A fluorescent immunochromatographic quality control card and analyzer

Abstract

The utility model relates to a kind of fluorescent immunochromatography quality control card and analyzer, the fluorescent immunochromatography quality control card includes upper shell, lower shell and test paper card, the upper shell is provided with observation window, the lower shell is provided with containing groove, the test paper card is set in the containing groove, it has fluorescent quality control line thereon, and the fluorescent quality control line is located in the corresponding area of observation window;Wherein, the corner of the upper shell is rotatably connected with the corner of the lower shell, and the end of the upper shell away from the rotatably connected with the lower shell is magnetically adsorbed between the lower shell.The fluorescent immunochromatography quality control card and analyzer are rotatably connected and magnetically adsorbed, so that the separation and folding of the upper shell and the lower shell is more rapid, to facilitate the separation or folding of the upper shell and the lower shell, the test paper card is replaced.

Description

Technical Field

[0001] This utility model belongs to the field of fluorescence detection technology, and in particular relates to a fluorescence immunochromatographic quality control card and analyzer. Background Technology

[0002] Fluorescence immunochromatographic assay (FICA) is a novel in vitro diagnostic technique that combines the advantages of rapid, simple, and point-of-care testing (POCT) of immunochromatography with the high sensitivity, high specificity, and quantitative detection capabilities of fluorescent labeling. Developed since the late 1990s, this technique has become an important area of ​​development in POCT thanks to advancements in high-performance fluorescent materials, precision optical detection devices, and microelectronics.

[0003] Fluorescence immunochromatography has been widely applied in various fields, such as rapid on-site screening in clinical diagnosis, food safety, environmental monitoring, animal disease diagnosis, and biosafety and emergency response. Fluorescence immunochromatography continues to develop towards higher performance, greater intelligence, and greater integration, including higher-performance fluorescent materials, miniaturized and intelligent instruments, widespread use of multiplex detection, automation and high throughput, and expansion of application areas, such as the development of more novel biomarkers and penetration into emerging fields (such as home health monitoring and personalized medicine).

[0004] The performance stability, accuracy, and reliability of the detection results of a fluorescence immunochromatographic analyzer are core guarantees for the application of this technology. However, the optical system, electronic system, and environmental factors of the instrument itself may experience slight fluctuations over time or batch-by-batch. If these fluctuations are not effectively monitored and calibrated, they will directly affect the accuracy of quantitative results, the comparability of results between different instruments, and the consistency of detection results from different batches of reagents. Therefore, developing a standard quality control card specifically for fluorescence immunochromatographic analyzers is crucial.

[0005] Currently, manufacturers of fluorescence immunochromatographic analyzers generally use time-resolved fluorescent microspheres, quantum dot fluorescent microspheres, upconversion fluorescent microspheres, and fluorescein isothiocyanate luminescent nanospheres as the main luminescent media for quality control card preparation. Although the use of these fluorescent microspheres in the development of in vitro diagnostic reagents is relatively mature, due to the special application requirements of quality control cards, such as large testing volume, high frequency of photoexcitation irradiation, and complex and variable operating environment, quality control cards prepared using the above microsphere materials are generally prone to fluorescence decay and quenching under repeated light exposure conditions, resulting in unstable light intensity signals. This makes it difficult to establish quality inspection standards and long-term calibration and traceability for the equipment, and new quality control cards need to be used every time the equipment is tested.

[0006] When a new quality control card is needed, replacing the entire quality control card would result in excessively high preparation costs. If only the test strip inside the control card housing is replaced, the housing needs to be disassembled. However, the existing quality control card housing is usually connected by clips to hold the test strip, which makes the disassembly process inconvenient. Utility Model Content

[0007] In view of this, the present invention provides a fluorescence immunochromatographic quality control card and analyzer, which solves the problem of replacing the test strip inside the quality control card housing.

[0008] To achieve the above objectives, firstly, the technical solution of this utility model to solve the technical problem is to provide a fluorescence immunochromatographic quality control card, comprising: an upper shell, a lower shell, and a test strip card. The upper shell is provided with an observation window, and the lower shell is provided with a receiving groove. The test strip card is placed in the receiving groove and has fluorescence control lines on it, with the fluorescence control lines located in the corresponding area of ​​the observation window. A corner of the upper shell is rotatably connected to a corner of the lower shell, and the end of the upper shell furthest from the rotatably connected end of the lower shell is magnetically adsorbed with the lower shell.

[0009] Preferably, the upper housing is provided with a rotating shaft, and the lower housing is provided with a rotating hole. The rotating shaft and the rotating hole are respectively located at one corner of the upper housing and the lower housing, and the rotating shaft and the rotating hole are rotatably engaged.

[0010] Preferably, the rotating shaft includes a rotating part and a limiting part. One end of the rotating part is connected to the upper housing. The limiting part is located at the end of the rotating part away from the upper housing, and the diameter of the limiting part is larger than the diameter of the rotating part. The rotating hole includes a rotating hole and a limiting hole. The limiting hole is located on the side of the rotating hole away from the upper housing and communicates with the rotating hole. The diameter of the limiting hole is larger than the diameter of the rotating hole. The rotating part and the limiting part are rotatably engaged with the rotating hole and the limiting hole, respectively.

[0011] Preferably, a positioning groove is provided on the end of the upper housing away from the rotatably connected lower housing, and a positioning boss is provided on the end of the lower housing away from the rotatably connected upper housing. The positioning groove and the positioning boss are adapted to each other in shape, and a magnetic component and a metal component are respectively provided on the positioning groove and the positioning boss.

[0012] Preferably, both the positioning groove and the positioning boss are arc-shaped.

[0013] Preferably, a QR code is provided on the side of the upper housing away from the lower housing.

[0014] Preferably, the test strip includes a PVC board and a nitrocellulose membrane, the PVC board is placed in the receiving groove, the nitrocellulose membrane is adhered to the side of the PVC board away from the receiving groove, and the fluorescent control line is located on the side of the nitrocellulose membrane away from the PVC board.

[0015] Preferably, the PVC board is provided with positioning holes, and the receiving groove is provided with positioning posts, which are inserted into the positioning holes.

[0016] Preferably, the fluorescence control line includes a C-line and a T-line, both of which are coated with a fluorescent microsphere solution.

[0017] Secondly, this utility model also provides a fluorescence immunochromatographic analyzer, including a quality control card, a housing, and an optical module. The optical detection module is located inside the housing, and the housing is provided with a card slot. The quality control card is inserted into the card slot, and the optical detection module is used to detect the fluorescence immunochromatographic quality control card in the card slot.

[0018] Compared with the prior art, the fluorescence immunochromatographic quality control card and analyzer provided by this utility model have the following beneficial effects: The upper and lower shells are slidably connected at one corner and magnetically attracted at the end away from the sliding connection, which makes it easier to separate and close the upper and lower shells to replace the test strip card. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the separation state of the fluorescence immunochromatographic quality control card provided in the first embodiment of the present invention; Figure 2 for Figure 1 A schematic diagram of the closed state of the fluorescence immunochromatographic quality control card; Figure 3 for Figure 1 Schematic diagram of the upper and middle shell structure; Figure 4 for Figure 1 Schematic diagram of the middle and lower shell structure; Figure 5 for Figure 1 A schematic diagram of the structure of the pilot test paper card; Figure 6 This is a schematic diagram of the structure of the fluorescence immunochromatographic analyzer provided in the second embodiment of the present invention; Figure 7 for Figure 6 Schematic diagram of the internal structure of the outer shell; Figure 8 for Figure 6Schematic diagram of the connection relationship of the fixed blocks in the middle; Explanation of reference numerals in the attached figures: 1. Upper shell; 11. Observation window; 12. Rotating shaft; 121. Rotating part; 122. Limiting part; 13. Positioning groove; 14. QR code; 2. Lower shell; 21. Receiving groove; 211. Positioning post; 22. Rotating hole; 221. Rotating hole; 222. Limiting hole; 23. Positioning boss; 3. Test strip card; 31. PVC board; 311. Positioning hole; 32. Nitrocellulose membrane; 4. Outer shell; 41. Card slot; 5. Optical inspection module; 6. Control board; 7. Interface board; 8. Barcode scanning module; 9. Mechanical motion module; 91. Lead screw motor; 10. Fixing block. Detailed Implementation

[0020] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0021] like Figures 1-4 As shown, the first embodiment of this application provides a fluorescence immunochromatographic quality control card, which includes: The test strip consists of an upper shell 1, a lower shell 2, and a test strip 3. The upper shell 1 is provided with an observation window 11, and the lower shell 2 is provided with a receiving groove 21. The test strip 3 is placed in the receiving groove 21 and has a fluorescence control line on it, with the fluorescence control line located in the corresponding area of ​​the observation window 11. One corner of the upper shell 1 is rotatably connected to one corner of the lower shell 2, and the end of the upper shell 1 that is rotatably connected to the lower shell 2 is magnetically attracted to the lower shell 2.

[0022] Specifically, one corner of the upper shell 1 is rotatably connected to one corner of the lower shell 2. When an external force is applied to the upper shell 1, it can be pushed to rotate relative to the lower shell 2 around the rotatably connected corner, thereby realizing the closing or separation of the upper shell 1 and the lower shell 2.

[0023] When it is necessary to replace the test strip card 3, rotate the upper housing 1 to separate it from the lower housing 2. At this point, the test strip card 3 to be replaced can be removed from the receiving slot 21, and the new test strip card 3 can be placed into the receiving slot 21. Then, rotate the upper housing 1 again until it closes with the lower housing 2, clamping and fixing the test strip card 3. At this point, the ends of the upper housing 1 and lower housing 2 furthest from the rotating connection form a magnetic attraction, and the test strip card 3 is clamped and fixed in the receiving slot 21 by the upper housing 1 and lower housing 2, with the fluorescence control line facing the observation window 11. This completes the replacement process.

[0024] The upper shell 1 and lower shell 2 are connected by a rotational joint and magnetic attraction. The upper shell 1 can be rotated to magnetically attract the lower shell 2, allowing them to close together. Alternatively, applying an external force greater than the magnetic attraction force to either the upper shell 1 or the lower shell 2 will push the upper shell 1 to rotate relative to the lower shell 2, thus separating them. Compared to traditional snap-fit ​​connections, this method allows for easier and faster separation and closure of the upper shell 1 and lower shell 2, facilitating the replacement of the test strip card 3.

[0025] In one embodiment, the upper housing 1 is provided with a rotating shaft 12, and the lower housing 2 is provided with a rotating hole 22. The rotating shaft 12 and the rotating hole 22 are respectively located at one corner of the upper housing 1 and the lower housing 2, and the rotating shaft 12 and the rotating hole 22 are rotatably engaged to realize the rotatable connection between the upper housing 1 and the lower housing 2.

[0026] It is understandable that a rotating shaft 12 could be provided on the lower housing 2 and a rotating hole 22 could be provided on the upper housing 1, as long as the rotating connection between the upper housing 1 and the lower housing 2 can be achieved through the rotating fit between the rotating shaft 12 and the rotating hole 22.

[0027] Furthermore, the rotating shaft 12 includes a rotating part 121 and a limiting part 122. One end of the rotating part 121 is connected to the upper housing 1, and the limiting part 122 is disposed at the end of the rotating part 121 away from the upper housing 1, and the diameter of the limiting part 122 is larger than the diameter of the rotating part 121. The rotating hole 22 includes a rotating hole 221 and a limiting hole 222. The limiting hole 222 is located on the side of the rotating hole 221 away from the upper housing 1 and communicates with the rotating hole 221. The diameter of the limiting hole 222 is larger than the diameter of the rotating hole 221. The rotating part 121 and the limiting part 122 are respectively rotatably engaged with the rotating hole 221 and the limiting hole 222.

[0028] It is understandable that by setting the rotating part 121 and the limiting part 122 to rotate and cooperate with the rotating hole 221 and the limiting hole 222 respectively, the separation of the upper housing 1 and the lower housing 2 along the axis of the rotating shaft 12 can be avoided.

[0029] It should be noted that the rotating shaft 12 can be integrally formed or formed by assembling the rotating part 121 and the limiting part 122.

[0030] Furthermore, a positioning groove 13 is provided on the end of the upper shell 1 away from the rotatably connected lower shell 2, and a positioning boss 23 is provided on the end of the lower shell 2 away from the rotatably connected upper shell 1. The positioning groove 13 and the positioning boss 23 are adapted to each other in shape, and magnetic and metal parts are respectively provided on the positioning groove 13 and the positioning boss 23 to realize magnetic adsorption between the upper shell 1 and the lower shell 2.

[0031] It is understandable that the magnetic component can be set in the positioning groove 13 or on the positioning boss 23. Correspondingly, the metal component can be set on the positioning boss 23 or in the positioning groove 13. As long as the upper shell 1 and the lower shell 2 can be magnetically attracted by the magnetic component and the metal component when the positioning groove 13 and the positioning boss 23 are engaged, the magnetic attraction between the upper shell 1 and the lower shell 2 can be achieved.

[0032] Furthermore, both the positioning groove 13 and the positioning boss 23 are arc-shaped.

[0033] It is understandable that setting both the positioning groove 13 and the positioning boss 23 to be arc-shaped can facilitate better cooperation between the positioning groove 13 and the positioning boss 23 after the upper housing 1 and the lower housing 2 are rotated.

[0034] Furthermore, a QR code 14 is provided on the side of the upper shell 1 that is away from the lower shell 2.

[0035] Understandably, QR code 14 is used to bind information for each quality control card.

[0036] In one embodiment, such as Figure 1 , 5 As shown, the test strip 3 includes a PVC board 31 and a nitrocellulose membrane 32. The PVC board 31 is disposed in the receiving groove 21, and the nitrocellulose membrane 32 is pasted on the side of the PVC board 31 away from the receiving groove 21. The fluorescent control line is located on the side of the nitrocellulose membrane 32 away from the PVC board 31.

[0037] In this embodiment, the fluorescence control lines on the nitrocellulose membrane 32 include a C-line and a T-line, both of which are coated with a fluorescent microsphere solution. The fluorescent microsphere solution used for coating the C-line and T-line is prepared by progressively diluting highly stable fluorescent microspheres with an aqueous solution containing 0.005% PVP-K40 to create a series of gradient concentrations of fluorescent microsphere solutions.

[0038] By using highly stable fluorescent microspheres as the luminescent medium for the quality control card, it exhibits high fluorescence intensity, strong fluorescence attenuation resistance, covers a variety of different wavelengths of fluorescence emission, and is highly resistant to high-temperature and high-humidity operating environments. It is compatible with various fluorescence chromatography analyzers with different wavelength parameters. A stable and reliable standard fluorescence signal source can be provided as a benchmark for instrument performance verification and calibration.

[0039] Furthermore, it is easy to store, has good card-to-card repeatability, and a simple preparation process, providing a convenient and efficient quality control tool for fluorescence immunochromatographic analyzers, effectively reducing maintenance difficulty and cost.

[0040] Furthermore, the PVC board 31 is provided with positioning holes 311, and the receiving groove 21 is provided with positioning posts 211. The positioning posts 211 are inserted into the positioning holes 311 to fix the position of the PVC board in the receiving groove 21.

[0041] It is understandable that by setting the positioning post 211 and the positioning hole 311, the position of the PVC board in the receiving groove 21 can be fixed, that is, the position of the nitrocellulose membrane 32 and the fluorescent quality control line can be fixed.

[0042] It should be noted that the dimensions of the receiving groove 21 and the positioning post 211 should be set to ensure that the test paper card 3 located in the receiving groove 21 does not interfere with the rotation process when the upper shell 1 and the lower shell 2 rotate.

[0043] like Figures 6-8 As shown, the second embodiment of this utility model provides a fluorescence immunochromatographic analyzer, which includes a housing 4 and an optical detection module 5. The optical detection module 5 is located inside the housing 4, and a slot 41 is provided on the housing 4. The fluorescence immunochromatographic quality control card is inserted into the card slot 41, and the optical detection module 5 is used to detect the fluorescence immunochromatographic quality control card in the card slot 41.

[0044] Understandably, when the upper shell 1 and lower shell 2 of the fluorescence immunochromatographic quality control card are closed to hold the test strip card 3, the fluorescence immunochromatographic quality control card can be inserted into the card slot 41, and the fluorescence immunochromatographic quality control card can be detected by the optical detection module 5 to achieve quality inspection of the fluorescence immunochromatographic analyzer.

[0045] Furthermore, the fluorescence immunochromatographic analyzer also includes a control board 6, an interface board 7, a barcode scanning module 8, and a mechanical motion module 9. The control board 6, interface board 7, barcode scanning module 8, and mechanical motion module 9 are all located inside the housing 4, and the optical detection module 5 is integrated on the control board 6.

[0046] The mechanical motion module 9 and the card slot 41 are located below the control board 6. The slide rail of the mechanical motion module 9 is parallel to the card slot 41. The card slot 41 is used to fix the quality control card and is engaged in the fixing block 10. The fixing block 10 is connected to the slider on the slide rail through a connector. The exterior of the housing 4 is equipped with a printer, a display, a quality control card inlet, and several interfaces. The printer and the display are respectively connected to the control board 6. The quality control card inlet is connected to one end of the card slot 41. Several interfaces are respectively connected to the interface board 7. The housing 4 has a base plate inside. The control board 6 is fixed to the base plate by a support member. The interface board 7 is directly fixed inside the housing 4. The control board 6 is supported on the base plate inside the housing by the support member to form a space between the control board 6 and the base plate for the reagent card quality control card to move through, so as to realize the detection of the reagent card in the card slot 41. The mechanical motion module 9 includes a lead screw motor 91, which drives the lead screw nut to perform forward and backward translational motion through the lead screw. The lead screw nut is connected to the slider on the slide rail and drives the slider to perform linear motion. The slider is connected to the fixed block 10 through the connector and drives the fixed block 10 to move. The lead screw motor 91 is connected to the control board 6.

[0047] A position sensor is located below the control board 6 to detect the position of the fixed block 10, thereby controlling the forward and reverse rotation of the lead screw motor 91 and realizing the reciprocating movement of the card slot 41. The quality control card inlet is located at the front of the housing 4, while several interfaces are located at the rear of the housing 4. The display and printer are located at the top of the housing 4. An ID card inlet is also located at the front of the housing 4 for inserting ID cards. The interfaces include a DC interface socket, an RS232 interface, a network port, dual USB interfaces, and a TF card interface. A DC power supply can be connected via the DC interface socket, and detection information can be transmitted to external devices via the RS232 interface, network port, dual USB interface, and TF card interface. The control board 6 also integrates a communication module for connecting to external devices via the RS232 interface, network port, dual USB interface, or TF card interface. The communication module can be implemented using existing mature modules, and the card slot 41 has an adjustable structure to accommodate different quality control cards.

[0048] In use, the quality control card is inserted through the quality control card inlet and pushed to the bottom of the card slot 41, pressing against the fixing block 10. The card slot 41 is connected to the slider of the mechanical motion module 9 through the fixing block 10. The mechanical motion module 9 drives the slider to move along the slide rail through the lead screw motor 91, which drives the fixing block 10 and the card slot 41 locked in the fixing block to move back and forth, thereby realizing the forward and backward movement of the quality control card. The optical detection module 5 and the barcode scanning module 8 are located above the quality control card. After the quality control card moves to the detection position, the optical detection module 5 and the barcode scanning module 8 start working to perform photoelectric conversion of the quality control card and realize the detection and analysis function. Finally, the detection and analysis results of the quality control card are displayed on the monitor, and the printer allows users to print out the information on paper.

[0049] Compared with the prior art, the fluorescence immunochromatographic quality control card and analyzer provided by this utility model are connected by sliding connection of the upper shell and the lower shell at one corner, and magnetic adsorption at the end away from the sliding connection, so that the separation and closing of the upper shell and the lower shell are faster, so as to facilitate the separation or closing of the upper shell and the lower shell and the replacement of the test strip card.

[0050] The specific embodiments of this utility model described above do not constitute a limitation on the scope of protection of this utility model. Any other corresponding changes and modifications made based on the technical concept of this utility model should be included within the scope of protection of the claims of this utility model.

Claims

1. A fluorescence immunochromatographic quality control card, characterized in that, include: The test strip consists of an upper shell, a lower shell, and a test strip card. The upper shell has an observation window, and the lower shell has a receiving groove. The test strip card is placed in the receiving groove and has a fluorescence control line on it, with the fluorescence control line located in the corresponding area of ​​the observation window. One corner of the upper shell is rotatably connected to one corner of the lower shell, and the end of the upper shell that is rotatably connected to the lower shell is magnetically attracted to the lower shell.

2. The fluorescence immunochromatographic quality control card as described in claim 1, characterized in that: The upper housing is provided with a rotating shaft, and the lower housing is provided with a rotating hole. The rotating shaft and the rotating hole are respectively located at one corner of the upper housing and the lower housing, and the rotating shaft and the rotating hole are rotatably engaged.

3. The fluorescence immunochromatographic quality control card as described in claim 2, characterized in that: The rotating shaft includes a rotating part and a limiting part. One end of the rotating part is connected to the upper housing. The limiting part is located at the end of the rotating part away from the upper housing, and the diameter of the limiting part is larger than the diameter of the rotating part. The rotating hole includes a rotating hole and a limiting hole. The limiting hole is located on the side of the rotating hole away from the upper housing and communicates with the rotating hole. The diameter of the limiting hole is larger than the diameter of the rotating hole. The rotating part and the limiting part are respectively rotatably engaged with the rotating hole and the limiting hole.

4. The fluorescence immunochromatographic quality control card as described in claim 1, characterized in that: The upper housing is provided with a positioning groove at the end away from the rotatably connected lower housing, and the lower housing is provided with a positioning boss at the end away from the rotatably connected upper housing. The positioning groove and the positioning boss are adapted to each other in shape, and magnetic and metal parts are respectively provided on the positioning groove and the positioning boss.

5. A fluorescence immunochromatographic quality control card as described in claim 4, characterized in that: Both the positioning groove and the positioning boss are arc-shaped.

6. The fluorescence immunochromatographic quality control card as described in claim 1, characterized in that: A QR code is provided on the side of the upper shell away from the lower shell.

7. The fluorescence immunochromatographic quality control card as described in claim 1, characterized in that: The test strip includes a PVC board and a nitrocellulose membrane. The PVC board is disposed in the receiving groove, and the nitrocellulose membrane is adhered to the side of the PVC board away from the receiving groove. The fluorescent control line is located on the side of the nitrocellulose membrane away from the PVC board.

8. The fluorescence immunochromatographic quality control card as described in claim 7, characterized in that: The PVC board is provided with positioning holes, and the receiving groove is provided with positioning posts, which are inserted into the positioning holes.

9. A fluorescence immunochromatographic quality control card as described in claim 7, characterized in that, include: The fluorescence control line includes a C-line and a T-line, both of which are coated with a fluorescent microsphere solution.

10. A fluorescence immunochromatographic analyzer, characterized in that, Includes the quality control card, housing, and optical detection module as described in any one of claims 1-9, wherein the optical detection module is located inside the housing, and the housing is provided with a card slot; The quality control card is inserted into the card slot, and the optical detection module is used to detect the fluorescence immunochromatographic quality control card in the card slot.

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