A primary aldehyde detection kit

Abstract

This utility model relates to the field of diagnostic kit technology, specifically a primary aldosterone detection kit, comprising a kit body and a lid. The kit body is divided by a partition into a shared reaction zone, an aldosterone detection reagent storage zone, and a renin detection reagent storage zone. Both the aldosterone and renin detection reagent storage zones have multiple reagent storage wells for storing aldosterone and renin detection reagents. The shared reaction zone contains a composite magnetic microparticle-coated plate, and its reaction wells are simultaneously pre-coated with anti-aldosterone and anti-renin antibodies. This kit integrates dual-indicator detection, enabling simultaneous aldosterone and renin detection in a single sample, significantly simplifying the process, reducing sample requirements and time lag, and improving the screening efficiency for primary aldosteronism.

Description

Technical Field

[0001] This utility model relates to the field of detection kit technology, specifically an aldehyde detection kit. Background Technology

[0002] Primary aldosteronism is the most common cause of secondary hypertension and is closely related to damage to target organs such as the heart, brain, and kidneys, but its early screening and diagnosis rate is low.

[0003] Currently, the preferred clinical screening method is the plasma aldosterone / renin ratio (ARR). Existing ARR tests require separate blood samples, different kits and testing procedures to measure aldosterone (ALD) and renin, and finally, the ratio is manually calculated by a doctor or laboratory personnel.

[0004] However, this method has the following drawbacks: it requires two independent immunoassay experiments each time, which is a long and time-consuming process. It also requires a sufficient amount of sample for both sides of the test, and there is a time difference between the two tests. To address this, this technical solution designs a primary aldehyde detection kit. Utility Model Content

[0005] The purpose of this invention is to provide a primary aldehyde detection kit to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, this utility model provides the following technical solution: A primary aldehyde detection kit includes a kit body and a lid. The lid is fitted onto the top of the kit body and is sealed with an external film. Inside the kit body, two sets of partitions separate a central shared reaction zone and two flanking zones for aldosterone and renin detection reagents. Both the aldosterone and renin detection reagent storage zones have at least four reagent storage holes. The aldosterone storage zone stores aldosterone calibrator, aldosterone quality control, aldosterone labeled reagent, and aldosterone solid-phase reagent, respectively. The renin detection reagent storage zone stores aldosterone calibrator, renin quality control, renin labeled reagent, and renin solid-phase reagent, respectively. The tops of the reagent storage holes are sealed with aluminum foil. The kit features a sealed, shared reaction zone with a composite magnetic microparticle-coated plate in the center. Multiple reaction wells are pre-coated with both anti-aldosterone and anti-renin antibodies. Two reagent pipette slots are located on either side of the composite magnetic microparticle-coated plate, each containing an embedded reagent pipette. Reaction reagents from the reagent storage wells are drawn into the composite magnetic microparticle-coated plate and then reacted with the test sample and the anti-aldosterone and anti-renin antibodies in the reaction wells. By incorporating the composite magnetic microparticle-coated plate and multiple reagent storage wells to store various types of reagents and reactants, the kit facilitates simultaneous detection of aldosterone (ALD) and renin, increasing detection efficiency, reducing process time, and improving accuracy.

[0007] Compared with the prior art, the beneficial effects of this utility model are: by using a shared reaction zone and a composite magnetic microparticle coated plate design, it enables the simultaneous detection of aldosterone (competitive inhibition method) and renin (double antibody sandwich method), avoiding two independent experiments and shortening the detection time.

[0008] Dual-indicator analysis can be completed with a single sample, reducing the required sample size.

[0009] The accuracy of the ARR ratio is improved by eliminating the error caused by the time difference between two detections.

[0010] The reagent storage hole integrates calibrators, quality control products, and reagents, and the reagent pipette in the reagent pipette slot simplifies the sample addition process. Attached Figure Description

[0011] Figure 1 This is a schematic diagram of the structure of a primary aldehyde detection kit.

[0012] Figure 2 This is a schematic diagram of the structure of a primary aldehyde detection kit from a second perspective.

[0013] Figure 3 for Figure 1 A magnified structural diagram of A in the diagram.

[0014] The kit includes: 10 reagent body, 11 base, 12 lid, 13 positioning strip, 14 positioning slot, 15 identification code, 16 separator, 17 aldosterone test reagent storage area, 18 renin test reagent storage area, 19 shared reaction area, 20 reagent pipette slot, 21 composite magnetic microparticle coating plate, 22 reagent storage hole, and 23 aluminum foil sealing film. Detailed Implementation

[0015] It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.

[0016] In the description of this utility model, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing this utility model 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, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this utility model, unless otherwise stated, "a plurality of" means two or more.

[0017] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0018] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0019] Please see Figures 1-3A primary aldehyde detection kit includes a kit body 10 and a lid 12. The lid 12 is fitted onto the top of the kit body 10 and is sealed with an external film. Inside the kit body 10, two sets of partitions 16 separate a centrally located shared reaction zone 19 and two adjacent aldosterone detection reagent storage zones 17 and 18 on either side of the shared reaction zone 19. Both the aldosterone and 18 storage zones have at least four reagent storage holes 22. The storage holes 22 in different locations within the aldosterone storage zone 17 store aldosterone calibrators, aldosterone quality controls, aldosterone labeled reagents, and aldosterone solid-phase reagents, respectively. Similarly, the storage holes 22 in different locations within the 18 storage zones store renin calibrators, renin quality controls, renin labeled reagents, and renin solid-phase reagents, respectively. The tops of the reagent storage holes 22 are sealed with aluminum foil. The membrane 23 is sealed. A composite magnetic microparticle coated plate 21 is set in the center of the shared reaction zone 19. Multiple reaction wells are set inside the composite magnetic microparticle coated plate 21. The reaction wells are simultaneously pre-coated with anti-aldosterone antibodies and anti-renin antibodies. At the same time, two reagent pipette slots 20 are opened inside the reagent kit 10 on both sides of the composite magnetic microparticle coated plate 21. Reagent pipettes are embedded in the reagent pipette slots 20. The reagents in the reagent storage holes 22 are adsorbed into the composite magnetic microparticle coated plate 21 through the reagent pipettes and then detected with the test sample, anti-aldosterone antibodies and anti-renin antibodies in the reaction wells. By setting the composite magnetic microparticle coated plate 21 and opening multiple reagent storage holes 22 inside the reagent kit 10 to store various types of reagents and other reactants, it is convenient to detect aldosterone (ALD) and renin simultaneously, increasing detection efficiency, reducing process time and increasing detection accuracy.

[0020] In this embodiment of the invention, a base 11 with an area larger than the bottom of the reagent kit 10 is fixedly installed at the bottom of the reagent kit 10 to increase the stability of the reagent kit 10 when it is placed for sample detection. The upper part of the side walls of the reagent kit 10 is symmetrically provided with positioning slots 14. Positioning strips 13 are installed in the inner wall of the lid 12 corresponding to the positioning slots 14. When the lid 12 is fitted onto the top of the reagent kit 10, the positioning strips 13 are inserted into the positioning slots 14 to accurately position the lid 12 and the top of the reagent kit 10. The top of the box cover 12 has a barcode 15, which is usually a QR code or a barcode. It contains batch information, calibration parameters and algorithm parameters required for ARR calculation of the composite magnetic microparticle coating plate 21. The detection method of this kit is based on the combined immunoreaction principle of double antibody sandwich method (for renin) and competitive inhibition method (for aldosterone).

[0021] Reagent pipettes include rigid steel needles, ceramic dispensing needles, or disposable tips. Rigid steel needles and ceramic dispensing needles are driven by high-precision stepper motors to perform vertical movement (Z-axis) to complete liquid aspiration and dispensing. They are usually connected to a high-precision syringe pump or peristaltic pump to control the volume. The disposable pipette tips are made of medical-grade polypropylene (PP) plastic. Working principle: The end of the dispensing arm has a connector for attaching pipette tips (similar to a large manual pipette). Before each use, a new pipette tip is taken from the tip box. After transferring a volume of liquid, the tip is discarded into the waste container before the next operation.

[0022] The above is only a brief introduction to hard steel needles, ceramic dispensing needles, or disposable suction tips. Since they are all common tools, they will not be described in detail here. Secondly, the structure of the reagent pipette slot 20 is designed according to the type of reagent pipette. In order to maintain quick installation and removal of the reagent pipette, the reagent pipette slot 20 can be set as a slot structure made of foam material.

[0023] In one embodiment of the present invention, the aldosterone labeling reagent is set as a chemiluminescently labeled aldosterone derivative; The renin labeling reagent was set as a chemiluminescently labeled anti-renin monoclonal antibody; Aldosterone labeling reagent and renin labeling reagent label the chemiluminescent substances of different types; For example, one labeling is a luminol derivative, and the other is an acridine ester compound; their luminescent signals can be distinguished and identified by detection instruments.

[0024] The working principle of this utility model is as follows: Opening preparation: Tear off the outer packaging film, open the box cover 12, and expose the internal structure of the reagent kit 10.

[0025] Reagent dispensing: Take out the reagent pipette (hard steel needle, ceramic dispensing needle or disposable pipette tip) from the reagent pipette slot 20.

[0026] Pierce the aluminum foil sealing film 23 of the aldosterone test reagent storage area 17 and aspirate aldosterone calibrators, quality control products, labeling reagents and solid phase reagents. Pierce the aluminum foil sealing film 23 of the renin test reagent storage area 18 and aspirate renin calibrators, quality control products, labeling reagents and solid phase reagents.

[0027] Sample addition reaction: Add the reagent and the sample to be tested into the reaction well of the composite magnetic microparticle coated plate 21 in the shared reaction zone 19.

[0028] ① Aldosterone detection: Labeling reagent (chemiluminescent labeled aldosterone derivatives compete with aldosterone in the sample for binding to pre-coated anti-aldosterone antibodies); ② Renin detection: Labeling reagent (chemiluminescent anti-renin monoclonal antibody) binds to renin in the sample and is pre-coated with anti-renin antibody to form a double antibody sandwich complex.

[0029] Signal detection: Use a chemiluminescence detector to read the reaction signal (e.g., distinguishing luminescence between luminol derivatives and acridine esters).

[0030] Results calculation: Scan the barcode 15 (QR code / barcode) on the box cover 12 to obtain the batch information, calibration parameters and ARR algorithm parameters of the composite magnetic microparticle coating plate 21, and automatically calculate the aldosterone / renin concentration ratio.

[0031] It should be understood that in this application, all rotating, sliding, meshing, belt-driven and other moving parts are well lubricated and not prone to slippage or wear, and each part is provided with a corresponding protective shell. However, in the accompanying drawings of this application, the connection state of each moving part is not shown. It should also be understood that each part in this application is made of metal or plastic material with suitable strength in the relevant field to ensure that its structural rigidity meets the actual requirements.

[0032] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention.

Claims

1. A primary aldehyde detection kit comprising a kit body (10) and a lid (12), characterized in that, The reagent kit (10) is internally divided into a shared reaction area (19), an aldosterone detection reagent storage area (17), and a renin detection reagent storage area (18) by a partition plate (16); At least four reagent storage holes (22) are provided in both the aldosterone test reagent storage area (17) and the renin test reagent storage area (18); The shared reaction zone (19) is provided with a composite magnetic microparticle coating plate (21), and the reaction pores of the composite magnetic microparticle coating plate (21) are simultaneously pre-coated with anti-aldosterone antibody and anti-renin antibody; The reagent kit body (10) has a reagent pipette slot (20) for accommodating reagent pipettes.

2. The primary aldehyde detection kit according to claim 1, characterized in that, The top of the reagent storage hole (22) is covered with an aluminum foil sealing film (23).

3. The primary aldehyde detection kit according to claim 1, characterized in that, A base (11) is fixedly installed at the bottom of the reagent kit (10), and the area of ​​the base (11) is larger than the area of ​​the bottom of the reagent kit (10).

4. The primary aldehyde detection kit according to claim 1, characterized in that, The reagent kit body (10) has symmetrically arranged positioning slots (14) on the upper part of both side walls. The inner wall of the box cover (12) is fixedly installed with a positioning strip (13), and the positioning strip (13) is engaged with the positioning slot (14).

5. The primary aldehyde detection kit according to claim 1, characterized in that, The top outer surface of the box cover (12) is provided with a barcode (15), which is a QR code or barcode, and stores batch information, calibration parameters and ARR algorithm parameters of the composite magnetic microparticle coating plate (21).

6. The primary aldehyde detection kit according to claim 1, characterized in that, The reagent pipette groove (20) is made of foam material and is used to embed and fix hard steel needles, ceramic dispensing needles or disposable pipette tips.

7. The primary aldehyde detection kit according to claim 1, characterized in that, The reagent storage holes (22) of the aldosterone detection reagent storage area (17) respectively store aldosterone calibrators, aldosterone quality control products, aldosterone labeling reagents and aldosterone solid phase reagents; The reagent storage holes (22) of the renin detection reagent storage area (18) respectively store renin calibrators, renin quality control products, renin labeling reagents and renin solid phase reagents.

8. The primary aldehyde detection kit according to claim 7, characterized in that, The aldosterone labeling reagent is a chemiluminescently labeled aldosterone derivative, and the renin labeling reagent is a chemiluminescently labeled anti-renin monoclonal antibody; the aldosterone labeling reagent and the renin labeling reagent are labeled with different chemiluminescent substances.

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