A test kit for anti-tuberculosis drugs

Abstract

This utility model relates to the field of drug detection technology, specifically an anti-tuberculosis drug detection kit, comprising a kit body, a lid, and a foam storage plate. The kit body includes a portable fluorescence reader positioning slot, a blood collection needle compartment, a buffer tube well array, and a composite chromatography test strip storage slot, for respectively embedding a portable fluorescence reader, a blood collection needle, a buffer tube, and a composite chromatography test strip. The lid engages with the kit body via a locking pin, and a spring-loaded pressure plate at the bottom secures the stored items. A spring-loaded stopper within the composite chromatography test strip storage slot independently fixes the test strip. This kit integrates detection tools, is easy to carry and operate quickly, and is suitable for quantitative monitoring of tuberculosis drug concentrations at the grassroots level.

Description

Technical Field

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

[0002] Tuberculosis treatment often requires long-term combined use of drugs such as isoniazid, rifampin, and pyrazinamide. Due to individual differences in metabolism among patients, blood drug concentrations can fluctuate by more than 20 times. Insufficient concentrations will directly lead to treatment failure and drug resistance, while excessive concentrations can cause liver toxicity and even endanger life.

[0003] Therefore, real-time monitoring of blood drug concentrations is key to optimizing individualized treatment for tuberculosis.

[0004] Currently, the mainstream clinical testing methods include large-scale instrument testing, colloidal gold test strips, or enzyme-linked immunosorbent assay (ELISA) kits. Among these, large-scale instrument testing is costly, colloidal gold test strips only provide qualitative results (such as "positive / negative"), which cannot meet the needs of monitoring therapeutic window concentrations. ELISA kits require multiple incubations and precise pipetting, leading to a high rate of operational errors at the primary care level. Furthermore, the equipment used for testing anti-tuberculosis drugs is diverse in type and often stored separately, making it difficult to carry and use quickly and efficiently during testing. In response to the above problems, this technical solution designs an anti-tuberculosis drug detection kit. Utility Model Content

[0005] The purpose of this invention is to provide an anti-tuberculosis drug 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: An anti-tuberculosis drug detection kit includes a kit body, a lid, and a foam storage plate. The lid is detachably connected to the kit body. The foam storage plate is fixed inside the kit body, with its top lower than the top wall of the kit body. The kit body contains a portable fluorescence reader positioning slot, a blood collection needle compartment, a buffer tube well array, and a composite chromatography test strip storage slot. A portable fluorescence reader is embedded in the portable fluorescence reader positioning slot, a blood collection needle is embedded in the blood collection needle compartment, the buffer tube well array consists of multiple evenly distributed buffer tube wells with buffer tubes inserted longitudinally inside, and multiple composite chromatography test strips are stacked and positioned laterally inside the composite chromatography test strip storage slot. Adjacent composite chromatography test strips are independently positioned. By storing the anti-tuberculosis drug detection tools together in the foam storage plate, rapid detection is facilitated.

[0007] Compared with the prior art, the beneficial effects of this utility model are: by centrally storing the portable fluorescence reader, blood collection needle, buffer tube and composite chromatography test strip in the kit, the problem of scattered storage and inconvenience of carrying the testing tools is solved.

[0008] By preloading anticoagulant and quantum dot fluorescently labeled antibodies onto composite chromatography test strips, sample processing steps are simplified, multiple incubations and pipetting are avoided, and the error rate of primary care operations is reduced.

[0009] The internal tools are secured by a combination of an elastic pressure plate and a foam storage board, and an elastic stop (independently positions the test strips to prevent wear during transportation).

[0010] By automatically reading the fluorescence intensity ratio of the T / C line using a portable fluorescence reader and converting it to drug concentration, the limitation of colloidal gold test strips, which can only perform qualitative detection, is overcome. Attached Figure Description

[0011] Figure 1 This is a schematic diagram of the structure of an anti-tuberculosis drug detection kit.

[0012] Figure 2 This is a top view schematic diagram of an anti-tuberculosis drug detection kit.

[0013] Figure 3 This is a schematic diagram of the lid of an anti-tuberculosis drug detection kit.

[0014] Figure 4 for Figure 2 A magnified structural diagram of A in the diagram.

[0015] Figure 5 This is a schematic diagram of the structure of a composite chromatography test strip in an anti-tuberculosis drug detection kit.

[0016] The kit includes: 10 test kit body, 11 box lid, 13 card hole, 14 locking pin, 15 elastic pressure plate, 16 foam storage plate, 17 portable fluorescence reader positioning slot, 18 blood collection needle compartment, 19 buffer tube hole row, 20 buffer tube, 21 composite chromatography test strip storage slot, 22 elastic block, 23 sample pad, 24 conjugate pad, 25 NC membrane, and 26 absorbent pad. Detailed Implementation

[0017] It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.

[0018] 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.

[0019] 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.

[0020] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0021] Please see Figures 1-4 An anti-tuberculosis drug detection kit includes a kit body 10, a lid 11, and a foam storage plate 16. The lid 11 is detachably connected to the kit body 10. The foam storage plate 16 is fixed inside the kit body 10, with its top lower than the top wall of the kit body 10. The kit body 10 has a portable fluorescence reader positioning slot 17, a blood collection needle compartment 18, a buffer tube well row 19, and a composite chromatography test strip storage slot 21. A portable fluorescence reader is embedded in the portable fluorescence reader positioning slot 17, a blood collection needle is embedded in the blood collection needle compartment 18, the buffer tube well row 19 consists of multiple evenly distributed buffer tube wells, and buffer tubes 20 are inserted longitudinally inside the buffer tube well row 19, and multiple composite chromatography test strips are stacked and positioned laterally inside the composite chromatography test strip storage slot 21. Adjacent composite chromatography test strips are independently positioned. That is, by storing the tools for detecting anti-tuberculosis drugs in the foam storage plate 16, rapid detection can be easily performed. Among them, the portable fluorescence reader has a built-in ultraviolet light source and photoelectric sensor, which can read the fluorescence intensity ratio of the T / C line within 3 seconds, automatically calculate the drug concentration and display it on the LCD screen (which has a built-in standard curve algorithm); The blood collection needle is a disposable, safe blood collection type, which includes a needle tube, sheath, and volume adapter; The buffer solution tube 20 uses a two-way easy-break ampoule, which contains a built-in pH stabilizer; like Figure 5 As shown, the composite chromatography test strip includes a sample pad 23, a conjugate pad 24, an NC membrane 25, and an absorbent pad 26 distributed from upstream to downstream. The sample pad 23 is located at the upstream end of the composite chromatography test strip and has a thickness of 0.5 mm to 0.8 mm. It is used to receive whole blood samples and is preloaded with anticoagulant and detergent to achieve integrated hemolysis and anticoagulation. Binding pad 24 is attached to the downstream of sample pad 23 and is 0.3mm-0.5mm thick. It is used to immobilize quantum dot fluorescently labeled drug antibodies. The NC membrane 25 is placed in the central core area, with a thickness of 0.1mm-0.5mm. The elastic plate is 15mm thick, and the detection lines (T lines) and control lines (C lines) are printed on it, resulting in an antigen-antibody competitive reaction. The absorbent pad 26, with a thickness of 1.0mm-1.2mm, is placed at the downstream end and is used to provide the driving force for chromatography and absorb excess liquid. In this embodiment of the invention, the four corners of the bottom wall of the box cover 11 are equipped with locking pins 14, and the top wall of the test kit body 10 corresponding to the locking pins 14 is provided with locking holes 13. The locking pins 14 are engaged with the locking holes 13, thereby maintaining the detachable connection between the box cover 11 and the test kit body 10. The connection between the foam storage plate 16 and the test kit body 10 includes interference fit, tongue and slot design, or adhesive fixation, etc. The specific connection method depends on the actual situation. Sample pad 23, conjugate pad 24, NC membrane 25, and absorbent pad 26 overlap each other, i.e., the edges of adjacent components overlap by 1-2mm to ensure uninterrupted unidirectional liquid chromatography. At the same time, each component is adhered to the PVC backing with medical-grade double-sided tape to form an integrated composite chromatography test strip. The NC membrane 25 is equipped with a detection line (T line) and a quality control line (C line); the T line includes three parallel lines T1, T2 and T3 with a spacing of 2 mm. The quality control line is set 5 mm downstream of the T line and is used to fix sheep anti-mouse IgG antibodies.

[0022] In one embodiment of the present invention, at least three blood collection needle compartments 18 are provided to facilitate the simultaneous storage of multiple blood collection needles. The buffer tube 20 and the buffer tube hole array 19 are interference-fitted to ensure the stability of the buffer tube 20 after positioning. Multiple elastic blocks 22 are evenly spaced on both ends of the inner end wall of the composite chromatographic test strip storage tank 21. The elastic buffering effect between the elastic blocks 22 is used to place the two ends of the composite chromatographic test strip inside the composite chromatographic test strip storage tank 21 inside it, thereby placing multiple elastic blocks 22 inside the composite chromatographic test strip storage tank 21 for horizontal independent storage. For composite chromatography test strips, when not in use, they are wrapped in a plastic bag or film for isolation.

[0023] In a preferred embodiment of the present invention, an elastic pressure plate 15 is installed at the bottom center of the lid 11. The thickness of the elastic pressure plate 15 is the same as the distance between the top of the foam storage plate 16 and the top wall of the test kit body 10. After the lid 11 is installed and positioned by the locking holes 13 and the locking pins 14, the elastic pressure plate 15 is placed on the upper side of the foam storage plate 16 to longitudinally press the internal components, thereby ensuring the stability of the components in each position during storage.

[0024] The working principle of this utility model is as follows: Open the box cover 11, and the locking pin 14 comes out from the locking hole 13; take out the blood collection needle, buffer tube 20 and composite chromatography test strip.

[0025] Sample processing: Collect whole blood with a lancet and add the whole blood drop into the sample pad 23 of the composite chromatography test strip to achieve integrated hemolysis and anticoagulation.

[0026] Chromatographic reaction: Break the buffer tube 20, add buffer to the sample pad 23, and the sample flows through the quantum dot fluorescently labeled antibody on the binding pad 24, where a competitive reaction occurs at the detection line and control line of the NC membrane 25; Results reading: The test strip is placed in a portable fluorescence reader. The instrument excites fluorescence using an ultraviolet light source, and the photoelectric sensor reads the T / C line intensity ratio, automatically calculates the drug concentration, and displays it.

[0027] 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 all parts in this application are made of metal or plastic materials with suitable strength in the relevant field to ensure that their structural rigidity meets the actual requirements.

[0028] 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. An anti-tuberculosis drug detection kit comprising a detection kit body (10) and a kit cover (11), characterized in that, Also includes: A foam storage plate (16) is fixedly disposed inside the test kit body (10), and its top is lower than the top wall of the test kit body (10); The test kit body (10) has a portable fluorescence reader positioning slot (17) inside, into which a portable fluorescence reader is embedded; At least one blood collection needle compartment (18) is embedded with a blood collection needle; The buffer tube hole row (19) consists of multiple evenly distributed buffer tube holes, with buffer tubes (20) inserted longitudinally. The composite chromatography test strip storage slot (21) contains multiple composite chromatography test strips that are horizontally stacked and positioned.

2. The anti-tuberculosis drug detection kit according to claim 1, characterized in that, The bottom wall of the box cover (11) is fitted with a locking pin (14), and the top wall of the test kit body (10) is provided with a corresponding locking hole (13), and the locking pin (14) engages with the locking hole (13).

3. The anti-tuberculosis drug detection kit according to claim 1, characterized in that, An elastic pressure plate (15) is installed at the bottom center of the box cover (11), the thickness of which is consistent with the distance from the top of the foam storage plate (16) to the top wall of the test kit body (10).

4. The anti-tuberculosis drug detection kit according to claim 1, characterized in that, The composite chromatography test strip storage tank (21) has multiple elastic blocks (22) installed at equal intervals on both ends of its internal end wall, which are used to lock the two ends of the composite chromatography test strip into position.

5. The anti-tuberculosis drug detection kit according to claim 1, characterized in that, The buffer solution tube (20) is a two-way easy-break ampoule with a built-in pH stabilizer.

6. The anti-tuberculosis drug detection kit according to claim 1, characterized in that, The composite chromatography test strip includes a sample pad (23), a conjugate pad (24), an NC membrane (25), and an absorbent pad (26) that are sequentially overlapped from upstream to downstream. The sample pad (23) is 0.5mm-0.8mm thick and preloaded with anticoagulant and detergent; The binding pad (24) has a thickness of 0.3 mm to 0.5 mm and is used to immobilize quantum dot fluorescently labeled drug antibodies; The NC film (25) is printed with three detection lines (T1 / T2 / T3) spaced 2 mm apart and a quality control line 5 mm downstream.

7. The anti-tuberculosis drug detection kit according to claim 1, characterized by, The portable fluorescence reader has a built-in ultraviolet light source and photoelectric sensor, which is used to read the fluorescence intensity ratio of the T / C line and automatically calculate the drug concentration.

8. The anti-tuberculosis drug detection kit according to claim 1, characterized by, The blood collection needle embedded in the blood collection needle compartment (18) is a disposable safety blood collection needle, including a needle tube and a sheath.

9. The anti-tuberculosis drug detection kit according to claim 1, characterized by, The foam storage plate (16) is fixed to the test kit body (10) by interference fit, tongue and slot or adhesive.

10. The anti-tuberculosis drug detection kit according to claim 6, characterized in that, The sample pad (23), conjugate pad (24), NC membrane (25) and absorbent pad (26) are adhered to the PVC backing with medical-grade double-sided tape, with the edges of adjacent components overlapping by 1-2 mm.

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