TWI381824B - Biological detection device with automatic correction function and operation method thereof - Google Patents

Description

Biological detection device with automatic correction function and operation method thereof

The present invention relates to a biological detection device and method, and more particularly to an innovative designer who can achieve automatic correction without inputting a correction code or inserting a cipher.

According to the invention, the term "biological detection" includes blood glucose, metabolites, endocrine and other detection items, among which blood glucose detection is currently familiar, because the majority of diabetic patients must understand blood sugar status through blood glucose testing, early diabetes. Patients must go to a medical institution to conduct blood glucose testing. However, under the breakthrough of research and development in related industries, diabetic patients can now use their home-made blood glucose machines to achieve self-monitoring of blood sugar at home. The blood glucose machine enables diabetics to know blood sugar instantly. High and low, and as a basis for adjusting the amount of insulin injected and the amount of food, so the blood glucose machine can delay the complications of diabetes (such as eyes, kidneys, nerves, blood vessels, etc.) to prevent dialysis, amputation, blindness, and other unfortunate occur.

The home-based bio-detection device still has its drawbacks and problems in practical application. In the case of blood glucose machines, blood glucose machines of different brands or different brands usually have their own special blood glucose test strips. And some brands of blood glucose machines, the test strips produced at the same time used by the same type of blood glucose machine, must also replace the code piece (or calibration chip) to ensure the accuracy of its detection; The blood glucose meter is equipped with a calibration code for blood glucose test strips produced at different times. When using the user, special attention must be paid to whether the entered calibration code matches the batch number of the blood glucose test strip used, otherwise the accuracy of the test may be Loss of blood glucose monitoring due to inconsistency with the facts.

However, whether it is a blood glucose machine or other biological testing devices, most of its users are elderly people. Their memory, responsiveness and comprehension ability are obviously not as young as they are. Therefore, the product design should be simple, and the more complicated, the more mistakes will occur. The greater the probability of the problem, the action of replacing the cipher and the input of the correction code in the previous paragraph, because the older users tend to have mixed old and new test pieces, and thus the corrective action is performed, still There may be an error situation, or some users may even forget to change the password chip or forget to input the correction code. It can be seen that the design of the conventional biological detection device obviously still has the use operation and easy to cause the error problem to occur. The problem of perfection.

The blood glucose machine (or other biological detection device) which uses the cipher chip, the operation steps thereof are as follows with the first figure, which includes:

1. Shutdown status;

2. Insert the password to set the password;

3. Take out the password and reply to the shutdown state;

4. Insert the test piece and start the blood glucose machine;

5. Drop in the sample;

6, stop waiting for a reaction time (such as 5 seconds);

7. The voltage is supplied at the start-up, and the calculation of the detected value is performed;

8. Display the detected value.

It is not difficult to understand from the above steps. It is known that the operation of the blood glucose machine using the cipher tablet must first perform the insertion and removal of the cipher chip, which is not only convenient to use and inefficient, but also has a large probability of causing the error to occur.

Moreover, a common electrochemical biosensing test piece (Electro Chemical Biose nsor), such as a commercially available blood glucose test piece, is mainly composed of an electrode and a chemical component (Reagent) coated on the reaction zone, and the electrode is sputtered and plated. , etching and screen printing manufacturing. The chemical component is coated in the production process according to the standard production process (sop); the reactive component and the volume of the reaction recipe (Reagent) are applied by dispensing, airbrush coating, printing or other means. Above the electrode of the reaction zone, during the coating process, the coating machine conditions are set, the operating environment temperature and humidity are under strict control, and the formulation is also prepared according to a fixed ratio. However, in the mass production process, each time an electrochemical biosensor test piece is produced, there is still a difference between the same batch (Within-Batch) test piece and the batch-to-batch difference of different batch production. The reasons for the differences between individual test pieces in such mass production may be:

(1) The electrodes produced in different batches are not identical in electrical properties;

(2) The formulation is difficult to achieve a completely consistent state in the volume and thickness of each test piece;

(3) The chemical substances in the formula may change in composition during the long-term coating process;

(4) This inconsistency in the production process may result in measurement errors due to differences in electrode electrical properties and differences in thickness and concentration of the coating layer on the chemical reaction zone.

Therefore, in the actual production process, the producer cannot assign the correction formula for each batch of production test pieces according to the empirical value. Samples must be taken in each batch of production test strips, using a series of concentrations of the analytes as a calibration curve (cal ibration curve), and the corresponding formula (password) corresponding to the produced test piece can be given according to the results. Accurate measurement. Commonly used in the same batch of production test strips, or in different batches of test strips, the area scores are corrected. Therefore, in the process of using the biosensor measurement, the user must first correct the instrument, and the correction can be inserted into the calibration card into a password card mode, and the key formula can be called by the button. Serious measurement errors caused by the user's unskilled operation mode or the insertion of a non-corresponding password card, or simply forgetting to make a pre-use correction.

In order to avoid the trouble of pre-detection correction and the measurement error that may be caused by mis-insertion of the cipher chip, it is ensured that the measurement is accurate, and if the inconsistency (electrode difference, coating layer thickness, formula concentration) of different test pieces can be performed, It is a good practice to perform electrical background value measurement and then give correction parameters before actual measurement.

The focus of the present invention is to provide a solution to the above problems. After the machine detects the insertion of the test piece, immediately before the test piece is engaged in the actual measurement of the test object, immediately after applying the background electrical measurement of the test voltage quantity test piece, the machine immediately stops the voltage supply, so as not to affect the subsequent Chemical reaction, machine test background, after comparison, find the corresponding detection parameters (such as magnification, slope, intercept, temperature, humidity compensation coefficient, etc.) in the memory. After the chemical reaction is completed, when the instrument performs the measurement of the analyte, the instrument reads this parameter, and the correct measurement value can be presented after the measurement.

That is, the main object of the present invention is to provide a biological detecting device with an automatic correcting function and a method for operating the same, and the problem to be solved is to use a correction chip or an input correction for a conventional biological detecting device. The code still has a problem in that the operation is easy to cause a problem of error and the simplicity is insufficient. The biodetection device includes: an apparatus body including an external operation display interface, a test strip insertion portion, and an internal circuit module. And a battery pack for supplying power required for operation of the circuit module, wherein the test strip insertion portion is configured to cooperate with a plurality of types of test strips;

The technical feature of the present invention is mainly to build a test strip data storage module and an automatic correction module in the biometric detecting device, wherein the test strip data storage module is used for storing and storing a plurality of test strips. Electrical value-related data; the automatic calibration module is electrically connected to the test strip insertion unit, the test piece data storage module and the circuit module, thereby detecting the test piece electrical value of the test piece insertion portion, and automatically Cooperating with the data stored in the sample data storage module, and automatically correcting the detection program reference value of the circuit module, thereby ensuring the detection accuracy of the biological detection device; thereby, the innovative and unique design makes the present invention compare with the prior art. The bio-detection device can be directly inserted into the test piece for detection, and the electric value correction operation can be automatically achieved through the automatic correction module and the test piece data storage module, so that no password or input is needed. The correction code can be used to achieve practical and practical use that is easier and more convenient to use.

Please refer to FIG. 2, which is a preferred embodiment of the biodetection device with automatic correction function of the present invention, but the embodiments are for illustrative purposes only, and are not limited by the structure in the patent application; The biological detection device A includes the following components:

a device body 10, which comprises an external operation display interface

11. A test strip insertion portion 12, and a circuit module 13 and a battery pack 14 disposed therein, wherein the battery pack 14 is used to supply power required for the operation of the circuit module 13, and the test strip is inserted. The setting portion 12 can be a flat insertion groove type, so that a plurality of types of test pieces 15 can be inserted and matched;

a test piece data storage module 20 for storing and storing data related to the electrical values (such as voltage value, resistance value, etc.) of the plurality of test pieces 15;

An automatic calibration module 30 is built in the device body 10, and is electrically connected to the test strip insertion unit 12, the test strip data storage module 20, and the circuit module 13. The automatic correction module 30 is electrically coupled. The function and operation state are as shown in FIG. 3, by which the electrical value of the test piece of the test strip insertion portion 12 is detected, and the data stored in the test strip data storage module 20 is automatically combined and re-automatically Correcting the detection program reference value of the circuit module 13 to ensure the detection accuracy of the biological detection device A; the reference value of the detection program may be: magnification, slope, intercept, temperature, humidity compensation coefficient, etc. .

According to the above structural composition design, the biodetection device with automatic correction function disclosed in the present invention uses the following operation method: (Please refer to FIG. 4 and cooperate with the second and third figures)

a, inserting the test piece into the biological detection device A to start the detection function;

b. The biodetection device A provides a voltage;

c. dropping the sample to be tested (such as blood, urine, and other secretions) into the set portion of the test piece 15;

The automatic calibration module 30 of the biodetection device A automatically detects the electrical value of the test strip 15 of the test strip insertion portion 12, and extracts the sample data storage module 20 according to the electrical value. Corresponding detection program reference values such as magnification, slope, intercept, temperature, humidity compensation coefficient, etc.

e, the detection action stops, waiting for a chemical reaction time (such as 5 seconds);

f. The biometric detection device A provides a voltage for detection, and the circuit module 13 extracts the reference value of the detection program corresponding to the sample data storage module 20 according to step d, such as magnification, slope, intercept, temperature, Calculate the value of the sample detection value (such as glucose concentration) by setting the value of the humidity compensation coefficient, etc.; a preset conversion formula: (detection value) = a × (current) + b;

g. The operation display interface 11 of the biometric detection device A operates to perform the detection function, and the detection value displayed on the operation display interface 11 can be read.

As shown in Fig. 5, the above-described operation method is converted into a time-axis mode. The axis L1 represents the time when the bio-detection device A uses the operation flow, and the axis L2 represents the change state of the detection voltage.

As can be seen from the fourth and fifth figures, the operation method of the biodetection device having the automatic correction function of the present invention starts directly from the operation of the "insertion test piece", so that the cipher chip is used as compared with the conventional one shown in Fig. 1. In terms of the operation mode of the biodetection device, the operation procedure of inserting, unplugging or inputting the correction code of the cipher chip component can be omitted, and the operation flow can be greatly simplified, and the use convenience and the error rate can be effectively reduced.

Advantages of the invention:

The invention relates to a "biological detection device with automatic correction function and an operation method thereof", which is mainly made up of a novel and unique design of a test piece data storage module and an automatic correction module built in the biological detection device, so that the present invention is compared [Prior Art] In the prior art, the biodetection device can be directly inserted into the test piece for detection, and the electrical value correction operation can be performed through the automatic correction module and the test piece data storage. The module is automatically achieved, so there is no need to use a cipher chip or input a correction code, so that the practical progress and advantages of using the error rate can be achieved more easily and greatly reduced.

The above embodiments are intended to be illustrative of the present invention, and are not to be construed as limiting the scope of the invention. The principles are changed and modified to achieve an equivalent purpose, and such changes and modifications are to be included in the scope defined by the scope of the patent application as described later.

A. . . Biological detection device

10. . . Device body

11. . . Operation display interface

12. . . Test strip insertion

13. . . Circuit module

14. . . Battery

15. . . Audition

20. . . Sample data storage module

30. . . Automatic calibration module

Figure 1: The block diagram of the operation steps of the blood glucose machine using the cipher.

Fig. 2 is a perspective view showing the structure of the biological detecting device of the present invention.

Fig. 3 is a block diagram showing the operation state of the automatic correction module of the present invention.

Fig. 4 is a block diagram showing the operation method of the biological detecting device of the present invention.

Fig. 5 is a schematic diagram showing the transformation of the method steps shown in Fig. 4 into a time axis manner.

A. . . Biological detection device

10. . . Device body

11. . . Operation display interface

12. . . Test strip insertion

13. . . Circuit module

14. . . Battery

15. . . Audition

20. . . Sample data storage module

30. . . Automatic calibration module

Claims (4)

A biodetection device with an automatic correction function, comprising: a device body, comprising: an external operation display interface, a test strip insertion portion, and a circuit module disposed inside and a battery pack, wherein The battery pack is used to supply the power required for the operation of the circuit module, and the test strip insertion portion is configured to cooperate with a plurality of types of test strips; a test strip data storage module for storing and storing the plurality of tests An electrical correction module is built in the main body of the device, and is electrically connected to the test strip insertion portion, the test strip data storage module and the circuit module, wherein the test strip is electrically connected. The data storage module and the automatic calibration module are integrated into the structure of the circuit module, and the automatic calibration module detects the electrical property value of the test strip insertion portion and automatically matches the test strip. The data stored in the data storage module is combined to automatically correct the reference value of the detection module of the circuit module, thereby ensuring the detection accuracy of the biological detection device. The biodetection device with the automatic correction function according to the first aspect of the patent application, wherein the test strip insertion portion can be a flat insertion slot type. A method for operating a biological detection device with an automatic correction function, the operation method for operating a biological detection device having an automatic correction function as described in claim 1 of the patent application, the operation method comprising: a, inserting the test piece into the biological detection device to initiate the detection function; b, the biological detection device provides a voltage; c, dropping the sample to be tested into the test piece setting portion; d, the biological detection device is set automatically The calibration module automatically detects the electrical value of the test strip of the test strip insertion portion, and automatically corrects the reference value of the test module of the circuit module according to a preset conversion formula; e, the detection action stops, waiting for a chemistry The reaction time; f, the biological detection device is provided for detecting a voltage, and the calculation of the sample detection value is performed by the circuit module; g, the operation of the biological detection device is displayed, and the interface operation is performed to perform the detection function, thereby reading Take the detection value. According to the method for operating a biological detection device with an automatic correction function according to claim 3, wherein the sample to be tested may be dropped before the test piece is inserted into the test piece insertion portion of the biological detection device. Enter the test piece.