JP4452783B2 - Cirrhosis test method and apparatus using breath analysis apparatus - Google Patents

Description

[0001]
[Technical field to which the invention belongs]
The present invention relates to a liver disease test method and a breath analysis apparatus for use in the test method.
[0002]
[Prior art]
Diagnosis of a liver disease is performed by clinical findings by a doctor, liver biopsy, laparoscopic examination, liver scanning, ultrasound examination, CT scanning, X-ray examination and the like. However, these methods are not suitable for the purpose of examining liver diseases in general medical examinations and the like because they require special techniques by doctors, specialists, etc., and expensive devices. For this reason, in medical examinations and the like, blood and urine are collected, and metabolites in blood and urine are analyzed to examine liver diseases.
Examples of such liver disease test methods include serum bilirubin, ZTT, TTT, ALP, CHE, GOT, GPT, γ-GTP, LDH, LAP, serum total protein, A / G ratio, urinary bilirubin, urinary urobilinogen, and the like. There is a measurement. And when it is determined that such a test has a suspicion of liver disease, the medical institution receives the above diagnosis and test.
On the other hand, in recent years, methods for examining various diseases by measuring metabolites in exhaled breath have been proposed. Such a method is described in, for example, (Yasuhiro Mitsui, “Exhalation trace amount component detection system”, S14-5 Proceedings of the National Congress of the Institute of Electrical Engineers of Japan in 1987 (1987)).
[0003]
[Problems to be solved by the invention]
However, as described above, testing for liver diseases by measuring metabolites in blood and urine takes time from the time of testing until results are obtained. Therefore, it may not be suitable for monitoring the patient's condition in a medical institution or for an emergency hospitalization. In addition, blood collection can be performed only by those who have a certain qualification, and is painful for the patient, which is particularly burdensome for seriously ill patients and pediatric patients. Furthermore, the measurement data of the metabolites in blood and urine are not necessarily specific for liver diseases. Therefore, in order to make the determination as accurate as possible, it is important to output as much measurement data as possible and combine them. At present, there is no disclosure of specific means for carrying out the breath analysis method in the examination of liver diseases.
Accordingly, an object of the present invention is to provide a method for examining a liver disease, which can make a quick determination, has little pain for a subject, and can contribute to an accurate determination, and an apparatus used for the method. .
[0004]
[Means for Solving the Problems]
In order to achieve the above object, the inventors of the present invention focused on breath analysis with little pain to the subject, and as a result of earnest research on the relationship between components in breath and liver disease, the present invention It came to complete.
(1) That is, this invention relates to the test | inspection method of a liver disease including extract | collecting expiration | expired_air, quantifying the isopropanol and / or cyanide compound in this expiration | expired_air, and analyzing the result.
(2) Moreover, this invention relates to the said method for the test | inspection of a cirrhosis.
[0005]
Furthermore, the present invention relates to the following breath analysis apparatus for liver disease examination.
(3) an exhalation collection unit for introducing exhalation to be analyzed, an exhalation analysis unit for quantifying isopropanol and / or cyanide compounds in the exhalation, and a data processing unit for analyzing analysis results obtained by the exhalation analysis unit A breath analysis apparatus 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 analysis apparatus according to (4), wherein the breath collection means is a mouthpiece or a mask.
(6) The breath analysis apparatus according to (4), wherein the breath collection unit is a connection port for connecting a breath storage container.
(7) The breath analysis apparatus 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 analysis unit so that the breath can be distributed.
(8) The exhalation analysis device according to (7), wherein the exhalation transfer means further includes pump means for sending exhalation to the exhalation analysis unit.
(9) The exhalation collecting means includes both a mouthpiece or a mask and a connection port for connecting the exhalation storage container, and only one selected according to the case can be distributed with the exhalation analysis unit. The breath analysis apparatus according to (7) or (8), wherein switchable valve means is provided in the conduit.
(10) The breath analysis apparatus according to any one of (3) to (9), wherein the breath analysis means is a mass spectrometer.
(11) The breath analysis apparatus according to any one of (3) to (10), which is used for examination of cirrhosis.
Furthermore, the present invention also provides the method and apparatus described above, wherein the cyanide compound in the breath is quantified by quantifying the decomposition product HCN.
[0006]
DETAILED DESCRIPTION OF THE INVENTION
1. Examination Methods Examples of liver diseases that can be examined by the method of the present invention include acute hepatitis, chronic hepatitis, fulminant hepatitis, fatty liver, and cirrhosis. In particular, the method of the present invention is suitable for examination of cirrhosis.
In order to enable more accurate determination, it is preferable to quantify both isopropanol and cyanide, but either one may be quantified.
An example of a cyanide compound is acetonitrile.
Exhaled breath may be directly introduced into the apparatus and immediately subjected to quantitative analysis, or once collected in a container and after a certain period of time, it may be introduced into the apparatus for quantitative analysis to perform quantitative analysis. .
In addition, depending on the quantitative analysis method, pre-treatment such as concentration, absorption into a solution, adsorption, condensation, removal of impurities and moisture by a filter, separation by gas chromatography, etc. may be performed on the collected breath before quantitative analysis. good.
[0007]
The quantification of isopropanol and / or cyanide compound can be performed by any means capable of quantifying the compound. For example, mass spectrometry, emission spectrometry, fluorescence analysis, gas chromatography (gas-solid chromatography, gas-liquid chromatography), liquid chromatography, detector tube method, semiconductor sensor method, IR analysis (FT-IR) Etc.). As mass spectrometry, 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, electrospray ionization Examples include mass spectrometry and laser desorption ionization mass spectrometry. As the analytical instrument, for example, a magnetic single focusing type, an electric field double focusing type, a quadrupole type, a three-dimensional quadrupole type, a TOF type, or an ICR type can be used. A GC-MS device, an MS-MS device, an LC-MS device, or the like can also be used.
Isopropanol and cyanide compounds 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. In addition, isopropanol can be quantified as CH ₃ C ⁺ HCH ₃ , CH ₃ C ⁺ HOH, (CH ₃ CH (OH) CH ₃ ) ₂ .H ₂ or the like as a decomposition product or a reaction product. Accordingly, throughout this specification, “quantification of isopropanol and / or cyanide compound” includes indirectly quantifying isopropanol and / or cyanide compound by quantification of these decomposition products and reaction products.
[0008]
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 example, the quantitative analysis data such as peak area, ionic strength, etc. is converted into concentration, and if the concentration is less than a certain value, it is determined that there is no possibility of suffering from liver disease, and a certain value The above cases can be carried out by determining that there is a possibility of being affected. In this case, a reference value (hereinafter referred to as a critical value) is determined in advance by measuring, for example, the concentration of isopropanol and / or cyanide compounds in the breath of 6 or more patients with liver disease and healthy individuals in advance. Can do.
The critical value can be set, for example, between 0.15 ppm and 10 ppm, preferably between 0.15 ppm and 1 ppm, for the concentration of isopropanol. Moreover, about the density | concentration of hydrogen cyanide, it can set, for example between 0.3 ppm-10 ppm, Preferably it can set between 0.5 ppm-2 ppm.
Conversion from quantitative analysis data to concentration can be performed by a conventional method such as a calibration curve method.
The determination is preferably performed by automatic analysis by a computer, but the person who performs the inspection can also determine based on the converted concentration.
Further, the determination may be made based on the relationship between the liver disease examined in advance and the quantitative analysis data (peak area, ionic strength, etc.) of isopropanol and / or cyanide without converting the quantitative analysis data into the concentration. . Further, for example, quantitative analysis data of isopropanol and / or cyanide in the breath of 6 or more patients each having a liver disease and a healthy person are input to the data processor in advance, and the data in the breath of the subject is the liver disease. It can also be determined by automatically analyzing which data is close to the diseased patient or the healthy person.
[0009]
In the above description, the subject is classified into a group that is not likely to suffer from liver disease and a group that is likely to be affected. It is also possible to classify into three or more groups divided step by step.
Analysis can also be performed using other data such as age, gender, pre-existing disease, factors from other tests, and the like. Factors from other tests are, for example, serum bilirubin, ZTT, TTT, ALP, CHE, GOT, GPT, γ-GTP, LDH, LAP, serum total protein, A / G ratio, urinary bilirubin, urinary urobilinogen obtain. For example, one or more of the above factors may be input into a pre-programmed data processor for liver disease determination and automatically combined with the quantitative analysis data for isopropanol and / or cyanide. Can be analyzed.
The determination method is not limited. The critical value can also be appropriately selected according to factors such as the group to be classified, factors such as the factors of the other tests, the accuracy of the intended liver disease screening, and the like. According to the present invention, it was found that the concentrations of isopropanol and cyanide in expired air were significantly different between healthy persons and patients with liver disease. By collecting quantitative analysis data of cyanide compounds, it is possible to adopt a determination method according to an actually performed test.
[0010]
2. Exhalation analyzer In the apparatus of the present invention, the exhalation collection unit is a part for collecting exhalation for analysis, introducing the exhalation into the apparatus, and leading it to the exhalation analyzer, preferably for collecting exhalation It consists of exhalation collection means and exhalation transfer means for transferring the collected exhalation to the exhalation analyzer.
The exhalation collecting means may be, for example, a mouthpiece for collecting exhalation directly, an exhalation inhaling port such as a mouth or a mask shaped to cover both the nose and the mouth, or a connection port for connecting an exhalation container.
When inspecting by introducing exhalation directly into the apparatus, the exhalation inhalation port is used, collected in the exhalation container, and after a certain period of time, exhalation in the container is introduced into the apparatus for quantification and inspected In this case, the connecting port is used.
The breath container is a container for temporarily storing breath for analysis. For example, a glass container such as a vacuum bottle, soft vinyl chloride, vinyl tetrafluoride, tetrafluoroethylene, polyethylene phthalate It can be a synthetic resin breath collection bag or the like.
The mouthpiece and the mask can have a structure capable of efficiently collecting exhaled air without leaking out. Furthermore, it is preferable to provide a means, for example, a valve, for preventing exhalation from leaking to the outside air after the exhalation.
[0011]
The exhalation transfer means includes, for example, a conduit connecting the exhalation collection means and the exhalation analysis unit so as to allow exhalation flow, a valve provided in the conduit, a pump for forcibly sending exhalation to the exhalation analysis unit, or the like Can be included.
The inner surface of the conduit is preferably electropolished in order to suppress the adsorption of the analyte substance in exhalation onto the conduit. Furthermore, the device of the present invention comprises a heating means for heating the breath collection part, in particular the conduit and the valve, to a constant temperature for the same purpose.
Further, the exhalation transfer means may include an exhalation volume control mechanism, and preferably has a structure for sending a certain amount of the collected exhalation to the exhalation analyzer.
In addition, in the exhalation sampling unit, pretreatment means may be provided in the exhalation to perform pretreatment such as concentration, absorption into a solution, adsorption, condensation, removal of impurities and moisture by a filter, separation by gas chromatography, etc. .
[0012]
In the present invention, the breath analysis unit is a region for quantifying isopropanol and / or cyanide compounds in the breath, and includes a quantitative analysis device capable of quantifying the substance.
Specific examples of the quantitative analysis instrument include a mass spectrometer, an emission analyzer, a fluorescence analyzer, a gas chromatograph device (gas-solid chromatograph device, a gas-liquid chromatograph device), a liquid chromatograph device, a detector tube, and a semiconductor. Examples include sensors, IR analyzers (for example, FT-IR), ion electrode concentration measuring devices, photoelectric photometers, and colorimeters. Mass spectrometers include, among others, electron ionization mass spectrometer, chemical ionization mass spectrometer, atmospheric pressure ionization mass spectrometer, secondary ion mass spectrometer, fast atom bombardment ionization mass spectrometer, thermospray ionization mass spectrometer, electro Examples thereof include a spray ionization mass spectrometer and a laser desorption ionization mass spectrometer. The ion separation method can be, for example, a magnetic single focusing type, an electric magnetic field double focusing type, a quadrupole type, a three-dimensional quadrupole type, a TOF type, or an ICR type. A GC-MS device, an MS-MS device, an LC-MS device, or the like can also be used.
[0013]
In the present invention, the “data processing unit” receives the analysis result obtained by the breath analysis unit, analyzes this, converts the concentration of isopropanol and / or cyanide compound as required, determines the possibility of liver disease, That is, this is an area for performing the determination relating to the liver disease detailed in the item of the inspection method and displaying the results thereof.
As described above, even if all data processing up to the determination is automatically performed by the computer program in the data processing unit, the data processing unit only converts and displays the concentration of isopropanol and / or cyanide, and the determination is performed by inspection. The person may go.
The data processing unit includes a database consisting of quantitative values of isopropanol and cyanide in exhaled breath of a plurality of patients with liver diseases, and quantitative values of isopropanol and cyanide in exhaled air of a healthy person, the measured value and the The configuration may be such that liver diseases are examined by comparing databases.
The device of the present invention can be used for the purpose of screening for liver diseases mainly in health checkups, etc., but can also be used as a diagnostic aid in medical institutions. In addition, by transmitting the analysis results using a communication line, etc., it is possible to connect remote areas such as non-medicine villages and doctors in hospitals in urban areas to monitor the medical condition of long-term caregivers and perform tests for remote treatment. You can also
[0014]
【Example】
Hereinafter, the present invention will be described in more detail with reference to examples. However, these do not limit the present invention. In all the drawings for explaining the embodiments, the same symbols are attached to those having the same function, and the repeated explanation thereof is omitted.
[0015]
Example 1
A schematic configuration diagram of the breath analysis apparatus of this embodiment is shown in FIG.
As shown in FIG. 1, the cirrhosis test apparatus using the breath analysis apparatus 1 a of the present embodiment includes a breath collection unit 28, a breath analysis unit 29, and a data processing unit 30. In the exhalation collection unit 28, the mouthpiece 2 and the exhalation collection back 6 are connected to the dual three-way structure valve body 5 by a conduit 52, and the exhalation switching valves 3 and 4 built in the valve body 5 The structure is used by switching between the case where the exhalation is directly introduced from the mouthpiece and the case where the exhalation is once collected in the exhalation collection bag 6 and then the exhalation is indirectly introduced. The valve body 5 is connected to the exhalation gas inlet of the exhalation analyzer 29 via the flow rate controller 7, and the exhaled gas introduced directly or indirectly is controlled at a constant flow rate and introduced into the exhalation analyzer 29.
In addition, a conduit whose inner surface is electropolished is used as a conduit constituting the breath collection unit 28, and the conduit and the valve body 5 are heated to a constant temperature by the heater 8, whereby the analysis target substance in the breath is supplied to the conduit. Adsorption is suppressed.
[0016]
As the analyzer of the breath analysis unit 29, an atmospheric pressure ionization mass spectrometer (hereinafter abbreviated as APIMS) capable of performing a trace amount analysis is used. This makes it possible to analyze with sensitivity. A cylinder of Ar + H ₂ (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 rate controller 11, and is applied to a discharge needle 16. Primary ions are generated by corona discharge caused by the high pressure. The second ionization chamber 17 is connected to an exhalation collection unit 28 and a diaphragm pump 13 via a pressure controller 12, and the second ionization chamber 17 is maintained at a pressure of 0.85 Pa. 28, the structure is configured to suck in the exhaled gas from the gas 28, and the primary ions generated in the first ionization chamber 15 collide with neutral molecules in the exhaled analyte to be analyzed, resulting in an ion-molecule reaction. Is ionized. The differential evacuation unit 18 is maintained in a low vacuum by the evacuation system 20, and is a region that connects the second ionization chamber 17 and the breath analysis unit 23. The breath analysis unit 23 is maintained at a high vacuum by the evacuation system 21. A quadrupole mass spectrometer 22 is arranged inside the breath analysis unit 23, and ions introduced into the breath analysis unit 23 through the narrow mouth of the slit 19 have a mass. This is a region that is separated and converted into an electrical signal. The signal amplifier 24 is connected to the breath analysis unit 23, amplifies the electrical signal converted by the breath analysis unit 23, and transmits it to the data processing unit 30.
[0017]
The data processing unit 30 includes a computer 25, a database 26, and a display unit 27, and the concentration of both or at least one of isopropanol and cyanide compounds to be analyzed in breath is determined from the signal amplifier 24. Which is calculated from the transmitted signal and compared to the database 26 created by isopropanol and cyanide concentrations in the exhaled breath of the cirrhosis patient group and the healthy group (those who were recognized as normal in the medical examination) in advance, By determining whether the density is close to that of the group, it is determined whether the cirrhosis is normal or normal and displayed on the display unit 27.
[0018]
The operation of this embodiment will be described. When the exhalation is directly introduced, it is introduced from the mouthpiece 2, and the exhalation switching valve 3 at this time is set to open and the exhalation switching valve 4 is set to close. In addition, when the exhalation is indirectly introduced, the exhalation collecting bag 6 is once collected, and then the exhalation collecting bag 6 is connected to the valve body 5 so that the exhalation switching valve 3 is closed and the exhalation switching is performed. Valve 4 is set open and introduced. The introduced exhaled air is flow-controlled by the flow controller 7 and introduced into the second ionization chamber 17 of the APIMS. On the other hand, Ar + H ₂ (1%) mixed gas 9 which is a primary ion generation gas is controlled to a constant pressure by a pressure reducing valve 10, and the flow rate is controlled by a flow rate controller 11 and introduced into the first ionization chamber 15 of APIMS. The The introduced Ar + H ₂ (1%) mixed gas 9 generates a corona discharge by a 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 breath introduced from the breath collection unit 28. As a result of the mixing, exhaled air collides with primary ions to cause an ion-molecule reaction, and the analysis target substance in the exhaled air is ionized. The ionized substance to be analyzed passes through the differential exhaust unit 18, is introduced into the breath analysis unit 23, is mass separated by the quadrupole mass spectrometer 22, is converted into an electrical signal, and is output. The converted electrical signal is amplified by the signal amplifier 24 and then introduced into the data processing unit 30. Among the introduced signals, in particular, the concentrations of the analytes, isopropanol and / or cyanide, or at least one of them are calculated from the transmitted signals, and the cirrhosis patient group and the healthy group (in the medical examination) The cirrhosis test is performed by determining which group is closer to the concentration compared to the database 26 created by isopropanol and cyanide concentrations in the exhaled breath.
[0019]
Using the apparatus of FIG. 1, the breaths of 20 healthy subjects and 20 cirrhosis patients were analyzed. The results of mass spectrometry are shown in FIG. FIG. 2A shows a comparison of the concentrations of cirrhosis patients and healthy subjects with respect to cyanide compounds. FIG. 2 (B) shows a comparison of the concentration of cirrhosis patients and healthy subjects with respect to isopropanol. From the figure, it is clear that the cyanide and isopropanol concentrations differ 4 to 10 times between the cirrhosis patient group and the healthy subject group. As described above, according to the present example, a simple cirrhosis test can be performed by analyzing the cyanide compound and isopropanol in the breath using the breath analyzer using APIMS.
[0020]
Example 2
A schematic configuration diagram of the breath analysis apparatus 1b of the present embodiment is shown in FIG. In this embodiment, an ion trap mass spectrometer 34 is used for the breath analysis unit. Since the ion trap mass spectrometer 34 is an analyzer capable of performing microanalysis in the same manner as APIMS, it is possible to analyze a substance to be analyzed in exhaled breath with high sensitivity. The ion trap mass spectrometer 34 includes an ionization unit 31 and a high vacuum unit 32. The ionization unit 31 has ionization means by discharge or the like, and has a function of ionizing the breath introduced from the breath collection unit 28. The high vacuum portion 32 is a region maintained at a high vacuum by a vacuum exhaust system 36, and an ion trap electrode 33 and a detector 35 are disposed therein, and ions generated by the ionization portion 31 are trap-concentrated and detected. After being detected by the device 35, it is converted into an electrical signal and transmitted.
As described above, according to the present embodiment, a simple cirrhosis test can be performed by analyzing the cyanide compound and isopropanol in the breath using the breath analyzer using the ion trap mass spectrometer 34.
[0021]
Example 3
A schematic configuration diagram of the breath analysis apparatus 1c of the present embodiment is shown in FIG. In this embodiment, a gas chromatograph mass spectrometer 42 is used for the breath analysis unit. Since the gas chromatograph mass spectrometer 42 has a feature that enables both qualitative analysis and quantitative analysis at the same time, breath analysis can be performed without performing peak identification in advance. The gas chromatograph mass spectrometer 42 includes a carrier gas introduction unit, a column 37, an interface 38, and a mass spectrometer 39. The carrier gas introduction unit has a configuration in which a carrier gas cylinder 43 is connected to the column 37 via a pressure reducing valve 44 and a flow rate controller 45, and supplies a carrier gas having a constant pressure and a constant flow rate to the column 37. The column 37 is a region where substances are separated by the difference in chemical adsorption properties of the substances. The interface 38 connects the column 37 and the mass spectrometer 39 to control gas flow rate, measurement timing, and the like. The mass spectrometer 39 is kept in a high vacuum by an evacuation system 40 and detects mass-separated ions by a detector 41 and converts them into an electrical signal for transmission.
The operation of this embodiment will be described. The carrier gas kept at a constant pressure by the pressure reducing valve 44 and kept 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 collection unit 28. The substance to be analyzed in the introduced breath is separated by the characteristics of the substance and then introduced into the mass spectrometer 39 through the interface 38. In the mass spectrometer 39, after being ionized and mass-separated, it is detected by the signal detector 41, converted into an electrical signal, and transmitted. As described above, according to the present embodiment, it is possible to perform a simple cirrhosis test by analyzing the cyanide compound and isopropanol in the breath using the breath analyzer using the gas chromatograph mass spectrometer 42.
[0022]
【The invention's effect】
According to the liver disease test method and breath analysis apparatus of the present invention, the liver disease test can be performed without causing pain to the subject and without requiring an engineer having a special technique, and the result can be obtained immediately. Can get to.
Further, by combining with other test results, it is possible to determine liver disease more accurately.
Therefore, according to the method and apparatus of the present invention, not only medical institutions such as hospitals, but also health check centers and health centers can perform simple, high-precision, and rapid liver disease tests. Furthermore, the device of the present invention also provides the possibility of remote treatment, such as monitoring a remote home caregiver.
[Brief description of the drawings]
FIG. 1 is a schematic diagram showing a breath analysis apparatus 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 analysis apparatus according to another embodiment of the present invention.
FIG. 4 is a schematic view showing a breath analysis apparatus according to another embodiment of the present invention.
FIG. 5 is a schematic view showing a breath analysis apparatus according to another embodiment of the present invention.
[Explanation of symbols]
1a, 1b, 1c, 1d Breath analysis device 28 Breath collection unit 29 Breath analysis unit 30 Data processing unit

Claims (9)

  A method for examining cirrhosis, which comprises collecting exhaled air, quantifying isopropanol and / or cyanide compound in the exhaled air, and analyzing the result.  Cirrhosis including an exhalation collection unit for introducing exhalation to be analyzed, an exhalation analysis unit for quantifying isopropanol and / or cyanide compounds in the exhalation, and a data processing unit for analyzing an analysis result obtained by the exhalation analysis unit Breath analysis device for testing.   3. The breath analysis apparatus according to claim 2, wherein the breath collection unit includes a breath collection unit and a breath transfer unit.   4. The breath analysis apparatus according to claim 3, wherein the breath collection means is a mouthpiece or a mask.   4. The breath analysis apparatus according to claim 3, wherein the breath collection means is a connection port for connecting a breath storage container.   The exhalation analysis device according to any one of claims 3 to 5, wherein the exhalation transfer unit includes a conduit that connects the exhalation collection unit and the exhalation analysis unit so that exhalation can be distributed.   The exhalation analysis device according to claim 6, wherein the exhalation transfer means further includes pump means for sending exhalation to the exhalation analysis unit. The exhalation collecting means includes both a mouthpiece or a mask and a connection port for connecting the exhalation storage container, and only one of them selected according to the case can be switched with the exhalation analysis unit. breath analysis device according to any one of claims 6 or 7 to a valve means, characterized in that provided in the conduit. The breath analysis device according to any one of claims 2 to 8 , wherein the breath analysis means is a mass spectrometer.

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