific embodiments of the present utility model, the piston cavity is a stepped sleeve structure, and the sleeve structure is a structure with a narrow bottom and a wide top or an equal top and bottom diameter.

In some embodiments of the utility model, the flow channel is formed by two films integrally formed at bottoms of the first hose, the second hose, the third hose, the fourth hose and the fifth hose.

In some embodiments of the present utility model, the first hose, the second hose, the third hose, the fourth hose and the fifth hose are arranged in a linear arrangement, and more preferably in a parallel arrangement.

In some specific embodiments of the present utility model, the distances between the first hose, the second hose, the third hose, the fourth hose and the fifth hose are all equal to or greater than 1mm.

In some specific embodiments of the utility model, the thickness of each flexible hose is greater than or equal to 0.01mm.

In some specific embodiments of the utility model, the diameter of each flexible hose is not less than 1mm.

In some embodiments of the utility model, each of the flexible hoses is a polymeric material, preferably one or more of PTFE, PA, PET and PI.

In some embodiments of the utility model, each of the flexible hoses is fully or partially transparent.

In some specific embodiments of the present utility model, the number of the sealing layers is at least one; preferably, the number of the sealing layers capable of being unsealed in each flexible hose is 1-2; more preferably, one of the unsealable sealing layers is provided near the end of the second hose which is engaged with the flow passage, near the end of the third hose which is engaged with the flow passage, and near the end of the fifth hose which is engaged with the flow passage; more preferably, said third hose is provided with a said resealable sealing layer for temporarily separating said first wash zone from said second wash zone; more preferably, said fifth hose is provided with one of said resealable sealing layers for temporarily separating said elution zone and said amplification zone.

In some embodiments of the present utility model, the sealing layer is integrally formed on the flexible hose by gluing or welding.

In some embodiments of the present utility model, the film is made of a polymer material, preferably one or more of PTFE, PA, PET and PI.

In some embodiments of the utility model, the film has a thickness of 0.01mm or more.

In some embodiments of the utility model, the film is transparent.

In some embodiments of the present utility model, the film and each of the flexible hoses are integrally formed by gluing, heat sealing or welding.

In some specific embodiments of the present utility model, the lower end sleeve of the piston cavity is connected to the membrane through the flexible hose, and the connection mode is gluing, welding or heat sealing.

In some specific embodiments of the present utility model, the lower end sleeve of the piston cavity is directly connected to the membrane by gluing, welding or heat sealing.

In some preferred embodiments of the present utility model, the diameter of the piston chamber is greater than or equal to the diameter of the junction of the transfer treatment zone and the flow passage.

In some preferred embodiments of the utility model, a porous filter element is provided between the nucleic acid collector and the junction of the staging area and the flow channel.

In some preferred embodiments of the utility model, the nucleic acid collector is a nucleic acid-adsorbing membrane or a nucleic acid-adsorbing particle.

In some embodiments of the utility model, when the nucleic acid collector is a nucleic acid adsorbing membrane, the material of the nucleic acid adsorbing membrane is a silica gel membrane.

In some specific embodiments of the utility model, when the nucleic acid collector is a nucleic acid adsorbing membrane, the nucleic acid adsorbing membrane is fixed in the staging area by gluing or welding.

In some embodiments of the utility model, when the nucleic acid collector is a nucleic acid adsorbing membrane, at least one permanent seal for limiting immobilization is provided at the upper and/or lower end of the nucleic acid adsorbing membrane; more preferably, when the number of the permanent seals is two and the permanent seals are arranged on the same side according to the interval of more than or equal to 1 mm.

In some specific embodiments of the utility model, when the nucleic acid collector is a nucleic acid adsorbing membrane, the nucleic acid adsorbing membrane is circular or polygonal in shape; more preferably rectangular or square; still more preferably, the rectangle has a transverse length x and a longitudinal length y, x.ltoreq.y.

In some specific embodiments of the utility model, when the nucleic acid collector is a nucleic acid-adsorbing membrane, the number of nucleic acid-adsorbing membranes is at least one; more preferably, when the number of the nucleic acid-adsorbing membranes is 1, the nucleic acid-adsorbing membranes are laid flat or folded; more preferably, when the number of the nucleic acid-adsorbing membranes is greater than 1, each of the nucleic acid-adsorbing membranes is stacked at intervals or stacked without intervals.

In some specific embodiments of the utility model, when the nucleic acid collector is a nucleic acid-adsorbing particle, the adsorbing particle comprises one or more of a magnetic bead, a filter, and a thin film layer.

In some preferred embodiments of the present utility model, the detecting consumable further comprises a holder; the support is fixedly connected with the edge of the film and the flexible hose respectively.

In some embodiments of the present utility model, the material of the bracket is ABS, PC, PE or PA.

In some embodiments of the utility model, the support is transparent or black.

In some specific embodiments of the present utility model, the fixing manner of the support and the edge of the film is gluing, heat sealing or welding.

In some specific embodiments of the present utility model, the support is directly fixed to the top end of the flexible hose, and the fixing manner is gluing, heat sealing or welding.

In some specific embodiments of the utility model, the support is fixedly connected with the flexible hose through a connector arranged on the support; more preferably, the number of joints is equal to the number of flexible hoses; more preferably, the joint is hollow cylindrical or hollow conical; even more preferably, when the joint is conical, the conical opening is upward.

In some specific embodiments of the present utility model, the bracket is provided with a sample inlet; the sample inlet comprises a sealing cover; the sealing cover is connected with the sample inlet through threads or buckled; more preferably, the sealing cover is made of a high polymer material, and even more preferably ABS, PC, PE or PA; more preferably, the sealing cover is made of elastic material, and even more preferably elastic rubber, such as silicone rubber or thermoplastic polyurethane.

In some preferred embodiments of the utility model, the swab holder is disposed at the feed end of the first hose.

In some specific embodiments of the present utility model, the swab container is made of a polymer material.

In some specific embodiments of the utility model, the swab holder is cylindrical, stepped cylindrical or stepped conical; when the swab container is in a stepped cylindrical shape or a stepped conical shape, the stepped cylindrical shape or the stepped conical shape is in a structure with a wide upper part and a narrow lower part.

In some embodiments of the utility model, the side wall or bottom of the swab container is provided with at least one groove; more preferably, the shape of the groove is polygonal or circular; more preferably, the diameter of the groove is equal to or less than the maximum diameter of the swab.

In some specific embodiments of the present utility model, when the swab container is cylindrical, an outer diameter of the swab container is greater than or equal to an inner diameter of the flexible hose and less than or equal to an inner diameter of the sample inlet of the holder; the inner diameter of the swab container is larger than or equal to the maximum diameter of the swab.

In some specific embodiments of the present utility model, when the swab container is in a stepped cylindrical shape or a stepped conical shape, the outer diameter of the large end of the swab container is greater than or equal to the inner diameter of the flexible hose and less than or equal to the inner diameter of the sample inlet of the bracket; the inner diameter of the small end of the swab container is larger than or equal to the maximum diameter of the swab.

In some preferred embodiments of the present utility model, the detecting consumable includes a pushing plate and a baffle, the pushing plate is disposed on the outer side of each flexible hose, and the reagent in the flexible hose breaks through the partition layer by closing the pushing plate, so as to realize material exchange; the baffle is arranged on the outer sides of the flexible hoses and the flow channels and is used for temporarily separating materials in the flexible hoses.

In some specific embodiments of the utility model, a first push plate is disposed on the outer side of the first hose.

In some specific embodiments of the utility model, a second push plate is disposed on the outer side of the second hose.

In some specific embodiments of the utility model, in the third hose, a third push plate is disposed outside the first washing zone.

In some specific embodiments of the utility model, in the third hose, a fourth push plate is disposed outside the second washing zone.

In some specific embodiments of the utility model, a fifth pushing plate is disposed on the outer side of the fourth hose.

In some specific embodiments of the utility model, in the fifth hose, a sixth pushing plate is disposed outside the elution region.

In some specific embodiments of the utility model, in the fifth hose, a seventh pushing plate is disposed outside the amplification region.

In some specific embodiments of the utility model, the inlet end of the first hose is provided with a first baffle.

In some specific embodiments of the utility model, a second baffle is disposed at the junction of the first hose and the flow channel.

In some embodiments of the utility model, the flow path between the first hose and the second hose is provided with a third baffle.

In some specific embodiments of the utility model, a fourth baffle is disposed at the junction of the second hose and the flow channel.

In some embodiments of the utility model, a fifth baffle is provided in the flow path between the second hose and the third hose.

In some specific embodiments of the utility model, a sixth baffle is disposed at the joint of the third hose and the flow channel.

In some embodiments of the utility model, a seventh baffle is disposed in the third hose between the first washing zone and the second washing zone.

In some specific embodiments of the utility model, the flow path between the third hose and the fourth hose is provided with an eighth baffle.

In some specific embodiments of the utility model, a ninth baffle is disposed at the joint of the fourth hose and the flow channel.

In some specific embodiments of the utility model, a flow passage between the fourth hose and the fifth hose is provided with a tenth baffle.

In some specific embodiments of the utility model, an eleventh baffle is disposed at the joint of the fifth hose and the flow channel.

In some embodiments of the utility model, a twelfth baffle is disposed between the elution zone and the amplification zone in the fifth hose.

In the present utility model, preferably, the number and positions of the heating devices in the detecting consumable material may be adjusted conventionally according to actual requirements, and preferably, the number is 2.

In some preferred embodiments of the present utility model, the detection consumable further comprises a first heating device for heating the elution zone and a second heating device for heating the amplification zone.

In the present utility model, preferably, the method for detecting nucleic acid using the above-mentioned detecting consumable comprises the steps of:

s1, carrying out a cracking reaction on a sample to be detected and a cracking liquid in the cracking zone to obtain a cracking mixed liquid;

s2, introducing the cracking mixed solution into the transfer treatment area, collecting nucleic acid through adsorption, and then draining the adsorbed cracking mixed solution to the cracking area;

s3, introducing the washing liquid of the washing area into the transit treatment area, washing the nucleic acid in the S1, and then draining the washed washing liquid to the washing area;

s4, introducing the eluent of the elution zone into the transit treatment zone, eluting the nucleic acid in the transit treatment zone to obtain the eluent containing the nucleic acid, and introducing the eluent containing the nucleic acid into the elution zone;

S5, heating the elution zone and the amplification zone respectively, and sending the eluent containing the nucleic acid into the amplification zone to obtain a nucleic acid amplification result.

In the present utility model, preferably, before step S1, the first baffle is opened, the sample to be detected is stored in the first hose, and the first baffle is closed;

in the present utility model, preferably, in step S1, the second baffle, the third baffle and the fourth baffle are opened, the cracking solution and the sample to be detected are mixed by opening and closing the first push plate and the second push plate, a cracking reaction is performed, the second push plate is opened, and the first push plate, the second baffle and the third baffle are sequentially closed;

in the present utility model, preferably, in step S2, the fifth baffle, the eighth baffle, and the ninth baffle are opened, the cracking mixed solution is introduced into the transfer treatment area through opening and closing of the second push plate and the fifth push plate, and nucleic acid adsorption is performed, and after the adsorbed cracking mixed solution is drained to the cracking area, the second push plate is opened, and the fifth push plate, the ninth baffle, the eighth baffle, the fifth baffle, and the fourth baffle are sequentially closed;

In the present utility model, preferably, in step S3, the sixth baffle, the eighth baffle and the ninth baffle are opened, and the first washing solution is introduced into the transfer treatment area through opening and closing of the third push plate and the fifth push plate, so as to wash the nucleic acid for the first time; after the first washing is finished, sequentially closing the third push plate and the sixth baffle plate, opening the second baffle plate, the third baffle plate and the fifth baffle plate, introducing washing liquid after the first washing into the liquid storage area, and sequentially closing the fifth push plate, the fifth baffle plate, the third baffle plate and the second baffle plate; opening the sixth baffle plate and the seventh baffle plate, and introducing the second washing liquid into the transfer treatment area through opening and closing of the fourth push plate and the fifth push plate to carry out nucleic acid second washing; after the second washing is completed, sequentially closing the fifth pushing plate, the ninth baffle plate, the eighth baffle plate and the sixth baffle plate;

in the present utility model, preferably, in step S4, the ninth baffle, the tenth baffle, and the eleventh baffle are opened, and the eluent is introduced into the transit treatment zone through opening and closing of the fifth push plate and the sixth push plate, so as to perform nucleic acid elution; after the nucleic acid is eluted, sequentially closing the fifth pushing plate, the ninth baffle, the tenth baffle and the eleventh baffle;

In the present utility model, preferably, in step S5, the twelfth baffle is opened, the eluent containing the nucleic acid is introduced into the amplification zone through opening and closing of the sixth push plate and the seventh push plate, the seventh push plate and the twelfth baffle are closed in sequence, and the first heating device and the second heating device are opened, so as to obtain a nucleic acid amplification result.

In the present utility model, the detection consumable as described above can be preferably used in a method for storing, processing and analyzing a sample or a reagent in a detection processing system.

On the basis of conforming to the common knowledge in the field, the above preferred conditions can be arbitrarily combined to obtain the preferred examples of the utility model.

The reagents and materials used in the present utility model are commercially available.

The utility model has the positive progress effects that:

the utility model also provides a totally-enclosed treatment technology without transfer and pollution. The different contents are not mutually communicated when being stored through the unsealable sealing line, and can be mixed internally when being used according to the needs. Compared with the traditional pcr laboratory which needs to consume huge manpower and cost and is divided into a sample receiving area, a nucleic acid processing area, an amplification area and an analysis area during decoration so as to prevent the pollution of each area, the utility model skillfully integrates the pcr laboratory through a low-cost device and simultaneously does not pollute the outside.

1. Integration: different contents are stored in the integrated device, and meanwhile, the different contents are separated by the unsealable sealing line inside the device, so that the different contents cannot cross each other to cause failure before being used.

2. And (3) fully sealing: the whole using process is finished in an integrated totally-enclosed device no matter whether an instrument is matched or not, except for adding a sample, the whole process does not need to be uncapped, the whole process does not need to be transferred in the environment, the content does not communicate with the outside, and no cross infection risk exists.

3. No site limitation: because the system is compact and flexible and portable, compared with the traditional molecular diagnosis, the system can only be carried out in a relevant laboratory partition, and operators can work in places other than the laboratory according to the requirements of test projects.

4. The cost is low: the sample can be detected by on-site extraction, so that the cost of transportation, storage and the like of the sample is saved. And the detection time is short, and clinical staff can quickly obtain and read the result, so that the time and the cost of patients or using institutions are saved for the most part.

5. Expansibility: the flexibility of the system determines that the same device can correspond to different detection items, thereby having great advantages in terms of openness. The detection platform is not only suitable for rapid detection in clinical departments and inspection centers of hospitals, but also suitable for relevant personnel in the field of scientific research institutions or molecular detection, and develops own detection projects on the platform.

6. Multi-domain: the utility model is not only suitable for molecular diagnosis, but also can be used for sample storage and treatment problems in other fields such as biochemistry, immunity and the like. In use scenarios including, but not limited to, clinical departments, ICU, emergency, disease control centers, food safety, scientific research, criminal investigation, home, military, drug, customs inspection and quarantine, pet, aquaculture, water quality, forestry, animal husbandry, and the like.

Drawings

FIG. 1 is a perspective view of the test consumables of examples 1 and 3 of the present utility model;

FIG. 2 is a cross-sectional view of the test consumable of examples 1 and 3 of the present utility model;

FIG. 3 is a schematic structural view of the detecting consumable material of embodiments 1 and 3 of the present utility model;

FIG. 4 is a schematic structural diagram of a consumable for testing according to embodiment 2 of the present utility model;

FIG. 5 is an exploded view of the components of the test consumable of example 2 of the present utility model;

FIG. 6 is a schematic view showing a part of a nucleic acid adsorbing membrane in a relay treatment area according to example 2 of the present utility model;

FIG. 7 is a schematic diagram of a material control structure of a consumable part for inspection according to embodiment 2 of the present utility model;

FIG. 8 is a schematic view of the zoning of the detection consumable of embodiment 2 of the present utility model;

FIG. 9 is a schematic view of a part of the feeding end of the detecting consumable in embodiment 2 of the present utility model;

FIG. 10 is a schematic view of a portion of a staging area according to embodiment 3 of the present utility model;

FIG. 11 is a perspective view of the swab container of embodiments 2 and 3 of the present utility model;

part b of fig. 11 is a front view of the swab container of embodiments 2 and 3 of the present utility model;

FIG. 11 is a top view of the swab container of embodiments 2 and 3 of the present utility model;

fig. 11, part d, is a bottom view of the swab container of embodiments 2 and 3 of the present utility model;

FIG. 11 is a cross-sectional view of the swab container of embodiments 2 and 3 of the present utility model;

FIG. 12 is a graph showing the effect of fluorescence test in example 4 of the present utility model.

Reference numerals illustrate:

flexible hose 1

Film 2

Bracket 3

Joint 31

Sample introduction end 32

Sample introduction end screw thread 321

Sealing cover 4

Nucleic acid collector 5

Nucleic acid adsorbing membrane 51

Unsealable sealing layer 6

Flow channel 7

Closed end 8

Permanent seal 9

Swab container 10

Swab 1001

Groove 1002

Liquid storage area 11

Cleavage zone 12

First washing zone 13

Second washing zone 14

Transfer processing zone 15

Elution zone 16

Amplification region 17

First baffle 2001

Second baffle 2002

Third baffle 2003

Fourth baffle 2004

Fifth baffle 2005

Sixth baffle 2006

Seventh baffle 2007

Eighth baffle 2008

Ninth baffle 2009

Tenth baffle 2010

Eleventh baffle 2011

Twelfth baffle 2012

First push plate 3001

Second push plate 3002

Third push plate 3003

Fourth push plate 3004

Fifth push plate 3005

Sixth push plate 3006

A seventh push plate 3007.

Detailed Description

Reference will now be made in detail to the present embodiments of the present utility model, examples of which are illustrated in the accompanying drawings, wherein the accompanying drawings are used to supplement the description of the written description so that one can intuitively and intuitively understand each technical feature and overall technical scheme of the present utility model, but not to limit the scope of the present utility model.

In the present utility model, if directions (up, down, left, right, front and rear) are described, they are merely for convenience of description of the technical solution of the present utility model, and do not indicate or imply that the technical features must be in a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as limiting the present utility model.

In the present utility model, "a plurality of" means one or more, and "a plurality of" means two or more, and "greater than", "less than", "exceeding", etc. are understood to not include the present number; "above", "below", "within" and the like are understood to include this number. In the description of the present utility model, the description of "first" and "second" if any is used solely for the purpose of distinguishing between technical features and not necessarily for the purpose of indicating or implying a relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.

In the present utility model, unless clearly defined otherwise, terms such as "disposed," "mounted," "connected," and the like should be construed broadly and may be connected directly or indirectly through an intermediate medium, for example; the connecting device can be fixedly connected, detachably connected and integrally formed; can be mechanically connected, electrically connected or capable of communicating with each other; may be a communication between two elements or an interaction between two elements. The specific meaning of the words in the utility model can be reasonably determined by a person skilled in the art in combination with the specific content of the technical solution.

Example 1

The embodiment of the present utility model provides a detection consumable, referring to fig. 1 and 2, including a first hose 110 for storing a sample, a second hose 120 for storing a lysis solution, a third hose 130 for storing a washing solution, a fourth hose 140 for collecting nucleic acids, a fifth hose 150 for storing an eluent and a reaction solution, and a flexible channel 200, wherein the flexible channel 200 communicates the first hose 110, the second hose 120, the third hose 130, the fourth hose 140 and the fifth hose 150, one end of the first hose 110 is a sample introduction end 111, the other end of the first hose 110 is communicated with the flexible channel 200, closing of the flexible channel 200 can be achieved by pressing the flexible channel 200, the second hose 120, the third hose 130 and the fifth hose 150 are each provided with an isolation membrane 300 capable of sealing a reagent, the isolation membrane 300 is sealed in the corresponding hose, the isolation membrane 300 can be ruptured by pressing the hoses, the fourth hose 140 is provided with a collection device 400 for adsorbing nucleic acids, the fourth hose 140 is provided with a piston 141 for pushing the liquid to flow through the collection device 400, and the piston 141 is provided with a piston 141 for pushing the liquid to flow through the collection device 400, so that the nucleic acids can flow through the collection device 400, and the detection consumable is improved, and the detection consumable is used as follows: step one, a liquid sample or a solid swab is placed into a first hose 110 through a sample introduction end 111, the sample introduction end 111 of the first hose 110 is sealed through a sample introduction end screw thread 321, only a flexible channel 200 is used for communicating the first hose 110 with a second hose 120, the second hose 120 is extruded, a cracking liquid in the second hose 120 breaks through a separation membrane 300 and enters the first hose 110, the first hose 110 and the second hose 120 are repeatedly extruded, the sample is mixed with the cracking liquid, nucleic acid release is realized, and then the mixed liquid is extruded into the second hose 120; step two, only the second hose 120 and the fourth tube 140 are communicated, the second hose 120 is repeatedly pressed and the piston 141 is reciprocally driven, the mixed solution is repeatedly passed through the collecting device 400 to collect nucleic acid, and then the mixed solution is positioned in the second hose 120 by pressing the piston 141 and the flexible channel 200; step three, only the third hose 130 and the fourth tube 140 are communicated, the third hose 130 is extruded, the cleaning solution in the third hose 130 breaks through the isolating membrane 300 and enters the fourth tube, the third hose 130 is repeatedly extruded, the piston 141 is reciprocally driven, and the impurities remained on the collecting device 400 can be washed down, so that the nucleic acid cleaning is realized; step four, only the fourth pipe 140 and the fifth hose 150 are communicated, the reaction liquid is stored in the closed end of the fifth hose 150, the eluent is stored in the end, connected with the flexible channel 200, of the fifth hose, the position of the eluent in the fifth hose 150 is pressed to enable the eluent to enter the fourth pipe 140, the position of the eluent and the fourth pipe are repeatedly pressed, the collecting device 400 is flushed, nucleic acid elution is completed, and the eluted eluent is located in the fifth hose; step five, the eluent of the fifth hose 150 is extruded to enable the eluent to break through the isolating membrane 300 and enter the region where the reaction liquid is located, nucleic acid amplification is completed, all reagents needing to be stored are separated in the hose of the detecting consumable by the detecting consumable, and the detecting consumable is not required to be opened when in use, the reagents stored in each separation can be mixed according to the use requirement, the detecting consumable is low in cost and convenient to use, the requirement of separating and storing each reagent is met, the convenience of unified use is improved, detection can be completed in a closed state, no pollution is caused to the outside, and it can be understood that the reagents stored in each hose can be replaced according to the requirement of detection items, and the position of the isolating membrane 300 can be flexibly adjusted according to the detection requirement.

Referring to fig. 1 and 2, one end of the second hose 120 is a closed end, the other end of the second hose 120 is communicated with the flexible channel 200, one end of the third hose 130 is a closed end, the other end of the third hose 130 is communicated with the flexible channel 200, one end of the fourth hose 140 is closed by the piston 141, the other end of the fourth hose 140 is communicated with the flexible channel 200, one end of the fifth hose 150 is a closed end, the other end of the fifth hose 150 is communicated with the flexible channel 200, different reagents are stored between the closed end of the hoses and the isolating membrane 300, and the flexible channel 200 communicates the hoses so as to better realize reagent mixing by pressing the hoses.

Referring to fig. 1, the sexual passage 200 is formed by sealing two films 210, the films 210 are hermetically connected to the first, second, third, fourth and fifth hoses 110, 120, 130, 140 and 150, passages communicating with the first, second, third, fourth and fifth hoses 110, 120, 130, 140 and 150 are formed between the two films 210, and in use, closing of the passages can be achieved at designated positions by pressing the films 210 with a shutter, blocking the circulation of liquid, preferably, the films 210 are 2 sheets, the hoses are placed between the two films 210, the two films are integrally connected by means of gluing, heat-sealing, welding or the like, the films 210 are made of a high molecular material such as PTFE, PA, PC, PET, preferably, for the convenience of observation, the films 210 and each hose are transparent materials.

Referring to fig. 1, the inspection consumable further includes a support frame 500, and the first, second, third, fourth and fifth hoses 110, 120, 130, 140 and 150 are disposed in parallel in the support frame 500, and one ends of the first, second, third, fourth and fifth hoses 110, 120, 130, 140 and 150 are connected to the support frame 500, and the other ends are fixedly connected to the support frame 500 through the film 210, so as to support the hoses, thereby facilitating the use of the inspection apparatus.

Referring to fig. 2, the support frame 500 is provided with a feed nozzle 510, one end of the feed nozzle 510 is fixedly connected with the sample introduction end 111 of the first hose 110, the other end of the feed nozzle 510 is provided with a sealing cap 511, and the sealing cap 511 and the sample introduction end 111 of the first hose 110 may be connected through screw threads or a buckle in order to ensure tightness.

Referring to fig. 1, a plurality of connectors 520 are provided on the support frame 500, the closed end of the second hose 120, the closed end of the third hose 130 and the closed end of the fifth hose 150 are fixedly connected with the support frame 500 sequentially through the connectors 520, and the fourth hose 140 and the support frame 500 are integrally formed, so that the hoses are effectively supported, and the subsequent use is facilitated.

Referring to FIG. 2, the collection apparatus 400 includes a nucleic acid adsorbing membrane disposed along a radial direction of the fourth tube 140, preferably, the nucleic acid adsorbing membrane is a silica gel membrane capable of adsorbing nucleic acids by electric charges under a specific environment, and the nucleic acid adsorbing membrane is circular, and in some embodiments, a plurality of nucleic acid adsorbing membranes may be disposed in the fourth tube 140 to increase the strength of nucleic acid adsorption.

In some embodiments, referring to fig. 2, a filter element 143 is disposed at one end of the fourth tube 140 connected to the flexible channel 200, a limiting ring 420 for limiting a movement range of the nucleic acid adsorption film is disposed in the fourth tube 140, the outer periphery of the limiting ring 420 is connected to the inner wall of the fourth tube 140 by means of gluing, welding, or the like, so that the limiting ring 420 is fastened inside the fourth tube 140, the nucleic acid adsorption film is disposed between the limiting ring 420 and the filter element 143, and the nucleic acid adsorption film is compressed by the limiting ring 420 and the filter element 143 to prevent the nucleic acid adsorption film from being separated during the reagent flushing process.

Preferably, referring to fig. 2, the piston 141 moves along the length direction of the fourth pipe 140, a piston rod 142 for driving the piston 141 to move is provided on the piston 141, and a conical recess structure is formed on one surface of the stop ring 420 adjacent to the piston 141 so as to be matched with the piston 141, so that the liquid is discharged more thoroughly.

Preferably, referring to fig. 2, a sleeve 410 is disposed between the fourth tube 140 and the flexible channel 200, the sleeve 410 connects the fourth tube 140 and the flexible channel 200 through a process of bonding, welding, heat sealing, etc. to facilitate the circulation of the reagent, the diameter of the sleeve 410 is less than or equal to the diameter of the fourth tube 140, and the structures of the fourth tube 140, the sleeve 410 and the flexible channel 200 are formed in a stepped structure to facilitate the flow of the reagent.

Preferably, the filter element 143 is a porous filter element, and the filter element 143 may filter larger particulate impurities while providing an average flow rate that allows for uniform passage of fluid through the nucleic acid adsorbing membrane.

The embodiment of the present utility model further provides a testing device, referring to fig. 3, including a pressing plate 700 for pressing a hose, a baffle 800 for closing the hose or the flexible channel 200, and the testing consumable described in the above embodiment, the first hose 110 is provided with a first pressing plate 710, the second hose 120 is provided with a second pressing plate 720, the third hose 130 is provided with a third pressing plate 730 and a fourth pressing plate 740, the fifth hose 150 is provided with a sixth pressing plate 760 and a seventh pressing plate 770, the sample introduction end of the first hose 110 is provided with a first baffle 801, the end of the first hose 110 connected to the flexible channel 200 is provided with a second baffle 802, the flexible channel 200 between the first hose 110 and the second hose 120 is provided with a third baffle 803, the end of the second hose 120 connected to the flexible channel 200 is provided with a fourth baffle 804, the flexible channel 200 between the second hose 120 and the third hose 130 is provided with a fifth baffle 805, a sixth baffle 806 is provided at one end of the third hose 130 connected to the flexible channel 200, a seventh baffle 807 is provided at an intermediate position of the third hose 130 for storing the first washing liquid and the second washing liquid, respectively, a separation membrane 300 is provided between the first washing liquid and the second washing liquid, an eighth baffle 808 is provided on the flexible channel 200 between the third hose 130 and the fourth hose 140, a ninth baffle 809 is provided at one end of the fourth hose 140 connected to the flexible channel 200, a tenth baffle 810 is provided on the flexible channel 200 between the fourth hose 140 and the fifth hose 150, an eleventh baffle 811 is provided at one end of the flexible channel 200 connected to the fifth hose 150, a twelfth baffle 812 is provided at an intermediate position of the fifth hose 150, a closed end of the fifth hose 150 is used for storing the reaction liquid, an end of the fifth hose 150 connected to the flexible channel 200 is used for storing the eluent, the reaction solution and the eluent are separated by a separation membrane 300.

Preferably, the detection device includes a first heating device and a second heating device, wherein the first heating device is disposed in the fifth hose 150, and preferably, the first heating device is provided with two heating devices, so that the reaction solution and the eluent can be heated to the required temperatures according to the detection requirement, so as to amplify the nucleic acid, and the second heating device is located at the opposite position of each baffle, so as to increase the reagent temperature and improve the detection efficiency, and it can be understood that the number of the first heating device and the second heating device can be adjusted according to the detection requirement.

The use method of the detection device is as follows:

step one, a liquid sample or a solid swab 1001 is placed into a first hose 110 through a sample introduction end 111, the sample introduction end 111 is sealed, all baffles are pressed, each hose and a flexible channel 200 are kept in a closed state, a second baffle 802, a third baffle 803 and a fourth baffle 804 are opened, the first hose 110 and the second hose 120 are communicated, a second pressing plate 720 is pressed, a cracking liquid in the second hose 120 breaks through an isolating membrane 300 into the first hose 110, the first pressing plate 710 and the second pressing plate 720 are repeatedly pressed, the sample is mixed with the cracking liquid to release nucleic acid, and then the mixed liquid is extruded into the second hose 120 and a fifth baffle 805 is closed;

Step two, the second baffle 802 and the third baffle 803 are closed, the fifth baffle 805, the eighth baffle 808 and the ninth baffle 809 are opened, only the second hose 120 and the fourth hose 140 are communicated, the second pressing plate 720 is repeatedly pressed, the piston 141 is reciprocally driven, the mixed solution is repeatedly passed through the collecting device 400, the nucleic acid adsorption film can collect the released nucleic acid in the mixed solution to realize nucleic acid collection, the piston 141 is sequentially pressed, the ninth baffle 809, the eighth baffle 808, the fifth baffle 805 and the fourth baffle 804 are closed, and the mixed solution is blocked in the second hose 120;

step three, opening the eighth baffle 808, the ninth baffle 809, the fifth baffle 805 and pulling the piston 141, communicating only the third hose 130 with the fourth pipe 140, extruding the third pressing plate 730, enabling the first washing liquid in the third hose 130 to break the isolation film 300 and enter the fourth pipe, repeatedly extruding the third pressing plate 730 and reciprocally driving the piston 141, enabling the first washing liquid to continuously wash out the nucleic acid adsorption film, enabling impurities, except nucleic acid, on the nucleic acid adsorption film to be washed out, opening the second baffle 802, the third baffle 803 and the fifth baffle 805, pressing the piston 141, sequentially closing the ninth baffle 809, the eighth baffle 808, the fifth baffle 805, the third baffle 803 and the second baffle 802, enabling the first washing liquid to be in the first hose 110, opening the ninth baffle 809, the eighth baffle 808, the sixth baffle 806, the seventh baffle 807 and the third pressing plate 730, pressing the piston 141, enabling the second washing liquid to break the isolation film 300, sequentially repeatedly extruding the fourth pressing plate 740, the third pressing plate 730 and reciprocally driving the piston 141, enabling the second washing liquid to repeatedly wash out the nucleic acid adsorption film, sequentially closing the ninth baffle 809, the eighth baffle 808 and the eighth baffle 803, and the second baffle 802, enabling the second washing liquid to be repeatedly washed out, and sequentially closing the eighth baffle 808 and the second baffle 808;

Step four, the reaction solution is stored in the closed end of the fifth hose 150, the eluent is stored in the end, connected with the flexible channel 200, of the fifth hose, the ninth baffle 809, the tenth baffle 810, the eleventh baffle 811 and the pressing piston 141 are opened, the sixth pressing plate 760 is pressed, the eluent in the fifth hose 150 enters the fourth pipe 140, the piston 141 is driven to reciprocate, the nucleic acid adsorption film is repeatedly washed, the nucleic acid elution is completed, the piston 141 is pressed, the ninth baffle 809, the tenth baffle 810 and the eleventh baffle 811 are closed in sequence, and the eluent with clean nucleic acid is located in the fifth hose 150;

and fifthly, extruding the sixth pressing plate 760 to enable the eluent to break through the isolating membrane 300 and mix with the reaction liquid, starting the first heater to ensure the temperature in the fifth hose 150, preferably ensuring the temperature of the reaction liquid at the seventh pressing plate 770 to be 95 ℃ for pre-denaturation and denaturation, ensuring the temperature of the eluent at the sixth pressing plate 760 to be 60 ℃ for annealing/extension, and under the condition of fluorescence pcr circulation, using fluorescence excitation and a receiver of a specific wave band for each circulation, so as to perform fluorescence collection, and obtaining a nucleic acid amplification result after data processing.

Example 2

FIG. 4 is a schematic diagram of the structure of the detecting consumable of the present embodiment; FIG. 5 is an exploded view of the components of the detection consumable of the present embodiment; FIG. 6 is a partial schematic view of the nucleic acid adsorbing membrane 51 in the intermediate treatment area 15 according to the present embodiment; FIG. 7 is a schematic diagram of a material control structure of the detecting consumable material according to the present embodiment; FIG. 8 is a schematic view of the area division of the consumable part for detection according to the present embodiment; fig. 9 is a partial schematic view of a feeding end of the inspection consumable of the present embodiment.

The detection consumables of this embodiment include a stock solution zone 11, a staging zone 15, a lysis zone 12, a wash zone, an elution zone 16, and an amplification zone 17. The lysis zone 12 is connected with the transfer treatment zone 15, and is used for carrying out lysis on the sample of the swab container 10 by adopting the lysis solution of the lysis zone 12 and storing the lysed nucleic acid into the transfer treatment zone 15; the transfer treatment area 15 is connected with the cleaning area and is used for cleaning nucleic acid stored in the transfer treatment area 15 by adopting a cleaning solution of the cleaning area; the transfer treatment region 15 is connected with the elution region 16, and is used for introducing the eluent of the elution region 16 to elute the washed nucleic acid and introducing the eluted nucleic acid into the elution region 16; the elution zone 16 is connected to an amplification zone 17 for amplifying the eluted nucleic acid.

Fig. 11 is a perspective view of the swab container 10 according to the present embodiment; part b is a front view of the swab container 10 of the present embodiment; part c is a top view of the swab container 10 of the present embodiment; part d is a bottom view of the swab container 10 of the present embodiment; part e is a cross-sectional view of the swab container 10 of the present embodiment.

The liquid storage area 11 is arranged in the first hose, and the swab container 10 is arranged at the feeding end of the first hose serving as the liquid storage area 11 and is made of a polymer material; the swab container 10 is in a stepped cylindrical shape with a wider upper part and a narrower lower part; the side wall or bottom of the swab container 10 is provided with at least one groove 1002, which is circular in shape; the diameter of the groove 1002 is equal to or less than the maximum diameter of the swab; the outer diameter of the large end of the swab container 10 is larger than or equal to the inner diameter of the flexible hose 1 and smaller than or equal to the inner diameter of the sample inlet of the bracket 3; the inside diameter of the small end of the swab container 10 is equal to or larger than the maximum diameter of the swab.

The cracking zone 12 and the cleaning zone are arranged in the second hose and the third hose, the cleaning zone comprises a first washing zone 13 and a second washing zone 14, the first washing zone 13 is a part close to the flow channel 7, and the second washing zone 14 is a part close to the closed end 8; the transfer treatment area 15 is arranged in the fourth hose, and a nucleic acid collector 5 is arranged near one end of the transfer treatment area 15, which is connected with the flow channel 7; the elution area 16 and the amplification area 17 are respectively arranged in the fifth hose, the elution area 16 is arranged at a part close to the flow channel 7, and the amplification area 17 is arranged at a part close to the closed end 8; the first hose, the second hose, the third hose, the fourth hose and the fifth hose are arranged in parallel, and the interval between every two hoses is 1mm; the thickness of each flexible hose 1 is 0.01mm, the diameter is 1mm, and the material is PTFE and is transparent. Each hose is a flexible hose 1, wherein a plurality of unsealable sealing layers 6 which are integrally formed in the pipeline by cementing are arranged along the axis vertical to the flexible hose 1 and are used for temporarily sealing the reagent in the pipeline. A sealing layer 6 which can be unsealed is respectively arranged near the end of the second hose which is jointed with the flow channel 7, near the end of the third hose which is jointed with the flow channel 7 and near the end of the fifth hose which is jointed with the flow channel 7; the third hose is provided with a resealable sealing layer 6 for temporarily separating the first washing zone 13 from the second washing zone 14; the fifth hose is provided with a resealable sealing layer 6 for temporarily separating the elution zone 16 from the amplification zone 17;

The flow passage 7 is formed of two films 2 integrally formed at one ends of the first, second, third, fourth and fifth hoses. The film 2 is made of PTFE; the thickness of the film 2 is 0.01mm, the film 2 is transparent, and the film 2 and each flexible hose 1 are integrally formed through heat sealing;

a porous filter element is arranged between the junction of the nucleic acid collector 5 and the transfer treatment area 15 and the runner 7; the nucleic acid collector 5 is a nucleic acid adsorption film 51, is made of a silica gel film, is fixed in the transit treatment area 15 in a gluing mode, and is provided with two permanent seals 9 which are arranged at two ends at intervals of 1mm and are used for limiting and fixing; the nucleic acid adsorbing membrane 51 has a rectangular shape, wherein the rectangular shape has a transverse length x and a longitudinal length y, and x is not more than y; the number of nucleic acid adsorbing membranes 51 is 1, which are laid flat.

The detecting consumable also comprises a bracket 3; the support 3 is fixedly connected with the edge of the film 2 in a heat sealing mode, the support 3 is fixedly connected with the flexible hose 1 through connectors 31 arranged on the support 3, the number of the connectors 31 is equal to that of the flexible hose 1, and the connectors 31 are conical with upward hollow openings; wherein, the bracket 3 is made of ABS and is transparent; the bracket 3 is provided with a sample inlet, and comprises a sealing cover 4, and the sealing cover 4 is connected with the sample inlet through threads; the sealing cover 4 is made of silicon rubber.

The detecting consumable also comprises a push plate and a baffle plate; the pushing plates are arranged on the outer sides of the flexible hoses 1, and the reagent in the flexible hoses 1 breaks the isolating layer by closing the pushing plates, so that the exchange of materials is realized; the baffles are arranged on the outer sides of the flexible hoses 1 and the flow channels 7 and are used for temporarily separating materials in the flexible hoses 1. Specifically, a first push plate 3001 is arranged on the outer side of the first hose, and a second push plate 3002 is arranged on the outer side of the second hose; in the third hose, a third push plate 3003 is provided outside the first washing zone 13; in the third hose, a fourth push plate 3004 is provided outside the second washing zone 14; a fifth push plate 3005 is arranged on the outer side of the fourth hose; in the fifth hose, a sixth push plate 3006 is provided outside the elution zone 16; in the fifth hose, a seventh push plate is provided outside the amplification zone 17; the inlet end of the first hose is provided with a first baffle 2001; a second baffle 2002 is arranged at the joint of the first hose and the flow channel 7; the flow passage 7 between the first hose and the second hose is provided with a third baffle 2003; a fourth baffle 2004 is arranged at the joint of the second hose and the flow channel 7; the flow passage 7 between the second hose and the third hose is provided with a fifth baffle 2005; a sixth baffle 2006 is arranged at the joint of the third hose and the runner 7;

In the third hose, a seventh baffle 2007 is provided between the first washing zone 13 and the second washing zone 14; an eighth baffle 2008 is arranged on the flow passage 7 between the third hose and the fourth hose; a ninth baffle 2009 is arranged at the joint of the fourth hose and the flow channel 7; the flow passage 7 between the fourth hose and the fifth hose is provided with a tenth baffle 2010; an eleventh baffle 2011 is arranged at the joint of the fifth hose and the flow channel 7; in the fifth hose, a twelfth barrier 2012 is provided between the elution zone 16 and the amplification zone 17;

the detection consumable further comprises a first heating means for heating the elution zone 16 and a second heating means for heating the amplification zone 17.

Example 3

Fig. 10 is a partial schematic view of the transfer processing area 15 in the present embodiment.

The detecting consumable of this embodiment is similar to embodiment 2 except that a nucleic acid collector 5 is provided near one end of the junction of the relay treatment area 15 and the flow channel 7, and a porous filter element 95 is provided between the nucleic acid collector 5 and the junction of the relay treatment area 15 and the flow channel 7; the other end of the transfer processing area 15 is provided with a piston rod, so that a piston cavity 91 is formed from the piston rod to the nucleic acid collector 5; a protruded rubber plug is arranged below the piston rod; the pressing ring 94 with the concave structure 941 with the wide upper part and the narrow lower part is stuck on the nucleic acid collector 5, and the convex rubber plug is matched with the pressing ring 94 with the concave structure; the piston cavity is of a sleeve structure with a stepped lower part and a narrow upper part. The lower sleeve of the piston cavity is connected with the film 2 through the flexible hose 1 by heat seal, and the diameter of the piston cavity is larger than or equal to the diameter of the joint of the transfer treatment area 15 and the runner 7.

Example 4

The present embodiment is a nucleic acid detection method using the detection consumable of embodiment 2, wherein the available areas in the detection consumable include: 300. Mu.L of lysate (lysis zone 12), 200. Mu.L of first wash solution (first wash zone 13), 200. Mu.L of second wash solution (second wash zone 14), 50. Mu.L of eluent (elution zone 16) and 50. Mu.L of LPCR reagent (reservoir zone 11), the PCR reagent may be a liquid reagent or may be lyophilized microspheres.

The sample tested in this example was a new crown sample preservation solution. Placing the swab in the swab holder 10 at the sample end 32 and breaking the swab; alternatively, the sample-holding liquid is added to the liquid storage area 11.

The method comprises the following steps:

s1, nucleic acid release: the second baffle 2002, the third baffle 2003 and the fourth baffle 2004 are opened, the cracking liquid is mixed with the sample to be detected through the opening and closing of the first push plate 3001 and the second push plate 3002, the cracking reaction is carried out, after repeating the steps for 5 times, the cracking mixed liquid is obtained, the second push plate 3002 is opened, and the first push plate 3001, the second baffle 2002 and the third baffle 2003 are sequentially closed;

s2, nucleic acid collection: the fifth baffle 2005, the eighth baffle 2008 and the ninth baffle 2009 are opened, the cracking mixed solution is introduced into the transfer treatment zone 15 through the opening and closing of the second baffle 3002 and the fifth baffle 3005, the nucleic acid adsorption film 51 collects the released nucleic acid in the mixed solution, the nucleic acid adsorption is carried out, after repeating the steps, the adsorbed cracking mixed solution is guided to the cracking zone 12, the second baffle 3002 is opened, the fifth baffle 3005, the ninth baffle 2009, the eighth baffle 2008, the fifth baffle 2005 and the fourth baffle 2004 are sequentially closed, and the adsorbed cracking mixed solution is guided to the cracking zone 12;

S3, nucleic acid cleaning: the sixth barrier 2006, the eighth barrier 2008 and the ninth barrier 2009 are opened, and the first washing liquid is introduced into the intermediate treatment zone 15 by opening and closing the third push plate 3003 and the fifth push plate 3005, so that impurities except nucleic acids on the nucleic acid adsorbing membrane 51 are washed away, nucleic acid is washed for the first time, and the above steps are repeated; after the first washing is completed, the third push plate 3003 and the sixth baffle 2006 are sequentially closed, the second baffle 2002, the third baffle 2003 and the fifth baffle 2005 are opened, the washing liquid after the first washing is introduced into the liquid storage area 11, and the fifth push plate 3005, the fifth baffle 2005, the third baffle 2003 and the second baffle 2002 are sequentially closed; the sixth baffle 2006 and the seventh baffle 2007 are opened, and the second washing liquid is introduced into the transit treatment zone 15 through the opening and closing of the fourth push plate 3004 and the fifth push plate 3005, so that the impurities remained on the adsorption film are washed down, nucleic acid is washed for the second time, and the steps are repeated; after the second washing is completed, the fifth push plate 3005, the ninth barrier 2009, the eighth barrier 2008 and the sixth barrier 2006 are sequentially closed; draining the washed washing liquid to a washing area;

s4, nucleic acid elution: opening a ninth baffle 2009, a tenth baffle 2010 and an eleventh baffle 2011, introducing the eluent into the transfer processing zone 15 through the opening and closing of the fifth push plate 3005 and the sixth push plate 3006, washing the nucleic acid on the adsorption film into the eluent, eluting the nucleic acid to obtain the eluent containing the nucleic acid, and repeating the steps; after nucleic acid elution, sequentially closing the fifth push plate 3005, the ninth baffle 2009, the tenth baffle 2010, and the eleventh baffle 2011, and introducing the nucleic acid-containing eluate into the elution zone 16;

S5, nucleic acid amplification: opening a twelfth baffle 2012, introducing the eluent containing the nucleic acid into the amplification zone 17 through opening and closing of a sixth push plate 3006 and a seventh push plate, sequentially closing the seventh push plate and the twelfth baffle 2012, starting a first heating device and a second heating device to enable the temperature of the elution zone 16 to reach 48 ℃, enabling the temperature of the amplification zone 17 to reach 94 ℃ required by the reagent, and extruding the liquid to the amplification zone 17 for 2 minutes after the liquid is maintained in the elution zone 16 for 5 minutes; heating the elution zone 16 to 60 ℃ and maintaining the amplification zone 17 at 94 ℃; after maintaining the liquid in the amplification zone 17 at 94℃for 10 seconds, squeezing the liquid into the elution zone 16, maintaining the liquid at 60℃for 35 seconds, and performing fluorescence collection in the elution zone 16; the above cycle was repeated 45 times to obtain a nucleic acid amplification result.

Fig. 12 is a graph showing the effect of fluorescence test in this example. The test effect is obtained through fluorescence acquisition, and comprises 4 detection channels: FAM channel, VIC channel, ROX channel, and Cy5 channel. Along with the increase of the cycle times, the fluorescence signal of the FAM channel is intermittently increased, the fluorescence signal of the Cy5 channel is continuously increased, the fluorescence signal of the ROX channel is slowly increased, and the fluorescence signal of the VIC channel is gradually flattened, wherein the FAM channel corresponds to a new crown n gene, the ROX channel corresponds to a new crown ORF gene, the Cy5 channel is an internal reference, and the ROX channel is a negative control. From this, it was confirmed that the nucleic acid amplification was successful. The method has the characteristics of simplicity, convenience and rapidness in operation, high repeatability, high sensitivity and the like.

In the description of the present specification, reference to the terms "example," "embodiment," or "some embodiments," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the utility model. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

The present utility model is, of course, not limited to the above-described embodiments, and one skilled in the art can make equivalent modifications or substitutions without departing from the spirit of the utility model, and these equivalent modifications or substitutions are intended to be included in the scope of the present utility model as defined in the appended claims.

Claims

1. A detect consumptive material, its characterized in that: including the first hose that is used for storing the sample, be used for storing the second hose of lysate, be used for storing the third hose of washing liquid, be used for collecting the fourth pipe of nucleic acid, be used for storing the fifth hose and the flexible passageway of eluent and reaction liquid, the flexible passageway will first hose the second hose the third hose the fourth pipe with the fifth hose is linked together, the one end of first hose is the sampling end, the other end of first hose with the flexible passageway is linked together, the second hose the third hose with all be equipped with the barrier film that can seal reagent in the fifth hose, the barrier film can break through the extrusion hose, be equipped with the collection device who is used for adsorbing the nucleic acid in the fourth pipe, be equipped with in the fourth pipe and be used for promoting the liquid to flow through collection device's piston.

2. The detection consumable of claim 1, wherein: one end of the second hose is a closed end, the other end of the second hose is communicated with the flexible channel, one end of the third hose is a closed end, the other end of the third hose is communicated with the flexible channel, one end of the fourth hose is closed by a piston, the other end of the fourth hose is communicated with the flexible channel, one end of the fifth hose is a closed end, and the other end of the fifth hose is communicated with the flexible channel.

3. The detection consumable of claim 2, wherein: the flexible channel is formed by sealing two layers of films, the films are in sealing connection with the first hose, the second hose, the third hose, the fourth hose and the fifth hose, and a channel communicated with the first hose, the second hose, the third hose, the fourth hose and the fifth hose is formed between the two layers of films.

4. A detection consumable according to claim 3, wherein: the flexible pipe comprises a first flexible pipe, a second flexible pipe, a third flexible pipe, a fourth pipe and a fifth flexible pipe, and is characterized by further comprising a supporting frame, wherein the first flexible pipe, the second flexible pipe, the fourth pipe and the fifth flexible pipe are arranged in the supporting frame in parallel, one ends of the first flexible pipe, the second flexible pipe, the third flexible pipe, the fourth pipe and the fifth flexible pipe are connected with the supporting frame, and the other ends of the first flexible pipe, the second flexible pipe, the third flexible pipe, the fourth pipe and the fifth flexible pipe are fixedly connected with the supporting frame through the thin film.

5. The assay consumable of claim 4, wherein: the feeding device is characterized in that a feeding nozzle is arranged on the supporting frame, one end of the feeding nozzle is fixedly connected with the sample feeding end of the first hose, and a sealing cover is arranged at the other end of the feeding nozzle.

6. The assay consumable of claim 4, wherein: the support frame is provided with a plurality of joints, the closed end of the second hose, the closed end of the third hose and the closed end of the fifth hose are fixedly connected with the support frame sequentially through the joints, and the fourth hose and the support frame are integrally formed.

7. The detection consumable of claim 1, wherein: the collection device includes a nucleic acid-adsorbing membrane disposed along a radial direction of the fourth tube.

8. The assay consumable of claim 7, wherein: the one end that links to each other with flexible channel in the fourth intraductal filter core that is equipped with, be equipped with in the fourth intraductal restriction be used for restriction the range of motion of nucleic acid adsorption membrane spacing ring with the nucleic acid adsorption membrane is located between the spacing ring with the filter core.

9. A detection device, characterized in that: comprising a platen for squeezing a hose, a flap for closing the hose and the flexible channel, and a detection consumable according to any one of claims 1 to 8.

10. The detection apparatus according to claim 9, wherein: the device comprises a first heating device and a second heating device, wherein the first heating device is arranged in the fifth hose, and the second heating device is positioned at the opposite position of the baffle plate.

11. The detection consumable is characterized by comprising a transfer treatment area, a cracking area, a cleaning area, an elution area and an amplification area; a swab container is arranged in an upstream pipeline of the cracking zone;

12. The detection consumable is characterized by comprising a transfer treatment area, a cracking area, a cleaning area, an elution area and an amplification area;

13. The assay consumable of claim 11 or 12, further comprising a reservoir zone disposed upstream of the lysing zone;

or the cracking zone, the transit treatment zone, the cleaning zone, the elution zone and the amplification zone are arranged in at least one pipeline;

or the cracking zone, the transfer treatment zone, the cleaning zone, the elution zone and the amplification zone are communicated with each other through a flow channel, and the other end which is not connected with the flow channel is a closed end;

Or a swab container is arranged in the upstream pipeline of the cracking zone.

14. The assay consumable of claim 13, wherein said reservoir zone, said lysing zone, said staging zone, said washing zone, said elution zone, and said amplification zone are disposed within at least one conduit;

or one end of the liquid storage area is connected with the flow channel, so that the liquid storage area is communicated with the cracking area, the transfer treatment area, the cleaning area, the elution area and the amplification area;

or, the flow channel is formed by a film integrally formed at one end of each pipeline;

or, the pipeline is a flexible hose; a plurality of isolating layers are arranged in each flexible hose along the axis perpendicular to the flexible hose; the partition layer is a unsealable sealing layer integrally formed in the pipeline, and the unsealable sealing layer is used for temporarily sealing the reagent in the pipeline;

or, a nucleic acid collector is arranged near one end of the transfer treatment area, which is connected with the flow channel, and a piston rod is arranged at the other end of the transfer treatment area, so that a piston cavity is formed from the piston rod to the nucleic acid collector; a protruding rubber plug is arranged below the piston rod; a pressing ring with a concave structure with a wide upper part and a narrow lower part is stuck on the nucleic acid collector, and the convex rubber plug is matched with the pressing ring with the concave structure;

Or one end of the liquid storage area is connected with the flow channel, and the other end is a feeding end; the swab container is arranged in the liquid storage area;

or, the cleaning zone comprises a first cleaning zone and a second cleaning zone, wherein the first cleaning zone is a part close to the flow channel, and the second cleaning zone is a part close to the closed end.

15. The assay consumable of claim 14, wherein the reservoir is disposed in a first hose;

or, the cracking zone and the cleaning zone are arranged in the second hose and the third hose;

or, the transfer treatment area is arranged in the fourth hose;

or the elution area and the amplification area are arranged in a fifth hose, the elution area is arranged at a part close to the flow channel, and the amplification area is arranged at a part close to the closed end;

or, the piston cavity is of a stepped sleeve structure, and the sleeve structure is of a structure with a narrow lower part and a wide upper part or an equal upper and lower diameter.

16. The sensing consumable of claim 15, wherein the flow channel is formed of two films integrally formed at bottoms of the first hose, the second hose, the third hose, the fourth hose, and the fifth hose; the thickness of the film is more than or equal to 0.01mm; the film is transparent;

Or, the first hose, the second hose, the third hose, the fourth hose and the fifth hose are arranged in parallel;

or the intervals among the first hose, the second hose, the third hose, the fourth hose and the fifth hose are all more than or equal to 1mm;

or, the thickness of each flexible hose is more than or equal to 0.01mm;

or, the diameter of each flexible hose is more than or equal to 1mm;

or, each flexible hose is fully transparent or partially transparent;

or, the number of the sealing layers capable of being unsealed is at least one; the number of the sealing layers capable of being unsealed in each flexible hose is 1-2; one sealing layer capable of being unsealed is arranged near one end of the second hose, one end of the third hose and one end of the fifth hose, and the sealing layer capable of being unsealed are arranged near the other end of the second hose, the other end of the third hose and the runner; said third hose is provided with a said resealable sealing layer for temporarily separating said first wash zone from said second wash zone; the fifth hose is provided with one of the unsealable sealing layers for temporarily separating the elution zone and the amplification zone.

17. The detection consumable of claim 14, wherein a diameter of the piston chamber is equal to or greater than a diameter of a junction of the staging area and the flow channel;

Or a porous filter element is arranged between the nucleic acid collector and the joint of the transfer treatment area and the flow channel;

or, the nucleic acid collector is a nucleic acid-adsorbing membrane or a nucleic acid-adsorbing particle.

18. The assay consumable of claim 17, wherein when the nucleic acid collector is a nucleic acid-adsorbing membrane, the upper and/or lower end of the nucleic acid-adsorbing membrane is provided with at least one permanent seal for limiting immobilization; when the number of the permanent seals is two, and the permanent seals are arranged on the same side according to the interval of more than or equal to 1 mm;

or, when the nucleic acid collector is a nucleic acid adsorbing membrane, the nucleic acid adsorbing membrane is rectangular in shape; the transverse length of the rectangle is x, the longitudinal length of the rectangle is y, and x is less than or equal to y;

or, when the nucleic acid collector is a nucleic acid adsorbing membrane, the number of the nucleic acid adsorbing membranes is at least one; when the number of the nucleic acid adsorbing membranes is 1, the nucleic acid adsorbing membranes are laid flat or folded; when the number of the nucleic acid-adsorbing membranes is greater than 1, each of the nucleic acid-adsorbing membranes is stacked at intervals or stacked without intervals.

19. The assay consumable of claim 15, wherein the assay consumable further comprises a holder; the support is fixedly connected with the edge of the film and the flexible hose respectively; wherein the bracket is transparent or black;

Or the bracket is directly fixedly connected with the top end of the flexible hose;

or the bracket is fixedly connected with the flexible hose through a connector arranged on the bracket; the number of joints is equal to the number of flexible hoses; the joint is hollow cylindrical or hollow and conical with an upward opening;

or, the bracket is provided with a sample inlet; the sample inlet comprises a sealing cover; the sealing cover is connected with the sample inlet through threads or buckled;

or, the swab container is arranged at the feeding end of the first hose; the swab container is cylindrical, is in a stepped cylindrical shape or a stepped conical shape with a wide upper part and a narrow lower part; at least one groove is formed in the side wall or the bottom of the swab container; the shape of the groove is polygonal or circular; the diameter of the groove is smaller than or equal to the maximum diameter of the swab; when the swab container is cylindrical, the outer diameter of the swab container is larger than or equal to the inner diameter of the flexible hose and smaller than or equal to the inner diameter of the sample inlet of the bracket; the inner diameter of the swab container is larger than or equal to the maximum diameter of the swab; when the swab container is in a stepped cylindrical shape or a stepped conical shape, the outer diameter of the large end of the swab container is larger than or equal to the inner diameter of the flexible hose and smaller than or equal to the inner diameter of the sample inlet of the bracket; the inner diameter of the small end of the swab container is larger than or equal to the maximum diameter of the swab.

20. The detecting consumable according to claim 15, wherein the detecting consumable comprises a pushing plate and a baffle plate, the pushing plate is arranged on the outer side of each flexible hose, and the reagent in the flexible hose breaks through the partition layer by closing the pushing plate, so that material exchange is realized; the baffle is arranged at the outer sides of the flexible hoses and the flow channels and is used for temporarily separating materials in the flexible hoses;

a first pushing plate is arranged on the outer side of the first hose;

a second pushing plate is arranged on the outer side of the second hose;

in the third hose, a third push plate is arranged on the outer side of the first washing zone;

in the third hose, a fourth push plate is arranged on the outer side of the second washing area;

a fifth pushing plate is arranged on the outer side of the fourth hose;

in the fifth hose, a sixth pushing plate is arranged on the outer side of the elution zone;

in the fifth hose, a seventh pushing plate is arranged on the outer side of the amplification area;

the inlet end of the first hose is provided with a first baffle;

a second baffle is arranged at the joint of the first hose and the flow passage;

a third baffle is arranged in a flow passage between the first hose and the second hose;

a fourth baffle is arranged at the joint of the second hose and the flow passage;

A fifth baffle is arranged in a flow passage between the second hose and the third hose;

a sixth baffle is arranged at the joint of the third hose and the flow passage;

a seventh baffle is arranged between the first washing area and the second washing area in the third hose;

an eighth baffle is arranged in a flow passage between the third hose and the fourth hose;

a ninth baffle is arranged at the joint of the fourth hose and the flow passage;

a tenth baffle is arranged in a flow passage between the fourth hose and the fifth hose;

an eleventh baffle is arranged at the joint of the fifth hose and the flow passage;

a twelfth baffle is arranged between the elution zone and the amplification zone in the fifth hose;

or, the detection consumable further comprises a first heating device and a second heating device, wherein the first heating device is used for heating the elution zone, and the second heating device is used for heating the amplification zone.