A pancreatic cancer diagnostic kit, a preparation method thereof, and a device thereof

Abstract

The application discloses a pancreatic cancer diagnosis kit, a preparation method and a device thereof, and relates to the technical field of medical devices. The device comprises a sample container for containing a reagent solution and a base for placing multiple groups of the sample containers, and further comprises a box body for supporting the base and a box cover for sealing the box body; the open end of the sample container is provided with a sealing plug; the box body is provided with a positioning structure for limiting the sample container from separating from the base; the positioning structure comprises an annular triangular blocking block which is sleeved on the sample container; the sample container comprises an integrally-formed end taper angle part and a slope surface part; the annular triangular blocking block is located between the end taper angle part and the slope surface part; the open cylinder body is provided with a jacking assembly for limiting the horizontal height of the sample container. The positioning structure is arranged to ensure that the sample container can be easily placed and fixed, thereby simplifying the operation process; meanwhile, under the action of the positioning structure, the stability of the reagent during transportation or storage is ensured, and the risk of reagent overturning or leakage caused by bumping or other external factors is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of kit devices, in particular to a pancreatic cancer diagnosis kit, a preparation method and a device thereof. BACKGROUND

[0002] Pancreatic cancer is one of the most common malignant tumors in the digestive system, and its incidence is increasing year by year. From a histological point of view, the pancreas is composed of exocrine and endocrine parts. The commonly referred to pancreatic cancer is an epithelial-derived malignant tumor occurring in the exocrine part.

[0003] The main function of pancreatic cancer diagnosis reagent is to diagnose pancreatic cancer by detecting specific biomarkers. These biomarkers may be directly produced by tumor cells or produced by the body's response to tumors. By measuring the levels of these markers, doctors can determine whether a patient has pancreatic cancer and the extent of tumor development. In addition, these markers can also be used to monitor treatment effectiveness and disease recurrence.

[0004] The Chinese patent with the granted publication number CN113884679B discloses a pepsin detection kit, a preparation method and a device thereof. The pepsin detection kit includes a box body, an enzyme-linked plate and a test tube. The preparation device of the pepsin detection kit includes an external support, a moving structure, a die casting structure and a mounting structure. The mounting structure includes a clamping head, a connecting arm and a moving frame. The preparation method of the pepsin detection kit includes the following steps: preparing the box body; preparing the enzyme-linked plate; and preparing the enzyme-labeled pepsin antibody. Based on the existing technology, a pepsin detection kit, a preparation method and a device thereof are proposed to detect pepsin, thereby performing preliminary screening for gastric cancer. The preparation method and device of the pepsin detection kit are improved to effectively cooperate with the production of the pepsin detection kit, thereby adapting the production of the pepsin detection kit to the demand for the pepsin detection kit.

[0005] The above-mentioned kit has difficulty in automatically fixing the sample container for storing reagents when the kit is closed. Therefore, during transportation, the reagents may be spilled and leaked, and thus a pancreatic cancer diagnosis kit, a preparation method and a device thereof are proposed. SUMMARY

[0006] The present application aims to provide a pancreatic cancer diagnosis kit, a preparation method and a device thereof, which have the advantage of ensuring the stability of reagents during transportation or storage, and solve the problem of reagent spillage and leakage during transportation.

[0007] To achieve the above object, the present application provides the following technical scheme: a pancreatic cancer diagnosis kit, comprising a sample container for containing a reagent solution and a base for placing multiple groups of sample containers, further comprising a box body for supporting the base and a box cover for sealing the box body, the open end of the sample container is provided with a sealing plug, the box body is provided with a positioning structure for limiting the sample container from separating from the base;

[0008] The positioning structure comprises an annular triangular blocking block slidingly sleeved on the sample container, the sample container comprises an integrally formed end taper corner portion and a slope portion, the annular triangular blocking block is between the end taper corner portion and the slope portion, and the annular triangular blocking block is in sliding contact with the outer peripheral surface of the sample container;

[0009] A plurality of groups of installation grooves are formed on the base in equidistant arrangement, the sample containers are placed in the installation grooves, the inner wall of the box body is fixedly connected with an upper horizontal plate, an open cylinder is arranged below the upper horizontal plate, and a jacking assembly for limiting the horizontal height of the sample container is arranged on the open cylinder;

[0010] The upper horizontal plate is provided with a clamping assembly for limiting the sample container from separating from the installation groove.

[0011] Preferably, the clamping assembly comprises a containing groove formed in the upper horizontal plate, a trapezoidal wedge is arranged in the containing groove, the inclined surface of the trapezoidal wedge faces the side of the sample container, the trapezoidal wedge is in sliding contact with the groove wall of the containing groove, a gap spring is arranged in the containing groove, and the two ends of the gap spring are fixedly connected to the trapezoidal wedge and the upper horizontal plate, respectively.

[0012] Preferably, the upper horizontal plate and the open cylinder are fixedly connected by bolts, and the trapezoidal wedge is in sliding contact with the upper surface of the open cylinder.

[0013] Preferably, the jacking assembly comprises an L-shaped lever reciprocating in the horizontal direction, a rectangular sliding groove is formed in the box body for horizontal sliding of the L-shaped lever, a blocking seat is arranged on the open cylinder, the outer peripheral surface of the blocking seat is in sliding contact with the inner wall of the open cylinder, a blocking plate is arranged on the blocking seat, and the two ends of the blocking plate are pivotally arranged on the blocking seat and the L-shaped lever, respectively.

[0014] Preferably, the inner wall of the box body is fixedly provided with an enclosing plate, a gap through slot is formed in the enclosing plate for horizontal sliding of the L-shaped lever, the top end of the L-shaped lever penetrates through the enclosing plate and is provided with a connecting rod, and the two ends of the connecting rod are pivotally arranged on the box cover and the L-shaped lever, respectively.

[0015] Preferably, the base comprises an integrally formed middle groove and an end corner groove portion, an annular frame is placed in the middle groove, the annular frame is in close contact with the inner wall of the middle groove, and a microwell plate is fixedly connected to the annular frame.

[0016] Preferably, the two end corners of the base away from the box cover are fixedly connected with end arc support blocks, the side of the enclosing plate facing the base is provided with an integrally formed middle arc support portion, and the base, the end arc support blocks and the middle arc support portion are fixedly connected by bolts.

[0017] The inner wall of the box body is fixedly connected with a positioning corner block, and the sealing plate is fixedly connected with the positioning corner block through bolts.

[0018] Preferably, a preparation device of a pancreatic cancer diagnostic kit comprises a mold for die casting a box body and a mold frame supporting the mold, the mold is composed of an upper mold base and a lower mold base, the lower mold base is provided with an inner chamber for forming the box body, and the upper mold base is fixedly connected with a positioning pin column on the side facing the lower mold base, and the lower mold base is provided with a positioning hole for sliding contact with the positioning pin column.

[0019] The side of the upper mold base facing the inner chamber is fixedly connected with a groove frame strip for die casting a rectangular sliding groove.

[0020] Preferably, a preparation method of a pancreatic cancer diagnostic kit comprises the following steps:

[0021] S1, box body forming: a certain amount of die casting raw material is filled in the inner chamber of the lower mold base, and the raw material is extruded by the upper mold base to form a box body;

[0022] S2, component installation: the formed components in the box body are installed according to the positional relationship;

[0023] S3, hole plate preparation: after dilution, the capture antibody is added to the holes of the microhole plate, the unfixed antibody is removed, and the blocking solution is added to block the part of the microhole plate not occupied by the antibody, prevent non-specific binding, and use the washing buffer to clean the microhole plate to remove the unfixed blocking agent and possible contaminants;

[0024] S4, reagent preparation: according to the requirements of the reagent, the buffer solution with appropriate pH value and concentration is prepared to maintain the stability of the reaction and the activity of the antibody, the reagent components are mixed according to the order and proportion, and the reaction is carried out at a suitable temperature and time, and an appropriate amount of stabilizer and preservative is added to prolong the storage time of the reagent.

[0025] S5, pancreatic cancer reagent diagnosis: after the blood sample is treated, the anti-CA antibody fixed on the microhole plate is incubated with the sample, so that it can specifically bind to the CA molecule, remove the unbound substances, improve the specificity of the detection, add the enzyme-labeled secondary antibody which forms a sandwich complex with the anti-CA antibody and incubate, wash again to remove the excess enzyme-labeled secondary antibody, add the substrate, react with the enzyme-labeled secondary antibody, produce a detectable signal, use the corresponding detection equipment to read the signal intensity, and analyze the detection results according to the standard curve or the control sample.

[0026] Compared with the prior art, the beneficial effects of the present application are as follows:

[0027] This invention, through the setting of a positioning structure and the use of sophisticated mechanical structures such as locking and lifting components, ensures that the sample tube can be easily placed and fixed, thereby simplifying the operation process. At the same time, the positioning structure ensures the stability of the reagent during transportation or storage, reducing the risk of reagent tipping or leakage due to bumps or other external factors.

[0028] This invention enables the kit to provide high-precision and high-specificity pancreatic cancer detection by setting up a specific binding between the microplate and anti-CA antibody, and a subsequent enzyme-labeled secondary antibody reaction, thereby increasing the reliability of diagnostic results. At the same time, the design of the kit allows for rapid sample processing and detection, and the optimized well plate preparation and reagent preparation steps improve the efficiency of the entire diagnostic process. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the structure of the reagent kit of the present invention;

[0030] Figure 2 This is a schematic diagram of the component containing the microporous plate of the present invention;

[0031] Figure 3 This is a schematic diagram of the component containing the base of the present invention;

[0032] Figure 4 This is a horizontal cross-sectional view of the component containing the sample container of the present invention;

[0033] Figure 5 For the present invention Figure 4 Enlarged view of point A in the middle;

[0034] Figure 6 This is a horizontal longitudinal section view of the component containing the sample container of the present invention;

[0035] Figure 7 For the present invention Figure 6 Enlarged view at point B in the middle;

[0036] Figure 8 For the present invention Figure 2 Enlarged view at point C;

[0037] Figure 9 This is a schematic diagram of the component containing the positioning corner block of the present invention;

[0038] Figure 10 This is a schematic diagram of the component containing the end arc support block of the present invention;

[0039] Figure 11 This is a schematic diagram of the component containing the inner cavity of the present invention;

[0040] Figure 12 This is a schematic diagram of the component containing the groove frame strip of the present invention;

[0041] Figure 13 The method steps of the present application are shown in the figure.

[0042] In the figure: 1, box body; 2, box cover; 3, base; 301, middle groove; 302, end corner groove part; 4, annular frame; 5, microwell plate; 6, sealing plate; 601, middle arc support part; 7, sample container; 701, end taper corner part; 702, slope part; 8, sealing plug; 9, annular triangular blocking block; 10, trapezoidal wedge block; 11, upper horizontal plate; 12, open cylinder; 13, blocking seat; 14, blocking plate; 15, L-shaped lever; 16, connecting rod; 17, clearance slot; 18, end arc support block; 19, positioning corner block; 20, lower mold seat; 21, upper mold seat; 22, positioning hole; 23, positioning pin column; 24, inner chamber; 25, groove frame strip; 26, clearance spring. DETAILED DESCRIPTION

[0043] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of protection of the present application.

[0044] Please refer to Figures 1 to 13 The present application provides a technical solution: a pancreatic cancer diagnosis kit, which comprises a sample container 7 for containing a reagent solution and a base 3 for placing multiple groups of sample containers 7, further comprises a box body 1 for supporting the base 3 and a box cover 2 for sealing the box body 1, and the opening end of the sample container 7 is provided with a sealing plug 8, and the box body 1 is provided with a positioning structure for limiting the sample container 7 from separating from the base 3;

[0045] The positioning structure comprises an annular triangular blocking block 9 which is sleeved on the sample container 7, the sample container 7 comprises an integral end taper corner part 701 and a slope part 702, the annular triangular blocking block 9 is between the end taper corner part 701 and the slope part 702, and the annular triangular blocking block 9 is in sliding contact with the outer peripheral surface of the sample container 7;

[0046] The base 3 is provided with multiple groups of equidistantly arranged installation grooves, the sample container 7 is placed in the installation groove, the inner wall of the box body 1 is fixedly connected with an upper horizontal plate 11, the lower portion of the upper horizontal plate 11 is provided with an open cylinder 12, and the open cylinder 12 is provided with a jacking assembly for limiting the horizontal height of the sample container 7;

[0047] The upper horizontal plate 11 is provided with a clamping assembly for limiting the sample container 7 from separating from the installation groove.

[0048] As Figures 1-7As shown, when using this kit, the sample tube 7 containing the pancreatic cancer diagnostic reagent solution is placed in the placement groove on the base 3. The position of the sample tube 7 is restricted by the locking component, so that the sample tube 7 cannot fall out of the placement groove. At the same time, the horizontal height of the sample tube 7 is restricted by the lifting component, so that the sample tube 7 cannot move up and down in the placement groove. Thus, when transporting the kit, it can be ensured that the sample tube 7 will not tip over due to factors such as bumps.

[0049] In one preferred embodiment, the locking assembly includes a receiving groove formed on the upper horizontal plate 11, a trapezoidal wedge 10 is provided in the receiving groove, the inclined surface of the trapezoidal wedge 10 faces the sample tube 7, the trapezoidal wedge 10 slides in contact with the groove wall, a relief spring 26 is provided in the receiving groove, the two ends of the relief spring 26 are respectively fixedly connected to the trapezoidal wedge 10 and the upper horizontal plate 11, the upper horizontal plate 11 is bolted to the open cylinder 12, and the trapezoidal wedge 10 slides in contact with the upper surface of the open cylinder 12.

[0050] like Figures 2-7 As shown, when the box cover 2 is in the open state, place the sample tube 7 so that the sample tube 7 corresponds to the position of the placement groove. Insert the sample tube 7 into the placement groove. At this time, the integrally formed end cone corner 701 and slope surface 702 of the sample tube 7 move downward synchronously, and drive the annular triangular block 9 sleeved on it to move downward.

[0051] At the same time, when the end cone corner 701 passes the position of the trapezoidal wedge 10, the arc surface of the end cone corner 701 is pressed and contacted with the inclined surface of the trapezoidal wedge 10, which in turn causes the relief spring 26 at one end of the trapezoidal wedge 10 to undergo compression deformation. As the sample tube 7 is continuously inserted, the end cone corner 701 passes smoothly through the position of the trapezoidal wedge 10. It should be noted that when the sample tube 7 is placed in the placement groove, the annular triangular block 9 is placed at one end close to the slope surface 702. The friction between the annular triangular block 9 and the outer circumferential surface of the sample tube 7 can prevent it from moving downward under the action of gravity.

[0052] When the end cone corner 701 passes the position of the trapezoidal wedge 10, the relief spring 26 returns to its original shape. When the sample tube 7 is taken out, the flat part of the trapezoidal wedge 10 contacts the end cone corner 701. Therefore, the relief spring 26 cannot be compressed under the squeezing action of the two, and thus the sample tube 7 cannot be taken out.

[0053] It should be noted that the open cylinder 12 is fixedly connected to the upper horizontal plate 11 by bolts, thereby sealing the lower opening of the receiving groove, thus ensuring that the trapezoidal wedge 10 can only move in the horizontal direction, thereby preventing the trapezoidal wedge 10 from shifting position and losing its pulling-out restriction function on the end cone corner 701.

[0054] Based on the locking component embodiment, the lifting component includes an L-shaped crank 15 that reciprocates in the horizontal direction. A rectangular groove is provided on the box body 1 for the L-shaped crank 15 to slide horizontally. A blocking seat 13 is provided on the open cylinder 12. The outer peripheral surface of the blocking seat 13 slides in contact with the inner wall of the open cylinder 12. A blocking plate 14 is provided on the blocking seat 13. The two ends of the blocking plate 14 are respectively fixed and rotated on the blocking seat 13 and the L-shaped crank 15.

[0055] A sealing plate 6 is fixedly installed on the inner wall of the box body 1. A clearance groove 17 is provided on the sealing plate 6 for the L-shaped crank 15 to slide horizontally. The top end of the L-shaped crank 15 passes through the sealing plate 6 and is provided with a connecting rod 16. The two ends of the connecting rod 16 are respectively fixedly rotated on the box cover 2 and the L-shaped crank 15.

[0056] like Figures 1-7 As shown, when it is necessary to take the sample tube 7, it is necessary to continuously press the sample tube 7, causing the sample tube 7 to continue to move downwards a certain distance until the bottom of the sample tube 7 contacts the blocking seat 13 and can no longer move downwards. As the height of the sample tube 7 continues to decrease, the annular triangular block 9 passes the position of the trapezoidal wedge block 10. During this process, the inclined surface in the trapezoidal wedge block 10 contacts the inclined surface in the annular triangular block 9, and then the pressure of the annular triangular block 9 drives the relief spring 26 to undergo compression deformation. After the annular triangular block 9 passes the position of the trapezoidal wedge block 10, the relief spring 26 returns to its original deformation. At this time, the trapezoidal wedge block 10 is between the annular triangular block 9 and the slope surface 702.

[0057] At the same time, when the bottom of the sample tube 7 contacts the blocking seat 13 and can no longer move downward, the sample tube 7 is pulled out, so that the horizontal height of the integrally formed end cone corner 701 and the slope surface 702 rises synchronously. During this process, the annular triangular block 9 cannot rise due to the obstruction of the trapezoidal wedge 10, so it can only move statically relative to the trapezoidal wedge 10 until the annular triangular block 9 contacts the end cone corner 701. As the sample tube 7 gradually rises, the relief spring 26 is compressed and deformed, so that the annular triangular block 9 and the end cone corner 701 can pass through the position of the trapezoidal wedge 10 in turn, thereby contacting the restrictive effect of the trapezoidal wedge 10 on the sample tube 7.

[0058] It should be noted that the lid 2 must be open during the placement and removal of the sample tube 7 to provide operating space for the placement and removal of the sample tube 7. Therefore, the horizontal height of the blocking seat 13 is at its lowest point at this time, so as to ensure that the sample tube 7 can move further downward a certain distance during the removal process.

[0059] Meanwhile, after placing the sample container 7, when the kit needs to be transported or sealed for storage of the sample container 7, the box cover 2 is closed, and the box cover 2 and the box body 1 can be locked by the lock body provided on the box cover 2 and the box body 1 to avoid accidental opening of the box cover 2. Meanwhile, during the closing of the box cover 2, the rotation of the box cover 2 can drive the deflection of the connecting rod 16, and then drive the horizontal movement of the L-shaped connecting rod 15 in the rectangular sliding groove, and the horizontal movement of the L-shaped connecting rod 15 can drive the deflection of the blocking plate 14, and the blocking plate 14 rotates on the blocking seat 13, and the blocking seat 13 is in sliding contact with the inner wall of the open cylinder 12. Therefore, with the deflection of the blocking plate 14, the horizontal height of the blocking seat 13 changes synchronously.

[0060] In actual use, when the box cover 2 is in the closed state, the blocking seat 13 is at the highest horizontal position and in contact with the bottom of the sample container 7. Therefore, the sample container 7 is limited by the blocking seat 13 and the trapezoidal wedge 10, thereby preventing the sample container 7 from overturning and shaking during transportation.

[0061] Based on the embodiment of the jacking assembly, the base 3 comprises an integral middle groove 301 and an end corner groove 302, the ring frame 4 is placed in the middle groove 301, the ring frame 4 is in close contact with the inner wall of the middle groove 301, and the microplate 5 is fixedly connected to the ring frame 4.

[0062] The two end corners of the base 3 away from the box cover 2 are fixedly connected with the end arc support blocks 18, the sealing plate 6 is provided with an integral middle arc support part 601 on the side facing the base 3, the base 3, the end arc support blocks 18 and the middle arc support part 601 are all fixed by bolts, the inner wall of the box body 1 is fixedly connected with the positioning corner block 19, and the sealing plate 6 is fixed by bolts with the positioning corner block 19.

[0063] As shown in Figure 1 , Figure 8 , Figure 9 and Figure 10 , when the sealing plate 6 is installed, the sealing plate 6 is positioned corresponding to the positioning corner block 19, and a plurality of groups of the accommodation grooves 17 correspond to the L-shaped connecting rods 15 one by one, and the two are fixed by bolts. Meanwhile, the sealing plate 6 comprises an integral middle arc support part 601, the middle arc support part 601 and the end arc support blocks 18 correspond to the end corner groove 302 of the base 3 which is integrally formed. Therefore, when the base 3 is installed, the end corner groove 302 corresponds to the middle arc support part 601 and the end arc support blocks 18, and then the base 3 is placed on the middle arc support part 601 and the end arc support blocks 18, and the two are fixed by bolts, thereby avoiding the installation process of the sealing plate 6 and the base 3.

[0064] Further, a preparation device of a pancreatic cancer diagnostic kit comprises a mold for die casting a box body 1 and a mold frame supporting the mold, the mold is composed of an upper mold base 21 and a lower mold base 20, the lower mold base 20 is provided with an inner chamber 24 for forming the box body 1, and the upper mold base 21 is fixedly connected with a positioning pin column 23 on the side facing the lower mold base 20, and the lower mold base 20 is provided with a positioning hole 22 corresponding to the position of the positioning pin column 23 for sliding contact.

[0065] The upper mold base 21 is fixedly connected with a groove frame strip 25 for die casting a rectangular chute on the side facing the inner chamber 24.

[0066] As shown in Figure 11 and Figure 12 During the die casting process of the box body 1, the amount of raw material required is determined according to the length, width, height and thickness of the box body 1, and the raw material is placed in the inner chamber 24 of the lower mold base 20, and the upper mold base 21 is driven by the cylinder fixedly arranged on the mold frame towards the lower mold base 20, and the raw material is continuously extruded until the die casting process of the box body 1 is completed, wherein the position of the upper mold base 21 and the lower mold base 20 can be determined by the positioning pin column 23 and the positioning hole 22 to avoid deviation or damage during the die casting process.

[0067] At the same time, the upper mold base 21 is fixedly connected with the groove frame strip 25, and when the raw material is die cast, the inner wall of the die cast raw material will have a notch corresponding to the groove frame strip 25, which is a rectangular groove, and the installation position of the L-shaped handle 15 can be determined through the rectangular groove.

[0068] It should be noted that the main purpose of the mold frame herein is to support the parts thereon, and considering that the design and structure of the mold frame belong to the conventional technology in the field, and the specific shape and size thereof will be different according to the actual application requirements, therefore it is not shown in the figure.

[0069] Further, a preparation method of a pancreatic cancer diagnostic kit comprises the following steps:

[0070] S1, box forming: a certain amount of die casting raw material is filled in the inner chamber 24 of the lower mold base 20, and the raw material is extruded by the upper mold base 21 to form the box body 1, the die casting raw material is filled into the inner chamber 24 of the mold, and the upper mold base 21 forms the box body 1 by extruding the raw material, and during this process, the positioning pin column 23 and the positioning hole 22 ensure the accurate positioning of the mold, preventing deviation or damage during the die casting process.

[0071] S2, component installation: install the shaped parts in the box 1 according to the positional relationship, which includes the fixation of the upper transverse plate 11, the open cylinder 12, the blocking seat 13 and the installation of the L-shaped crutch 15 and the connecting rod 16, which are used to ensure the stability of the sample tube 7;

[0072] S3, hole plate preparation: dilute the capture antibody and add it to the holes of the micro-hole plate 5, remove the un-fixed antibody, and add a blocking solution to block the part of the micro-hole plate 5 not occupied by the antibody, prevent non-specific binding, wash the micro-hole plate 5 with a washing buffer to remove un-fixed blocking agent and possible contaminants, which is mainly to prepare the micro-hole plate 5 for detection.

[0073] S4, reagent preparation: according to the requirements of the reagent, prepare a buffer solution with appropriate pH value and concentration to maintain the stability of the reaction and the activity of the antibody, mix the reagent components according to the order and proportion, and react at a suitable temperature and time, add an appropriate amount of stabilizer and preservative to prolong the storage time of the reagent, the steps are mainly to prepare the reagent for detection.

[0074] S5, pancreatic cancer reagent diagnosis: after processing the blood sample, incubate the anti-CA19-9 antibody fixed on the micro-hole plate 5 with the sample to enable specific binding of CA19-9 molecules, remove unbound substances to improve detection specificity, add enzyme-labeled secondary antibody that forms a sandwich complex with anti-CA19-9 antibody and incubate, wash again to remove excess enzyme-labeled secondary antibody, add substrate and react with enzyme-labeled secondary antibody to produce a detectable signal, use the corresponding detection equipment to read the signal intensity, analyze the detection results according to the standard curve or control sample, the purpose is mainly to diagnose pancreatic cancer by using the reagent kit.

[0075] Although embodiments of the present application have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and alterations can be made thereto without departing from the principles and spirit of the present application, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A pancreatic cancer diagnostic kit, comprising sample containers (7) for containing reagent solutions and a base (3) for placing a plurality of the sample containers (7), further comprising a box body (1) for supporting the base (3) and a box cover (2) for sealing the box body (1), the open ends of the sample containers (7) being provided with sealing plugs (8), characterized in that: The box body (1) is provided with a positioning structure for limiting the sample tube (7) from being separated from the base (3); ​ The positioning structure comprises an annular triangular blocking block (9) which is sleeved on the sample tube (7), the sample tube (7) comprises an integral end taper corner portion (701) and a slope surface portion (702), the annular triangular blocking block (9) is located between the end taper corner portion (701) and the slope surface portion (702), and the annular triangular blocking block (9) is in sliding contact with the outer peripheral surface of the sample tube (7); The base (3) is provided with a plurality of groups of equidistantly arranged accommodation grooves, the sample tube (7) is placed in the accommodation grooves, the inner wall of the box body (1) is fixedly connected with an upper horizontal plate (11), an open cylinder (12) is arranged below the upper horizontal plate (11), and the open cylinder (12) is provided with a jacking assembly for limiting the horizontal height of the sample tube (7); The upper horizontal plate (11) is provided with a clamping assembly for limiting the sample tube (7) from being separated from the accommodation grooves; The clamping assembly comprises an accommodation groove formed in the upper horizontal plate (11), a trapezoidal wedge (10) is arranged in the accommodation groove, the inclined surface of the trapezoidal wedge (10) faces one side of the sample tube (7), the trapezoidal wedge (10) is in sliding contact with the groove wall of the accommodation groove, a give-way spring (26) is arranged in the accommodation groove, and the two ends of the give-way spring (26) are fixedly connected to the trapezoidal wedge (10) and the upper horizontal plate (11) respectively; The upper horizontal plate (11) and the open cylinder (12) are fixedly connected by bolts, and the trapezoidal wedge (10) is in sliding contact with the upper surface of the open cylinder (12); The jacking assembly comprises an L-shaped lever (15) which reciprocates in the horizontal direction, the box body (1) is provided with a rectangular sliding groove for the horizontal sliding of the L-shaped lever (15), the open cylinder (12) is provided with a blocking seat (13), the outer peripheral surface of the blocking seat (13) is in sliding contact with the inner wall of the open cylinder (12), the blocking seat (13) is provided with a blocking plate (14), and the two ends of the blocking plate (14) are pivotally arranged on the blocking seat (13) and the L-shaped lever (15) respectively.

2. The pancreatic cancer diagnostic kit according to claim 1, characterized by: The inner wall of the box body (1) is fixedly provided with an enclosing plate (6), the enclosing plate (6) is provided with a give-way through groove (17) for the horizontal sliding of the L-shaped lever (15), the top end of the L-shaped lever (15) penetrates through the enclosing plate (6) and is provided with a connecting rod (16), and the two ends of the connecting rod (16) are pivotally arranged on the box cover (2) and the L-shaped lever (15) respectively.

3. The pancreatic cancer diagnostic kit according to claim 2, characterized by: The base (3) comprises an integral middle groove (301) and an end corner groove portion (302), the middle groove (301) is arranged with a ring frame (4), the ring frame (4) is in close contact with the inner wall of the middle groove (301), and the ring frame (4) is fixedly connected with a microwell plate (5).

4. The pancreatic cancer diagnostic kit according to claim 1, characterized by: The two end corners of the base (3) away from the box cover (2) are fixedly connected with end arc supporting blocks (18), the side of the enclosing plate (6) facing the base (3) is provided with an integral middle arc supporting portion (601), and the base (3), the end arc supporting blocks (18) and the middle arc supporting portion (601) are fixedly connected by bolts; The inner wall of the box body (1) is fixedly connected with a positioning corner block (19), and the enclosing plate (6) and the positioning corner block (19) are fixedly connected by bolts.

5. A device for preparing a pancreatic cancer diagnostic kit according to any one of claims 1-4, comprising a mold for die-casting the box (1) and a mold support, the mold consisting of an upper mold base (21) and a lower mold base (20), the lower mold base (20) being provided with an inner chamber (24) for forming the box (1), characterized in that: The upper die holder (21) is fixedly connected with a positioning pin column (23) on the side facing the lower die holder (20), and the lower die holder (20) is provided with a positioning hole (22) corresponding to the position of the positioning pin column (23) for sliding contact; The upper die holder (21) is fixedly connected with a groove body frame strip (25) for pressure casting a rectangular sliding groove on the side facing the inner cavity (24).

6. A preparation method of a preparation device for the pancreatic cancer diagnostic kit of claim 5, comprising the following steps: S1, box forming: a certain amount of pressure casting raw material is filled in the inner cavity (24) of the lower die holder (20), and the raw material is extruded by the upper die holder (21) to form the box body (1); S2, component installation: the formed parts in the box body (1) are installed according to the positional relationship; S3, hole plate preparation: after dilution, the capture antibody is added to the holes of the microhole plate (5), the unfixed antibody is removed, and a blocking solution is added to block the part of the microhole plate (5) not occupied by the antibody, prevent non-specific binding, use washing buffer to clean the microhole plate (5), remove the unfixed blocking agent and possible contaminants; S4, reagent preparation: according to the requirements of the reagent, prepare a buffer solution with appropriate pH value and concentration to maintain the stability of the reaction and the activity of the antibody, mix the reagent components according to the order and proportion, and react at a suitable temperature and time, add an appropriate amount of stabilizer and preservative to prolong the storage time of the reagent; S5, pancreatic cancer reagent diagnosis: after the blood sample is processed, the anti-CA19-9 antibody fixed on the microhole plate (5) is incubated with the sample, so that it can specifically bind to the CA19-9 molecule, remove the unbound substances, improve the specificity of the detection, add enzyme-labeled secondary antibody which forms a sandwich complex with anti-CA19-9 antibody and incubate, wash again to remove excess enzyme-labeled secondary antibody, add substrate, react with enzyme-labeled secondary antibody, produce detectable signal, use the corresponding detection equipment to read the signal intensity, according to the standard curve or control sample, analyze the detection result.

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