Rapid in-vitro diagnostic kit for creatine kinase isoenzyme

By designing a squeezing and limiting mechanism, combined with a magnetic strip and a tilting base, the problem of reagent spillage during transportation of in vitro diagnostic kits has been solved, achieving safe fixation of reagents and convenient operation, ensuring smooth testing.

CN121799765APending Publication Date: 2026-04-07BEIJING 3S CENTURY TECH CORP
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-02-11
Publication Date
2026-04-07

AI Technical Summary

Technical Problem

Existing in vitro diagnostic reagent kits lack protection during storage and transportation, leading to easy spillage of reagents, affecting their use and causing resource waste.

Method used

A rapid in vitro diagnostic kit for creatine kinase isoenzymes was designed. It employs a squeezing mechanism, a limiting mechanism, and a magnetic strip. The reagent tubes are fixed and sealed by rotating and connecting the cover plate. Combined with the tilting base, it facilitates the insertion and removal of components and prevents reagent spillage.

Benefits of technology

It effectively prevents reagents from spilling during movement and transportation, ensures the normal use of reagents, avoids resource waste, and facilitates reagent handling and testing operations.

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Abstract

The invention discloses a rapid in-vitro diagnostic kit for creatine kinase isoenzyme, and relates to the technical field of kits, the rapid in-vitro diagnostic kit comprises a kit body, the periphery of the interior of the kit body is provided with extrusion mechanisms, the bottom side of the interior of the kit body is provided with a base, the interior of the base is provided with a plurality of detection strips, and the detection strips are arranged in the kit body. The middle side of the top of the base is fixedly connected with a middle plate, and the front side of the top side of the middle plate is provided with a fixing mechanism. The device has the advantages that the cover plate I and the cover plate II which are rotated by 90 degrees are connected through a magnetic attraction strip, a reagent tube is placed in the corresponding clamping piece I and the clamping piece II, a movable plate is pressed through a corresponding spring, and the movable plate is clamped by the clamping piece I and the clamping piece II; the reagent tube can enter the first clamping piece and the second clamping piece and is extruded and fixed, then the first cover plate is closed, the top end of the reagent tube is sealed and stored through the rubber pad, and the situation that a sample reagent in the reagent tube is collided and spilled out, and normal use of the reagent is affected is avoided.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of reagent kits, in particular to a rapid in-vitro diagnosis reagent kit for creatine kinase isoenzyme. BACKGROUND

[0002] Creatine kinase isoenzyme is a specific myocardial marker, when acute myocardial infarction occurs, creatine kinase is released from damaged myocardial cells, resulting in a significant increase in CK-MB in the serum of patients with acute myocardial infarction; when myocardial infarction occurs, serum CK-MB can increase by 10-25 times, usually reaching a peak in 12-24 hours after myocardial infarction, and returning to normal in 48-72 hours; detecting the activity of CK-MB in patients by the reagent kit is very valuable for clinicians to early diagnose myocardial infarction, and the reagent kit is a device for storing and storing reagents, which has the advantages of good sealing, high physical performance and easy carrying, and is widely used in various chemical laboratories, and the existence of the reagent kit ensures the quality of the reagent to a great extent. The in-vitro diagnosis reagent kit on the market usually does not have a protection function after the reagent is put into it, so that the reagent in the reagent kit is easy to be spilled due to collision during storage and movement of the reagent, affecting the normal use of the reagent, and causing waste of resources, therefore, the present application provides a rapid in-vitro diagnosis reagent kit for creatine kinase isoenzyme. SUMMARY

[0003] The present application provides a rapid in-vitro diagnosis reagent kit for creatine kinase isoenzyme.

[0004] To achieve the above-mentioned purpose, the present application provides the following technical scheme: a rapid in-vitro diagnosis reagent kit for creatine kinase isoenzyme, comprising a box body, a plurality of pressing mechanisms are arranged around the inside of the box body, a base is arranged on the bottom side of the inside of the box body, a plurality of detection strips are arranged in the inside of the base, a middle plate is fixedly connected to the top of the base, a fixing mechanism is arranged on the front side of the top of the middle plate, a microwell plate is slidably connected to the inside of the middle plate, a limiting mechanism is arranged on the top right end of the inside of the middle plate, an R1 reagent is arranged on the top rear right end of the base, a calibrator is arranged on the left side of the R1 reagent, a quality control product is arranged on the left side of the calibrator, and an R2 reagent is arranged on the left side of the quality control product. The fixing mechanism comprises a cover plate one, the rear side of the cover plate one is rotatably connected to the top front side of the middle plate, two fixed strips are fixedly connected to the front side of the middle plate, one side of the two fixed strips is fixedly connected with a sliding rod, one end of a plurality of moving plates is slidably connected to the outer wall of the sliding rod, the other end of the moving plates is slidably connected to the front side wall of the middle plate, two clamping pieces one are fixedly connected to the middle of one side of the two fixed strips, and two clamping pieces two are fixedly connected to the outer wall of the moving plates on the left and right sides.

[0005] As a further scheme of the present application: the fixing mechanism further comprises a second cover plate, the bottom side of the second cover plate and the bottom side of the first cover plate are both provided with rubber pads, the rubber pads are both provided with grooves on the rear side, and the grooves are one-to-one corresponding to the R1 reagent, the R2 reagent, the calibrators and the quality control samples.

[0006] As a further scheme of the present application: the pressing mechanism comprises a plurality of convex strips, one end of each of the plurality of convex strips is fixedly connected with an elastic piece, the other end of the elastic piece is fixedly connected with a limiting plate, the limiting plate slides in the convex strip, and the right side of each of the plurality of convex strips is inclined.

[0007] As a further scheme of the present application: the limiting mechanism comprises a rotating rod, the left end of the rotating rod is fixedly connected with a fixed ring, one end of a return spring is fixedly connected with the right side of the fixed ring, the other end of the return spring is fixedly connected with a sliding ring, the sliding ring slides on the left side outer wall of the rotating rod, and the return spring is located on the left side outside of the rotating rod.

[0008] As a further scheme of the present application: the rotating rod is arranged on the top right side of the middle plate, the right end of the rotating rod is fixedly connected with a connecting strip, and the left side of the connecting strip is attached to the right side surface of the microplate.

[0009] As a further scheme of the present application: the top side of the first cover plate and the top side of the second cover plate are both fixedly connected with magnetic strips, and the magnetic poles of the two magnetic strips are arranged to be different in nature.

[0010] As a further scheme of the present application: the outer wall of the sliding rod is provided with a plurality of springs, one end of each of the left and right springs is fixedly connected to the outer wall of the moving plate, the other end of each of the left and right springs is fixedly connected to the outer wall of the fixed strip, and both ends of each of the middle springs are respectively fixedly connected to the outer walls of two adjacent moving plates.

[0011] As a further scheme of the present application: the side close to the box body of the base, the first cover plate and the second cover plate are all arranged to be inclined, and the inclined surfaces of the base, the first cover plate and the second cover plate are one-to-one corresponding to the inclined surfaces of the plurality of convex strips.

[0012] As a further scheme of the present application: the inside of the base is provided with a heat preservation layer, and the plurality of detection strips are located in the heat preservation layer, and the heat preservation layer is arranged by using aluminum foil.

[0013] Compared with the prior art, the beneficial effects of the present application are as follows: 1. This invention connects cover plate one and cover plate two after rotating 90 degrees using magnetic strips. The reagent tube is placed in the corresponding clamping member one and clamping member two. The moving plate is pressed by the corresponding spring, so that the reagent tube can enter the clamping member one and clamping member two and is squeezed and fixed. Then cover plate one is closed and the top of the reagent tube is sealed by a rubber pad to prevent the sample reagent inside the reagent tube from being spilled due to collision, which would affect the normal use of the reagent. 2. The present invention uses the combination of cover plate two and multiple grooves to fix the upper and lower sides of reagent R1, reagent R2, calibrator and quality control sample respectively. When in use, the cover plate two can be rotated to expose them for easy handling, avoiding damage to the reagent kit during movement or transportation, thus avoiding waste of resources, and not affecting normal use. 3. This invention allows the microplate to move outward by pulling the handle. At this time, due to the limiting effect of the connecting strip, the base and the components above it are moved out of the box at the same time, making it easy to pick up. In addition, by rotating the connecting strip, it can be separated from the surface of the microplate, and it can be manually taken out from the middle plate for subsequent testing. Furthermore, the protrusion and the inclined surface of one side of the base make it easy for the base and the components above it to enter the box.

[0014] Other advantages, objectives and features of the invention will be set forth in part in the description which follows, and in part will be apparent to those skilled in the art from the following examination or study, or may be learned from the practice of the invention. Attached Figure Description

[0015] Figure 1 This is an overall schematic diagram of an embodiment of the present invention; Figure 2 This is a schematic diagram showing the position of the detection strip in an embodiment of the present invention; Figure 3 This is a schematic diagram of the unfolded cover plate in an embodiment of the present invention; Figure 4 for Figure 3 Enlarged view of point A in the middle; Figure 5 This is a schematic diagram showing the position of the fixing ring in an embodiment of the present invention; Figure 6 This is a schematic diagram of the unfolded cover plate two in an embodiment of the present invention; Figure 7 This is a schematic diagram showing the position of the protrusion in an embodiment of the present invention; Figure 8 This is a schematic diagram showing the position of the elastic element in an embodiment of the present invention.

[0016] In the diagram: 1. Box body; 2. Base; 3. Detection strip; 4. Middle plate; 5. Microplate; 6. Cover plate one; 7. Fixing strip; 8. Slide rod; 9. Moving plate; 10. Spring; 11. Clamping component one; 12. Clamping component two; 13. Cover plate two; 14. Rubber pad; 15. Groove; 16. R1 reagent; 17. R2 reagent; 18. Calibrator; 19. Quality control product; 20. Raised strip; 21. Elastic component; 22. Limiting plate; 23. Rotating rod; 24. Fixing ring; 25. Return spring; 26. Sliding ring; 27. Connecting strip; 28. Magnetic strip. Detailed Implementation

[0017] The specific embodiments of the present invention will be further described below with reference to the accompanying drawings. It should be noted that the description of these embodiments is for the purpose of helping to understand the present invention, but does not constitute a limitation of the present invention.

[0018] Furthermore, the technical features involved in the various embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0019] Please see the appendix Figure 1 -Appendix Figure 8 This invention discloses a rapid in vitro diagnostic kit for creatine kinase isoenzymes, comprising a box body 1, with compression mechanisms arranged around the inside of the box body 1, a base 2 arranged on the bottom inside the box body 1, multiple test strips 3 arranged inside the base 2, a middle plate 4 fixedly connected to the top center of the base 2, a fixing mechanism arranged on the front top side of the middle plate 4, a microplate 5 slidably connected inside the middle plate 4, a limiting mechanism arranged on the right top side inside the middle plate 4, an R1 reagent 16 arranged on the right rear top side of the base 2, a calibrator 18 arranged to the left of the R1 reagent 16, a quality control sample 19 arranged to the left of the calibrator 18, and an R2 reagent 17 arranged to the left of the quality control sample 19.

[0020] In embodiment one, the fixing mechanism includes a cover plate 6. Magnetic strips 28 are fixedly connected to the top sides of both cover plate 6 and cover plate 13. The magnetic poles of the two magnetic strips 28 are opposite. The rear side of cover plate 6 is rotatably connected to the top front side of the middle plate 4. Fixing strips 7 are fixedly connected to both the left and right ends of the front side of the middle plate 4. A sliding rod 8 is fixedly connected to the side of the two fixing strips 7 that are close to each other. Multiple movable plates 9 are slidably connected to one end of the outer wall of the sliding rod 8. The other end of the movable plates 9 is slidably connected to the front of the middle plate 4. On the side wall, two clamping parts 11 are fixedly connected to the middle of the side of the two fixing strips 7. Two clamping parts 22 are fixedly connected to the left and right sides of the outer wall of the moving plate 9. The fixing mechanism also includes a cover plate 2 13. Rubber pads 14 are provided on the bottom side of the cover plate 2 13 and the cover plate 1 6. Grooves 15 are provided on the rear rubber pads 14 and the top rear side of the base 2. Multiple grooves 15 are respectively set one-to-one with R1 reagent 16, R2 reagent 17, calibrator 18 and quality control sample 19. Specifically, the cover plate 16 and cover plate 23, after being rotated 90 degrees, are connected by magnetic strip 28. The reagent tube is placed in the corresponding clamping member 11 and clamping member 22. The moving plate 9 is pressed by the corresponding spring 10, so that the reagent tube can enter the clamping member 11 and clamping member 22 and be squeezed and fixed. Then, the cover plate 16 is closed, and the top of the reagent tube is sealed by rubber pad 14 to prevent the sample reagent inside the reagent tube from being hit and spilled, which would affect the normal use of the reagent.

[0021] In embodiment 2, the extrusion mechanism includes multiple protrusions 20. One end of multiple elastic members 21 is fixedly connected inside the protrusions 20, and the other end of the elastic members 21 is fixedly connected to a limiting plate 22. The limiting plate 22 slides inside the protrusions 20. The right side of the multiple protrusions 20 is inclined. The side of the base 2, cover plate 6 and cover plate 13 near the box body 1 is also inclined. The inclined surfaces of the base 2, cover plate 6 and cover plate 13 correspond one-to-one with the inclined surfaces of the multiple protrusions 20. Specifically, the protrusion 20 and the inclined surface of one side of the base 2 make it easy for the base 2 and the components above it to enter the box 1, and the elastic element 21 limits the detection strip 3 to prevent it from slipping.

[0022] In embodiment 3, the limiting mechanism includes a rotating rod 23. A fixed ring 24 is fixedly connected to the left end of the rotating rod 23. One end of a return spring 25 is fixedly connected to the right side of the fixed ring 24. A sliding ring 26 is fixedly connected to the other end of the return spring 25. The sliding ring 26 slides on the left outer wall of the rotating rod 23. The return spring 25 is located on the left outer side of the rotating rod 23. The rotating rod 23 is located on the top right side of the middle plate 4. A connecting strip 27 is fixedly connected to the right end of the rotating rod 23. The left side of the connecting strip 27 is in contact with the right surface of the microporous plate 5. Specifically, by pulling the handle, the microplate 5 is moved outward. At this time, due to the limiting effect of the connecting strip 27, the base 2 and the components above it are moved out of the box 1 at the same time, making it easy to pick up. In addition, by rotating the connecting strip 27, it is separated from the surface of the microplate 5, and it can be manually taken out of the middle plate 4 for subsequent testing.

[0023] Working principle: First, open the box 1. Pull the handle to move the microplate 5 outward. At this time, due to the limiting of the connecting strip 27, the base 2 and the components above it are moved out of the box 1 at the same time. Then, rotate the cover plate 1 6 and the cover plate 2 13 90 degrees towards each other. The magnetic strip 28 connects the rotated cover plate 1 6 and the cover plate 2 13. The cover plate 2 13 and the multiple grooves 15 are used to fix the upper and lower sides of the R1 reagent 16, R2 reagent 17, calibrator 18 and quality control sample 19 respectively. When in use, the cover plate 2 13 can be rotated to expose them for removal. By rotating the connecting strip 27, it is detached from the surface of the microplate 5, and the microplate 5 can be manually removed from the middle plate 4 for subsequent testing. Immunosuppression assay procedure: After completion, place the sample to be tested into a reagent tube or microplate 5 according to different usage conditions. Then, add reagents R1 (16) and R2 (17) in the correct order and corresponding volumes. Place the reagent tube or microplate 5 with the added sample into a spectrophotometer or automated biochemical analyzer for detection. The parameters are: temperature 37°C, cuvette optical path 1.0 cm, sample volume: 10 μl, R1: 200 μl, R2: 50 μl. Incubate the reaction at the specified wavelength (e.g., 340 nm) and secondary wavelength. The absorbance change of the reaction system is measured at a long wavelength (e.g., 405 nm), and the absorbance value is recorded. A calibration curve is prepared using the matching calibrator 18. The calibration curve is calibrated using the two-point linear method. The calibration curve is re-prepared every 7 days. Recalibration is required when the following situations occur: when the reagent batch number is changed, when the instrument parts are replaced or maintained, or when the quality control product 19 or sample results are abnormal. Quality control procedure: Use the matching quality control product 19 to perform quality control experiments every day, and calculate the creatine kinase isoenzyme CK-MB activity in the sample according to the formula or method in the instruction manual. During the detection process, a certain reaction time is required. During this process, the sample needs to be preserved. At this time, the reagent tube can be placed in the corresponding clamp 11 and clamp 2 12. The corresponding spring 10 applies pressure to the moving plate 9, so that the reagent tube can enter the clamp 11 and clamp 2 12 and be squeezed and fixed. Then, the cover plate 6 is closed, and the top of the reagent tube is sealed by the rubber pad 14 to prevent the sample reagent inside the reagent tube from being spilled due to collision, which would affect the normal use of the reagent. The protrusion 20 and the inclined surface of one side of the base 2 make it easy for the base 2 and the components above it to enter the box 1 for protection and preservation. Colloidal gold detection procedure: First, remove the base 2 from the box 1 and take out the test strip 3 from the base 2. Open and lay it flat at room temperature. Then, according to the instructions, drop an appropriate amount of sample into the sample slot on the test strip 3. Let it stand for 15 to 20 minutes to allow the sample to fully react with the test strip 3. Then read the results. If a red C control line and an MB zone test line appear at the top of the display window, it indicates that the CK-MB concentration in the sample exceeds the threshold, which is a positive result. If only a red C control line appears at the top of the display window, it indicates that the CK-MB concentration in the sample is below the threshold, which is a negative result. If there is no red control line at the top of the display window, it indicates that the test has failed or the kit is invalid. This completes the entire workflow.

[0024] The terms "front," "back," "left," "right," "top," and "bottom" all refer to the figures in the accompanying drawings. Figure 1 Based on the perspective of the observer, the side of the device facing the observer is defined as the front, the left side of the observer is defined as the left, and so on.

[0025] In the description of this invention, it should be understood that the terms "center", "longitudinal", "lateral", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the scope of protection of this invention.

[0026] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the described embodiments.

[0027] For those skilled in the art, various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and these variations still fall within the protection scope of the present invention.

Claims

1. A rapid in vitro diagnostic kit for creatine kinase isoenzymes, comprising a housing (1), characterized in that: The box body (1) is provided with a squeezing mechanism on all four sides. The box body (1) is provided with a base (2) on the bottom side. The base (2) is provided with multiple test strips (3). The middle plate (4) is fixedly connected to the top of the base (2). The front side of the top of the middle plate (4) is provided with a fixing mechanism. The middle plate (4) is slidably connected with a microporous plate (5). The right end of the top of the middle plate (4) is provided with a limiting mechanism. The right end of the rear side of the top of the base (2) is provided with an R1 reagent (16). The left side of the R1 reagent (16) is provided with a calibrator (18). The left side of the calibrator (18) is provided with a quality control sample (19). The left side of the quality control sample (19) is provided with an R2 reagent (17). The fixing mechanism includes a cover plate (6), the rear side of which is rotatably connected to the top front side of the middle plate (4). Fixing strips (7) are fixedly connected to both the left and right ends of the front side of the middle plate (4). A sliding rod (8) is fixedly connected to one side of the two fixing strips (7). One end of a plurality of movable plates (9) is slidably connected to the outer wall of the sliding rod (8). The other end of the movable plates (9) is slidably connected to the front side wall of the middle plate (4). Two clamping parts (11) are fixedly connected to the middle of the side of the two fixing strips (7). Two clamping parts (12) are fixedly connected to the left and right sides of the outer wall of the movable plate (9).

2. The rapid in vitro diagnostic kit for creatine kinase isoenzymes according to claim 1, characterized in that: The fixing mechanism also includes a second cover plate (13). Both the second cover plate (13) and the first cover plate (6) are provided with rubber pads (14) on their bottom sides. The rubber pads (14) and the top rear side of the base (2) are provided with grooves (15). The multiple grooves (15) are respectively provided with R1 reagent (16), R2 reagent (17), calibrator (18) and quality control sample (19).

3. The rapid in vitro diagnostic kit for creatine kinase isoenzymes according to claim 1, characterized in that: The extrusion mechanism includes multiple protrusions (20), and one end of multiple elastic elements (21) is fixedly connected inside the protrusions (20). The other end of the elastic elements (21) is fixedly connected to a limiting plate (22). The limiting plate (22) slides inside the protrusions (20), and the right side of the multiple protrusions (20) is inclined.

4. The rapid in vitro diagnostic kit for creatine kinase isoenzymes according to claim 1, characterized in that: The limiting mechanism includes a rotating rod (23), a fixed ring (24) is fixedly connected to the left end of the rotating rod (23), a return spring (25) is fixedly connected to the right side of the fixed ring (24), and a sliding ring (26) is fixedly connected to the other end of the return spring (25). The sliding ring (26) slides on the left outer wall of the rotating rod (23), and the return spring (25) is located on the left outer side of the rotating rod (23).

5. A rapid in vitro diagnostic kit for creatine kinase isoenzymes according to claim 4, characterized in that: The rotating rod (23) is located on the top right side of the middle plate (4), and a connecting strip (27) is fixedly connected to the right end of the rotating rod (23). The left side of the connecting strip (27) is in contact with the right side surface of the microporous plate (5).

6. A rapid in vitro diagnostic kit for creatine kinase isoenzymes according to claim 1, characterized in that: Magnetic strips (28) are fixedly connected to the top sides of both the first cover plate (6) and the second cover plate (13), and the magnetic poles of the two magnetic strips (28) are set to opposite polarities.

7. A rapid in vitro diagnostic kit for creatine kinase isoenzymes according to claim 1, characterized in that: The outer wall of the slide bar (8) is provided with multiple springs (10). One end of the springs (10) on the left and right sides is fixedly connected to the outer wall of the moving plate (9), and the other end of the springs (10) on the left and right sides is fixedly connected to the outer wall of the fixing strip (7). The two ends of the spring (10) on the middle side are respectively fixedly connected to the outer walls of two adjacent moving plates (9).

8. A rapid in vitro diagnostic kit for creatine kinase isoenzymes according to claim 1, characterized in that: The base (2), cover plate one (6) and cover plate two (13) are all inclined on the side near the box body (1), and the inclined surfaces of the base (2), cover plate one (6) and cover plate two (13) correspond one-to-one with the inclined surfaces of the multiple protrusions (20).

9. A rapid in vitro diagnostic kit for creatine kinase isoenzymes according to claim 1, characterized in that: The base (2) has an internal insulation layer, and the multiple detection strips (3) are located in the insulation layer. The insulation layer is made of aluminum foil.