WO2017005124A1

WO2017005124A1 - Reagent reaction box and application thereof in biological sample testing

Info

Publication number: WO2017005124A1
Application number: PCT/CN2016/087523
Authority: WO
Inventors: 刘圣强; 龚挺锋; 何焕军
Original assignee: 利多(香港)有限公司
Priority date: 2015-07-03
Filing date: 2016-06-28
Publication date: 2017-01-12
Also published as: CN105021807A; CN105021807B

Abstract

This application relates to the technical field of biological sample testing, and in particular, to a reagent reaction box (100) and an application of the reagent reaction box (100) in biological sample testing. The reagent reaction box (100) of this application comprises a reagent storage portion (102), a reagent releasing portion (150), and a reaction portion. The reagent storage portion (102), the reagent releasing portion (150), and the reaction portion are all disposed inside the reaction box (100). The reagent storage portion (102) comprises at least one reagent containing cavity, and the reagent containing cavity is sealed by a sealing element (104). The reagent releasing portion (150) comprises a push rod (152) movable relative to the reagent storage portion (102), the push rod (152) is connected to the sealing element (104), and the push rod (152) is used to coordinate with an external device to separate the sealing element (104) from the reagent storage portion (102). The reaction portion comprises at least one reaction region, and the reaction region receives a reagent released by the reagent storage portion (102). The application of the reagent reaction box (100) in biological sample testing of this application comprises the reagent reaction box (100). The reagent reaction box (100) of this application is a single entity, and only needs to coordinate with a test kit (200). With one operation, the reagent in the reagent storage portion (102) can be released rapidly.

Description

Reagent reaction kit and its application in biological sample detection

Technical field

The invention relates to the technical field of biological sample detection, in particular to a reagent reaction box and the application thereof in biological sample detection.

Background technique

Medical in vitro diagnostics play a very important role in today's medical industry. They can qualitatively or quantitatively measure changes in various biological indicators in human fluids to provide advice on disease diagnosis or treatment indicators, such as glycated hemoglobin in the blood (HbA1c). The detection is critical for the diagnosis and control of diabetes.

Glycated hemoglobin is a product of hemoglobin and blood sugar in red blood cells in human blood. When the blood glucose concentration is high, the amount of HbA1c formed by the human body is relatively high. The average lifespan of red blood cells in human body is 120 days. Before the cell death, the content of HbA1c in the blood will remain relatively unchanged. Therefore, the glycosylated hemoglobin test can usually reflect the blood glucose control of patients for nearly 8 to 12 weeks. The effect of elevated or decreased blood sugar.

There are also a number of designs in the prior art for detecting the concentration of an analyte, such as:

As shown in Fig. 1, US Patent No. 1,562,237 discloses a reaction cartridge comprising a reaction channel and a liquid reagent storage portion, a reaction reagent is provided with a dry reagent, and a liquid reagent storage portion is used for storing a buffer or other liquid reagent, a liquid reagent The storage portion includes a storage body 30' sealed by a seal or film 32' having a distal end 33' that tears the film directly from the distal end to separate the film from the storage body, releasing the reagents in the storage body to In the reaction channel.

When the liquid reagent is released, it is necessary to artificially separate the film 32' originally sealed on the storage body 30' and then remove the film. Although the above method can tear the film and release the liquid reagent, it is very difficult to tear the film from the storage body 30' through an extended distal end 33'. If the force is excessively applied or the force is too light, the film is broken. The opening or tearing is incomplete, so that the liquid reagent cannot be completely released, and the liquid reagent is too small during the detection, which causes a deviation of the detection result; on the other hand, in the non-detection period, the film 32' is exposed to the air, which is prone to artificial occurrence. Or the risk of other factors being broken or destroyed.

As shown in Fig. 2, US Pat. No. 5,272, 093 discloses a "reagent container and its delivery method" comprising a reagent storage chamber 12' and a seal 40' sealed on a reagent storage chamber, the seal being a two-layered folding arrangement, one The layer is used to seal the reagent storage chamber and the other layer extends outside the reagent storage chamber to form an extension 42' for tearing off the reagent in the reagent storage chamber. When releasing liquid reagents, it is necessary to artificially close the original The sealing member 40' sealed on the reagent storage chamber 12' is separated. If the force is excessive or the force is too light, the film is easily broken or the tearing is incomplete, so that the liquid reagent cannot be completely released, so that the liquid reagent is detected. Less, causing deviations in test results.

As shown in Fig. 3, US Pat. No. 8,846,380 discloses a "reaction cartridge for detecting the concentration of glycated hemoglobin", which comprises a first zone for containing a blood sample of the kit, a second zone for containing the washing solution, and detection. The zone and the reagent pack, the reagent and the wash solution in the reagent pack are stored separately and sealed with aluminum foil 120'. When the reagent package is inserted into the reaction box, the aluminum foil is torn by the reaction box, and the reagent and the washing solution in the reagent package are temporarily stored in the first reaction zone and the second reaction zone of the reaction cartridge, respectively, and the blood sample is sequentially rotated through the reaction cartridge. A reaction occurs that solves the problem of reagent storage and distribution.

When the above reaction cartridge is inspected, firstly, the release portion 130' on the artificially folded aluminum foil is required, the release portion 130' is aligned with the holder in the detection box, and the aligned reagent package is inserted into the detection box, so that the detection box is The release portion can be cut off to separate the aluminum foil from the reagent pack. This kind of design is relatively complicated, and has many operation steps. Moreover, it is required to be manually aligned during the insertion, and it is easy to cause repeated insertion by the situation that the plug is not in place. On the other hand, the reaction box and the reagent package are designed in a split type, and the open design of the reaction box, if improperly operated, it is easy to drop foreign matter into the reaction box, thereby affecting the accuracy of the detection result. Moreover, during the non-detection period, the release portion 130' is exposed to the air, which is prone to risk of tearing or breaking by human or other factors.

Summary of the invention

The technical problem to be solved by the present invention is to provide a reagent reaction cartridge and a reagent reaction cartridge for the detection of biological samples in view of the above problems existing in the prior art.

In order to solve the above problems, one of the technical solutions of the present invention is:

A reagent reaction cartridge includes a reagent storage portion, a reagent release portion, and a reaction portion, wherein the reagent storage portion, the reagent release portion, and the reaction portion are disposed inside the reaction cartridge; the reagent storage portion includes at least one reagent storage chamber, and a reagent The accommodating chamber is sealed by a sealing member; the reagent releasing portion includes a push rod movable relative to the reagent storage portion, the push rod is connected to the sealing member, and the push rod is used for cooperating with the external device to separate the sealing member from the reagent storage portion; The reaction portion includes at least one reaction zone that receives the reagent released by the reagent storage portion.

Preferably, the reagent storage portion includes a plurality of reagent accommodating chambers, and the plurality of reagent accommodating chambers are distributed in an array.

Preferably, the reagent storage portion includes at least two columns of reagent receiving chambers, each column including at least one reagent receiving chamber.

Preferably, at least one of the reagent holding chambers is for storing solid particles or powder particle reagents.

Preferably, the reaction portion includes a first reaction zone and a second reaction zone, and the first reaction zone and the second reaction zone respectively receive and temporarily store reagents released by different reagent holding chambers.

Preferably, the first reaction zone is used for temporarily storing the solid particle reagent, the first reaction zone comprises a support portion and a blocking portion, and a gap is formed between the support portion and the barrier portion, and the maximum width of the slit is smaller than the minimum width of the solid particle reagent. The support portion is a step.

Preferably, the first reaction zone further comprises a second baffle, the second baffle is disposed obliquely, and the second baffle forms a second gap with the barrier, the minimum width of the second slit being greater than the maximum width of the solid particle reagent.

Preferably, the blocking portion and the second baffle are baffles having an arc.

Preferably, the second reaction zone is used for temporarily storing a liquid reagent, and the second reaction zone is provided with a flow guiding member, and the flow guiding member comprises a first drainage plate and a second drainage plate.

The second technical solution of the present invention is:

A reagent reaction cartridge for detecting a biological sample, the reagent reaction cartridge comprising a reagent storage portion, a reagent release portion and a reaction portion, wherein the reagent storage portion, the reagent release portion and the reaction portion are both disposed inside the reaction cartridge; The reagent storage portion includes at least one reagent receiving chamber, the reagent receiving chamber is sealed by a seal; the reagent releasing portion includes a push rod movable relative to the reagent storage portion, the push rod is connected to the sealing member, and the push rod is used for external equipment Interacting to separate the seal from the reagent storage portion; the reaction portion includes at least one reaction zone, and the reaction zone receives the reagent released by the reagent storage portion.

The third technical solution of the present invention is:

A reagent reservoir comprising a reagent receiving chamber for storing a solid particulate reagent or a powder particulate reagent, the reagent receiving chamber being sealed by a seal.

Preferably, the solid particle reagent or powder particle reagent is a lyophilized solid particle reagent or a lyophilized powder particle reagent.

Preferably, the solid particulate reagent is a latex freeze-dried sphere.

Preferably, the reagent reservoir further comprises a reagent receiving chamber for storing a liquid reagent or a powder reagent.

Preferably, the reagent accommodating chamber for storing the liquid reagent or the powder reagent is provided with an injection hole that communicates with the reagent accommodating chamber and the external space, and the injection hole is sealed by the sealing member.

Preferably, the reagent reservoir comprises at least two reagent holding chambers, at least two reagent receiving chambers being distributed in an array.

Preferably, the reagent reservoir comprises two reagent receiving chambers, and the two reagent receiving chambers are arranged side by side or vertically.

Preferably, the reagent reservoir comprises four reagent receiving chambers, four reagent receiving chambers are arranged in two rows and four rows, each row is provided with two reagent receiving chambers, and each column is provided with one reagent receiving chamber.

Preferably, a cavity for containing a desiccant is provided on the back of the reagent reservoir.

The fourth technical solution of the present invention is:

a biological sample reaction cartridge, wherein the reaction cartridge is packaged with a reagent storage portion and a push rod movable relative to the reagent storage portion; the reagent storage portion is provided with at least one reagent receiving chamber, and the reagent receiving chamber is sealed by a sealing member; The push rod is coupled to a seal for interfacing with an external device to separate the seal from the reagent storage portion.

Preferably, the push rod is provided with a force receiving portion that cooperates with an external device.

Preferably, the reaction box is provided with an opening, the force receiving portion is exposed in the opening, and the force receiving portion cooperates with the external device through the opening.

Preferably, the force receiving portion is a back of the push rod.

Preferably, the force receiving portion is a bottom surface of the push rod.

Preferably, the reaction box is provided with a sliding slot, and the sliding slot is slidably coupled with the push rod.

Preferably, the sliding slot is provided with a separating plate, and the separating plate isolates the sliding groove from the inner space of the reaction box.

Preferably, at least one limiting protrusion is provided on at least one side of the push rod.

Preferably, the push rod is provided with at least one hollowed groove body near the edge, and the limiting protrusion is disposed on the outer side wall of the groove body, and the limiting protrusion is disposed in pairs with the groove body.

Preferably, the reaction box is provided with a limiting groove that cooperates with the limiting protrusion.

The fifth technical solution of the present invention is:

A detection system includes a reagent reaction box and a detection device, wherein the reagent reaction box is packaged with a reagent storage portion and a push rod movable relative to the reagent storage portion, and the reagent storage portion is provided with at least one reagent receiving chamber and a reagent receiving chamber Sealed by a sealing member; the push rod is connected to a sealing member for cooperating with the detecting device to separate the sealing member from the reagent storage portion; the detecting device comprises a detecting box, and the detecting box is provided with a ejector rod The top rod and the push rod cooperate to separate the seal from the reagent storage portion.

Preferably, the jack is movable relative to the test cartridge.

Preferably, the jack is disposed on a bottom plate of the test cartridge.

Preferably, the jack is disposed on an inner side panel of the test cartridge.

Preferably, the reagent reaction box is provided with an opening, and the ejector rod cooperates with the push rod through the opening.

Preferably, the inner side of the detection box is provided with a movable plate.

Preferably, the movable panel comprises a substrate and an elastic member, and the substrate is connected to the detection box by an elastic member.

Preferably, the substrate is a heating plate.

Preferably, a resilient piece is disposed on one of the inner sides of the detection box.

Preferably, the detection box is provided with a groove on an inner side surface of the movable panel.

The sixth technical solution of the present invention is:

A test box is provided with a movable plate, wherein the movable plate comprises a substrate and an elastic member, and the substrate is fixedly connected to the inner wall of the detecting box by an elastic member.

Preferably, the substrate is a heating plate.

Preferably, the elastic members are two.

Preferably, a spring piece is disposed on one of the inner side surfaces of the detection box adjacent to the movable panel.

Preferably, a ejector rod is disposed in the detection box.

Preferably, the jack is movable relative to the test cartridge.

Preferably, the jack is disposed on a bottom plate of the test cartridge.

Preferably, the upper end of the jack is chamfered.

Preferably, the jack is disposed on an inner side panel of the test cartridge.

The seventh technical solution of the present invention is:

A biological sample analysis kit comprising a reaction portion, the reaction portion comprising at least one reaction zone, wherein at least one reaction zone is a first reaction zone, the first reaction zone is for temporarily storing a solid particle reagent, and the first reaction zone The support portion and the blocking portion are formed, and a gap is formed between the support portion and the blocking portion, and the maximum width of the slit is smaller than the minimum width of the solid particle reagent.

Preferably, the support portion is a step.

Preferably, the blocking portion is a baffle, which is referred to as a first baffle.

Preferably, the first baffle is a vertical baffle, and a bottom of the first baffle forms a gap with the support portion.

Preferably, the first reaction zone further includes a second baffle, the second baffle is disposed obliquely, and the second baffle forms a second gap with the first baffle, and the minimum width of the second slit is greater than the maximum width of the solid particle reagent .

Preferably, the first baffle and the second baffle are baffles having an arc.

Preferably, a powder drying reagent is fixed in the reaction zone.

Preferably, the reaction portion further includes a second reaction zone for temporarily storing the liquid reagent.

Preferably, the second reaction zone is provided with a flow guiding member, and the flow guiding member comprises a first drainage plate and a second drainage plate.

Preferably, the solid particulate reagent is a latex freeze-dried ball reagent.

The eighth aspect of the technical solution of the present invention is:

A reagent storage unit includes at least one reagent accommodating chamber, at least one reagent accommodating chamber is provided with an injection hole, the injection hole communicates with the reagent accommodating chamber and the external space, and the reagent accommodating chamber and the injection hole are both sealed by a seal.

Preferably, the reagent receiving chamber is for storing a powder reagent or a liquid reagent.

Preferably, the reagent reservoir comprises a plurality of reagent receiving chambers, the plurality of reagent receiving chambers being distributed in an array.

Preferably, the reagent reservoir comprises two reagent receiving chambers, and the two reagent receiving chambers are arranged laterally to the left and right.

Preferably, the reagent reservoir comprises two reagent receiving chambers, and the two reagent receiving chambers are vertically arranged vertically.

The nine aspects of the technical solution of the present invention are:

A detection reaction cartridge includes a reagent storage unit installed in a reaction cartridge, and a reagent release position is disposed on the reagent storage chamber, the reaction cartridge includes a wall plate facing the reagent release position, and the guide plate has a guide rib. The flow rib is in contact with the droplet on the end of the reagent release site, and the flow leader is used to direct the droplet on the end of the reagent release site.

Preferably, the flow guiding rib is in contact with the end of the reagent release site.

Preferably, the reaction cartridge further includes a reaction portion, and the flow guiding rib extends into the reaction portion.

Preferably, the reaction cartridge includes a side plate, and the flow guiding rib is at an angle to the side plate.

Preferably, the flow guiding rib is arched.

Preferably, the flow guiding rib comprises a flow guiding surface facing the reagent release position, the flow guiding surface being a rounded curved surface.

Preferably, the guiding rib further comprises two side guiding surfaces adjacent to the flow guiding surface, and the joint between the two side guiding surfaces and the wall plate is a smooth curved surface.

Preferably, the reagent release site comprises a reagent release port.

Preferably, the reagent release site further comprises a baffle attached below the reagent release port.

The reagent reaction cassettes referred to herein may also be referred to as reaction cassettes, biological sample reaction cassettes, biological sample analysis cassettes, and detection reaction cassettes.

Compared with the prior art, the beneficial effects of the present invention are:

1. The reagent reaction cassette of the present invention is a single unit, and the reagent storage part and the push rod are both enclosed in the reagent reaction box. In the reaction, only the test box needs to be combined, and the reagent box is inserted into the external device in one step. In this case, the rapid release of the reagent in the reagent storage portion can be achieved. The above structure reduces the artificial manual operation portion of the detection reaction to the most simplified degree, and improves the automation degree of the reaction. In the reaction, the artificial manual operation step only includes sampling the sample to collect the sample and adding the sample to the reagent reaction box. The step of inserting the reagent reaction cartridge into an external device.

2. The reagent cartridge of the present invention contains various parts contained in the reagent reaction cartridge, in particular, the reagent storage portion and the push rod are contained inside the reagent reaction cartridge, so that the reagent storage portion and the push rod cannot be touched manually. Only when the external thrust of the detection box in the external device is inserted into the reagent reaction box can the push rod be actuated; when the unreacted, the improper operation or other factors are caused, the seal portion and the reagent storage portion are torn off, resulting in The possibility of reagent leakage in advance.

3. The gap between the opening and the components of the reagent reaction box of the invention is a gap fit, which provides a simple reaction space inside the reagent reaction box, ensures the purity of each reaction reagent, and avoids the external foreign matter being mixed into the reagent reaction box. Possibly, the accuracy of the reaction is improved.

4. The reagent reservoir of the present invention is a separate component packaged in a reagent reaction cartridge that includes a reagent containment chamber for storing solid particulate reagents or powder particulate reagents. The solid particle reagent or the powder particle reagent is sealed in the reagent storage, avoiding the random movement of the reagent in the reagent reaction box, avoiding the problem that the prior art needs to fix the dry reagent, and at the same time, improving the reagent in the sealed state. The shelf life of the effective period at room temperature is distinguished from other reagents, and is particularly suitable for reagents that are difficult to store at room temperature.

5. The reagent storage unit of the present invention is provided with a latex freeze-dried ball, on the one hand, maximizing the protection of the reactivity of the latex antibody, and on the other hand, greatly improving the shelf life of the reagent at normal temperature.

6. The reagent reaction cartridge of the present invention can realize simultaneous release of a plurality of reagents, and multiple reagents in accordance with reaction time and sequence, by arranging the number of reagent accommodating chambers in the reagent storage portion and their arrangement, and the function of the push rod automation function. At the same time, adding and mixing drying reagents can complete the detection of various samples.

7. The detection system of the invention can quickly push the ejector action when the reagent reaction box is inserted, and at the same time, the reagent reaction box is quickly and firmly fixed in the detection box, thereby ensuring that the detection area is aligned with the light-passing hole, that is, one step operation At the same time, the functions of reagent release, reagent reaction box fixation and detection zone light are completed, which simplifies the reaction step.

8. The reaction cartridge of the present invention is provided with a flow guiding rib. When the liquid reagent is released from the reagent reservoir into the reaction cartridge, the flow guiding rib is in contact with the droplet at the end of the reagent releasing end, so that the droplet follows the guiding rib. The drainage direction leaves the reagent release position, avoiding the local residue of the reagent droplets, ensuring the accuracy of the reagent capacity control, and making the reaction more complete.

DRAWINGS

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic view showing the structure of a reaction cartridge in the prior art.

2 is a schematic view showing the structure of a reagent container in the prior art.

Fig. 3 is a partial schematic view showing the structure of a reaction cartridge in the prior art.

4 is a schematic view of a perspective of a local structure in a detection system.

Fig. 5 is a schematic view showing the structure of the panel in the reagent reaction cartridge after being hidden.

Figure 6 is a schematic view showing the structure of the backing plate hidden in the reagent reaction cartridge.

Fig. 7 is a schematic view showing the connection structure of the reagent storage portion, the sealing member and the reagent releasing portion.

Fig. 7A is a schematic view showing the structure of the sealing member of Fig. 7 after being torn.

Fig. 8 is a schematic structural view of a reagent storage unit.

Fig. 8A is a schematic structural view of the reagent storage unit at an angle.

Fig. 8B is a schematic structural view of another angle of the reagent storage unit.

Fig. 9 is a schematic structural view showing an embodiment of a reagent storage unit.

Fig. 10 is a schematic structural view showing another embodiment of the reagent storage unit.

Fig. 11 is a view showing the connection structure of the upper cap, the reagent storage portion, and the reagent releasing portion in the reagent reaction cartridge.

Figure 12 is a schematic view showing the connection structure of the cartridge and the push rod in the reagent reaction cartridge.

Fig. 12A is a schematic view showing the structure of the pusher in the reagent reaction cartridge after sliding relative to the cartridge.

Figure 13 is a schematic view showing the structure of another embodiment in which the cartridge is connected to the pusher in the reagent reaction cartridge.

Figure 14 is a schematic view showing the axial structure of the release portion in the reagent reaction cartridge.

Figure 15 is a schematic enlarged view of the structure at A in Figure 6.

Figure 16 is a schematic view showing the axial structure of the cartridge in the reagent reaction cartridge connected to the push rod.

Fig. 16A is a schematic enlarged view of the structure C at Fig. 16.

Figure 17 is a schematic isometric view showing another embodiment of the cartridge in the reagent reaction cartridge connected to the pusher.

Figure 18 is a schematic enlarged view of the structure at D in Figure 5.

Figure 19 is a schematic isometric view of the external structure of the reagent reaction cartridge.

Figure 19A is a schematic rear view of the reagent reaction cartridge.

Figure 20 is a schematic view showing the structure of the upper cover in the reagent reaction cartridge.

Figure 20A is an enlarged schematic view of the structure at B in Figure 20.

Fig. 20B is a schematic view showing another angle structure of the upper cover in the reagent reaction cartridge.

Figure 21 is a schematic view showing the connection structure of the upper lid and the reagent storage portion in the reagent reaction cartridge.

Figure 22 is an exploded view of the reagent reaction cartridge.

Figure 23 is a schematic cross-sectional view of the test cartridge.

Figure 24 is a schematic view showing the structure of internal components in the test cartridge.

Figure 25 is a schematic cross-sectional view showing the pusher of the reagent reaction cartridge inserted into the test cartridge by the jack.

Figure 26 is a schematic view showing the structure of the elastic member in the detecting case.

Figure 27 is a schematic view showing the structure of the elastic piece in the detecting case.

Figure 28 is a schematic view showing the state of the reagent in step 0 when the reagent reaction cartridge is detected.

28A-28F are schematic views of the reagent states in steps 1-6, respectively, when the reagent reaction cartridge is detected.

Figure 29 is a schematic view showing the structure of the flow guiding rib on the reaction cartridge.

Figure 30 is a schematic view showing the flow guiding structure of the back panel of the reaction cartridge after see-through.

Figure 30A is a schematic view showing the structure of Figure 30 in the H-H section.

Figure 30B is an enlarged schematic view of the structure at E in Figure 30A.

Figure 31 is a schematic view showing the structure of an embodiment of a flow guiding rib in a reaction cartridge.

Figure 32 is a schematic view showing the structure of another embodiment of the flow guiding rib in the reaction cartridge.

Figure 33 is a schematic view showing the structure of still another embodiment of the flow guiding rib in the reaction cartridge.

Figure 34 is a schematic view showing the structure of an embodiment of a flow guiding rib and a reagent reservoir in a reaction cartridge.

detailed description

The present invention will be further described in detail below with reference to the accompanying drawings and embodiments, but the scope of the invention is not limited thereto.

As shown in FIG. 4, the detection system of the present invention is for rapidly detecting the concentration of an analyte in a biological sample, including a reagent reaction cartridge 100 and an external device, and the external device is a device other than the body of the reagent reaction cartridge 100, wherein the external device Also known as a detection device, an external device or detection device is provided with a detection box 200, and the reagent reaction box 100 and the detection box 200 are used together. The reagent reaction cartridge 100 serves as a reaction vessel, and can realize storage of a plurality of reagents, sequential addition of a plurality of reagents, and recovery of waste liquid. The detecting box 200 is used for placing the reagent reaction box 100, and the detecting box 200 is mounted on the detecting device, and the detecting device provides mechanical power and control for rotating the reagent reaction box 100, mixing the reagents in the reagent reaction box 100, releasing the reagent, and the like. Optics are also provided on the external device for detecting the concentration of the analyte in the liquid sample.

As shown in FIGS. 5 and 6, a reagent storage unit 102, a reagent releasing unit 150, a reaction unit, and a detection area 28 are provided in the reagent reaction cartridge 100. The reagent storage unit 102 and the reagent release unit 150 are both enclosed in the reagent reaction cartridge 100. Preferably, a cavity is disposed in the reagent reaction cartridge 100, and the reagent storage portion 102 is housed in the cavity. The reagent storage unit 120 is packaged as a separate component in the reagent reaction cartridge 100, facilitating rapid assembly of the reagent reaction cartridge. The reagent storage portion 102 is for sealing and storing solid particles, powder or liquid reagents, and the reagent releasing portion 150 can quickly open the reagent storage portion 102 to release the reagents into the reaction portion of the reagent reaction cartridge 100 under the cooperation of the detection cartridge 200 in the detecting device. The reaction portion is used for the temporary storage, mixing and reaction of the biological sample and the reagent, and the reaction intermediate or final product is detected through the detection zone 28.

As shown in FIGS. 7 and 8, the reagent storage portion 102 includes at least one reagent accommodating chamber, and the reagent storage portion 102 is sealed by the sealing member 104, that is, the reagent accommodating chamber is sealed by the sealing member 104. The reagent storage unit 102 is also referred to as a reagent storage, and the reagent storage unit 102 includes a plurality of reagent storage chambers, and a plurality of reagent storage chambers are arranged in an array. The number of reagent accommodating chambers is set according to the kind of reagents required for detecting the reaction, and the order of addition, for example, one, two or more, and the reagent accommodating chambers are independent from each other, that is, the plurality of reagent accommodating chambers are mutually With spacing, they are distributed in an array. For example, the two reagent accommodating chambers may be laterally arranged in a row, or may be longitudinally arranged in a row, or may be diagonally distributed; for example, a plurality of reagent accommodating chambers may be spaced apart from each other. The capacity of the reagent holding chamber is also set according to the dose required to detect the reaction.

Preferably, the reagent storage portion includes at least two columns of reagent receiving chambers, each column including at least one reagent receiving chamber. Preferably, as shown in FIG. 8, the reagent storage portion 102 includes two reagent accommodating chambers, and the two reagent accommodating chambers are laterally arranged side by side. That is, the reagent accommodating chamber 106 and the reagent accommodating chamber 108 are distributed in a row and two columns, and the bottom of the reagent accommodating chamber is substantially on the same horizontal line. Therefore, when the seal 104 is torn open, the reagent accommodating chamber 106 and the reagent in the reagent accommodating chamber 108 can be released together into the reagent reaction cartridge 100.

As shown in FIG. 9, as one embodiment of the reagent storage unit 102, the two reagent accommodating chambers are longitudinally arranged, that is, the reagent accommodating chamber 110 and the reagent accommodating chamber 112 are arranged in two rows and one column, and the partial tearing seal is partially opened. At 104 o'clock, the reagent accommodating chamber 112 located in the lower row preferentially releases the reagent, and continues to tear the sealing member 104 according to the reaction time requirement, so that the reagent accommodating chamber 110 located in the upper row releases the reagent. To the extent that the control seal 104 is torn, it is possible to add reagents in sequence to control the progress of the reaction.

As shown in FIG. 10, as another embodiment of the reagent storage portion, four reagent receiving chambers are arranged in an array, that is, the reagent receiving chamber 114, the reagent receiving chamber 116, the reagent receiving chamber 118, and the reagent receiving chamber 120 are two. Four rows are arranged. To the extent that the control seal 104 is torn, the reagents in the lower row of reagent receiving chamber 118 and reagent receiving chamber 120 are preferentially released, followed by the release of the upper row of reagents.

Preferably, the reagent reservoir comprises a reagent receiving chamber for storing a solid particulate reagent or a powder particulate reagent. The solid particle reagent or the powder particle reagent is sealed in the reagent storage, avoiding the random movement of the reagent in the reagent reaction box, avoiding the problem that the prior art needs to fix the dry reagent, and at the same time, improving the reagent in the sealed state. The shelf life of the effective period at room temperature is distinguished from other reagents, and is particularly suitable for reagents that are difficult to store at room temperature.

Preferably, the solid particle reagent or powder particle reagent is a lyophilized solid particle reagent or a lyophilized powder particle reagent. Preferably, the solid particulate reagent is a latex freeze-dried sphere. The latex freeze-dried ball, on the one hand, maximizes the protection of the latex antibody reactivity, and on the other hand, greatly improves the shelf life of the reagent at room temperature.

Preferably, the reagent reservoir further includes a reagent receiving chamber for storing the liquid reagent. The reagent holding chamber can be used to store solid particles, powder particles or liquid reagents, which can be set according to the detection needs.

As a preferred example, as shown in FIG. 8A, at least one reagent accommodating chamber is provided with an injection hole 130 that communicates with the reagent accommodating chamber and the external space, and the reagent accommodating chamber and the injection hole 130 are sealed by the sealing member 104. Preferably, the injection hole 130 is provided on a reagent accommodating chamber for storing a powder reagent or a liquid reagent. In order to seal the liquid reagent or the powder reagent more easily, when sealing, the reagent accommodating chamber is sealed with the sealing member 104 and the injection hole 130 is exposed outside, and the liquid or powder reagent is injected into the reagent accommodating chamber, and then the injection is sealed. The hole 130, thereby ensuring the sealing effect and reducing the difficulty of sealing the liquid or powder reagent. The reagent accommodating chamber and the injection hole can be sealed step by step by the same sealing member, and can be sealed by two sealing members, such as sealing the injection hole with a sealing plug.

As a preferred example, as shown in FIG. 8B, a cavity 132 for mounting a desiccant is further provided on the back of the reagent storage portion 102. When the reagent storage unit 102 is mounted in the reagent reaction cartridge 100, the desiccant is mounted in the cavity 132 by the cooperation of the cavity 132 and the inner wall of the panel 10.

Preferably, the reagent storage portion 102 includes two reagent holding chambers for storing the solid particle reagent and the liquid reagent, respectively. In this embodiment, the reagent storage unit 102 includes two

reagent accommodating chambers

106, 108 as an example. The reagent accommodating chamber 106 stores the solid particle reagent and the reagent accommodating chamber 108 for storing the liquid reagent, and the injection port is provided at the upper end of the reagent accommodating chamber 108. 130. The solid particle reagent is first placed in the reagent accommodating chamber 106 during sealing, the chamber opening of the reagent accommodating chamber 106 and the reagent accommodating chamber 108 is sealed with a seal 104, and the liquid reagent is injected into the reagent accommodating chamber 108, followed by sealing. The piece 104 seals the injection hole 130.

Preferably, the bottom of the reagent receiving chamber is beveled. When the reagent is released, the reagent is quickly discharged, the residue of the reagent in the accommodating chamber is minimized, and the precision of the reagent capacity control is ensured.

As shown in FIG. 7, the reagent storage portion 102 is sealed by the sealing member 104, that is, the reagent is sealed in the reagent accommodating chamber, and the sealing member 104 can be detached from the reagent accommodating chamber under the action of an external force, and the tearing off of the sealing member 104 can be From left to right, from bottom to top, etc., the description will be made by taking the seal from the bottom to the top as an example, as shown in Fig. 7A. The seal 104 can be a seal conventionally used in the prior art such as aluminum foil, film, and the like.

As shown in Figures 29, 30, 30A and 30B, the reaction cartridge includes a reagent reservoir 102 mounted in a reaction cartridge having a reagent release site thereon, and the reaction cartridge 100 includes a wall facing the reagent release site The wall plate is provided with a guiding rib 70, and the guiding rib 70 is in contact with the droplet on the end of the reagent releasing position, and the guiding rib 70 is used for guiding the droplet on the end of the reagent releasing position. The reagent release site refers to a position at which the liquid reagent flows from the reagent reservoir to a position where the reagent exits the reagent reservoir, that is, a liquid passage of the liquid reagent on the reagent reservoir. Correspondingly, the end of the reagent release site refers to the tail end of the liquid channel. The wall panel is the backing plate 12 or the isolating plate 36 on the reaction cartridge 100 mentioned below. When the guiding rib 70 is mounted on the backing plate 12, the reagent releasing portion adopts a manual manual method in the prior art when the guiding is performed. When the ribs 70 are mounted on the insulation panel 36, the reagent release portion is employed in an automated manner herein. When the liquid reagent is released from the reagent reservoir into the reaction cartridge, a part of the droplets tend to remain on the end of the reagent release site or adsorb between the end of the reagent release site and the wall plate, and the droplets at the end of the flow release rib and the reagent release site The contact causes the droplet to leave the reagent release position along the drainage direction of the flow guiding rib, thereby avoiding the local residue of the reagent droplet, ensuring the precision of the reagent capacity control and making the reaction more complete.

In the embodiment shown in Figure 34, the reagent release site includes a reagent release port 140. The bottom of the reagent release port 140 is the end of the reagent release site. In the embodiment shown in Figures 30-33, the reagent release site further includes a baffle 142 attached below the reagent release port 140. The deflector 142 is used for guiding the liquid to make the liquid reagent flow more smoothly away from the reagent reservoir 102. The deflector 142 has a sharp angle, and the bottom of the deflector 142 is the reagent release end.

Preferably, the flow guiding rib 70 is in contact with the end of the reagent release site. The contact surface of the droplet at the end of the reagent release site with the guide rib 70 is increased, and the droplet is drained more quickly. As shown in FIG. 30B, the flow guiding rib includes a contact end 72 and a leading end 74 which are sequentially connected, and the contact end 72 is in contact with a droplet on the end of the reagent releasing end or is in contact with a reagent releasing end, the guiding end 74 extends downwardly from the contact end 72. Preferably, the flow guiding ribs are in the form of thin strips. The contact end 72 is for contacting the droplets and draining the droplets onto the leading end 74 for directing the droplets on the contact end 72 to a designated location of the reaction cartridge 100. The cross-sectional area of the guiding end 74 is sequentially decreased from top to bottom, and the bottom of the guiding end forms a tip end, which facilitates the drainage of the liquid droplets and reduces the liquid hanging phenomenon at the bottom of the guiding end as much as possible. The contact end is in contact with the droplet, which can quickly drain the droplet. The closer the contact end is to the end of the reagent release site, the larger the contact surface of the contact end with the droplet, and the more obvious the drainage effect of the guide rib.

As shown in Fig. 31-33, the reaction cartridge 100 further includes a reaction portion, and the guide rib 70 extends into the reaction portion. That is, the leading end 74 of the guide rib 70 extends into the reaction portion and is in contact with the liquid reagent in the reaction portion. The extension of the guide rib 70 allows the droplet to be quickly and accurately guided into the reaction section. At the same time, after the large droplet attached to the end of the reagent release position is drained by the guide rib, there may be a small liquid point suspended at the bottom of the guide end of the guide rib, and the droplet suspended on the leading end is in contact with the liquid reagent in the reaction portion. After being taken away, the residual of small droplets on the guide ribs is avoided. In the embodiment shown in Figure 32, the contact end 72 of the flow guide rib 70 extends upwardly. It facilitates the rapid introduction of liquid from the reagent reservoir into the reaction section.

In the embodiment shown in Figures 29-34, the reaction cartridge 100 includes a side panel, and the flow guiding rib 70 is at an angle to the side panel. The guide ribs 70 may be disposed obliquely or in parallel with the side plates. The side panels are the left side panel 6 or the right side panel 8 on the reaction cartridge 100 mentioned below. Preferably, the flow guiding direction of the flow guiding rib 70 coincides with the flow direction of the liquid in the reagent reservoir. When the flow direction of the reagent reservoir releasing the liquid reagent is perpendicular to the horizontal plane, the flow guiding rib is disposed at a vertical horizontal plane; when the reagent reservoir of the reaction cartridge releases the reagent, the reaction box is inclined at an angle to the horizontal plane, and the flow direction of the liquid reagent at this time Released at an oblique angle to the side plates, the guide bars are inclined, and the direction of inclination of the guide bars is the flow direction of the liquid in the reagent reservoir. The direction of the flow guiding of the guide ribs is consistent with the flow direction of the liquid in the reagent reservoir, which is advantageous for reducing the resistance during the drainage process and allowing the reagent to flow down quickly. Preferably, the flow guiding rib is arched. Preferably, the longitudinal direction of the flow guiding rib is triangular. The triangle is a rounded triangle. The triangle is selected from the group consisting of a right triangle, an obtuse triangle, or an acute triangle. In the embodiment shown in FIG. 33, the longitudinal section of the guide rib 70 has a right-angled triangular shape, and one of the right-angled sides of the right-angled triangle is fixed on the wall plate, and the portion of the guide rib 70 that can contact the liquid droplet To be the contact end 72, the portion below the contact end 72 is the leading end 74. In the embodiment shown in FIGS. 30A, 31 and 32, the longitudinal section of the guide rib 70 has an obtuse triangular shape, and the largest oblique side of the obtuse-angled triangle is fixed on the wall plate, and the flow guiding rib 70 can be liquid-liquid. The portion of the drop contact is the contact end 72, the portion below the contact end 72 is the leading end 74, and the portion above the contact end 72 is the extension of the contact end 72.

As shown in FIG. 30B, the guide rib 70 includes a mounting surface 80, a flow guiding surface 82 opposite to the mounting surface, and two side flow guiding surfaces 84 adjacent to the mounting surface, the mounting surface 80 being fixed at On the siding. The flow guiding surface 82 is disposed facing the reagent release position, and the flow guiding surface 82 is a rounded curved surface, and the joint between the two side flow guiding surfaces 84 and the wall plate is a rounded curved surface. The design of the smooth surface makes the drainage of the guide ribs smoother and the resistance is smaller.

As shown in Figures 11 and 12, the reagent release portion 150 includes a push rod 152 that is coupled to a seal 104 that cooperates with an external device to separate the seal from the reagent storage portion. As shown in FIG. 7A, the sealing member 104 is attached or fixed to the push rod 152. When the external device acts on the push rod 152, the push rod 152 cooperates with the inner wall of the reagent reaction box 100 to generate movement relative to the reagent storage portion 102. Simultaneously with the movement of the push rod 152, the action of the seal 104 relative to the reagent storage portion 102, that is, the tearing of the seal 104, causes the reagent in the reagent receiving chamber to be released into the reagent reaction cartridge 100. The movement of the push rod 152 relative to the reagent storage portion 102 can be implemented from left to right, from right to left, from bottom to top, and the like.

As a preferred example, as shown in FIG. 7, one end of the sealing member 104 seals the reagent storage portion 102, and the other end is folded and attached to the push rod 152.

Preferably, the push rod 152 is provided with a force receiving portion that cooperates with an external device. The force receiving part is used to take the thrust provided by the external device.

Preferably, the push rods 152 are all housed inside the reagent reaction cartridge 100, and the thrust members of the external device need to protrude into the reagent reaction cartridge 100 or otherwise act on the force receiving portion of the push rod 152. The push rods 152 are all housed in the reagent reaction box, and the push rods in the reagent reaction box are not touched by the human hand, and the push rod 152 cannot be actuated by the human hand. The push rod 152 can be operated only by the external tool. This way The possibility of premature leakage of the reagent caused by the erroneous operation or other causes of tearing or damaging the seal 104 during the non-detection period is avoided.

As a preferred, as shown in FIG. 13, a chute 38 is provided in the reagent reaction cartridge 100. On the one hand, the chute 38 embeds the push rod 152 in the slide, and on the other hand, the chute 38 is in sliding engagement with the push rod 152. As an embodiment, the chute 38 is disposed on the back plate 12. The chute 38 can be designed to be composed only of the back plate 12 and the two groove sides. At this time, the side portions of the push rod 152 are received in the chute 38.

As a preferred example, as shown in FIG. 12 and FIG. 12A, the chute 38 is provided with a partitioning plate 36 that isolates the chute 38 from the internal space of the reagent reaction cartridge 100. As an embodiment, the chute 38 is a columnar body having at least one end open, and the four sides of the columnar body are composed of a part of the back plate 12, both sides of the chute 38 and the isolating plate 36, that is, the chute 38 is sealed and connected. The separator 36 separates the chute 38 from the internal space of the reagent reaction cartridge 100. The height of the separator 36 is such that the reaction liquid does not flow outside the reagent reaction cartridge. The chute 38 is designed as a separate area that isolates the push rod 152 or the outer thrust member from the reagent to prevent the push rod 152 or the outer thrust member from contacting the reagents and carrying away some of the reagent.

As a preferred example, as shown in FIG. 14, at least one of the limiting protrusions 154 is disposed on at least one side of the push rod 152. The limit projection 154 allows the push rod 152 to be more stably installed inside the reagent reaction cartridge 100. Preferably, the number of the limiting protrusions 154 is two, which are respectively disposed on the left and right sides of the push rod 152. Preferably, the limiting protrusion 154 is disposed at an upper portion of the side of the push rod 152. When the push rod 152 is installed in the reagent reaction box 100, the limiting protrusion 154 on the push rod 152 is elastically deformed by the reagent reaction box 100, and the push rod 152 and the reagent reaction box are added. The friction of 100 allows the push rod 152 to be stably installed in the reagent reaction cartridge 100, and also increases the resistance of the push rod 152 during movement.

As a preferred embodiment, as shown in FIG. 14, the push rod 152 is provided with at least one hollowed groove body 156 near the edge, and the limiting protrusion 154 is disposed on the outer side wall of the groove body 156, and the limiting protrusion is provided. The 154 is disposed in pairs with the trough body 156. As a specific embodiment, the limiting protrusions 154 are two, and the two limiting protrusions 154 are respectively disposed on the left and right sides of the push rod 152. Correspondingly, the hollow groove bodies 156 are also two, respectively The left side and the right side of the push rod are disposed near the edge, that is, the outer side wall of the left side groove body 156 is the left side surface of the push rod 152, and the outer side wall of the right side side groove body 156 is the right side surface of the push rod 152. That is, the limiting protrusion 154 is disposed on the outer side wall of the groove body 156. The arrangement of the hollowing trough 156 makes it easier to deform when the push rod 152 is operated, thereby avoiding the inflexibility of the push rod 152 due to excessive friction.

If the push rod 152 is in a deformed state for a long time, it is easy to lose a certain elasticity, and the fastening effect is not good. In order to solve the above problem, as a preferred example, as shown in FIG. 15, the reagent reaction cartridge 100 is provided with a limiting groove 158 that cooperates with the limiting protrusion 154. Preferably, the chute 38 is provided with a limiting groove 158 that engages with the limiting protrusion 154. The number of the limiting groove 158 is the same as that of the limiting protrusion 154. When the push rod 152 is in the initial state, that is, the normal state, the limiting groove 158 is engaged with the limiting protrusion 154. At this time, the push rod 152 is not deformed; when the push rod 152 is pushed by the external force, the push rod 152 is pushed. Deformation occurs at the stop protrusion 154 and exits the limit groove 158.

As a preferred, as shown in FIG. 14, the push rod is provided with a recess 162. The groove 162 is disposed at the upper end of the push rod 152, and the groove 162 is an adhesive groove for attaching the sealing member 104. Before the seal is not attached, the groove bottom of the groove 162 is slightly lower than the plane of the groove of the groove 162. When the seal 104 is pasted, the seal 104 fills the groove 162 to make the pusher plane flush. When the pusher 152 is pushed, the peeling of the pusher 152 is caused by the seal 104 being raised.

Preferably, the force receiving portion of the push rod 152 is the bottom surface or the back portion of the push rod. When the force receiving portion is the bottom portion of the push rod, an external force acts on the bottom surface of the push rod to tear the push rod 152 from the bottom to the top. In the piece 104, when the force receiving portion is the back of the push rod, an external force acts on the back of the push rod, which also causes the push rod 152 to tear the seal member 104 from the bottom up. The force receiving portion of the push rod 152 may also be the upper bottom surface, the left side surface or the right side surface of the push rod. When the upper bottom surface is the upper bottom surface, the push rod can be pulled from the upper portion; when the left side surface is the left side, the push rod can be pushed from the left to the right side. Rod; for the right side, the pusher can be pushed from right to left.

In another embodiment, the force receiving portion of the push rod 152 is magnetically connected to the external thrust member, that is, the force receiving portion of the push rod 152 and the external thrust member are magnetic components that attract each other, such as iron blocks, magnets, and the like. The push rod 152 and the external thrust member are separated by the reagent reaction box 100, and under the action of the magnetic force, the push rod 152 is driven by the external thrust member.

Preferably, the reagent reaction cartridge 100 is provided with an opening, the force receiving portion is exposed in the opening, and the force receiving portion receives the external thrust through the opening. That is, the outer thrust member can protrude into the opening, contact with the push rod 152 in the reagent reaction box 100 and urge it to move, and the opening position setting is related to the force receiving portion of the push rod 152.

As an embodiment, as shown in FIG. 16, the force receiving portion of the push rod 152 is the bottom surface of the push rod, and the aforementioned opening 34 is provided on the bottom plate 4 of the reagent reaction cartridge 100. Preferably, as shown in FIG. 16A, the opening 34 is provided with a chamfer 40, and the push rods 152 are all housed in the chute 38 and spaced apart from the opening 34 to avoid collision during misoperation. The outer thrust member is introduced from the chamfer 40 of the opening 34 and extends into the chute 38. Contact with the push rod 152 and urge the push rod 152 and the outer thrust member to slidably engage the chute 38.

As another embodiment, as shown in FIG. 17, the force receiving portion of the push rod 152 is the back of the push rod 152, and the opening 34 is provided on the back plate 12 of the reagent reaction cartridge 100. Preferably, the back of the push rod 152 is provided with a rib or recess 160, and the rib or recess 160 is a force receiving portion, and the rib or recess 160 is exposed in the opening 34. The outer thrust member contacts the rib or recess 160 and urges the push rod 152 into sliding engagement with the chute 38.

The reaction portion includes at least one reaction zone that receives the reagent released by the reagent storage portion 102. The reaction part includes a plurality of reaction zones, and the number and position setting of the reaction zones are related according to the number of reagent accommodating chambers in the reagent storage unit 102 and the reaction steps. For example, the two reagents simultaneously released may be temporarily stored in one reaction zone, or may be separately There are two separate reaction zones temporarily; if there are drying reagents in the reaction zone, other reaction zones can be separately set, and each reaction zone is connected to each other, and the reagents in each reaction zone can be mixed by rotating the reagent reaction box. .

As shown in FIG. 5 and FIG. 6, a detection area 28 is disposed in the reaction portion. The detection area 28 may be disposed on a flow path of any reagent of the reagent reaction cartridge 100. The detection area 28 is generally made of a transparent material to transmit light emitted by the optical device. Or scattered light enters the reagent reaction cartridge 100. A flow guiding member is disposed between the reagent storage portion 102 and the reaction portion. More specifically, the flow guiding member is disposed between the reagent receiving chamber and the corresponding reaction region, and the flow guiding member enables the reagent in the reagent receiving chamber to be fast and accurate. Released into the reaction zone.

As a preferred example, as shown in FIG. 5 and FIG. 18, the reaction portion includes at least one reaction zone, wherein at least one reaction zone is a first reaction zone 26, and the first reaction zone 26 is used for temporarily storing solid particle reagents, A reaction zone 26 includes a support portion and a barrier portion. A gap 47 is formed between the support portion and the barrier portion. The maximum width of the slit 47 is smaller than the minimum width of the solid particle reagent. The gap between the support portion and the barrier portion serves to block the solid particle reagent in the first reaction zone from entering the other reaction zone, so that the solid particle reagent can be stably stored on the support portion. As an embodiment, the support portion is a step 46, and the blocking portion is a baffle, which is referred to as a first baffle 48. The first baffle 48 is a vertical baffle, and the bottom of the first baffle 48 forms a slit 47 with the support portion. Preferably, the solid particulate reagent is a latex freeze-dried ball reagent. The minimum width of the latex freeze-dried ball reagent, i.e., the diameter of the latex freeze-dried ball, is greater than the maximum width of the slit 47, so that the latex freeze-dried ball reagent is blocked by the slit 47.

As a preferred example, as shown in FIG. 5 and FIG. 18, the first reaction zone 26 further includes a second baffle 50, the second baffle 50 is disposed obliquely, and the second baffle 50 forms a second slit 49 with the blocking portion. The minimum width of the second slit 49 is greater than the maximum width of the solid particle reagent. Second baffle 50 and barrier for solid particle test The agent is drained so that the solid particle reagent can smoothly enter the first reaction zone 26. As a specific embodiment, the maximum width of the latex freeze-dried ball reagent, that is, the diameter of the latex freeze-dried ball is smaller than the minimum width of the second slit 49, so that the latex freeze-dried ball reagent can easily enter the first reaction zone 26.

As a preference, the first baffle 48 and the second baffle 50 are baffles having an arc. On the one hand, the solid particle reagent can be quickly introduced, and in consideration of the difference in the diameter of the solid particles, the solid particles are prevented from being caught between the first baffle 48 and the second baffle 50 and cannot fall onto the step 46.

Preferably, the reaction portion further includes a second reaction zone for temporarily storing the liquid reagent. Preferably, the second reaction zone is provided with a flow guiding member, and the flow guiding member comprises a first drainage plate and a second drainage plate.

As a specific embodiment, as shown in FIG. 5 and FIG. 6, the reaction portion includes a first reaction zone 26 and a second reaction zone 25, and the first reaction zone 26 is for receiving solid particles released by the reagent accommodating chamber 106, and second. The reaction zone 25 is for receiving a liquid reagent released by the reagent receiving chamber 108. A flow guiding member is disposed on the second reaction zone 25, and the flow guiding member includes a first drainage plate 42 and a second drainage plate 44 to rapidly flow the liquid reagent into the second reaction zone 25. The first reaction zone 26 includes a step 46 for temporarily storing reagents, a first baffle 48 and a second baffle 50 for guiding solid particles into the step 46, and simultaneously A gap 47 is formed between a baffle 48 and the step 46 which prevents solid particles from entering the second reaction zone 25 and allows liquid reagent to flow into the first reaction zone 26.

As shown in FIGS. 19 and 19A, the reagent reaction cartridge 100 includes a top plate 2, a bottom plate 4, a left side plate 6, a right side plate 8, a panel 10, and a back plate 12. The reagent reaction cartridge 100 is generally a square box-shaped body made of a plastic material.

As a preferred example, as shown in FIG. 19, one end of the left side plate 6 or the right side plate 8 of the reagent reaction cartridge 100 is a slope 22. Preferably, the back plate 12 of the reagent reaction cartridge 100 is provided with an extension 24 extending out to the outside of the slope 22. Preferably, the slope 22 is disposed at the lower left corner of the reagent reaction cartridge 100. In one embodiment, the back plate 12 has a square shape, the panel 10 has a pentagon shape, the left side plate 6 has a side surface and a sloped surface, and the extending portion 24 has a right-angled triangular shape, and the oblique side of the right-angled triangle is the back plate 12 and the extension. The junction of the portion 24. The arrangement of the inclined surface 22 and the extending portion 24 facilitates artificially distinguishing the front and back sides of the reagent reaction box 100, avoiding the reverse insertion of the reagent reaction box 100 into the detection box 200, and on the other hand, automatically when the reagent reaction box is matched with the detection box. Identify the front and back of the reagent reaction cartridge to avoid misuse.

As a preferred, as shown in FIG. 20, the reagent reaction cartridge 100 is provided with positioning projections 16. The positioning protrusion 16 is disposed on the panel 10, and the positioning protrusion 16 has an inverted triangular shape, as shown in FIG. 20A, the positioning protrusion 16 is used. The reagent reaction box 100 is firmly positioned in the corresponding groove of the detection box 200, and the positioning protrusion 16 is engaged with the groove limit to fasten the reagent reaction box 100 in the detection box 200 to avoid reagent reaction when rotating. The displacement of the cartridge 100 relative to the cartridge 200 is detected.

As a preferred example, as shown in FIG. 19A, the top plate 2 of the reagent reaction cartridge 100 is provided with a handle 14 for facilitating the user to hold the handle 14 to quickly insert the reagent reaction cartridge 100 into the detection cartridge 200 after the detection is completed. The reagent reaction cartridge 100 is quickly removed. As a preferred, the back plate 12 of the reagent reaction cartridge 100 is provided with a notch 52. The provision of the notch 52 makes the injection molding of the reagent reaction cartridge 100 more convenient.

As a specific embodiment, as shown in FIG. 5, FIG. 6 and FIG. 22, the reagent reaction box 100 is provided with a reagent storage unit 102, a reagent release unit 150, a reaction unit, a detection area 28, a sampling rod 30, and a liquid absorption pad. 32. The reagent reaction cartridge 100, the reagent storage portion 102, the reagent releasing portion 104, and the sampling rod 30 are each made of a plastic material. The sampling rod 30 is for collecting a liquid sample such as blood, urine, or the like, and adding the liquid sample to the reagent reaction cartridge 100. After the test is completed, the liquid absorption pad 32 is used to recover the waste liquid to avoid contamination by liquid leakage.

As shown in FIG. 5, FIG. 6, and FIG. 22, the reagent reaction cartridge 100 is a cavity which can be divided into a casing 18 and an upper cover 20. The casing 18 includes a backing plate 12, a bottom plate 4, a left side plate 6, and a right side plate. 8. The upper cover 20 includes a top plate 2 and a panel 10, and the upper cover 20 and the case 18 are sealed and connected by welding or the like to facilitate assembly of the reagent reaction cartridge 100. The liquid absorbing pad 32 is disposed at an upper portion of the inclined surface 22, the liquid absorbing pad 32 sequentially faces the sampling plate 30 and the reagent storage portion 102 in the direction of the right side plate 8, and the reaction portion and the reagent releasing portion 104 are disposed in the reagent storage portion 102. Below, the detection zone 28 is disposed within the reaction section. The sampling rod 30 is disposed in the reagent reaction cartridge 100 through an opening, and the sampling rod 30 is fitted to the opening to prevent foreign matter from being mixed during sampling. The inclined surface 22 is disposed on the left side of the sampling rod 30, which is favorable for the sample on the sampling rod 30 to be in sufficient contact with the reaction liquid to prevent the reaction liquid from being too small to contact the sample. The layout of the liquid absorbing pad 32, the reagent storage portion 102, the sampling rod 30, the reaction portion, and the reagent releasing portion 104 is not limited to the above manner. Preferably, the second drainage plate 44 is connected to the upper end of the first baffle 48. The upper end of the first drainage plate 42 is further connected with a sampling needle guiding plate 57, and the sampling needle guiding plate 57 is disposed in the vertical direction. As shown in Fig. 12 and Fig. 20B, the casing 18 and the upper cover 20 are each provided with a sampling needle fixing member 59 for sampling the needle fixing member 59 to prevent it from shaking.

As a specific embodiment, the reagent storage unit and the reagent reaction box are connected. As shown in FIG. 8A, the reagent storage unit 102 is provided with positioning members, and each positioning member constitutes a cavity for accommodating the reagent storage. The portion 102 causes the reagent storage portion 102 to be fixedly mounted in the reagent reaction cartridge 100. The cavity can also be constructed using conventional techniques in the prior art. As a specific embodiment, as shown in FIGS. 12 and 12A, FIG. 20 and FIG. 20B, the panel 10 is provided with a positioning post 54 and a support plate 61. The left positioning plate 56 and the right positioning plate 58 are a plurality of discrete positioning positions. The components are dispersedly disposed on the casing 18 and the upper cover 20, and the positioning members are used for fixing the connection reagent storage portion 102. As shown in FIGS. 8A and 8B, the positioning member of the reagent storage portion 102 includes a mounting hole 122, a left positioning member 124, a right positioning member 126, and a lower positioning member 128. As shown in FIG. 21, the mounting hole 122 is fastened on the positioning post 54 for fixing the upper end of the reagent storage portion 102; the left positioning member 124 and the right positioning member 126 are respectively limited to the left positioning plate 56 and the right positioning plate 58. The lower positioning member 128 is placed on the support plate 61. Therefore, the reagent storage portion 102 is stably installed in the reagent reaction cartridge 100, and displacement of the reagent storage portion 102 during the movement or shaking of the reagent reaction cartridge 100 is avoided.

Any of the above preferences and embodiments can be optionally selected and combined as needed to achieve the ultimate rapid sample concentration detection.

As shown in Figs. 23 and 24, the detecting cartridge 200 is provided with a plunger 204 which is in contact with the force receiving portion through the opening 34 in the reagent reaction cartridge and provides the force of the external device.

As a preference, the jack 204 is movable relative to the test cartridge 200. The jack 204 can be fixed to the casing or can move relative to the casing. When the jack 204 is active, the active area of the jack 204 and the position of the movement are controlled by an external device. For example, the movement of the jack 204 can be controlled by a motor, or conventional techniques in the prior art can be employed. When the plunger 204 is fixed to the cartridge and the reagent cartridge 100 is inserted into the cartridge 200 of the external device, the plunger 204 is engaged with the plunger 152 by the insertion force to move the plunger 152.

As a preference, the jack 204 is disposed on the bottom plate of the detecting cartridge 200 or the jack 204 is disposed on the inner panel of the detecting cartridge 200. As shown in FIG. 25, when the detecting cartridge 200 is engaged with the bottom surface of the push rod 152, the opening 34 is provided on the bottom plate 4 of the reagent reaction cartridge 100, and the jack 204 is disposed on the bottom plate of the detecting cartridge 200. Preferably, the upper end of the jack 204 is chamfered to facilitate the insertion of the jack 204 into the opening 34. When the detecting box 200 is engaged with the back portion of the push rod 152, the opening 34 is disposed on the back plate 12 of the reagent reaction cartridge 100, and the jack 204 is disposed on the inner side panel of the detecting box 200.

As a preferred example, as shown in FIG. 24 and FIG. 26, the detecting box 200 is provided with a movable plate including a substrate 206 and an elastic member 210, and the substrate 206 is fixedly coupled to the inner wall of the detecting case 200 by the elastic member 210. Preferably, the number of the elastic members 210 is two, and the elastic member 210 includes a mounting surface 212 and two elastic arms 214. The mounting surface 212 is fixedly connected to the inner side surface of the detecting box 200, and the two elastic arms 214 are respectively combined with the base. The plate 206 is fixedly connected.

As a preferred, the substrate 206 is a heating plate, which is referred to as a first heating plate. That is, the movable plate serves as a heating member and as an elastic fastener.

As a preferred example, a spring piece 216 is provided on one of the inner side faces of the test cartridge 200 as shown in Figs. Preferably, the elastic piece 216 is disposed on one of the inner side faces adjacent to the movable plate. The elastic piece 216 is provided with a spring arm 218. One end of the elastic arm 218 is fixed to the elastic piece 216, and the other end of the elastic arm 218 has a rounded curved shape, and the elastic arm 218 is mounted facing the inner cavity of the detection box 200. The elastic piece 216 is used to fit the inclined surface 22 on the reagent reaction box 100, so that the side of the reverse box 100 on which the slope is not provided is in close contact with the inner side wall of the detection box 200. Since the elastic piece 216 has a certain elasticity, if the reagent reaction box 100 is reversely inserted into the detection box 200, the reagent reaction box 100 cannot be completely inserted into the detection box 200 due to the action of the elastic piece 216, and therefore, the elastic piece 216 and the inclined surface 22 The cooperation can also serve as an identification function for the correct insertion of the reagent reaction cartridge 100.

As a preferred example, as shown in FIG. 23, a groove 202 is provided on one of the inner side faces of the detecting cartridge 200. Preferably, the groove 202 is disposed on the inner side of the opposite movable panel. The groove 202 is used for snapping the positioning protrusion 16 on the reagent reaction box 100, so that the reagent reaction box 100 can be snapped onto the groove 202, and the movement of the reagent reaction box 100 during the rotation or vibration of the detection box 200 is avoided. Bit.

As shown in FIG. 4, FIG. 23 and FIG. 24, the detection box 200 is fixed on an external device to achieve mixing or rotation, and the detection box 200 includes a box body with an open end, and the box body is provided. There is a light-passing hole 201, and a ejector 204, a first heating plate 206 and a second heating plate 208 are disposed in the casing. The first heating plate 206 is a movable plate, and the ejector 204 contacts the force receiving portion through the opening 34 and provides an external portion. Thrust, first heating plate 206 and second heating plate 208 are used to heat the reagent to meet the reaction temperature requirements.

As shown in FIG. 25, when the reagent reaction cartridge 100 is inserted into the detection cartridge 200, the reagent reaction cartridge 100 presses the first heating plate 206, and the first heating plate 206 deforms the elastic member 210 under the action of pressure, and the reagent reaction cartridge The 100 can be quickly inserted and snapped into the recess 202. At the same time, the bevel 22 of the reagent reaction cartridge 100 compresses the elastic piece 216 to align the detection area 28 on the reagent reaction cartridge 100 with the light-passing hole 201 on the detection cartridge 200. During insertion of the reagent reaction cartridge 100 into the test cartridge 200, the plunger 204 extends into the opening 34 to contact the push rod 152. As the reagent cartridge 100 is moved from top to bottom, the push rod 152 moves from bottom to top. The driving seal 104 is moved from bottom to top to tear the sealing member 104 away from the reagent storage portion 102, and the releasing reagent is as shown in Fig. 7A.

There are many methods for detecting glycated hemoglobin on the market, and the commonly used detection methods are ion exchange. Chromatography, affinity chromatography, high pressure liquid phase, immunoassay, ion trapping, electrophoresis, and the like. The immunological method refers to measuring HbA1c based on the interaction of an antigen molecule and a specific antibody after erythrocyte lysis.

Detection of HbA1c by immunoagglutination involves the following two detection steps: detection of total hemoglobin Hb concentration and glycated hemoglobin HbA1c concentration in the sample, respectively. Total hemoglobin (Hb) is detected by oxidizing ferrous ions in hemoglobin with potassium ferricyanide to form methemoglobin, methemoglobin reacts with thiocyanate to form thiocyanate, and absorbance at 531 nm is detected to obtain Hb. concentration. Glycated hemoglobin (HbA1c) competes with HbA1c containing multiple HbA1c immunoreactive binding sites to compete with HbA1c in blood for binding to anti-HbA1c antibodies labeled on latex microspheres. The former binding causes changes in turbidity of the reaction solution. The change in absorbance at 531 nm gives the concentration of HbA1c in the blood. The concentration of HbA1c in the blood is also high, the lower the turbidity, the smaller the absorbance value, and the change in absorbance and HbA1c concentration is obtained by a calibration curve.

Therefore, immunoassay for HbA1c requires the use of a thiocyanate liquid reagent (Buffer), a latex sphere labeled with an anti-HbA1c antibody, a potassium ferricyanide drying reagent (drying), and agglutination with multiple HbA1c immunoreactive binding sites. Dry reagent (drying). As shown in Fig. 28, the thiocyanate liquid reagent 60 is stored in the reagent accommodating chamber 108, the latex ball 62 labeled with the anti-HbA1c antibody is stored in the reagent accommodating chamber 106, and the potassium ferricyanide drying reagent 64 is solidified in the second reaction zone. At 25, the lectin drying reagent 66 is cured in the first reaction zone 26.

Among them, the latex sphere is a latex freeze-dried pellet, and the specific HbA1c antibody is attached to the latex pellet by covalent bonding in advance, and then the latex sphere is rapidly frozen into a pellet of the same volume by freeze-drying technology, thereby realizing the latex. The maximization of antibody reactivity protection, while greatly improving the shelf life of the effective period at room temperature.

The concentration of HbA1C in the blood is detected using the reagent reaction cartridge of the present invention. The steps of immunoassay for detecting HbA1c are as follows:

Step 0: As shown in Fig. 28, the sampling rod 30 with the sample was inserted into the reagent reaction cartridge.

Step 1: As shown in Fig. 28A, the detection box is rotated, the reagent reaction cartridge is inserted into the detection box, and the push rod 152 is moved upward by the external thrust, and the sealing member 104, the latex ball 62 and the thiocyanate 60 are pulled off. At the same time, the latex ball 62 falls into the first reaction zone 26 for temporary storage, and the thiocyanate liquid reagent 60 falls into the detection zone 28 of the second reaction zone 25.

Step 2: As shown in Fig. 28B, the reagent reaction cartridge was rotated, and Buffer 60 (thiocyanate), dried matter 64 (potassium ferricyanide) and a blood sample were mixed to form a mixture X.

Step 3: As shown in Fig. 28C, the reagent reaction cartridge is rotated, and the mixture X in the step 2 is rotated to the detection zone 28 to detect the content of hemoglobin (Hb) in the sample.

Step 4: As shown in Fig. 28D, continue to rotate the reagent reaction cartridge so that the mixture X in the step 2 enters the first reaction zone 26, and the mixture and the dried material 66 (a lectin containing multiple HbA1c immunoreactive binding sites) and Latex balls 62 (latex microspheres labeled with anti-HbA1c antibody) were mixed to form a mixture Y.

Step 5: As shown in Fig. 28E, the reagent reaction cartridge is rotated, and the mixture Y in the step 4 is introduced into the detection zone 28 to detect the content of glycated hemoglobin (HbA1C) in the sample.

Step 6: As shown in Fig. 28F, the reagent reaction cartridge is rotated, and the mixture Y in the step 4 is introduced into the liquid absorption pad 32, so that the waste liquid after the reaction is absorbed.

The detection of HbA1c ends, and the detection structure is calculated by an external device and output.

The reagent reaction cassette of the present invention is not limited to the detection of HbA1c in the above blood sample, and can also be used for detection of other biological samples such as urine, saliva, spinal fluid, etc., and can also be used for C-reactive protein, cholesterol, blood lipids and biological samples. Concentration detection of analytes such as blood sugar.

In the above description, the conventional technical means in the prior art are used unless otherwise specified.

Claims

a reagent reaction cartridge comprising a reagent storage portion, a reagent release portion and a reaction portion, wherein the reagent storage portion, the reagent release portion and the reaction portion are both disposed inside the reaction cartridge;

The reagent storage portion includes at least one reagent receiving chamber, and the reagent receiving chamber is sealed by a seal;

The reagent releasing portion includes a push rod movable relative to the reagent storage portion, the push rod is connected to the sealing member, and the push rod is used for cooperating with the external device to separate the sealing member from the reagent storage portion;

The reaction portion includes at least one reaction zone that receives the reagent released by the reagent storage portion.
The reagent reaction cartridge according to claim 1, wherein the reagent storage portion includes a plurality of reagent accommodating chambers, and the plurality of reagent accommodating chambers are distributed in an array.
The reagent reaction cartridge according to claim 2, wherein said reagent storage portion comprises at least two columns of reagent accommodating chambers, each column including at least one reagent accommodating chamber.
A reagent reaction cartridge according to any one of claims 1 to 3, wherein at least one of said reagent holding chambers is for storing solid particles or powder particle reagents.
The reagent reaction cartridge according to claim 3, wherein the reaction portion comprises a first reaction zone and a second reaction zone, and the first reaction zone and the second reaction zone respectively receive and temporarily store the release of different reagent accommodating chambers. Reagents.
The reagent reaction cartridge according to claim 5, wherein the first reaction zone is for temporarily storing a solid particle reagent, and the first reaction zone comprises a support portion and a blocking portion, and a gap is formed between the support portion and the blocking portion The maximum width of the slit is smaller than the minimum width of the solid particle reagent, and the support portion is a step.
The reagent reaction cartridge according to claim 6, wherein the first reaction zone further comprises a second baffle, the second baffle is disposed obliquely, and the second baffle forms a second slit with the blocking portion, and the second slit The minimum width is greater than the maximum width of the solid particle reagent.
The reagent reaction cartridge according to claim 7, wherein the blocking portion and the second baffle are baffles having an arc.
The reagent reaction cartridge according to any one of claims 5 to 8, wherein the second reaction zone is for temporarily storing a liquid reagent, the second reaction zone is provided with a flow guiding member, and the flow guiding member comprises the first A drain plate and a second drain plate.
A reagent reaction cartridge for use in biological sample detection, characterized in that

The reagent reaction cartridge includes a reagent storage portion, a reagent release portion, and a reaction portion, the reagent storage a portion, a reagent release portion and a reaction portion are all disposed inside the reaction cartridge;

The reagent storage portion includes at least one reagent receiving chamber, and the reagent receiving chamber is sealed by a seal;

The reagent releasing portion includes a push rod movable relative to the reagent storage portion, the push rod is connected to the sealing member, and the push rod is used for cooperating with the external device to separate the sealing member from the reagent storage portion;

The reaction portion includes at least one reaction zone that receives the reagent released by the reagent storage portion.