A body fluid exclusive fitting recognition and cross contamination blocking system for a multi-body fluid test paper detection device

Abstract

This invention relates to the field of body fluid test strip testing equipment, and discloses a body fluid-specific adapter identification and cross-contamination prevention system for multi-body fluid test strip testing devices. The system includes a single-slot sample inlet channel, a detection reading window, a body fluid-specific adapter, an adapter identification unit, a background residue detection unit, a task type acquisition unit, a historical test record unit, a control module, a blocking execution unit, and a sampling module. The system determines the current body fluid switching conditions by identifying the body fluid type of the adapter and reading the body fluid type records of historical test tasks, and detects the background residue status of the channel or reading window. If the adapter is incompatible or there is a risk of cross-contamination, the system prevents the sampling module from performing formal testing before sampling. This system is mainly used in multi-body fluid test strip testing equipment such as urine, saliva, and breath condensate, and can reduce detection errors caused by misinsertion, residual contamination, and cross-body fluid switching.

Description

Technical Field

[0001] This invention relates to the field of body fluid test strip detection equipment technology, and in particular to a body fluid-specific adapter identification and cross-contamination prevention system for a multi-body fluid test strip detection device. Background Technology

[0002] Body fluid samples such as urine, saliva, and breath condensate can be tested or screened using corresponding test strips. To improve equipment reusability, existing testing equipment is gradually adopting a method of using the same main unit with different test strips or different sample carrier structures to complete the reading of multiple body fluid test strips.

[0003] However, when multiple body fluids share the same testing device, the following problems may easily occur: First, test strips, carriers, or adapters for different body fluids have similar structures, and users may mistakenly insert incompatible test strips or adapters into the device; Second, urine, saliva, or breath condensate residue from the previous test may adhere to the single-slot sample inlet, detection window, or contact area, causing cross-contamination in the next test; Third, some devices rely solely on user selection of test items or software interface prompts, without performing linked verification of adapter type, historical body fluid types, and background residue status before sampling; Fourth, when switching body fluid types or when the residual background is abnormal, the device may still continue to sample and output results, leading to reduced detection stability.

[0004] Therefore, there is a need for a system that can combine body fluid-specific adapter identification, historical body fluid switching records, background residue detection, and hard sampling blocking in multi-body fluid test strip detection devices, so as to directly block the sampling process before formal testing when adapter types are incompatible or there is a risk of cross-contamination. Summary of the Invention

[0005] The purpose of this invention is to provide a body fluid-specific adapter identification and cross-contamination prevention system for a multi-body fluid test strip detection device, in order to solve the problems of adapter misuse, cross-body fluid residue, failure to identify background contamination, and failure to enter formal testing under abnormal conditions in existing multi-body fluid test strip detection devices.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: a body fluid-specific adapter identification and cross-contamination blocking system for a multi-body fluid test strip detection device, comprising a housing, a single-slot sample inlet channel disposed within the housing, a detection reading window corresponding to the single-slot sample inlet channel, a body fluid-specific adapter that can be inserted into the single-slot sample inlet channel, an adapter identification unit, a background residue detection unit, a task type acquisition unit, a historical detection recording unit, a control module, a blocking execution unit, and a sampling module. A body fluid-specific adapter is used to carry test strips corresponding to the target body fluid type and has a coding structure characterizing the body fluid type. The adapter identification unit is used to read the coding structure and generate adapter type information. The background residue detection unit is used to detect the background residue detection area corresponding to the single-slot sample inlet channel and / or detection reading window before formal detection and generate the background residue status. The task type acquisition unit is used to acquire the target body fluid type corresponding to the current detection task. The historical detection record unit is used to provide the body fluid type record of the previous detection task or at least one historical detection task. The control module is used to determine the current body fluid switching conditions based on the target body fluid type and the body fluid type record of the historical detection task, and to perform matching judgment based on the target body fluid type, adapter type information and background residue status. When the target body fluid type matches the adapter type information and the background residue status meets the current body fluid switching conditions, an allow detection signal is output. When the target body fluid type does not match the adapter type information, or when the background residue status does not meet the current body fluid switching conditions, a blocking signal is output to the blocking execution unit before the sampling module performs formal detection to prevent the sampling module from performing formal detection.

[0007] Furthermore, the body fluid-specific adapters may include at least two of the following: urine adapters, saliva adapters, and breath condensate adapters. Each body fluid-specific adapter may have a different coding structure and / or a different insertion and mating structure. The coding structure may include a mechanical notch, a protrusion, an optical coding area, a conductive contact, a magnetic element, or a combination thereof. The insertion and mating structure may include a limiting groove, a positioning notch, an end shoulder, a lateral positioning rib, or a combination thereof, so that the device can identify the body fluid type before the test strip enters the detection process and reduce the risk of misinsertion.

[0008] Furthermore, the background residue detection area includes the channel background detection area located within the single-slot sample inlet channel and the reading window background detection area located at the corresponding position of the detection reading window. The background residue detection unit determines whether there is a risk of residue in the single-slot sample inlet channel and the detection reading window area through characteristics such as color reflection, brightness, wetting, capacitance or conductivity.

[0009] Furthermore, the current body fluid switching conditions include the allowable residual threshold corresponding to the current target body fluid type. When the body fluid type of the previous detection task or historical detection task is the same as the current target body fluid type and no cross-body fluid switching occurs, the control module calls the first allowable residual threshold; when the body fluid type of the historical detection task is different from the current target body fluid type, or when different body fluid type switching occurs consecutively, the control module calls the second allowable residual threshold, which is lower than the first allowable residual threshold, or calls the forced cleaning confirmation rule.

[0010] This invention also provides a method for preventing cross-contamination, comprising: acquiring the target body fluid type corresponding to the current detection task; reading the coding structure of the body fluid-specific adapter and generating adapter type information; determining whether the adapter type information matches the target body fluid type; if they do not match, outputting a blocking signal and prohibiting formal detection before the sampling module performs formal detection; if they match, retrieving the body fluid type record of the historical detection task and determining the current body fluid switching state; performing pre-detection on the background residue detection area corresponding to the single-slot sampling channel and / or detection reading window and generating a background residue state; under the condition that the adapter type information matches the target body fluid type, when the background residue state meets the current body fluid switching conditions, outputting an allow detection signal and entering the sampling process; when the background residue state does not meet the current body fluid switching conditions, outputting a blocking signal and prohibiting formal detection.

[0011] Compared with the prior art, the present invention has at least the following beneficial effects: First, by using a body fluid-specific adapter and its coding structure and / or insertion and mating structure, the device can identify the body fluid type corresponding to the adapter before the test strip enters the formal test, reducing the risk of misinsertion and misuse; Second, by using a background residue detection unit to pre-detect the corresponding area of ​​the single-slot sample inlet channel and the detection reading window, the risk of residual contamination can be identified before sampling; Third, by using a historical detection recording unit to include the body fluid type in the previous test task or continuous test task in the judgment, a lower allowable residue threshold or cleaning confirmation rule can be used when switching between body fluids; Fourth, by using a blocking execution unit to prohibit the sampling module from performing formal testing under abnormal conditions, a closed-loop mechanism of body fluid type matching, residue identification, cleaning confirmation, and blocking before result release is formed. Attached Figure Description

[0012] Figure 1 This is a schematic diagram of the overall structure of the body fluid-specific adapter identification and cross-contamination blocking system of the multi-body fluid test strip detection device of the present invention; Figure 2 This is a schematic diagram of the fluid-specific adapter of the present invention and its coding structure and insertion mating structure; Figure 3 This is a schematic flowchart of the cross-contamination blocking method of the present invention; Figure 4This is a schematic diagram illustrating the relationship between the residual detection area and the blocking execution in the background of this invention. Detailed Implementation

[0013] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of protection of the present invention.

[0014] like Figures 1 to 4 As shown, a body fluid-specific adapter identification and cross-contamination blocking system for a multi-body fluid test strip detection device includes a housing 1, a single-slot sample inlet channel 2, a detection reading window 3, a body fluid-specific adapter 4, an adapter identification unit 5, a background residue detection unit 6, a control module 7, a blocking execution unit 8, a historical detection recording unit 9, a task type acquisition unit 10, a cleaning confirmation unit 11, and a sampling module 12.

[0015] The housing 1 provides installation space and external protection. The single-slot sample inlet channel 2 receives the body fluid-specific adapter 4 and guides the body fluid-specific adapter 4, which carries the test strip, into the corresponding position of the detection reading window 3. The detection reading window 3 is used in conjunction with the sampling module 12 to perform optical sampling on the reaction area of ​​the test strip; when using a non-optical sampling structure, it can also be used in conjunction with the corresponding sampling module to complete the detection.

[0016] The body fluid-specific adapter 4 is used to carry test strips corresponding to the target body fluid type. In this embodiment, the body fluid-specific adapter 4 may include at least two of the following: a urine adapter 41, a saliva adapter 42, and a breath condensate adapter 43. Different body fluid-specific adapters 4 are provided with different coding structures 44, which may be mechanical notches, protrusions, optical coding areas, conductive contacts, magnetic elements, or combinations thereof. Figure 2 As shown, different body fluid-specific adapters 4 can also be provided with different insertion and mating structures 45 at the end or side. The insertion and mating structure 45 includes a limiting groove, a positioning notch, an end shoulder, a lateral positioning rib, or a combination thereof, so that mismatched adapters cannot stably enter the preset detection position.

[0017] The adapter identification unit 5 is located near the inlet, side wall, or detection position of the single-slot sample inlet channel 2. It is used to read the coding structure 44 and generate adapter type information. The adapter identification unit 5 can be a mechanical trigger, an optical reader, a conductive detector, a magnetic detector, or a combination thereof. When the user inserts the body fluid-specific adapter 4, the adapter identification unit 5 completes type identification before formal sampling.

[0018] The task type acquisition unit 10 is used to acquire the target body fluid type corresponding to the current detection task. The target body fluid type can be determined by host computer commands, device local interface, detection process configuration, or other input methods. The historical detection record unit 9 is used to save the body fluid type, detection time, blocking status, cleaning confirmation status, and background residue status of the previous detection task or at least one historical detection task, and is used to determine whether the current detection task belongs to cross-body fluid switching or continuous cross-body fluid switching.

[0019] Background residue detection unit 6 is used to pre-detect the background residue detection area before the sampling module 12 performs formal detection. In this embodiment, the background residue detection area includes a channel background detection area 61 located in the single-slot sample inlet channel 2 and a reading window background detection area 62 located at the corresponding position of the detection reading window 3. The background residue detection unit 6 can generate the background residue state through color reflection characteristics, brightness characteristics, wetting characteristics, capacitance characteristics, conductivity characteristics, or combinations thereof.

[0020] Control module 7 receives information on the target body fluid type, adapter type, body fluid type records from historical testing tasks, and background residual status, and makes a judgment based on the current body fluid switching conditions. The current body fluid switching conditions include the allowable residual threshold corresponding to the current target body fluid type. When the body fluid type of the previous or historical testing task is the same as the current target body fluid type and no cross-body fluid switching occurs, control module 7 calls the first allowable residual threshold; when the body fluid type of a historical testing task is different from the current target body fluid type, or when different body fluid type switching occurs consecutively, control module 7 calls a second allowable residual threshold lower than the first allowable residual threshold, or calls a forced cleaning confirmation rule.

[0021] In one working state, when the target body fluid type is urine, the adapter identification unit 5 identifies the urine adapter 41, and the background residual state meets the current body fluid switching conditions corresponding to urine detection, the control module 7 outputs an allow detection signal, and the sampling module 12 enters the formal sampling process.

[0022] In another working state, when the target body fluid type is saliva, but the adapter identification unit 5 identifies urine adapter 41 or exhaled condensate adapter 43, the control module 7 determines that the adapter type is mismatched. Before the sampling module 12 performs the formal test, it outputs a blocking signal to the blocking execution unit 8. The blocking execution unit 8 prohibits the sampling module 12 from performing the formal test and prompts the user to replace the adapter or reinsert it through the prompt output terminal.

[0023] In another working state, when the target body fluid type matches the adapter type information, but the historical detection record unit 9 shows that the previous detection task and the current detection task belong to different body fluid types, and the background residue detection unit 6 detects that the residual characteristics of the channel background detection area 61 or the reading window background detection area 62 exceed the allowable residue threshold corresponding to the current body fluid switching condition, the control module 7 outputs a blocking signal and requires cleaning confirmation.

[0024] The blocking execution unit 8 includes a sampling prohibition control terminal and a prompt output terminal, and is communicatively connected to the cleaning confirmation unit 11. Upon receiving a blocking signal, the sampling prohibition control terminal prevents the sampling module 12 from performing formal testing; the prompt output terminal outputs prompts for replacing the adapter, re-inserting, or cleaning; the cleaning confirmation unit 11 outputs a cleaning confirmation result after cleaning is completed and triggers a re-detection of the background residual state. The control module 7 only releases the prohibition state after cleaning confirmation is completed and the background residual state once again meets the current body fluid switching conditions.

[0025] like Figure 3 As shown, the cross-contamination blocking method of the present invention includes the following steps: S101, obtaining the target body fluid type corresponding to the current detection task; S102, reading the encoding structure 44 of the body fluid-specific adapter 4 and generating adapter type information; S103, determining whether the adapter type information matches the target body fluid type; if not, outputting a blocking signal and prohibiting formal detection before the sampling module 12 performs formal detection; if matching, proceeding to S104; S104, retrieving the body fluid type record of the historical detection task and determining the current body fluid switching state; S105, performing pre-detection on the background residue detection area corresponding to the single-slot sampling channel 2 and / or detection reading window 3 and generating a background residue state; S106, under the condition that the adapter type information has matched the target body fluid type, when the background residue state meets the current body fluid switching conditions, outputting an allow detection signal and entering the sampling process; when the background residue state does not meet the current body fluid switching conditions, outputting a blocking signal and prohibiting formal detection.

[0026] In one optional implementation, after outputting the blocking signal, the control module 7 associates the current target body fluid type, adapter type information, body fluid type records from historical testing tasks, background residual status, and blocking cause to generate a blocking record. This blocking record can be used for subsequent quality traceability, equipment maintenance, and user operation analysis.

[0027] The body fluid-specific adapter 4 in this invention can be a support frame, insert, support strip, disposable kit, or consumable component with a test strip positioning surface. All of them are provided with an encoding structure 44 that can be read by the adapter identification unit 5 and / or an insertion and mating structure 45 corresponding to the target body fluid type.

[0028] The background residue detection unit 6 in this invention can select optical detection, capacitance detection, conductivity detection, contact wetting detection or a combination thereof according to equipment cost, body fluid type and test strip structure, and compare the detection result with the allowable residue threshold corresponding to the current body fluid switching condition to generate background residue status.

[0029] The above embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention.

Claims

1. A body fluid-specific adapter identification and cross-contamination prevention system for a multi-body fluid test strip detection device, characterized in that, The device includes a housing, a single-slot sample inlet channel disposed within the housing, a detection reading window corresponding to the single-slot sample inlet channel, a body fluid-specific adapter that can be inserted into the single-slot sample inlet channel, an adapter identification unit, a background residue detection unit, a task type acquisition unit, a historical detection recording unit, a control module, a blocking execution unit, and a sampling module. The body fluid-specific adapter is used to carry a test strip corresponding to the target body fluid type and is provided with a coding structure characterizing the body fluid type. The adapter identification unit is used to read the coding structure and generate adapter type information. The background residue detection unit is used to detect the background residue detection area corresponding to the single-slot sample inlet channel and / or the detection reading window before formal detection, and generate a background residue status; the task type acquisition unit is used to acquire the target body fluid type corresponding to the current detection task, and the historical detection record unit is used to provide the body fluid type record of the previous detection task or at least one historical detection task; the control module is used to determine the current body fluid switching condition based on the target body fluid type and the body fluid type record of the historical detection task, and to perform a matching judgment based on the target body fluid type, the adapter type information and the background residue status. When the target body fluid type matches the adapter type information and the background residue status meets the current body fluid switching condition, an allow detection signal is output; when the target body fluid type does not match the adapter type information, or when the background residue status does not meet the current body fluid switching condition, an interruption signal is output to the interruption execution unit before the sampling module performs formal detection, so as to prevent the sampling module from performing formal detection.

2. The body fluid-specific adapter identification and cross-contamination prevention system according to claim 1, characterized in that, The fluid-specific adapters include at least two of the following: urine adapters, saliva adapters, and exhaled condensate adapters. Each fluid-specific adapter has a different coding structure and / or a different insertion and mating structure.

3. The body fluid-specific adapter identification and cross-contamination prevention system according to claim 2, characterized in that, The coding structure includes a mechanical notch, a protrusion, an optical coding area, a conductive contact, a magnetic component, or a combination thereof; the insertion and mating structure includes a limiting groove, a positioning notch, an end shoulder, a lateral positioning rib, or a combination thereof; the adapter identification unit includes a mechanical trigger, an optical reading component, a conductive detection component, a magnetic detection component, or a combination thereof corresponding to the coding structure.

4. The body fluid-specific adapter identification and cross-contamination prevention system according to claim 1, characterized in that, The background residue detection area includes a channel background detection area located within the single-slot injection channel and a reading window background detection area located at the corresponding position of the detection reading window. The background residue detection unit is used to acquire the residual features of the channel background detection area and the reading window background detection area, respectively.

5. The body fluid-specific adapter identification and cross-contamination prevention system according to claim 4, characterized in that, The residual features include color reflection features, brightness features, wetting features, capacitance features, conductivity features, or combinations thereof, and the control module generates a background residual state based on the residual features.

6. The body fluid-specific adapter identification and cross-contamination prevention system according to claim 1, characterized in that, The current body fluid switching conditions include the allowable residual threshold corresponding to the current target body fluid type; when the body fluid type record of the previous detection task or historical detection task is the same as the current target body fluid type and no cross-body fluid switching has occurred, the control module calls the first allowable residual threshold; when the body fluid type record of the historical detection task is different from the current target body fluid type, or when different body fluid type switching occurs consecutively, the control module calls the second allowable residual threshold which is lower than the first allowable residual threshold, or calls the forced cleaning confirmation rule.

7. The body fluid-specific adapter identification and cross-contamination prevention system according to claim 1, characterized in that, The blocking execution unit includes a sampling prohibition control terminal and a prompt output terminal, and is communicatively connected to the cleaning confirmation unit. The sampling prohibition control terminal is used to prohibit the sampling module from performing formal testing after receiving a blocking signal. The prompt output terminal is used to output prompts for replacing the adapter, re-inserting, or cleaning. The cleaning confirmation unit is used to output the cleaning confirmation result. The control module releases the prohibition state after the cleaning confirmation is completed and the background residual state meets the current body fluid switching conditions again.

8. A method for preventing cross-contamination, applied to the body fluid-specific adapter identification and cross-contamination prevention system of the multi-body fluid test strip detection device according to any one of claims 1 to 7, characterized in that, The process includes the following steps: S101, obtaining the target body fluid type corresponding to the current detection task; S102, reading the coding structure of the body fluid-specific adapter and generating adapter type information; S103, determining whether the adapter type information matches the target body fluid type; if they do not match, outputting a blocking signal and prohibiting formal detection before the sampling module performs formal detection; if they match, proceeding to S104; S104, retrieving the body fluid type record of historical detection tasks and determining the current body fluid switching state; S105, performing pre-detection on the background residue detection area corresponding to the single-slot injection channel and / or detection reading window and generating a background residue state; S106, under the condition that the adapter type information matches the target body fluid type, when the background residue state meets the current body fluid switching conditions, outputting an allow detection signal and entering the sampling process; when the background residue state does not meet the current body fluid switching conditions, outputting a blocking signal and prohibiting formal detection.

9. The method for preventing cross-contamination according to claim 8, characterized in that, In step S104, when the body fluid type record of the historical detection task is different from the current target body fluid type, a lower allowable residual threshold is invoked compared to the continuous detection conditions of the same body fluid, or a cleaning confirmation is required.

10. The method for preventing cross-contamination according to claim 8, characterized in that, After outputting the blocking signal, the current target body fluid type, adapter type information, body fluid type records of historical detection tasks, background residual status and blocking reason are associated to generate a blocking record. Before re-detection, the control module decides whether to release the blocking based on the cleaning confirmation result and the re-acquired background residual status.

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