Electronic early pregnancy detection rod

Through the spectral analysis system and temperature compensation technology of the electronic early pregnancy detection rod, the problem that existing early pregnancy detection methods cannot accurately predict gestational age and are affected by environmental factors is solved, and high accuracy and reliability gestational age estimation is achieved.

CN120064152AActive Publication Date: 2025-05-30天津鸿宇泰生物科技有限公司
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Patent Information

Application Number
CN202510191141.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-02-20
Publication Date
2025-05-30
Estimated Expiration
2045-02-20

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Abstract

The invention relates to the technical field of pregnancy test bars, in particular to an electronic early pregnancy detection bar. The invention provides an electronic early pregnancy detection bar, which comprises a reagent strip, a spectral analysis system, a temperature sensor, a processor and a display unit, and is characterized in that firstly, the reagent strip is irradiated by an LED light source, and reflected light is received through a corresponding photosensitive sensor; then monitoring the temperature of the reagent strip in real time by using a temperature sensor, compensating and correcting the photosensitive signal by a processor based on temperature data, and calculating the human chorionic gonadotropin level by analyzing corrected spectral data; and finally estimating a gestational week based on a calculation result and displaying the gestational week on a display unit. The accuracy and reliability of detection are improved, active compensation of environmental factors is also realized, and meanwhile, a quantitative result and accurate gestational week estimation are provided through spectral analysis.
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Description

Technical Field

[0001] This application relates to the technical field of pregnancy test sticks, and particularly to an electronic early pregnancy test stick. Background Art

[0002] Early pregnancy detection is an important part of women's health management. Timely and accurate test results are crucial for prenatal care and medical decision-making. With the development of society and the progress of medical technology, people have put forward higher requirements for the accuracy, convenience, and information content of early pregnancy detection.

[0003] The existing technology generally adopts immunochromatography technology, and judges whether a woman is pregnant by detecting the level of human chorionic gonadotropin (hCG) in urine through a test strip. This method is simple to operate and convenient to use, and has been widely used in home self-examination and primary screening in medical institutions. The detection principle is based on the specific binding of antigen and antibody, and indicates the presence of hCG through a color reaction.

[0004] The traditional detection method judges whether a woman is pregnant by visual inspection, and cannot accurately predict the pregnancy period. At the same time, visual interpretation is affected by insufficient light or subjectivity, especially when the analyte level is low at the detection area with weak intensity, and users cannot draw accurate conclusions, which is difficult to meet the needs of modern women for accurate estimation of gestational weeks. This situation needs to be further improved. Summary of the Invention

[0005] In order to solve the problem of the existing technology that cannot accurately predict the pregnancy period, this application provides an electronic early pregnancy test stick, and adopts the following technical solutions: In a first aspect, this application provides an electronic early pregnancy test stick, including: A reagent strip for receiving a sample to be tested and performing an immunochromatography reaction; A spectral analysis system, including: An LED light source for irradiating the test line and the control line on the reagent strip; A photosensitive sensor corresponding to the LED light source for receiving light of different wavelengths reflected from the test line and the control line; A temperature sensor for detecting the temperature of the reagent strip; A processor electrically connected to the spectral analysis system and the temperature sensor, and the processor is configured to: Receive and process the signal data from the photosensitive sensor; Receive and process the temperature data from the temperature sensor; Based on the temperature data, perform temperature compensation and correction on the signal data; Based on the corrected signal data, analyze the color and intensity of the test line and the control line, and calculate the level of human chorionic gonadotropin; Estimate the gestational week based on the human chorionic gonadotropin level; A display unit, electrically connected to the processor, for displaying the estimated gestational week and / or the human chorionic gonadotropin level.

[0006] By adopting the above technical solution, traditional methods often lead to inaccurate or unstable detection results due to factors such as light conditions, subjective judgment of users, and environmental temperature changes. For example, in an environment with insufficient light, a faint test line may be misjudged as a negative result; while in a high-temperature environment, the immunochromatographic reaction rate may increase, affecting the accuracy of the result. In this application, an LED light source is first used to irradiate the reagent strip, and the reflected light is received by a corresponding photosensitive sensor; then, a temperature sensor is used to monitor the temperature of the reagent strip in real time, and the processor compensates and corrects the photosensitive signal based on the temperature data, and calculates the human chorionic gonadotropin level by analyzing the corrected spectral data; finally, the gestational week is estimated based on the calculation result and presented on the display unit; not only improves the accuracy and reliability of the detection, but also realizes active compensation for environmental factors, and at the same time provides a quantitative result and an accurate gestational week estimate through spectral analysis.

[0007] Optionally, it further includes a storage unit, which is electrically connected to the processor and used to store calibration algorithm parameters, and the processor performs temperature compensation and correction on the signal data according to the calibration algorithm parameters.

[0008] By adopting the above technical solution, traditional temperature compensation methods often use fixed calibration formulas, which are difficult to adapt to the characteristic differences of different batches of reagent strips and complex environmental changes. For example, under extreme temperature conditions or when using reagent strips of different production batches, fixed calibration methods may result in insufficient or excessive compensation, affecting the reliability of the detection results; in this application, calibration algorithm parameters for different batches of reagent strips and temperature ranges are pre-stored in the storage unit. During the detection process, the processor retrieves the corresponding calibration algorithm parameters from the storage unit according to the currently detected temperature data; then, the processor uses these parameters to perform precise temperature compensation and correction on the signal data of the photosensitive sensor; finally, the human chorionic gonadotropin level is calculated and the gestational week is estimated based on the corrected data, improving the accuracy and reliability of the detection results.

[0009] Optionally, the storage unit is further used to store historical detection data, and the processor is further configured to: Analyze the change trend of the human chorionic gonadotropin level based on the current detection data and historical detection data.

[0010] By adopting the above technical solution, traditional early pregnancy detection methods usually only provide single test results and cannot reflect the dynamic change trend of human chorionic gonadotropin (hCG) levels, which limits users' comprehensive understanding of their pregnancy status. For example, in some cases, abnormal increases or decreases in hCG levels may indicate the risk of pregnancy complications, but these potential problems are difficult to detect through single tests; in this application, the results of each test are stored in a storage unit; when the processor conducts a new test, it reads the stored historical data simultaneously; then, by combining the current test data and the historical data, it uses a statistical analysis algorithm to calculate the change trend of hCG levels, which can help users better understand their pregnancy progress and detect potential abnormalities at an early stage.

[0011] Optionally, the processor is further configured to: Adjust the light emission intensity of the LED light source based on the temperature data.

[0012] By adopting the above technical solution, traditional electronic detection devices usually use LED light sources with a fixed light emission intensity. However, the luminous efficiency of LEDs changes with temperature. For example, in a high-temperature environment, the luminous efficiency of LEDs decreases, which may lead to a weakening of the signal intensity of the detection line and affect the accuracy of the detection; while in a low-temperature environment, the luminous efficiency of LEDs increases, which may cause signal saturation and reduce the detection sensitivity; in this application, the light emission intensity of the LED is adjusted based on the temperature data to achieve dynamic adjustment of the LED light source intensity, ensuring the consistency and stability of the signal in different temperature environments, and improving the accuracy and reliability of the detection results.

[0013] Optionally, the processor is further configured to: Obtain preset batch calibration parameters as the initial calibration parameters for each LED light source and each photosensitive sensor; Obtain detection data at multiple time points during a single test, and evaluate the short-term performance changes of each photosensitive sensor based on the detection data; Adjust the calibration parameters in real time according to the short-term performance changes and the initial calibration parameters; Apply the adjusted calibration parameters to the spectral analysis system to optimize the detection results.

[0014] By adopting the above technical solution, traditional electronic detection devices usually rely on fixed calibration parameters and cannot adapt to the real-time performance changes of devices. For example, due to production batch differences, there may be initial performance differences in LEDs and photosensitive sensors of different devices. During use, factors such as temperature changes and device aging may cause short-term performance drift, which will affect the accuracy and consistency of detection. This application first uses preset batch calibration parameters as initial values. Then, during a single detection process, data at multiple time points are continuously collected to evaluate the short-term performance changes of each photosensitive sensor. Based on these short-term changes and the initial calibration parameters, the calibration parameters are calculated and adjusted in real time. Finally, the adjusted parameters are applied to the spectral analysis system to optimize the detection results, achieving real-time adaptive calibration of the detection system, not only solving the batch difference problem but also being able to dynamically compensate for performance drift during use, significantly improving the accuracy, stability, and consistency of the detection results.

[0015] Optionally, evaluating the short-term performance changes of each photosensitive sensor according to the detection data specifically includes the following steps: Classify the photosensitive sensors into main photosensitive sensors and auxiliary photosensitive sensors according to the received light wavelength of each photosensitive sensor. According to the detection data at the multiple time points, calculate the signal intensity change index of the main photosensitive sensors and the signal-to-noise ratio change index of the auxiliary photosensitive sensors respectively. Evaluate the short-term performance changes of each photosensitive sensor according to the signal intensity change index and the signal-to-noise ratio change index.

[0016] By adopting the above technical solution, the performance evaluation of traditional photosensitive sensors usually adopts a unified standard, ignoring the different importance and characteristics of sensors with different wavelengths in detection. For example, in early pregnancy detection, certain specific wavelengths are crucial for the identification of the test line, while other wavelengths are mainly used for auxiliary judgment or background correction. Adopting a unified standard may cause the performance changes of key wavelength sensors to be masked, or the minor fluctuations of non-key sensors to be over-amplified, thus affecting the overall detection accuracy. This application first classifies the sensors into main photosensitive sensors and auxiliary photosensitive sensors according to the wavelength of light received by each photosensitive sensor and its importance in detection. Then, for the main photosensitive sensors, focus on calculating the change index of their signal intensity to ensure the detection stability of key wavelengths. For the auxiliary photosensitive sensors, mainly calculate the change index of their signal-to-noise ratio to optimize the reliability of background correction and auxiliary judgment. Finally, comprehensively considering the two types of indexes, comprehensively evaluate the short-term performance changes of each photosensitive sensor, realizing targeted evaluation of sensors with different functions, not only ensuring the accuracy of key wavelength detection but also optimizing the detection effect of auxiliary wavelengths, and improving the performance and reliability of the overall detection system.

[0017] Optionally, according to the short-term performance change and the initial calibration parameters, the calibration parameters are adjusted in real time, specifically including the following steps: According to the signal strength change index of the main photosensitive sensor, adjust the light emission intensity of the corresponding LED light source and the gain parameter of the main photosensitive sensor; According to the signal-to-noise ratio change index of the auxiliary photosensitive sensor, adjust the filtering parameter and threshold setting of the auxiliary photosensitive sensor; Integrate the adjustment results of the main photosensitive sensor and the auxiliary photosensitive sensor to generate comprehensive calibration parameters.

[0018] By adopting the above technical solution, the present application first dynamically adjusts the light emission intensity of the corresponding LED light source and the gain parameter of the sensor according to the signal strength change index of the main photosensitive sensor to ensure the detection accuracy of the key wavelength; then based on the signal-to-noise ratio change index of the auxiliary photosensitive sensor, adjusts its filtering parameter and threshold setting to optimize the background correction effect; finally integrates the adjustment results of the main sensor and the auxiliary sensor to generate comprehensive calibration parameters to optimize the overall system; realizes the targeted calibration of different types of sensors and enhances the stability and reliability of the entire detection system.

[0019] Optionally, the processor is further configured to: During the detection process, according to the adjusted calibration parameters, adjust the working parameters of the spectral analysis system in real time; Based on the adjusted working parameters, perform multiple sampling analyses on the test line and the control line; According to the results of the multiple sampling analyses, calculate the final human chorionic gonadotropin level and estimate the gestational week.

[0020] By adopting the above technical solution, traditional early pregnancy detection devices cannot adapt to various changes and interferences that may occur during the detection process. For example, the water absorption speed of the test strip may change due to environmental temperature or humidity, resulting in inconsistent color development time and intensity of the test line and the control line. In the detection process of the present application, according to the latest calibration parameters provided by the dynamic calibration parameter adjustment module, the working parameters of the spectral analysis system are adjusted in real time. Based on the adjusted working parameters, multiple sampling analyses are performed on the test line and the control line to capture the dynamic changes in the hCG level; finally, according to the results of the multiple sampling analyses, the final hCG level is comprehensively calculated and the gestational week is estimated; realizes the real-time optimization and dynamic adjustment of the detection process, can adapt to different samples and environmental conditions, and can improve the reliability of the results through multiple samplings.

[0021] Optionally, it further includes a power supply unit for supplying power to each component of the electronic early pregnancy detection stick.

[0022] By adopting the above technical solution, the integrated power supply unit realizes the complete portability and independence of the device, and users can conveniently perform detections at any time and place.

[0023] Optionally, it further includes a communication module for transmitting the detection result to an external device.

[0024] By adopting the above technical solution, through the communication module, not only is the visualization of the detection result more intuitive, but also the long-term storage, trend analysis and remote sharing of data are realized, improving the user experience and medical value.

[0025] In summary, the present application includes at least one of the following beneficial technical effects: 1. Traditional methods often result in inaccurate or unstable detection results due to factors such as light conditions, users' subjective judgments, and environmental temperature changes. For example, in an environment with insufficient light, a faint test line may be misjudged as a negative result; while in a high-temperature environment, the immunochromatographic reaction rate may increase, affecting the accuracy of the result. The present application first uses an LED light source to irradiate the reagent strip and receives the reflected light through a corresponding photosensitive sensor; then uses a temperature sensor to monitor the temperature of the reagent strip in real time, and the processor compensates and corrects the photosensitive signal based on the temperature data, and calculates the human chorionic gonadotropin level by analyzing the corrected spectral data; finally, estimates the gestational week based on the calculation result and presents it on the display unit; not only improves the accuracy and reliability of the detection, but also realizes the active compensation for environmental factors, and at the same time provides a quantitative result and an accurate gestational week estimate through spectral analysis; 2. Traditional electronic detection devices usually adopt an LED light source with a fixed luminous intensity. However, the luminous efficiency of the LED changes with temperature. For example, in a high-temperature environment, the luminous efficiency of the LED decreases, which may lead to a weakening of the test line signal intensity and affect the accuracy of the detection; while in a low-temperature environment, the luminous efficiency of the LED increases, which may cause signal saturation and reduce the detection sensitivity. The present application adjusts the luminous intensity of the LED based on the temperature data, realizes the dynamic adjustment of the LED light source intensity, ensures the consistency and stability of the signal in different temperature environments, and can improve the accuracy and reliability of the detection result; 3. Traditional electronic detection devices usually rely on fixed calibration parameters and cannot adapt to the real-time performance changes of devices. For example, due to production batch differences, there may be initial performance differences in LEDs and photosensitive sensors of different devices. During use, factors such as temperature changes and device aging may cause short-term performance drift, which will affect the accuracy and consistency of detection. In this application, preset batch calibration parameters are first used as initial values. Then, data at multiple time points are continuously collected during a single detection process to evaluate the short-term performance changes of each photosensitive sensor. Based on these short-term changes and the initial calibration parameters, the calibration parameters are calculated and adjusted in real time. Finally, the adjusted parameters are applied to the spectral analysis system to optimize the detection results, achieving real-time adaptive calibration of the detection system, not only solving the batch difference problem but also dynamically compensating for performance drift during use, significantly improving the accuracy, stability, and consistency of the detection results. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 FIG. is a schematic diagram of the modules of an electronic early pregnancy test stick according to Embodiment 1 of the present application; Figure 2 FIG. is a schematic diagram of the method flow executed by the processor in an electronic early pregnancy test stick according to Embodiment 1 of the present application; Figure 3 FIG. is a schematic diagram of the method flow executed by the processor in an electronic early pregnancy test stick according to Embodiment 2 of the present application; Figure 4 FIG. is a schematic diagram of the method flow executed by the processor in an electronic early pregnancy test stick according to Embodiment 3 of the present application; Figure 5 FIG. is a schematic diagram of the flow of step S420 executed by the processor in an electronic early pregnancy test stick according to Embodiment 3 of the present application; Figure 6 FIG. is a schematic diagram of the flow of step S430 executed by the processor in an electronic early pregnancy test stick according to Embodiment 3 of the present application; Figure 7 FIG. is a schematic diagram of the flow of the multiple sampling and analysis steps executed by the processor in an electronic early pregnancy test stick according to Embodiment 3 of the present application. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0027] The terms used in the following embodiments of the present application are only for the purpose of describing specific embodiments and are not intended to limit the present application. As used in the specification and appended claims of the present application, the singular forms "a", "an", "the", "above", "said", "this" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It should also be understood that the term "and / or" used in the present application refers to any and all possible combinations including one or more of the listed items.

[0028] Hereinafter, the terms "first" and "second" are for descriptive purposes only and should not be construed as implying or suggesting relative importance or implicitly indicating the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the embodiments of the present application, unless otherwise specified, the meaning of "a plurality" is two or more.

[0029] The embodiments of the present application will be further described in detail below with reference to the accompanying drawings of the specification.

[0030] Embodiment 1 The present application provides an early pregnancy detection stick, referring to Figure 1 , which includes a reagent strip, a spectral analysis system, a temperature sensor, a processor, and a display unit.

[0031] The reagent strip is used to receive the urine sample to be tested and perform an immunochromatographic reaction. This reagent strip uses a highly sensitive immunochromatographic technique and can quickly capture human chorionic gonadotropin (hCG) in the sample. The reagent strip is provided with a test line (T line) and a control line (C line).

[0032] The spectral analysis system is the core part of this detector, including an LED light source and a corresponding photosensitive sensor. Specifically, in this embodiment, a D2D4 light source configuration is adopted, including two LEDs with different wavelengths. D2 is used to excite and detect the T line, and D4 is used to excite and detect the C line. The photosensitive sensor corresponds to the LED light source and uses two photosensitive receivers D1 and D3. D1 mainly receives the light reflected from the T line, and D3 mainly receives the light reflected from the C line.

[0033] The temperature sensor is installed near the reagent strip and is used to monitor the temperature change of the reagent strip in real time, providing a basis for data correction.

[0034] The MCU main control chip U1 serves as the processor and is electrically connected to the spectral analysis system, the temperature sensor, and the LED display screen. Referring to Figure 2 , the main functions of the processor include the following steps: S210: Receive and process the signal data from the photosensitive sensor.

[0035] S220: Receive and process the temperature data from the temperature sensor.

[0036] S230: Based on the temperature data, perform temperature compensation and correction on the signal data.

[0037] S240: Based on the corrected signal data, analyze the color and intensity of the test line and the control line, and calculate the human chorionic gonadotropin level.

[0038] S250: Estimate the gestational age based on the human chorionic gonadotropin level.

[0039] In this embodiment, the display unit is an LED display screen, which is electrically connected to the processor and is used to display the estimated gestational age and / or hCG level.

[0040] It also includes a power supply unit, namely a battery, which is used to supply power to each component of the test stick to ensure the stable operation of the entire system.

[0041] A communication module, which is used to transmit the test results to an external device.

[0042] A buzzer, which is used to provide a sound prompt to enhance the user experience.

[0043] A switch button, which is used to cooperate with the reagent card insertion mechanism to realize the automatic power-on function.

[0044] To ensure the accuracy and reliability of the test results, this embodiment also includes a voltage and current stabilization module. Through a high-precision current detection circuit and a feedback control loop, a stable working current is provided for the LED light sources D2 and D4, and the current fluctuation is controlled within ±1%. At the same time, a temperature compensation mechanism is integrated. According to the real-time data of the temperature sensor, the drive parameters are automatically adjusted to ensure that the luminous intensity of the LED light source remains constant within the working temperature range of -10°C to 40°C. In addition, this module also has overcurrent protection and short-circuit protection functions. In case of an abnormality, the power supply can be quickly cut off, and the response time is less than 1 ms, effectively protecting the LED light source and other circuit components. Through the application of the voltage and current stabilization module, the stability of the light intensity is significantly improved, ensuring the accuracy and repeatability of the test results during long-term use, and at the same time extending the service life of the LED light source.

[0045] The working process of this embodiment is as follows: The user drops the urine sample onto the reagent strip, inserts the reagent card, triggers the switch button S1, and starts the test process. The MCU main control chip U1 activates the LED light sources D2 and D4 to irradiate the T line and C line on the reagent strip respectively. The photosensitive sensor D1 receives the reflected light of the T line, D3 receives the reflected light of the C line, and transmits the signals to the MCU main control chip U1. The temperature sensor simultaneously detects the temperature of the reagent strip and transmits the temperature data to the MCU main control chip U1. The MCU main control chip U1 performs temperature compensation and correction on the signal data according to the temperature data, analyzes the corrected signal data, calculates the hCG level, estimates the gestational age, and then transmits the results to the LED display screen to display the estimated gestational age and / or hCG level. The buzzer BAT gives a sound prompt to inform the user that the test is completed.

[0046] Specifically, the test results are divided into 5 types: not pregnant (NO), pregnant for 3 - 7 days (0.5 - 1W), pregnant for 1 - 2 weeks (1 - 2W), pregnant for 2 - 3 weeks (2 - 3W), pregnant for more than 3 weeks (3+W).

[0047] Example 2 In one embodiment, referring to Figure 3 This embodiment provides an improved electronic pregnancy test stick. A storage unit is added on the basis of Embodiment 1. The storage unit is electrically connected to the processor (MCU main control chip U1) for storing calibration algorithm parameters and historical test data. The function of the processor is expanded. The processor also includes the following steps: S310, obtaining correction algorithm parameters, and performing temperature compensation correction on signal data according to the correction algorithm parameters.

[0048] Specifically, the processor adds the following functions on the basis of Example 1: the processor reads the correction algorithm parameters for different batches of reagent strips and temperature ranges from the storage unit. These parameters are obtained in advance through a large number of experiments and data analysis, and can adapt to the characteristic differences of different batches of reagent strips and complex environmental changes. During the detection process, the processor retrieves the corresponding correction algorithm parameters from the storage unit according to the currently detected temperature data, and performs accurate temperature compensation correction on the signal data of the photosensitive sensors D1 and D3.

[0049] S320. Obtain historical test data, and analyze the changing trend of human chorionic gonadotropin levels based on current test data and historical test data.

[0050] Specifically, the processor is configured to access the historical test data in the storage unit, and analyze the change trend of the hCG level in combination with the current test data. The specific steps are as follows: after each test is completed, the test result is stored in the storage unit; when a new test is performed, the processor reads the stored historical data; using a statistical analysis algorithm, combined with the current test data and historical data, calculates the change trend of the hCG level; based on the analysis results, it is determined whether the hCG level is showing an upward, stable or downward trend.

[0051] S330: Acquire temperature data, and adjust the luminous intensity of the LED light source based on the temperature data.

[0052] Specifically, the processor dynamically adjusts the luminous intensity of the LED light sources D2 and D4 according to the temperature data provided by the temperature sensor. Since the luminous efficiency of the LED changes with temperature. In a high temperature environment, the luminous efficiency of the LED decreases; in a low temperature environment, the luminous efficiency of the LED increases. Therefore, the processor calculates the optimal LED luminous intensity according to the current temperature and the preset temperature-luminous intensity correspondence, and realizes precise control of the luminous intensity by adjusting the power supply current or pulse width modulation (PWM) of the LED.

[0053] The workflow of this embodiment is as follows: The user drops the urine sample onto the reagent strip, inserts it into the reagent card, triggers the switch button S1, and starts the detection process. The temperature sensor immediately detects the ambient temperature and transmits the temperature data to the MCU main control chip U1. The MCU main control chip U1 reads the corresponding calibration algorithm parameters from the storage unit according to the temperature data. At the same time, it adjusts the luminous intensity of the LED light sources D2 and D4 according to the temperature data and activates the LED light sources. The photosensitive sensor D1 receives the reflected light of the T line, and D3 receives the reflected light of the C line, and transmits the signals to the MCU main control chip U1. The MCU main control chip U1 uses the read calibration algorithm parameters to perform precise temperature compensation calibration on the signal data, analyzes the calibrated signal data, calculates the hCG level, reads the historical detection data (if any) from the storage unit, combines the current detection data and the historical detection data, analyzes the change trend of the hCG level, estimates the gestational age, and then transmits the result to the LED display screen to display the estimated gestational age, hCG level, and change trend. The buzzer BAT emits a sound prompt to inform the user that the detection is completed. Then the MCU main control chip U1 stores the current detection data in the storage unit for future analysis.

[0054] The test results show that in addition to the 5 results mentioned in Embodiment 1 (not pregnant, pregnant for 3 - 7 days, 1 - 2 weeks, 2 - 3 weeks, more than 3 weeks), this embodiment also adds the display of the change trend of the hCG level, such as "rising", "stable", "falling".

[0055] Embodiment 3 In one embodiment, based on Embodiment 1 or Embodiment 2, with reference to Figure 4 , this embodiment provides a further improved early pregnancy detection stick. Based on the previous two embodiments, it uses light sources with multiple different wavelengths and adds dynamic calibration and real - time optimization functions. The processor (MCU main control chip U1) is configured to perform the following steps in addition to the functions in the previous two embodiments: S410: Obtain the preset batch calibration parameters as the initial calibration parameters for each LED light source and each photosensitive sensor.

[0056] Specifically, the processor reads the preset batch calibration parameters from the storage unit. These parameters are obtained based on production batch tests and are used to initialize the working parameters of each LED light source and photosensitive sensor.

[0057] S420: Obtain the detection data at multiple time points during a single detection process, and evaluate the short - term performance changes of each photosensitive sensor according to the detection data.

[0058] In this embodiment, the system collects data every 5 seconds during the detection process, and a total of 30 data points are collected. For each photosensitive sensor, the system calculates the mean, variance, and peak-to-valley ratio of the signal intensity at these 30 time points. For example, for the main photosensitive sensor, if it is found that the mean signal intensity gradually decreases or the variance gradually increases, it may indicate fluctuations in the sensor performance.

[0059] S430. According to the short-term performance changes and the initial calibration parameters, adjust the calibration parameters in real time.

[0060] In this embodiment, the system uses a fuzzy logic control algorithm to achieve real-time adjustment of the calibration parameters. For example, if it is found that the mean signal intensity of the main photosensitive sensor has decreased by 10%, the system increases the luminous intensity of the LED light source by 8% and increases the gain parameter of the sensor by 5% at the same time. For the auxiliary photosensitive sensor, if it is found that its peak-to-valley ratio has decreased, the system adjusts the cut-off frequency of the digital filter or changes the sampling rate.

[0061] S440. Apply the adjusted calibration parameters to the spectral analysis system to optimize the detection results.

[0062] In one embodiment, referring to Figure 5 , in step S420, according to the detection data, evaluate the short-term performance changes of each photosensitive sensor, which specifically includes the following steps: S510. Classify the photosensitive sensors into main photosensitive sensors and auxiliary photosensitive sensors according to the received light wavelength of each photosensitive sensor.

[0063] In this embodiment, the LED light source includes multiple light sources with different wavelengths, which are classified into main light sources and auxiliary light sources, and the photosensitive sensors are classified into main photosensitive sensors and auxiliary photosensitive sensors.

[0064] S520. According to the detection data at multiple time points, calculate the signal intensity change index of the main photosensitive sensor and the signal-to-noise ratio change index of the auxiliary photosensitive sensor respectively.

[0065] Specifically, during the detection process, data is collected at a fixed time interval, and a total of data at multiple time points is collected.

[0066] Calculate the signal intensity change index for the main photosensitive sensor. The specific method is: calculate the average value, standard deviation, and coefficient of variation of the signal intensity at 20 time points; for the auxiliary photosensitive sensor, calculate the signal-to-noise ratio change index. The specific method is: calculate the average value, standard deviation, and coefficient of variation of the signal-to-noise ratio at 20 time points.

[0067] S530. Evaluate the short-term performance changes of each photosensitive sensor according to the signal intensity change index and the signal-to-noise ratio change index.

[0068] In one embodiment, referring to Figure 6 , in step S430, according to the short-term performance change and the initial calibration parameters, the calibration parameters are adjusted in real time, specifically including the following steps: S610. Adjust the emission intensity of the corresponding LED light source and the gain parameter of the main photosensitive sensor according to the signal intensity change index of the main photosensitive sensor.

[0069] Specifically, when it is detected that the signal intensity decreases, the system increases the emission intensity of the LED light source to provide a stronger optical signal input; at the same time, the gain parameter of the main photosensitive sensor is increased to enhance its ability to capture weak signals.

[0070] S620. Adjust the filtering parameter and the threshold setting of the auxiliary photosensitive sensor according to the signal-to-noise ratio change index of the auxiliary photosensitive sensor.

[0071] Specifically, when it is detected that the signal-to-noise ratio decreases, the system adjusts the filtering parameter, such as increasing the order of the filter or changing the filtering algorithm. At the same time, the system adjusts the threshold setting to improve the accuracy of signal judgment.

[0072] S630. Integrate the adjustment results of the main photosensitive sensor and the auxiliary photosensitive sensor to generate comprehensive calibration parameters.

[0073] Specifically, the system assigns different weights according to the importance and reliability of the main sensor and the auxiliary sensor, and then obtains the final comprehensive calibration parameters through a specific calculation formula.

[0074] Further, referring to Figure 7 , the processor is further configured to: S710. During the detection process, according to the adjusted calibration parameters, the working parameters of the spectral analysis system are adjusted in real time.

[0075] Specifically, the processor modifies the emission intensity of the light source, the gain of the photosensitive sensor, the parameters of the signal processing algorithm, etc. according to the adjusted calibration parameters. For example, if the calibration parameters indicate that the ambient light has changed, the processor may adjust the brightness of the LED light source accordingly; if it is detected that the signal intensity decreases, the sensitivity of the photosensitive sensor may be increased.

[0076] S720. Based on the adjusted working parameters, multiple samplings and analyses are performed on the test line and the control line.

[0077] Specifically, the processor presets a sampling number, such as 10 times or 20 times, and performs repeated measurements on the test line and the control line respectively. Each measurement uses the latest adjusted working parameters to ensure the accuracy of the measurement.

[0078] S730. Calculate the final human chorionic gonadotropin (hCG) level and estimated gestational age based on the results of multiple sampling analyses.

[0079] Specifically, the processor performs outlier detection on the data from multiple samplings and eliminates possible error data. Then, it uses the mean, median, or other statistical methods to synthesize the results of multiple measurements to obtain the final hCG level. Based on this level, it queries a pre-established comparison table or uses a specific algorithm to estimate the gestational age.

[0080] Through this, during the detection process of the present application, according to the latest calibration parameters provided by the dynamic calibration parameter adjustment module, the working parameters of the spectral analysis system are adjusted in real time. Based on the adjusted working parameters, multiple sampling analyses are performed on the test line and the control line to capture the dynamic changes in the hCG level. Finally, based on the results of multiple sampling analyses, the final hCG level is comprehensively calculated and the gestational age is estimated, realizing the real-time optimization and dynamic adjustment of the detection process, which can not only adapt to different samples and environmental conditions, but also improve the reliability of the results through multiple samplings.

[0081] It should be understood that the magnitudes of the sequence numbers of the steps in the above embodiments do not mean the order of execution. The order of execution of each process should be determined by its function and internal logic, and should not constitute any limitation to the implementation process of the embodiments of the present application.

[0082] The above are all the preferred embodiments of the present application. The protection scope of the present application is not limited by this. Therefore, all equivalent changes made according to the structure, shape, and principle of the present application should be covered within the protection scope of the present application.

Claims

1. An electronic pregnancy test stick, characterized in that: include: A reagent strip, used to receive a sample to be tested and perform an immunochromatographic reaction; Spectral analysis system, including: An LED light source, used to illuminate the test line and the control line on the reagent strip; A photosensitive sensor corresponding to the LED light source, used to receive light of different wavelengths reflected from the detection line and the control line; A temperature sensor, used to detect the temperature of the reagent strip; A processor is electrically connected to the spectral analysis system and the temperature sensor, and the processor is configured as follows: Receiving and processing signal data from the photosensitive sensor; receiving and processing temperature data from the temperature sensor; Based on the temperature data, performing temperature compensation correction on the signal data; Based on the corrected signal data, the color and intensity of the test line and the control line are analyzed, and the human chorionic gonadotropin level is calculated; Based on the human chorionic gonadotropin level, the gestational age was estimated; A display unit is electrically connected to the processor and is used to display the estimated gestational age and / or human chorionic gonadotropin level.

2. The electronic pregnancy test stick according to claim 1, characterized in that: It also includes a storage unit, which is electrically connected to the processor and is used to store correction algorithm parameters. The processor performs temperature compensation correction on the signal data according to the correction algorithm parameters.

3. The electronic pregnancy test stick according to claim 2, characterized in that: The storage unit is also used to store historical detection data, and the processor is further configured to: Analyze the changing trend of human chorionic gonadotropin levels based on current and historical test data.

4. The electronic pregnancy test stick according to claim 1, characterized in that: The processor is further configured to: The light intensity of the LED light source is adjusted based on the temperature data.

5. The electronic pregnancy test stick according to claim 1, characterized in that: The processor is further configured to: Obtaining preset batch calibration parameters as initial calibration parameters for each LED light source and each photosensitive sensor; Acquire detection data at multiple time points during a single detection process, and evaluate short-term performance changes of each photosensor based on the detection data; adjusting calibration parameters in real time according to the short-term performance change and the initial calibration parameters; The adjusted calibration parameters are applied to the spectral analysis system to optimize the detection results.

6. The electronic pregnancy test stick according to claim 5, characterized in that: According to the detection data, the short-term performance change of each photosensor is evaluated, which specifically includes the following steps: According to the wavelength of light received by each photosensitive sensor, the photosensitive sensors are classified into a main photosensitive sensor and an auxiliary photosensitive sensor; Calculating the signal strength change index of the main photosensor and the signal-to-noise ratio change index of the auxiliary photosensor respectively according to the detection data at the multiple time points; The short-term performance change of each photosensor is evaluated according to the signal strength change indicator and the signal-to-noise ratio change indicator.

7. The electronic pregnancy test stick according to claim 6, characterized in that: According to the short-term performance change and the initial calibration parameters, the calibration parameters are adjusted in real time, specifically comprising the following steps: According to the signal strength change index of the main photosensor, adjusting the luminous intensity of the corresponding LED light source and the gain parameter of the main photosensor; According to the signal-to-noise ratio change index of the auxiliary photosensor, adjusting the filter parameters and threshold settings of the auxiliary photosensor; The adjustment results of the main photosensitive sensor and the auxiliary photosensitive sensor are integrated to generate comprehensive calibration parameters.

8. The electronic pregnancy test stick according to claim 5, characterized in that: The processor is further configured to: During the detection process, the operating parameters of the spectrum analysis system are adjusted in real time according to the adjusted calibration parameters; Based on the adjusted working parameters, multiple sampling and analysis of the test line and the control line are performed; Based on the results of multiple sampling analyses, the final human chorionic gonadotropin level and estimated gestational age were calculated.

9. The electronic pregnancy test stick according to claim 1, characterized in that: It also includes a power supply unit for supplying power to various components of the electronic pregnancy test stick.

10. The electronic pregnancy test stick according to claim 1, characterized in that: It also includes a communication module for transmitting the detection results to an external device.

Citation Information

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