WO2001025785A1

WO2001025785A1 - Method and device for examining hepatic cirrhosis using expiration analysis device

Info

Publication number: WO2001025785A1
Application number: PCT/JP2000/006979
Authority: WO
Inventors: Kouichi Ishikawa; Yukimoto Ishii; Satoshi Asai; Kazuo Nakano; Keiji Hasumi
Original assignee: Nihon University; Hitachi Tokyo Electronics Co., Ltd.
Priority date: 1999-10-07
Filing date: 2000-10-06
Publication date: 2001-04-12
Also published as: AU7557800A; JP2001108673A; JP4452783B2

Abstract

A method of examining liver diseases comprising the steps of collecting expiration, quantifying isopropanol and/or cyanide compounds in the expiration, and analyzing the results; and an expiration analysis device for examining liver diseases, comprising an expiration collection unit for introducing expiration to be analyzed, an expiration analysis unit for quantifying isopropanol and/or cyanide compounds in the expiration, and a data processing unit for analyzing the analysis results obtained in the expiration analysis unit. The method of examining liver diseases is simple and high in accuracy and can be conducted without giving pains to examinees and without requiring a technician having a special technique, and the expiration analysis device used for the method is provided.

Description

Description ^: Cirrhosis test method and device using breath analyzer

The present invention relates to a method for testing liver disease and a breath analyzer for use in the method. Background art

Diagnosis of liver disease is made by doctors' clinical findings, liver biopsy, laparoscopy, liver scanning, ultrasound, CT scanning, X-ray examination, and the like. However, these methods require special techniques by doctors and specialists and expensive equipment, and are not suitable for the purpose of examining liver diseases in general medical examinations and the like. Therefore, in health examinations, etc., liver disease is examined by collecting blood and urine and analyzing metabolites in blood and urine.

Test methods for such liver diseases include serum pyrilrubin, ZTT, TTT, ALP, CHE, G〇T, GPT, α-GTP, LDH, LAP, serum total protein, A / G ratio, urinary pyrilrubin, There is measurement of urinary urobilinogen. If such a test determines that a liver disease is suspected, the medical institution will undergo the above-mentioned diagnosis and test.

On the other hand, in recent years, a method for examining various diseases by measuring metabolites in breath has been proposed. Such a method is described in, for example, (Yasuhiro Mitsui, "A System for Detecting Trace Components in Exhaled Breath", S14-5 Proceedings of the 1987 IEEJ National Convention (1987)).

However, as described above, liver disease tests based on the measurement of metabolites in blood and urine take time from the time of the test until results are obtained. Therefore, it may not be suitable for monitoring the condition of patients in medical institutions or for testing during emergency hospitalization. In addition, blood sampling can only be performed by qualified personnel, and it is painful for patients, especially for severely ill patients and pediatric patients. In addition, the above blood, urine Metabolite data is not necessarily specific to liver disease. Therefore, it is important to generate as much measurement data as possible and combine them in order to make the judgment as accurate as possible. At the present time, there is no disclosure about specific means for performing the above-mentioned breath analysis method in a test for liver disease. Accordingly, an object of the present invention is to provide a method for testing a liver disease capable of performing a quick determination, reducing the pain of a subject, and contributing to an accurate determination, and an apparatus used for the method. . Disclosure of the invention

In order to achieve the above object, the inventors of the present invention focused on breath analysis with little or no pain to subjects, and as a result of intensive studies on the relationship between components in breath and liver disease, The invention has been completed.

(1) That is, the present invention relates to a method for examining liver disease, which comprises collecting exhaled breath, quantifying isopropanol and / or a cyanide compound in the exhaled breath, and analyzing the result.

(2) The present invention also relates to the above method for testing liver cirrhosis.

Furthermore, the present invention relates to the following breath analyzer for liver disease inspection.

(3) a breath sampling unit for introducing the breath to be analyzed, a breath analysis unit for quantifying isopropanol and / or cyanide compounds in the breath, and a data processing unit for analyzing the analysis result obtained by the breath analysis unit A breath analyzer for liver disease testing.

(4) The breath analysis apparatus according to (3), wherein the breath collection unit includes a breath collection unit and a breath transfer unit.

(5) The breath analyzer according to (4), wherein the breath collecting means is a mouse bead or a mask.

(6) The breath analysis apparatus according to (4), wherein the breath collection means is a connection port for connecting a breath storage container.

(7) The breath analyzer according to any one of (4) to (6), wherein the breath transfer unit includes a conduit that connects the breath collection unit and the breath analyzer so that the breath can flow.

(8) The expiratory transfer means further comprises: a pump means for transmitting expiration to the expiratory analyzer. (7) The breath analyzer according to (7).

(9) The breath collection means includes both a mouse bead or a mask and a connection port for connecting the breath storage container, and only one of them selected as occasion demands can be distributed with the breath analysis unit. The breath analyzer according to (7) or (8), wherein a switchable valve means is provided on the conduit.

(10) The breath analyzer according to any one of (3) to (9), wherein the breath analyzer includes a mass spectrometer.

(11) The breath analyzer according to (3) to (10), which is used for an examination of cirrhosis. Further, the present invention also provides the above method and apparatus, wherein the quantitative determination of the cyanide compound in breath is performed by the quantitative determination of its decomposition product, HCN. BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a schematic diagram showing a breath analyzer according to one embodiment of the present invention.

FIG. 2 is a graph showing the relationship between cirrhosis and quantitative values of isopropanol and cyanide.

FIG. 3 is a schematic view showing a breath analyzer according to another embodiment of the present invention.

FIG. 4 is a schematic diagram showing a breath analyzer according to another embodiment of the present invention.

FIG. 5 is a schematic diagram showing a breath analyzer according to another embodiment of the present invention. BEST MODE FOR CARRYING OUT THE INVENTION

1. Inspection method

Examples of liver diseases that can be tested by the method of the present invention include acute hepatitis, chronic hepatitis, fulminant hepatitis, fatty liver, cirrhosis. In particular, the method of the present invention is suitable for examination of cirrhosis.

To enable a more accurate determination, it is preferable to quantify both isopropanol and the cyanide compound, but either one may be quantified.

Examples of cyanide include acetonitrile.

The exhaled breath may be directly introduced into the device and subjected to quantitative analysis immediately, or it may be collected once in a container, and after a certain period of time, introduced into the device for quantitative analysis to perform quantitative analysis. You may use it.

In addition, depending on the quantitative analysis method, the collected breath is subjected to pretreatment such as concentration, absorption into solution, adsorption, coagulation, removal of impurities and water by a filter, and separation by gas chromatography before quantitative analysis. Is also good.

The quantification of the isopropanol and / or cyanide compound can be performed by any means capable of quantifying the compound. For example, mass spectrometry, emission spectroscopy, fluorescence spectroscopy, gas chromatography (gas-solid chromatography, gas-liquid chromatography

-), Liquid chromatography, detector tube method, method using a semiconductor sensor, IR analysis (FT-IR, etc.), etc. Mass spectrometry includes electron ionization mass spectrometry, chemical ionization mass spectrometry, atmospheric pressure ionization mass spectrometry, secondary ion mass spectrometry, fast atom bombardment ionization mass spectrometry, thermospray ionization mass spectrometry Method, electrospray ionization mass spectrometry, laser desorption ionization mass spectrometry, and the like. As the analysis instrument, for example, a magnetic field single focusing type, an electric field double focusing type, a quadrupole type, a three-dimensional quadrupole type, a TOF type, and an ICR type can be used. Alternatively, a GC-MS device, an MS-MS device, an LC-MS device, etc. may be used.

Isopropanol and cyanide can be detected and quantified as decomposition products or reaction products depending on the analytical method. For example, cyanide can be quantified as HCN or the like as a decomposition product. Further, isopropanol, CH _₃ C ⁺ H CH ₃ as the degradation products or reaction products, CH ₃ C ⁺ HOH, can be quantified as _{(CH 3 CH (OH) CH} 3) 2 · H 2 and the like. Thus, throughout this specification, "quantifying isopropanol and / or cyanide" also includes indirectly quantifying isopropanol and / or cyanide by quantifying these degradation products and reaction products.

In the present invention, “analysis” refers to determining the possibility of suffering from liver disease based on quantitative analysis data of isopropanol and / or cyanide. For the determination, for example, quantitative analysis data such as beak area and ionic strength are converted into a concentration, and if the concentration is less than a certain value, it is determined that there is no possibility of having a liver disease, and a certain value is determined. The above cases can be performed by determining that there is a possibility of disease. In this case, the reference value for the judgment (hereinafter referred to as the critical value) is, for example, It can be determined by measuring the isopropanol and / or cyanide compound concentration in the breath of six or more liver disease patients and healthy subjects.

The critical value can be set for the concentration of isopropanol, for example, between 0.15 ppm and 10 ppm, preferably between 0.15 ppm and 1 ppm. Also, regarding the concentration of hydrogen cyanide, for example, 0.3 p ρπ! It can be set between 1010 ppm and preferably between 0.5 ppm and 2 ppm.

Conversion from the quantitative analysis data to the concentration can be performed by a conventional method such as a calibration curve method. Judgment is preferably performed by automatic analysis by a convenience store, but it is also possible for the person who performs the inspection to make a judgment based on the converted concentration.

In addition, the determination can be made based on the relationship between the liver disease and the quantitative analysis data (peak area, ionic strength, etc.) of isopropanol and / or cyanide, which were previously examined, without converting the quantitative analysis data into concentrations. Good. Furthermore, for example, quantitative analysis data of isopropanol and / or cyanide compounds in the breath of 6 or more patients with liver disease and healthy subjects are input to a data processing device in advance, and the data of the subject's breath are analyzed. Judgment can also be made by automatically analyzing whether the data is closer to the data of patients with liver disease or healthy subjects.

In the above explanation, the subjects are classified into groups that are unlikely to have liver disease and those that are likely to have liver disease. It can also be classified into three or more groups that are divided step by step.

The analysis can also be performed using other data such as age, gender, pre-existing conditions, and factors from other tests. Factors from other tests include, for example, serum pyrilrubin, ZTT, TTT, ALP, CHE, GOT, GPT, αGTP, LDH, LAP, serum total protein, AZG ratio, urinary pyrilrubin, urobilobino-gen Can be overnight. For example, one or more of the above factors may be input into a pre-programmed data processor for liver disease determination, and the data combined with the quantitative analysis data for isopropanol and / or cyanide. Can be automatically analyzed.

Note that the above determination method is not limited. Also, the critical values are It can be appropriately selected according to factors such as the factor 1 by the other tests described above, the accuracy of the intended liver disease screening, and the like. According to the present invention, it has been found that the concentrations of isopropanol and cyanide in breath are significantly different between healthy subjects and liver disease patients. By collecting data on the quantitative analysis of sopropanol and cyanide, it is possible to adopt a judgment method according to the test actually performed.

2. Breath analyzer

In the device of the present invention, the breath collection unit is a unit for collecting a breath for analysis, introducing the breath into the device, and leading the breath to the breath analyzer, and preferably, a breath collection unit for collecting the breath. And breath transfer means for transferring the collected breath to the breath analyzer.

The breath collecting means may be, for example, a mouth bead for directly collecting breath, a breath blowing port such as a mask shaped to cover the mouth or both the nose and the mouth, or a connection port for connecting a breath holding container.

When testing is performed by introducing exhaled air directly into the device, the above-mentioned exhalation blow-in port is used, and is collected in an exhalation storage container, and after a certain period of time, the exhaled air in the container is introduced into a device for quantification and tested. In this case, the connection port is used.

The breath holding container is a container for temporarily holding the breath for analysis, for example, a glass container such as a vacuum bottle, soft vinyl chloride, vinyl tetrafluoride, and ethylene tetrafluoride. And a breath collection bag made of synthetic resin made of polyethylene phthalate.

The mouth beads and the mask can have a structure that allows efficient collection without exhaling breath. Further, it is preferable to provide a means for preventing the exhalation from leaking to the outside air after the exhalation is blown, for example, a valve.

The exhalation transfer means includes, for example, a conduit for connecting the exhalation collection means and the exhalation analyzer so that exhalation can flow, a valve provided in the conduit, a pump for forcibly sending or drawing exhalation to the exhalation analyzer. And the like.

Preferably, the inner surface of the conduit is electropolished to suppress the adsorption of the analyte in the breath to the conduit. Furthermore, the device according to the invention can Heating means for heating the parts, in particular the conduits and the valves, to a constant temperature.

Further, the expiratory transfer means may include an expiratory volume control mechanism, and preferably has a structure for sending a fixed amount of the exhaled breath to the expiratory analyzer.

In the breath collection section, a pretreatment means is provided for the breath to perform pretreatment such as concentration, absorption into solution, adsorption, coagulation, removal of impurities and water by a filter, and separation by gas chromatography. Is also good.

In the present invention, the breath analysis section is a region for quantifying isopropanol and / or a cyanide compound in breath, and includes a quantitative analyzer capable of quantifying the substance.

Specific examples of the quantitative analyzer include a mass spectrometer, an emission spectrometer, a fluorescence spectrometer, a gas chromatograph (gas-solid chromatograph, gas-liquid chromatograph), a liquid chromatograph, a detector tube. , A semiconductor sensor, an IR analyzer (for example, FT-IR), an ion electrode concentration measuring device, a photoelectric photometer, and a colorimeter. Examples of mass spectrometers include electron ionization mass spectrometers, chemical ionization mass spectrometers, atmospheric pressure ionization mass spectrometers, secondary ion mass spectrometers, fast atom bombardment ionization mass spectrometers, and thermospray ionization mass spectrometers , An electrospray ionization mass spectrometer, a laser desorption ionization mass spectrometer, and the like. The ion separation method can be, for example, a magnetic field single focusing type, an electric field double focusing type, a quadrupole type, a three-dimensional quadrupole type, a TOF type, or an ICR type. Also, a GC-MS device, a MS-MS device, an LC-MS device, etc. may be used.

In the present invention, the “data processing unit” receives the analysis result obtained by the breath analysis unit, analyzes the result, converts the concentration of isopropanol and / or cyanide compound if necessary, and determines the possibility of liver disease. This is an area for performing the determination, that is, the determination regarding the liver disease described in the item of the above-described test method and / or the display of the results thereof.

As described above, even if all data processing up to the judgment is automatically performed by the compilation overnight program in the data processing unit, the data processing unit converts the concentration of isopropanol and / or cyanide and displays the concentration. Only the judgment may be made by the inspector.

The data processing unit measures the quantitative values of isopropanol and cyanide compounds in the exhaled breath of multiple liver disease patients, and the isopropanol and cyanidated exhaled breath of healthy subjects. A configuration may be provided in which a database comprising quantitative values of the compound is provided, and the measured value is compared with the database to check for liver disease.

Note that the device of the present invention can be used mainly for the purpose of screening for liver disease in health examinations and the like, but can also be used in medical institutions to assist diagnosis. In addition, by transmitting the analysis results using a communication line, etc., it is possible to connect physicians at urban hospitals to remote areas such as non-medical villages, to monitor the condition of long-term care recipients, and to conduct tests for remote treatment. You can also. Example

The present invention is further described in the following examples. These examples are illustrative and do not limit the invention. Those skilled in the art can make various improvements and modifications based on the description of the present invention and the information known in the art. In all the drawings for describing the embodiments, those having the same functions are denoted by the same reference symbols, and their repeated description will be omitted.

Example 1

FIG. 1 shows a schematic configuration diagram of the breath analyzer of the present embodiment.

As shown in FIG. 1, the cirrhosis testing apparatus using the breath analyzer 1a of the present embodiment includes a breath sampling unit 28, a breath analyzer 29, and a data processing unit 30. The exhalation sampling section 28 has a mouth bead 2 and an exhalation collecting bag 6 connected to a two-way, three-way valve body 5 by a conduit 52, and an exhalation switching valve 3 built in the valve body 5. According to 4 and 4, there is a structure in which the exhalation is introduced directly from the mouse bead and the exhalation is indirectly introduced by exhaling the air once in the exhalation collecting bag 6. The valve main body 5 is connected to a breath gas inlet of a breath analyzer 29 via a flow controller 7, and controls a directly or indirectly introduced breath to a constant flow rate, and a breath analyzer 2. Introduce to 9.

In addition, a conduit having an electropolished inner surface is used as a conduit composing the exhalation sampling unit 28, and the conduit and the valve body 5 are heated to a constant temperature by the heating unit 8, so that the analysis target during exhalation is obtained. Adsorption of substances to the conduit is suppressed.

Atmospheric pressure ionization mass spectrometry capable of trace analysis 5 `` (Atomospheric Pres sure Ioni zation Mass Spectrometry ^ Below,

APIMS), which makes it possible to analyze analytes in breath with ultra-high sensitivity. A cylinder of Ar + H: (1%) mixed gas 9 as a primary ion generation gas is connected to the first ionization chamber 15 of the APIMS via a pressure reducing valve 10 and a flow controller 11. Thus, primary ions are generated by corona discharge caused by the high pressure applied to the discharge needle 16. In addition, the second ionization chamber 17 is connected to a breath collection unit 28 and a diaphragm pump 13 via a pressure controller 12, and the internal pressure of the second ionization chamber 17 is reduced to 0.85. The pressure is maintained at Pa, and the structure is such that the breath gas from the breath sampling unit 28 is sucked, and the primary ions generated in the first ionization chamber 15 collide with neutral molecules of the analyte in breath. The ion-molecule reaction is performed to ionize the analyte. The differential pumping section 18 is maintained at a low vacuum by the vacuum pumping system 20 and is an area connecting the second ionization chamber 17 and the breath analyzer 23. The breath analysis unit 23 is maintained in a high vacuum by a vacuum exhaust system 21.A quadrupole mass spectrometer 22 is disposed inside the breath analysis unit 23, and the breath analysis unit 23 passes through the narrow mouth of the slit 19. This is the area where ions introduced into the mass are separated by mass and converted into electric signals. The signal amplifier 24 is connected to the breath analyzer 23, amplifies the electric signal converted by the breath analyzer 23, and transmits the electric signal to the data processor 30.

The data processing unit 30 is composed of a convenience store 25, a database 26, and a display unit 27, and is used to measure both or at least one of isopropanol and cyanide, which are the analytes in breath. One of the concentrations was calculated from the signal transmitted from the signal amplifier 24, and was calculated based on the concentrations of isopropanol and cyanide in the exhaled breath of the group of cirrhosis patients and the group of healthy subjects (those who were determined to be normal by a health examination) in advance. By comparing with the prepared database 26 to determine which group concentration is closer to it, it is determined whether the liver cirrhosis is normal or normal, and displayed on the display unit 27.

The operation of the present embodiment will be described. When exhalation is introduced directly, the exhalation switching valve 3 is opened and the exhalation switching valve 4 is closed at this time. When the exhalation is introduced indirectly, the exhalation is collected once in the exhalation collection bag 6, and then the exhalation collection bag 6 is connected to the valve body 5, and the exhalation switching valve is used. /

3 is set to closed and exhalation switching valve 4 is set to open and introduced. The introduced breath is flow-controlled by the flow controller 7 and introduced into the second ionization chamber 1 室 of the AP IMS. On the other hand, Ar + H: (1%) mixed gas 9, which is the primary ion generation gas, is controlled to a constant pressure by the pressure reducing valve 10 and the flow rate is controlled by the flow rate controller 11. Introduced into chemical chamber 15. The introduced Ar + H: (1%) mixed gas 9 generates corona discharge due to the high voltage applied to the discharge needle 16 and, as a result, generates primary ions. The generated primary ions are introduced into the secondary ionization chamber 17 and mixed with the exhalation introduced from the exhalation sampling unit 28. As a result of the mixing, the exhaled air collides with the primary ions, causing an ion-molecule reaction, and the analyte in the exhaled air is ionized. The ionized analysis target substance passes through the differential evacuation unit 18, is introduced into the breath analysis unit 23, is mass-separated by the quadrupole mass spectrometer 22, is converted into an electric signal, and is output. The converted electric signal is amplified by a signal amplifier 24 and then introduced into a data processing unit 30. Among the introduced signals, in particular, the concentration of both or at least one of the analytes isopropanol and / or cyanide is calculated from the transmitted signal, and the cirrhosis patient group and the healthy subject group (pre- To determine which one is closer to the concentration of either group by comparing with the data 26 created by the concentrations of isopropanol and cyanide in the breath of the person who was recognized as normal) By doing this, a test for cirrhosis is performed.

Using the apparatus shown in FIG. 1, the breath of 20 healthy subjects and 20 cirrhosis patients was analyzed. Figure 2 shows the results of mass spectrometry. FIG. 2 (A) shows a comparison of the concentration of cyanide between a liver cirrhosis patient and a healthy subject. FIG. 2 (B) shows the comparison of the concentration of isopropanol between cirrhosis patients and healthy subjects. From the figure, it is clear that there is a 4- to 10-fold difference in the concentrations of cyanide and isopropanol between the group of cirrhosis patients and the group of healthy subjects. As described above, according to this example, a simple cirrhosis test can be performed by analyzing the cyanide and isopropanol in the breath using the breath analyzer using AP IMS.

Example 2

FIG. 3 shows a schematic configuration diagram of the breath analyzer 1b of the present embodiment. In this embodiment, an ion trap mass spectrometer 34 is used for the breath analyzer. Iontra Since the top-up mass spectrometer 34 is a spectrometer capable of microanalysis, like the AP IMS, it enables highly sensitive analysis of the analyte in breath. The ion trap mass spectrometer 34 includes an ionization section 31 and a high vacuum section 32. The ionization section 31 has ionization means by discharge or the like, and has a function of ionizing the exhalation introduced from the exhalation collection section 28. The high vacuum section 32 is an area maintained in a high vacuum by a vacuum evacuation system 36, in which an ion trap electrode 33 and a detector 35 are disposed, and the ions generated in the ionization section 31 are formed. After trap enrichment and detection by the detector 35, it is converted into an electric signal and transmitted.

As described above, according to the present embodiment, a simple cirrhosis test can be performed by analyzing the cyanide and isopropanol in the breath using the breath analyzer using the ion trap mass spectrometer 34. .

Example 3

FIG. 4 shows a schematic configuration diagram of the breath analyzer 1c of the present embodiment. In this embodiment, a gas chromatograph / mass spectrometer 42 is used for the breath analyzer. The gas chromatograph / mass spectrometer 42 has the feature that both qualitative analysis and quantitative analysis can be performed at the same time, so that breath analysis can be performed without identifying the beak in advance. The gas chromatograph mass spectrometer 42 includes a carrier gas inlet, a column 37, an interface 38, and a mass spectrometer 39. The carrier gas introduction section has a configuration in which a carrier gas cylinder 43 is connected to a power ram 37 via a pressure reducing valve 4 and a flow rate controller 45, and a carrier gas having a constant pressure and a constant flow rate is supplied to the column 37. Supply. The column 37 is a region where a substance is separated due to a difference in chemical adsorption of the substance. The interface 38 connects the column 37 and the mass spectrometer 39 to control gas flow, measurement timing, and the like. The mass spectrometer 39 is maintained in a high vacuum by a vacuum evacuation system 40. The mass-separated ions are detected by a detector 41, converted into an electric signal, and transmitted.

The operation of this embodiment will be described. The carrier gas maintained at a constant pressure by the pressure reducing valve 44 and maintained at a constant flow rate by the flow rate controller 45 is introduced into the column 37 together with the exhalation introduced by the exhalation sampling unit 28. Analytes in the exhaled breath are separated according to the characteristics of the substances, and then passed through the interface 38 to obtain the mass spectrometer 3 9 Will be introduced. In the mass spectrometer 39, after being ionized and mass-separated, it is detected by the signal detector 41, converted into an electric signal, and transmitted. As described above, according to the present example, a simple liver cirrhosis test can be performed by analyzing the cyanide and isopropanol in the breath using the breath analyzer using the gas chromatograph mass spectrometer 42. Will be possible. Industrial applicability

ADVANTAGE OF THE INVENTION According to the liver disease test method and breath analyzer of the present invention, a liver disease test can be performed without causing pain to the subject and without requiring a technician having a special technique, and the results can be obtained immediately. Can be obtained.

Also, by combining it with other test results, it is possible to determine liver disease more accurately.

Therefore, according to the method and apparatus of the present invention, a simple, high-accuracy, and rapid liver disease test can be performed not only at a medical institution such as a hospital, but also at a health check center or a health center. In addition, the device of the present invention also offers the possibility of remote treatment, such as a remote home caregiver.

Claims

The scope of the claims

1. A method for examining liver disease, which comprises collecting exhaled breath, quantifying isopropanol and / or cyanide in the exhaled breath, and analyzing the results.

2. The method for testing liver disease according to claim 1, which is used for testing cirrhosis.

3. A breath sampling unit for introducing a breath to be analyzed, a breath analysis unit for quantifying isopropanol and / or a cyanide compound in the breath, and a data processing unit for analyzing an analysis result obtained by the breath analysis unit. A breath analyzer for liver disease testing.

4. The breath analysis apparatus according to claim 3, wherein the breath collection unit includes a breath collection unit and a breath transfer unit.

5. The breath analyzer according to claim 4, wherein the breath collecting means is a mouthpiece or a mask.

6. The breath analyzer according to claim 4, wherein the breath collecting means is a connection port for connecting a breath storage container.

7. The breath analysis apparatus according to claim 4, wherein the breath transfer means includes a conduit connecting the breath collection means and the breath analysis section so that the breath can flow.

8. The breath analyzer according to claim 7, wherein the breath transfer means further includes a pump means for sending breath to the breath analyzer.

9. The breath transfer means includes both a mouthpiece or a mask and a connection port for connecting a breath storage container, and only one of them, which is selected depending on the case, can be distributed with the breath analysis unit. 8. The breath analyzer according to claim 7, wherein a switchable valve means is provided on the conduit.

10. The breath analyzer according to claim 3, wherein the breath analyzer is a mass spectrometer.

11. The breath analyzer according to claim 4, wherein the breath analyzer includes a mass spectrometer.

12. The breath analyzer according to claim 7, wherein the breath analyzer includes a mass spectrometer.

13. The breath analyzer according to claim 9, wherein the breath analyzer includes a mass spectrometer. Place.

14. The breath analyzer according to claim 3, which is used for a liver cirrhosis test.

15. The breath analyzer according to claim 4, which is used for liver cirrhosis testing.

16. The breath analyzer according to claim 7, which is used for cirrhosis test.

17. The breath analyzer according to claim 9, which is used for liver cirrhosis testing.

18. The breath analyzer according to claim 10, which is used for cirrhosis test.

19. The breath analyzer according to claim 11, which is used for an examination of cirrhosis.

20. The breath analyzer according to claim 13, which is used for a liver cirrhosis test.