CN112903984B - Kit for detecting salivation sugar chain antigen 6, adaptive detection device and detection method - Google Patents

Kit for detecting salivation sugar chain antigen 6, adaptive detection device and detection method Download PDF

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Publication number
CN112903984B
CN112903984B CN202110062162.8A CN202110062162A CN112903984B CN 112903984 B CN112903984 B CN 112903984B CN 202110062162 A CN202110062162 A CN 202110062162A CN 112903984 B CN112903984 B CN 112903984B
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reagent
driving
valve
kit
driven
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CN112903984A (en
Inventor
曾曜龙
易剑峰
蔡其浩
胡小雄
施清蓉
钱伟
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Jiangxi Yingda Biotechnology Co ltd
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Jiangxi Yingda Biotechnology Co ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers

Abstract

The invention relates to a kit for detecting a sialylated glycoantigen 6, an adaptive detection device and a detection method. The kit comprises a plurality of reagent bags which can be inserted into external analysis equipment and pipelines for connecting the reagent bags and the external analysis equipment; the lines being selectively connectable to a liquid input of an external analytical device, the reagent bag including a multi-way valve disposed on its respective line and at its input output; the multi-directional valve has at least three valve positions for communicating the line with the reagent bags, the input and the output of the reagent bags, respectively, wherein the input of one of the reagent bags is communicable with an external gas source. Through using special multidirectional valve, can also wash, disinfect and disinfect in the valve body when switching between different pipelines and flow paths, reduced the batch interference in its testing process and taken place to the valve body fully clean and disinfect.

Description

Kit for detecting salivation sugar chain antigen 6, adaptive detection device and detection method
Technical Field
The invention relates to the technical field of detection kits, in particular to a kit for detecting a sialylated glycocalyx antigen 6, an adaptive detection device and a detection method.
Background
Sialylated glycochain antigen 6 (abbreviated as KL-6) is a high molecular weight glycoprotein discovered and named by Kohno et al in 1985, and its gene belongs to the MUC1 family, and is mainly expressed in type II alveolar epithelial cells and bronchiolar epithelial cells. In normal lung tissue, KL-6 is expressed on type II alveolar cells, respiratory bronchiolar epithelial cells and bronchial gland serous cells. When the somatic alveolar epithelial cells suffer a certain degree of damage, on the one hand, type II alveolar epithelial cells proliferate and activate, and the secretion of KL-6 rapidly increases: on the other hand, the permeability of the lung interstitial basement membrane is increased, so that KL-6 begins to diffuse to blood circulation, and the level of KL-6 in serum is also increased to a certain degree. In cases of interstitial pneumonia, particularly high activity, the serum KL-6 is particularly high. Healthy patients and respiratory diseases without interstitial pneumonia and pulmonary fibrosis have low values. KL-6 is a brand new serum biomarker (high sensitivity and high specificity) for detecting interstitial pneumonia, is a useful index for diagnosis, monitoring and prognosis, can evaluate the activity of interstitial lung diseases, can predict the clinical outcome of ILDs, and can provide a valuable solution.
Although the prior art test of KL-6 for the storage time of KL-6 cassettes kept simple bag open/close latching valves closed and they were opened first and irreversibly during insertion, these valves remained open during use of the kit and a separate valve connected downstream would draw liquid through the connecting line. These valves do not allow the connection line to be emptied, especially when the cartridge is left standing for a long time during testing or during off-use, which often results in valve clogging or batch-to-batch interference due to its inability to empty.
Disclosure of Invention
In view of this, it is necessary to provide a kit for detecting a sialylated sugar chain antigen 6, which can empty, sterilize and disinfect the interior of a valve body by using a special multi-way valve, thereby reducing the occurrence of valve blockage and batch interference.
The invention provides a kit for detecting a sialylated glycoantigen 6, which comprises a plurality of reagent bags capable of being inserted into external analysis equipment and pipelines for connecting the reagent bags with the external analysis equipment;
the lines being selectively connectable to the liquid input of an external analytical device, the reagent bag comprising a multi-way valve disposed on its respective line and at its input output; the multi-way valve has at least three valve positions for communicating a line with the reagent bag, an input of the reagent bag and an output of the reagent bag, respectively, wherein the input of one of the reagent bags is communicable with an external gas source;
the multi-way valve includes:
the valve shell forms a sealed switching cavity, and the switching cavity is provided with at least six outlets;
the valve body comprises a driven part connected with the switching cavity and a driving part in driving connection with the driven part, and the driven part can elastically deform to enable the outlets to be communicated.
The driven part is made of flexible materials and fixedly connected in the switching cavity, a plurality of mutually crossed circulation passages are formed in the driven part along the radial direction of the driven part, two ends of each circulation passage are correspondingly communicated to the two outlets, a gap is reserved between the driven part and the valve casing, and the driving part is movably connected with the valve casing.
Optionally, the driven portion is in a disc shape, and one end of the driving portion, located in the switching cavity, is also in a disc shape and is radially formed with a notch.
Optionally, a portion of the driving portion located in the switching cavity includes a plurality of pressing claws, each pressing claw corresponds to one of the flow paths, and each pressing claw can be individually controlled by a portion of the driving portion located outside the switching cavity, so that a corresponding one of the flow paths is switched.
Optionally, the passive portion includes a hose segment and a moving ring movably sleeved on an outer wall of the hose segment; the flexible pipe section is made of flexible elastic material, the flow passage is formed in the flexible pipe section, and the moving ring can be driven by the driving part to enable the flexible pipe section to be elastically deformed so as to enable one or more of the flow passages to be closed or opened.
Further optionally, the driving portion includes a handle rod, a sliding hole is formed in the valve housing, one end of the handle rod is fixedly connected to the moving ring, and the other end of the handle rod penetrates through the sliding hole and extends out of the switching cavity.
Further optionally, the moving ring is a magnetic ring, the driving portion includes a driving ring and a rotating cylinder, the driving ring and the moving ring are magnetically repelled, the driving ring and the moving ring are magnetically connected in one-to-one correspondence, an external thread is disposed on a side wall of the driving ring, an internal thread is disposed on an inner wall of the rotating cylinder, and the driving ring is in threaded connection with the inner wall of the rotating cylinder;
the rotating cylinder rotates to drive the driving ring to move along the length direction of the rotating cylinder.
The invention also provides a detection device matched with the kit, which is characterized by comprising the kit, a collecting pipe, an infusion apparatus, a butt joint element, an analyzer, a hose pump and a waste liquid bag; the collecting pipe can be communicated with a pipeline of the kit, the collecting pipe is communicated with the infusion apparatus through a pipeline, the analyzer is provided with a measuring chamber and a sensor arranged in the measuring chamber, the infusion apparatus is communicated into the measuring chamber through the butt joint element, the analyzer obtains a detection result through the sensor in the measuring chamber, and the pipeline in the measuring chamber is also communicated with the waste liquid bag through the hose pump.
The invention also provides a detection method of the sialylated glycoantigen 6, which is carried out by using the detection device of claim 8, wherein the reagent bag is replaceable and can contain sample liquid, calibration liquid, auxiliary liquid, cleaning liquid or disinfectant;
the detection method comprises the following steps:
s1, connecting the reagent bag to the collecting pipe through the pipeline, communicating the collecting pipe, the infusion apparatus, the measuring chamber of the butt joint element and the waste liquid bag through the pipeline in sequence, and arranging the soft high pump on the pipeline from the measuring chamber to the waste liquid bag;
s2, switching the multi-way valve on the reagent bag and on the line to an open position, thereby establishing a fluid path to the contents of the reagent bag, and wherein a small stream of liquid is transported in the direction of the measurement chamber, and wherein the multi-way valve is switched to an open position after the liquid has been withdrawn, such that the path to the contents of the reagent bag is closed and an access to an aeration source is established, and gaseous medium from the aeration source is sucked into the measurement chamber.
Wherein the rotational switching of the multi-way valve comprises the steps of:
s11, when the driven part is driven to contract by the driving part, the driven part is released from the inner wall of the switching cavity, and then the driven part is rotated to the two outlets which need to be communicated;
and S12, driving the driven part to extend to abut against the inner wall of the switching part through the driving part again, and realizing the tight conduction of the two outlets.
Has the advantages that:
1. the kit is connected to a reagent bag via a line and a multi-way valve so that the gas permeability of the tube material in the connecting line or the back flow of the functional liquid that has been withdrawn does not cause adverse effects on the gas concentration of the calibration or quality control liquid. Due to the fact that the special multi-way valve is used, when different pipelines and flow paths are switched, the interior of the valve body can be cleaned, sterilized and disinfected, batch interference in the detection process is reduced, and the valve body is sufficiently cleaned and disinfected. In addition, the detection operation process is simple and convenient, and the use cost and the maintenance cost are low. Simultaneously, whole reagent bag can realize taking out empty reagent bag into vacuum state earlier, pours into gas-liquid mixture reagent into the reagent bag again, pours into the back, and sealing joint can self sealedly, guarantees that solution keeps apart with external air in the bag, can seal each reagent homoenergetic that sample and detection need in the system, reduces to detecting the influence, also can reduce the contact with detect reagent, reduces the chance of personnel's infection, improves its biological safety nature.
2. According to a preferred variant of the invention, each multi-way valve has a third valve position, in which both the passage to the reagent bag and the fluid passage to the ventilation source are closed. This will ensure that the connecting lines are not contaminated by impurities from the environment during storage and transport of the kit or during long measurement pauses.
Drawings
FIG. 1 is a schematic structural diagram of a kit for detecting sialylated glycocalyx antigen 6 according to an embodiment of the present invention.
FIG. 2 is a schematic structural diagram of a detection device adapted to the detection kit for detecting sialylated glycoantigen 6 according to the embodiment of the present invention.
FIG. 3 is a schematic diagram of an alternative multi-directional valve structure in a saliva liquefaction sugar chain antigen 6 detection kit provided by an embodiment of the present invention.
FIG. 4 provides an alternative multi-valve block diagram in plan view for an embodiment of the invention.
FIG. 5 provides an alternative multi-valve block diagram in plan view for an embodiment of the invention.
FIG. 6 provides an alternative multi-valve block diagram in plan view for an embodiment of the invention.
FIG. 7 provides an alternative multi-valve block diagram in plan view for an embodiment of the invention.
FIG. 8 provides an alternative multi-valve block diagram in plan view for an embodiment of the invention.
Fig. 9 is an enlarged view of fig. 7 at a.
Fig. 10 is a schematic perspective view of an alternative driving portion according to an embodiment of the present invention.
Fig. 11 is a perspective view of an alternative driven portion according to an embodiment of the present invention.
Fig. 12 is a schematic perspective view of an alternative driving portion according to an embodiment of the present invention.
Fig. 13 is a perspective view of an alternative driven portion according to an embodiment of the present invention.
FIG. 14 is a flowchart of the steps of an alternative method for detecting sialylated oligosaccharide antigen 6 according to an embodiment of the present invention.
Fig. 15 is a flowchart of an operation procedure of the driving portion for driving the driven portion according to an embodiment of the present invention.
Fig. 16 is a flowchart of an operation procedure of the driving portion for driving the driven portion according to an embodiment of the present invention.
Fig. 17 is a flowchart of an operation procedure of the driving portion for driving the driven portion according to an embodiment of the present invention.
1 reagent bag, 2 pipelines,
3 multi-way valve, 30 valve casing, 300 switching cavity, 301 outlet, 302 limit groove, 303 installing groove, 304 sliding hole,
31 a valve body, 310 a passive part, 3102 a flexible pipe section, 31020 a tubular structure, 3103 a moving ring, 3104 a flow passage, 3105 a second buffer spring,
311 drive part, 3110 handle, 3111 first buffer spring,
3113 drive ring, 3114 rotary barrel, 3115 notch, 3116 press claw,
4 collecting pipes, 5 infusion pipes, 6 butt joint elements, 7 analyzers, 70 measuring chambers, 71 sensors, 8 hose pumps and 9 waste liquid bags.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
The invention provides a reagent kit for detecting a sialylated glycoantigen 6, which comprises a plurality of reagent bags 1 capable of being inserted into external analysis equipment and a pipeline 2 for connecting the reagent bags 1 with the external analysis equipment, as shown in figure 1. The lines 2 can be selectively connected to the liquid input of an external analytical device, the reagent bag 1 comprising a multi-way valve 3 arranged on its respective line 2 and at its input output. The multi-way valve 3 has at least three valve positions for communicating the lines with the reagent bags 1, the input and the output of the reagent bags 1, respectively, wherein the input of one of the reagent bags 1 is communicable with an external gas source.
The object of the invention is to improve a kit that can be inserted into an analyzer and that contains a reagent cartridge as described above
The reagent bag described is such that the gas permeability of the tube material in the connecting line or the return flow of the functional liquid which has been withdrawn does not cause an adverse effect on the gas concentration of the calibration or quality control liquid. Due to the fact that the special multi-way valve is used, when different pipelines and flow paths are switched, the interior of the valve body can be cleaned, sterilized and disinfected, batch interference in the detection process is reduced, and the valve body is sufficiently cleaned and disinfected. In addition, the detection operation process is simple and convenient, and the use cost and the maintenance cost are low. Simultaneously, whole reagent bag can realize taking out empty reagent bag into vacuum state earlier, pours into gas-liquid mixture reagent into the reagent bag again, pours into the back, and sealing joint can self sealedly, guarantees that solution keeps apart with external air in the bag, can seal each reagent homoenergetic that sample and detection need in the system, reduces to detecting the influence, also can reduce the contact with detect reagent, reduces the chance of personnel's infection, improves its biological safety nature.
As shown in fig. 3, the multi-way valve 3 includes a valve housing 30 and a valve body 31. The valve housing 30 forms a sealed switching chamber 300, and the switching chamber 300 is opened with at least six outlets 301. The valve body 31 includes a driven portion 310 connected to the switching chamber 301 and a driving portion 311 drivingly connected to the driven portion 310. The passive portion 310 may be elastically deformed such that two of the outlets 301 communicate.
Specifically, in one embodiment in which the driven portion 310 can be elastically deformed, the driven portion 310 can be further driven by the driving portion 311 to extend and contract along the radial direction of the switching cavity 301, and the driven portion 310 can extend along the radial direction of the switching cavity 301 to abut against the inner wall of the switching cavity 300. Thus, by arranging at least six outlets 301 on the switching chamber 300, when the driven part 310 is driven to contract by the driving part 311, the driven part 310 is released from the inner wall of the switching chamber 300, and then the driven part 310 is rotated to the two outlets 301, and then the driven part 310 is driven by the driving part 311 to extend to be pressed against the inner wall of the switching chamber 300, so that the two outlets 301 are tightly communicated, and other outlets 301 of the switching chamber 300 are communicated with an external air source to blow the residual liquid in the switching chamber 300, or are communicated with the external sterilization air source or the sterilization liquid to sterilize and disinfect the switching chamber 300. Each shift ring 3103 slides along the outer wall of the hose segment 3102. Further, a sealing groove matched with the telescopic end of the driven part 310 is formed on the inner wall of the outlet 301 corresponding to the switching cavity 300, so as to be tightly matched with the switching cavity and realize tight sealing after being pressed.
Further optionally, the driven portion 310 includes a driven section and a telescopic section connected to the driven section, the driven section is in transmission connection with the driving portion 311, and can be driven by the driving portion 311 to elastically deform to drive the telescopic section to extend and contract along the radial direction of the switching cavity 300. The driven section makes it flexible through receiving the extrusion to drive flexible section and realize flexible, drive portion 311 and driven section all have elasticity, and the driven section sets up in switching chamber 300, and drive portion 311 has the one end that sets up outside switching chamber 300, and drive portion 311 still has elastic connection and just receives the pressure to support the other end on the driven section on switching chamber 300 inner wall, in order to make the driven section take place elastic deformation.
In another embodiment in which the driven portion 310 can elastically deform, as shown in fig. 4 to 13, the driven portion 310 is made of a flexible material, the driven portion 310 is fixedly connected in the switching chamber 300, six mutually intersecting flow passages 3104 are formed inside the driven portion 310 along a radial direction thereof, two ends of each flow passage 3104 are correspondingly communicated to the two outlets 301, and a gap is left between the driven portion 310 and the valve housing 30 for accommodating a pressing portion of the driving portion 311. Specifically, the driving portion 311 may be pressed against the driven portion 310 by rotating or/and moving relative to the valve housing 30. In this way, when the pressing portion of the driving portion 311 presses against the outer wall of the driven portion 310, at least one of the flow paths 3104 can be closed by the pressing, and the flow path 3104 can be closed.
Further alternatively, as shown in fig. 10 and 11, the driven portion 310 is formed in a disk shape, and one end of the driving portion 311 located in the switching chamber 300 is also formed in a disk shape, but a notch 3115 is formed in a radial direction. As described above, by rotating the driving portion 311, the notch 3115 is made to correspond to one of the flow paths 3104, and the driving portion 311 is pressed against the driven portion 310, and the other portion of the driving portion 311 located in the switching chamber 300 is pressed against the driven portion 310 to close the other five flow paths 3104, but the notch 3115 is present, so that the flow path 3104 corresponding thereto cannot be closed to flow, and the flow path 3104 corresponding thereto is closed, and the purpose of one flow path 3104 being circulated and the other being closed is achieved. In this embodiment, since the passive part 310 is a closed space and is not theoretically connected to the valve housing 30, the sealing property of the liquid inside the passive part is ensured, which is helpful for improving the biosafety.
As a further alternative, as shown in fig. 11 and 12, in order to control the opening and closing of each flow path 3104 individually, the driving portion 311 includes six pressing claws 3116 at the position inside the switching chamber 300, each pressing claw 3116 corresponds to one flow path 3104, and each pressing claw 3116 can be controlled individually by the portion of the driving portion 310 outside the switching chamber 300, so that each pressing claw 3116 can be operated individually to open and close the corresponding one of the flow paths 3104 without interference, thereby increasing the flow possibility of the multi-way valve 3. Correspondingly, each pressing claw 3116 has an end extending out of the switching chamber 300 so as to operate each pressing claw 3116 separately. Specifically, each pressing claw 3116 has a pressing end and an operating end, the pressing end is located in the switching chamber 300, the operating end is located outside the switching chamber 300, the middle portion passes through the wall of the valve housing 30, and can rotate relative to the wall of the valve housing 30 and move toward the driven portion 310, so that the pressing end can press against one of the flow passages 3104 of the corresponding driven portion 310 by operating the operating end.
Further, the passive portion further includes a flexible tube section 3102 and a moving ring 3103 movably sleeved on the outer wall of the flexible tube section 3102. The flexible tube section 3102 is made of a flexible, resilient material, six flow passages 3104 are formed in the flexible tube section 3102, and the movable ring 3103 is actuated by the actuating portion 311 to elastically deform the flexible tube section 3102 to close or open one or more of the flow passages 3103. Specifically, as shown in fig. 13, the flexible pipe section 3102 is formed into six tubular structures 31020 which are intersected with each other, and the moving ring 3103 is sleeved on each branch of the tubular structures 31020, wherein the cross section of each branch is gradually increased from the center of the flexible pipe section 3102 to the outer side, while the cross section of the branch is kept consistent, and the moving ring 3103 correspondingly takes the shape of a large end and a small end. Thus, when the driving portion 311 drives the moving ring 3103 to move outwards along the center of the flexible pipe section 3102, since the branch section is increased and the section of one end of the moving ring 3103 is fixed, the increased branch is pressed by the moving ring 3103 to deform the same, so that the branch is pressed inside the same to close the branch; on the contrary, when the moving ring 3103 moves reversely, the branch is opened, thus realizing that the respective flow paths 3103 can be individually opened and closed.
Further, in a driving method corresponding to the movement of the driving moving ring 3103, the driving portion 311 may be driven by the transmission assembly to move the moving ring 3103. Specifically, as shown in fig. 5 and 6, the driving portion 311 includes a lever 3110, a sliding hole 304 is formed in the valve housing 30, one end of the lever 3110 is fixedly connected to the moving ring 3103, and the other end of the lever 3110 extends out of the switching chamber 300 through the sliding hole 304, so that the moving ring 3103 can be driven to slide along the branch of the tubular structure 31020 by sliding the lever 3110 along the sliding hole 304 outside the switching chamber 300, thereby opening and closing each flow path 3104. In further embodiments, a lever 3110 is disposed on each of the shift rings 3103 of each branch to facilitate driving each shift ring 3103 to slide. Further, in order to make the movement of the lever 3110 more stable, the driving portion 311 further includes a first buffer spring 3111 connected between the lever 3110 and the inner wall of the switching chamber 300 and sleeved outside the tubular structure 31020.
The driving unit 311 may drive the driven unit 310 to operate by magnetic force. Specifically, as shown in fig. 7, 8, and 9, the moving ring 3103 is a magnetic ring, and the driving portion 311 includes a driving ring 3113 and a rotary sleeve 3114 magnetically repulsive to the moving ring 3103. The drive ring 3113 is magnetically coupled to the shift ring 3103 in a one-to-one correspondence, the side wall of the drive ring 3113 is provided with external threads, the inner wall of the rotary barrel 3114 is provided with internal threads, and the drive ring 3113 is threadedly coupled to the inner wall of the rotary barrel 3114. Thus, by rotating the rotating barrel 3114, the driving ring 3113 is driven to move along the length direction of the rotating barrel 3114, so as to drive the two moving rings 3103 to move along the branch length direction of the tubular structure 31020, thereby opening and closing the corresponding flow passages 3104.
In this embodiment, as shown in fig. 7, 8 and 9, the valve housing 30 is formed with a stopper groove 302 on each of the inner and outer walls thereof, the moving ring 3103 moves in the stopper groove 302 on the inner wall of the valve housing 30 along the length direction of the valve housing 30, and the driving ring 3113 moves in the stopper groove 302 on the outer wall of the valve housing 30 along the length direction of the valve housing 30; in this manner, the driving ring 3113 and the moving ring 3103 may be respectively defined by the two limiting grooves 302, respectively, to respectively define the respective limiting grooves 302, so that the movement of the two, particularly the movement of the moving ring 3103, is limited, so that the movement of the moving ring 3103 is more stable. In addition, the outer wall of the valve housing 30 is also formed with an installation groove 303 for connecting the rotary drum 3114, so that the rotary drum 3114 can be restricted to rotate in the installation groove 303, and the rotation is smoother. Furthermore, the driven portion 310 further includes a second buffer spring 3105 connected between the moving ring 3103 and the inner wall of the valve housing 30, and the second buffer spring 3105 can reduce the movement of the moving ring 3103 and reduce the abrasion of the moving ring 3103 on the tubular structure 31020, so that the movement is more stable.
In the embodiment where the driving portion 311 drives the driven portion 310 to operate by the lever 3110 and the driving portion 311 through magnetic force, the driving portion 311 does not enter the switching chamber 300 or does not enter the driven portion 310, so that the inside and the outside of the driven portion 310 are isolated from each other, thereby avoiding direct contact with liquid in the driven portion 310, being beneficial to sealing the valve body 31, and reducing the use of sealing accessories such as other rubber sealing rings.
The invention also provides a detection device matched with the kit, which comprises the kit, a collecting pipe 4, an infusion apparatus 5, a butt joint element 6, an analyzer 7, a hose pump 8 and a waste liquid bag 9, as shown in figure 2; the collecting pipe 4 can be communicated with a pipeline of the kit, the collecting pipe 4 is communicated with the infusion apparatus 5 through the pipeline, the analyzer 7 is provided with a measuring chamber 70 and a sensor 71 arranged in the measuring chamber 70, the infusion apparatus 5 is communicated into the measuring chamber 70 through the butt joint element 6, the analyzer 7 obtains a detection result through the sensor 71 in the measuring chamber 70, and the pipeline in the measuring chamber 70 is communicated with the waste liquid bag 9 through the hose pump 8. Sample input can be performed from various containers (e.g. syringes, capillaries, glass containers, etc.), preferably via a movable (e.g. tiltable) infusion set 5.
The reagent bags are switched directly at a multi-way valve at the inlet of the connection lines, the multi-way valve having at least three valve positions, wherein a first valve position establishes a fluid passage between the connection line and the reagent bag, a second valve position closes the fluid passage between the reagent bag and the connection line, and a third valve position is used for communicating a sterile liquid or gas. By means of the second valve position, a backflow of the pumped-out functional liquid from the connecting line is avoided, while the introduction of air (or inert gas) causes the liquid to be removed from the bag, the connecting line from which the valve starts being dried and sucked off without the bag contents being contaminated by air or inert gas.
In a preferred embodiment of the invention, the reagent bag connection lines from the multi-way valve lead directly into the manifold connected before the input to the analyzer. By using a collecting main, a valveless connection to the input of the analyzer can be established.
According to a preferred variant of the invention, each multi-way valve has a third valve position, in which both the passage to the reagent bag and the fluid passage to the ventilation source are closed. This will ensure that the connecting lines are not contaminated by impurities from the environment during storage and transport of the kit or during long measurement pauses.
The invention also provides a detection method of the sialylated glycoantigen 6, which is carried out by utilizing the detection device, the reagent bag 1 can be replaced, and can contain sample liquid, calibration liquid, auxiliary liquid, cleaning liquid or disinfectant.
Specifically, as shown in fig. 14, the detection method includes:
s1, connecting the reagent bag to the collecting pipe through the pipeline, communicating the collecting pipe, the infusion apparatus, the measuring chamber of the butt joint element and the waste liquid bag through the pipeline in sequence, and arranging the soft high pump on the pipeline from the measuring chamber to the waste liquid bag;
s2, switching the multi-way valve on the reagent bag and on the line to an open position, thereby establishing a fluid path to the contents of the reagent bag, and wherein a small stream of liquid is transported in the direction of the measurement chamber, and wherein the multi-way valve is switched to an open position after the liquid has been withdrawn, such that the path to the contents of the reagent bag is closed and an access to an aeration source is established, and gaseous medium from the aeration source is sucked into the measurement chamber.
Wherein, as shown in fig. 15, the rotation switching of the multi-way valve comprises the following steps:
s11, when the driven part is driven to contract by the driving part, the driven part is released from the inner wall of the switching cavity, and then the driven part is rotated to the two outlets which need to be communicated;
and S12, driving the driven part to extend to abut against the inner wall of the switching part through the driving part again, and realizing the tight conduction of the two outlets.
Further, the rotation switching of the multi-way valve further includes that after the step S12, other outlets of the switching chamber are either communicated with an external air source to purge the residual liquid in the switching chamber, or communicated with an external sterilization air source or sterilization liquid to sterilize and disinfect the switching chamber.
Wherein the multi-way valve of at least one of the reagent bags alternately switches from inhaling liquid to inhaling gaseous medium, so that alternately small liquid and gas separation small streams are formed and transported through the tubing of the analyzer into the measurement chamber. In particular, the pressure in the transport line for the liquid and gas separation small flows and in the connecting line for the ventilation gas of the reagent bag is first reduced.
In the process of switching the rotation of the multi-way valve, in an embodiment where the passive component is made of a flexible elastic material, as shown in fig. 16, the step of driving the passive component by the driving component may further specifically include:
s21, the driving part rotates to enable the notch to correspond to one of the flow passages;
and S22, pressing the driving part against the driven part, pressing other parts of the driving part in the switching cavity against the driven part to close other flow passages, and because the grooves exist, the corresponding flow passages cannot be closed to flow, so that the purpose that one flow passage flows and the other flow passages are closed is achieved.
More optionally, as shown in fig. 17, the step of driving the driven portion by the driving portion may further specifically include:
s31, when the driving part drives the moving ring to move outwards along the center of the hose segment, because the branch cross section is continuously increased and the cross section of one end of the moving ring is fixed, the increased branch is continuously pressed by the moving ring to deform the moving ring, so that the branch is continuously pressed in the moving ring to close the branch;
s32, when the moving ring is driven to move reversely, the branch is opened, so that each flow passage can be opened and closed separately.
Further, the moving ring can be driven by a mechanical transmission connection or a magnetic drive.
According to the invention, a method for operating an analyzer with a measuring chamber and a replaceable reagent cartridge, the reagent bags of which contain a liquid for calibration, quality control, flushing, cleaning or sterilization, is provided, in which a small liquid strand is withdrawn from one of the reagent bags, a multi-way valve arranged directly in the reagent bag is displaced into one valve position, whereby a fluid path to the contents of the reagent bag is established, which liquid strand is conveyed towards or into the measuring chamber, for example by means of a hose pump, which multi-way valve is connected to the other valve position after the liquid withdrawal, whereby the path to the contents of the reagent bag is closed and simultaneously a fluid path to a venting source, preferably clean air or inert gas, is established.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention.

Claims (7)

1. A reagent kit for detecting a sialylated glycoantigen 6 is characterized by comprising a plurality of reagent bags capable of being inserted into external analysis equipment and pipelines for connecting the reagent bags with the external analysis equipment;
the lines being selectively connectable to the liquid input of an external analytical device, the reagent bag comprising a multi-way valve disposed on its respective line and at its input output; the multi-way valve has at least three valve positions for communicating a line with the reagent bag, an input of the reagent bag and an output of the reagent bag, respectively, wherein the input of one of the reagent bags is communicable with an external gas source;
the multi-way valve includes:
the valve shell forms a sealed switching cavity, and the switching cavity is provided with at least six outlets;
the valve body comprises a driven part connected in the switching cavity and a driving part in driving connection with the driven part, and the driven part can elastically deform to enable two outlets to be communicated; the driven part is made of flexible materials, the driven part is fixedly connected with the switching cavity, a plurality of mutually crossed circulation passages are formed in the driven part along the radial direction of the driven part, two ends of each circulation passage are correspondingly communicated to the two outlets, a gap is reserved between the driven part and the valve casing, and the driving part is movably connected with the valve casing.
2. The reagent cartridge according to claim 1, wherein the driven portion is formed in a disk shape, and the driving portion is formed in a disk shape at an end thereof located in the switching chamber and has a notch formed in a radial direction.
3. The reagent cartridge according to claim 2, wherein the portion of the driving portion located in the switching chamber includes a plurality of pressing claws, each pressing claw corresponds to one of the flow paths, and each pressing claw can be individually controlled by a portion of the driving portion located outside the switching chamber so as to switch the corresponding one of the flow paths.
4. The kit of claim 3, wherein the passive portion comprises a tube section and a movable ring movably sleeved on an outer wall of the tube section; the flexible pipe section is made of flexible elastic material, the flow passage is formed in the flexible pipe section, and the moving ring can be driven by the driving part to enable the flexible pipe section to be elastically deformed so as to enable one or more of the flow passages to be closed or opened.
5. The reagent kit of claim 4, wherein the driving part comprises a rod, the valve housing is provided with a slide hole, one end of the rod is fixedly connected to the moving ring, and the other end of the rod extends out of the switching cavity through the slide hole.
6. The reagent kit according to claim 5, characterized in that the moving ring is a magnetic ring, the driving part comprises a driving ring and a rotating barrel which are magnetically repelled from the moving ring, the driving ring and the moving ring are magnetically connected in a one-to-one correspondence, the side wall of the driving ring is provided with an external thread, the inner wall of the rotating barrel is provided with an internal thread, and the driving ring is connected to the inner wall of the rotating barrel in a threaded manner;
the rotating cylinder rotates to drive the driving ring to move along the length direction of the rotating cylinder.
7. A test device adapted to the kit of any one of claims 1 to 6, comprising the kit of any one of claims 1 to 6, a manifold, an infusion set, a docking element, an analyzer, a hose pump and a waste bag; the collecting pipe can be communicated with a pipeline of the kit, the collecting pipe is communicated with the infusion apparatus through a pipeline, the analyzer is provided with a measuring chamber and a sensor arranged in the measuring chamber, the infusion apparatus is communicated into the measuring chamber through the butt joint element, the analyzer obtains a detection result through the sensor in the measuring chamber, and the pipeline in the measuring chamber is also communicated with the waste liquid bag through the hose pump.
CN202110062162.8A 2021-01-18 2021-01-18 Kit for detecting salivation sugar chain antigen 6, adaptive detection device and detection method Active CN112903984B (en)

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