阅读说明：本技术 一种血糖仪校准方法 (Glucometer calibration method ) 是由 阳萼 何海锋 于 2019-10-11 设计创作，主要内容包括：本申请公开了一种血糖仪校准测试方法,其中血糖仪校准测试方法包括以下步骤：获取试条的实际信号值；当所述实际信号值小于等于第一阈值时,进入测试模式,并通过校准码校准后输出测试值；当所述实际信号值大于第一阈值时,判断所述试条是否为校准试条；当所述试条为校准试条时,根据所述实际信号值获取新的校准码以更新现有校准码；当所述试条不是校准试条时,输出错误指令。本申请所提供的方法,通过对试条的类型判断,既可实现校准码的获取,也可实现普通的血糖监测,无需给校准试条配置单独的接口,共用试条接口,节省仪器成本；并且,校准试条的成本远低于密码牌成本,可以有效节省仪器成本；另外,优化了因密码牌接口带来的静电干扰风险。(The application discloses a blood glucose meter calibration test method, which comprises the following steps: acquiring an actual signal value of the test strip; when the actual signal value is smaller than or equal to a first threshold value, entering a test mode, and outputting a test value after calibration through a calibration code; when the actual signal value is larger than a first threshold value, judging whether the test strip is a calibration test strip; when the test strip is a calibration test strip, acquiring a new calibration code according to the actual signal value to update the existing calibration code; outputting an error instruction when the test strip is not a calibration test strip. According to the method provided by the application, the type of the test strip is judged, so that the acquisition of the calibration code can be realized, the ordinary blood sugar monitoring can also be realized, an independent interface does not need to be configured for the calibration test strip, the test strip interfaces are shared, and the instrument cost is saved; moreover, the cost of the calibration test strip is far lower than that of the password board, so that the cost of the instrument can be effectively saved; in addition, the risk of electrostatic interference caused by the password board interface is optimized.)

1. A blood glucose meter calibration test method is characterized by comprising the following steps:

acquiring an actual signal value of the test strip (2);

when the actual signal value is smaller than or equal to a first threshold value, the blood glucose meter (1) enters a test mode and outputs a test value after being calibrated by a calibration code;

when the actual signal value is larger than a first threshold value, judging whether the test strip (2) is a calibration test strip or not;

when the test strip (2) is a calibration test strip, acquiring a new calibration code according to the actual signal value to update the existing calibration code;

outputting an error instruction when the test strip (2) is not a calibration test strip.

2. The blood glucose meter calibration test method according to claim 1, wherein the step of "determining whether the test strip (2) is a calibration test strip" specifically comprises the steps of:

and determining whether the actual signal value is greater than a second threshold value, and judging whether the test strip (2) is a calibration test strip when the actual signal value is greater than the second threshold value.

3. The blood glucose meter calibration test method according to claim 2, wherein it is determined that the test strip (2) is not a calibration test strip when the actual signal value is equal to or less than the second threshold value.

4. The blood glucose meter calibration test method according to claim 2, wherein the step of "determining whether the test strip (2) is a calibration test strip" further comprises the steps of:

when the actual signal value is larger than the second threshold value, acquiring n actual signal values of the test strip (2);

when the fluctuation range of the n actual signal values is smaller than or equal to a preset value, determining the test strip (2) as a calibration test strip;

otherwise, determining that the test strip (2) is not a calibration test strip.

5. The blood glucose meter calibration test method according to claim 4, wherein the step "when the fluctuation range of the n actual signal values is less than or equal to a preset value, the test strip (2) is determined to be a calibration test strip", specifically:

continuously collecting n actual signal values;

making difference values of two adjacent signal values to obtain n-1 difference values;

and comparing the absolute values of the n-1 difference values with a preset value, if the absolute values of the n-1 difference values are all smaller than the preset value, determining the test strip as a calibration test strip, otherwise, determining the test strip (2) as not the calibration test strip.

6. The blood glucose meter calibration test method of claim 5, wherein the method of determining the preset value comprises:

and collecting a plurality of AD values of the test strip (2) by adopting the same type of instrument and test strip under an interference environment, wherein the difference value between the maximum value and the minimum value in the AD values is the preset value.

7. The method for calibrating and testing a blood glucose meter according to any one of claims 1 to 6, wherein the step of "obtaining a new calibration code to update an existing calibration code according to the actual signal value" is specifically:

and taking the average value of the m times of actual signal values of the test strip (2) as a target actual signal value, and acquiring a new calibration code according to the target actual signal value to update the existing calibration code.

8. The method for calibrating and testing a blood glucose meter according to claim 7, wherein the step of "obtaining a new calibration code according to the target actual signal value to update an existing calibration code" includes:

and calling the calibration code corresponding to the target actual signal value as a new calibration code according to the signal value and calibration code corresponding table prestored in the blood glucose meter (1) by taking the target actual signal value as a basis so as to update the existing calibration code.

9. The method for calibrating and testing the blood glucose meter according to any one of claims 1 to 6, wherein the first threshold value is obtained by: the test strip is influenced by the ambient temperature and the humidity, the resistance value is changed, and the minimum signal value is acquired when the test result is not influenced.

10. The method for calibrating and testing the blood glucose meter according to any one of claims 2 to 6, wherein the second threshold value is obtained by: the test strip is influenced by the ambient temperature and humidity, the resistance value is changed, and the minimum value is acquired when the test result is influenced.

Technical Field

The application relates to the field of biological pharmacy, in particular to a method for calibrating and testing a glucometer.

Background

In the use process of the glucometer, the product raw materials and the production conditions of test strips are different, the consistency of the glucose oxidase test paper is not well controlled in the manufacturing process, so that the reaction activities on different batches of test paper are different, and therefore, the code is required to be adjusted in the use process, namely, the glucometer and each batch of test paper are matched through adjustment. Specifically, each calibration code of the blood glucose meter corresponds to a small set of programs, and a user must correspond the calibration codes of the blood glucose meter to obtain a correct result when using the blood glucose meter.

Disclosure of Invention

The application aims to provide a glucometer calibration test method, which is used for saving cost, avoiding electrostatic interference, improving calibration test efficiency and further improving the precision of a detection result.

In order to achieve the above purpose, the present application provides the following technical solutions:

a blood glucose meter calibration test method, comprising the steps of:

acquiring an actual signal value of the test strip;

when the actual signal value is smaller than or equal to a first threshold value, the blood glucose meter enters a test mode and outputs a test value after being calibrated through a calibration code;

when the actual signal value is larger than a first threshold value, judging whether the test strip is a calibration test strip;

when the test strip is a calibration test strip, acquiring a new calibration code according to the actual signal value to update the existing calibration code;

outputting an error instruction when the test strip is not a calibration test strip.

Preferably, the step of "judging whether the test strip is a calibration test strip" specifically includes the following steps:

and determining whether the actual signal value is greater than a second threshold value, and judging whether the test strip is a calibration test strip when the actual signal value is greater than the second threshold value.

Preferably, when the actual signal value is equal to or less than the second threshold value, it is determined that the test strip is not a calibration test strip.

Preferably, the step of "determining whether the test strip is a calibration test strip" further comprises the steps of:

when the actual signal value is larger than the second threshold value, acquiring n actual signal values of the test strip;

when the fluctuation range of the actual signal value is less than or equal to a preset value, determining the test strip as a calibration test strip 5;

otherwise, the test strip is determined not to be a calibration test strip.

Preferably, in the step "when the fluctuation range of the n actual signal values is less than or equal to a preset value, the test strip is determined to be a calibration test strip", specifically:

continuously collecting n actual signal values;

making difference values of two adjacent signal values to obtain n-1 difference values;

and comparing the absolute values of the n-1 difference values with a preset value, if the absolute values of the n-1 difference values are all smaller than the preset value, determining that the test strip is a calibration test strip, otherwise, determining that the test strip is not the calibration test strip.

Preferably, the method for determining the preset value includes:

and acquiring a plurality of AD values of the test strip by adopting the same type of instrument and test strip under an interference environment, wherein the difference value between the maximum value and the minimum value in the AD values is the preset value.

Preferably, the step of "obtaining a new calibration code according to the actual signal value to update the existing calibration code" specifically includes:

and taking the average value of the m actual signal values of the test strip as a target actual signal value, and acquiring a new calibration code according to the target actual signal value to update the existing calibration code.

Preferably, the step of "acquiring a new calibration code according to the target actual signal value to update an existing calibration code" specifically includes:

and calling the calibration code corresponding to the target actual signal value as a new calibration code according to the signal value and calibration code corresponding table prestored in the blood glucose meter by taking the target actual signal value as a basis so as to update the existing calibration code.

Preferably, the value taking method of the first threshold is as follows: the test strip is influenced by the ambient temperature and the humidity, the resistance value is changed, and the minimum signal value is acquired when the test result is not influenced.

Preferably, the value of the second threshold is as follows: the test strip is influenced by the ambient temperature and humidity, the resistance value is changed, and the minimum value is acquired when the test result is influenced.

The application provides a blood glucose meter calibration test method, which comprises the following steps: acquiring an actual signal value of the test strip; when the actual signal value is smaller than or equal to a first threshold value, the blood glucose meter enters a test mode and outputs a test value after being calibrated through a calibration code; when the actual signal value is larger than a first threshold value, judging whether the test strip is a calibration test strip; when the test strip is a calibration test strip, acquiring a new calibration code according to the actual signal value to update the existing calibration code; outputting an error instruction when the test strip is not a calibration test strip. According to the glucometer calibration test method provided by the application, the calibration code can be obtained through the judgment of the test strip, meanwhile, the common test can be realized, the calibration test strip is not required to be provided with a separate interface, the test strip interface is shared, and the instrument cost is saved; moreover, the cost of the calibration test strip is far lower than that of the password board, so that the cost of the instrument can be effectively saved; in addition, the risk of electrostatic interference caused by the password board interface is optimized.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

FIG. 1 is a flow chart of a method of calibrating a test of a blood glucose meter provided herein;

FIG. 2 is a flow chart of one embodiment of a method for calibrating a blood glucose meter provided herein;

FIG. 3 is a schematic diagram of a structure of one embodiment of a blood glucose meter provided herein;

FIG. 4 is a graphical comparison of values in a blood glucose meter calibration test method provided herein;

wherein: blood glucose meter (1), test strip (2), test strip interface (3).

Detailed Description

The core of the application is to provide a glucometer calibration test method, which is used for saving cost, avoiding electrostatic interference, improving calibration test efficiency and further improving the precision of a detection result.

In order that those skilled in the art will better understand the disclosure, the following detailed description will be given with reference to the accompanying drawings.

Referring to fig. 1 to 4, fig. 1 is a flowchart illustrating a calibration testing method for a blood glucose meter provided in the present application; FIG. 2 is a flow chart of one embodiment of a method for calibrating a blood glucose meter provided herein; FIG. 3 is a schematic diagram of a structure of one embodiment of a blood glucose meter provided herein; fig. 4 is a diagram illustrating comparison of values in a blood glucose meter calibration test method provided in the present application.

In this embodiment, the blood glucose meter calibration test method comprises the steps of:

step S1: acquiring an actual signal value of the test strip 2;

step S2: when the actual signal value is less than or equal to a first threshold value, entering a test mode, and outputting a test value after calibration through a calibration code, wherein the first threshold value can be a signal value obtained by experimental data, the actual signal values of normal test strips which can be normally used are all less than or equal to the first threshold value, and when the test strip 2 is a calibration test strip or a test strip which cannot be normally used, the actual signal values of the test strip 2 are all greater than the first threshold value;

step S3: when the actual signal value is greater than the first threshold value E3, judging whether the test strip 2 is a calibration test strip;

step S4: when the test strip 2 is a calibration test strip, acquiring a new calibration code according to the actual signal value to update the existing calibration code;

step S5: when test strip 2 is not a calibration strip, an error command is output.

The actual signal value of the test strip 2 is a value that can be recognized by the controller through conversion of current, resistance signal, and the like, and is denoted by AD herein.

Specifically, in the time of in-service use, in order to improve the accuracy of examination strip 2, when opening a new examination strip 2, should insert the blood glucose meter 1 with calibration examination strip at first, blood glucose meter 1 can judge that this examination strip 2 is ordinary examination strip, still calibration examination strip or unable normal use examination strip, and unable normal examination strip of using can be for the examination strip that wets, used examination strip etc. that makes progress, and unable ordinary examination strip of using is wrong examination strip promptly.

Moreover, each box of test strips 2 of the test strips 2 used by the blood glucose meter 1 provided by the application is provided with a corresponding calibration test strip, so that the risk that a user mistakenly thinks that the code does not need to be adjusted or forgets to adjust the code is prevented.

The system for calibrating and testing the glucometer 1 can realize the acquisition of the calibration code and the common test by judging the test strips 2, does not need to configure separate interfaces for the calibration test strips, and shares the test strip interface 3, thereby saving the instrument cost; moreover, the cost of the calibration test strip is far lower than that of the password board, so that the cost of the instrument can be effectively saved; in addition, the risk of electrostatic interference caused by the password board interface is optimized.

Further, before obtaining the actual signal value of the test strip 2, the test strip 2 installation process is also included, for example, the test strip is inserted into the meter, the test strip 2 may be an actual test strip or a calibration test strip, the actual test strip may contain the conditions of expiration, moisture or used sample absorption, and the meter will perform signal collection and self-judge.

On the basis of the above embodiments, the step of "determining whether or not the strip 2 is a calibration strip" includes the steps of:

it is determined whether the actual signal value is greater than the second threshold value and, when the actual signal value is greater than the second threshold value, it is determined whether strip 2 is a calibration strip.

Specifically, the second threshold is the minimum value in the calibration signal value range, and the test strip 2 smaller than or equal to the second threshold is an error test strip, specifically, when the actual signal value is smaller than or equal to the second threshold, it may be determined that the test strip 2 is not a calibration test strip, and at this time, an error signal may be sent. The test strip 2 is an abnormal test strip, and may be an expired or damp test strip.

On the basis of the above embodiments, the step of "determining whether or not the test strip 2 is a calibration test strip" further includes the steps of:

when the actual signal value is larger than the second threshold value, acquiring n actual signal values of the test strip 2;

and when the fluctuation range of the n actual signal values is smaller than or equal to the preset value, determining the test strip 2 as a calibration test strip.

Specifically, if the fluctuation range of the data of the actual signal value obtained for multiple times is within the preset value, that is, the fluctuation range of the actual signal value of the test strip 2 is smaller, the test strip 2 larger than the second threshold value can be regarded as a calibration test strip; more specifically, when the fluctuation range of the n actual signal values is larger than the preset value, it is determined that the test strip 2 is not a calibration test strip, that is, the fluctuation range of the actual signal values of the test strip 2 is large, it can be determined as an error test strip, and an error signal can be output.

On the basis of the above embodiments, the step "acquiring a new calibration code according to an actual signal value to update an existing calibration code" specifically includes:

the average value of the m actual signal values of the test strip 2 is used as the target actual signal value, and a new calibration code is obtained according to the target actual signal value to update the existing calibration code.

On the basis of the foregoing embodiments, the step "acquiring a new calibration code according to a target actual signal value to update an existing calibration code", specifically includes:

and when the target actual signal value is within the calibration signal value range, acquiring a new calibration code according to the target actual signal value to update the existing calibration code.

Through the steps, whether the target actual signal value is within the calibration signal value range or not can be judged, and the process of selecting the calibration code can be executed within the calibration signal value range.

Further, the method can be applied to a glucometer 1 calibration test system, the glucometer 1 calibration test system comprises a glucometer 1, test strips 2 and a controller installed on the glucometer 1, the test strips 2 can be common test strips or calibration test strips, the glucometer 1 is also provided with test strip interfaces 3 for the test strips 2 to be inserted, the common test strips and the calibration test strips share the same test strip interface 3, the controller can automatically judge the types of the test strips 2, and the controller is used for executing the glucometer calibration test method.

Further, the blood glucose meter 1 is also provided with a display screen for displaying a test value or an error instruction, so that an operator can conveniently observe the blood glucose meter.

As shown in fig. 4, the first threshold E3: the test strip threshold value is used for judging whether the test strip is a normal test strip threshold value or not; second threshold CODE _ E3: for determining whether the strip is a threshold for calibrating the strip.

Further, the value method of the first threshold E3 is as follows: the resistance value of the test strip is changed under the influence of the environmental temperature and the humidity, and the minimum signal value is acquired when the test result is not influenced; the value of the second threshold CODE _ E3 is as follows: the resistance of the test strip changes under the influence of ambient temperature and humidity, and the minimum value of the test result is influenced. This minimum is less than the signal value collected by the instrument when the calibration strip is used.

Specifically, in the same type of instrument and test strip, through multiple experiments, different test environments are artificially created, and under extreme environments as far as possible, the first threshold value E3 and the second threshold value CODE _ E3 can be obtained and then stored in the instrument for later use.

For the AD value is not infinitely small or infinitely large, the AD circuit in the instrument itself has a signal processing range, for example, for an AD currently used in a certain style, the lower range limit is 0 (i.e., no signal can be acquired), and the upper range limit is 4096 (i.e., the AD value mentioned in the patent is 4096 corresponding to the maximum signal that can be acquired by the AD).

Further, the calibration and test method for a blood glucose meter provided by this embodiment includes the following steps in a specific embodiment:

inserting the test strip 2 or the calibration test strip, and starting the instrument; the instrument collects an initial actual signal value and judges a trigger value of E3, when the actual signal value is less than or equal to a first threshold value E3, the instrument enters a sample sucking waiting mode, namely, the instrument enters a test mode, and if the actual signal value is greater than the first threshold value E3, the instrument enters the next step of judging a calibration test strip; if the actual signal value is less than or equal to the second threshold value CODE _ E3, the instrument prompts an error signal E-3; entering calibration test strip judgment if the actual signal value is greater than a second threshold value CODE _ E3; and (4) entering a calibration test strip for judgment: continuously collecting n actual signal values;

the difference value is made between two adjacent signal values, so that n-1 difference values can be obtained;

comparing the absolute values of the n-1 difference values with a preset value (a parameter prestored in the instrument), if the absolute values of the n-1 difference values are all smaller than the preset value, judging the test strip as a calibration test strip, otherwise, judging the test strip as a used or damp actual test strip, and reporting an error by the instrument to display an E-3 error prompt.

The preset value is determined in the following manner:

the method comprises the following steps of collecting a plurality of AD values by adopting the same type of instrument and test strip under an interference environment, such as strong magnetic interference, wherein the difference value between the maximum value and the minimum value in the AD values is a preset value, and the preset value is set as follows.

TABLE 1 Standard test strip values

For the explanation of table 1:

1. concept of calibration strip: the calibration test strip can be used when the performance of the glucometer 1 is detected, the calibration test strip is the same as the calibration test strip, the condition of simulating an actual test strip under different resistance values is realized through resistors, each calibration test strip has different resistance values, and the calibration test strip corresponds to the detection result of the actual test strip under different conditions. Therefore, when the instrument is used for testing, an actual test strip and a blood sample are not needed, and the test is more convenient.

The calibration test strip is a specific calibration test strip, and the resistance value of the calibration test strip only corresponds to the calibration code, so that the resistance value of the calibration test strip is certain specific resistance values.

Whether the test strip is a calibration test strip or a calibration test strip, after the resistance value is determined, only one test result can be corresponded; when other test results need to be detected, the calibration test strips with different resistance values or the calibration test strips need to be replaced.

2. The data in table 1 were obtained as follows: selecting 5 calibration test strips with different resistance values, wherein the resistance values of the calibration test strips respectively correspond to 5 AD theoretical values obtained by testing under normal conditions, the theoretical values are some discrete AD values artificially selected in a measuring range, the 5 theoretical values in the table 1 are selected in the measuring range (0, 4096), and the selected theoretical values can be different if the measuring ranges are different for different instruments; and then, respectively testing the 5 calibration test strips in an artificial strong electromagnetic interference environment, continuously acquiring AD values, then changing the interference intensity, continuously acquiring the AD values, and obtaining a plurality of AD values in different interference environments after a plurality of experiments, wherein the largest one is MAX in the table 1, and the smallest one is MIN in the table 1.

3. And (3) obtaining 5 difference values by taking the difference value of the MAX and MIN corresponding to each group, wherein the largest one of the 5 difference values is a preset value, and the preset value is stored in the instrument for later use.

Theoretically, the more calibration strips are selected, the more accurate the preset value can be selected.

After the calibration test strip is judged, the AD value (average value of 3 times) acquired by the circuit is matched with the calibration test strip and AD corresponding value table in the table 1, and correct calibration code setting is completed; if the corresponding calibration code value is not found, an error signal E-3 is prompted; the calibration strip has a plurality of different codes, each of the calibration codes corresponding to a fixed resistance, and each of the calibration strips is coded with a fixed code according to the different resistances. See table 2 for examples.

TABLE 2 calibration test strip and AD correspondence table

Resistance corresponds to the AD calculation formula:

AD/4096＝U₀/2000mV (4096 is AD full scale; 2000mV is chip reference voltage)

U₀-300mV/R_{Inverse direction}＝300mV/R(R_{Inverse direction}Is a feedback resistor; r is the resistance value of the calibration test strip; 300mV as excitation voltage)

AD＝4096*((1600*300)/R+300)/2000

It should be noted that the parameters of span, reference voltage, feedback resistance, excitation voltage may be somewhat different for different instruments and strip types, but are known quantities as long as the instrument and strip type can be determined.

Wherein, example 1: the resistance of the calibration strip is 45.12K omega, the AD value collected by the instrument inserted into the glucometer 1 is 2793, and the code value of C24 is judged in the range (2752, 2832).

Example 2: judging the range: 2793 is the theoretical AD value corresponding to C24, 2871 is the theoretical AD value corresponding to C23, then 2832 is (2793+2871)/2, the decision between 2793 and 2832 is C24, and the decision between 2832 and 2912 is C23; 2710 is a theoretical AD value corresponding to C25, 2793 is a theoretical AD value corresponding to C24, 2752 is (2710+2793)/2, and a decision is made as C25 when it is located between 2670 and 2752, and a decision is made as C24 when it is located between 2752 and 2832.

Example 3: the validation data are shown in Table 3:

TABLE 3 test results record

1) Insert normal strip 2, instrument AD 616, < E3 (E3: 921), enter aspirate wait;

2) inserting expired or damp strips, the apparatus AD generally ranging from 1000 to 1400, E3 < AD < CODE _ E3(CODE _ E3 is 1433), the apparatus display E-3;

3) the test strip inserting instrument for low concentration test and the test strip inserting instrument for high concentration test are used, the initial AD value of the instrument is greater than 1433, the calibration test strip is used for judging, 3 times of values are continuously collected, AD 0, AD 1 and AD 2 are obtained, the difference value is △ C1 ═ AD 0-AD 1, △ C2 ═ AD 1-AD 2, the conclusion is obtained from the test result, △ C1>102 or △ C2>61, the instrument is judged to be not the calibration test strip, and the instrument prompts E-3.

4) Calibration test strips C23 and C24 are inserted, the device initial AD value is more than 1433, the calibration test strips are entered for judgment, 3 times of values are continuously collected, AD [0], AD [1] and AD [2], the difference values △ C1-AD [0] -AD [1], △ C2-AD [1] -AD [2] are made, the test result shows that the condition that the result does not meet △ C1>102 or △ C2>61, and the collected AD value is matched with a calibration code and AD corresponding value table (table 2), so that the correct calibration code setting is completed.

The blood glucose meter calibration test method provided by the present application is described in detail above. The principles and embodiments of the present application are explained herein using specific examples, which are provided only to help understand the method and the core idea of the present application. It should be noted that, for those skilled in the art, it is possible to make several improvements and modifications to the present application without departing from the principle of the present application, and such improvements and modifications also fall within the scope of the claims of the present application.