Creatinine detection card, slot device and creatinine detector

Abstract

The utility model discloses a creatinine detection card, and belongs to the technical field of in-vitro detection. The creatinine detection card comprises an upper cover provided with a sample adding hole, a first reaction tank and a plurality of positioning holes, the sample adding hole is communicated with the first reaction tank, a first reactant is placed in the first reaction tank, and the first reactant is used for removing creatine in a sample to be detected; the plurality of positioning holes are distributed at all positions of the upper cover; the bottom plate is arranged opposite to the upper cover, a second reactant and a plurality of positioning columns are arranged on the bottom plate, the positioning columns correspond to the positioning holes in a one-to-one mode, a circle of clamping ring is arranged on the side wall of each positioning column in a protruding mode, and the outer diameter of each clamping ring is larger than the diameter of each positioning hole; the second reactant is used for carrying out chromogenic reaction with creatinine. By improving the structure of the detection card, creatinine can be tested by perfectly matching with a fractional step method, the result is accurate, the operation is simple, and the sample and reagent cost can be reduced. The utility model further discloses a slot device and a creatinine detector.

Description

Technical Field

[0001] This application relates to the field of in vitro detection technology, and in particular to a creatinine detection card, slot device and creatinine detector. Background Technology

[0002] In clinical practice, wet chemical picrate methods and enzymatic methods are commonly used for creatinine testing. However, for emergency or primary care settings, due to limitations in equipment and testing objectives, dry chemical methods, which enable rapid screening, are more frequently required. However, dry chemical creatinine testing is often affected by interfering substances such as creatine, bilirubin, and vitamin C, leading to inaccurate test values.

[0003] Chinese Patent Application No. 201210168765.7, entitled "Two-Step Enzymatic Determination Method and Reagents for Serum Creatinine," discloses a two-step method for determining creatinine. This method utilizes catalase to eliminate hydrogen peroxide produced from creatine. The resulting water and oxygen do not cause background elevation. The catalase in the reagent is completely inhibited by the inhibitor during the detection reaction, thus avoiding the background elevation caused by peroxidase oxidation of hydrogen peroxide, which leads to poor accuracy and precision of the test results. However, this method requires the addition of reagents twice, is common in wet chemical enzymatic methods, and is not suitable for dry chemical methods.

[0004] Furthermore, the method disclosed in Chinese Patent Application No. 202210394348.8, "An Optical Differential Signal Processing Blood Creatinine Detection Card, Preparation Method and Application", involves setting up two signal holes, one specifically for testing creatine and the other for testing creatine + creatinine. The creatinine concentration is calculated using the signal difference between the two signal holes. This method can effectively solve the problem of removing interference from creatinine, but the two signal areas will lead to problems such as low precision, large sample requirements, and high reagent costs.

[0005] In view of this, a new technical solution is needed to solve the above-mentioned technical problems. Summary of the Invention

[0006] The purpose of this application is to provide a creatinine test card, slot device, and creatinine analyzer suitable for dry chemical methods. By improving the structure of the test card, it can perfectly match the stepwise method for testing creatinine, and the results are accurate and the operation is simple, which can reduce the cost of samples and reagents.

[0007] To achieve the above objectives, the first aspect of this application provides a creatinine testing card, comprising:

[0008] The top cover has a sample application hole, a first reaction tank, and several positioning holes. The sample application hole is connected to the first reaction tank, and a first reactant is placed in the first reaction tank. The first reactant is used to remove creatine from the sample to be tested. The several positioning holes are distributed in various parts of the top cover.

[0009] A base plate is disposed opposite to the top cover. The base plate is provided with a second reactant and several positioning posts. Each positioning post corresponds to a positioning hole, and a retaining ring is protruding from the side wall of each positioning post. The outer diameter of the retaining ring is larger than the diameter of the positioning hole. The second reactant is used to react with creatinine to produce a colorimetric reaction.

[0010] As a further improvement, the first reactant includes an interference-reducing membrane layer comprising an enzyme capable of reacting with creatine; the second reactant includes a reaction membrane layer comprising an enzyme capable of reacting with creatinine.

[0011] As a further improvement, the first reactant also includes a diffusion membrane layer and a blood filtration membrane layer, which are stacked on top of the interference membrane layer.

[0012] As a further improvement, the membrane layer includes one or more of nylon membrane, PES membrane, NC membrane or glass fiber membrane.

[0013] As a further improvement, the reactive membrane layer is adhered to the surface of the substrate.

[0014] As a further improvement, the cross-section of the retaining ring is semi-circular.

[0015] A second aspect of this application provides a slot device including a card insertion channel, with symmetrical grooves on both sides of the card insertion channel, the grooves being used to surround and hold one edge of the creatinine test card as described above;

[0016] Furthermore, the thickness of the upper cover is set to be thinner at the front and thicker at the back, and the upper and lower widths of the sliding groove are correspondingly set to be narrower at the front and wider at the back.

[0017] A third aspect of this application provides a creatinine analyzer, which includes the slot device, signal acquisition device and controller as described above;

[0018] An observation hole is provided on the bottom wall of the card insertion channel. The signal acquisition device is located below the slot device and is used to observe the creatinine test card through the observation hole.

[0019] As a further improvement, a driving device is also included, which includes a slider and a pull rod. The slider is movably disposed at the front end of the slot device, and the pull rod is vertically disposed on the slider. The front end of the creatinine test card has a structural hole for the pull rod to pass through.

[0020] The drive device is used to pull the creatinine test card from the first position to the second position.

[0021] As a further improvement, the observation hole is provided in two places, corresponding to the first position and the second position respectively;

[0022] When the creatinine test card is in the first position, the structural hole is directly opposite the top of the pull rod.

[0023] Compared with existing technologies, this application brings the following technical effects:

[0024] The creatinine detection card of this application includes a top cover and a bottom plate. During the fastening process, the top cover and bottom plate can be fitted in stages by means of a specially structured positioning post and positioning hole. Therefore, after the blood sample is dripped in, the blood sample first reacts with the first reactant on the top cover to undergo a first-stage reaction. This stage is used to remove creatine from the blood sample. At this time, the top cover is above the retaining ring and is not in contact with the bottom plate, thus ensuring the smooth progress of the first-stage reaction. Subsequently, under the action of external force, the top cover overcomes the resistance of the retaining ring and moves further downward, finally fastening to the bottom plate, so that the first reactant comes into contact with the second reactant. The blood sample smoothly enters the second reactant, and then the second-stage reaction, namely the creatinine colorimetric reaction, occurs, and the creatinine detection is finally completed. This application uses wet chemical enzymatic method as the underlying principle and implements it in the form of dry chemical test strips, which can ensure accurate measurement results, is simpler to operate, and reduces sample and reagent costs, thus having great application value.

[0025] The slot device and creatinine analyzer that match the above-mentioned creatinine test card also have the same beneficial effects. Attached Figure Description

[0026] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0027] Figure 1 This illustration shows a schematic diagram of the creatinine detection card in the first stage of snapping, according to an embodiment of this application.

[0028] Figure 2 This illustration shows a schematic diagram of the fully engaged creatinine detection card according to an embodiment of this application.

[0029] Figure 3 A schematic diagram of the top cover structure of a creatinine testing card according to an embodiment of this application is shown;

[0030] Figure 4 A schematic diagram of the base plate structure of a creatinine testing card according to an embodiment of this application is shown;

[0031] Figure 5 A schematic diagram of the structure of a slot device according to an embodiment of this application is shown.

[0032] Explanation of key component symbols:

[0033] Creatinine test card-100; top cover-110; sample application port-111; first reaction chamber-112; first reactant-113; positioning hole-116; bottom plate-120; second reactant-121; positioning column-122; structural hole-130; card insertion channel-200; slide groove-201; observation hole-202. Detailed Implementation

[0034] The technical solutions of this application will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this application. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0035] Furthermore, the technical features involved in the different embodiments of this application described below can be combined with each other as long as they do not conflict with each other. Embodiments of this application are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout.

[0036] Example

[0037] Please see Figures 1-4 This embodiment provides a creatinine analyzer for testing the creatinine content in whole blood samples. The consumable for this creatinine analyzer is a creatinine test card 100 suitable for dry chemistry methods. The card insertion direction is defined as forward.

[0038] In this embodiment, the creatinine analyzer includes a housing, a frame, a slot device, a signal acquisition device, a drive device, and a controller. The creatinine test card 100 is inserted into the slot device through the instrument's socket to complete subsequent testing.

[0039] It should be noted that the focus of this application is on the technical aspects related to the slot device and the creatinine detection card 100. Therefore, this embodiment will focus on describing the above structure, but it does not mean that this creatinine detector does not include other structures, such as power supply.

[0040] In this embodiment, the creatinine test card 100 is formed by two parts fastening together, including an upper cover 110 and a bottom plate 120, both of which are rectangular, wherein the length of the bottom plate 120 is greater than the length of the upper cover 110.

[0041] A sample application hole 111 is provided in the middle of the upper cover 110, extending throughout the entire upper cover 110. A first reaction groove 112 is formed on the lower surface of the upper cover 110, which communicates with the sample application hole 111. Specifically, the lower surface of the upper cover 110 is recessed into the upper cover 110. A first reactant 113 is placed in the first reaction groove 112. The first reactant 113 is used to remove creatine from the blood sample, thereby eliminating interference for subsequent creatinine concentration detection.

[0042] Specifically, the first reactant 113 includes a diffusion membrane layer, a filtration membrane layer, and an interference-reducing membrane layer. The interference-reducing membrane layer is the main functional layer, containing an enzyme that reacts with creatine. The diffusion membrane layer and the filtration membrane layer are stacked above the interference membrane layer, respectively used to rapidly diffuse the blood sample and filter large particles and blood cells from the blood sample, thereby reducing the interference of these substances on subsequent creatinine measurements. The remaining serum then enters the interference-reducing membrane layer, where the creatine in the serum is reacted and removed.

[0043] Specifically, the substrate of the diffusion membrane can be a mesh-like nylon membrane or a PES membrane, or other substrates that facilitate rapid diffusion of blood samples. The substrate of the blood filtration membrane can be a multi-layered glass fiber or PES membrane material, or a combination of both materials, utilizing the mesh pores of the substrate to filter large particles and blood cells.

[0044] In this embodiment, a second reactant 121 is provided on the base plate 120. The second reactant 121 includes a reaction membrane layer on which an enzyme capable of reacting with creatinine is disposed. Specifically, the substrate of the reaction membrane layer can be a nylon membrane, a PES membrane, or an NC membrane with a transparent precipitate. The membrane material is labeled with creatinine enzyme, sarcosine oxidase, peroxidase, and a chromogenic substrate. It may also contain one or more surfactants, enzyme protectants, etc. The reaction membrane layer is specifically adhered to the upper surface of the base plate 120 by adhesive.

[0045] In this embodiment, the lower surface of the upper cover 110 is provided with four positioning holes 116, and the upper surface of the base plate 120 is provided with four positioning posts 122. The positioning posts 122 are aligned with the positioning holes 116 one by one, and each positioning post 122 has a retaining ring (not shown in the figure) protruding outward from the middle sidewall. The creatinine test card 100 is formed by fastening the upper cover 110 and the base plate 120, and the fastening process can be divided into two stages by means of the retaining ring of the positioning post 122. Specifically, in the first stage, the upper part of the positioning post 122 is inserted into the positioning hole 116, but the upper cover 110 is suspended on the base plate 120, so that the first reactant 113 does not come into contact with the second reactant 121; in the second stage, an external force is applied to the upper cover 110 to continue to fasten downward, overcoming the resistance of the retaining ring, and finally adhering to the base plate 120, at which time the first reactant 113 comes into contact with the second reactant 121.

[0046] The specific testing process is as follows:

[0047] 1. The top cover 110 is in the first locking stage, suspended above the bottom plate 120, and the first reactant 113 and the second reactant 121 are not in contact. At this time, a whole blood sample is dripped into the sample well 111, and the blood sample diffuses rapidly through the diffusion membrane layer; when passing through the blood filtration membrane layer, large particles and blood cells are filtered out; the remaining serum then permeates into the interference removal membrane layer, where the following reaction occurs:

[0048] first step:

[0049] Step Two:

[0050] Step 3:

[0051] At this point, the creatine in the blood sample has been removed.

[0052] 2. An external force is applied to the top cover 110, causing it to continue moving downwards until it is fully engaged, bringing the first reactant 113 into contact with the second reactant 121. At this point, the serum, having undergone the first stage of reaction, continues to permeate downwards and reacts with the second reactant 121, as follows:

[0053] first step:

[0054] Step Two:

[0055] Step 3:

[0056] Step 4:

[0057] The first and second stage reactions described above are both wet chemical enzymatic methods, and their principles are existing technologies. However, the creatinine test card 100 of this embodiment achieves a phased engagement between the upper cover 110 and the base plate 120 through a clever structural design, trading space for time. This allows for the measurement of creatinine concentration using a dry chemical method, achieving a wet chemical enzymatic method. Compared to existing technologies, this method is simpler to operate, consumes less blood sample and reagents, and also retains the advantages of stepwise creatinine concentration measurement, reducing the influence of various interfering substances on the measurement results and ensuring accuracy.

[0058] Please refer to the above. Figure 5In this embodiment, the slot device is used to support the creatinine test card 100. Specifically, it includes a card insertion channel 200 that matches the creatinine test card 100. The card insertion channel 200 has symmetrically arranged grooves 201 on both sides. The grooves 201 surround and hold one edge of the creatinine test card 100, thereby constraining the position and movement of the creatinine test card 100. Specifically, the upper and lower widths of the grooves 201 are set to be narrower at the front and wider at the back, and the thickness of the upper cover 110 is set to be thinner at the front and thicker at the back. Through the interference of the grooves 201 on the upper cover 110, the upper cover 110 and the base plate 120 can automatically engage when the creatinine test card 100 is inserted to a certain depth. Therefore, by controlling the insertion depth of the creatinine test card 100, the staged engagement of the upper cover 110 and the base plate 120 can be achieved.

[0059] Of course, in some other embodiments, the slot device may not be configured as narrow in the front and wide in the back as described above. In this case, it can be manually operated to make the upper cover 110 and the base plate 120 engage in stages, or other power mechanisms can be used to drive the upper cover 110 and the base plate 120 to engage in stages.

[0060] In this embodiment, an observation hole 202 is provided on the bottom wall of the card insertion channel 200. A signal acquisition device (not shown) is located below the slot device. This signal acquisition device is used to observe the creatinine test card 100 through the observation hole 202. It is worth mentioning that the signal acquisition device in this embodiment is a camera, used to take pictures of the creatinine test card 100. The pictures are transmitted to the controller for subsequent analysis and processing. Since the underlying principle of this creatinine detector is wet chemical enzymatic method, the principle of image analysis can refer to related technologies of wet chemical enzymatic method, such as color-concentration comparison method. This embodiment will not go into detail about this.

[0061] To facilitate automation of the creatinine analyzer, this embodiment also includes a drive device (not shown). This drive device includes a slider and a pull rod. The slider is movably disposed at the front end of the slot device, and the pull rod is vertically disposed on the slider. A structural hole 130 is provided at the front end of the creatinine test card 100 for the pull rod to pass through. The drive device is used to pull the creatinine test card 100 from a first position to a second position.

[0062] Specifically, the slider can move back and forth via a slide rail and lead screw structure, with the lead screw connected to a motor for transmission. The side wall of the pull rod is provided with teeth, which are connected to a motor gear transmission, thereby enabling the pull rod to move up and down. It should be noted that the drive device of this application can adopt any feasible solution in the prior art.

[0063] In this embodiment, two observation holes 202 are provided, arranged one in front of the other along the card insertion direction. These two observation holes 202 correspond to the first and second positions of the creatinine test card 100, respectively. Specifically, when the creatinine test card 100 is in the first position, the structural hole 130 is directly opposite the top of the pull rod. The pull rod, driven by the motor gear, rises above the upper surface of the slider and inserts into the structural hole 130. At this time, the rear observation hole 202 is directly opposite the reaction zone of the creatinine test card 100, i.e., the area where the first reactant 113 and the second reactant 121 are located. The first reactant 113 of the creatinine test card 100 undergoes a first-stage reaction, and the upper cover 110 and the bottom plate 120 are isolated from each other.

[0064] Then, the lever moves forward with the slider, which in turn drives the creatinine test card 100 to continue to be inserted. When the creatinine test card 100 is in the second position, it stops. At this time, the observation hole 202 in front is directly facing the reaction area of ​​the creatinine test card 100, and the top cover 110 is also fully fastened to the bottom plate 120. The first reactant 113 and the second reactant 121 come into contact, and the second stage reaction occurs.

[0065] During the above process, the signal acquisition device acquires the first position signal and the second position signal respectively. The first position signal can help determine whether the creatinine detection card 100 is in the correct position, thereby ensuring that the pull rod can be smoothly inserted into the structural hole 130; the second position signal is used to determine the creatinine concentration in the blood sample, thereby obtaining the measurement result.

[0066] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom still fall within the scope of protection of this application.

Claims

1. A creatinine test card, characterized by, include: The top cover has a sample application hole, a first reaction tank, and several positioning holes. The sample application hole is connected to the first reaction tank, and a first reactant is placed in the first reaction tank. The first reactant is used to remove creatine from the sample to be tested. The several positioning holes are distributed in various parts of the top cover. A base plate is disposed opposite to the top cover. The base plate is provided with a second reactant and several positioning posts. Each positioning post corresponds to a positioning hole, and a retaining ring is protruding from the side wall of each positioning post. The outer diameter of the retaining ring is larger than the diameter of the positioning hole. The second reactant is used to react with creatinine to produce a colorimetric reaction.

2. The creatinine test card according to claim 1, wherein The first reactant includes an interference-reducing membrane layer, which includes an enzyme capable of reacting with creatine; the second reactant includes a reaction membrane layer, which includes an enzyme capable of reacting with creatinine.

3. The creatinine test card of claim 2, wherein, The first reactant also includes a diffusion membrane layer and a blood filtration membrane layer, which are stacked on top of the interference membrane layer.

4. The creatinine test card according to claim 2 or 3, wherein The membrane layer includes one or more of nylon membrane, PES membrane, NC membrane or glass fiber membrane.

5. The creatinine test card of claim 2, wherein, The reactive membrane layer is adhered to the upper surface of the base plate.

6. The creatinine test card of claim 1, wherein, The cross-section of the retaining ring is semi-circular.

7. A socket device, characterized by It includes a card insertion channel, with symmetrical grooves on both sides of the card insertion channel, the grooves being used to surround and hold one edge of the creatinine test card as described in claims 1-6; Furthermore, the thickness of the upper cover is set to be thinner at the front and thicker at the back, and the upper and lower widths of the sliding groove are correspondingly set to be narrower at the front and wider at the back.

8. A creatinine meter characterized by Includes the slot device, signal acquisition device, and controller as described in claim 7; An observation hole is provided on the bottom wall of the card insertion channel. The signal acquisition device is located below the slot device and is used to observe the creatinine test card through the observation hole.

9. The creatinine meter according to claim 8, wherein It also includes a driving device, which includes a slider and a pull rod. The slider is movably disposed at the front end of the slot device, and the pull rod is vertically disposed on the slider. The front end of the creatinine test card has a structural hole for the pull rod to pass through. The drive device is used to pull the creatinine test card from the first position to the second position.

10. The creatinine meter according to claim 9, wherein There are two observation holes, corresponding to the first position and the second position respectively; When the creatinine test card is in the first position, the structural hole is directly opposite the top of the pull rod.

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