A nucleic acid detection cartridge

Abstract

The utility model discloses a nucleic acid detection card box belongs to medical examination and testing instrument, molecular diagnostic detection instrument field, and its technical key points lie in, and the reaction bin and each function bin are communicated with the flow -guiding space through a corresponding U type flow channel respectively, and the opening center of the U type flow channel of the reaction bin in the flow -guiding space is recorded as A point, and the opening center of the U type flow channel of N function bin in the flow -guiding space is recorded as B1 point~B N Point respectively, and B1 point~B N Point is same with A point, and the flow -guiding component is placed in the flow -guiding space, and the flow -guiding component is provided with flow -guiding pipeline, and the box body and detection area chip layer still are provided with detection flow channel, and one end opening is arranged in the flow -guiding space, and the other end opening is communicated with the amplification pipe. The utility model proposes the technical scheme, can avoid the demand of the bubble of detection area and satisfy ultrasonic elution.

Description

Technical Field

[0001] This utility model relates to the technical field of medical examination and testing instruments and molecular diagnostic testing instruments, specifically to a nucleic acid detection cartridge. Background Technology

[0002] The existing technology CN118907609A proposes a detection kit based on microfluidics. It integrates sample pretreatment steps (lysis, dilution, mixing, reaction, etc.) and detection steps into a single detection kit.

[0003] However, it has the following two technical problems:

[0004] (1) The reaction chamber is located at the center of several containment chambers, and the control mechanism (the rotary control mechanism can select the connection between the reaction chamber and the selected containment chamber) corresponds to the reaction chamber. However, since the reaction chamber is located at the center of the box, it is not suitable for ultrasonic elution.

[0005] (2) Although placing the detection zone on the microfluidic substrate can improve the integration of the device and reduce the cost of the product, air bubbles that cannot be eliminated often exist in the detection zone during actual testing. The presence of air bubbles in the detection zone will lead to a decrease in the accuracy of PCR detection. Utility Model Content

[0006] The purpose of this invention is to address the shortcomings of the existing technology by providing a nucleic acid detection cartridge.

[0007] The technical solution of this utility model is as follows:

[0008] A nucleic acid testing cartridge includes: a cartridge body, a flow guiding component, a detection chip layer, and an amplification tube;

[0009] The box body includes: a reaction chamber and N functional chambers, and a flow guide space; the reaction chamber is located at the end of the box body; N is a natural number greater than or equal to 4;

[0010] The reaction chamber and each functional chamber are connected to the flow guide space through a corresponding U-shaped flow channel; the center of the opening of the U-shaped flow channel corresponding to the reaction chamber in the flow guide space is marked as point A;

[0011] The centers of the openings of the U-shaped flow channels corresponding to the N functional compartments in the flow guiding space are respectively denoted as points B1 to B2. N point;

[0012] B1 point ~ B N The distance between point A and point B is the same, denoted as r2;

[0013] The flow guiding component is placed in the flow guiding space. The flow guiding component is provided with a flow guiding pipe. The first opening of the flow guiding pipe corresponds to point A. The distance between the second opening of the flow guiding pipe and the first opening is also r2. When the flow guiding component rotates, it can rotate about the central axis of the first opening of the flow guiding pipe.

[0014] The detection area chip layer is located at the front of the bottom of the housing, and the amplification tube is located below the front end of the detection area chip layer.

[0015] The housing and the chip layer of the detection area are also provided with a detection channel: one end of the channel is set in the flow guide space, and the other end of the channel is connected to the amplification tube; the center of the opening of the flow guide space is set as point C, and the distance between point C and point A is also r2.

[0016] Furthermore, the bottom layer of the box includes: a box chip layer and a lower sealing layer; the flow channel portion between the reaction chamber, the N functional chambers and the flow guiding space is disposed on the lower surface of the box chip layer, and the lower sealing layer is disposed on the lower surface of the box chip layer.

[0017] Furthermore, the detection flow channel includes: a first detection flow channel and a second detection flow channel; the first detection flow channel and the second detection flow channel are connected.

[0018] The first flow channel for detection uses a U-shaped pipe, which is set in the chip layer of the housing and the chip layer of the detection area;

[0019] The second flow channel is located on the upper surface of the chip layer in the detection area.

[0020] Furthermore, the N functional compartments are arranged circumferentially around the flow guide space.

[0021] Furthermore, all N functional compartments are at the same distance from the flow guidance space.

[0022] Furthermore, N is 10, and the 10 functional compartments are: magnetic bead compartment, first waste liquid compartment, pyrolysis liquid compartment, sample compartment, second waste liquid compartment, spare compartment, first cleaning liquid compartment, second cleaning liquid compartment, elution liquid compartment, and paraffin oil compartment.

[0023] Furthermore, the nucleic acid test kit also includes: an upper sealing layer; the upper sealing layer is provided on the upper surface of the chip layer in the detection area.

[0024] Furthermore, the amplification tube is an eight-tube joint, and the other end of the detection channel is connected to each port of the eight-tube joint.

[0025] Furthermore, the box body also includes an upper cover assembly; the upper cover assembly is provided with an opening at the top of the box body; the upper cover assembly includes: a first cover plate and a second cover plate disposed above the first cover plate;

[0026] The upper part of the first cover plate is provided with a reaction chamber filling / exhausting pipe that is connected to the reaction chamber. The first cover plate is also provided with N through holes corresponding to the functional chambers.

[0027] N functional compartments contain sample compartments;

[0028] For the through holes corresponding to the sample compartment in the first cover plate, a corresponding sealing component is provided at the bottom of the second cover plate;

[0029] For the other N-1 through holes of the first cover plate and the filling / exhausting pipe of the reaction chamber, the second cover plate is provided with corresponding connecting vents.

[0030] The beneficial effects of this application are as follows:

[0031] First, the core design concept of this application is that the reaction chamber is no longer located at the center of rotation, but rather at the end of the housing. This allows the ultrasonic elution device to contact the reaction chamber. However, since the reaction chamber is no longer located at the center of rotation, how it connects with the functional chamber becomes a new technical challenge.

[0032] To solve the above problems, this application adopts the following design:

[0033] 1.1 The reaction chamber and each functional chamber are connected to the guide space via a corresponding U-shaped flow channel; the center of the opening of the U-shaped flow channel corresponding to the reaction chamber in the guide space is denoted as point A; the centers of the openings of the U-shaped flow channels corresponding to the N functional chambers in the guide space are denoted as points B1 to B1 respectively. N Point; B1 point ~ B N The distance between point A and point B is the same, denoted as r2;

[0034] 1.2, The flow guiding component is placed in the flow guiding space. The flow guiding component is provided with a flow guiding pipe. The first opening of the flow guiding pipe corresponds to point A. The distance between the second opening of the flow guiding pipe and the first opening is also r2. When the flow guiding component rotates, it can rotate about the central axis of the first opening of the flow guiding pipe.

[0035] 1.3 The housing and the chip layer of the detection area are also provided with a detection channel. One end of the detection channel is set in the flow guiding space, and the channel and the other end are connected to the amplification tube. The center of the opening of the detection channel in the flow guiding space is denoted as point C, and the distance between point C and point A is also r2.

[0036] Second, to prevent air bubbles in the detection area of ​​the chip layer, this application uses a method where "the detection area chip layer is located at the front of the bottom of the housing, and the amplification tube is located below the front end of the detection area chip layer," that is, using the amplification tube to replace the detection area of ​​the chip layer, thereby avoiding this problem. Attached Figure Description

[0037] The present invention will be further described in detail below with reference to the embodiments shown in the accompanying drawings, but this does not constitute any limitation on the present invention.

[0038] Figure 1 The diagram illustrates a three-dimensional structural design of a nucleic acid detection cartridge according to Embodiment 1.

[0039] Figure 2 A three-dimensional structural diagram of the box body of Embodiment 1 is shown.

[0040] Figure 3 The diagram shows a top view of the box body and the flow guiding component of Embodiment 1.

[0041] Figure 4 The diagram illustrates the structure of the first cover plate in Embodiment 1.

[0042] Figure 5 The diagram shows a top view of the second cover plate of Embodiment 1.

[0043] Figure 6 The diagram shows a bottom view of the second cover plate of Embodiment 1.

[0044] Figure 7 The diagram illustrates the positional relationship between the openings of the U-shaped flow channels corresponding to the reaction chamber in Embodiment 1, the openings of the U-shaped flow channels corresponding to the 10 functional chambers in the flow space, and the opening of the first detection flow channel in the flow space.

[0045] Figure 8 A three-dimensional structural diagram of the flow guiding component in Embodiment 1 is shown.

[0046] Figure 9 The diagram illustrates the three-dimensional structure of the detection area chip layer in Example 1.

[0047] Figure 10 The design diagram of the first flow channel for testing is shown.

[0048] Figure 11 A three-dimensional structural diagram of the top cover plate of Embodiment 1 is shown.

[0049] The annotations in the attached figures are explained as follows:

[0050] 100 nucleic acid test kits;

[0051] Box body 1000, box body chip layer 1300, lower sealing layer 1400;

[0052] The upper cover assembly 1100, the first cover 1110, the reaction chamber filling / exhausting pipe 1111, the second cover 1120, and the sealing component 1121;

[0053] The container body 1200, reaction chamber 1201, magnetic bead chamber 1202, first waste liquid chamber 1203, pyrolysis liquid chamber 1204, sample chamber 1205, second waste liquid chamber 1206, spare chamber 1207, first cleaning liquid chamber 1208, second cleaning liquid chamber 1209, eluent chamber 1210, paraffin oil chamber 1211, and flow guide space 1212;

[0054] Flow guiding component 2000, flow guiding pipe 2001;

[0055] The detection area consists of chip layer 3000, the second detection channel 3001, and the first detection channel 3002.

[0056] Upper sealing layer 4000;

[0057] Eight-pipe set, 5000. Detailed Implementation

[0058] <Example 1: A Nucleic Acid Detection Kit>

[0059] Figure 1 The diagram illustrates the three-dimensional structure of a nucleic acid testing cartridge. A nucleic acid testing cartridge 100 includes:

[0060] a. Box body 1000. The box body 1000 includes, from top to bottom: upper cover assembly 1100, box body 1200, box chip layer 1300, and lower sealing layer 1400.

[0061] The key design features of the box 1000 are:

[0062] i, Figure 2 The three-dimensional structure of the box body 1200 is shown. Figure 3 This shows a top view of the box body 1200. From Figure 2 and Figure 3 It is known that the main body 1200 of the box includes: a reaction chamber 1201, a magnetic bead chamber 1202, a first waste liquid chamber 1203, a pyrolysis liquid chamber 1204, a sample chamber 1205, a second waste liquid chamber 1206, a spare chamber 1207, a first cleaning liquid chamber 1208, a second cleaning liquid chamber 1209, an eluent chamber 1210, and a paraffin oil chamber 1211 (the magnetic bead chamber 1202, the first waste liquid chamber 1203, the pyrolysis liquid chamber 1204, the sample chamber 1205, the second waste liquid chamber 1206, the spare chamber 1207, the first cleaning liquid chamber 1208, the second cleaning liquid chamber 1209, the eluent chamber 1210, and the paraffin oil chamber 1211 are referred to as functional chambers), and a flow guiding space 1212; the distance between each functional chamber and the flow guiding space 1212 is the same, denoted as r. The reaction chamber 1201 is located at one end of the box body 1200, and its distance from the guide space 1212 is denoted as r1, where r1 is greater than r.

[0063] ii. The upper cover assembly 1100 includes: a first cover 1110 and a second cover 1120. Figure 11 The diagram illustrates the combined structure of the upper cover assembly 1100. Figure 4 The structural diagram of the first cover plate 1110 is shown. Figure 5 and Figure 6 The top and bottom views of the second cover plate 1120 are shown respectively.

[0064] The upper part of the first cover plate 1110 is provided with a reaction chamber filling / exhausting pipe 1111 that communicates with the reaction chamber 1201. The first cover plate 1110 is also provided with first to tenth through holes that communicate with the magnetic bead chamber 1202, the first waste liquid chamber 1203, the pyrolysis liquid chamber 1204, the sample chamber 1205, the second waste liquid chamber 1206, the spare chamber 1207, the first cleaning liquid chamber 1208, the second cleaning liquid chamber 1209, the eluent chamber 1210, and the paraffin oil chamber 1211, respectively.

[0065] The second cover plate 1120 is provided with connecting air holes corresponding to the reaction chamber filling / exhausting pipe 1111 of the first cover plate 1110 and the first to third and fifth to tenth through holes; a sealing member 1121 for sealing the fourth through hole (corresponding to the sample chamber 1205) is provided at the bottom of the second cover plate 1120.

[0066] The 10 connecting vents of the second cover plate 1120 are used to connect an air pump (the air pump is capable of both evacuating and filling air). The flow of materials in each chamber is controlled by evacuating / filling air into the reaction chamber 1201, magnetic bead chamber 1202, first waste liquid chamber 1203, pyrolysis liquid chamber 1204, sample chamber 1205, second waste liquid chamber 1206, spare chamber 1207, first cleaning liquid chamber 1208, second cleaning liquid chamber 1209, eluent chamber 1210, and paraffin oil chamber 1211.

[0067] iii. The reaction chamber 1201 and each functional chamber are connected to the flow guide space 1212 through independent U-shaped flow channels; the flow channels are set in the chip layer 1300 of the box body;

[0068] The reaction chamber and each functional chamber are connected to the flow guide space through a corresponding U-shaped flow channel; the center of the opening of the U-shaped flow channel corresponding to the reaction chamber in the flow guide space is marked as point A;

[0069] The centers of the openings of the U-shaped flow channels corresponding to the 10 functional compartments are respectively denoted as points B1 to B1. 10 Point; B1 point ~ B 10 The distance between point A and point B is recorded as r2;

[0070] B1 point ~ B 10 Point A is the same distance from point A. Figure 7Points A and B1 are shown. 10 (Positional relationship of points);

[0071] iv. The lower sealing layer 1400 is disposed at the lower part of the chip layer 1300 of the housing and is used to seal the lower part of the flow channel.

[0072] b, Flow guiding component 2000. Figure 8 The three-dimensional structure of the flow guiding component 2000 is illustrated. The flow guiding component 2000 is placed in the flow guiding space 1212. The flow guiding component 2000 is provided with a flow guiding pipe 2001. The first opening of the flow guiding pipe 2001 corresponds to point A, and the distance between the second opening and the first opening is also r2. That is, when the flow guiding component 2000 rotates, it can rotate about the central axis of the first opening of the flow guiding pipe 2001. At this time, the second opening of the flow guiding pipe 2001 can correspond to the openings of the U-shaped flow channels corresponding to the 10 functional compartments in the flow guiding space.

[0073] c, the detection area chip layer 3000 and the upper sealing layer 4000. Figure 9 The diagram illustrates the structure of the detection area chip layer. The detection area chip layer 3000 is provided with a second detection channel 3001, which is connected to the eight-tube connector 4000. An upper sealing layer 4000 is provided on the upper surface of the detection area chip layer 3000.

[0074] d, eight-tube 5000. The relationship between the detection area chip layer 3000 and the eight-tube 4000 is as follows: the eight-tube 4000 contains lyophilized bulbs, that is, the eight-tube 4000 is used for amplification detection.

[0075] It should be noted that the housing chip layer 1300 and the detection area chip layer 3000 are connected as a single unit (the lower sealing layer 1400 is also partially disposed at the lower part of the detection area chip layer 3000). A first detection flow channel 3002 is provided in both the housing chip layer 1300 and the detection area chip layer 3000. Figure 10 The diagram illustrates the structure of the first flow channel for detection. The first flow channel 3002 also uses a U-shaped pipe, with the center of its opening in the guide space being... Figure 7 Point C in the diagram. The distance from point A to point C is also r2. The other end of the first flow channel 3002 is connected to the second flow channel 3001.

[0076] It should be noted that the detection second channel 3001 has 8 branched channels, and each branched channel corresponds to one amplification tube.

[0077] The workflow of a nucleic acid testing kit according to this application is as follows:

[0078] S100, the sample solution is placed into the sample chamber 1205, and then the first cover plate 1110 and the second cover plate 1120 are installed in sequence on the box body 1200.

[0079] S200, the magnetic beads are drawn into the reaction chamber 1201;

[0080] First, rotate the flow guide assembly 2000 to connect the reaction chamber 1201 with the magnetic bead chamber 1202; second, evacuate the reaction chamber 1201 and inflate the magnetic bead chamber 1202 to extract the magnetic beads into the reaction chamber 1201.

[0081] S300, the waste liquid (preservative liquid adhering to the surface of the magnetic beads) in the reaction chamber 1201 is discharged from the reaction chamber into the first waste liquid chamber 1203;

[0082] First, rotate the flow guide assembly 2000 to connect the reaction chamber 1201 with the first waste liquid chamber 1203; second, inflate the reaction chamber 1201 and evacuate the first waste liquid chamber 1203 to discharge the waste liquid in the reaction chamber 1201 into the first waste liquid chamber 1203 (during this process, a magnet is placed on the outside of the reaction chamber, and the placed magnetic beads are also sucked into the first waste liquid chamber 1203).

[0083] S400, the sample solution enters the reaction chamber 1201;

[0084] First, rotate the flow guide assembly 2000 to connect the reaction chamber 1201 with the sample chamber 1205; second, evacuate the reaction chamber 1201 and inflate the sample chamber 1205 to extract the sample solution into the reaction chamber 1201.

[0085] S500, the lysis buffer enters reaction chamber 1201 for reaction, releasing nucleic acids:

[0086] First, rotate the flow guide assembly 2000 to connect the reaction chamber 1201 with the pyrolysis liquid chamber 1204; second, evacuate the reaction chamber 1201 and inflate the pyrolysis liquid chamber 1204 to draw the pyrolysis liquid into the reaction chamber 1201.

[0087] S600, after pyrolysis is complete, rotate the flow guide assembly 2000 to connect the reaction chamber with the second waste liquid chamber 1206. The reaction chamber 1201 is aerated, and the second waste liquid chamber 1206 is evacuated to discharge the waste liquid into the second waste liquid chamber 1206.

[0088] S700, the reaction chamber 1201 draws in cleaning fluid and then discharges the cleaning waste fluid (the number of cleaning cycles can be selected according to requirements);

[0089] First, rotate the flow guide assembly 2000 to connect the reaction chamber 1201 with the first cleaning fluid chamber 1208;

[0090] Secondly, the reaction chamber 1201 is evacuated and the first cleaning fluid chamber 1208 is purged, and the cleaning fluid is drawn into the reaction chamber 1201.

[0091] Next, rotate the flow guide component 2000 to connect with the second waste liquid tank 1206. The reaction tank 1201 is filled with air, and the second waste liquid tank 1206 is evacuated to discharge the waste liquid into the second waste liquid tank 1206.

[0092] S800, reaction chamber 1201 aspirates eluent;

[0093] First, rotate the flow guide assembly 2000 to connect the reaction chamber 1201 with the eluent chamber 1210;

[0094] Secondly, the reaction chamber 1201 is evacuated and the eluent chamber 1210 is purged with air, and the eluent is drawn into the reaction chamber 1201.

[0095] After S900 is fully eluted, rotate the flow guide assembly 2000, and then pressurize the reaction chamber to force the solution in the reaction chamber into the first detection channel 3002, and then through the second detection channel 3001 into each tube of the eight-tube 5000. The solution reacts with the lyophilized reagent in the eight-tube 5000 to amplify the solution.

[0096] The above-described embodiments are preferred embodiments of the present utility model and are only used to facilitate the illustration of the present utility model. They are not intended to limit the present utility model in any way. Any person skilled in the art who makes partial modifications or alterations to the technical content disclosed in the present utility model without departing from the scope of the technical features of the present utility model shall still fall within the scope of the technical features of the present utility model.

Claims

1. A nucleic acid testing kit, characterized in that, include: Box body, flow guiding component, detection area chip layer, amplification tube; The box body includes: a reaction chamber and N functional chambers, and a flow guide space; the reaction chamber is located at the end of the box body; N is a natural number greater than or equal to 4; The reaction chamber and each functional chamber are connected to the flow guide space through a corresponding U-shaped flow channel; the center of the opening of the U-shaped flow channel corresponding to the reaction chamber in the flow guide space is marked as point A; The centers of the openings of the U-shaped flow channels corresponding to the N functional compartments in the flow guiding space are respectively denoted as points B1 to B2. N point; B1 point ~ B N The distance between point A and point B is the same, denoted as r2; The flow guiding component is placed in the flow guiding space. The flow guiding component is provided with a flow guiding pipe. The first opening of the flow guiding pipe corresponds to point A. The distance between the second opening of the flow guiding pipe and the first opening is also r2. When the flow guiding component rotates, it can rotate about the central axis of the first opening of the flow guiding pipe. The detection area chip layer is located at the front of the bottom of the housing, and the amplification tube is located below the front end of the detection area chip layer. The housing and the chip layer of the detection area are also provided with a detection channel. One end of the detection channel is set in the flow guide space, and the other end is connected to the amplification tube. The center of the opening of the detection channel in the flow guide space is denoted as point C, and the distance between point C and point A is also r2.

2. The nucleic acid detection cartridge according to claim 1, characterized in that, The bottom layer of the box includes: a box chip layer and a lower sealing layer; the flow channel portion between the reaction chamber, N functional chambers and the flow guide space is disposed on the lower surface of the box chip layer, and the lower sealing layer is disposed on the lower surface of the box chip layer.

3. A nucleic acid detection cartridge according to claim 2, characterized in that, The detection flow path includes: a first detection flow path and a second detection flow path; the first detection flow path and the second detection flow path are connected. The first flow channel for detection uses a U-shaped pipe, which is set in the chip layer of the housing and the chip layer of the detection area. The second flow channel is located on the upper surface of the chip layer in the detection area.

4. A nucleic acid detection cartridge according to claim 1, characterized in that, N functional compartments are arranged circumferentially around the flow guide space.

5. A nucleic acid detection cartridge according to claim 4, characterized in that, All N functional compartments are at the same distance from the flow guide space.

6. A nucleic acid detection cartridge according to claim 1, characterized in that, N is 10, and the 10 functional compartments are: magnetic bead compartment, first waste liquid compartment, pyrolysis liquid compartment, sample compartment, second waste liquid compartment, spare compartment, first cleaning liquid compartment, second cleaning liquid compartment, elution liquid compartment, and paraffin oil compartment.

7. A nucleic acid detection cartridge according to claim 1, characterized in that, The nucleic acid test kit also includes: an upper sealing layer; the upper sealing layer is provided on the upper surface of the chip layer in the detection area.

8. A nucleic acid detection cartridge according to claim 1, characterized in that, The amplification tube is an eight-tube joint, and the other end of the detection channel is connected to each of the eight tube openings.

9. A nucleic acid detection cartridge according to claim 1, characterized in that, The box body also includes an upper cover assembly; the upper cover assembly is provided with an opening at the top of the box body; the upper cover assembly includes: a first cover plate and a second cover plate disposed above the first cover plate; The upper part of the first cover plate is provided with a reaction chamber filling / exhausting pipe that is connected to the reaction chamber. The first cover plate is also provided with N through holes corresponding to the functional chambers. N functional compartments contain sample compartments; For the through holes corresponding to the sample compartment in the first cover plate, a corresponding sealing component is provided at the bottom of the second cover plate; For the other N-1 through holes of the first cover plate and the filling / exhausting pipe of the reaction chamber, the second cover plate is provided with corresponding connecting vents.

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