KR101703997B1 - Test strip and assay device - Google Patents

Abstract

The present invention relates to a test strip and an analyzer for measuring a health condition of a patient. And more particularly, to a test strip and analyzer that more accurately measures a health condition of a patient in consideration of the output characteristics of the test strip.

Description

[0001] TEST STRIP AND ASSAY DEVICE [0002]

The present invention relates to a test strip and an analyzer for measuring a health condition of a patient. And more particularly, to a test strip and analyzer that more accurately measures a health condition of a patient in consideration of the output characteristics of the test strip.

As society develops, quality of life is increasingly recognized as an important issue, and as interest in personal health increases, the development of home medical devices is advancing rapidly. According to this tendency, when a consumer selects a home medical device to be used directly by the end user in the medical device field, the convenience of the user is emphasized as well as the performance or the function of the product.

In such medical devices, there is a growing need for portable medical devices for diseases that require routine management and measurement, such as hypertension, diabetes and metabolic syndrome, one of which is diabetes mellitus It is a blood glucose meter. Recently, the World Diabetes Federation announced that there will be 360 million diabetic patients in the world over the next 20 years, and diabetic patients will increase by about 9% every year in adults as well as adults due to unbalanced diet and lack of exercise As expected, the blood glucose meter is the largest market for medical devices. Particularly, in the case of diabetes, the diabetic patient has to check the diabetic state by measuring the blood glucose concentration periodically every several times a day, so that the convenience of the user is more emphasized in the blood glucose meter.

Recent blood glucose meters have been able to diagnose diabetes regardless of time and place simply by knowing their health condition by going to a hospital in the past according to the development of technology. However, in the case of a test strip or a biochip currently used for blood glucose measurement, an error occurs in the blood glucose concentration measured for each test strip or chip according to the production lot due to manufacturing reasons. Therefore, the user has to input the code information for the production lot of the test strip or the bio chip to correct the error in order to obtain the correct measurement result when measuring the blood glucose using the blood glucose meter. In particular, the input of such code information may be a restriction on the use of the patient when the patient is a child or an elderly person.

The problems to be solved by the present invention are as follows.

An object of the present invention is to provide a test strip and analyzing apparatus which minimizes an input of a user and thereby improves user's convenience.

Another object of the present invention is to provide a test strip and an analyzing apparatus that operate normally without receiving input from a user for code information.

It is still another object of the present invention to provide a test strip and analyzer that recognize output characteristics according to a production lot of a test strip and correct measured values based thereon.

Another object of the present invention is to provide a test strip and an analyzing device for measuring a health condition of a patient from a plurality of substances.

It is still another object of the present invention to provide an analyzing apparatus communicating with an external device.

The present invention solves the problem by providing a test strip and an analyzing apparatus as described below.

A test strip according to an aspect of the present invention is a test strip having output characteristics of one of a plurality of output characteristics, wherein the test strip is provided with a body fluid and outputs a reaction signal due to reaction of the indicator substance contained in the body fluid, And an identification unit including an identification structure reflecting the reaction unit and the output characteristics thereof. At this time, the identification structure allows the analyzer to acquire an electrical signal indicating an output characteristic from the identification structure using an electronic measuring device.

An analyzer according to an aspect of the present invention includes a reaction unit having an output characteristic of one of a plurality of output characteristics and outputting a reaction signal due to a reaction of an indicator substance contained in body fluids, A receiving section for receiving a test strip including an identification section including an identification structure reflecting an output characteristic, a recognition section for obtaining an electrical signal indicating an output characteristic from the identification structure using an electronic measurement device, And obtaining a correction value based on the measured value and the electrical signal.

The present invention has the following effects.

One effect of the present invention is to measure the health status of a patient without the user entering code information when using the test strip and analyzer.

Another effect according to the present invention is that the analyzer automatically recognizes the output characteristics of the test strip and corrects the measured values accordingly.

Another effect according to the present invention is that in the test strip and analyzer using the electrochemical measurement method, the output characteristics of the test strip are recognized by the electrical measurement method, thereby reducing the production cost.

 Another advantage of the present invention is that the analyzing device performs wireless communication with an external device to more efficiently manage the health state of the patient.

1 is a configuration diagram of a test strip and analyzing apparatus according to the present invention.
2 is an exploded perspective view of a test strip according to the present invention.
3 is a front view of a test strip according to the present invention.
4 is a rear view of a test strip according to the present invention.
5 is a diagram of output characteristics of a test strip according to the present invention.
6 is a perspective view of the identification structure and the recognition unit according to the first embodiment of the present invention.
7 is a perspective view of an identification structure and a recognition unit according to a second embodiment of the present invention.
8 is a perspective view of an identification structure and a recognition unit according to a third embodiment of the present invention.
9 is an exploded perspective view of a first embodiment of a test strip capable of measuring a plurality of materials according to the present invention.
10 is an exploded perspective view of a second embodiment of a test strip capable of measuring a plurality of materials according to the present invention.
11 is a perspective view of an analysis apparatus according to the present invention.
12 is a flowchart illustrating a method of measuring the health status of a patient according to the present invention.
13 is a diagram showing an environment in which the analyzing apparatus according to the present invention communicates.
14 is a diagram showing a structure of an information recording field used by the communication unit according to the present invention.
15 is a configuration diagram of a control unit and a communication unit of the analyzer according to the present invention.

The terms used in the present specification are used to easily explain the present invention. Accordingly, the invention is not limited by the terms used herein.

The present invention can be modified or modified without departing from the spirit and scope of the invention. Modifications or variations that do not depart from the spirit and scope of the present invention will be apparent to those skilled in the art. Accordingly, the invention includes modifications or variations that do not depart from the spirit and scope of the invention.

For the same components, the same reference numerals are used in the drawings, and redundant explanations can be omitted.

The present invention is not limited by the examples described below.

Hereinafter, the overall configuration of the test strip 100 and the analysis apparatus 200 according to the present invention will be described with reference to FIG. 1 is a configuration diagram of a test strip 100 and an analysis apparatus 200 according to the present invention.

The test strip 100 may be provided with a body fluid and output a reaction signal due to the reaction of the indicator substance contained in the body fluid.

The test strip 100 includes an inlet 110 through which the body fluid flows, a flow channel 120 through which the introduced body fluid is delivered to the reaction unit 130, a reaction unit 130 that outputs a reaction signal by reacting the indicator substances in the body fluid, A signal unit 140 for transmitting the output reaction signal to the analyzer 200 and an identification unit 150 for indicating the output characteristics of the test strip 100. A more detailed description of each configuration will be given later.

The analyzer 200 receives the response signal from the test strip 100 and can measure the health condition of the patient based on the response signal. Measurements of these health conditions can be quantitative or qualitative.

The analysis apparatus 200 includes a storage unit 210 in which the test strip 100 is stored, a recognition unit 220 that recognizes the output characteristics of the test strip 100, A communication unit 240 for communicating with an external device, an input unit 250 for receiving input from a user, an output unit 260 for outputting the measured health status of the patient and various other information, A storage unit 270 for storing values and various other information, and a power supply unit 280 for supplying power to the analysis apparatus. A more detailed description of each configuration of the analyzer 200 will be described later.

Hereinafter, the configuration of the test strip 100 according to the present invention will be described with reference to FIGS. 2, 3, and 4. FIG. FIG. 2 is an exploded perspective view of a test strip 100 according to the present invention, FIG. 3 is a front view of the test strip 100, and FIG. 4 is a rear view of the test strip 100.

The test strip 100 may be formed of a single substrate on which all of the above-described components are provided, or a plurality of substrates on which some components are provided as shown in Fig.

The inlet 110 can receive body fluids from the outside. For example, a patient may use a predetermined instrument to collect blood from a finger and then flow it into the inlet 110 of the test strip 100. Here, the body fluid may be any one of blood, urine, saliva, semen and a combination thereof. The inlet 110 may be provided to allow such bodily fluids to flow smoothly into the test strip 100. For example, the shape of the inlet 110 may be circular or polygonal or semicircular as shown in FIG. Circular or semicircular shapes are not only suitable for influx of body fluids, but may also have the effect of relaxing the patient's psychological state of providing body fluids. In addition, the inlet 110 may be provided at one side of the test strip 100, which may be advantageous for inflow of body fluids.

The flow path 120 can transfer the body fluid flowing into the inlet 110 to the reaction part 130. This transfer of body fluids can be effected by gravity, lateral flow, or capillary action. The flow path 120 may be formed of a material suitable for side flow. For example, the flow path 120 may be provided with a porous membrane or an absorbent material such as paper or cotton. On the other hand, the flow path 120 may be adapted to capillary phenomenon. For example, the flow path 120 may be provided as a fine flow path formed in a thin groove shape to cause a capillary phenomenon, as shown in FIG. The width of the fine flow path may be 0.1 mm to 1 mm.

The reaction unit 130 can receive the body fluid from the channel 120 and output a reaction signal due to the reaction of the indicator substance present in the body fluid.

The reaction unit 130 may contain an indicator substance in the body fluid and a reaction substance that causes an analysis reaction. In addition, the reaction material is not necessarily contained in the reaction part 130, but a separate space for containing the reaction material may be provided on the test strip 100, or the reaction material may be contained in the flow path 120 You can do it. At this time, the reactant may be a substance that reacts with a specific indicator substance in body fluids.

The reaction part 130 may be a material suitable for containing the reaction material. An example of such a material may be a membrane or a polymer layer.

When the biochemical reaction occurs in the reaction part 130, in addition to the indicator substance and the reactive substance, a bonding substance which is linked to the indicator substance may participate in the biochemical reaction more. For example, the bonding material may be a material that generates a specific signal during the reaction, such as a colloidal gold. The analysis reaction occurring in the reaction unit 130 may be a biochemical reaction such as an antigen-antibody reaction or an enzymatic reaction, and an optical signal or an electrochemical signal may be generated by the analysis reaction.

The test strip 100 may be used to measure cholesterol levels, and to measure blood glucose for determining diabetes. The test strip 100 may use, for example, the following principle to measure blood glucose.

The method of measuring diabetes can be roughly classified into optical measurement and electrochemical measurement.

Here, in the optical measurement method, the glucose concentration in the blood can be specified by using the oxidation reaction of sugar by the peroxidase and the peroxidase as a basic principle. Optical measurement methods include colorimetry, which quantitatively measures the optical signal by comparing the hue of the sample with the hue of the standard solution, and the inherent optical signal that the material emits when it receives light, for example, visible light, Fluorescence in the measurement and chemiluminescence in the measurement of the optical signal generated in the assay reaction. In the measurement of diabetes, the concentration of blood glucose can be measured by a colorimetric method for analyzing the color change of a reagent to be reacted. The blood is supplied to the reaction part 130 through the inlet 110 and the flow path 120 of the test strip 100 and then the blood is supplied to the reaction part 130 of the test strip 100 in this state And the reaction part 130 of the test strip 100 is irradiated with light through the light emitting part of the analyzer 200. The light reflected by the light receiving part is received and reflected by the reflection part Based on this, blood glucose can be measured.

On the other hand, in the electrochemical measurement method, when blood is supplied to the reaction part 130 of the test strip 100 instead of using a dye source, oxidation of glucose and glucose in the blood, that is, oxidation of glucose oxidase And the current generated by accepting electrons generated in the reduction process at the electrode. At this time, the electron transfer mediator oxidizes the saccharide oxidizing enzyme, and then it is reduced, whereby the reduced electron transfer mediator loses electrons on the surface of the electron to which a certain voltage is applied, and is electrochemically reoxidized, The concentration of glucose is measured by measuring the amount of current. A method of electrochemically measuring diabetes mellitus will be described in detail as follows.

Glucose + GOx-FAD → Gluconic acid + GOx-FADH2

GOx-FADH2 + electron transfer mediator (oxidation) → GOx-FAD + electron transfer mediator (reduction)

In the above equation, GOx represents glucose oxidase, and GOX-FAD and GOX-FADH2 represent oxidation state and reduction state of FAD (flavin adenine dinucleotide), which is an active site of glucose oxidase, respectively. Examples of the electron transfer medium include ferrocene derivatives, ferrocene derivatives, quinones, quinone derivatives, transition metal-containing organic and inorganic materials (hexaamine ruthenium, osmium-containing polymer and potassium ferricyanide) , Electron transport organic materials such as viologen, and the like can be used.

First, in the assay reaction, glucose is oxidized to gluconic acid by the catalytic action of glucose oxidase. At this time, FAD which is an active site of glucose oxidase is reduced to FADH2. The reduced FADH2 undergoes a redox reaction with the electron transport mediator, whereby FADH2 is oxidized to FAD and the electron transport mediator is reduced. The reduced electron transfer mediator diffuses to the surface of the electrode. At this time, the concentration of blood glucose can be measured by measuring the electric current generated by applying the oxidation potential of the reduced electron transfer mediator on the working electrode surface.

Unlike the conventional colorimetric method, this electrochemical measurement method can reduce the influence of oxygen, and can have an advantage that the sample can be used without any pretreatment even if the sample is turbid. As described above, the test strip 100 for measuring the concentration of blood glucose electrochemically is obtained through measurement of the amount of current, so that the concentration of blood glucose can be measured relatively accurately, and the measurement time of blood glucose is shortened. The performance in use can be greatly improved.

The signal unit 140 may transmit a reaction signal generated in the reaction unit 130 to an external device. At this time, the external device may be the analyzer 200 of the test strip 100. When the reaction signal is an electrochemical signal, as shown in FIG. 3, the signal unit 140 may be provided in the form of an electrode for transmitting an electrical signal. Here, one end of the electrode may be connected to the reaction part 130 to receive the reaction signal generated in the analysis reaction from the reaction part. The other end of the electrode may be provided so as to extend to the side where the test strip 100 is inserted into the analyzer 200 and may transmit the received response signal to the analyzer 200. At this time, the electrode may include a working electrode and a counter electrode as shown in FIG. The electrode may further include a reference electrode as shown in FIG.

The identification unit 150 may reflect the output characteristics of the test strip 100 for the response signal. As shown in Fig. 4, the identification unit 150 can reflect the output characteristic by providing the identification structure 151 indicating the output characteristic. In the case of the test strip 100 used in the electrochemical measurement method, there is an advantage that the measurement is more smooth and convenient than the test strip 100 used in the optical measurement method, And may provide information on the output characteristics of the test strip 100 to the analysis apparatus 200 in order to compensate for the deviation.

Hereinafter, a method of supplementing measurement values using an identification structure according to an embodiment of the present invention will be described in detail.

The test strip 100 measuring blood glucose can generally be mass produced. In such a case, there may be a deviation in the reaction signal generated in the analysis reaction for each production lot, and this deviation may act as an error in the measured value. In order to eliminate such an error, in most commercial test strips 100, output characteristic information for this deviation at the factory may be shipped in the form of an identification code or the like on the outer surface of the test strip 100. The user can read the identification code and input the identification code to the analysis device 200. This makes it possible for the analysis device 200 to correct the error of the measurement value based on the user's input. Here, the user reads the code information from the test strip 100 and inputs the code information to the analyzer 200 manually. However, such a manual input method may inconvenience a user, and may cause a user to incorrectly obtain an input error. In order to solve such a problem, there is an identification unit 150 in which the test strip 100 reflects information on the output characteristics, so that the analysis apparatus 200 automatically acquires from the identification unit 150 the production There may be a need to acquire lot information, i.e., information on the output characteristics. Accordingly, in the present invention, the test strip 100 includes the identification unit 150 provided with the identification structure 151 that reflects the output characteristics of the test strip 100.

Methods for identifying information on the output characteristics of the test strip 100 may include an optical identification method and an electrical identification method. The optical identification method is a method in which a color tone is arranged on a test strip 100 in a predetermined manner or a barcode or the like is provided and the color tone pattern provided in the test strip 100 is analyzed using an optical measurement device of the analysis device 200 And detecting the output characteristics of the test strip 100 by detecting bar codes.

The determination of the output characteristics of the test strip 100 by the electrical identification method may be performed by providing a resistor on the test strip 100 so that the analysis apparatus 200 distinguishes the production lot information according to the resistance value, A conductor or protrusion capable of confirming whether the conductor or protrusion is present through an electrical measuring device is arranged and the analyzer 200 checks the arrangement state of the conductor or protrusion using an electrical measuring device, And the like. A more detailed description of this electrical identification method will be given later.

The optical identification method can be advantageously used in the test strip 100 and the analysis apparatus 200 mainly using optical measurement methods. This is because the optical measuring device for measuring the reaction signal generated in the analysis reaction can be used again to confirm the production lot information of the test strip 100. [ For example, in the case of the analyzer 200 having the light emitting unit and the light receiving unit for irradiating the light to the reaction unit 130, the light emitting unit and the light receiving unit may be arranged in the color pattern of the identification unit 150 provided in the test strip 100 It can be used again to read the bar code. However, in the test strip 100 and the analyzer 200 using the electrochemical measurement method, it may be advantageous to use an electrical identification method. This is because, when an electrochemical measurement method is used, a separate spectroscopic system must be provided in order to use an optical identification method, which may be technically difficult and economically unsuitable. For example, in order to constitute an apparatus and a circuit for spectroscopically recognizing the structure or the like in which the production lot information or the like is inputted to the part where the electrochemical test strip 100 is inserted into the analysis apparatus 200 for electrical connection, There may be a disadvantage that the configuration cost of the system is greatly increased economically.

Hereinafter, the identification unit 150 of the test strip 100 according to the present invention will be described with reference to FIG. 5 is a plot of the output characteristics of the test strip 100. FIG.

The identification unit 150 may include an identification structure 151. The analysis apparatus 200 can read the production lot information of the test strip 100 from the identification structure 151, that is, information on the output characteristics of the test strip 100. [ The identification unit 150 and the identification structure 151 can be configured such that the recognition unit 220 of the analysis device 200 receives a part of the test strip 100 from the identification structure 151 It can be provided in a position where information can be easily obtained. This location may be the location where the test strip 100 is inserted into the analyzer 200 and may be, for example, one end of the test strip 100. In the case of a test strip 100 using an electrochemical measurement method, a signal unit 140, for example, an electrode or the like is provided to transmit an electrical signal generated in the reaction unit 130 to the analysis apparatus 200 In this case, the identification part 150 may be provided at a position spaced apart from the signal part 140. For example, when the signal unit 140, that is, the electrode is provided at one end of the front surface where the test strip 100 is connected to the analysis apparatus 200, the identification unit 150 is provided at one end of the back surface of the test strip 100 .

The identification structure 151 may reflect the output characteristics of the test strip 100. In the case of a test strip 100 that measures electrochemically glucose in a commercially used blood glucose, it may be practically difficult to uniformly manufacture all such test strips 100 so as to have substantially the same output characteristics. Thus, such a test strip 100 may have different output characteristics depending on its production process. At this time, the output characteristic may mean the intensity or intensity of the response signal depending on the amount of the indicator substance in the body fluid. More specifically, for example, when the concentration of glucose in the blood corresponds to a specific value, as shown in FIG. 5, some test strips 100 output a response signal of 1 while the other test strips 100 output 2 And the other test strips 100 are capable of outputting a signal of three. For this reason, in order for the analyzer 200 to accurately measure the glucose level from the test strip 100, the individual test strips 100 (in order to substantially eliminate the error of the measured values of the values obtained from the reaction signals by the analysis reaction Lt; RTI ID = 0.0 > of < / RTI > However, the output characteristic may not always have a linear characteristic as shown in the figure. The output information of such a test strip 100 may be determined according to the production lot of the test strip 100.

Hereinafter, the identification structure 151 according to the present invention will be described with reference to FIGS. 6 to 8. FIG. 6 is a perspective view of an identification structure 151 and an identification unit 220 of the analysis apparatus 200 capable of identifying output characteristics through a resistance measurement apparatus and FIG. 8 is a perspective view of an identification structure 151 and a recognition unit 220 capable of identifying output characteristics through a piezoelectric measuring device.

As described above, all of the test strips 100 may be difficult to produce so as to have uniform output characteristics. In general, test strips 100 may have different output characteristics by production date or production lot. Here, the mass-produced test strips 100 may be manufactured to have output characteristics that are substantially the same according to the production lot.

In the test strip 100 and the analysis apparatus 200 according to the present invention, the identification structure 151 of the test strip 100 can have a certain property that the recognition unit 220 of the analysis apparatus 200 can detect have. Accordingly, the recognition unit 220 of the analysis apparatus 200 can acquire an electrical signal corresponding to the attribute of the identification structure 151, and the signal obtained by the recognition unit 220 can be obtained from the analysis apparatus 200 And may be transmitted to the control unit 230. Herein, information on a plurality of output characteristics of the test strip 100 may be stored in the storage unit 270 of the analysis apparatus 200. The control unit 230 refers to the information about the output characteristics stored in the storage unit 270 and checks the output characteristics of the test strip 100 or corrects the error of the measured value according to the signal obtained from the recognition unit 220 .

6 shows an identification structure 151 and a recognition unit 220 capable of identifying output characteristics through a resistance measurement device. At this time, the identification structure 151 may be provided to have a resistance value of one of a plurality of resistance values. The plurality of resistance values may correspond to the output characteristics of the test strip 100, respectively. Likewise, one resistance value may be a value that reflects the inherent output characteristics of the test strip 100 among a plurality of output characteristics. The recognition unit 220 of the analysis apparatus 200 may be provided with a resistance measurement device capable of measuring the resistance value of the identification structure 151. [ The resistance measuring device can measure the resistance value of the identification structure in such a manner that it is connected to the identification structure 151 to apply electricity, and obtains a resistance value based on the current value or the voltage value obtained from the identification value. The controller 230 of the analyzer 200 may check the output characteristics of the test strip 100 based on a current value, a voltage value, a resistance value, or the like, or may use the measured output characteristics to correct the measured result.

The resistance value of the identification structure 151 may be at least one of the type of the material constituting the identification structure 151, the thickness of the identification structure 151, the shape of the identification structure 151, and the manner in which the identification structure 151 is applied Can be determined accordingly. Such a resistor may be a single material, and a single material may be a metal or a nonmetal. For example, the metal may be carbon, silver (Ag), gold (Au), carbon nanotubes (CNT), etc., and the base metal may be indium tin oxide (ITO), IZC, On the other hand, a resistor may be a synthetic material synthesized from two or more materials, in which the resistance value can be determined according to the proportion of the materials to be synthesized. In addition, the resistance value may be determined by adjusting the thickness of the identification structure 151 or by changing the application method. The identification structure 151 using such a resistor may be advantageous in that the structure is simple and the manufacturing cost is low. For example, the identification structure 151 may be provided in such a manner that the conductor is thinly coated on the identification portion 150 and then coated.

7 shows an identification structure 151 and a recognition unit 220 capable of identifying output characteristics through a capacitance measurement apparatus. The identification structure 151 may be provided to have one of a plurality of predetermined arrays. For example, the identification structure 151 may be divided into one or more compartments, and each compartment may or may not be provided with a conductor. As a result, the arrangement can be determined depending on the presence or absence of a conductor in each section. In the case of expressing the output characteristic according to the arrangement method of the conductors, since the digitized method is used, there is an advantage that the error in recognizing the output information of the test strip 100 is small. The predetermined arrangements may correspond to the output characteristics of the test strip 100, respectively.

The recognition unit 220 of the analysis apparatus 200 may include a capacitance measurement device. The capacitance measuring apparatus can detect that a capacitance is generated when a conductor is present as it approaches each section of the identification structure 151 and that no capacitance is generated when there is no conductor. Accordingly, the recognition unit 220 can detect whether or not a conductor is disposed in each of the compartments. The recognition unit 220 may generate an electrical signal corresponding to the manner in which the conductors of the identification structure 151 are arranged according to whether or not the conductors are arranged in the respective sections. The controller 230 may correct the measured result according to the electrical signal indicating the output characteristic of the test strip 100. [

In an identification structure 151 that identifies output characteristics through a capacitance measurement device, the capacitance measurement device may obtain an electrical signal digitized according to the presence or absence of conductors in the respective compartments. In this case, the total number of arrangements may correspond to the number of divisions of the division. For example, an identification structure having three sections may reflect a total of eight output characteristics. The number of arrangements may be at least greater than the number of output properties. For example, if the production lot or the output characteristics of the test strip 100 are 10 types, the number of compartments can be set to reflect 16 types of 4 or more. On the other hand, the compartments are subject to certain spatial restrictions and may not be overly large. In addition, the more the division of the division is, the more the precision of the capacitance measurement apparatus must be, and thus the manufacturing cost may be a problem. Moreover, the capacitance measurement apparatus may be interfered with by the conductor provided in the adjacent division not the division to be measured. Here, the compartment may be in the form of a square so as to form a compartment that requires a minimum of space. For example, the compartment may be a total of four compartments, two compartments each in the horizontal and vertical directions, or a total of nine compartments, three compartments in the horizontal and vertical directions.

8 shows an identification structure 151 and a recognition unit 220 capable of identifying output characteristics through a piezoelectric measuring device. The identification structure 151 may be provided to have one of the plurality of arrangements. The identification structure 151 is divided into one or more sections, and each section may or may not have a protrusion. Thereby, the arrangement is determined depending on the presence or absence of the projections of the respective sections, and these arrangements may correspond to the output characteristics of the test strip 100, respectively. In the case of reflecting the output characteristics according to the arrangement method of the protrusions, since the digitized method is used, it may be advantageous in that errors are less recognized in recognizing the output information of the test strip 100.

The recognition unit 220 of the analysis apparatus 200 may include a piezoelectric measurement device. Piezoelectric measuring devices can generate a voltage when a pressure is applied. In this case, when the piezoelectric measuring apparatus moves to the identifying unit 150 and there is a protrusion, a pressure is generated, and when there is no protrusion, no pressure may be generated. In this case, when the protrusion is present, the pressure is generated in the piezoelectric measuring device as the pressure is generated, so that the recognition unit 220 can determine the presence or absence of the protrusion of each compartment through this, and consequently, can recognize the arrangement method of the protrusion. The recognition unit 220 obtains an electrical signal indicative of an output characteristic of the test strip 100 according to the voltage thus generated, and the controller 230 can calculate the correction value by correcting the measured value accordingly.

Hereinafter, a test strip 100 capable of measuring a plurality of substances will be described with reference to Figs. 9 and 10. Fig. FIG. 9 is an exploded perspective view of a first embodiment of a test strip 100 capable of measuring a plurality of materials according to the present invention, FIG. 10 is an exploded perspective view of a test strip 100 according to the present invention, Fig.

When measuring the health status of a patient using the test strip 100 and the analysis apparatus 200, it is possible to measure a single indicator substance from the body fluid and measure the health condition of the patient according to the concentration or amount thereof. However, when measuring the health status of a patient from such a single indicator material, interference may occur during the reaction due to other interference substances in the body fluids, resulting in an inaccurate reaction signal, or the test strip 100), it is possible that interference may occur during measurement or analysis, resulting in inaccurate results.

For example, in the case of a test strip 100 measuring an amount of cholesterol using an optical measurement method, the red color of red blood cells may affect the degree of reflection of light when measured by erythrocytes in the solution, resulting in inaccurate results . For example, in order to measure diabetes, glucose concentration should be measured. This blood glucose concentration is influenced by Hct (hematocrit), Hb (hemoglobin), globulin, It may be difficult to obtain accurate results without consideration of. For example, in the case of Hct, since the blood cell volume ratio of blood is different for each person, it may be difficult to obtain accurate glucose concentration without considering these factors. That is, in the case of people with 15% of Hct and 20% of people, blood glucose concentration may be different even if the same glucose is contained in a certain blood.

9 and 10 illustrate a test strip 100 that simultaneously measures interference substances in addition to the indicator material to compensate for this. The test strip 100 includes an inlet 110 for receiving body fluids, a first flow path 121 for transferring the body fluid to the first reaction part 131, a first reaction part 131 for analyzing the indicator substance, 2 reaction unit 132, a second reaction unit 132 for analyzing the interference substance, and a signal unit 140. The second reaction unit 132 may include a second reaction unit 132, At this time, the basic principle of each site can be the same as the test strip 100 for a single indicator material. In the first reaction part 131, the indicator material reacts to output the first reaction signal, and in the second reaction part 132, the interference material reacts to output the second reaction signal. For example, the first reaction part 131 contains a first reaction material that reacts with the indicator material, reacts with the indicator material in the transferred body fluid, and the second reaction part 132 includes a second reaction part 132, The reaction material may contain and react with the interfering substances in the delivered body fluids. Alternatively, the first flow path 121 selectively transfers the indicator material only to the first reaction part 131 in the body fluid, and the second flow path 122 selectively transmits only the interference substance in the body fluid to the second reaction part 131. [ (132). At this time, one end of the signal unit 140 may be connected to the first reaction unit 131 and the second reaction unit 132, respectively. If there are a plurality of index substances and interference substances according to the health condition of the patient to be analyzed, the reaction unit 130 may be provided for the number of the corresponding substances. Three reaction parts 130 are provided as the first reaction part 131, the second reaction part 132 and the third reaction part 133 in order to measure glucose, Hct and Hb, for example, .

At least one of the inlet 110, the flow path 120, the reaction part 130, and the signal part 140 may be provided on another substrate. At this time, an insulating layer may be provided between the substrate provided with at least one of the inlet 110, the flow path 120, the reaction part 130, and the signal part 140 and other substrates. The insulating layer may prevent the electrical signal or the like from interfering with the body fluid in the signal unit 140.

Each reaction part 130 may be provided on the same substrate. The first reaction part 131, the second reaction part 132, the first flow path 121 and the second flow path 122 may be provided on one plane as shown in FIG. On the other hand, the test strips 100 may be configured in such a manner that they are provided on a separate substrate for each of the reaction units 130 and stacked. The test strip 100 may be provided by laminating three substrates each having three reactors 131, 132, and 133, respectively, so that one reaction unit 130 is provided for each substrate as shown in FIG. When a plurality of reaction parts 130 are on the same plane, the manufacturing cost may be relatively low. On the other hand, in the case of a method of stacking a plurality of substrates, it is possible to analyze more various materials at the same time And it may be advantageous to minimize the interference between the substances in the measurement.

Hereinafter, the analyzer 200 according to the present invention will be described with reference to FIGS. 11 and 12. FIG. FIG. 11 is a perspective view of an analyzing apparatus according to the present invention, and FIG. 12 is a flowchart illustrating a method of measuring a health state of a patient according to an analyzing apparatus according to the present invention.

The method for measuring the health status of the patient according to the present invention will be described using the analysis apparatus 200 according to the present invention. At this time, the analysis apparatus 200 is used to easily explain a method of measuring a health condition of a patient according to the present invention. Therefore, the method for measuring the health status of the patient according to the present invention is not limited to the analysis apparatus 200 according to the present invention.

The method for measuring the health state of the patient according to the present invention may use another apparatus performing the same function as the analyzing apparatus 200 according to the present invention.

As shown in FIG. 11, the analyzer 200 may acquire a response signal output from the test strip 100 and measure the health state of the patient based on the response signal. The analyzer 200 obtains an electrical signal relating to the output characteristics of the test strip 100 from the storage unit 210 in which the test strip 100 is stored and the identification unit 150 of the received test strip 100 A control unit 230 for calculating a health state of the patient, a communication unit 240 for communicating with an external device, an input unit 250 for receiving input from the user, an output unit 260 for displaying information to the user, A storage unit 270 for storing the measurement result, and a power unit 280 for supplying power to the analysis device 200.

The accommodating portion 210 can accommodate the test strip 100. A part or the whole of the test strip 100 may be stored or inserted into the storage part 210. [ For example, in the case of blood glucose measurement, the test strip 100 may be inserted or housed in each measurement, so that the storage part 210 may be a shape easily detachable from the test strip 100. In the case of using an electrochemical measurement method, since the signal unit 140 of the test strip 100, that is, the electrode is connected to the analyzer 200, this connection can be facilitated. For example, when the test strip 100 having a rectangular shape is inserted, the receiving part 210 may be provided on one side of the analyzer 200 in a rectangular shape.

The recognition unit 220 may obtain an electrical signal indicating the output characteristics or production lot information of the test strip 100 from the identification unit 150 of the test strip 100. [ The recognition unit 220 may obtain a signal indicating the output characteristics of the test strip 100 from the identification structure 151 of the identification unit 150 provided in the test strip 100. [ For example, the recognition unit 220 may acquire a signal regarding the output characteristics of the test strip 100 through an optical identification method or an electrical identification method. The recognition unit 220 using the optical method may include a light emitting unit for emitting light to the identification structure 151 of the test strip 100 and a light receiving unit for receiving the light reflected from the identification structure 151. At this time, the recognition unit 220 may acquire a signal indicating the output characteristic of the test strip 100 according to the intensity or amount of the received light.

In the case of the analysis apparatus 200 for measuring the health status of a patient by an electrochemical method, it may be advantageous to recognize the output characteristics of the test strip 100 by an electrical identification method. In this case, the recognition unit 220 may be one of a resistance measurement device, a capacitance measurement device, and a piezoelectric measurement device. For example, when the identification structure 151 reflects the output characteristic of the test strip 100 as a resistance value corresponding thereto, the current value or voltage value obtained by applying electricity to the identification structure 151 through the resistance measurement device An electric signal can be obtained. In another example, when the identification structure 151 reflects the output characteristics of the test strip 100 with the arrangement of the conductors, the capacitance is measured by approaching the capacitance to the conductor using the capacitance measurement apparatus The presence or absence of a conductor can be determined and an electrical signal according to the arrangement of the conductor can be obtained. As another example, when the identification structure 151 reflects the output characteristics of the test strip 100 by the arrangement of the protrusions, pressure is applied to the identification structure 151 using the piezoelectric measurement device, It is possible to acquire an electrical signal according to the arrangement of the protrusions by detecting the presence or absence of the protrusion using the principle of generating the voltage.

The control unit 230 can measure the health condition of the patient. As shown in FIG. 12, the control unit 230 may measure the health condition of the patient based on the reaction signal generated in the reaction unit 130 of the test strip 100 (S101). For example, in the case of measuring blood cholesterol, when a signal generated by a reaction of high density lipoprotein (HDL) or low density lipoprotein (LDL) or the like occurs in the reaction unit 130, 230), it is possible to measure the presence or absence of a disease such as hyperlipidemia or atherosclerosis in a patient based on the reaction signal. For example, in the case of measuring diabetic state, when a reaction signal due to blood glucose concentration occurs in the reaction unit 130, the control unit 230 can acquire a measurement value regarding diabetic state therefrom.

In this case, when the measurement value is calculated from a single index material, the influence of the interference substance is not taken into consideration, so that a slight error may occur in the measured value. Accordingly, the analysis apparatus 200 for analyzing the health condition of the patient using the test strip 100 for measuring the plurality of substances described above can eliminate such an error. For example, in the blood glucose measurement, when the first reaction signal according to the glucose concentration, the second reaction signal with respect to the Hct and the third reaction signal with respect to the other interference substance are outputted in the test strip 100 for measuring a plurality of substances , The analyzer 200 can calculate a measurement value in which an error is removed based on the first reaction signal, the second reaction signal, and the third reaction signal. Alternatively, the controller 230 may acquire the first measurement value based on the first response signal (S102) and calculate the second measurement value whose error is corrected according to the interference effect or the like according to the second reaction signal or the third reaction signal (S103).

However, since the measurement value obtained or calculated by the control unit 230 does not take into consideration the output characteristic of the test strip 100, an error may occur in the measured value. The control unit 230 may acquire an electrical signal related to the output characteristic of the test strip 100 from the recognition unit 220 and correct the measured value based on the obtained electrical signal. The control unit 230 may obtain the output characteristics of the test strip 100 corresponding to the obtained electrical signal from the storage unit 270 and may calculate the correction value by correcting the measured value.

The storage unit 270 may store information on the output characteristics of the test strip 100, measured result values, and the like. And the result stored in the storage unit 270 may be displayed through the output unit 260 through the input unit 250 by the user's input. The time measured by the analysis apparatus 200 may be stored in the storage unit 270. For example, since the measurement time may be important in the storage unit 270 of the analysis device 200 for measuring blood glucose, each measurement time may be stored. In the case of diabetes, it may be important to periodically measure the blood glucose level, so that the output unit 260 can inform the user that the blood glucose measurement time has passed. Here, the time to be measured may be stored in the storage unit 270, and the control unit 230 may determine whether the time is to be measured, and the output unit 260 may determine that the time to be measured by the user is This can be reported to the user when the time has come to be measured.

The input unit 250 may receive input from a user. The user can operate various functions of the analysis apparatus 200 through the input unit 250. [ The input unit 250 may be configured to be easily used by a user. For example, the input unit 250 may receive input from a user through a plurality of buttons or a touch pad or voice recognition.

The output unit 260 can output video or audio. When the measurement is performed through the analyzer 200, the controller 230 may inform the user of the measurement result analyzed through the output unit 260. On the other hand, in the case of the analysis device 200 for a patient to be periodically measured, the patient can be notified of the measurement time through an alarm or the like. In the case of the analyzer 200 for measuring blood glucose, the blood glucose value may be outputted through the output unit 260 or the one-week coincidence blood glucose information may be displayed. On the other hand, if an error occurs in the use of the analyzer 200, an error message may be displayed on the output unit 260. In addition, the output unit 260 can display the current time, the time to be measured, the measured time, and the like. When the test strip 100 is stored inside the analyzer 200, it may indicate whether the test strip 100 is stored or the number of the stored test strips 100 and the like.

The power supply unit 280 may supply power to the analyzer 200. In particular, in the case of the portable analyzer 200, an independent power unit 280 can be mounted on the analyzer 200 so that the user can use the analyzer 200 regardless of position or time. For example, the power supply unit 280 may be a battery, and preferably a rechargeable battery.

Hereinafter, the environment in which the analysis apparatus 200 according to the present invention communicates will be described with reference to FIG. 13 is a diagram showing a communication environment of the analyzer 200. As shown in Fig.

The communication unit 240 can perform communication with an external device. 13, the external device may be a mobile communication terminal, a health care server, or the like. A health care server may be provided on, for example, a hospital, pharmacy, health care center or other Internet. The health care server may be a server that manages information about the health status of the patient. When the communication unit 240 communicates with the mobile communication terminal, information may be transmitted to the mobile communication terminal once and then the information may be transmitted to the health management server in a manner that the mobile communication terminal performs communication with the health management server. When the user of the analysis apparatus 200 is a user who has low understanding of the use of the analysis apparatus 200 such as an infant or the elderly and the health management through the communication apparatus 240, the communication unit 240 communicates with the external apparatus, Can be assisted by a third party with

At this time, the communication unit 240 can communicate with the external device through the wired network. Wired communication can be done through serial communication method such as RS-232 or USB method. Or the communication unit 240 can communicate with an external device wirelessly. Here, the wireless communication may be a communication standard such as Zigbee, Bluetooth or Wi-Fi.

Hereinafter, information communicated by the communication unit 240 will be described with reference to FIG. 14 is a diagram showing an information recording field used in the communication unit 240 according to the present invention.

The communication unit 240 of the analysis apparatus 200 may be implemented as a SPP (serial port profile). The communication unit 240 can create a virtual serial port and transmit information to the mobile communication terminal. The information to be transmitted may include a packet frame and a data record field. As shown in FIG. 14, the information recording field may include measurement absolute time information, production lot information or output characteristic information of the test strip 100, measured values and event values calculated by the controller 230, and the like. The measurement absolute time information may indicate the time at which the analysis apparatus 200 performed the measurement. The measurement absolute time information may include year, month, day, hour, and minute. The event value may include measurement relative time information. The measurement relative time information may mean the relative time between the measurement time and the predetermined event. For example, in the measurement of blood glucose for confirming diabetes, the blood glucose level is relatively high at the time of consuming food, so the elapsed time from the meal time, fasting time, or meal time may be important. Therefore, the measured relative time information may be related to the elapsed time between the measurement and the meal.

Hereinafter, the control unit 230 and the communication unit 240 of the analysis apparatus 200 will be described with reference to FIG. FIG. 15 is a configuration diagram of the control unit 230 and the communication unit 240 of the analysis apparatus 200. FIG.

The communication unit 240 of the analyzer 200 can communicate according to a medical standard. For example, such a communication standard may be an IEEE 1103 personal medical device communication standard. The analyzer 200 may be a blood pressure monitor, a blood glucose meter, an oxygen saturation meter, or the like. In particular, in the case of a blood glucose meter, the analyzer 200 can communicate according to the IEEE 11073-10417 standard. When communicating using these standard standards, communication with external devices can be smooth, and there is an advantage in terms of compatibility, and the convenience of the user can be increased.

15, the control unit 230 includes an operation unit for receiving a reaction signal from the test strip 100 and calculating a measurement value and a correction value, an input unit 250 and an output unit 260 of the analysis device 200 A conversion unit for converting the measured value into a format conforming to a standard standard, and a transmission unit for transmitting the converted value to the communication unit. The communication unit 240 can transmit a result received from the control unit 230 to an external device.

At this time, if the analyzer 200 is a blood glucose meter that communicates by Bluetooth according to the IEEE 11073-10417 standard, the information communication process is as follows.

The input / output control unit may control the input unit 250 and the output unit 260. On the other hand, the operation unit can acquire the reaction signal from the signal unit 140 of the test strip 100 and calculate the measurement value or the correction value. The conversion unit can convert the information obtained from the input / output control unit or the operation unit into a data structure for communication with an external device. At this time, such information can be converted into a data structure conforming to a medical standard. In addition, such information can be converted into a data structure conforming to a communication standard for communication. For example, in the case of measuring blood glucose level of 100 mg / dL on Jan. 1, 2000, the date and the measurement value are firstly formed in a packet format conforming to IEEE 11073 and again in a packet format conforming to the Bluetooth communication standard . The information converted by the conversion unit may be converted into a structure suitable for transmission from the transmission unit to the communication unit 240 and then transmitted. For example, the control unit 230 receives information from the operation unit, creates a packet conforming to the IEEE 11073 via the OEP stack, re-processes the packet according to the Bluetooth communication standard through LTP, and transmits the packet to the communication unit 240 using the UART .

The communication unit 240 may include a first communication unit for communicating with the controller 230 and a second communication unit for communicating with the external apparatus. In the case of the communication unit 240 that performs Bluetooth communication according to the IEEE 11073 standard, the first communication unit may be a UART that communicates with the control unit 230 in serial. Here, the second communication unit for communicating with the external device may be a Bluetooth module. The Bluetooth module can convert the information received from the controller 230 into an RF signal and transmit the RF signal to an external device or an RF signal from an external device. At this time, the external device may be a health care server or a mobile communication terminal.

100: Test strip
110: inlet
120: Euro 121: First Euro 122: Second Euro 123: Third Euro
130: Reactor 131: First Reactor 132: Second Reactor 133: Third Reactor
140: signal part 150: identification part
200: Analyzer
210: storage part 220: recognition part 230: control part 240: communication part
250: input unit 260: output unit 270: storage unit 280:

Claims (14)

1. A test strip having an output characteristic of one of a plurality of output characteristics,
A reaction unit which receives a body fluid and outputs a reaction signal due to a reaction of the indicator substance contained in the body fluid according to the output characteristic; And
And an identification unit including an identification structure reflecting the output characteristics,
Wherein the identification structure comprises:
A protrusion disposed in accordance with one of the plurality of arrangement types reflecting the plurality of output characteristics,
Wherein the analyzing device obtains an electrical signal indicative of the output characteristic by measuring an arrangement of the identification structure using a piezoelectric pressure measuring device
Test strips.
Claim 2 has been abandoned due to the setting registration fee. 2. The identification structure according to claim 1,
Each of the resistors having a resistance value of one of a plurality of resistance values reflecting the plurality of output characteristics, the analyzer obtaining the electrical signal indicating the output characteristic by measuring the resistance value using a resistance measuring device
Test strips.
Claim 3 has been abandoned due to the setting registration fee. 3. The method of claim 2,
The type of the material forming the identification structure, the shape of the identification structure, the application method of the identification structure, or a combination thereof
Test strips.
Claim 4 has been abandoned due to the setting registration fee. 2. The identification structure according to claim 1,
Each conductor being arranged according to one of a plurality of array shapes reflecting the plurality of output characteristics,
Wherein the analyzer obtains an electrical signal indicative of the output characteristic by measuring an arrangement of the identification structure using a capacitance measurement device
Test strips.
delete Claim 6 has been abandoned due to the setting registration fee. The method according to claim 1,
Wherein the reaction part includes a first reaction part and a second reaction part,
The first reaction unit outputs a first reaction signal due to the reaction of the first indicator material according to the output characteristic,
The second reaction unit outputs the second reaction signal due to the reaction of the second indicator material according to the output characteristic
Test strips.
A reaction unit having an output characteristic of one of a plurality of output characteristics and outputting a reaction signal based on the reaction of the indicator substance contained in the bodily fluid with the bodily fluid according to the output characteristic and an identification structure reflecting the output characteristic A test strip including an identification portion including the identification portion;
A receiving portion into which the test strip is inserted;
A recognition unit for acquiring an electrical signal indicating the output characteristic from the identification structure using an electronic measuring device; And
And a control unit for acquiring a measurement value based on the response signal and acquiring a correction value based on the obtained measurement value and the electrical signal,
Wherein the identification structure comprises:
A protrusion disposed in accordance with one of the plurality of arrangement types reflecting the plurality of output characteristics,
And the analyzing device obtains an electrical signal indicating the output characteristic by measuring the arrangement form of the identification structure using a piezoelectric pressure measuring device
Analysis device.
Claim 8 has been abandoned due to the setting registration fee. 8. The method of claim 7,
Wherein the identification structure has a resistance value of one of a plurality of resistance values each reflecting the plurality of output characteristics,
Wherein the recognition unit acquires an electrical signal indicating the output characteristic by measuring the resistance value of the identification structure using a resistance measurement device
Analysis device.
Claim 9 has been abandoned due to the setting registration fee. 8. The method of claim 7,
Wherein the identification structure is a conductor disposed in an array form of a plurality of array types each reflecting the plurality of output characteristics,
The recognition unit acquires an electric signal indicating the output characteristic by measuring the arrangement form of the identification structure using a capacitance measurement device
Analysis device.
delete Claim 11 has been abandoned due to the set registration fee. 8. The method of claim 7,
The reaction unit may include a first reaction unit reacting with the first indicator material and outputting a first reaction signal according to the output characteristic and a second reaction unit reacting with the second indicator material and outputting a second reaction signal according to the output characteristic, ≪ / RTI >
Wherein the control unit obtains the measurement value based on the first reaction signal and the second reaction signal
Analysis device.
Claim 12 is abandoned in setting registration fee. 8. The method of claim 7,
Further comprising a communication unit for communicating with an external device according to a medical standard and a communication standard,
Wherein the control unit generates a first packet indicating a health state of the patient according to the medical standard using at least one of the measured value and the correction value, 2 packet and controls the communication unit to transmit the second packet to the external device
Analysis device.
Claim 13 has been abandoned due to the set registration fee. 13. The method of claim 12,
The medical standard is IEEE 11073,
The communication standard is Bluetooth,
The control unit transmits the second packet to the communication unit using the UART,
The communication unit transmits the received second packet in the form of an RF signal according to the Bluetooth system
Analysis device.
Claim 14 has been abandoned due to the setting registration fee. 14. The method of claim 13,
Wherein the first packet includes information about at least one of the measurement value, the correction value, the output characteristics of the test strip, the measurement date, and the elapsed time from the patient's meal to the measurement
Analysis device.

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