A reagent dosage self-calibration method and a urine test instrument

Abstract

The application discloses a reagent consumption self-calibration method and a urine test instrument. The reagent consumption self-calibration method comprises the following steps: executing a test item, if a detection value of an index of the test item deviates from a medical range, it is inferred that reagent required for detecting the index has been consumed, a reagent box is prompted to be replaced, and the test item is set as undetectable; before a next detection process is started, the reagent is detected first, if a detection result is not within a normal range, the reagent box is prompted to be replaced again, and other test items are continuously executed; otherwise, it is determined that a user has completed the operation of replacing the reagent box. By using the reagent consumption self-calibration method, reagent is not wasted on one hand, and detection result accuracy can be ensured on the other hand.

Description

Technical Field

[0001] This invention relates to the field of detection technology, specifically to a self-calibration method for reagent dosage and a urine analyzer. Background Technology

[0002] As human lifespan increases, the importance of health care and maintenance has received increasing attention. Currently, home testing devices are available to allow users to perform personal health checks at home, such as urine and saliva tests.

[0003] Currently, to ensure efficient mass production, each reagent capsule has a uniform capacity and is fully filled. However, the amount of different reagents used in each test varies. The usual approach is to calculate the remaining amount of the reagent used in the largest single test and then work backwards from the cumulative number of uses after changing the kit to estimate the remaining number of uses. However, this method is inaccurate and prone to the following problems: either the reagent is not used up before a replacement is indicated, resulting in waste; or the reagent is used up without any indication, leading to inaccurate measurement results. Summary of the Invention

[0004] The purpose of this invention is to provide a self-calibration method for reagent dosage and a urine analyzer to solve the above-mentioned problems. Therefore, the technical solution adopted by this invention is as follows:

[0005] According to an embodiment of the present invention, a reagent dosage self-calibration method is provided, the reagent dosage self-calibration method comprising:

[0006] When performing a test, if the measured value of a certain indicator of the test deviates from the medical range, it is inferred that the reagents required to test that indicator have been exhausted, prompting the replacement of the reagent kit and setting the test to be undetectable.

[0007] Before starting the testing process again, test the reagent first. If the test result is not within the normal range, prompt again to replace the reagent kit and continue to perform other tests; otherwise, determine that the user has completed the reagent kit replacement operation.

[0008] The reagent dosage self-calibration method of the present invention avoids reagent waste and ensures the accuracy of test results.

[0009] In a preferred embodiment, the inspection items are performed using an optical detection device. The optical detection device has advantages such as small size and convenient operation. Specifically, the optical detection device includes a light source and an optical sensor, which are respectively positioned on opposite sides of the reaction chamber, such that light emitted by the light source passes through the liquid in the reaction chamber and is received by the optical sensor.

[0010] In a preferred embodiment, the specific process of first detecting the reagent is as follows: first, water is pumped into the reaction chamber; then, the reagent is pumped into the reaction chamber; and finally, the transmitted light intensity of the reaction chamber is measured using an optical detection device. Specifically, the detection result being outside the normal range means that the transmitted light intensity value is outside the error range of the standard light intensity value. Preferably, the error is ±5%.

[0011] In a preferred embodiment, the process of determining the medical range is as follows: preparing distilled water samples and artificial urine samples with different index concentrations; adding reagents corresponding to the index to each sample and measuring the corresponding transmitted light intensity; calculating the absorbance value A, A = -lg(In / I0), where I0 is the incident light intensity, i.e., the transmitted light intensity of distilled water, and In is the transmitted light intensity of the artificial urine sample; and fitting a standard curve of the relationship between index concentration and absorbance value to obtain the medical range.

[0012] In a preferred embodiment, setting the test item to undetectable is achieved by executing a temporary configuration file; and the normal configuration file is resumed after it is determined that the user has completed the operation of changing the reagent kit.

[0013] In a preferred embodiment, restoring the configuration file to normal operation includes resetting the remaining quantities of each reagent in the kit.

[0014] In a preferred embodiment, the indicators include urinary creatinine, urinary protein, urinary pH, urinary ketones, ascorbic acid, nitrite, urinary glucose, urinary bilirubin, urinary hemoglobin, albumin, leukocytes, ethanol, and nicotine.

[0015] In a preferred embodiment, the prompt to change the reagent is displayed on the APP.

[0016] In a preferred embodiment, the prompt to change the reagent includes one or more of the following: text, icons, and sounds.

[0017] According to another embodiment of the present invention, a urine analyzer is also provided, wherein the urine analyzer includes a reagent kit, a detection module and a controller, wherein the detection module is electrically connected to the controller, and the controller is used to perform the reagent dosage self-calibration method as described above, which on the one hand avoids waste of reagents, and on the other hand ensures the accuracy of the test results. Attached Figure Description

[0018] Figure 1 This is a flowchart illustrating the reagent dosage self-calibration method of the present invention.

[0019] Figure 2 This is a flowchart illustrating the creation of the standard curve of the index and absorbance value of this invention;

[0020] Figure 3It is a standard curve of creatinine versus absorbance. Detailed Implementation

[0021] The preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings, so as to better understand the purpose, features and advantages of the present invention. It should be understood that the embodiments shown in the drawings are not intended to limit the scope of the present invention, but are only for illustrating the essential spirit of the technical solution of the present invention.

[0022] In the following description, certain specific details are set forth for the purpose of illustrating various disclosed embodiments in order to provide a thorough understanding of the various disclosed embodiments. However, those skilled in the art will recognize that embodiments may be practiced without one or more of these specific details. In other instances, well-known apparatuses, structures, and techniques associated with this application may not have been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0023] Throughout this specification, references to "an embodiment" or "an embodiment" indicate that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Therefore, the appearance of "in an embodiment" or "an embodiment" in various places throughout the specification does not necessarily refer to the same embodiment. Furthermore, a particular feature, structure, or characteristic may be combined in any manner in one or more embodiments.

[0024] In the following description, in order to clearly demonstrate the structure and working method of the present invention, a number of directional terms will be used. However, terms such as "front", "back", "left", "right", "outside", "inside", "outward", "inward", "up", and "down" should be understood as convenient terms and not as limiting terms.

[0025] like Figure 1 As shown, the first embodiment of the present invention relates to a reagent dosage self-calibration method, the reagent dosage self-calibration method comprising:

[0026] S1. If the test result of a certain indicator of the test item deviates from the medical range, it is inferred that the reagent required to test the indicator has been exhausted, prompting the replacement of the reagent kit and setting the test item as undetectable.

[0027] Specifically, the test items can include one or more indicators. Indicators include, but are not limited to: urine pH, urine white blood cells (WBC / LEU), urine nitrite (NIT), urine protein (PRO), glucose (GLU), urine urobilinogen (URO / UBG), ketone bodies (KET), occult blood (BLU), bilirubin (BIL), ascorbic acid (VC), salts, creatinine (CrE), and may also include tumor markers such as alpha-fetoprotein, carcinoembryonic antigen, albumin, and urinary β2-microglobulin, as well as microbial indicators such as nicotine, ethanol, and vitamin C. For example, the routine urinalysis test includes urine white blood cells, urine pH, urine ketone bodies, urine nitrite, urine urobilinogen, urine bilirubin, urine protein, glucose, occult blood, and vitamin C. Different reagents are needed to detect these indicators. Therefore, the configuration file contains the various reagents and dosages required for each test item and its corresponding indicator. When the reagents run out, the configuration file needs to be modified in the background. Specifically, the test item needs to be set to undetectable in the temporary configuration file to avoid inaccurate measurement results due to the lack of reagents.

[0028] The testing is performed using an optical detection device. This device offers advantages such as small size and ease of use. Specifically, the optical detection device includes a light source and an optical sensor, which are positioned on opposite sides of the reaction chamber (colorimetric chamber). Light emitted by the light source passes through the liquid in the reaction chamber and is received by the optical sensor. The light source can be an LED lamp. LED lamps can emit different wavelengths of light as needed. That is, for different reagents, the wavelength of the detection light can be the same or different. The optical sensor measures the intensity of the transmitted light.

[0029] Accordingly, the medical scope of the indicators can be obtained experimentally. Specifically, such as Figure 2 As shown, the process for determining the medical range is as follows: 101. Prepare samples, including distilled water and artificial urine samples with different index concentrations; 102. Add the reagents corresponding to the index to each sample and measure the transmitted light intensity of each sample; 103. Calculate the absorbance value A, A = -lg(In / I0), where I0 is the incident light intensity, i.e., the transmitted light intensity of distilled water, and In is the transmitted light intensity of the artificial urine sample; 104. Fit a standard curve of the relationship between index concentration and absorbance value to obtain the medical range. The following explanation uses creatinine as an example.

[0030] Creatinine test:

[0031] 1. Concentration gradients for standard curve preparation (9): 1 mmol / L, 800 μmol / L, 500 μmol / L, 400 μmol / L, 200 μmol / L, 100 μmol / L, 50 μmol / L, 10 μmol / L, 1 μmol / L.

[0032] The standard was diluted with artificial urine.

[0033] 2. Preparation of reaction solution, as shown in Table 1.

[0034] Table 1

[0035]

[0036] 3. The experimental results are shown in Table 2.

[0037] Table 2

[0038]

[0039]

[0040] Note: When calculating the absorbance, a blank control (distilled water) is used as the incident light intensity.

[0041] 4. Fitted curve, such as Figure 3 As shown in the figure, the solid line represents the experimental data, and the dashed line represents the fitted curve. The graph shows a linear relationship between creatinine and absorbance; a higher absorbance indicates a higher creatinine concentration. For urine, the normal creatinine concentration is no lower than 10 μmol / L. If the detected creatinine concentration is less than 10 μmol / L, it can be assumed that the reagent was not added, meaning the reagent may have been depleted.

[0042] When the detected indicators are outside the medical range, a corresponding prompt will be displayed on the user's mobile app. This prompt may be made through one or more methods, such as text, icons, and sounds, to remind the user to replace the medicine box in time. For example, the text and icons may be displayed in yellow with a flashing effect.

[0043] S2. Before starting the next testing process, test the reagent. If the result is outside the normal range, prompt again to replace the reagent kit and continue with other tests; otherwise, determine that the user has completed the reagent kit replacement. When the result is outside the normal range, it indicates that the reagent has been exhausted. By confirming whether the reagent is exhausted before the next testing process, unreliable test results due to failure to replace the reagent kit in time can be avoided. At the same time, continuing with other tests after being prompted can improve the utilization efficiency of other reagents in the kit and avoid waste. After the user has completed the reagent kit replacement, resume the normal configuration file execution and reset the remaining amount of each reagent in the kit to ensure that subsequent testing processes proceed normally.

[0044] Specifically, the process for detecting the reagent is as follows: first, water is pumped into the reaction chamber; then, the reagent is pumped into the reaction chamber; and finally, the transmitted light intensity of the reaction chamber is measured using an optical detection device. Correspondingly, the statement that the detection result is outside the normal range specifically means that the transmitted light intensity value is outside the error range of the standard light intensity value. Preferably, the error is ±5%. The standard light intensity value is obtained through the above experiment, for example, the average light intensity of the blank control sample in Table 2 above.

[0045] If the test result is outside the normal range, the user's mobile app will prompt them to replace the test kit. At this time, text and / or icons will be displayed in red and flashing to increase the warning level.

[0046] For kits containing multiple identical reagents in separate compartments, which are opened and used in rotation to minimize the time from opening to depletion, when the reagent in the current compartment is determined to be exhausted, the configuration file can be updated to allow the next test using the same reagent to be performed from the next compartment containing the same reagent. This ensures that the reagents in the kit are fully utilized, reducing waste, and extends the lifespan of the kit.

[0047] A second embodiment of the present invention also discloses a urine analyzer, which includes a reagent kit, a detection module, and a controller. The detection module is electrically connected to the controller, and the controller is used to perform the reagent dosage self-calibration method described above, which avoids reagent waste and ensures the accuracy of the test results. The structure of this urine analyzer has been described in detail in the applicant's invention patent applications with publication numbers CN113945709A and CN113820480A, and will not be repeated here.

[0048] The controller includes a processor and a memory (RAM). The memory stores a computer program, and the microprocessor executes the calculation program to implement the above-mentioned reagent dosage self-calibration method.

[0049] For example, the computer program may be divided into one or more modules / units, which are stored in the memory and executed by the processor to complete the present invention. The one or more modules / units may be a series of computer program instruction segments capable of performing a specific function, which describe the execution process of the computer program in the terminal device.

[0050] Terminal devices can be computing devices such as desktop computers, laptops, handheld computers, and cloud servers. Terminal devices may include, but are not limited to, processors and memory. For example, they may also include input / output devices, network access devices, and buses.

[0051] The processor can be a Central Processing Unit (CPU), or other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. A general-purpose processor can be a microprocessor or any conventional processor. The processor is the control center of the terminal device, connecting various parts of the terminal device via various interfaces and lines.

[0052] The memory can be used to store the computer programs and / or modules. The processor implements various functions of the terminal device by running or executing the computer programs and / or modules stored in the memory and by calling data stored in the memory. The memory may mainly include a program storage area and a data storage area. The program storage area may store the operating system, at least one application program required for a function (such as sound playback function, image playback function, etc.), etc.; the data storage area may store data created according to the use of the mobile phone (such as audio data, phonebook, etc.). In addition, the memory may include high-speed random access memory, and may also include non-volatile memory, such as hard disk, memory, plug-in hard disk, smart media card (SMC), secure digital (SD) card, flash card, at least one disk storage device, flash memory device, or other volatile solid-state storage device.

[0053] If the various modules / units of a computer program are implemented as software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, all or part of the processes in the methods of the above embodiments of the present invention can also be implemented by a computer program instructing related hardware. The computer program can be stored in a computer-readable storage medium, and when executed by a processor, it can implement the steps of the various method embodiments described above. The computer program includes computer program code, which can be in the form of source code, object code, executable files, or certain intermediate forms. The computer-readable medium can include: any entity or device capable of carrying the computer program code, recording media, USB flash drives, portable hard drives, magnetic disks, optical disks, computer memory, read-only memory (ROM), random access memory (RAM), electrical carrier signals, telecommunication signals, and software distribution media, etc. It should be noted that the content included in the computer-readable medium can be appropriately added or removed according to the requirements of legislation and patent practice in the jurisdiction. For example, in some jurisdictions, according to legislation and patent practice, computer-readable media do not include electrical carrier signals and telecommunication signals.

[0054] The preferred embodiments of the present invention have been described in detail above, but it should be understood that, if necessary, aspects of the embodiments can be modified to utilize aspects, features, and concepts from various patents, applications, and publications to provide other embodiments.

[0055] In light of the detailed description above, these and other changes can be made to the embodiments. Generally, the terminology used in the claims should not be considered limited to the specific embodiments disclosed in the specification and claims, but should be understood to include all possible embodiments together with the full scope of equivalents enjoyed by these claims.

Claims

1. A reagent usage self-calibration method, characterized by, The method comprises: performing a test item, if a detection value of an index of the test item deviates from a medical range, it is inferred that the reagent required for detecting the index has been consumed, prompting to replace the reagent kit and setting the test item as undetectable; before starting the detection process next time, detecting the reagent first, pumping clean water into the reaction chamber first, then performing the operation of pumping the reagent into the reaction chamber, and finally measuring the light transmission intensity of the reaction chamber by the optical detection device; if the value of the light transmission intensity is not within the error of the standard light intensity value, the reagent kit is prompted to be replaced again, and other test items are continuously performed; otherwise, it is determined that the user has completed the operation of replacing the reagent kit; wherein the setting of the test item as undetectable is achieved by executing a temporary configuration file; and after determining that the user has completed the operation of replacing the reagent kit, the normal configuration file is restored to execute and reset the remaining amount of each reagent in the reagent kit; wherein for a plurality of same reagents stored in a group of reagent kits, a rotation opening mode is used, when it is judged that the reagent in the current bin has been consumed, the sampling of the reagent for next detection is executed from the bin of the next same reagent by updating the configuration file.

2. The reagent dosing self-calibration method of claim 1, wherein, The error is ±5%.

3. The reagent dosing self-calibration method of claim 1, wherein, The determination process of the medical range is: preparing distilled water samples and artificial urine samples with different index concentrations; adding the reagent corresponding to the index into each sample and measuring the corresponding light transmission intensity; calculating the absorbance A, A = -lg(In / I0), wherein I0 is the incident light intensity, i.e. the light transmission intensity of distilled water, and In is the light transmission intensity of the artificial urine sample; and fitting the standard curve of the relationship between the index concentration and the absorbance, i.e. obtaining the medical range.

4. The reagent dosing self-calibration method of claim 1, wherein, The index includes urine creatinine, urine protein, urine acidity, urine ketone body, ascorbic acid, nitrite, urine sugar, urine bilirubin, urine hemoglobin, albumin, white blood cells, ethanol and nicotine.

5. The reagent dosing self-calibration method of claim 1, wherein, The way of prompting to replace the reagent includes one or more of the following: text, icon and sound.

6. A urine test meter, characterized by, The urine test instrument comprises a reagent kit, a detection module and a controller, wherein the detection module is electrically connected with the controller, and the controller is used to execute the reagent consumption self-calibration method according to any one of claims 1-5.

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