Electronic early pregnancy test kit

Abstract

The present application relates to the technical field of pregnancy test kits, and in particular to an electronic early pregnancy test kit. The present application provides an electronic early pregnancy test kit, comprising a reagent strip, a spectral analysis system, a temperature sensor, a processor, and a display unit. First, an LED light source is used for illuminating the reagent strip, and reflected light is received by means of a corresponding photosensitive sensor; then the temperature sensor is used for monitoring the temperature of the reagent strip in real time, and the processor compensates and corrects a photosensitive signal on the basis of temperature data, and calculates the level of human chorionic gonadotropin by analyzing corrected spectral data; and finally, the gestational age is estimated on the basis of a calculation result and is presented on the display unit, thereby not only improving the accuracy and reliability of test, but also achieving active compensation for environmental factors, while providing a quantitative result and accurate gestational age estimation by means of spectral analysis.

Description

An electronic early pregnancy test stick Technical Field

[0001] This application relates to the technical field of pregnancy test strips, and more particularly to an electronic early pregnancy test strip. Background Technology

[0002] Early pregnancy testing is a crucial part of women's health management, and timely and accurate test results are essential for prenatal care and medical decision-making. With social development and advancements in medical technology, people have higher expectations for the accuracy, convenience, and comprehensive information provided by early pregnancy testing.

[0003] Current technologies commonly employ immunochromatography, using test strips to detect human chorionic gonadotropin (hCG) levels in urine to determine pregnancy. This method is simple to operate and convenient to use, and has been widely adopted for home testing and initial screening in medical institutions. The detection principle is based on the specific binding of antigen and antibody, with a colorimetric reaction indicating the presence of hCG.

[0004] Traditional pregnancy testing methods rely on visual assessment to determine pregnancy status, which cannot accurately predict the gestational age. Furthermore, the interpretation of the viewing angle is affected by insufficient lighting or subjective factors, especially when the intensity of the test area is low, resulting in low levels of analytes. Users cannot draw accurate conclusions, making it difficult to meet the needs of modern women for precise gestational age estimation. This situation needs further improvement. Summary of the Invention

[0005] To address the problem of inaccurate prediction of gestational age in existing tests, this application provides an electronic early pregnancy test strip, employing the following technical solution: Firstly, this application provides an electronic early pregnancy test strip, comprising: a test strip for receiving a sample and performing an immunochromatographic reaction; a spectral analysis system, comprising: an LED light source for illuminating a test line and a control line on the test strip; and 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 test strip; a processor electrically connected to the spectral analysis system and the temperature sensor, the processor being configured to: receive and process signal data from the photosensitive sensor; receive and process temperature data from the temperature sensor; perform temperature compensation correction on the signal data based on the temperature data; analyze the color and intensity of the test line and the control line based on the corrected signal data, and calculate the human chorionic gonadotropin (hCG) level; estimate gestational age based on the hCG level; and a display unit electrically connected to the processor for displaying the estimated gestational age and / or hCG level.

[0006] Optionally, it also includes a storage unit electrically connected to the processor for storing correction algorithm parameters, and the processor performs temperature compensation correction on the signal data according to the correction algorithm parameters.

[0007] Optionally, 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 detection data and historical detection data.

[0008] Optionally, the processor is further configured to adjust the luminous intensity of the LED light source based on the temperature data.

[0009] Optionally, the processor is further configured to: acquire 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 the short-term performance changes of each photosensitive sensor based on the detection data; adjust the calibration parameters in real time based on the short-term performance changes and the initial calibration parameters; and apply the adjusted calibration parameters to the spectral analysis system to optimize the detection results.

[0010] Optionally, based on the detection data, the short-term performance changes of each photosensitive sensor are evaluated, specifically including the following steps: classifying the photosensitive sensors into primary photosensitive sensors and auxiliary photosensitive sensors according to the received light wavelength of each photosensitive sensor; calculating the signal intensity change index of the primary photosensitive sensor and the signal-to-noise ratio change index of the auxiliary photosensitive sensor respectively based on the detection data at the multiple time points; and evaluating the short-term performance changes of each photosensitive sensor based on the signal intensity change index and the signal-to-noise ratio change index.

[0011] Optionally, the calibration parameters are adjusted in real time based on the short-term performance changes and the initial calibration parameters, specifically including the following steps: adjusting the luminous 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; adjusting the filtering parameters and threshold settings of the auxiliary photosensitive sensor according to the signal-to-noise ratio change index of the auxiliary photosensitive sensor; and integrating the adjustment results of the main photosensitive sensor and the auxiliary photosensitive sensor to generate comprehensive calibration parameters.

[0012] Optionally, the processor is further configured to: adjust the operating parameters of the spectral analysis system in real time according to the adjusted calibration parameters during the detection process; perform multiple sampling analyses on the detection line and control line based on the adjusted operating parameters; and calculate the final human chorionic gonadotropin level and estimate gestational age based on the results of the multiple sampling analyses.

[0013] Optionally, a power supply unit is also included for powering the various components of the electronic early pregnancy test.

[0014] Optionally, a communication module may also be included for transmitting the detection results to external devices.

[0015] In summary, this application includes at least one of the following beneficial technical effects: 1. Traditional methods often result in inaccurate or unstable test results due to factors such as lighting conditions, user subjective judgment, and changes in ambient temperature. For example, in environments with insufficient light, a weak test line may be misjudged as a negative result; while in high-temperature environments, the immunochromatographic reaction rate may be accelerated, affecting the accuracy of the results. This application first uses an LED light source to illuminate the test strip, and receives the reflected light through a corresponding photosensitive sensor; then, a temperature sensor monitors the temperature of the test strip in real time, and the processor compensates and corrects the photosensitive signal based on the temperature data, and calculates the human chorionic gonadotropin (hCG) level by analyzing the corrected spectral data; finally, the gestational age is estimated based on the calculation results and presented on the display unit; this not only improves the accuracy and reliability of the test, but also achieves active compensation for environmental factors, and provides quantitative results and accurate gestational age estimation through spectral analysis; 2. Traditional electronic testing equipment typically uses LED light sources with fixed luminous intensity. However, the luminous efficiency of LEDs changes with temperature. For example, in high-temperature environments, the luminous efficiency of LEDs decreases, which may weaken the signal strength of the detection line and affect the accuracy of the detection. Conversely, in low-temperature environments, the luminous efficiency of LEDs increases, which may cause signal saturation and reduce the sensitivity of the detection. This application adjusts the luminous intensity of the LED based on temperature data, achieving dynamic adjustment of the LED light source intensity, ensuring the consistency and stability of the signal under different temperature environments, and improving the accuracy and reliability of the detection results. 3. Traditional electronic testing equipment usually relies on fixed calibration parameters and cannot adapt to real-time performance changes of devices. For example, Due to batch variations in production, LEDs and photosensitive sensors in different devices may exhibit initial performance differences. Furthermore, during use, factors such as temperature changes and device aging can cause short-term performance drift, all of which 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 is continuously collected at multiple time points 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. This achieves real-time adaptive calibration of the detection system, not only solving the batch variation problem but also dynamically compensating for performance drift during use, significantly improving the accuracy, stability, and consistency of the detection results. Attached Figure Description

[0016] Figure 1 is a schematic diagram of the modules of an electronic early pregnancy test strip according to Embodiment 1 of this application; Figure 2 is a schematic flowchart of the method executed by the processor in an electronic early pregnancy test strip according to Embodiment 1 of this application; Figure 3 is a schematic flowchart of the method executed by the processor in an electronic early pregnancy test strip according to Embodiment 2 of this application; Figure 4 is a schematic flowchart of the method executed by the processor in an electronic early pregnancy test strip according to Embodiment 3 of this application; Figure 5 is a schematic flowchart of step S420 executed by the processor in an electronic early pregnancy test strip according to Embodiment 3 of this application; Figure 6 is a schematic flowchart of step S430 executed by the processor in an electronic early pregnancy test strip according to Embodiment 3 of this application; Figure 7 is a schematic flowchart of the multiple sampling analysis steps executed by the processor in an electronic early pregnancy test strip according to Embodiment 3 of this application. Detailed Implementation

[0017] The terminology used in the following embodiments of this application is for the purpose of describing particular embodiments only and is not intended to be limiting of this application. As used in the specification and appended claims of this application, the singular expressions “a,” “an,” “the,” “the,” “the,” and “this” are intended to include the plural expressions as well, unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used in this application refers to any or all possible combinations including one or more of the listed items.

[0018] Hereinafter, the terms "first" and "second" are used for descriptive purposes only and should not be construed as implying or suggesting relative importance or implicitly indicating the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature, and in the description of the embodiments of this application, unless otherwise stated, "multiple" means two or more.

[0019] The embodiments of this application will now be described in further detail with reference to the accompanying drawings.

[0020] Example 1 This application provides an electronic early pregnancy test strip, as shown in FIG1, including a test strip, a spectral analysis system, a temperature sensor, a processor, and a display unit.

[0021] The test strip is used to receive urine samples for testing and perform an immunochromatographic reaction. This test strip utilizes highly sensitive immunochromatographic technology to rapidly capture human chorionic gonadotropin (hCG) in the sample. The test strip includes a test line (T line) and a control line (C line).

[0022] The spectral analysis system is the core component of this detector, comprising an LED light source and a corresponding photosensitive sensor. Specifically, this embodiment uses a D2D4 light source configuration, including two LEDs of 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, employing two photosensitive receivers, D1 and D3. D1 primarily receives light reflected from the T-line, and D3 primarily receives light reflected from the C-line.

[0023] A temperature sensor, installed near the reagent strip, is used to monitor the temperature change of the reagent strip in real time, providing a basis for data calibration.

[0024] The MCU main control chip U1 acts as a processor and is electrically connected to the spectral analysis system, temperature sensor, and LED display. Referring to Figure 2, the main functions of the processor include the following steps: S210, receiving and processing signal data from the photosensitive sensor.

[0025] S220 receives and processes temperature data from a temperature sensor.

[0026] S230: Based on temperature data, perform temperature compensation correction on the signal data.

[0027] S240. Based on the corrected signal data, analyze the color and intensity of the detection line and control line, and calculate the level of human chorionic gonadotropin.

[0028] S250. Based on human chorionic gonadotropin (hCG) levels, estimate gestational age.

[0029] In this embodiment, the display unit is an LED display screen, electrically connected to the processor, used to display the estimated gestational age and / or hCG level.

[0030] The electronic early pregnancy test strip according to this application also includes a power supply unit, i.e., a battery, for powering the various components of the test strip and ensuring the stable operation of the entire system. The integrated power supply unit enables complete portability and independence of the device, allowing users to conveniently perform tests anytime, anywhere.

[0031] The electronic early pregnancy test according to this application also includes a communication module for transmitting the test results to an external device. The communication module not only makes the test results more visually intuitive but also enables long-term data storage, trend analysis, and remote sharing, thus improving user experience and medical value.

[0032] The electronic early pregnancy test stick according to this application also includes a buzzer for providing audible prompts and enhancing the user experience.

[0033] The electronic early pregnancy test strip according to this application also includes a switch button for use in conjunction with a reagent card insertion mechanism to achieve an automatic power-on function.

[0034] 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 feedback control loop, it provides a stable operating current to LED light sources D2 and D4, with current fluctuations controlled within ±1%. Simultaneously, a temperature compensation mechanism is integrated, automatically adjusting the drive parameters based on real-time data from the temperature sensor to ensure that the luminous intensity of the LED light source remains constant within the operating temperature range of -10℃ to 40℃. Furthermore, this module also features overcurrent and short-circuit protection functions, quickly cutting off the power supply in abnormal situations with a response time of less than 1ms, effectively protecting the LED light source and other circuit components. The application of the voltage and current stabilization module significantly improves the stability of the light intensity, ensuring the accuracy and repeatability of test results during long-term use, while also extending the lifespan of the LED light source.

[0035] The workflow of this embodiment is as follows: The user adds a urine sample to the test strip, inserts the test card, and triggers the switch button S1 to start the testing process. The MCU main control chip U1 activates LED light sources D2 and D4, illuminating the T line and C line on the test strip, respectively. The photosensor D1 receives the reflected light from the T line, and D3 receives the reflected light from the C line, transmitting the signals to the MCU main control chip U1. The temperature sensor simultaneously detects the temperature of the test strip and transmits the temperature data to the MCU main control chip U1. The MCU main control chip U1 performs temperature compensation correction on the signal data based on 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 emits an audible prompt to inform the user that the test is complete.

[0036] Specifically, the test results are divided into 5 categories: not pregnant (NO), 3-7 days pregnant (0.5-1 weeks), 1-2 weeks pregnant (1-2 weeks), 2-3 weeks pregnant (2-3 weeks), and 3+ weeks pregnant (3+ weeks).

[0037] In one embodiment, referring to Figure 3, this embodiment provides an improved electronic early pregnancy test strip. Based on Embodiment 1, a storage unit is added. The storage unit is electrically connected to the processor (MCU main control chip U1) and is used to store correction algorithm parameters and historical test data. The functionality of the processor is also expanded, and the processor further includes the following steps: S310, acquiring correction algorithm parameters and performing temperature compensation correction on the signal data according to the correction algorithm parameters.

[0038] Specifically, the processor adds the following function to the implementation of Example 1: The processor reads calibration algorithm parameters for different batches of test strips and temperature ranges from the storage unit. Traditional temperature compensation methods often use fixed calibration formulas, which are difficult to adapt to the differences in characteristics of different batches of test strips and complex environmental changes. For example, under extreme temperature conditions or when using test strips from different production batches, a fixed calibration method may lead to insufficient or excessive compensation, affecting the reliability of the test results. This application first pre-stores calibration algorithm parameters for different batches of test strips and temperature ranges in the storage unit. These parameters are derived in advance through extensive experiments and data analysis, and can adapt to the differences in characteristics of different batches of test strips and complex environmental changes. During the detection process, the processor retrieves the corresponding calibration algorithm parameters from the storage unit based on the current temperature data and performs precise temperature compensation calibration on the signal data of the photosensitive sensors D1 and D3. Finally, based on the calibrated data, the human chorionic gonadotropin (hCG) level is calculated and gestational age is estimated, improving the accuracy and reliability of the test results.

[0039] S320. Obtain historical test data and analyze the changing trend of human chorionic gonadotropin levels based on current test data and historical test data.

[0040] Specifically, the processor is configured to access historical test data in the storage unit and, in conjunction with current test data, analyze the changing trend of hCG levels. The specific steps are as follows: after each test, the test results are stored in the storage unit; when a new test is performed, the processor reads the stored historical data; using a statistical analysis algorithm, combining current and historical data, the changing trend of hCG levels is calculated; based on the analysis results, it is determined whether the hCG level is showing an upward, stable, or downward trend. Traditional early pregnancy testing methods typically only provide a single test result and cannot reflect the dynamic changing trend of human chorionic gonadotropin (hCG) levels. This limits the user's comprehensive understanding of their pregnancy status. For example, in some cases, an abnormal rise or fall in hCG levels may indicate a risk of pregnancy complications, but a single test is unlikely to detect these potential problems. This application, by adopting the above-mentioned technical solution, can help users better understand their pregnancy progress and detect potential abnormalities early.

[0041] S330: Acquire temperature data and adjust the luminous intensity of the LED light source based on the temperature data.

[0042] Specifically, the processor dynamically adjusts the luminous intensity of LED light sources D2 and D4 based on temperature data provided by the temperature sensor. Since the luminous efficiency of LEDs changes with temperature—decreasing at high temperatures and increasing at low temperatures—the processor calculates the optimal LED luminous intensity based on the current temperature and a preset temperature-luminous intensity relationship. This precise control of the luminous intensity is achieved by adjusting the LED's supply current or pulse width modulation (PWM).

[0043] Traditional electronic testing equipment typically uses LED light sources with fixed luminous intensity. However, the luminous efficiency of LEDs changes with temperature. For example, in high-temperature environments, the luminous efficiency of LEDs decreases, which may weaken the signal strength of the detection line and affect the accuracy of the detection. In low-temperature environments, the luminous efficiency of LEDs increases, which may cause signal saturation and reduce the sensitivity of the detection. This application adjusts the luminous intensity of LEDs based on temperature data to achieve dynamic adjustment of the LED light source intensity, ensuring the consistency and stability of the signal under different temperature environments, and improving the accuracy and reliability of the detection results.

[0044] The workflow of this embodiment is as follows: The user adds a urine sample to the test strip, inserts the test card, and triggers the switch button S1 to start the testing process. The temperature sensor immediately detects the ambient temperature and transmits the temperature data to the MCU main control chip U1. Based on the temperature data, the MCU main control chip U1 reads the corresponding correction algorithm parameters from the storage unit. Simultaneously, it adjusts the luminous intensity of LED light sources D2 and D4 according to the temperature data and activates the LED light sources. The photosensors D1 receive T-line reflected light, and D3 receives C-line reflected light, transmitting the signals to the MCU main control chip U1. The MCU main control chip U1 uses the read correction algorithm parameters to perform precise temperature compensation correction on the signal data, analyzes the corrected signal data, calculates the hCG level, reads historical test data (if available) from the storage unit, combines the current test data and historical test data to analyze the trend of hCG level changes, estimates the gestational age, and then transmits the results to the LED display screen, showing the estimated gestational age, hCG level, and trend. The buzzer BAT sounds an audible alert to inform the user that the test is complete. Then, the MCU main control chip U1 stores the current test data in the storage unit for future analysis.

[0045] In addition to the five results mentioned in Example 1 (not pregnant, pregnant for 3-7 days, 1-2 weeks, 2-3 weeks, 3+ weeks), this example also adds the display of hCG level change trends, such as "increasing", "stable", and "decreasing".

[0046] Example 3: In one embodiment, based on Example 1 or Example 2, referring to Figure 4, this embodiment provides a further improved electronic early pregnancy test strip. Building upon the previous two embodiments, it employs multiple light sources of different wavelengths and adds dynamic calibration and real-time optimization functions. In addition to the functions of the previous two embodiments, the processor (MCU main control chip U1) is configured to perform the following steps: S410, obtaining preset batch calibration parameters as initial calibration parameters for each LED light source and each photosensitive sensor.

[0047] Specifically, the processor reads pre-set batch calibration parameters from the storage unit. These parameters, derived from production batch testing, are used to initialize the operating parameters of each LED light source and photosensor.

[0048] S420: Acquire detection data at multiple time points during a single detection process, and evaluate the short-term performance changes of each photosensitive sensor based on the detection data.

[0049] In this embodiment, the system collects data every 5 seconds during the detection process, for a total of 30 time points. 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 the mean signal intensity gradually decreases or the variance gradually increases, it may indicate that the sensor performance is fluctuating.

[0050] S430 adjusts calibration parameters in real time based on short-term performance changes and initial calibration parameters.

[0051] In this embodiment, the system employs a fuzzy logic control algorithm to achieve real-time adjustment of calibration parameters. For example, if the average signal strength of the main photosensitive sensor decreases by 10%, the system increases the luminous intensity of the LED light source by 8% and simultaneously increases the sensor's gain parameter by 5%. For the auxiliary photosensitive sensor, if a decrease in its peak-to-valley ratio is detected, the system adjusts the cutoff frequency of the digital filter or changes the sampling rate.

[0052] S440. Apply the adjusted calibration parameters to the spectral analysis system to optimize the detection results.

[0053] In one embodiment, referring to FIG5, in step S420, the short-term performance changes of each photosensitive sensor are evaluated based on the detection data, specifically including the following steps: S510, the photosensitive sensors are classified into primary photosensitive sensors and auxiliary photosensitive sensors according to the received light wavelength of each photosensitive sensor.

[0054] In this embodiment, the LED light source includes multiple light sources of different wavelengths, which are classified as main light sources and auxiliary light sources, and the photosensitive sensor is classified as main photosensitive sensor and auxiliary photosensitive sensor.

[0055] S520. Based on 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.

[0056] Specifically, during the detection process, data is collected at fixed time intervals, and data is collected at multiple time points.

[0057] For the primary photosensitive sensor, calculate the signal intensity variation index. Specifically, calculate the average, 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 variation index. Specifically, calculate the average, standard deviation, and coefficient of variation of the signal-to-noise ratio at 20 time points.

[0058] S530: Evaluate the short-term performance changes of each photosensitive sensor based on the signal strength change index and the signal-to-noise ratio change index.

[0059] By adopting the above technical solution, traditional photosensitive sensor performance evaluation typically uses a uniform standard, neglecting the different importance and characteristics of sensors with different wavelengths in detection. For example, in early pregnancy detection, certain specific wavelengths are crucial for identifying the test line, while other wavelengths are mainly used for auxiliary judgment or background correction. Using a uniform standard may mask the performance changes of key wavelength sensors or over-amplify the minor fluctuations of non-key sensors, thus affecting the overall accuracy of detection. This application first divides the sensors into primary photosensitive sensors and auxiliary photosensitive sensors based on the wavelength of light received by each photosensitive sensor and its importance in detection. Then, for the primary photosensitive sensors, the focus is on calculating the change index of their signal intensity to ensure the detection stability of key wavelengths. For the auxiliary photosensitive sensors, the focus is on calculating the change index of their signal-to-noise ratio to optimize the reliability of background correction and auxiliary judgment. Finally, by combining the two types of indicators, the short-term performance changes of each photosensitive sensor are comprehensively evaluated, achieving targeted evaluation of sensors with different functions. This ensures the accuracy of key wavelength detection, optimizes the detection effect of auxiliary wavelengths, and improves the overall performance and reliability of the detection system.

[0060] In one embodiment, referring to FIG6, in step S430, the calibration parameters are adjusted in real time according to short-term performance changes and initial calibration parameters, specifically including the following steps: S610, adjust the luminous intensity of the corresponding LED light source and the gain parameters of the main photosensitive sensor according to the signal intensity change index of the main photosensitive sensor.

[0061] Specifically, when a decrease in signal strength is detected, the system increases the luminous intensity of the LED light source to provide a stronger light signal input; at the same time, it increases the gain parameter of the main photosensitive sensor to enhance its ability to capture weak signals.

[0062] S620. Adjust the filtering parameters and threshold settings of the auxiliary photosensitive sensor according to the signal-to-noise ratio change index of the auxiliary photosensitive sensor.

[0063] Specifically, when a decrease in signal-to-noise ratio is detected, the system adjusts the filtering parameters, such as increasing the filter order or changing the filtering algorithm. At the same time, the system adjusts the threshold settings to improve the accuracy of signal judgment.

[0064] S630 integrates the adjustment results of the main photosensitive sensor and the auxiliary photosensitive sensor to generate comprehensive calibration parameters.

[0065] Specifically, the system assigns different weights to the main and auxiliary sensors based on their importance and reliability, and then derives the final comprehensive calibration parameters through a specific calculation formula.

[0066] By adopting the above technical solution, this application first dynamically adjusts the luminous intensity of the corresponding LED light source and the gain parameters of the sensor based on the signal intensity 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, its filtering parameters and threshold settings are adjusted to optimize the background correction effect; finally, the adjustment results of the main sensor and the auxiliary sensor are integrated to generate comprehensive calibration parameters, thereby optimizing the overall system; targeted calibration of different types of sensors is achieved, enhancing the stability and reliability of the entire detection system.

[0067] Furthermore, referring to Figure 7, the processor is also configured as follows: S710, during the detection process, to adjust the operating parameters of the spectral analysis system in real time according to the adjusted calibration parameters.

[0068] Specifically, the processor modifies the luminous intensity of the light source, the gain of the photosensor, and the parameters of the signal processing algorithm based on the adjusted calibration parameters. For example, if the calibration parameters indicate a change in ambient light, the processor may adjust the brightness of the LED light source accordingly; if a decrease in signal strength is detected, the processor may increase the sensitivity of the photosensor.

[0069] S720: Based on the adjusted operating parameters, perform multiple sampling analyses on the detection line and control line.

[0070] Specifically, the processor is pre-set to perform a sampling number, such as 10 or 20 times, to repeatedly measure the detection line and control line. Each measurement uses the latest adjusted operating parameters to ensure accuracy.

[0071] S730. Based on the results of multiple sampling analyses, calculate the final human chorionic gonadotropin level and estimate the gestational age.

[0072] Specifically, the processor performs outlier detection on the data from multiple samplings, removing potentially erroneous data. Then, it uses the mean, median, or other statistical methods to synthesize the results of multiple measurements to arrive at the final hCG level. Based on this level, a pre-established reference table is consulted or a specific algorithm is used to estimate gestational age.

[0073] Traditional early pregnancy testing equipment cannot adapt to various changes and interferences that may occur during the testing process. For example, the water absorption rate of the test strip may vary due to changes in ambient temperature or humidity, resulting in inconsistent color development time and intensity between the test line and the control line. In contrast, this application adjusts the operating parameters of the spectral analysis system in real time based on the latest calibration parameters provided by the dynamic calibration parameter adjustment module. Based on the adjusted operating parameters, multiple sampling analyses are performed on the test line and control line to capture dynamic changes in hCG levels. Finally, based on the results of multiple sampling analyses, the final hCG level is calculated and gestational age is estimated. This achieves real-time optimization and dynamic adjustment of the testing process, adapting to different sample and environmental conditions while improving the reliability of the results through multiple sampling.

[0074] It should be understood that the sequence number of each step in the above embodiments does not imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of this application.

[0075] The above are all preferred embodiments of this application, and are not intended to limit the scope of protection of this application. Therefore, all equivalent changes made in accordance with the structure, shape and principle of this application should be covered within the scope of protection of this application.

Claims

1. An electronic early pregnancy test strip, characterized in that, include: Reagent strips are used to receive samples for testing and to perform immunochromatographic reactions. A spectral analysis system includes: an LED light source for illuminating the detection line and control line on the reagent strip; and a photosensitive sensor corresponding to the LED light source for receiving light of different wavelengths reflected from the detection line and control line. A temperature sensor is used to detect the temperature of the reagent strip; A processor, electrically connected to the spectral analysis system and the temperature sensor, is configured to: receive and process signal data from the photosensitive sensor; receive and process temperature data from the temperature sensor; perform temperature compensation correction on the signal data based on the temperature data; analyze the color and intensity of the detection line and control line based on the corrected signal data, and calculate the human chorionic gonadotropin (hCG) level; and estimate gestational age based on the hCG level. A display unit, electrically connected to the processor, is used to display the estimated gestational age and / or human chorionic gonadotropin (hCG) levels.

2. The electronic early pregnancy test strip according to claim 1, characterized in that, It also includes a storage unit electrically connected to the processor for storing correction algorithm parameters, and the processor performs temperature compensation correction on the signal data according to the correction algorithm parameters.

3. The electronic early pregnancy test strip 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 detection data and historical detection data.

4. The electronic early pregnancy test strip according to claim 1, characterized in that, The processor is also configured to adjust the luminous intensity of the LED light source based on the temperature data.

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

6. The electronic early pregnancy test strip according to claim 5, characterized in that, Based on the detection data, the short-term performance changes of each photosensitive sensor are evaluated, including the following steps: Based on the received light wavelength of each photosensitive sensor, the photosensitive sensors are classified into primary photosensitive sensors and auxiliary photosensitive sensors; based on the detection data at the multiple time points, the signal intensity change index of the primary photosensitive sensor and the signal-to-noise ratio change index of the auxiliary photosensitive sensor are calculated respectively. The short-term performance changes of each photosensitive sensor are evaluated based on the signal strength change index and the signal-to-noise ratio change index.

7. The electronic early pregnancy test strip according to claim 6, characterized in that, Based on the short-term performance changes and the initial calibration parameters, the calibration parameters are adjusted in real time, including the following steps: Based on the signal intensity change index of the main photosensitive sensor, adjust the luminous intensity of the corresponding LED light source and the gain parameter of the main photosensitive sensor; Based on the signal-to-noise ratio change index of the auxiliary photosensitive sensor, adjust the filtering parameters and threshold settings of the auxiliary photosensitive sensor; The adjustment results of the main photosensitive sensor and the auxiliary photosensitive sensor are integrated to generate comprehensive calibration parameters.

8. The electronic early pregnancy test strip according to claim 5, characterized in that, The processor is also configured to: During the detection process, the operating parameters of the spectral analysis system are adjusted in real time according to the adjusted calibration parameters; Based on the adjusted operating parameters, the detection line and control line were sampled and analyzed multiple times. Based on the results of multiple sampling analyses, the final human chorionic gonadotropin (hCG) level was calculated and the gestational age was estimated.

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

10. The electronic early pregnancy test strip according to claim 1, characterized in that, It also includes a communication module for transmitting test results to external devices.

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