Drug susceptibility testing equipment

The drug susceptibility testing device addresses AST challenges by using light sources and spectral processing to convert color information into wavelength data, ensuring accurate and rapid sample analysis while minimizing human error and infection risks.

JP3252953UActive Publication Date: 2025-09-24BAIXIAN TECHNOLOGY CO LTD
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Patent Information

Application Number
JP2025002528U
Authority / Receiving Office
JP · JP
Patent Type
Utility models
Current Assignee / Owner
Priority Date
2024-11-15
Filing Date
2025-07-25
Publication Date
2025-09-24
Estimated Expiration
2035-07-25

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Abstract

A drug susceptibility testing device is provided. [Solution] Before starting the test device 1 and conducting the test, the incubation unit 3 is irradiated using a growth-identifying light source 4, and the light source detection module 41 receives growth information obtained from the original sample volume after irradiation to determine whether incubation is complete. The sample is diluted and placed in the reaction chamber of the reagent disk plate 2, and the entire plate is placed in the detection installation slot 11 to perform the test. After the reaction, the same reaction chamber is sequentially irradiated with a first detection light source 51 and a second detection light source 52, each with different wavelengths. Finally, the color information obtained from the AST-specific indicator is converted into wavelength information by the spectral processing module, resulting in the detection result. The sample growth status and detection results can be accurately determined in a simple and quick manner. The detection results are analyzed using two inspection light sources and the spectral processing module, eliminating manual judgment and allowing highly accurate results to be obtained by comparing them with each other.
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Description

[Technical Field]

[0001] The present invention relates to a drug susceptibility testing device, and more particularly to a drug susceptibility testing device that can accurately determine the growth status and detection results of a sample before and after an AST test in a simple and rapid manner. [Background technology]

[0002] Antimicrobial susceptibility testing (AST), also known as antimicrobial susceptibility testing, aims to assess the susceptibility of bacteria, fungi, or other microorganisms to antimicrobial drugs (e.g., antibiotics) so that the most effective treatment can be selected.

[0003] Before and after an AST experiment, the sample concentration or sample volume must be tested. The pre-experiment test is to check the microorganism culture status; only after the microorganisms in the culture dish reach a certain concentration can the sample volume required for the subsequent experiment be provided. The post-experiment test is to check the reaction between the microorganisms and the antibiotic; checking the number of microorganisms after the reaction can determine whether the antibiotic meets the experimental conditions.

[0004] However, the above-mentioned AST laboratory specimen testing has the following problems and drawbacks when used, and improvements are expected.

[0005] 1. Generally, when testing the number of microorganisms in a culture dish, microorganisms are grown at a specific temperature for several hours to several tens of hours, and after a certain period of incubation, it is determined that the microorganisms have reached a certain concentration. However, the growth conditions and conditions for each microorganism vary, and determining whether microorganisms are growing normally using such a vague culture method requires visual inspection, even if a scheduled notification function is provided. If it is determined that microorganisms are not growing properly, the culture dish must be repeatedly removed and placed in a space that provides the appropriate conditions for growth. This creates risks such as judgment errors, unclear sample concentration or sample volume, and infection due to repeated removal.

[0006] 2. Conventional AST test results are determined using the Kirby-Bauer disk diffusion method, and the antibiotic susceptibility of the sample is determined by measuring the size of the inhibition zone. This method has a high risk of misinterpretation, and although it uses a method to determine the color intensity after the reaction with an acid-base indicator, visual inspection is required, and the accuracy and precision of the test results still need to be investigated. Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, taking into account the above-mentioned shortcomings, the applicant of the present invention collected relevant materials, conducted evaluations and studies from various angles, and, by utilizing the experience accumulated over many years in this industry and through continuous prototyping and improvement, developed a drug susceptibility testing device that can accurately determine the growth status and detection results of samples before and after AST testing in a simple and rapid manner.

[0008] The purpose of this invention is to provide a drug susceptibility testing device that utilizes the design of a growth discrimination light source and a light source detection module to accurately determine the growth status of a sample in a culture unit, eliminating the need for manual judgment to reduce the risk of infection, and at the same time, obtaining the concentration of the sample after growth.

[0009] Another object of the present invention is to provide an antimicrobial susceptibility testing device that utilizes the design of a first detection light source, a second detection light source, and a spectral processing module to sequentially irradiate different wavelengths and compare them with each other, thereby converting the color information of an indicator specifically for antimicrobial susceptibility testing (AST) into wavelength information, thereby enabling rapid and accurate detection results to be obtained. [Means for solving the problem]

[0010] To achieve the above-mentioned objectives, the present invention provides a structure comprising a testing device, at least two detection installation slots, a reagent disk plate, a plurality of reaction chambers for containing AST-specific indicators, at least two incubation units for containing original samples, a growth discrimination light source, at least two first detection light sources, at least two second detection light sources with wavelengths different from the first detection light sources, at least one light source detection module, and at least one spectral processing module. The detection installation slots are located within the testing device, and the reaction chambers are located within the reagent disk plate. Each incubation unit is located on one side of the detection installation slot, and the growth discrimination light source is located on one side of the incubation unit and irradiates the original sample. The first detection light source is located on one side of the detection installation slot and irradiates one of the reaction chambers. The second detection light source is located on one side of the detection installation slot and irradiates the same reaction chamber as the first detection light source. The light source detection module receives growth information obtained from the amount of original sample after the incubation units are irradiated by the growth discrimination light source. The spectrum processing module receives color information obtained by the AST-specific indicator after the first and second detection light sources illuminate the reaction vessel, and converts the color information into wavelength information.

[0011] Before using this device to perform a drug susceptibility test, the user places the original sample in the incubation unit of the testing device for pre-incubation. During the incubation period, the incubation unit is illuminated with a growth-detection light source. After illumination with the growth-detection light source, the light source detection module receives growth information obtained from the amount of the original sample to determine whether it has been cultured as a usable sample. The usable sample is then diluted to an appropriate sample and placed in a reaction chamber of a reagent disk plate, which is then placed in the detection installation slot of the testing device and the testing device is started. After the reaction is complete, the appropriate sample in the same reaction chamber is sequentially illuminated with a first detection light source and a second detection light source with different wavelengths. Finally, the spectral processing module receives color information from the reaction chamber after the AST-specific indicator is irradiated and converts the color information into wavelength information to obtain the detection result. This allows for a simple, quick, and accurate determination of the sample growth status and detection results. The detection results are analyzed by two test light sources and the spectral processing module, eliminating manual interpretation and enabling more accurate results by comparing the results. [Effects of the Invention]

[0012] The above-mentioned technology solves the problems that exist in sample testing in conventional AST experiments, such as errors due to human judgment, unclear sample concentration or sample volume, the risk of infection due to multiple extractions and confirmations, and the low precision and accuracy of experimental results due to the need for visual inspection in either case, and achieves the practical advancement of the above-mentioned advantages. [Brief explanation of the drawings]

[0013] [Figure 1] FIG. 1 is an exploded perspective view of a preferred embodiment of the present invention. [Figure 2] FIG. 2 is an exploded view of a preferred embodiment of the present invention. [Figure 3] 1 is a cross-sectional view of a preferred embodiment of the present invention; [Figure 4] 1 is a diagram illustrating the inspection of an incubation unit in a preferred embodiment of the present invention. [Figure 5] FIG. 1 illustrates the addition of a sample in a preferred embodiment of the present invention. [Figure 6] FIG. 2 illustrates the inspection of a reactor in a preferred embodiment of the present invention. [Figure 7] FIG. 10 is a diagram illustrating the identification of specimens in another preferred embodiment of the present invention. [Figure 8] FIG. 10 is a diagram showing a display in another preferred embodiment of the present invention. [Figure 9] FIG. 10 is a diagram illustrating temperature uniformity in yet another preferred embodiment of the present invention. [Figure 10] FIG. 10 is a diagram illustrating light collection in yet another preferred embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0014] Please refer to Figures 1 to 6, which show a reaction vessel inspection from an exploded perspective view of a preferred embodiment of the present invention. As can be seen from the figures, the present invention comprises a test device 1, at least two detection installation slots 11, at least two incubation units 3, a growth discrimination light source 4, at least two first detection light sources 51, at least two second detection light sources 52, at least one light source detection module 41, and at least one spectral processing module 53.

[0015] At least two detection placement slots 11 are provided in the test device 1 and are used to place reagent disc plates 2, respectively, and the reagent disc plates 2 have multiple reaction chambers 21 used to contain indicator reagents 211 dedicated to antimicrobial susceptibility testing (AST).

[0016] A partition plate 12 is provided between each of the detection installation slots 11, and a lid 13 is movably provided on each of the detection installation slots 11.

[0017] At least two incubation units 3 are provided on one side of each detection installation slot 11, and are used to accommodate the original specimen A1.

[0018] The growth discrimination light source 4 is provided on one side of the culture unit 3 and is used to irradiate the original specimen A1 and check its growth status.

[0019] At least two first detection light sources 51 are respectively provided on one side of each of the detection installation slots 11 and illuminate one of the reaction chambers 21 .

[0020] At least two second detection light sources 52 having a wavelength different from that of the first detection light source 51 are respectively provided on one side of each detection installation slot 11 and irradiate the same reaction vessel 21 as the first detection light source 51.

[0021] At least one light source detection module 41 is used to receive proliferation information obtained from the quantity of the original specimens A1 after the proliferation discrimination light source 4 illuminates the incubation unit 3.

[0022] At least one spectral processing module 53 is used to receive color information obtained from the AST-specific indicator 211 after the first detection light source 51 and the second detection light source 52 illuminate the reaction vessel 21, and convert the color information into wavelength information.

[0023] The test device 1 has a box-shaped structure with lids that open upward, and there are two lids 13, which can be opened independently. The detection installation slot 11 is a groove-shaped storage space within the test device 1, and includes an installation area for installing the reagent disk plate 2. The incubation unit 3 is located on one side of the installation area within the test device 1. In this embodiment, two culture bottles are located at the corners of the detection installation slots 11. The growth identification light source 4 is a light-emitting component that specifies a wavelength, and the light source detection module 41 is a light receiver corresponding to the growth identification light source 4 and includes a chip with the function of calculating the growth state. In this embodiment, the growth identification light source 4 and the light source detection module 41 are installed on opposite side walls of the installation stand of the incubation unit 3. The first detection light source 51 and the second detection light source 52 are light-emitting components that specify a wavelength, and the spectrum processing module 53 is a light receiver corresponding to the first detection light source 51 and the second detection light source 52 and includes a chip with the function of converting color information. In this embodiment, the first detection light source 51 and the second detection light source 52 are mounted on the cover 13 of the test device 1, and their irradiation directions are controlled to irradiate the same reaction chamber 21. In principle, the irradiation angles of the first detection light source 51 and the second detection light source 52 are fixed, and a different reaction chamber 21 can be irradiated each time simply by rotating the reagent disk plate 2. The spectral processing module 53 is mounted on the bottom surface of the test device 1 adjacent to the reaction chamber 21. Alternatively, the chips of the light source detection module 41 and the spectral processing module 53 can be integrated into a single processing chip, installed on the test device 1, and electrically connected to the test device 1, thereby enabling the optical receiving function and the calculation function to be separated. However, the corresponding forms of the above-mentioned components are merely examples of preferred embodiments, and any form having equivalent functions is within the scope of the present invention and is not limited to the above examples.

[0024] The above description allows for a clear understanding of the structure of the present technology. By combining this structure, it is possible to easily and quickly accurately determine the growth status and detection results of a sample before and after an AST test. As can be seen from the diagram, before using the present invention to perform a drug susceptibility test, a user places an original sample A1 in the incubation unit 3 of the testing device 1 for pre-incubation. During the incubation period, the incubation unit 3 is illuminated using the growth-detecting light source 4. After illumination by the growth-detecting light source 4, the light source detection module 41 receives growth information obtained from the change in the quantity of the original sample A1, thereby determining whether the original sample A1 has been cultivated as a usable sample A2. In this embodiment, the light source detection module 41 performs the test using turbidimetry. Turbidimetry is a method for evaluating the concentration of suspended particles in a solution. Light emitted by the growth-detecting light source 4 passes through the incubation unit 3, and the light intensity transmitted through the bacterial solution is measured by the light source detection module 41. The decrease in light intensity is proportional to the sample concentration in the bacterial solution. Standardizing the bacterial solution concentration using the McFarland turbidity standard ensures consistency between different experiments. Alternatively, a standard curve of known sample concentrations can be created and the test data can be compared with the standard curve to determine the sample concentration in the bacterial solution. This allows confirmation that the sample is growing reliably and has a sufficient concentration before conducting the test, thereby eliminating invalid tests.

[0025] Next, the usable sample A2 is diluted with culture medium to make the appropriate sample A3, and then placed in the reaction chamber 21 of the reagent disc plate 2, which is then placed in the detection installation slot 11 of the testing device 1, and the testing device 1 is then started. To ensure the same reaction conditions in each reaction chamber 21, not only are equal amounts of AST-specific indicator 211 placed in each reaction chamber 21, but centrifugal force is also used to evenly distribute the appropriate sample A3 to each reaction chamber 21. The diluted appropriate sample A3 is more advantageous in the above-mentioned distribution operation, and by diluting the usable sample A2, the baseline concentration of the bacterial solution can be aligned, allowing for a more accurate understanding of the concentration of the appropriate sample A3 before the reaction.

[0026] After the reaction is complete, the testing device 1 automatically and sequentially irradiates the appropriate specimen A3 in the same reaction chamber 21 with the first detection light source 51 and the second detection light source 52, each with a different wavelength. When the appropriate specimen A3 reacts with the AST indicator 211, a color change occurs. The color change varies depending on the AST indicator 211 used. For example, when the AST indicator 211, which is a resazurin indicator, is used, three color changes occur: blue, purple, and pink. When the AST indicator 211, which is a 2,3,5-triphenyltetrazolium chloride indicator, is used, a color change occurs: colorless, light pink, and dark pink. In this example, the AST indicator 211, which is a resazurin indicator, is used as an example. The resazurin indicator is a redox indicator and is blue in color before the specimen grows. However, when it is subjected to the action of dehydrogenase by NADH in the specimen's mitochondria, it is reduced to purple or pink. Among these, NAD is nicotinamide adenine dinucleotide (NAD), a coenzyme for dehydrogenase, and NADH is the reduced form of nicotinamide adenine dinucleotide. Therefore, the color before the reaction is detected using a first detection light source 51 with an absorbance of OD 600-580 nm, and the color after the reaction is detected using a second detection light source 52 with an absorbance of OD 580-560 nm. When using the AST-specific indicator 211, a 2,3,5-triphenyltetrazolium chloride indicator, the color is detected at an absorbance of OD 245-248 nm.

[0027] The first and second detection light sources 51 and 52 irradiate the AST-specific indicator 211, then pass through the reaction chamber 21 and reach the spectral processing module 53. The spectral processing module 53 receives the post-irradiation color information and converts it into wavelength information to obtain the detection result. Because the detection result is a specific number rather than a vague color, comparing the wavelength information before and after the reaction makes it easy to eliminate abnormal data or select the most clear data result as the basis for judgment. Because the color change of the AST-specific indicator 211 is gradual, the wavelength information converted from the color information is practically a spectral band. As shown in Table 1, the optimal test wavelengths for this test are 600 nm for the first detection light source 51 and 570 nm for the second detection light source 52. For example, the wavelength information measured before and after the reaction of four sets of bacterial solutions was (0.928, 0.198), (0.666, 0.43), (0.535, 0.566), and (0.377, 0.523), respectively. This indicates that there is a possibility of error in artificially determined color changes, and the closer the data before and after the reaction, the more clear the bacteriostatic effect of the antibiotic. This allows for accurate determination of the sample growth status and detection results in a simple and quick manner. Furthermore, because the detection results are analyzed using two test light sources and the spectral processing module 53, manual determination is eliminated, and more accurate results can be obtained by comparing the results with each other.

[0028] [Table 1]

[0029] Furthermore, the test device 1 of the present invention has two detector mounting slots 11, a partition plate 12 between the two detector mounting slots 11, and each of the two detector mounting slots 11 has a cover 13. Therefore, the two detector mounting slots 11 can operate independently, and the partition plate 12 separates the two detector mounting slots 11 to prevent cross-contamination of samples. The cover 13 not only provides dust and dirt protection, but also notifies the user of the operating status of the test device 1. For example, a safety mechanism can be installed to activate only when the cover 13 is closed. This makes the operation of the test device 1 more convenient and efficient.

[0030] Furthermore, the test device 1 of the present invention is provided with a high-speed driving module 54, which rotates each of the reagent disc plates 2 before the first detection light source 51 and the second detection light source 52 are activated, thereby removing any bubbles generated by the reaction in each of the reaction chambers 21 from their central positions. The high-speed driving module 54 is a chip (e.g., provided on one side of the spectral processing module 53) on which control software is installed, or can be integrated into the spectral processing module 53 chip. In this case, a timer and a rotation motor within the test device 1 can be combined. After mixing the sample and the AST indicator 211, the mixture must be left to react for a certain period of time. During the biochemical reaction, bubbles may form. These bubbles may shift the light beams from the first detection light source 51 and the second detection light source 52, affecting the signal reading operation of the spectral processing module 53. Therefore, after the standing time has elapsed, before the first detection light source 51 and the second detection light source 52 are activated, the high-speed driving module 54 in the test device 1 is used to rotate the reagent disk plate 2 at high speed for a short period of time, and centrifugal force is used to remove air bubbles from the center of the reaction chamber 21. This allows the spectrum processing module 53 to receive the light source signal accurately and stably.

[0031] Please refer to FIGS. 8 and 9 together. FIGS. 8 and 9 are diagrams and displays illustrating sample identification in another preferred embodiment of the present invention. As can be seen from the figures, this embodiment is essentially the same as the above-described embodiment, except that an identification reader 14 is provided on the outside of the test device 1. In this embodiment, the identification reader 14 is a combination of a lens and an identification module. Therefore, before starting the test device 1, the identification reader 14 on the outside of the test device 1 is used to read the container identification portion A11 of the original sample A1. The identification module can identify the container identification portion A11, such as characters, a barcode, or a QR code. Therefore, when culturing a sample, the user can first use the identification reader 14 to confirm whether the disc plate being used is correct. This eliminates the risk of misjudgment due to visual inspection by the user and improves the convenience and efficiency of the entire operation. Furthermore, because the identification operation does not contact the test device 1, it does not affect the operational stability of the test device 1. Naturally, the criteria for this judgment can be established by building data on the corresponding materials in a database in advance, but we will not go into detail here.

[0032] The test apparatus 1 further includes a display monitor 15 electrically connected to the spectral processing module 53, and a network connection module 16 for transmitting the detection results of the spectral processing module 53 to the electronic device 6. In this embodiment, the light source detection module 41 and the spectral processing module 53 are integrated into a processing chip, which is installed on the test apparatus 1 and electrically connected to the test apparatus 1. In this manner, the color information, wavelength information, or detection results obtained by the spectral processing module 53 can be directly displayed on the display monitor 15, eliminating the need for a separate transmission line or other display device, allowing users to more intuitively understand the experimental results. Furthermore, the network connection module 16 can be used to transmit the color information, wavelength information, or detection results obtained by the spectral processing module 53 to a remote electronic device 6, such as a mobile phone, so that the content of the display monitor 15 can be synchronized and displayed on the screen of the electronic device 6.

[0033] Please refer to Figures 9 and 10 together. Figures 9 and 10 are temperature equalization diagrams and light collection diagrams for yet another preferred embodiment of the present invention. As can be seen from the figures, this embodiment is similar to the above-mentioned embodiment, except that the testing device 1 includes a heating device 7 and a temperature equalization passage 71 located on one side of the heating device 7 and communicating with each of the detection mounting slots 11. The temperature in each of the detection mounting slots 11 is maintained based on the temperature sensors 72 in each of the detection mounting slots 11. Thus, the two temperature sensors 72 detect the temperature in each of the detection mounting slots 11 and heat the heating device 7 according to the set temperature. However, if the temperature drops due to some factor (for example, working with the lid open on one side), to prevent that drop from affecting the temperature in the other detection installation slot 11, if the temperature fed back by one of the temperature sensors 72 falls below the set value, the testing device 1 automatically starts the heating device 7, blowing out hot air at the set temperature and sending the hot air into the two detection installation slots 11 through the temperature equalization passage 71 that communicates with the two detection installation slots 11. In this way, if the temperature is low, the hot air can raise the temperature, and if the temperature is normal, it is not affected because it is approximately the same temperature as the hot air. This allows the temperature in the two detection installation slots 11 to be kept uniform.

[0034] Furthermore, a focusing element 17 is provided on one side of the first detection light source 51 and the second detection light source 52 in the same detection installation slot 11, so that the light beam can be focused into the reaction vessel 21. In this embodiment, the focusing element 17 is a truncated conical cover, the inner wall of which has a light reflecting effect, and only the front end transmits light, which is hollow or has a convex lens attached thereto to focus the light. In this way, the light beam can be converged to focus the detection light source and accurately project it into the reaction vessel 21 of the reagent disc plate, thereby preventing the effects of scattering and allowing the spectral processing module 53 to collect data more accurately. [Explanation of symbols]

[0035] 1 Test equipment 11 Detection installation slot 12 Divider 13 Lid 14 Identification reading unit 15 Display Monitor 16 Network Connection Module 17 Light-collecting element 2 Reagent disc plates 21 Reaction tank 211 AST Dedicated Indicator 3. Culture Unit 4. Growth identification light source 41 Light Source Detection Module 51 First detection light source 52 Second detection light source 53 Spectral Processing Module 54 High-speed drive module 6 Electronic equipment 7 Heating device 71 Soaking aisle 72 Temperature Sensor A1 Original sample A11 Container identification part A2 Usable specimens A3 Appropriate specimen

Claims

1. A drug susceptibility testing device comprising a test device, at least two detection installation slots, at least two incubation units, a growth discrimination light source, at least two first detection light sources, at least two second detection light sources, at least one light source detection module, and at least one spectral processing module, the at least two detection placement slots are provided in the test device and are used to place reagent disc plates therein, respectively, and the reagent disc plates have a plurality of reaction chambers for containing indicator reagents dedicated to antimicrobial susceptibility testing (AST); The at least two incubation units are respectively provided on one side of the detection installation slots and are used to accommodate original samples; The growth discrimination light source is provided on one side of each of the culture units, and irradiates the original specimen to confirm its growth status; The at least two first detection light sources are respectively provided on one side of the detection installation slots and illuminate any one of the reaction vessels; The at least two second detection light sources having wavelengths different from that of the first detection light source are respectively provided on one side of each of the detection installation slots, and irradiate the same reaction vessel as the first detection light source; the at least one light source detection module is used to receive growth information obtained by the original sample volume after the growth discrimination light source illuminates the incubation unit; A drug susceptibility testing device, characterized in that the at least one spectral processing module is used to receive color information obtained by the indicator after the first detection light source and the second detection light source illuminate the reaction chamber, and convert the color information into wavelength information.

2. The drug susceptibility testing device of claim 1, characterized in that an identification reading unit is provided on the outside of the testing device, the testing device is provided with a display monitor electrically connected to the spectral processing module, and the testing device is provided with a network connection module inside, which transmits the detection results of the spectral processing module to an electronic device.

3. The drug susceptibility testing device of claim 1, characterized in that the testing device comprises a heating device and a temperature equalizing passage provided on one side of the heating device and communicating with each of the detection installation slots, and the temperature in each of the detection installation slots is maintained based on a temperature sensor in each of the detection installation slots.

4. The drug susceptibility testing device of claim 1, characterized in that a focusing element is provided on one side of the first detection light source and the second detection light source in the same detection installation slot, thereby concentrating the light beam within the reaction chamber.

5. The drug susceptibility testing device of claim 1, characterized in that a high-speed drive module is provided within the testing device, thereby rotating each of the reagent disc plates to remove air bubbles generated by reaction in each of the reaction chambers from a central position before each of the first detection light sources and each of the second detection light sources are activated.