CN113917164A - POCT sample analyzer and kit - Google Patents

Abstract

The invention provides a point-of-care testing (POCT) sample analyzer and a kit, wherein the kit comprises a box body, a plurality of impedance detection cells, a plurality of optical detection cells and a plurality of reagent cells, wherein the impedance detection cells are connected with the box body and are used for matching impedance detection; the plurality of optical detection cells are connected with the box body and are used for matching photoelectric detection; the plurality of reagent pools are connected with the box body and used for installing a plurality of reagents, wherein at least one of the impedance detection pools is provided with a light-transmitting window for matching to carry out photoelectric detection. The kit can support the impedance detection and/or colorimetric detection and/or turbidimetric detection of a blood sample by arranging the plurality of impedance detection tanks, the plurality of optical detection tanks and the plurality of reagent tanks, has more detection items and good expandability of the detection items, and can allocate the dilution of the sample to be detected and the pretreatment of adding the reagent by the reagent pre-installed in the reagent tanks, thereby optimizing the POCT detection efficiency.

Description

POCT sample analyzer and kit

Technical Field

The invention relates to the technical field of blood sample analysis, in particular to a POCT sample analyzer and a kit.

Background

The blood cell analyzer is also called blood cell analyzer, blood globe, blood cell counter, etc. and it and biochemical analyzer are two kinds of instruments widely used in clinical examination in hospital.

Traditional blood cell analyzer, there are sample application and reagent adding device and pipeline and valve inside the instrument, and in the device, all will be full of by the reagent in pipeline and the valve, there is reagent just to have the requirement to the operational environment temperature of instrument in the machine, and the very big part of built-in part all belongs to cleaning system, because before next blood sample detection, must guarantee to remain the sanitization with the test of last blood sample. The whole system is complex in structure and multiple in parts, and a large amount of reagents are needed in the cleaning process, so that the cleaning time is long. Therefore, the traditional blood cell analyzer has the advantages of complex instrument structure, high cost, high use cost of consumables, complex instrument, high maintenance cost and difficulty in comprehensive popularization and use in primary medical treatment. And the temperature of the working environment is required, and the laboratory is required to work.

Conventional biochemical analyzer aspects: the large-scale full-automatic biochemical analyzer has extremely complex structure, comprises a pure water preparation part, a heating and refrigerating temperature control part, a reaction plate part, a reagent bin part, a sample bin part, a rocker arm sample needle part, a rocker arm reagent needle part, a cleaning station and the like, has extremely high cost, and is difficult to use and maintain and is difficult to be used in basic medical institutions, particularly small-sized health hospitals and clinics. The semi-automatic small biochemical analyzer suitable for the basic medical unit adopts the steps of adding a sample and adding a reagent outside the analyzer, mixing uniformly, incubating and sucking the sample into the analyzer for testing, and the analyzer needs to be cleaned after testing, and is complex to operate and needs to consume the reagent for cleaning. And both types of biochemical analyzers can only be used in laboratories.

Compared with the traditional sample analyzer, the POCT blood and biochemical combined detection analyzer is greatly simplified on an instrument assembly, a blood sample adding device and a reagent adding device are used for adding the blood sample and the reagent, the POCT blood and biochemical combined detection analyzer completely removes related assemblies of a cleaning liquid path in the traditional blood analysis, a biochemical detection part of the POCT blood and biochemical combined detection analyzer is a sample adding reagent device shared with a blood analysis part, a cleaning part of the traditional biochemical analyzer is also completely removed, automatic sample adding and reagent adding can be realized, and the use experience is superior to that of the traditional semi-automatic biochemical analyzer; the POCT blood and biochemical combined detection analyzer greatly reduces the complexity and production cost of products and the use and maintenance cost of users, and simultaneously realizes full-automatic test; in addition, because the machine does not have reagent and the detection module is provided with a heating and refrigerating system, and the structure is simple, small and exquisite and portable, the failure rate of the POCT blood and biochemical combined detection analyzer is low, and the POCT blood and biochemical combined detection analyzer can be used in a laboratory. And the detection of blood and biochemistry which are most widely applied is realized on the same machine at low cost, which undoubtedly well meets the requirements of primary medical users. .

However, the existing single POCT blood cell analyzer has simpler functions, generally detects a single item, has relatively complex specific operation and low automation degree, and cannot meet the requirements of low cost, less maintenance and good experience expected by primary medical units.

Disclosure of Invention

The invention provides a POCT sample analyzer and a kit, which can solve the problem that POCT detection in the prior art can only detect a single item.

In order to solve the technical problems, the invention adopts a technical scheme that: providing a kit comprising:

a box body;

the impedance detection cells are connected with the box body and are used for matching impedance detection;

the optical detection cells are connected with the box body and are used for matching photoelectric detection;

and the reagent pool is connected with the box body and used for installing reagents, and at least one optical detection pool is used for carrying out biochemical detection.

The invention has the beneficial effects that: different from the situation of the prior art, the kit provided by the invention can support impedance detection and/or colorimetric detection and/or turbidimetric detection on a blood sample by arranging the plurality of impedance detection cells, the plurality of optical detection cells and the plurality of reagent cells, has more detection items and good expandability of the detection items, and can allocate the dilution of the sample to be detected and the pretreatment of adding the reagent by using the reagent pre-loaded in the reagent cells, thereby optimizing the POCT detection efficiency and realizing the full-automatic detection of two items of one blood sample.

Drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, it is obvious that the drawings in the following description are only some embodiments of the invention, and other drawings can be obtained by those skilled in the art without inventive efforts, wherein:

fig. 1 is a schematic perspective view of a POCT sample analyzer according to an embodiment of the present invention;

FIG. 2 is a schematic diagram of a POCT sample analyzer receiving kit loading according to an embodiment of the present invention;

fig. 3 is a schematic diagram of an internal structure of a POCT sample analyzer according to an embodiment of the present invention;

FIG. 4 is a schematic view illustrating a separation state of the reagent cartridge and the test seat according to an embodiment of the present invention;

FIG. 5 is an exploded view of a kit provided in accordance with an embodiment of the present invention;

FIG. 6 is a partial cross-sectional view of a kit provided in accordance with an embodiment of the present invention;

fig. 7 is a schematic perspective view of a detection seat of a POCT sample analyzer according to an embodiment of the present invention;

fig. 8 is a schematic cross-sectional view of a test socket of a POCT sample analyzer according to an embodiment of the invention;

fig. 9 is a schematic diagram of an internal structure of a POCT sample analyzer according to an embodiment of the present invention;

FIG. 10 is a schematic view of a film tearing mechanism provided in accordance with an embodiment of the present invention;

FIG. 11 is a schematic view of a film tearing mechanism provided in accordance with another embodiment of the present invention;

FIG. 12 is a schematic top view of a kit according to an embodiment of the present invention;

FIG. 13 is a schematic top view of a reagent cartridge provided in accordance with another embodiment of the present invention;

FIGS. 14A and 14B are schematic perspective views of the reagent cartridges shown in FIGS. 12 and 13, respectively;

FIG. 15 is a simplified perspective schematic view of a POCT sample analyzer according to an embodiment of the present invention;

FIG. 16 is a simplified perspective schematic view of a POCT sample analyzer according to another embodiment of the present invention;

fig. 17A and 17B are schematic diagrams illustrating simplified detection principles of a POCT sample analyzer according to an embodiment of the present invention;

fig. 18A to 18D are schematic diagrams of a battery module of a POCT sample analyzer according to an embodiment of the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive work based on the embodiments of the present invention, are within the scope of the present invention.

It should be noted that, if directional indications (such as up, down, left, right, front, and back … …) are involved in the embodiment of the present invention, the directional indications are only used to explain the relative positional relationship between the components, the movement situation, and the like in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indications are changed accordingly.

In addition, if there is a description of "first", "second", etc. in an embodiment of the present invention, the description of "first", "second", etc. is for descriptive purposes only and is not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present invention.

Referring to fig. 1 to 11 together, an embodiment of the POCT sample analyzer 10 includes a housing 11, a detection seat 200, a liquid-moving device 300, and a movement mechanism 400.

The housing 11 is provided with a display module 12, a door 13, and a handle 15. The display screen module 12 can be fixedly installed on the upper portion of the side surface of the housing 11, the display screen module 12 can be arranged in an inclined manner so as to be convenient to view, the display screen module 12 can be used for displaying a detection result and performing touch operation, the housing 11 is provided with an opening 14, the door panel 13 is used for covering the opening 14 and can be rotatably connected with the lower portion or the side portion of the housing 11, and the handle portion 15 can be arranged on the top portion of the housing 11 so as to facilitate the POCT sample analyzer 10 to move in a portable manner. Of course, the display screen module 12 may also be eliminated, the main control module in the POCT sample analyzer 10 is connected to a mobile communication device such as a mobile phone or a tablet computer through a communication method such as bluetooth connection, and the detection result and the corresponding touch operation are displayed through the mobile phone or the tablet computer.

The detection seat 200 is disposed on the casing 11 for receiving the reagent cartridge 100, the detection seat 200 is provided with a plurality of impedance detection components 210 and/or a plurality of optical detection components 220, when the door 13 is opened relative to the casing 11, the detection seat 200 can be moved out of the casing 11 through a sliding component or a hinge component inside the casing 11 to receive the reagent cartridge 100, the impedance detection components 210 have electrode conductive devices 211 (see fig. 8), the electrode conductive devices 211 may specifically be elastic ejector pins (pogo pins), and the electrode conductive devices 211 are electrically connected with the impedance detection cells 120 of the reagent cartridge 100 after the reagent cartridge 100 is installed in the detection seat 200. The detection principle of using the impedance detection component 210 and the optical detection component 220 to perform impedance detection and optical detection on blood does not relate to the invention point, and is not described in detail in this application. Each impedance detection element 210 and each optical detection element 220 can detect a separate item to obtain a specific blood parameter value.

The pipette 300 is disposed in the housing 11 and can be located above the detection seat 200, and is used for sleeving a pipette head 114 (such as a tip head) to perform a pipetting operation on the kit 100, wherein the pipetting operation refers to a liquid suction, moving and liquid discharge operation, and the pipette 300 can also be used for repeatedly sucking and discharging liquid to form a sucking, discharging and uniformly mixing effect, unlike a conventional sampling needle, a sample can enter the inside of the sampling needle during the pipetting operation of the conventional sampling needle, so that the inner wall and the outer wall of the sampling needle can be polluted, a cleaning operation is required before each detection, the pipette head 114 is sleeved on the pipette 300 provided by the present invention, and the pipette head 114 has a certain volume, the sample does not enter the interior of the pipette 300 during the pipetting operation, does not contaminate the pipette 300, therefore, the liquid transfer device 300 does not need to be cleaned, complex cleaning components and cleaning processes are omitted, and the detection efficiency is improved.

The pipette 300 of the present invention may include a motor, a cavity, and a piston, wherein the motor is used to drive the piston to reciprocate in the cavity to perform a pipetting operation.

The pipette 300 of the present invention may be an ADP (Air Driven Pump), which is a power device with precise volume and capable of generating positive and negative pressure.

The traditional blood cell analyzer adopts a set of complex devices such as an air pump, an air valve, a pressure chamber and the like to realize liquid preparation, counting and cleaning. The POCT sample analyzer provided by the application finishes liquid preparation and counting by ADP and does not need cleaning. In addition, the ADP is a modular component, the structure is flexible, the ADP is accurately driven by a motor, and the ADP is slightly interfered by other systems.

The pipette 300 may also be used to bubble the liquid in the kit 100 for the mixing operation, and specifically, when the pipette 300 performs the mixing operation by bubbling, the pipette 300 sucks air above the liquid surface and discharges air below the liquid surface. Of course, also can adopt independent air pressure system to the bottom input air of cell body, corresponding increase extra air pressure system subassembly can, pipettor 300 is used for moving the liquid promptly in this application, still can be used to carry out the bubble mixing, and the subassembly is very simplified.

The movement mechanism 400 is used to move the pipette 300 and the detection seat 200 relative to each other, and the movement mechanism 400 may be a three-axis movement system to drive the pipette 300 to displace in the direction X, Y, Z, of course, the implementation manner of the movement mechanism 400 is not limited thereto, and the movement mechanism 400 may also drive the detection seat 200 to displace relative to the pipette 300 or drive the pipette 300 and the detection seat 200 to displace simultaneously.

In one embodiment, the moving mechanism includes a first motor transmission component 410, a second motor transmission component 420, and a third motor transmission component 430, wherein the first motor transmission component 410 is used for driving the detection seat to move in the X direction; the second motor transmission assembly 420 is used for driving the pipettor to move in the Y direction; the third motor transmission assembly 430 is used for driving the pipettor to move in the Z direction, the first motor transmission assembly 410, the second motor transmission assembly 420, and the third motor transmission assembly 430 may all include a motor 401, a transmission wheel 402, a transmission belt 403, and a transmission member 404, the motor 401 and the transmission wheel 402 are arranged at an interval, the transmission belt 403 is sleeved on the output end of the motor 401 and the transmission wheel 402, the transmission member 404 is fixed with the transmission belt 403 and is in transmission fit with the detection seat 200 or the ADP, for example, the transmission member 404 is provided with a U-shaped bayonet, and the detection seat 200 and the ADP are slidably arranged through a slider and a slide rail mechanism and receive a driving force transmitted from the U-shaped bayonet to perform corresponding sliding.

According to the POCT sample analyzer provided by the embodiment of the invention, the kit 100 integrates the necessary accessories (the impedance detection cell 120 and the optical detection cell 130) of the test system and various reagents, and the kit 100 is disposable, so that a huge cleaning system can be eliminated, and the number of the parts of the whole analyzer is greatly reduced, wherein the impedance detection cell 120 and the optical detection cell 130 are main cleaning objects in the traditional sample analyzer.

Referring to fig. 4 to 6, the embodiment of the invention provides a kit 100, where the kit 100 may be a disposable kit or a reusable kit, and the kit 100 includes a kit body 110, a plurality of impedance detection cells 120, a plurality of optical detection cells 130, a reagent cell 140, a kit bottom 150, and a sealing layer 160. The kit 100 has an asymmetric structure, and is convenient to be placed in the detection seat 200 in a foolproof manner.

In one embodiment, the cassette body 110 may be rectangular, and the cassette body 110 may have a first insertion hole 111, where the first insertion hole 111 is used to receive a sample tube 113; alternatively, the cartridge 110 may be directly connected to a sample cell, such as an integral connection or a sleeve connection, and the sample tube 113 may be used to receive a sample, such as a blood sample. The cassette 110 may further be provided with a second insertion hole 112, a first insertion hole 111 for receiving a pipette tip 114, the pipette tip 114 being adapted to be mounted on a pipette 300 for cooperating pipetting operations.

A plurality of impedance detection cells 120 are connected to cartridge 110 for matching impedance detection, and the number of impedance detection cells 120 is at least one, and two are shown in fig. 5.

A plurality of optical detection cells 130 are connected to the box body 110 for performing photoelectric detection, and the number of the optical detection cells 130 is at least one, and two are shown in fig. 5.

The reagent reservoir 140 is connected to the cartridge body 110 for accommodating reagents, such as a hemolytic agent, an antibody reagent, a diluent, and the like. The reagent reservoir 140 may be provided in plural so as to accommodate plural kinds of reagents, and of course, one reagent reservoir 140 may be provided.

The box body 110 is arranged at the opening end of the box bottom 150, and the impedance detection pool 120 and the reagent pool 140 are contained in the box bottom 150; the optical detection cell 130 extends out of the cassette bottom 150; the impedance measuring cell 120, the optical measuring cell 130, and the reagent cell 140 each have an opening 115 communicating with the cartridge 110, and the sealing layer 160 seals and covers the opening 115 (see fig. 10 and 11).

In a specific embodiment, the opening 115 corresponding to the optical detection cell 130 may be a rectangular hole 115a, the opening 115 corresponding to the reagent cell 140 may be a kidney-shaped hole, and includes a large number of small kidney-shaped holes 115b and a large kidney-shaped hole 115c, the reagent cell 140 corresponding to the small kidney-shaped hole 115b may be used to install a plurality of special reagents, such as hemolytic agents and antibody reagents, the reagent cell 140 corresponding to the large kidney-shaped hole 115c may be used to install a diluent and serve as a mixing cell, receive a blood sample and other reagent inputs to support dilution and mixing, the opening 115 corresponding to the impedance detection cell 120 is special, and is a small kidney-shaped hole 115d, the existing impedance detection cell 120 is drained by a negative pressure mode, that is, a liquid in the front cell enters the rear cell by a cell flow mode through the negative pressure acting on the rear cell, an additional negative pressure component is needed for draining by the negative pressure mode, and the application directly uses a 300 pipette to provide positive pressure to the opening 115 of the small kidney-shaped hole 115d so that the front cell provides positive pressure to the front cell The liquid in the chamber 121 enters the rear pool 122 in a cell flow mode, so that negative pressure components can be reduced, and the equipment structure is simplified.

The impedance detection pool 120 is a group or a plurality of groups, the impedance detection pool 120 includes a front pool 121, a rear pool 122 and a detection device 123 for matching impedance detection, the detection device 123 can be an electrode plate, the box bottom 150 is provided with an exposed hole corresponding to the detection device 123 so as to realize that the detection device 123 is electrically connected with an electrode conductive device 211 (see fig. 8) of the impedance detection assembly 210, the electrode conductive device can be an elastic thimble (pogo pin), the impedance detection pool 120 can further include a waste liquid cavity (not shown) communicated with the rear pool 122 for receiving waste liquid, and after positive pressure is provided so that liquid in the front pool 121 enters the rear pool 122 in a cell flow manner, the waste liquid is finally collected by the waste liquid cavity, thereby avoiding waste liquid flowing and scattering.

The optical detection cells 130 are one or more and are adapted to perform a transmitted light photodetection and/or a scattered light photodetection.

The impedance detection cell 120, the optical detection cell 130, and the reagent cell 140 may be integrally formed with the cartridge body 110; or the cartridge body 110 is integrally formed with the assembly cartridge 116, and at least some of the impedance detection cell 120, the optical detection cell 130, and the reagent cell 140 are connected with the assembly cartridge 116 in an abutting manner, such as a snap connection or an interference fit.

The optical detection cell 130 may be made of optical plastic, transparent plastic, or glass.

In one embodiment, the reagent kit 100 is provided with a plurality of cell bodies, which may be arranged in a single row, and correspondingly, the motion mechanism may be a two-dimensional motion mechanism, and drives the ADP to perform reciprocating motion and lifting motion on a two-dimensional plane.

In another embodiment, the reagent kit is provided with a plurality of cell bodies which are arranged in a plurality of rows, and the movement mechanism is a three-dimensional movement mechanism which drives ADP to perform three-dimensional movement in a three-dimensional space.

The kit 100 provided by the invention can support impedance detection and/or colorimetric detection and/or turbidimetric detection on a blood sample by arranging the plurality of impedance detection cells 120, the plurality of optical detection cells 130 and the plurality of reagent cells 140, each optical detection cell 130 and each reagent cell 140 can be matched for detecting an independent item to obtain a specific blood parameter value, the detection items are more, the detection items have good expandability, and the pre-treatment of diluting and adding the reagent to the sample to be detected can be allocated by the reagent pre-filled in the reagent cell 140, so that the POCT detection efficiency is optimized. In addition, the reagent kit 100 itself can be used as a waste liquid collector, so that a reagent barrel and a waste liquid barrel which are required to be connected with a traditional blood cell analyzer are omitted, and the POCT sample analyzer 10 can be portable and movable.

Referring to fig. 1 to 11 together, an embodiment of the POCT sample analyzer 10 includes a housing 11, a bracket 16, a detection seat 200, a pipette 300, a movement mechanism 400, a battery module 500, a power supply module, a temperature control module, and a film tearing mechanism.

The housing 11 is provided with a display module 12, a door 13, and a handle 15. The display screen module 12 can be fixedly installed on the upper portion of the side surface of the casing 11, the display screen module 12 can be obliquely arranged so as to be convenient to view, the display screen module 12 can be used for displaying a detection result and performing touch operation, the casing 11 is provided with an opening 14, the door panel 13 is used for covering the opening 14 and can be rotatably connected with the lower portion or the side portion of the casing 11, the detection seat 200 can be moved out of the casing 11 and receives the reagent kit 100 to be loaded when the door panel 13 is opened, and the handle portion 15 can be arranged on the top of the casing 11 so as to facilitate the portable movement of the POCT sample analyzer 10. Of course, the display screen module 12 may also be eliminated, the main control module in the POCT sample analyzer 10 is connected to a mobile communication device such as a mobile phone or a tablet computer through a communication method such as bluetooth connection, and the detection result and the corresponding touch operation are displayed through the mobile phone or the tablet computer.

The detection seat 200 is arranged in the shell 11 and is used for receiving the kit 100 to be loaded, wherein the detection seat 200 is arranged in a sliding manner relative to the shell 11, and the detection seat 200 is used for receiving the kit 100 to be loaded when sliding out of the shell 11; alternatively, the test socket 200 is hinged with respect to the housing 11, and the test socket 200 is used for receiving the reagent cartridge 100 when being screwed out of the housing 11.

The detection seat 200 is provided with a plurality of impedance detection components 210 and/or a plurality of optical detection components 220, the impedance detection components 210 include electrode conductive devices 211 (see fig. 8), the electrode conductive devices 211 can be elastic ejector pins (pogo pins), the reagent kit 100 is provided with detection devices 123, the detection devices 123 can be electrode plates, the electrode conductive devices 211 and the detection devices 123 are in electrical contact when the reagent kit 100 is installed in the detection seat 200, and the optical detection components 220 include light emitting components and light receiving components which are arranged at intervals. The detection principle of detecting blood by using the impedance detection component 210 and the optical detection component 220 does not relate to the invention point, and is not described in detail in this application.

The pipette 300 is disposed in the housing 11 and above the detection seat 200, and is used for sleeving a pipette head 114 (such as a tip head) to perform a pipetting operation on the kit 100. The pipette 300 of the present invention may include a motor, a cavity, and a piston, wherein the motor is used to drive the piston to reciprocate in the cavity to perform a pipetting operation. The pipette 300 of the present invention may be an ADP (Air Driven Pump), which is a power device with precise volume and capable of generating positive and negative pressure. The traditional blood cell analyzer adopts a set of complex devices such as an air pump, an air valve, a pressure chamber and the like to realize liquid preparation, counting and cleaning. The POCT sample analyzer provided by the application finishes liquid preparation and counting by ADP and does not need cleaning. In addition, the ADP is a modular component, the structure is flexible, the ADP is accurately driven by a motor, and the ADP is slightly interfered by other systems.

A carriage 16 is provided within the housing 11 and the ADP is mounted on the carriage 16 by a movement mechanism 400.

Wherein, move liquid operation and refer to imbibition, remove, spit liquid operation, include specifically:

dispensing the blood sample to a specific reagent reservoir 140, which may be pre-filled with a diluent, the specific reagent reservoir 140 may be a reagent reservoir 140 having a large kidney-shaped aperture 115 c;

adding the reagents in the other reagent pools 140 into the specific reagent pool 140 to mix so as to form a sample to be detected, wherein the other reagent pools 140 can be reagent pools 140 with small waist-shaped holes 115 b;

the sample to be detected is moved into the impedance detection cell 120 and/or the optical detection cell 130 for impedance detection and/or optical detection.

The movement mechanism 400 is disposed in the housing 11, and is used for moving the pipette 300 relative to the detection seat 200 to support a pipetting operation, and the movement mechanism 400 may be a three-axis movement system to drive the pipette 300 to displace in the direction X, Y, Z, of course, the implementation manner of the movement mechanism 400 is not limited thereto, and the movement mechanism 400 may also drive the detection seat 200 to displace relative to the pipette 300 or drive the pipette 300 and the detection seat 200 to displace simultaneously.

The battery module 500 is electrically connected to the test socket 200, the movement mechanism 400, and the pipette 300, and the POCT sample analyzer 10 can be conveniently used in various places, for example, outdoors, by providing the battery module 500. In order to facilitate the assembly and disassembly of the battery module 500, a battery cavity may be disposed on the outer surface of the housing 11, and the battery module 500 and the battery cavity are assembled by a snap fit, or the POCT sample analyzer is provided with a battery cavity and a cover plate, the battery module and the battery cavity are assembled by a snap fit and are covered by the cover plate, the cover plate may be an instrument housing, or may be a panel on any side surface or top end of the instrument, and the two ways may be both convenient and fast assembly and disassembly of the battery module 500. Of course, the POCT sample analyzer 10 further includes a power supply module electrically connected to the detection seat 200, the movement mechanism 400 and the pipette 300, for connecting to the commercial power.

The temperature control module is attached to the detection base 200 to provide a detection temperature. As shown in fig. 7, the temperature control module may be a heating film 510 attached to the bottom surface or the side surface of the detection seat 200, or the temperature control module may be a heating rod, and accordingly, the detection seat 200 is provided with a mounting hole for receiving the heating rod; the temperature control module can also be a peltier 520, and the peltier 520 is used for heating or cooling the heating base. The POCT sample analyzer provided by the invention can independently heat or refrigerate by arranging the temperature control module, and the environmental temperature has little influence on detection.

In one embodiment, the pipette 300 includes a motor, a cavity, and a piston, wherein the motor is used to drive the piston to reciprocate in the cavity to perform pipetting operations.

Pipette 300 may also be used to provide positive pressure to force fluid flow within impedance detection reservoir 120 of kit 100, i.e., by providing positive pressure to front reservoir 121 to force fluid within front reservoir 121 to flow through the microwells to back reservoir 122. The liquid transfer device 300 is also used for sucking and spitting to realize uniform mixing operation; the pipette 300 may also be used to bubble a liquid to achieve a blending operation.

The film tearing mechanism is used for tearing the sealing layer 160 on the surface of the kit 100; or a peel mechanism for puncturing the sealing layer 160 on the surface of the kit 100.

As shown in fig. 10, the film tearing mechanism may be a fixedly arranged hook 610, the hook 610 is used for hooking the tab portion 162 of the sealing layer 160 when the detection seat 200 receives the reagent kit 100 and enters the housing 11, so as to realize automatic film tearing, the hook 610 may be in an L-shaped plate, and the tab portion 162 is provided with a corresponding hook hole. If a manual film tearing mode is adopted, namely the reagent kit 100 is arranged in the detection seat 200 after the sealing layer 160 is torn off, due to the uncertainty of operation, the reagent pre-arranged in the reagent kit 100 is easily spilled, so that the normal detection is influenced due to the insufficient amount of the reagent.

As shown in fig. 11, in another embodiment, the film tearing mechanism includes a plate 621, a film breaking column 622 disposed on one surface of the plate 621, and a driving mechanism 623 for driving the plate 621 to ascend and descend, the film breaking column 621 corresponds to the cell body of the reagent kit 100, the driving mechanism 623 is configured to drive the plate 621 so that the film breaking column 622 pierces the sealing layer 160 on the surface of the reagent kit 100, a free end of the film breaking column 622 has a gradually decreasing cross-sectional area, the film breaking column 622 may be in a conical shape, and the driving mechanism 623 may be a motor and a transmission belt or a motor and gear transmission mechanism.

The embodiment of the present invention further provides a detection method based on the POCT sample analyzer 10, where the method includes:

receiving the reagent kit 100 and putting the reagent kit 100 into the detection seat 200, wherein the reagent kit 100 comprises a plurality of impedance detection cells 120 and/or a plurality of optical detection cells 130 which are used for matching impedance and/or photoelectric detection, the reagent kit 100 further comprises a plurality of reagent cells 140, the reagent cells 140 are used for containing a plurality of reagents, the reagent kit 100 is further provided with a sample tube, and a blood sample is filled in the sample tube;

dispensing a blood sample into a specific reagent reservoir 140 by a pipette 300, i.e. automatic blood dispensing by a device;

adding the reagents in other reagent pools 140 into the specific reagent pool 140 through the pipettor 300 for mixing to form a sample to be detected, namely, automatically adding the reagents through equipment;

the sample to be detected is moved into the impedance detection cell 120 and/or the optical detection cell 130 by the pipette 300 to perform impedance detection and/or optical detection.

According to the POCT sample analyzer and the detection method provided by the invention, the blood sample can be automatically distributed and the reagent can be automatically added through the matching of the motion mechanism and the pipettor, so that the POCT detection efficiency is optimized. In the existing detection method, reagents are required to be added manually, and the reagents are poured into an instrument for detection after being mixed manually.

Wherein, the step of receiving the reagent kit 100 into the test seat 200 comprises the following steps:

tearing the sealing layer 160 on the surface of the kit 100 by using a film tearing mechanism; or a tear mechanism may be used to puncture the sealing layer 160 on the surface of the kit 100.

Wherein the step of dispensing the blood sample into the specific reagent reservoir 140 by the pipette 300 is preceded by:

the pipette 300 is inserted and butted with a pipette tip 114 preset on the kit 100, so that the blood sample, the reagent and the sample to be detected are contacted only through the pipette tip 114 when the pipette 300 performs the pipetting operation, and the pipette 300 is prevented from being polluted.

Wherein, utilize pipettor 300 to provide the malleation in order to impel the sample that awaits measuring in the impedance detection pond to flow when carrying out the impedance detection, can reduce among the prior art need extra negative pressure device to carry out the impedance detection drainage through multiplexing pipettor 300, reduced the product subassembly.

According to the POCT sample analyzer and the detection method provided by the embodiment, automatic blood sample distribution and automatic reagent addition can be realized through the cooperation of the movement mechanism and the pipettor, and the POCT detection efficiency is optimized.

The embodiment of the present invention further provides a liquid flow driving device for the impedance detection cell 120, the driving device includes a pressure source, the impedance detection cell 120 includes a front cell 121, a rear cell 122 and a detection device 123 for performing impedance detection in cooperation, the pressure source is configured to apply pressure to the front cell 121 so that the liquid in the front cell 121 flows to the rear cell 122 through the micro-hole.

The pressure source may be embodied as a pipette 300, the pipette 300 being configured for pipetting when the pipette head 114 is docked and the pipette 300 being further configured for applying pressure when the pipette head 114 is undocked. The pipette 300 of the present invention may be an ADP (Air Driven Pump), which is a power device with precise volume and capable of generating positive and negative pressure. The traditional blood cell analyzer adopts a set of complex devices such as an air pump, an air valve, a pressure chamber and the like to realize liquid preparation, counting and cleaning. The POCT sample analyzer provided by the application finishes liquid preparation and counting by ADP and does not need cleaning. In addition, the ADP is a modular component, and has a flexible architecture and is less interfered by other systems.

The pipette 300 includes a motor, a cavity, and a piston, and the motor is used to drive the piston to reciprocate in the cavity to perform pipetting operations.

The top end of forebay 121 is provided with an opening 115, and opening 115 is used for close-fitting docking with the free end of pipette 300 to receive pressure input into forebay 121. The opening 115 may be in the shape of a small circular hole 115d to facilitate a tight fit with the free end of the pipette 300.

The embodiment of the invention also provides a POCT sample analyzer, which comprises a shell 11, a detection seat 200, a pressure source, a motion mechanism 400, a temperature control module, a storage battery module 50 and a power supply module.

The housing 11 is provided with a display module 12, a door 13, and a handle 15. The display screen module 12 can be fixedly installed on the upper portion of the side surface of the casing 11, the display screen module 12 can be obliquely arranged so as to be convenient to watch, the display screen module 12 can be used for displaying a detection result and performing touch operation, the casing 11 is provided with an opening 14, the door panel 13 is used for covering the opening 14 and can be rotatably connected with the lower portion of the casing 11, the detection seat 200 can be moved out of the casing 11 and receive the reagent kit 100 to be loaded when the door panel 13 is opened, and the handle portion 15 can be arranged on the top of the casing 11 so as to facilitate the portable movement of the POCT sample analyzer 10. Of course, the display screen module 12 may also be eliminated, the main control module in the POCT sample analyzer 10 is connected to a mobile communication device such as a mobile phone or a tablet computer through a communication method such as bluetooth connection, and the detection result and the corresponding touch operation are displayed through the mobile phone or the tablet computer.

The detection seat 200 is arranged in the shell 11 and used for receiving the reagent kit 100, the reagent kit 100 comprises an impedance detection cell 120, the impedance detection cell 120 comprises a front cell 121 and a rear cell 122 which are communicated through micropores and a detection device 123 used for matching to perform impedance detection, the detection seat 200 is provided with an impedance detection assembly 210 corresponding to the impedance detection cell 120, the impedance detection assembly 210 comprises an electrode conductive device 211, and the electrode conductive device 211 is electrically contacted with the detection device 123 when the reagent kit 100 is arranged in the detection seat 200.

A pressure source is disposed within the housing 11 for applying pressure to the front reservoir 121 to cause liquid in the front reservoir 121 to flow through the pores to the back reservoir 122. The pressure source may be embodied as a pipette 300, the pipette 300 being configured for pipetting when the pipette head 114 is docked and the pipette 300 being further configured for applying pressure when the pipette head 114 is undocked. The pipette 300 of the present invention may be an ADP (Air Driven Pump), which is a power device with precise volume and capable of generating positive and negative pressure. The traditional blood cell analyzer adopts a set of complex devices such as an air pump, an air valve, a pressure chamber and the like to realize liquid preparation, counting and cleaning. The POCT sample analyzer provided by the application finishes liquid preparation and counting by ADP and does not need cleaning. In addition, the ADP is a modular component, and has a flexible architecture and is less interfered by other systems.

The liquid transfer device 300 comprises a motor, a cavity and a piston, wherein the motor is used for driving the piston to reciprocate in the cavity so as to perform liquid transfer operation, sucking and spitting mixing operation or inflating and mixing.

As shown in fig. 5, the top end of forebay 121 is provided with an opening 115, and opening 115 is adapted to mate with the free end of pipette 300 to receive pressure input into forebay 121. The opening 115 may be in the shape of a small circular hole 115d to facilitate a tight fit with the free end of the pipette 300.

In particular embodiments, the pipette 300 may include a first syringe and a second syringe slidably nested, with the free end of the second syringe retracted into the free end of the first syringe such that the free end of the first syringe is exposed and thereby received by the pipette head 114, and the second syringe separated from the pipette head 114 when moved toward the free end of the first syringe.

The movement mechanism 400 is disposed in the housing 11, and is used for moving the pipette 300 relative to the detection seat 200 to perform a pipette holding operation; the temperature control module is attached to the detection seat 200 to provide a detection temperature; the battery module 500 is electrically connected to the detection holder 200, the movement mechanism 400, and the pipette 300; and/or the power supply module is electrically connected with the detection seat 200, the movement mechanism 400 and the pipette 300, and is used for connecting with the mains supply.

According to the POCT sample analyzer and the driving device for liquid flow of the impedance detection cell, provided by the embodiment of the invention, pressure is applied to the front cell, so that liquid in the front cell flows to the rear cell through the micropores, an additional negative pressure generating device is not needed, and the structure of a product assembly can be simplified.

As shown in fig. 12 to 17, an embodiment of the present invention further provides a kit, which includes a box body 700, a plurality of impedance detection cells (711, 712), a plurality of optical detection cells (714, 716, 718), and a plurality of reagent cells (707 to 710).

The cartridge 700 has a first insertion hole (705, 706), a second insertion hole (703, 704), and a third insertion hole 702.

The first insertion holes (705, 706) are used for receiving a sample tube 753, or the cartridge 700 is integrally connected with the sample tube 753, the sample tube 753 is used for receiving a sample, and the sample can be a biological sample such as whole blood, serum, plasma, urine and the like.

The second insertion holes (703, 704) are used for installing a plurality of pipette heads 752, and the pipette heads 752 are used for being assembled on the connector 731 of the pipettor 730 to cooperate with pipetting operations.

The kit further comprises a sealing layer (not shown) for sealing the reagent wells (707-710) and/or the impedance detection wells (711, 712) and/or the optical detection wells (714, 716, 718); the third insertion hole 702 is used for installing a piercing member 751, and the piercing member 751 is used for matching to pierce a sealing layer.

A plurality of impedance detection cells (711, 712) are connected with the box body 700 and are used for matching impedance detection; a plurality of optical detection cells (714, 716, 718) are connected with the cartridge body 700 and are used for matching photoelectric detection, wherein at least one optical detection cell (714, 716, 718) is used for biochemical detection; the reagent reservoirs (707-710) are connected to the cassette body 700 for containing reagents.

Wherein, at least one impedance detection cell (711, 712) is equipped with light transmission window 758 in order to be used for cooperating and carrying on photoelectric detection, the optical detection cell (714, 716, 718) for carrying on biochemical detection can be the multiunit and be the straight line and arrange, pitch arc arrange or circular arrange, can set up around impedance detection cell (711, 712) when the optical detection cell (714, 716, 718) for carrying on biochemical detection is pitch arc arrange or circular arrange.

Further, the cartridge includes an elastic clip 755 for fitting the stopper 756 with a cartridge holder when the cartridge is set in the test holder of the POCT sample analyzer for stopping the cap 754 of the sample tube 753 when the sample tube 753 is set in the first insertion hole (705, 706), and a stopper 756.

The impedance detection cells (711, 712) are one or more groups, the impedance detection cells (711, 712) comprise a front cell and a rear cell which are communicated through a micropore and a detection electrode 757 used for matching impedance detection, the box body 700 is provided with a pressure plug hole 751, and the pressure plug hole 751 can be communicated with the front cell or the rear cell to apply positive pressure to the front cell or negative pressure to the rear cell. In a specific embodiment, the front wells of the multiple impedance detection wells are independent wells, the rear wells are communicated with each other and communicated with the pressure insertion hole 751, the pressure insertion hole 751 is used for connecting a negative pressure source, wherein the openings of the pressure insertion hole 751 and the front wells are both located on the upper surface of the case body 700, the pressure insertion hole 751 is directly butted with a connector (a connector 731 of the reusable pipette 730) of the negative pressure source, or a soft rubber ring formed at the position of the pressure insertion hole 751 through a secondary injection molding process is in elastic sealing fit with the connector of the negative pressure source, or the connector of the negative pressure source is provided with an auxiliary sealing piece to be in sealing fit with the pressure insertion hole 751.

In one embodiment, the impedance detection cells (711, 712) are divided into two groups for performing WBC detection and RBC detection respectively, wherein the front cell of the impedance detection cell 712 corresponding to the WBC detection is provided with a light-transmitting window 758, and the outer surface of the light-transmitting window 758 is recessed in the outer surface of the front cell.

Hemolytic agent for matching WBC detection can be arranged in the reagent pool 710, diluent can be arranged in the reagent pool 709, cleaning liquid can be arranged in the reagent pool 708, and the reagent pool 707 can be used as a pre-dilution pool.

The optical detection cells (714, 716 and 718) are one or more and are used for matching with photoelectric detection of transmitted light and/or photoelectric detection of scattered light, the optical detection cells (714, 716 and 718) are made of optical plastics, transparent plastics or glass and are provided with first biochemical detection reagents for matching with biochemical detection, second biochemical detection reagents for matching with biochemical detection can be arranged in the reagent cells (713, 715 and 717), and two opposite outer surfaces of the optical detection cells (714, 716 and 718) for transmitting detection light can be provided with concave parts to protect the light transmitting surfaces of the optical detection cells from being touched easily.

The impedance detection cells (711, 712), the optical detection cells (714, 716, 718), and the reagent cells (707-710) can be integrally formed with the case body 700; or the box body 700 is integrally formed with an assembly cylinder, and at least parts of the impedance detection cells (711, 712), the optical detection cells (714, 716, 718) and the reagent cells (707-710) are in butt joint with the assembly cylinder.

When the sample that installs in sample pipe 753 is whole blood sample and the required sample of biochemical detection is the serum sample (some biochemical detections can adopt whole blood sample, some biochemical detections must adopt serum sample), can add serum separable set on the box body.

In one embodiment, the case 700 is provided with a turntable mounting groove 719, the turntable mounting groove 719 is used to provide the serum preparation turntable 790, and the serum preparation turntable 790 includes a centrifugal connection part 791, a sampling hole 792, a whole blood storage cavity 793, an exhaust hole 794, and a serum storage cavity 795.

When a serum sample needs to be prepared, the whole blood sample can be added through the sample adding hole 792, after the centrifugal connecting part 791 is connected with the centrifugal device 743 on the sample analyzer, the centrifugal device 743 drives the serum preparation rotary disc 790 to move so as to realize serum separation, and the serum is stored in the serum storage cavity 795.

In another embodiment, the cartridge 700 is provided with a whole blood filter chamber 780, a cell filter membrane 781 is provided in the whole blood filter chamber 780, and a serum storage chamber 782 is provided at a side of the whole blood filter chamber 780.

When it is desired to prepare a serum sample, the whole blood sample may be added to the whole blood filter chamber 780, and then a pressure is applied to the whole blood filter chamber 780 such that the serum permeates the cyto-filtration membrane 781 and flows to the serum storage chamber 782.

As shown in fig. 15, the embodiment of the present invention further provides a POCT sample analyzer, which includes a detection seat and a pipette 730. The detection seat is used for receiving the kit loading of the previous embodiment and is provided with an impedance detection component 741 and/or an optical detection component 742; the pipettor 730 is used to sleeve the pipette head 752 for pipetting the reagent kit, and may be formed by connecting low-cost components of a valve, a tube, a syringe or a dosing pump.

As shown in fig. 16, the POCT sample analyzer further includes a centrifugal device 743, and the centrifugal device 743 is used for driving the serum preparation turntable 790 to move to realize serum separation.

The embodiment of the invention also provides a POCT sample analyzer, which comprises a shell 720, a detection seat, a pipettor 730, a movement mechanism and a main control module.

The detection seat is arranged in the shell 720 and is used for receiving the installation of the kit, the detection seat is provided with a plurality of impedance detection assemblies 741 and/or a plurality of optical detection assemblies 742, the impedance detection assemblies 741 comprise electrode conductive devices, the kit is provided with a detection device (namely a detection electrode 757), the electrode conductive devices are electrically contacted with the detection device when the kit is installed in the detection seat, the optical detection assemblies 742 comprise light emitting assemblies and light receiving assemblies which are arranged at intervals, the optical detection assemblies 742 comprise a first optical detection assembly and a second optical detection assembly, the first optical detection assembly is used for matching biochemical detection, the second optical detection assembly is used for matching HGB parameter acquisition and detection, wherein the first optical detection assembly is relatively complicated and needs light with different wavelengths according to different biochemical detection items, and therefore the first optical detection assembly can comprise a biochemical light source 771, An optical fiber 772, a biochemical optical lens 773, a biochemical optical receiving device 774 and an optical signal processing device 775; the second optical detection assembly is relatively simple, using a monochromatic light source, and thus may include an impedance channel light source 761 and an impedance channel optical receiver 762

The pipettor 730 is arranged in the shell 720 and used for carrying out pipetting operation on the kit, and the pipettor 730 can be formed by connecting a valve, a pipeline, an injector or a quantitative pump, so that the high-integration ADP is directly adopted as the pipettor, and the cost is lower.

The movement mechanism is arranged in the housing 720 and is used for enabling the pipettor 730 to move relative to the detection seat so as to support pipetting operation, and the main control module (not shown) is electrically connected with the detection seat, the pipettor 730 and the movement mechanism and is electrically connected with the human-computer interaction display module (not shown).

The POCT sample analyzer further includes a battery module 500, the battery module 500 is electrically connected to the main control module, the detection seat, the movement mechanism, and the pipette 730, as shown in fig. 18A, a battery cavity 501 may be formed on a side surface of the housing 720, and the battery module 500 and the battery cavity 501 are assembled and the insertion stability may be enhanced by a snap or a magnetic suction manner; alternatively, as shown in fig. 18C, the POCT sample analyzer is provided with a battery chamber and a cover plate (not shown), and the battery module 500 is fixed in the battery chamber and covered by the cover plate. Alternatively, as shown in fig. 18B, the battery module 500 is a mounting base, and the housing 720 is mounted on the mounting base, which may be in the form of a boss. Alternatively, as shown in fig. 18D, an electrical connection port 721 is formed on the surface of the housing 720, the battery module 500 is externally connected, and an electrical connection portion 502 matching with the electrical connection port 721 is formed on the battery module 500, and the electrical connection portion 502 and the battery module 500 can be connected 503 through a wire.

The POCT sample analyzer further comprises a power supply module, wherein the power supply module is electrically connected with the detection seat, the movement mechanism and the liquid transfer device 730 and is used for being connected with a mains supply. The POCT sample analyzer also comprises a temperature control module, and the temperature control module is attached to the detection seat to provide detection temperature; wherein the temperature control module is a heating film; and/or the temperature control module is a Peltier which is used for heating or refrigerating the heating seat. The POCT sample analyzer further includes a door, the housing 720 has an opening, the door is used to open or close the opening, and the test socket can be removed from the housing 720 through the tray 740 and receive the reagent cartridge to be loaded when the door is opened.

The POCT sample analyzer further includes a pressure building block (not shown), which may include a valve, a pressure storage cavity, a pressure sensor, and a pressure building power device, where the pressure building power device is a syringe or a pump, and the pressure building block may be an independently disposed pressure system, or the pressure building block communicates with the pipette 730 and provides positive or negative pressure power to the pipette 730 to support the pipette 730 to perform sucking and spitting operations.

The movement mechanism can be a three-axis movement mechanism, and the three-axis movement mechanism is used for driving the liquid shifter 730 to perform three-axis movement relative to the detection seat; or the movement mechanism comprises a first motor transmission component, a second motor transmission component and a third motor transmission component, and the first motor transmission component is used for driving the detection seat or the liquid transfer device 730 to move in the X direction; the second motor transmission component is used for driving the detection seat or the liquid shifter 730 to move in the Y direction; the third motor-driven component is used for driving the detection seat or the liquid shifter 730 to move in the Z direction.

The embodiment of the invention also provides a detection method based on the POCT sample analyzer, which comprises the following steps:

the receiving kit is loaded into the detection seat, wherein the kit comprises a plurality of impedance detection cells (711, 712) and/or a plurality of optical detection cells (714, 716, 718) which are used for matching impedance and/or photoelectric detection, the kit further comprises a plurality of reagent cells (707-710), the reagent cells (707-710) are used for containing a plurality of reagents, the kit is further provided with a pipette head 752 and a sample tube 753, the sample tube 753 is filled with a blood sample, and of course, the pipette head 752 can be arranged at other positions in the POCT sample analyzer without being arranged on the kit;

the pipettor 730 is inserted into the pipette head 752;

sucking a blood sample through the pipette head 752 and dispensing the blood sample into the optical detection cell (714, 716, 718) and/or the impedance detection cell (711, 712), wherein if the blood sample is a whole blood sample and the sample required for the optical biochemical detection is a serum sample, the method further comprises: aspirating the whole blood sample through the pipette head 752 and adding to the serum preparation carousel 790 or the whole blood filter 780 to prepare the serum sample by centrifugation or filtration; aspirating the serum sample through the pipette head 752 and dispensing the serum sample into the optical detection cell (714, 716, 718);

sucking reagents in reagent cells (707-710) through a pipette head 752 and adding to optical detection cells (714, 716, 718) and/or impedance detection cells (711, 712) to form a sample to be detected;

impedance detection and/or optical detection is performed by the impedance detection component 741 and/or the optical detection component 742.

The kit is further provided with a puncture member 751 and a sealing layer, the sealing layer is used for sealing reagent wells (707-710) and/or impedance detection wells (711, 712) and/or optical detection wells (714, 716, 718), and the method further comprises the following steps before the pipette 730 is inserted into the pipette head 752:

the pipettor 730 is inserted into the puncture member 751 and punctures the sealing layer by using the puncture member 751, however, the sealing layer can be punctured by tearing the sealing layer or puncturing the sealing layer by using the film tearing mechanism described above;

unloading the piercing member 751; or

Tearing the sealing layer by using a film tearing mechanism; or

And puncturing the sealing layer by using a film tearing mechanism.

Before or after the receiving kit is loaded into the detection seat, the receiving kit also comprises: receiving the detection item and/or sample type selected by the user through the human-computer interaction display module, or automatically confirming the detection item and/or sample type through scanning a bar code on the kit/sample tube. The POCT sample analyzer provided by the invention can support blood cell detection, biochemical detection and combined detection of blood cells and biochemistry.

The optical detection cell (714, 716, 718) is provided with a first biochemical detection reagent for matching biochemical detection, and the method further comprises the following steps after the blood sample is sucked by the pipette head 752 and distributed into the optical detection cell (714, 716, 718):

sucking and spitting the mixture through a pipette tip 752, inflating the mixture, stirring the mixture or mixing the mixture in a magnetic bead mode.

Reagent pond (707 ~ 710) include washing pond 708, wash the built-in washing liquid that is equipped with of pond 708, still include after inhaling through pipette head 752 and spit the mixing, inflate the bubble mixing, stir the mixing or the magnetic bead mode mixing:

the pipette head 752 is cleaned by a cleaning solution.

Reagent pond (707 ~ 710) include biochemical detection reagent pond (113, 115, 117), and biochemical detection reagent pond (113, 115, 117) are built-in to be equipped with and are used for the cooperation to carry out the second biochemical detection reagent that biochemical detected, still include after inhaling through pipette head 752 and spit the mixing, inflate the bubble mixing, stir mixing or the mixing of magnetic bead mode:

the second biochemical detection reagent is sucked by the pipette tip 752 and added into the optical detection cells (714, 716, 718), and then the mixture is sucked, discharged, mixed, bubbled, mixed, stirred and mixed or mixed by magnetic beads through the pipette tip 752.

The reagent pool (707-710) can include a diluent pool 709 and a hemolytic agent pool 710, the diluent pool 709 is filled with diluent, the hemolytic agent pool 710 is filled with hemolytic agent, the impedance detection pool (711, 712) includes a WBC pool 712 for WBC full parameter detection and an RBC pool 711 for RBC and PLT full parameter detection, the drawing of the blood sample through the pipette head 752 and the distribution of the blood sample into the impedance detection pool (711, 712) includes:

draw the diluent through the pipette head 752 and add to the WBC reservoir 712 and the RBC reservoir 711;

aspirating a blood sample through the pipette head 752 and adding to the WBC pool 712;

sucking and spitting the mixture through a pipette head 752, and inflating the mixture or stirring the mixture uniformly;

the sample fluid in the WBC cell 712 is aspirated through the pipette head 752 and added to the RBC cell 711;

sucking and spitting the mixture through a pipette head 752, and inflating the mixture or stirring the mixture uniformly;

the hemolyzing agent is aspirated through the pipette tip 752 and added to the WBC pool 712;

sucking and spitting the mixture through a pipette head 752, and inflating the mixture or stirring the mixture uniformly;

and performing HGB parameter acquisition detection on the WBC pool by using the second optical detection assembly.

In another embodiment, the reagent reservoir (707-710) may include a diluent reservoir 709 and a hemolytic agent reservoir 710, the diluent reservoir 709 contains a diluent, the hemolytic agent reservoir 710 contains a hemolytic agent, the impedance detection reservoir (711, 712) includes a WBC reservoir 712 for WBC full parameter detection and a RBC reservoir 711 for RBC and PLT full parameter detection, the reagent reservoir (707-710) further includes a pre-dilution reservoir 707, and the drawing the blood sample through a pipette head 752 and dispensing the blood sample into the impedance detection reservoir (711, 712) includes:

the diluent is sucked up through a pipette head 752 and added into the pre-dilution tank 707;

aspirating the blood sample through the pipette head 752 and adding to the pre-dilution reservoir 707;

sucking and spitting the mixture through a pipette head 752, and inflating the mixture or stirring the mixture uniformly;

the sample fluid in the pre-dilution reservoir 707 is aspirated through the pipette head 752 and added to the WBC reservoir 712;

aspirating sample fluid from the pre-dilution tank 707 or the WBC tank 712 through a pipette head 752 and adding to the RBC tank 711;

sucking and spitting the mixture through a pipette head 752, and inflating the mixture or stirring the mixture uniformly;

the hemolyzing agent is aspirated through the pipette tip 752 and added to the WBC pool 712;

sucking and spitting the mixture through a pipette head 752, and inflating the mixture or stirring the mixture uniformly;

and performing HGB parameter acquisition detection on the WBC pool by using the second optical detection assembly.

The WBC tank 712 and the RBC tank 711 respectively comprise a front tank and a rear tank which are communicated through micropores, and a detection electrode 757 used for matching impedance detection, the rear tanks of the WBC tank 712 and the RBC tank 711 are communicated and provided with pressure plug holes 751, the pressure plug holes 751 are used for connecting a negative pressure source, and the openings of the pressure plug holes 751 and the front tanks are positioned on the upper surface of the box body 700;

after the hemolyzing agent is drawn through the pipette head 752 and added to the WBC pool 712, it further includes:

unloading the pipette head 752;

and the negative pressure and impedance detection component 741 is butted with the pressure inserting hole 751 and is started to detect.

The sequence of the above steps is not limited, and can be adjusted according to actual detection items, and when two liquids are mixed, mixing action is generally carried out to improve reaction and detection efficiency.

The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes, which are made by using the contents of the present specification and the accompanying drawings, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims (21)

1. A kit, comprising:

a box body;

the impedance detection cells are connected with the box body and are used for matching impedance detection;

the optical detection cells are connected with the box body and are used for being matched with each other to carry out photoelectric detection, and at least one optical detection cell is used for carrying out biochemical detection;

and the reagent pool is connected with the box body and used for installing reagents.

2. The kit of claim 1, wherein: at least one impedance detection cell is provided with a light-transmitting window for matching photoelectric detection.

3. The kit of claim 1, wherein: the optical detection tanks for biochemical detection are in multiple groups and are arranged in a straight line, arc line or circular manner, and the optical detection tanks for biochemical detection surround the impedance detection tanks when being arranged in an arc line or circular manner.

4. The kit of claim 1, wherein:

the box body is provided with a first insertion hole, the first insertion hole is used for receiving a sample tube to be loaded, or the box body is connected with a sample tube, and the sample tube is used for receiving a sample to be loaded.

5. The kit of claim 1, wherein:

the box body is equipped with second cartridge hole, second cartridge hole is used for installing a plurality of pipette heads, the pipette head is used for assembling and carries out the liquid removal operation with the cooperation on the pipettor.

6. The kit of claim 1, wherein:

the kit further comprises a sealing layer for covering the reagent cell and/or the impedance detection cell and/or the optical detection cell;

the box body is provided with a third insertion hole, the third insertion hole is used for installing a puncture piece, and the puncture piece is used for being matched to puncture the sealing layer.

7. The kit of claim 1, wherein: the kit comprises an elastic clamping piece, and the elastic clamping piece is used for clamping and matching with a detection seat of the POCT sample analyzer when the kit is placed in the detection seat.

8. The kit of claim 4, wherein: the reagent cartridge comprises a stopper for stopping the cap of the sample tube when the sample tube is loaded into the first insertion hole.

9. The kit of claim 1, wherein:

the impedance detection pool is one group or a plurality of groups, the impedance detection pool comprises a front pool, a rear pool and a detection electrode, the front pool and the rear pool are communicated through micropores, the detection electrode is used for being matched with the front pool and the rear pool to detect impedance, the box body is provided with a pressure plug hole, and the pressure plug hole is communicated with the front pool or the rear pool to apply positive pressure to the front pool or apply negative pressure to the rear pool.

10. The kit of claim 9, wherein: the back pools of the impedance detection pools are communicated with each other, and the pressure plug holes are communicated with the back pools and are used for being connected with a negative pressure source.

11. The kit of claim 9, wherein: the pressure plug hole and the opening of the forebay are both positioned on the upper surface of the box body.

12. The kit of claim 11, wherein:

the pressure plug hole is directly connected with a connector of the negative pressure source in a butt joint mode; or

A soft rubber ring is formed at the pressure plug hole through a secondary injection molding process so as to be in elastic sealing fit with a connector of a negative pressure source; or

And the connector of the negative pressure source is provided with an auxiliary sealing element to be in sealing fit with the pressure plug hole.

13. The kit of claim 9, wherein:

the impedance detection cells are divided into two groups to respectively and correspondingly carry out WBC detection and RBC detection, wherein the front cell of the impedance detection cell correspondingly carrying out WBC detection is provided with the light-transmitting window, and the outer surface of the light-transmitting window is recessed in the outer surface of the front cell.

14. The kit of claim 1, wherein:

at least one reagent pool is internally provided with a hemolytic agent for matching WBC detection, at least one reagent pool is internally provided with a diluent, and at least one reagent pool is internally provided with a cleaning solution.

15. The kit of claim 1, wherein:

the optical detection pool is one or more for the cooperation carries out transmitted light photoelectric detection and/or scattered light photoelectric detection, the optical detection pool adopts optical plastic, transparent plastic or glass to make and is equipped with and is used for the cooperation to carry out biochemical detection's first biochemical detection reagent, at least one install in the reagent cell and be used for the cooperation to carry out biochemical detection's second biochemical detection reagent, the optical detection pool is used for permeating two relative surfaces that detect light and is equipped with the depressed part.

16. The kit of claim 1, wherein:

the impedance detection cell, the optical detection cell, the reagent cell and the box body are integrally formed; or

An assembly cylinder is formed on the box body through an integral cylinder, and at least parts of the impedance detection pool, the optical detection pool and the reagent pool are in butt joint connection with the assembly cylinder.

17. The kit of claim 1, wherein: the box body is equipped with the carousel mounting groove, the carousel mounting groove is used for setting up the serum preparation carousel.

18. The kit of claim 17, wherein: the serum preparation carousel includes that centrifugal connecting portion, application of sample hole, whole blood store the chamber, exhaust hole and serum store the chamber.

19. The kit of claim 1, wherein: the box body is equipped with whole blood filter chamber, be equipped with the cell in the whole blood filter chamber and strain the membrane, whole blood filter chamber side is equipped with the serum and stores the chamber.

20. A POCT sample analyzer, comprising:

a test receptacle for receiving a cartridge according to any one of claims 1 to 22, the test receptacle being provided with an impedance test assembly and/or an optical test assembly;

and the pipettor is used for sleeving the pipette head so as to perform pipetting operation on the kit.

21. The sample analyzer of claim 22, wherein: the sample analyzer further comprises a centrifugal device for driving the serum preparation turntable to move so as to realize serum separation.

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