DIAGNOSTIC APPARATUS AND DIAGNOSTIC PROCEDURES FOR SALIVA MEASUREMENTS

DE602017095760T2Active Publication Date: 2026-06-24DONG WOON ANATECH CO LTD

Patent Information

Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
DONG WOON ANATECH CO LTD
Filing Date
2017-11-24
Publication Date
2026-06-24

AI Technical Summary

Technical Problem

Existing bio sensors for diagnosing diseases require invasive blood drawing methods and are limited to a single purpose, such as measuring blood glucose or cancer markers.

Method used

A diagnosis apparatus and method using saliva that induces an electrochemical reaction of disease factors in saliva through a detection unit with multiple layers, including a porous metal-organic solid structure and enzymes, to generate an electric current for disease factor concentration analysis.

Benefits of technology

Enables non-invasive, frequent disease diagnosis via saliva, providing accurate measurement results to a user terminal for self-health management, with enhanced sensitivity and economic flexibility for various disease factors.

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Description

[Technical Field]

[0001] The present invention relates to a diagnosis apparatus for analyzing saliva and a diagnosis method using the same, and more particularly, to an apparatus and a method for diagnosing a disease by using saliva.[Background Art]

[0002] All existing bio sensors for diagnosing diseases are, in terms of an operational principle, diagnosis instruments employing invasive blood drawing methods, that is, separate diagnosis instruments configured to diagnose diseases by drawing blood and used only for one purpose such as the purpose of measuring blood glucose of a diabetic patient or the purpose of measuring cancer.

[0003] For example, US 2006 / 081469 A1 describes a battery pack and system for self-diagnosis, which can read a data value from a body via a biosensor reacting with body fluid such as urine; and indicate a measurement value of a test item such as a blood glucose level, a cholesterol level etc. The battery pack includes: a power supply for supplying electric power to a working electrode of the body fluid sensor; a current detector for detecting the amount of electric current flowing into the working electrode; a battery pack controller for controlling an electric power supply operation for the working electrode, reading, from a memory, the test item-based measurement value corresponding to the detected current amount, and outputting the read measurement value; and an interface for carrying out an interface function so that the test item-based measurement value outputted from the battery pack controller can be sent to the main body of the mobile communication terminal.

[0004] WO 02 / 18924 A1 discloses a method for analyzing a sample using a biosensor. The biosensor has a structure in which electrodes are formed in the same plane by use of electrically conductive materials and reaction reagents including at least a dehydrogenase, a coenzyme, an electronic mediator and a tetrazolium salt fixed on absorbent carriers and arranged on or above the electrodes.[Disclosure] [Technical Problem]

[0005] A technical problem to be solved by the present invention is to provide a diagnosis device using saliva, which is capable of diagnosing diseases by using saliva instead of blood and capable of utilizing (measuring) saliva for each particular purpose (disease) by allowing a detection unit suitable for a particular purpose (disease) to react with saliva, and a diagnosis method using the same.[Technical Solution]

[0006] To solve the aforementioned technical problem, the present invention provides a diagnosis apparatus in accordance with claim 1 and a diagnosis method in accordance with claim 3.

[0007] The detection unit is configured to induce an electrochemical reaction of a disease factor in the saliva by the voltage applied through the diagnosis device, and provide the control unit with electric current generated by the electrochemical reaction of the disease factor.

[0008] In one aspect, therefore, there is provided a diagnosis apparatus for analyzing the concentration of a disease factor in saliva, the apparatus comprising: a diagnosis device; a detection unit which is detachably coupled to the diagnosis device, wherein the detection unit is configured to induce an electrochemical reaction of a disease factor in the saliva by the voltage applied through the diagnosis device, and provide an electric current generated by the electrochemical reaction of the disease factor; a communication unit; and a control unit which is configured to apply a voltage to the detection unit, measure the electric current received from the detection unit, convert the measured result into a digital signal, and provide the digital signal to a user terminal through the communication unit; characterized in that the detection unit includes: a first layer which comprises an electrode; a second layer which has a nanostructure in the form of a porous metal-organic solid structure and is attached on the first layer, in use to induce the electrochemical reaction of the disease factor in the saliva; a third layer which is positioned on the second layer and comprises an enzyme suitable for detecting the disease factor in the saliva; a fourth layer which is positioned on the third layer and comprises a filter configured to separate a material that hinders the detection of the disease factor; and a fifth layer which is positioned on the fourth layer and comprises a composite fiber membrane, wherein the third layer, in use selectively detects the disease factor.

[0009] In embodiments, the detection unit includes: a device connecting unit which is supplied with the voltage from the diagnosis device, and provides the diagnosis device with the electric current generated by the electrochemical reaction of the disease factor in the saliva; and a saliva detecting unit which is configured to induce the electrochemical reaction of the disease factor in the saliva by the voltage applied from the diagnosis device through the device connecting unit, and provides the device connecting unit with the electric current generated by the electrochemical reaction of the disease factor.

[0010] The digital signal is converted into concentration of the disease factor by the user terminal based on a predetermined calibration curve. In one embodiment, the diagnosis apparatus further comprises a user terminal, wherein the user terminal is configured to convert the digital signa into the concentration of the disease factor based on a predetermined calibration curve.

[0011] In another aspect, there is provided a diagnosis method using an apparatus comprising a diagnosis device for analyzing the concentration of a disease factor in saliva, the diagnosis method comprising: applying a voltage to a detection unit detachably coupled to the diagnosis device; inducing an electrochemical reaction of a disease factor in the saliva by the voltage applied to the detection unit through the diagnosis device and providing an electric current generated by the electrochemical reaction of the disease factor; measuring the electric current received from the detection unit and converting the measured result into a digital signal; and providing the digital signal to a user terminal via a communication network, characterized in that the detection unit includes: a first layer which comprises an electrode; a second layer which has a nanostructure in the form of a porous metal-organic solid structure and is attached on the first layer, in use to induce the electrochemical reaction of the disease factor in the saliva; a third layer which is positioned on the second layer and comprises an enzyme suitable for detecting the disease factor in the saliva; a fourth layer which is positioned on the third layer and comprises a filter configured to separate a material that hinders the detection of the disease factor; and a fifth layer which is positioned on the fourth layer and comprises a composite fiber membrane, wherein the third layer selectively detects a disease factor that is that is not glucose, wherein user terminal converts the digital signal into the concentration of the disease factor based on a predetermined calibration curve.

[0012] In embodiments, the detection unit includes: a device connecting unit which is connected to the diagnosis device to receive the voltage from the diagnosis device, and provides the diagnosis device with the electric current generated by the electrochemical reaction of the disease factor in the saliva; and a saliva detecting unit which induces the electrochemical reaction of the disease factor in the saliva by the voltage applied from the diagnosis device through the device connecting unit, and provides the device connecting unit with the electric current generated by the electrochemical reaction of the disease factor.[Advantageous Effects]

[0013] According to the diagnosis apparatus analyzing saliva and the diagnosis method using the same according to the present invention, it is possible to diagnose diseases several times even in a day without causing pain by using saliva instead of blood. In addition, there may be an economic advantage in that the detection unit may be selected and used for measurement for each particular purpose (disease). Moreover, a measurement result is provided to a user terminal via a communication network, and as a result, a user may manage his / her health based on the measurement result, and thus may individually carry out self-health care.[Description of Drawings]

[0014] FIG. 1 is a block diagram for explaining a diagnosis device using saliva according to an exemplary embodiment of the present invention. FIG. 2 is a view for explaining an example of the diagnosis device illustrated in FIG. 1. FIG. 3 is a block diagram illustrating in more detail a configuration of the diagnosis device illustrated in FIG. 1. FIG. 4 is a block diagram illustrating in more detail a configuration of a detection unit illustrated in FIG. 3. FIG. 5A is a view for explaining an example of the detection unit illustrated in FIG. 3, and FIG. 5B is a cross-sectional view taken along line A-A' illustrated in FIG. 5A. FIG. 6 is a view for explaining a state in which a protective cover unit is separated from the detection unit illustrated in FIG. 5. FIG. 7 is a view illustrating in more detail a configuration of a saliva detecting unit illustrated in FIG. 5. FIG. 8 is a view for explaining an example of individual processes of diagnosing a disease according to the exemplary embodiment of the present invention. FIG. 9 is a view for explaining an example of an entire process of diagnosing a disease according to the exemplary embodiment of the present invention. FIG. 10 is a graph for explaining an example of a disease diagnosis result according to the exemplary embodiment of the present invention. FIG. 11 is a flowchart for explaining a diagnosis method using the diagnosis device using saliva according to the exemplary embodiment of the present invention. [Modes of the Invention]

[0015] Hereinafter, exemplary embodiments of a diagnosis device using saliva and a diagnosis method using the same according to the present invention will be described in detail with reference to the accompanying drawings.

[0016] First, a diagnosis device using saliva according to an exemplary embodiment of the present invention will be described with reference to FIGS. 1 and 2.

[0017] FIG. 1 is a block diagram for explaining a diagnosis device using saliva according to an exemplary embodiment of the present invention, and FIG. 2 is a view for explaining an example of the diagnosis device illustrated in FIG. 1.

[0018] Referring to FIGS. 1 and 2, a diagnosis device 100 using saliva (hereinafter, referred to as a 'diagnosis device') according to the present invention is connected to a user terminal 200 via a communication network 300.

[0019] The diagnosis device 100 diagnoses a disease by using an electrochemical method using saliva instead of blood. In this case, the diagnosis device 100 utilizes (measures) saliva for each particular purpose (disease) by allowing a detection unit suitable for a particular purpose (disease) to react with saliva. Further, the diagnosis device 100 converts diagnosis data into a digital signal and provides the digital signal to the user terminal 200 via the communication network 300.

[0020] The user terminal 200 is connected to the diagnosis device 100 via the communication network 300 and transmits and receives various types of data to / from the diagnosis device 100.

[0021] That is, the user terminal 300 converts the digital signal, which is provided from the diagnosis device via the communication network 300, into concentration of a disease factor based on a predetermined calibration curve. Here, the disease factor is a particular factor capable of diagnosing a disease and refers to antigens, glucose, and the like. For example, in a case in which the disease factor is glucose, the calibration curve includes an electric current value in accordance with concentration of glucose, and the calibration curve may be acquired in advance through preceding experiments and the like. In an embodiment, the disease factor is not glucose. In another embodiment, the disease factor is an antigen. In an embodiment, the user terminal 300 displays the converted concentration of the disease factor.

[0022] Therefore, in a case in which the diagnosis device according to the present invention diagnoses diabetes, concentration of glucose related to diabetes is determined as numerical values in advance, and the diagnosis device may diagnose diabetes by using the numerical value and the diagnosis result, that is, quantified concentration of glucose.

[0023] In an embodiment, the user terminal 200 is a terminal, which is equipped with a memory means and a microprocessor and has a calculation ability, such as a desktop computer, a notebook computer, a workstation , a palmtop computer, an ultra-mobile personal computer (UMPC), a tablet PC, a personal digital assistant (PDA), a web pad, a smartphone, and a mobile phone.

[0024] The communication network 300 may include a telephone network as well as a data communication network including a local area network (LAN), a metropolitan area network (MAN), a wide area network (WAN), and the Internet, and any communication method may be used regardless of a wired communication method and a wireless communication method.

[0025] Then, the diagnosis device according to the exemplary embodiment of the present invention will be described in more detail with reference to FIG. 3.

[0026] FIG. 3 is a block diagram illustrating in more detail a configuration of the diagnosis device illustrated in FIG. 1.

[0027] Referring to FIG. 3, the diagnosis device 100 may include a communication unit 110, a DAC unit 120, an ADC unit 130, a power source unit 140, a voltage applying unit 150, a detection unit 160, and a control unit 170.

[0028] The communication unit 110 has a wired communication module (not illustrated) or a wireless communication module (not illustrated) and serves to transmit and receive corresponding data for wired or wireless communication of the diagnosis device 100. The communication unit 110 transmits data, which are received from other constituent elements of the diagnosis device 100, to the user terminal 200 via the communication network 300.

[0029] The DAC unit 120 converts a digital signal into an analog signal under control of the control unit 170.

[0030] The ADC unit 130 converts an analog signal into a digital signal under control of the control unit 170.

[0031] The power source unit 140 includes a battery (not illustrated) and supplies electric power required to operate the respective constituent elements of the diagnosis device 100. Here, the battery may be an integral battery fixed to the diagnosis device 100 or a separable battery attachable to or detachable from the diagnosis device 100. Of course, the power source unit 140 may be supplied with electric power from an external power source (not illustrated).

[0032] The voltage applying unit 150 applies a predetermined voltage to the detection unit 160 under control of the control unit 170. Further, the voltage applying unit 150 measures electric current generated by the detection unit 160 and provides the electric current to the control unit 170.

[0033] The detection unit 160 is detachably coupled to the diagnosis device 100 and diagnoses a disease by using saliva. That is, the detection unit 160 induces an electrochemical reaction (that is, oxidation-reduction reaction) of a disease factor in sampled saliva by the voltage applied by the voltage applying unit 150.

[0034] Further, the detection unit 160 provides diagnosis data to the control unit 170. That is, the detection unit 160 provides the control unit 170, via the voltage applying unit 150, with the electric current generated by the electrochemical reaction of the disease factor.

[0035] The control unit 170 controls overall operations of the respective constituent elements of the diagnosis device 100.

[0036] In particular, the control unit 170 controls the voltage applying unit 150 to apply voltage to the detection unit 160. Further, the control unit 170 converts the diagnosis data, which are provided through the detection unit 160, into a digital signal by using the ADC unit 130. That is, the control unit 170 measures electric current, which is generated by the detection unit 160 by the electrochemical reaction of the disease factor, by using the voltage applying unit 150, and the control unit 170 converts the measurement result into the digital signal.

[0037] In addition, the control unit 170 provides the user terminal 200 with the digital signal via the communication unit 110. Then, the user terminal 300 converts the digital signal, which is provided from the diagnosis device 100, into concentration of the disease factor based on a predetermined calibration curve.

[0038] Then, the detection unit according to the exemplary embodiment of the present invention will be described in more detail with reference to FIG. 4.

[0039] FIG. 4 is a block diagram illustrating in more detail a configuration of the detection unit illustrated in FIG. 3.

[0040] Referring to FIG. 4, the detection unit 160 may include a device connecting unit 161, a saliva detecting unit 163, and a protective cover unit 165.

[0041] The device connecting unit 161 is supplied with voltage from the diagnosis device 100. Further, the device connecting unit 161 provides the diagnosis device 100 with electric current generated by the electrochemical reaction of the disease factor in the saliva.

[0042] The saliva detecting unit 163 induces the electrochemical reaction of the disease factor in the saliva by the voltage applied from the diagnosis device 100 via the device connecting unit 161. Further, the saliva detecting unit 163 provides the device connecting unit 161 with the electric current generated by the electrochemical reaction of the disease factor. Here, saliva of a patient may be sampled as the patient spits out the saliva to the saliva detecting unit 163 or the saliva detecting unit 163 is brought into contact with a diseased part in an oral cavity of the patient. That is, the saliva detecting unit 163 may serve as a reactor which mixes the saliva sample of the patient and performs the electrochemical reaction.

[0043] The protective cover unit 165 is a housing for protecting the device connecting unit 161 and the saliva detecting unit 163 from outside substances or stimulation.

[0044] Then, an example of the detection unit according to the exemplary embodiment of the present invention will be described with reference to FIGS. 5 to 10.

[0045] FIG. 5A is a view for explaining an example of the detection unit illustrated in FIG. 3, and FIG. 5B is a cross-sectional view taken along line A-A' illustrated in FIG. 5A, FIG. 6 is a view for explaining a state in which a protective cover unit is separated from the detection unit illustrated in FIG. 5, FIG. 7 is a view illustrating in more detail a configuration of a saliva detecting unit illustrated in FIG. 5, FIG. 8 is a view for explaining an example of individual processes of diagnosing a disease according to the exemplary embodiment of the present invention, FIG. 9 is a view for explaining an example of an entire process of diagnosing a disease according to the exemplary embodiment of the present invention, and FIG. 10 is a graph for explaining an example of a disease diagnosis result according to the exemplary embodiment of the present invention.

[0046] Referring to FIGS. 5 to 10, the saliva detecting unit 163 according to the present invention includes multiple layers L 1 to L5.

[0047] The fifth layer L5 is positioned on the fourth layer L4 and formed by a composite fiber membrane. That is, as illustrated in FIG. BA, when saliva SL comes into contact with the fifth layer L5 formed by the composite fiber membrane, the fifth layer L5 disperses the saliva to the entire composite fiber membrane.

[0048] The fourth layer L4 is positioned on the third layer L3 and configured as a filter for separating predetermined materials. That is, as illustrated in FIG. 8B, the fourth layer L4 separates the predetermined materials among the multiple materials included in the saliva. For example, many materials such as protein, amylase, and urea are included in the saliva in addition to glucose, and in the case in which the disease factor is glucose, the fourth layer L4 separates a material that hinders the detection of glucose. Of course, in a case in which the disease factor is not glucose but another factor, the fourth layer L4 separates a material that hinders the detection of the factor.

[0049] The third layer L3 is positioned on the second layer L2 and includes an enzyme that detects the disease factor in the saliva. That is, as illustrated in FIG. 8C, in the case in which the disease factor is glucose, the third layer L3 decomposes the glucose into hydrogen peroxide and gluconic acid. In addition, in a case in which the disease factor is not glucose but another factor, the third layer L3 may include an enzyme that may detect the factor in the saliva. Therefore, the present invention may constitute the saliva detecting unit 163 by using the third layer L3 that may detect a disease factor related to a disease to be measured. As described above, the detection unit may be selected and used for measurement for each particular purpose (disease), and as a result, the present invention may provide an economic advantage in that various disease factors may be selectively detected in addition to glucose.

[0050] The second layer L2 is attached to the first layer L1 and induces an electrochemical reaction of a disease factor in saliva. That is, as illustrated in FIG. 8D, in the case in which the disease factor is glucose, the second layer L2 reduces hydrogen peroxide produced when the third layer L3 decomposes glucose, the second layer L2 itself is oxidized, and in this process, electric current is generated while electrons are transmitted and received.

[0051] The second layer L2 has a nanostructure in the form of a porous metal-organic solid structure. The nanostructure is a nontoxic catalyst having no biological risk, the nanostructure reduces a product of a metabolic reaction of glucose by using an electrochemical method, and the nanostructure itself is oxidized again at the electrode, thereby generating an electric current signal.

[0052] Further, the nanostructure has a chemical composition, M a (lll)M' b (lll)(CN) 6 , and M and M' are metal elements. For example, a solid structure, which is made of a coordinate compound including metal positive ions, M 2+< and M' 3+< , and a negative ion, that is, a cyanide ion, CN-, promotes a quick reduction reaction of hydrogen peroxide, which is a metabolite of an enzyme, because of electrochemical catalytic characteristics of the center metal positive ion. M and M', which are metal elements, may be Fe, Zn, K, Mg, Al, Cu, Co, Ni, Cr, Mn, Rb, or the like, and as an example, the nanostructure may be a structure in the form of Prussian blue, Fe III< [Fe II< (CN) 6 ] 3 based on Fe 2+< and Fe 3+< . With this nanostructure, it is possible to constitute the saliva detecting unit 163 having high sensitivity. For example, as illustrated in FIG. 10, by using the nanostructure, with respect to the detection amount, the present invention may acquire detection sensitivity (detection limit= 10 to 1 µM) of 100 to 1,000 times sensitivity of the existing blood glucose sensor that adopts a blood drawing method.

[0053] The first layer L1 is configured as an electrode connected to the device connecting unit 161. That is, the first layer L 1 provides the device connecting unit 161 with the electric current generated by the second layer L2. Meanwhile, the first layer L1 is illustrated, in the drawing, as having three electrodes including a reference electrode EN1, a working electrode EN2, and an auxiliary electrode EN3, but the first layer L1 is not limited thereto, and the first layer L 1 may have two electrodes in accordance with an exemplary embodiment.

[0054] Then, a diagnosis method using the diagnosis device using saliva according to the exemplary embodiment of the present invention will be described with reference to FIG. 11.

[0055] FIG. 11 is a flowchart for explaining the diagnosis method using the diagnosis device using saliva according to the exemplary embodiment of the present invention.

[0056] Referring to FIG. 11 , the diagnosis device 100 applies a predetermined voltage to the detection unit 160 coupled to the diagnosis device 100 (S110).

[0057] Then, the diagnosis device 100 diagnoses a disease by using saliva (S 130). That is, the detection unit 160 induces an electrochemical reaction of a disease factor in sampled saliva by the applied voltage. Further, the detection unit 160 provides the diagnosis device 100 with electric current generated by the electrochemical reaction of the disease factor.

[0058] Further, the diagnosis device 100 converts diagnosis data (that is, a result of measuring the electric current generated by the detection unit 160) into a digital signal (S150).

[0059] Then, the diagnosis device 100 provides the digital signal to the user terminal 200 via the communication network 300 (S170). Then, the user terminal 200 converts the digital signal, which is provided from the diagnosis device 100, into concentration of the disease factor based on a predetermined calibration curve.

[0060] While the exemplary embodiments of the present invention have been described in detail as described above, the present invention is not limited to the aforementioned particular exemplary embodiments, and the present invention may be variously modified by those skilled in the art.

[0061] Having thus described the invention of the present application in detail and by reference to embodiments thereof, it will be apparent that modifications and variations are possible without departing from the scope of the invention defined in the appended claims.

Claims

1. A diagnosis apparatus for analyzing the concentration of a disease factor in saliva, the apparatus comprising: a diagnosis device (100); a detection unit (160) which is detachably coupled to the diagnosis device (100), wherein the detection unit (160) is configured to induce an electrochemical reaction of a disease factor in the saliva by the voltage applied through the diagnosis device (100), and provide an electric current generated by the electrochemical reaction of the disease factor; a communication unit (110); and a control unit (170) which is configured to apply a voltage to the detection unit (160), measure the electric current received from the detection unit (160), convert the measured result into a digital signal (S150), and provide the digital signal (S150) to a user terminal (200) through the communication unit (110); characterized in that the detection unit (160) includes: a first layer (L1) which comprises an electrode; a second layer (L2) which has a nanostructure in the form of a porous metal-organic solid structure and is attached on the first layer (L1), in use to induce the electrochemical reaction of the disease factor in the saliva; a third layer (L3) which is positioned on the second layer (L2) and comprises an enzyme suitable for detecting the disease factor in the saliva; a fourth layer (L4) which is positioned on the third layer (L3) and comprises a filter configured to separate a material that hinders the detection of the disease factor; and a fifth layer (L5) which is positioned on the fourth layer (L4) and comprises a composite fiber membrane, wherein the third layer (L3), in use selectively detects the disease factor.

2. The diagnosis apparatus (100) according to claim 1, wherein the detection unit (16) includes: a device connecting unit (161) which is connected to the diagnosis device (100) and configured to receive the voltage from the diagnosis device (100), and provide the diagnosis device (100) with the electric current generated by the electrochemical reaction of the disease factor in the saliva; and a saliva detecting unit (163) which is configured to induce the electrochemical reaction of the disease factor in the saliva by the voltage applied from the diagnosis device (100) through the device connecting unit (161), and provide the device connecting unit (161) with the electric current generated by the electrochemical reaction of the disease factor.

3. A diagnosis method using an apparatus comprising a diagnosis device (100) for analyzing the concentration of a disease factor in saliva, the diagnosis method comprising: applying a voltage to a detection unit (160) detachably coupled to the diagnosis device (100); inducing an electrochemical reaction of a disease factor in the saliva by the voltage applied to the detection unit (160) through the diagnosis device (100) and providing an electric current generated by the electrochemical reaction of the disease factor; measuring the electric current received from the detection unit (160) and converting the measured result into a digital signal (S150); and providing the digital signal (S150) to a user terminal (200) via a communication network (300), characterized in that the detection unit (160) includes: a first layer (L1) which comprises an electrode; a second layer (L2) which has a nanostructure in the form of a porous metal-organic solid structure and is attached on the first layer (L1) to induce the electrochemical reaction of the disease factor in the saliva; a third layer (L3) which is positioned on the second layer (L2) and comprises an enzyme for detecting the disease factor in the saliva; a fourth layer (L4) which is positioned on the third layer (L3) and comprises a filter to separate a material that hinders the detection of the disease factor; and a fifth layer (L5) which is positioned on the fourth layer (L4) and comprises a composite fiber membrane, wherein the third layer (L3) selectively detects a disease factor that is not glucose, wherein the user terminal (200) converts the digital signal (S150) into the concentration of the disease factor based on a predetermined calibration curve.

4. The diagnosis method according to claim 3, wherein the detection unit (160) includes: a device connecting unit (161) which is connected to the diagnosis device (100) to receive the voltage from the diagnosis device (100), and provide the diagnosis device (100) with the electric current generated by the electrochemical reaction of the disease factor in the saliva; and a saliva detecting unit (163) which induces the electrochemical reaction of the disease factor in the saliva by the voltage applied from the diagnosis device (100) through the device connecting unit (161), and provides the device connecting unit (161) with the electric current generated by the electrochemical reaction of the disease factor.

5. The diagnosis apparatus (100) according to claim 2 or the method according to claim 4, wherein the nanostructure has a chemical composition, Ma(II)M'b(III)(CN)6, and M and M' are any one of the metal elements selected from the group consisting of: Fe, Zn, K, Mg, Al, Cu, Co, Ni, Cr, Mn and Rb.

6. The diagnosis apparatus (100) according to claim 1, further comprising a user terminal, wherein the user terminal (200) is configured to convert the digital signal (S150) into the concentration of the disease factor based on a predetermined calibration curve.

7. The diagnosis apparatus according to claim 8 or the method according to claim 3, wherein the user terminal (200) displays the converted concentration of the disease factor.

8. The diagnosis apparatus (100) according to claim 1, wherein the disease factor is not glucose.

9. The diagnosis apparatus (100) according to claim 1 or the method according to claim 3, wherein the disease factor is an antigen.

10. The diagnosis apparatus according to claim 1 adapted to diagnose diabetes, wherein the concentration of glucose relates to a diagnosis of diabetes.

11. The diagnosis apparatus according to claim 1 or the method according to claim 3, wherein the user terminal (200) is selected from a desktop computer, a notebook computer, a workstation , a palmtop computer, an ultra-mobile personal computer (UMPC), a tablet PC, a personal digital assistant (PDA), a web pad, a smartphone, and a mobile phone.