JP2005143500A - Enzyme activity measuring apparatus and method for measuring enzyme activity, sample transfer apparatus and color measuring apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide enzyme activity measuring apparatus capable of more accurately measuring the activity of enzyme in measuring the activity of the enzyme by using an enzyme activity measuring reagent, and to provide a method for measuring the activity of enzyme, sample transfer apparatus and color measuring apparatus. <P>SOLUTION: The enzyme activity measuring apparatus comprising a reagent/sample disposing unit 5 configured to dispose a sample and a reagent containing member 13 including the enzyme activity measuring reagent at a distance from each other, a sample transfer unit 7 configured to bring the sample and the reagent containing member 13 disposed into contact with each other, and to transfer a predetermined volume of the sample to the reagent containing member, a color depth measuring unit 9 configured to measure a color depth of reagent included in the reagent containing member 13 when predetermined time is elapsed after the sample is transferred, and an enzyme activity detector CPU101 configured to detect the activity of enzyme included in the sample based on the color depth measured by the color depth measuring unit. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to an enzyme activity measuring device, an enzyme activity measuring method, a sample transfer device, and a color measuring device used for measuring enzyme activity, and in particular, by measuring the color of a test paper that varies depending on the transferred sample. The present invention relates to an enzyme activity measuring device, an enzyme activity measuring method, a sample transfer device, and a color measuring device for measuring the activity of an enzyme contained in a sample.

  It is known that by measuring the activity of amylase (a kind of enzyme) contained in saliva, it is possible to determine the degree of stress of a subject and the presence or absence of a disease.

  Since amylase is contained not only in saliva but also in specimens such as blood, the degree of stress of the subject can also be measured by measuring the activity of amylase contained in blood. However, the collection of blood is generally not a simple method compared to the collection of saliva because it may be accompanied by pain in the subject.

  On the other hand, collection of saliva is easy. However, the activity of amylase contained in saliva is higher than that of amylase contained in blood. For this reason, if saliva is directly infiltrated into a reagent paper (reagent-containing member) that measures the amylase activity value, the reaction of the reagent contained in the reagent paper immediately proceeds and terminates. Therefore, it becomes difficult to measure the difference (difference) in amylase activity.

Therefore, the user sandwiches a specimen-containing member such as non-woven fabric infiltrated with saliva (specimen) and a reagent-containing member such as reagent paper with a finger, and transfers the saliva to the reagent-containing member for a predetermined time. A method has been proposed in which the activity value of amylase contained in saliva is measured by detecting the color concentration of the reagent-containing member transferred by. (For example, patent document 1).
JP 2004-121214 A

  However, there is a large difference in the color change of the reagent paper depending on the amount of amylase (saliva), specifically, the amount of saliva transferred to the reagent paper containing a substrate that reacts with saliva, and the elapsed time from the transfer. In particular, the color of the reagent paper varies greatly depending on the difference in elapsed time from the transfer.

  As described above, in the prior art, since the user transfers saliva to the reagent paper by pinching the reagent paper and the nonwoven fabric containing saliva with a finger, the force with which the nonwoven fabric is pressed against the reagent paper However, there was a problem that the amount of saliva transferred to the test paper was not constant.

  In the prior art, after saliva is transferred to the reagent paper, the reagent paper is inserted into the measuring device and the color density of the reagent paper is detected. There was also a problem that the interval with the time of measuring was not constant.

  That is, the prior art has a problem that the activity value of amylase cannot be measured accurately. This problem also occurs in enzymes other than amylase and samples other than saliva.

  Therefore, the present invention has been made in view of such problems, and in the case where the enzyme activity value is measured using an enzyme activity measurement reagent for measuring the enzyme activity, the enzyme activity value is more accurately determined. It is an object of the present invention to provide an enzyme activity measuring device, an enzyme activity measuring method, a sample transfer device, and a color measuring device that can be measured.

  In order to solve the problems described above, the present invention has the following features. The first feature of the present invention is that a reagent-containing member (reagent-containing member 13) containing an enzyme activity measuring reagent for measuring an activity value of an enzyme (for example, amylase) is separated from a specimen (for example, saliva). A reagent / sample placement part (reagent / sample placement part 5) to be placed, the reagent-containing member placed by the reagent / sample placement part and the specimen are brought into contact with each other, and a predetermined amount of the specimen is placed on the reagent-containing member. Specimen transfer sections (sample transfer section 7 and specimen transfer section 230) to be transferred, and when the predetermined time has elapsed since the specimen was transferred, the color concentration of the reagent contained in the reagent-containing member is measured. Enzyme activity measurement comprising a concentration measurement unit (concentration measurement unit 9) and an enzyme activity detection unit (CPU 101) that detects an activity value of an enzyme contained in the sample based on the concentration measured by the concentration measurement unit. Equipment (fermentation And summarized in that the active measuring apparatus 1 or an enzyme activity measuring apparatus 200).

  The second feature of the present invention relates to the first feature of the present invention, wherein the reagent-containing member is a sheet-like member, and the specimen is a sheet-like member (sample-saliva collecting sheet 15). ), And the reagent / sample placement portion includes a reagent-containing member plane (planar portion 13A) that is a plane portion of the reagent-containing member, and a sample-containing member plane that is a plane portion of the sample-containing member ( And the specimen-transfer member plane is placed between the reagent-containing member plane and the specimen-containing member plane at a predetermined pressure for a predetermined time. The gist is to contact them.

  A third feature of the present invention relates to the second feature of the present invention, wherein the reagent / sample placement unit uses the holder (holder 17) that holds the reagent-containing member and the sample-containing member. The gist is that the reagent-containing member and the sample-containing member are arranged apart from each other, and the sample transfer unit presses the holder to bring the reagent-containing member plane into contact with the sample-containing member plane.

  According to a fourth aspect of the present invention, there is provided a cover (cover 3, cover 210) that covers the concentration measurement unit and that opens and closes about a rotation shaft (hinge 3G, hinge 215). Further, the gist is that the specimen transfer portion is provided on the cover.

  A fifth feature of the present invention is according to the fourth feature of the present invention, further comprising a protruding member (hook 257) that moves in an orthogonal direction substantially perpendicular to a pressing direction in which the specimen transfer unit presses the holder, The gist of the invention is that the cover is provided with an insertion hole (insertion hole 210a) into which the protruding member is inserted in a state where the cover is closed.

  A sixth feature of the present invention is according to the fifth feature of the present invention, wherein the projection member is biased in the insertion direction into the insertion hole, is engaged with the projection member, and has a rotating shaft (rotation). A projecting member moving lever (lever 253) that moves the projecting member in a direction opposite to the insertion direction by rotating about a moving shaft 254), and pressing the projecting member moving lever by being pressed; The gist of the present invention is to further include a cover opening button portion (cover opening button 250 and push rod 252) for rotating the protruding member moving lever.

  The seventh feature of the present invention relates to the fourth feature of the present invention, in which the specimen transfer section presses the holder against the pressing surface (pressing surface 237pp) and the cam contact surface (facing the pressing surface). A movable member (movable member 237) having a cam contact surface 237cp) that is movable in a pressing direction for pressing the holder, and a distance from a rotation shaft (rotation shaft 234) is larger than that of other portions. A cam having a flat portion (plane portion 231p) on a part of the long outer peripheral surface, and a transfer lever (transfer lever 232) that makes the flat portion come into contact with the cam contact surface by rotating in the first direction. ), A first urging member (coil spring 233) that urges the cam to rotate in a second direction opposite to the first direction, and the movable member in the direction of the cam. A second biasing member (coil spring 239) for biasing The gist be obtained.

  An eighth feature of the present invention is according to the seventh feature of the present invention, further comprising a third biasing member (coil spring 235) for biasing the transfer lever so as to rotate in the second direction. This is the gist.

  A ninth feature of the present invention relates to the first feature of the present invention, and is a temperature detection unit (PD26 and temperature detection unit 129) that detects a sample temperature that is the temperature of the sample, the sample temperature, and the enzyme activity. A sample temperature correction data storage unit (storage unit 109) that stores sample temperature correction data associated with a correction ratio for correcting the activity value detected by the detection unit; the sample temperature; and the sample temperature correction data; The present invention further includes an activity value correction unit (CPU 101) for correcting the activity value based on the above.

  A tenth feature of the present invention relates to the ninth feature of the present invention, in which a heater (heater 260) for warming the specimen to a predetermined temperature, and that the temperature detecting section indicates that the specimen temperature has reached the predetermined temperature. If it is detected by the above, the gist is to further include a heater control unit (CPU 101) that stops the operation of the heater.

  An eleventh feature of the present invention relates to the first feature of the present invention, wherein the concentration measurement unit irradiates light at a substantially right angle with respect to the reagent-containing member plane and reflects it from the reagent-containing member plane. The gist is to measure the concentration by measuring light from an oblique direction with respect to the reagent-containing member plane.

  A twelfth feature of the present invention relates to the eleventh feature of the present invention, and is summarized in that the concentration measuring unit receives and measures the reflected light through an optical fiber (optical fiber 25).

  A thirteenth feature of the present invention relates to the first feature of the present invention, and is summarized in that the enzyme is amylase and the specimen is saliva.

  The fourteenth feature of the present invention is that a reagent-containing member containing an enzyme activity measuring reagent for measuring the activity of an enzyme, a reagent / sample arranging step for arranging the sample apart, and an arrangement in the reagent / sample arranging step The reagent-containing member brought into contact with the specimen, a specimen transfer step for transferring a predetermined amount of the specimen to the reagent-containing member, and when a predetermined time has passed since the specimen was transferred, A concentration measuring step for measuring the color concentration of the reagent contained in the reagent-containing member; and an enzyme activity detecting step for detecting an activity value of the enzyme contained in the sample based on the concentration measured in the concentration measuring step; In the reagent / sample arrangement step, in the reagent / sample arrangement step, a reagent-containing member plane which is a plane portion of the reagent-containing member, and the sample-containing portion The specimen-containing member plane, which is a flat surface portion of the specimen-containing member plane, is arranged so as to be substantially parallel to each other, and in the specimen transfer step, the reagent-containing member plane and the specimen-containing member plane are The gist is that it is a method for measuring an enzyme activity which is brought into contact over time.

  A fifteenth feature of the present invention is a reagent / specimen in which a sheet-like reagent-containing member containing an enzyme activity measuring reagent for measuring enzyme activity and a sheet-like specimen-containing member containing a specimen are arranged separately An arrangement unit; and a sample transfer unit that brings the sample into contact with the reagent-containing member arranged by the reagent / sample arrangement unit and transfers a predetermined amount of the sample to the reagent-containing member. The specimen transferring section is arranged so that the reagent containing member plane which is a plane portion of the reagent containing member and the specimen containing member plane which is a plane portion of the specimen containing member are opposed to each other so as to be substantially parallel. However, the gist of the invention is that it is a specimen transfer device that brings the reagent-containing member plane and the specimen-containing member plane into contact with each other at a predetermined pressure for a predetermined time.

  The sixteenth feature of the present invention is that the reagent is irradiated with light at a substantially right angle to the plane of the reagent-containing member which is a plane portion of the sheet-like reagent-containing member containing an enzyme activity measuring reagent for measuring the activity of the enzyme. It is a color measuring device including a concentration measuring unit that measures the density of the color of the reagent-containing member by measuring reflected light reflected from the containing member plane from an oblique direction with respect to the reagent-containing member plane. And

  A seventeenth feature of the present invention relates to the sixteenth feature of the present invention, and is summarized in that the concentration measuring unit receives and measures the reflected light through an optical fiber.

  According to the characteristics of the present invention, an enzyme activity measuring apparatus and enzyme capable of measuring the enzyme activity value more accurately when measuring the enzyme activity value using an enzyme activity measuring reagent for measuring the enzyme activity An activity measurement method, a sample transfer device, and a color measurement device can be provided.

[First Embodiment]
A first embodiment of an enzyme activity measuring apparatus according to the present invention will be described. FIG. 1 is a perspective view showing a schematic configuration of an enzyme activity measuring apparatus 1 according to the first embodiment of the present invention. FIG. 2 is a perspective view of the enzyme activity measuring apparatus 1 from the direction F2 shown in FIG.

  1 shows a state in which the cover 3 is open, and FIG. 2 shows a state in which the cover 3 is closed.

  The enzyme activity measuring apparatus 1 measures enzyme activity using an enzyme activity measuring reagent. In the following description, saliva (human saliva) is used as an example of a sample, and amylase is used as an example of an enzyme. However, the present invention is not limited to saliva or amylase.

  The enzyme activity measuring apparatus 1 includes a reagent / sample arranging unit 5 that separates and arranges a reagent-containing member 13 containing an amylase activity measuring reagent, which is one of enzyme activity measuring reagents, and a saliva collection sheet 15 containing saliva. I have.

  In addition, the enzyme activity measuring apparatus 1 includes a specimen transfer unit 7 that brings the reagent-containing member 13 and saliva (saliva collection sheet 15) arranged into contact with each other and transfers a predetermined amount of saliva to the reagent-containing member 13. .

  Furthermore, the enzyme activity measuring device 1 includes a concentration measuring unit 9 that measures the concentration of the color of the reagent contained in the reagent-containing member 13 when a predetermined time has elapsed since the saliva was transferred. The detected amylase activity value is displayed on the LCD panel 117A (see FIG. 2).

  Here, amylase will be described. Typical amylases include α-amylases that are secreted mainly from human salivary glands and pancreatic glands. Amylase is a digestive enzyme having a molecular weight of 54,000 to 62,000 that hydrolyzes polysaccharides such as starch and amylose.

  It is known that the activity value of amylase in saliva varies greatly depending on physical condition and varies greatly among individuals. The normal value is about tens of thousands IL / U, but depending on the physical condition and constitution, even a healthy person may exceed 100,000 IL / U.

  A modified oligosaccharide is used as a reagent substrate for measuring the activity value of amylase used in the present embodiment. The term “modification” means that an identification labeling compound is bound to the terminal or reducing terminal of the oligosaccharide, and can be released by amylase or a conjugate enzyme. The number of sugars of the modified oligosaccharide is G2 to G7, preferably G2 to G5.

  As the modifying compound, what is called a chromogen can generally be used. Examples of suitable groups include 4-nitrophenol (PNP), 2-chloro-4-nitrophenol (CNP), and 2,4-dichloro. There is phenol (Cl2P).

  Specific examples of the modified oligosaccharide modified with such a chromogen include 2-chloro-4-nitrophenol-4-O-β-D-galactopyranosyl maltoside (hereinafter referred to as GAL-G2-CNP). , GAL-G-4-CNP, GAL-G5-CNP, G5-CNP (2-chloro-4-nitrophenyl-maltopentaose), G7-CNP, G5-PNP (p-nitrophenyl-maltopentaose) G6-CNP (2-chloro-p-nitrophenyl maltotetraose) and G7-PNP.

Among these modified oligosaccharides, GAL2-G2-CNP, GAL-G4-CNP, and the like, in which the cleavage site upon hydrolysis with amylase is limited to one site, are particularly preferable. The modified oligosaccharide is represented by the following general formula.

  R1 and R2 in the formula each represent a hydrogen atom or a protecting group. The protecting group is not particularly limited, but is an unsubstituted or substituted lower alkyl group, lower alkoxyl group or phenyl group, azide group, halogen atom, N-monoalkylcarbamoyloxy group, alkyl or arylsulfonyloxy group or alkyl. An oxy group, an α-glucosyl group, an α-maltosyl group, a β-galactosyl group, and the like. R1 and R2 may be cross-linked with each other, and this cross-linking group may further have a substituent.

  R3 is a signal generating group, for example, a group capable of optically detecting a signal (preferably a chromogenic aromatic group), and n is 0-5. In the above formula, -OR3 is a group in which β- is bonded to a part of the reducing terminal glucose, but α- may be bonded.

  In the amylase activity measurement reagent (reagent-containing member 13) according to the present embodiment, the substrate is supported on a support (reagent paper such as filter paper).

  “Supported on a support” means a state in which a substrate and a competitive inhibitor are immobilized or trapped on a water-insoluble organic or inorganic carrier. The shape of the support is preferably a thin film, and the thickness of the support pair is 100 μm to 500 μm, preferably 150 μm to 400 μm.

  The thin film is preferably white. The material of the thin film is preferably nitrocellulose, porous glass, or paper, but is not limited thereto, and can be widely used as long as it can efficiently carry the above-described substrate. In this embodiment, even when the reagent is supported on a support of a material other than paper (such as nitrocellulose described above), it is appropriately described as “reagent paper”. Other materials are also included.

  The amount of the modified oligosaccharide supported by the support is preferably adjusted to be constant. As a simple method, there is a method obtained by impregnating a support with a modified oligosaccharide substrate in a solution containing 2 to 500 mmol / L for about 1 to 5 minutes and drying it.

  In the measurement of the activity value of amylase in this embodiment, the activity value of amylase is determined based on the change in absorbance due to the color development of the reagent support due to the release of chromogens such as CNP and PNP which are substrate modifiers. The For example, CNP is measured at an absorbance of 405 nm.

  Usually, this chromogen release is possible only by the action of a large excess of amylase. In addition, a conjugated enzyme method including a reaction of liberating a chromogen by amylase, α-glucosidase, β-glucosidase, or the like after the hydrolysis reaction of amylase is used as necessary. In this case, it is necessary to introduce means for adding an additional enzyme as a reagent. In order to accelerate the reaction, a known α-amylase activator may be used.

  The reaction temperature in the measurement is not particularly limited, but is preferably about 25 to 40 degrees Celsius. The reaction time is from 1 to 10 minutes, but depends on the type of substrate and conjugate enzyme.

  An LED 21 and a photodiode 23, which will be described later, are used for measurement of changes due to color development, and changes in absorbance due to color development of the support can be measured by reflected light or transmitted light.

  As a light source for measurement, a laser, a halogen lamp, a tungsten lamp, or the like can be used in addition to a light emitting diode (LED 21 shown in FIG. 5). The light source is not limited to these.

  The reagent containing member 13 is a sheet-like member. Moreover, the saliva collection sheet | seat 15 is also comprised by the sheet-like member (for example, nonwoven fabric).

  The reagent / sample placement unit 5 includes a planar portion 13A (reagent-containing member plane) that is a planar portion of the reagent-containing member 13 and a planar portion 15A (sample-containing member) that is a planar portion of the saliva collection sheet 15 containing saliva. The flat surface is arranged so as to be substantially parallel to each other.

  In addition, the reagent / specimen placement unit 5 uses the holder 17 that holds the reagent-containing member 13 and the saliva collecting sheet 15 containing the sample (saliva), and the reagent-containing member 13 and the saliva collecting sheet 15 containing the sample, Place them apart.

  The specimen transfer unit 7 is configured to bring the planar part 13A of the reagent-containing member 13 and the planar part 15A of the saliva collection sheet 15 into contact with each other at a predetermined pressure for a predetermined time.

  Specifically, the specimen transfer unit 7 presses the holder 17 with a cam 41 to be described later to bring the planar part 13A into contact with the planar part 15A. More specifically, the specimen transfer unit 7 deforms the reagent holding part 17A holding the reagent-containing member 13 and the vicinity of the reagent holding part 17A by a predetermined amount, and thereby forms the planar part 13A and the planar part 15A. To come into contact.

  Instead of the reagent holding part 17A holding the reagent-containing member 13 and the vicinity of the reagent holding part 17A, the part holding the saliva collection sheet 15 and the vicinity of the part may be deformed. That is, at least one of the reagent holding part 17A holding the reagent-containing member 13 or the part (including the vicinity) holding the saliva collection sheet 15 is deformed by a predetermined amount, and the planar part 13A and the planar part 15A are deformed. May be brought into contact with each other.

  As described above, the concentration measurement unit 9 measures the concentration of the color of the reagent contained in the reagent-containing member 13.

  Specifically, as shown in FIG. 5, the concentration measuring unit 9 irradiates light at a substantially right angle with respect to the planar part 13A by the LED 21, and reflects the reflected light reflected from the planar part 13A to the planar part. The concentration of the color of the reagent-containing member 13 (planar portion 13A) is measured by using a photodiode 23 (hereinafter referred to as PD23) from an oblique direction with respect to 13A.

  The PD 23 receives the reflected light from the planar portion 13 </ b> A via the optical fiber 25. The enzyme activity measuring apparatus 1 includes a cover 3 that suppresses disturbance light from entering the concentration measuring unit 9. When the cover 3 is closed, the holder 17 is fixed to the pedestal 29.

  Further, the specimen transfer portion 7 is provided on the cover 3, and when the cover 3 is closed, the reagent holding portion 17A of the holder 17 can be deformed to bring the planar portion 13A and the planar portion 15A into contact with each other. It is configured as follows.

  Here, the reagent / sample placement unit 5 and the sample transfer unit 7 will be described in detail. FIG. 3 is a cross-sectional view in the F3-F3 direction shown in FIG. In the figure, the reagent-containing member 13 and the saliva collection sheet 15 are arranged by the reagent / sample arrangement unit 5. Further, in the drawing, the state in which the reagent containing member 13 and the saliva collection sheet 15 are in contact with each other by the specimen transfer unit 7 is shown.

  FIG. 4 is a cross-sectional view in the F4 direction shown in FIG. In FIG. 4, for easy understanding, the reagent-containing member 13, the reagent holding portion 17 </ b> A in which the reagent-containing member 13 is held, the saliva collection sheet 15, and a part of the sample transfer unit 7 are shown. Note that the reagent holding portion 17 </ b> A is provided on the inner surface side of the holder 17.

  As shown in FIG. 1, the saliva collection sheet 15 is provided on one surface of one end of a long plate-like base material 27 (for example, white synthetic resin). The holder 17 has a rectangular parallelepiped shape, and is configured so that the base material 27 can be inserted into the holder 17.

  The reagent holding portion 17A for holding the reagent-containing member 13 is located on the upper surface of the holder 17, and the reagent holding portion 17A functions as a leaf spring by a notch 17B extending substantially parallel to the longitudinal direction of the holder 17. .

  Furthermore, as shown in FIG. 4, arc-shaped arc portions 17C are formed at both ends in the longitudinal direction of the reagent holding portion 17A, and the reagent holding portion 17A is configured to be easily bent.

  When the base material 27 provided with the saliva collection sheet 15 is inserted into the holder 17 from the AR1 direction (see FIG. 1), and the holder 17 is set on the pedestal 29 so that the saliva collection sheet 15 is at a position P indicated by a broken line, The reagent-containing member 13 (planar portion 13A) and the saliva collection sheet 15 (planar portion 15A) are spaced apart.

  The pedestal 29 is provided on the upper surface of the enzyme activity measuring apparatus 1, extends in the length direction of the enzyme activity measuring apparatus 1, and has a groove shape. The housing 1A of the enzyme activity measuring apparatus 1 including the pedestal 29 is made of a black synthetic resin.

  When the holder 17 is set on the pedestal 29, the bottom surface 17D of the holder 17 facing the reagent holding portion 17A and the bottom surface 29A of the pedestal 29 are in surface contact. Furthermore, the end surface 17E of the holder 17 and the end surface 29B of the pedestal 29 are in surface contact, and the side surface 17F of the holder 17 and the side surface 29C of the pedestal 29 are in surface contact.

  Further, the protrusion 17G provided on the side surface of the holder 17 and the notch 29D provided on the side surface 29C of the pedestal 29 come into contact with each other. Since the holder 17 is set on the pedestal 29 in this way, the holder 17 cannot move in a direction other than the upward direction of the enzyme activity measuring apparatus 1.

  Further, since the shape of the upper surface, the lower surface and each side surface of the holder 17 is different, the holder 17 can be easily and accurately set on the base 29. Further, the holder 17 cannot be set on the pedestal 29 except in the correct orientation, and an operation error of the user can be prevented.

  Next, the specimen transfer unit 7 will be described. As shown in FIG. 3, the specimen transfer portion 7 is engaged with a cylindrical guide portion 31 erected perpendicularly to the inner surface 3A of the box-shaped cover 3 and approaches or separates from the inner surface 3A. The movable part 33 is shaped. Note that the planar portions 33A and 33B of the movable portion 33 are substantially parallel to the inner surface 3A. In addition, the cover 3 and the movable part 33 are comprised by the black synthetic resin in this embodiment.

  Further, the inner surface 3A is provided with a columnar guide portion 35 erected perpendicularly to the inner surface 3A. A spring holding portion 37 having an outer diameter larger than the outer diameter of the guide portion 35 is provided at the distal end portion 35 </ b> A of the guide portion 35.

  Further, a coil spring 39 is provided between the spring holding portion 37 and the movable portion 33. That is, the movable portion 33 is biased by the coil spring 39 in the direction of the inner surface 3A.

  Further, the cam 41 abuts on the planar portion 33B (the inner surface 3A side) of the movable portion 33, and the movable portion 33 moves in accordance with the rotation of the cam 41. The cam 41 is rotatable about a rotation shaft 41r, and a transfer lever 41A for allowing a user to rotate the cam 41 is provided at one end of the cam 41.

  3 and 4 show a state in which the reagent-containing member 13 and the saliva collection sheet 15 are in contact with each other. On the other hand, when the cam 41 is rotated as shown by the two-dot chain line in FIG. 4 (or from the state shown by the two-dot chain line in FIG. 2 to the state shown by the solid line), the movable portion 33 of the AR 3 is moved by the coil spring 39. It moves in the direction (see FIG. 3), that is, the direction of the inner surface 3A, and the reagent-containing member 13 and the saliva collection sheet 15 are separated.

  The cam 41 is manually operated by the user of the enzyme activity measuring apparatus 1, but instead of the cam 41, a solenoid or the like that presses the holder 17 may be operated under the control of the CPU 101 described later. Moreover, in the state which the cam 41 is contacting the reagent containing member 13 and the saliva collection sheet | seat 15, the position of the cam 41 is hold | maintained and it does not rotate arbitrarily.

  The planar portion 33A of the movable portion 33 is provided with a rectangular parallelepiped transfer pad 43 (pressing member) that presses the reagent holding portion 17A. The transfer pad 43 is made of, for example, a hard member such as metal.

  The cover 3 rotates around a hinge 3G (rotating shaft, see FIG. 1). As shown in FIG. 2, the cover 3 can be closed by rotating the cover 3 around the hinge 3G. When the cover 3 is closed, the cover 3 can be fixed so as not to be opened by using the hook 45.

  When the transfer lever 41A is rotated to move the movable portion 33 in the direction of the holder 17, the reagent holding portion 17A is pushed and deformed by the transfer pad 43, and the reagent-containing member 13 and the saliva collection sheet 15 are predetermined. Contact with the pressure of.

  As shown in FIG. 1, the inner surface 3A is provided with a rib 3B. When the cover 3 is closed, the end surface 3C of the rib 3B comes into contact with the upper surface portion 17H of the holder 17, and the upper surface portion 17H is formed. Energize slightly. For this reason, the holder 17 is fixed so that it cannot move upward.

  The inner surface 3A is provided with a protrusion 3D. When the cover 3 is closed, the protrusion 3D is inserted into the hole 1B provided in the housing 1A.

  The protrusion 3D inserted into the hole 1B operates a limit switch (not shown) provided inside the housing 1A, and detects that the cover 3 is closed.

  Further, as described above, when the cover 3 is closed, the arrival of light to the pedestal 29 and the like is blocked. When the cover 3 is closed, the end surface 3E around the opening of the cover 3 comes into contact with the planar portion 1C around the pedestal 29. In the vertical position of the contacted portion and the bottom surface 29A of the pedestal 29 (specifically, the upper surface 47A of the substrate 47 provided with the PD 23, see FIG. 5), the bottom surface 29A is more than the contacted portion. Is also located on the upper side.

  The reason for this is to prevent adverse effects on the measurement due to ambient light. That is, disturbing light (sunlight or electric light) falls from the upper direction to the lower direction in a normal state. Therefore, as described above, if the bottom surface 29A is positioned above the contacted portion, It is possible to prevent adverse effects on measurement due to ambient light.

  The movable portion 33 is provided with a protrusion 33C. When the cover 3 is closed, the protrusion 33C is inserted into the hole 1D provided in the housing 1A.

  When the movable portion 33 moves to a state in which the holder 17 is pressed (the state shown in FIGS. 3 and 4), a limit switch (not shown) provided inside the housing 1A by the protrusion 33C inserted into the hole 1D. Is activated, and the transfer of saliva to the reagent-containing member 13 is detected.

  According to the specimen transfer unit 7, since the movable unit 33 and the transfer pad 43 move in parallel, a uniform load can be applied to the holder 17. Therefore, uniform saliva transfer without unevenness can be realized. Further, since the transfer lever 41A is used, it is possible to prevent an excessive load from being applied to the holder 17.

  Moreover, since the specimen transfer part 7 is provided in the cover 3, the enzyme activity measuring apparatus 1 can be reduced in size. Further, the cover 3 can easily create a dark room state, and can effectively block ambient light that causes adverse effects on the measurement.

  In addition, as described above, when measuring the color change of the reagent-containing member 13, it is necessary to precisely manage the time for which the reagent-containing member 13 is brought into contact with the saliva collection sheet 15. According to the sample transfer unit 7, since the limit switch that operates according to the operation of the movable unit 33 is provided, the time during which the reagent-containing member 13 and the saliva collection sheet 15 are in contact, that is, the saliva transfer time. Can be accurately detected.

  Further, since the transfer pad 43 is made of a hard member such as metal, the transfer pad 43 can be prevented from being worn. Further, since the transfer pad 43 is formed of a member different from the movable portion 33, it is possible to easily cope with changes in specifications such as the shape, material, and hardness of the transfer pad 43.

  Furthermore, since saliva can be transferred only by rotating the transfer lever 41A, it is possible to realize easier and more reliable transfer of saliva compared to the prior art.

  Next, the concentration measuring unit 9 will be described in detail. FIG. 5 is a schematic cross-sectional view of the concentration measuring unit 9.

  As described above, the concentration measuring unit 9 measures the color concentration of the reagent-containing member 13 (planar portion 13A).

  The concentration measurement unit 9 measures the color concentration of the reagent-containing member 13 (planar portion 13A) when a predetermined time has elapsed since the transfer of saliva was started by the sample transfer unit 7.

  Further, the substrate 27 is removed from the holder 17 when the density measuring unit 9 measures the color density. That is, nothing is interposed between the LED 21 (optical fiber 25) and the PD 23 and the reagent-containing member 13 (planar portion 13A). In addition, as shown in FIG. 2, the base material 27 can be extracted through the notch part 3F provided in the cover 3, even if the cover 3 is closed.

  The LED 21, the PD 23, and the optical fiber 25 are provided on a substrate 47 made of black synthetic resin, and the upper surface 47 A of the substrate 47 is positioned at substantially the same height as the bottom surface 29 A of the pedestal 29. Further, the upper surface 47A and the planar portion 13A are arranged so as to be substantially parallel.

  Further, a straight line CL1 connecting the LED 21 and the central portion of the planar portion 13A is substantially perpendicular to the planar portion 13A, and a straight line CL3 connecting the PD 23 and the central portion of the planar portion 13A is a planar portion 13A. Is slanted.

  When the reflected light from the planar portion 13A is measured by the PD 23, the angle (angle θ) between the reagent-containing member 13 (test paper) and the coloring portion (planar portion 13A) is 0 to 50 degrees, preferably 10 to 10 degrees. It is 45 degrees, more preferably 10 to 30 degrees.

  The distance between the planar portion 13A and the PD 23 is 10 to 30 mm, preferably 15 to 25 mm, and more preferably 18 to 22 mm. Furthermore, the reagent spot diameter (the diameter of the portion irradiated with light) is 1 mm to 5 mm, preferably 2 mm to 4 mm, more preferably 2.5 mm to 3.5 mm.

  The concentration measurement unit 9 measures the color concentration of the reagent-containing member 13, but if the degree of reaction of the reagent contained in the reagent-containing member 13 (reagent concentration) can be detected, Other methods may be used.

  Next, the decomposition of the reagent substrate by amylase will be described. FIG. 6 is a graph showing the relationship between the degree of enzyme reaction and the elapsed time when the substrate and amylase are in contact with each other. Here, a graph G1 shown in the figure shows a case where the amylase activity is low, and a graph G3 shows a case where the amylase activity is moderate. Graph G5 shows a case where amylase activity is high.

  As shown in the figure, the higher the amylase activity, the faster the enzyme reaction proceeds. The enzyme reaction is performed until the substrate is not degraded. As the enzyme reaction is performed, the reagent-containing member 13 is colored so that the yellow color becomes deeper.

  FIG. 7 is a graph showing the relationship between the output voltage converted based on the reflected light detected by the PD 23 and the elapsed time. Graph G7 shown in FIG. 7 shows a case where the activity of amylase is low, and graph G9 shows a case where the activity of amylase is medium. Graph G11 shows a case where amylase activity is high.

  FIG. 8 is a graph showing the relationship between the substrate concentration and the elapsed time when the substrate and amylase are in contact. A graph G13 shown in FIG. 8 shows a case where the activity of amylase is low, and a graph G15 shows a case where the activity of amylase is moderate. Graph G17 shows a case where amylase activity is high.

  As shown in FIG. 8, when the amylase activity is higher, more enzyme reactions occur in a shorter time, and the concentration of the substrate decreases.

  As described above, the enzyme reaction (decomposition reaction of the substrate by amylase) starts from the time when the saliva collection sheet 15 containing saliva and the reagent-containing member 13 (test paper) come into contact with each other. While saliva infiltrates from the saliva collection sheet 15 to the entire reagent-containing member 13 (test paper), the reaction proceeds at the contact surface portion. Since the time point at which the enzyme reaction starts is a reference for measuring the color concentration of the reagent-containing member 13, the time point can be accurately detected as described above.

  Note that the time required for the saliva transfer may be a time that allows the saliva contained in the saliva collection sheet 15 to infiltrate the entire reagent-containing member 13 (test paper). However, if the transfer is continued more than necessary, the dissolved substrate is reversely transferred to the saliva collection sheet 15 and causes a measurement error. Therefore, it is preferable to complete the transfer at an appropriate time.

  As described above, the saliva transfer is terminated by rotating the transfer lever 41A from the position indicated by the two-dot chain line to the position indicated by the solid line (see FIG. 2). In other words, the saliva transfer is terminated by a simple operation of returning the transfer lever 41A.

  By returning the transfer lever 41A, the planar portion 13A and the planar portion 15A are separated from each other, and the transfer of saliva is completed.

  The user manually returns the transfer lever 41A, but the timing for returning the transfer lever 41A is notified to the user by, for example, sounding a buzzer provided in the enzyme activity measuring apparatus 1. The Note that the timing for sounding the buzzer is set when a predetermined time (for example, 10 seconds) elapses after the limit switch is operated by the protrusion 33C.

  When the transfer of the saliva is completed, the user removes the base material 27 from the enzyme activity measuring apparatus 1 and the measurement by the concentration measuring unit 9 is performed without delay.

  As described above, the measurement of the amylase activity value must be performed before the enzymatic reaction is completed. In addition, the measured value varies depending on the elapsed time from the start time of the enzyme reaction. Therefore, the elapsed time from the start of saliva transfer is measured by a real-time clock IC (CPU 101 shown in FIG. 9), and when a preset time has elapsed, the measurement is automatically performed.

  According to the enzyme activity measuring apparatus 1 according to the present embodiment described above, the following actions and effects can be obtained.

  First, manual transfer and transfer cancellation operations that do not require such high accuracy can reduce the number of parts of the specimen transfer unit 7 and simplify the configuration.

  Further, by measuring the saliva transfer time using the CPU 101, it is possible to accurately manage the elapsed time from the start of saliva transfer. Further, since the buzzer sounds when a predetermined time has elapsed, it is possible to prevent the saliva transfer from being continued more than necessary.

  Next, the color development of the reagent contained in the reagent-containing member 13 will be described in detail. The coloring of the reagent is that the concentration of the coloring substance is increased by the enzyme reaction, but it is generally difficult to quantitatively grasp the degree of coloring with the naked eye.

  Therefore, in order to quantify the degree of color development, the reagent-containing member 13 (test paper) is irradiated from the LED 21 with light having a wavelength corresponding to the wavelength of the color to be developed, and the reflected light of the irradiated light or the brightness of the scattered light Is measured by the PD 23.

  As described above, the LED 21, the PD 23, and the optical fiber 25 are all attached to the substrate 47. In the present embodiment, a diode having a peak wavelength of 430 nm is used as the LED 21, and a photodiode having sensitivity at a wavelength of 430 to 450 nm is used as the PD 23.

  As the optical fiber 25, a single-core sensor optical fiber is used. Furthermore, the bottom 29A of the pedestal 29 and the substrate 47 are colored matte black.

  The light emitted from the LED 21 is narrowed to a predetermined spot diameter by a diaphragm (not shown), and the narrowed light is irradiated to the reagent-containing member 13 (planar part 13A). Here, the irradiated light is transmitted, scattered, or reflected, and a part of the light reaches the PD 23 via the optical fiber 25. The PD 23 outputs a voltage (specifically, a voltage value converted based on the current value output from the PD 23) according to the illuminance of the light that has reached through the optical fiber 25 as shown in FIG. .

  Further, since the bottom surface 29A and the substrate 47 are colored in matte black, irregular reflection of light leaking from the LED 21 or light entering the LED 21 is prevented. Furthermore, by adjusting the spot diameter to the size of the reagent-containing member 13 (planar portion 13A), it is possible to prevent light from being irradiated to portions other than the planar portion 13A, and to reduce irregular reflection that causes an error.

  Further, by defocusing the light emitted from the LED 21, the planar portion 13A can be uniformly irradiated, and the color density of the planar portion 13A (reagent) can be stably measured.

  Further, the absorbance of the colored reagent color changes most markedly in the wavelength band of 420 to 450 nm. For this reason, by using the LED 21 matched with the wavelength, it is possible to detect the color density (degree of color development) of the reagent that has developed with high sensitivity.

  Furthermore, by using the PD 23 having sensitivity at 430 to 450 nm, it is possible to reduce the influence of extraneous disturbance light and obtain an output voltage with a good S / N ratio.

  Moreover, since the optical fiber 25 is used, attenuation of reflected light can be suppressed, and highly sensitive illuminance can be detected. Furthermore, since the reagent-containing member 13 and the PD 23 are not in the same atmosphere (that is, separated), the influence of moisture (humidity due to saliva) on the interference filter (not shown) of the PD 23 can be reduced.

  Moreover, since LED21 and PD23 are attached on the same surface of the board | substrate 47, the board | substrate 47 (concentration measurement part 9) can be assembled efficiently.

  Next, an operation for displaying the measurement result of the activity value of amylase will be described. The illuminance of light measured by the concentration measuring unit 9 is output as the current value of the PD 23. Therefore, it is necessary to convert the current value into an amylase activity value.

  Therefore, the electronic circuit board mounted on the enzyme activity measuring apparatus 1 has a function of storing a calibration curve and converting it into an amylase activity value or a target index.

  The electronic circuit board has a function of guiding a measurement procedure and a function of a real time clock.

  FIG. 9 shows a block configuration of the CPU substrate 100, and FIG. 10 shows a block configuration of the sensor substrate 121. The CPU 101 incorporates a 256 kB flash ROM and supports program rewriting. The oscillation unit 103 supplies a clock signal to the CPU 101. In the present embodiment, the CPU 101 constitutes an enzyme activity detection unit that detects the activity value of amylase contained in saliva.

  The communication unit 105 includes an RS232C driver or the like, and is used for outputting measurement data or downloading a rewriting program. The clock unit 107 is composed of a real-time clock IC and generates an accurate timing signal.

  The storage unit 109 can store data related to measurement time and measurement results, and can output the data as required. The buzzer output unit 111 is a circuit that generates an audible sound when an error occurs or when the user is prompted to perform an operation (for example, an operation to end saliva transfer).

  The power supply unit 113 is configured by a circuit that converts the voltage of a battery loaded in the housing 1A into a desired voltage and supplies the voltage to the CPU 101 or the like. The backup power supply unit 115 is used for backing up data stored in the storage unit 109 or the clock unit 107.

  The liquid crystal display unit 117 displays an operation menu, operation guidance, measurement results, and the like. The switch unit 119 includes a power switch, a cursor switch, and the like, and a circuit that detects the operation of the switch.

  As shown in FIG. 10, the sensor substrate 121 includes a reference voltage generation unit 123 that generates a reference voltage used in AD conversion, an LED drive unit 125 that supplies a constant current to the LED 21, and a current value output by the PD 23. It comprises a PD amplifier unit 127 that converts to a voltage value and amplifies it, and a temperature detection unit 129.

  In addition, the sensor substrate 121 is provided with a switch operation detection unit 131 that detects the operation of a cover switch (a limit switch operated by the protrusion 3D) and a transfer start switch (a limit switch operated by the protrusion 33C).

  Next, the operation | movement which measures the activity value of amylase using the enzyme activity measuring apparatus 1 is demonstrated.

  As described above, the enzyme activity measuring apparatus 1 places the reagent-containing member 13 and the saliva collection sheet 15 containing saliva apart from each other. Next, the enzyme activity measuring apparatus 1 makes the reagent-containing member 13 and the saliva collection sheet 15 arranged in contact with each other to transfer a predetermined amount of saliva to the reagent-containing member 13.

  Furthermore, the enzyme activity measuring apparatus 1 measures the concentration of the reagent (color concentration) in the reagent-containing member 13 when a predetermined time has elapsed since the start of saliva transfer, and based on the measured concentration. Then, the activity value of amylase contained in saliva is calculated.

  FIGS. 11 to 13 show an operation of measuring the activity value of amylase using the enzyme activity measuring apparatus 1.

  First, in step S1, the user turns on the power switch of the enzyme activity measuring apparatus 1.

  When the power switch is turned on, the LED 21 provided on the substrate 47 is turned on in step S3. In step S5, the CPU 101 is initialized. In step S7, an error check is performed on the backed up data.

  In step S9, the title is displayed on the LCD panel 117A, and in step S11, an operation menu is displayed.

  Next, in step S13, the operating state of the cover switch is detected, and in step S15, it is determined whether or not the cover 3 is open. When it is detected that the cover 3 is closed (Yes in Step S15), in Step S17, the characters “OPEN COVER” are displayed on the LCD panel 117A, and the process returns to Step S13.

  On the other hand, if it is detected that the cover 3 is open (No in step S15), the characters “SET UNIT CLOSE CLOSE” are displayed on the LCD panel 117A in step S19, and the cover 3 is closed in step S21. It is detected whether or not.

  In response to the display of “SET UNIT COVER CLOSE”, the user inserts the base material 27 provided with the saliva collection sheet 15 into the holder 17, and inserts the holder 17 with the base material 27 into the pedestal 29. Set to a predetermined position. Next, the user closes the cover 3 and uses the hook 45 to fix the cover 3.

  When the cover 3 is closed (Yes in step S21), in steps S23 and S25, the characters “CALIBRATING” are displayed on the LCD panel 117A, and the enzyme activity measuring apparatus 1 has a stable output (for example, 3 seconds). Wait until.

  In step S27, the enzyme activity measuring apparatus 1 irradiates the white portion of the base material 27 (the back side of the portion where the saliva collection sheet 15 is provided) with light from the LED 21, and measures the output current value of the PD 23, The current value is converted into a voltage value.

  If the voltage value is higher than 4V (No in step S29), an error character is displayed on the LCD panel 117A and a beep sound is generated in step S31.

  On the other hand, when the output voltage is 4 V or less (Yes in step S29), in step S33, the enzyme activity measuring apparatus 1 stores the measured voltage value in the storage unit 109 as a reference voltage. In step S35, the characters “PULL UP THE LEVER” are displayed on the LCD panel 117A.

  Based on the display in step S35, the user starts to transfer saliva by rotating the transfer lever 41A (rotating to a position indicated by a two-dot chain line in FIG. 2).

  In steps S37 and S39, the enzyme activity measuring apparatus 1 detects whether or not saliva transfer has started (and whether or not saliva transfer is in progress) by a limit switch operated by the protrusion 33C.

  When the transfer lever 41A is not rotated, that is, when the start of saliva transfer cannot be detected (No in step S39), the enzyme activity measuring apparatus 1 repeats the processing from step S35.

  On the other hand, when the start of saliva transcription is detected (Yes in step S39), in step S41, the enzyme activity measuring apparatus 1 starts measuring the transcription time (sets T0). In step S43, the characters “TRANSCRIPTING” are displayed on the LCD panel 117A.

  In step S45, the enzyme activity measuring apparatus 1 detects whether 10 seconds (T1) have elapsed since the start of transcription.

  If 10 seconds have not elapsed since the start of transcription (No in step S45), the enzyme activity measuring apparatus 1 repeats the processing from step S43.

  On the other hand, if 10 seconds have elapsed from the start of transfer (Yes in step S45), a beep sound is generated in step S47. Further, in step S49, the characters “PUSH RELEASE BUTTON SLIDE THE SHEET” are displayed on the LCD panel 117A.

  In response to the beep sound in step S47 and the display in step S49, the user rotates the transfer lever 41A and removes the base material 27 from the holder 17 (enzyme activity measuring device 1) to complete the saliva transfer. .

  In steps S51 and S53, the enzyme activity measuring apparatus 1 starts measurement. That is, the enzyme activity measuring apparatus 1 emits the LED 21 to irradiate the reagent-containing member 13 and measures reflected light by the PD 23.

  In step S <b> 55, the enzyme activity measuring apparatus 1 stores data relating to the measured reflected light in the storage unit 109.

  In step S57, the enzyme activity measuring apparatus 1 detects whether or not the transfer lever 41A has returned to the position indicated by the solid line in FIG. If the transfer lever 41A has not returned (No in step S57), in step S61, the characters “PUSH RELEASE BUTTON SLIDE THE SHEEET” are displayed on the LCD panel 117A.

  On the other hand, when it is detected that the transfer lever 41A has returned to the position indicated by the solid line in FIG. 2 (Yes in step S57), in step S59, the measured value (amylase activity value) based on the measurement by the PD 23 is displayed on the LCD panel 117A. ) And the voltage value are displayed.

  In step S63, the enzyme activity measuring apparatus 1 determines whether or not a predetermined time (T2) has elapsed since the time when saliva transfer was started (time T0).

  If the predetermined time has not elapsed (No in step S63), the enzyme activity measuring apparatus 1 repeats the processing from step S53.

  On the other hand, if the predetermined time has elapsed (Yes in step S63), a beep sound is generated in step S65, and the characters “MEASURE COMPLETE” are displayed on the LCD panel 117A in step S67.

  In step S69, a list of measurement data is displayed on the LCD panel 117A. The measurement data is data relating to the activity value of amylase, and the reagent concentration (color concentration or color development) calculated based on the voltage value measured in step S27 and the voltage value measured in step S53. Data).

  In step S71, the enzyme activity measuring apparatus 1 detects whether or not a MODE button (not shown) is pressed. If the MODE button is pressed, the operation menu is displayed again on the LCD panel 117A in step S73.

(Action / Effect)
According to the enzyme activity measuring apparatus 1 according to the first embodiment of the present invention described above, a predetermined amount of saliva can be accurately transferred to the reagent-containing member 13, and a predetermined time has elapsed since the saliva was transferred. Since the reagent concentration (the degree of color development of the reagent) in the reagent-containing member 13 is measured when the time has elapsed, the activity value of amylase contained in saliva can be accurately detected.

  Further, according to the enzyme activity measuring apparatus 1, the planar portion 13A of the reagent-containing member 13 and the planar portion 15A of the saliva collection sheet 15 are disposed so as to be substantially parallel to each other, and the planar portion 13A Since the planar portion 15A is brought into contact with the planar portion at a predetermined pressure for a predetermined time, the amount of saliva transferred to the reagent-containing member 13 can be made substantially constant.

  Further, according to the enzyme activity measuring apparatus 1, the reagent-containing member 13 and the saliva collection sheet 15 are spaced apart by using the holder 17. Furthermore, since saliva is transferred by deforming the holder 17 by a predetermined amount, the operation of transferring saliva, that is, the operation of measuring the activity value of amylase is simplified.

  Furthermore, according to the enzyme activity measuring apparatus 1, since the concentration of the reagent contained in the reagent-containing member 13 can be detected by measuring the color concentration of the reagent, the concentration of the reagent can be easily measured. it can.

  Moreover, according to the enzyme activity measuring apparatus 1, since the cover 3 which can be opened and closed which suppresses that a disturbance light penetrate | invades into the density | concentration measuring part 9 is provided, when the cover 3 is open, the enzyme activity measuring apparatus 1 The reagent-containing member 13 and the holder 17 can be easily set.

  Furthermore, when the cover 3 is closed, the ambient light can be blocked and the color of the reagent-containing member 13 can be accurately detected. Moreover, since the cover 3 is a form which fixes the holder 17, the structure of the enzyme activity measuring apparatus 1 is simple.

  Further, according to the concentration measuring unit 9 of the enzyme activity measuring apparatus 1, the LED 21 uniformly irradiates the reagent-containing member 13 with light, and the PD 23 receives reflected light from the oblique direction with respect to the reagent-containing member 13. For this reason, the PD 23 can receive the averaged stable reflected light, and can accurately measure the color of the reagent-containing member 13.

  Further, according to the concentration measuring unit 9 of the enzyme activity measuring apparatus 1, since the PD 23 receives and measures the reflected light via the optical fiber 25, the installation position of the PD 23 can be set flexibly. Furthermore, since a filter (not shown) provided at the tip of the PD 23 can be provided separately from the reagent-containing member 13, damage to the moisture-sensitive filter is avoided.

  In addition, according to the enzyme activity measuring apparatus 1, since saliva is used as a sample, it is easier to collect a sample (for example, without causing pain to the subject) than when blood or urine is used as a sample. can do.

  Furthermore, according to the enzyme activity measuring apparatus 1 that makes it possible to easily measure the activity value of amylase contained in human saliva, it is possible to provide a simple and effective means for detecting the stress level of a subject. .

  Specifically, the subject (user) measures the activity value of amylase contained in saliva collected at rest, and stores the measured activity value as a reference value in the enzyme activity measuring apparatus 1.

  Thereafter, the subject measures the activity value of amylase in a predetermined state (for example, a state under stress), and compares the measured activity value with a reference value. If the measured activity value is larger than the reference value, it can be determined that the stress is unpleasant, and if the activity value is small, it can be determined that the stress is comfortable.

  Further, it can be determined that the greater the difference between the reference value and the measured activity value, the greater the stress being received, and the degree of stress being physically or mentally received can also be determined.

  Furthermore, by continuously measuring the activity value of amylase, changes in stress over time can be captured. When an unpleasant stress is applied, the activity value of amylase contained in saliva increases. In this case, the degree of the magnitude of the stress can be determined based on the magnitude of the positive time gradient.

  On the other hand, when comfortable stress is applied, the activity value of amylase decreases. Therefore, the degree of the amount of estre can also be determined by the magnitude of the negative time gradient.

  Furthermore, by measuring the activity value of amylase continuously, the change in the activity value of amylase before and after applying a specific stress to the subject is captured, and the time to return to the activity value (reference value) before applying the stress -It is also possible to determine the degree of stress from the magnitude of change.

[Second Embodiment]
(Schematic configuration of enzyme activity measuring device)
Next, a second embodiment of the enzyme activity measuring apparatus according to the present invention will be described. FIG. 14 is a perspective view of an enzyme activity measuring apparatus 200 according to the second embodiment of the present invention. The enzyme activity measuring apparatus 200 is an improvement of the enzyme activity measuring apparatus 1 according to the first embodiment of the present invention described above.

  Therefore, the following description will mainly focus on the differences from the enzyme activity measuring apparatus 1, and the description of the same configuration and function as those of the enzyme activity measuring apparatus 1 will be omitted as appropriate.

  As shown in FIG. 14, a cover opening button 250, an LCD panel 270, and a switch unit 280 are provided on the surface of the housing 220 of the enzyme activity measuring apparatus 200. The enzyme activity measuring apparatus 200 operates by connecting four AAA batteries or an AC power source loaded therein.

  The LCD panel 270 has the same function as the LCD panel 117A (see FIG. 2) of the enzyme activity measuring apparatus 1 described above. Moreover, the switch part 280 is connected to CPU101 similarly to the switch part 119 (refer FIG. 9) of the enzyme activity measuring apparatus 1. FIG.

  In addition, the cover 210 of the enzyme activity measuring apparatus 200 has a specimen that presses a holder 17 (see FIG. 1) that can be set on a pedestal 229 (not shown in FIG. 14, see FIG. 16) provided in the housing 220. A transfer unit 230 is provided.

  FIG. 15 is a plan view of the enzyme activity measuring apparatus 200. As shown in FIG. 15, the cover 210 is configured to open and close about a hinge 215 (rotating shaft). FIG. 16 shows a state where the cover 210 is opened around the hinge 215.

  As shown in FIG. 16, the sample transfer unit 230 according to the present embodiment is provided on the cover 210. In addition, the sample transfer unit 230 is provided with a metal transfer pad 240 (pressing member) that presses the holder 17 set on the base 229 constituting the reagent / sample arranging unit according to the present embodiment. The base 229 has the same shape as the base 29 of the enzyme activity measuring apparatus 1 described above. Furthermore, in the present embodiment, a heater 260 is provided below the pedestal 229 to warm the specimen held by the holder 17 set on the pedestal 229 to a predetermined temperature (for example, 20 degrees Celsius).

  The enzyme activity measuring apparatus 200 (housing 220) is provided with a pair of hooks 257 (end portions 257e). Further, the cover 210 is provided with a pair of insertion holes 210a into which the hooks 257 are inserted in a state where the cover 210 is closed.

  The hook 257 is biased in the direction of insertion into the insertion hole 210a, and is configured to be pulled in the direction inside the housing 220 when the cover release button 250 is pressed. That is, the cover 210 is fixed by the hook 257 in a closed state.

  Further, when the cover 210 is closed, the upper end portion 210te of the cover 210 is configured to contact the upper end portion 225te of the inner cover 225. Similarly, the lower end portion 210be of the cover 210 is configured to contact the lower end portion 225be of the inner cover 225.

(Cover opening / closing mechanism)
Next, a cover opening / closing mechanism provided in the enzyme activity measuring apparatus 200 will be described with reference to FIGS. 17 and 18. 17 is a cross-sectional view in the direction F17-F17 shown in FIG. FIG. 18 is an explanatory diagram for explaining the operation of the cover opening / closing mechanism.

  As shown in the figure, the housing 220 is provided with a cover release button 250, a coil spring 251, a push rod 252, a lever 253, a rotating shaft 254, a connecting pin 255, a support shaft 256, and a hook 257.

  The cover release button 250 is a button that is pressed when the cover 210 is opened. That is, when the holder 17 into which the saliva collection sheet 15 is inserted is set on the pedestal 229, or when the holder 17 whose measurement has been completed is removed from the pedestal 229, the cover release button 250 is pressed.

  The cover release button 250 is connected to a push rod 252 inserted through the coil spring 251, and when pressed, presses the lever 253 to rotate the lever 253. In the present embodiment, the cover opening button 250 and the push rod 252 constitute a cover opening button portion.

  Further, as shown in the figure, the upper end portion 210te of the cover 210 is convex, and the upper end portion 225te of the inner cover 225 is concave. That is, the convex upper end portion 210te is configured to fit into the concave upper end portion 225te.

Furthermore, the lower end 225be of the inner cover 225 is slightly raised from the housing 220,
The cover 210 is configured to come into contact with the lower end portion 210be of the cover 210.

  The lever 253 is engaged with the hook 257 and rotates about the rotation shaft 254. The lever 253 moves the hook 257 in the insertion direction of the insertion hole 210a and in the direction opposite to the insertion direction. In the present embodiment, the lever 253 constitutes a protruding member moving lever.

  A connecting pin 255 that connects the lever 253 and the hook 257 is inserted through the upper edge of the lever 253. The lever 253 urges the hook 257 in the insertion direction of the insertion hole 210a by a spring provided inside. In this embodiment, in order to ensure strength, the rotation shaft 254, the support shaft 256, and the hook 257 are made of metal.

  The hook 257 is supported by a support shaft 256 so that in a state where the cover 210 is closed, the specimen transfer unit 230 can move in an orthogonal direction substantially orthogonal to the direction of AR10 (pressing direction) pressing the holder 17. It is configured.

  Specifically, as shown in FIG. 18, when the cover release button 250 is pressed in the direction of AR11, the lever 253 rotates about the rotation shaft 254 in the direction of AR12. Further, the hook 257 connected to the lever 253 by the connecting pin 255 is moved in the AR13 direction (the direction opposite to the insertion direction of the insertion hole 210a).

  When the hook 257 is moved in the direction of AR13, the end portion 257e of the hook 257 is pulled out from the insertion hole 210a. When the hook 257 is pulled out from the insertion hole 210a, the cover 210 is rotated in the direction of AR14 by a spring provided inside the hinge 215.

(Sample transfer part)
Next, with reference to FIG. 19 and FIG. 20, the specimen transfer unit 230 provided in the enzyme activity measuring apparatus 200 will be described. FIG. 19 is a side view of the sample transfer unit 230 viewed from the F19 direction shown in FIG. FIG. 20 is an explanatory diagram for explaining the operation of the specimen transfer unit 230.

  As shown in the figure, the sample transfer unit 230 includes a cam 231, a transfer lever 232, a movable member 237, a transfer pad 240, and a base plate 241. The sample transfer unit 230 is assembled as a unit, and the assembled sample transfer unit 230 is attached to the cover 210 using screws.

  The movable member 237 has a pressing surface 237pp that is joined to the transfer pad 240 that presses the holder 17 that holds the reagent-containing member 13 and the saliva collection sheet 15, and a cam contact surface 237cp that faces the pressing surface 237pp. It is configured to be movable along a pressing direction for pressing the holder 17.

  The cam 231 is a cam that rotates about the rotation shaft 234, and has a flat surface portion 231p on a part of the outer peripheral surface that is longer than the other portions by the distance from the rotation shaft 234.

  As shown in FIG. 20, the transfer lever 232 rotates in the direction of the AR 15 (first direction) to bring the flat surface portion 231p of the cam 231 into contact with the cam contact surface 237cp of the movable member 237. is there.

  Specifically, the transfer lever 232 is configured to be rotatable about a rotation shaft 234, as with the cam 231. When the transfer lever 232 rotates in the direction of AR15, the cam 231 adjacent to the transfer lever 232 is rotated about the rotation shaft 234, and the planar portion 231p contacts the cam contact surface 237cp of the movable member 237. .

  The guide bar 238 is attached to the base plate 241 so that the movable member 237 can move. The guide rod 238 is inserted through a coil spring 239 (second biasing member) that biases the movable member 237 in the direction of the cam 231.

  The base plate 241 has a locking projection 241a, a locking projection 241c, and a rotating shaft support portion 241e.

  The locking projection 241a is provided with a locking hole 241b, and the locking hole 241b and the locking hole 231a provided in the cam 231 are provided with the cam 231 in the AR15 direction (first direction). A coil spring 233 (first urging member) that urges to rotate in the direction of AR 17 (second direction) that is opposite to the direction is attached.

  Further, the locking projection 241c is provided with a locking hole 241d. The transfer lever 232 is placed in the direction of the AR 17 (first direction) in the locking hole 241d and the locking hole 232a provided in the transfer lever 232. A coil spring 235 (third urging member) that urges to rotate in the direction (2) is attached.

  The rotation shaft support portion 241e supports both ends of the rotation shaft 234 so as to be rotatable.

  Next, the operation of the specimen transfer unit 230 will be described with reference to FIG. When the transfer lever 232 is rotated in the direction of AR15 by the user, the cam 231 is rotated about the rotation shaft 234, and the flat portion 231p contacts the cam contact surface 237cp.

  Since the flat portion 231p is provided on the outer peripheral surface whose distance from the rotation shaft 234 is longer than that of the other portions, the movable member 237 is moved downward.

  When the movable member 237 is moved downward, the transfer pad 240 joined to the pressing surface 237pp of the movable member 237 presses the holder 17 to deform it. When the holder 17 is deformed, the reagent-containing member 13 (planar portion 13A) held by the holder 17 comes into contact with the saliva collection sheet 15 (planar portion 15A), and saliva contained in the saliva collection sheet 15 Transcription starts.

  Here, the movable member 237 (and the transfer pad 240) is loaded in the direction of the cam 231 by the reaction force of the holder 17 and the coil spring 239 that are deformed by pressing. Therefore, the flat portion 231p and the pressing surface 237pp are held in contact with each other, and the reagent-containing member 13 and the saliva collection sheet 15 are in contact with each other, that is, the “saliva transfer state”.

In other words, the transfer lever 232 is held at the position of _{P 2.} The transfer lever 232 can freely rotate from the position of P ₁ between the position of P ₃ where the end 232 e of the transfer lever 232 contacts the movable member 237.

"Transcriptional state of saliva", the user is released by pressing lightly transfer lever 232 is located in P ₂ downwards (P ₁ direction). Specifically, the transfer lever 232 is biased by the coil spring 235 so as to rotate in the direction of the AR 17. The cam 231 is biased by the coil spring 233 so as to rotate in the direction of the AR 17.

  Therefore, when the transfer lever 232 is lightly pressed, the transfer lever 232 and the cam 231 are rotated in the direction of the AR 17 to release the “saliva transfer state”.

  When the cover 210 (see FIG. 16) is not closed, the movable member 237 (and the transfer pad 240) cannot obtain a reaction force from the holder 17. The cam 231 is biased by the coil spring 233 so as to rotate in the direction of the AR 17. That is, the specimen transfer unit 230 is configured to avoid holding the planar portion 231p and the pressing surface 237pp in contact with each other when the cover 210 is not closed.

(Sample temperature compensation mechanism)
Next, the specimen temperature compensation mechanism provided in the enzyme activity measuring apparatus 200 will be described. The enzyme activity measuring apparatus 200 includes a CPU substrate 100 and a sensor substrate 121 (see FIGS. 9 and 10) that are substantially the same as those of the enzyme activity measuring apparatus 1 according to the first embodiment of the present invention described above.

  The specimen temperature compensation mechanism provided in the enzyme activity measuring apparatus 200 has (1) a function of correcting the detected amylase activity value, and (2) a function of keeping the specimen warm.

(1) Correction of amylase activity value The temperature detector 129 (see FIG. 10) of the enzyme activity measuring apparatus 200 detects the temperature of the specimen, that is, the temperature of the reagent-containing member 13 to which saliva has been transferred. is there.

  Specifically, the temperature detection unit 129 is connected to a photodiode 26 (hereinafter referred to as PD 26) that detects infrared rays.

  FIG. 21 is a schematic configuration diagram of a concentration measuring unit 9 ′ provided in the enzyme activity measuring apparatus 200. In the concentration measuring unit 9 ′, PD 26 is added to the concentration measuring unit 9 (see FIG. 5) of the enzyme activity measuring apparatus 1 described above.

  The PD 26 detects the intensity of infrared rays emitted from the reagent-containing member 13 to which saliva has been transferred. The temperature detection unit 129 connected to the PD 26 detects the specimen temperature by calculating the radiation temperature of the reagent-containing member 13 based on the detected infrared intensity.

  The storage unit 109 (see FIG. 9) of the enzyme activity measuring apparatus 200 associates the sample temperature detected by the temperature detection unit 129 with the correction ratio for correcting the amylase activity value detected by the CPU substrate 100. The obtained specimen temperature correction data can also be stored. In this embodiment, the specimen temperature correction data storage unit is configured.

  FIG. 22A is a graph showing the relationship (temperature characteristic) between the specimen temperature and the activity ratio of amylase contained in the specimen. In FIG. 5A, the amylase activity value at 37 degrees Celsius (human body temperature) is shown as 100%.

  As shown in FIG. 6A, for example, when the specimen temperature is reduced to 10 degrees Celsius, the amylase activity value is reduced to about 20% of the activity value at 37 degrees Celsius (actual measurement value). That is, the activity of amylase contained in the specimen (saliva) greatly depends on the temperature.

  That is, the measurement error increases depending on the temperature at the time of measurement. Therefore, in this embodiment, the specimen temperature correction data shown in FIG. 22 (b) is used.

  FIG. 22B shows a specimen temperature correction curve determined based on the temperature characteristics shown in FIG. The correction curve is determined based on 25 degrees Celsius in consideration of a general indoor temperature and a calibration curve set based on 25 degrees Celsius. The reference temperature may be other than 25 degrees.

  Further, the CPU 101 (see FIG. 9) of the enzyme activity measuring apparatus 200 detects the activity of the amylase detected based on the sample temperature detected by the temperature detection unit 129 and the sample temperature correction data stored in the storage unit 109. The value can be corrected, and in this embodiment, an active value correction unit is configured.

  Specifically, the detected amylase activity value is corrected by the processing flow shown in FIG. FIG. 23 shows an operation flow executed between step S53 and step S55 in the operation flow of the enzyme activity measuring apparatus 1 (see FIG. 13).

  As shown in FIG. 23, in step S54a, the enzyme activity measuring apparatus 200 calculates the value of the output voltage, which is the voltage value converted from the current value output by the PD 23 that measures the reflected light from the reagent-containing member 13, as an amylase Convert to the activity value.

  In step S54b, the enzyme activity measuring apparatus 200 detects the temperature (specimen temperature) of the reagent-containing member 13 to which saliva has been transferred. Specifically, the enzyme activity measuring apparatus 200 detects the intensity of infrared rays emitted from the reagent-containing member 13 (test paper) by the PD 26 as described above.

  In step S54c, the enzyme activity measuring apparatus 200 calculates a correction ratio of the amylase activity value based on the sample temperature detected in step S54b and the stored sample temperature correction data (see FIG. 22B). .

  Note that the processing in steps S54b and S54c can be executed in parallel with the processing in step S54a or prior to the processing in step S54a.

  In step S54d, the enzyme activity measuring apparatus 200 corrects the amylase activity value converted in step S54a using the correction ratio calculated in step S54c.

  In step S54e, the enzyme activity measuring apparatus 200 displays the corrected amylase activity value on the LCD panel 270.

(2) Incubation of specimen By correcting the activity value of amylase described above, measurement errors due to temperature during measurement can be suppressed. However, when the temperature at the time of measurement is low (10 degrees Celsius or less), the amylase activity is greatly reduced as shown in FIG.

  If the amylase activity is greatly reduced, the reagent contained in the reagent-containing member 13 may not react even though amylase is contained. In this case, the above-described correction cannot be applied.

  Therefore, as described above, the enzyme activity measuring apparatus 200 is provided with the heater 260 that warms the specimen (saliva) set on the pedestal 229 to a predetermined temperature (for example, 20 degrees Celsius).

  Specifically, as shown in FIG. 24, a heater 260 configured using a heating wire is provided below the pedestal 229. Further, in order to efficiently conduct the heat generated by the heater 260 to the reagent-containing member 13, the pedestal 229 is made of an aluminum alloy having a good thermal conductivity.

  Further, the CPU 101 (see FIGS. 9 and 10) of the enzyme activity measuring apparatus 200 can stop the operation of the heater 260 when detecting that the sample temperature has reached a predetermined temperature. A heater control unit is configured.

  Furthermore, since the power consumption of the enzyme activity measuring apparatus 200 is increased by providing the heater 260, a separate battery pack can be connected to the enzyme activity measuring apparatus 200.

(Action / Effect)
According to the cover opening / closing mechanism provided in the enzyme activity measuring apparatus 200 described above, the hook 257 is configured so that the specimen transfer unit 230 can move in the orthogonal direction substantially orthogonal to the direction of AR10 (pressing direction) pressing the holder 17. Has been.

  For this reason, even when the load accompanying the pressing of the holder 17 is applied to the hook 257, it is possible to prevent the cover 210 (insertion hole 210a) from coming off the hook 257 and opening the cover 210.

  That is, in the enzyme activity measuring apparatus 1, since the pressing direction for pressing the holder 17 is the same as the direction in which the load is applied to the hook 45, when the holder 17 is pressed by rotating the transfer lever 41A, the hook 45 comes off. As a result, the cover 3 may open. In the enzyme activity measuring apparatus 200, it is possible to reliably prevent the cover 210 from opening as the holder 17 is pressed.

  Further, according to the cover opening / closing mechanism, since the cover opening button 250 is provided, the user can easily open the cover 210 simply by pressing the cover opening button 250.

  Further, according to the cover opening / closing mechanism, the shape of the cover 210 (the upper end portion 210te, the lower end portion 210be) and the inner cover 225 (the upper end portion 225te, the lower end portion 225be) suppresses disturbance light from entering, The change in the color of the reagent-containing member 13 can be accurately measured.

  According to the specimen transfer unit 230 provided in the enzyme activity measuring apparatus 200, the cam 231 and the transfer pad can be rotated even if the transfer lever 232 is rotated except when the holder 17 is set on the base 229 and the cover 210 is closed. 240 (and the movable member 237) is pulled back to the position before the rotation.

  For this reason, in a state other than the state in which the holder 17 is set on the base 229 and the cover 210 is closed (for example, the state in which the cover 210 is opened), the holder 17 is pressed and saliva transfer starts. Can be prevented.

  That is, in the enzyme activity measuring apparatus 1, since the holder 17 can be pressed by rotating the transfer lever 41A even when the cover 3 is not closed, the saliva transfer may be started at an unexpected timing. there were. The enzyme activity measuring apparatus 200 can reliably prevent the start of saliva transcription at an unexpected timing.

  In addition, the specimen transfer unit 230 is assembled as a unit, and the assembled specimen transfer unit 230 is attached to the cover 210 using screws, so that each component is compared with the enzyme activity measuring apparatus 1 that is individually attached to the cover 3. Thus, assembly of the specimen transfer unit 230 and attachment of the cover 210 can be performed efficiently.

  Furthermore, according to the sample transfer unit 230, when the user pushes the transfer lever 232 lightly, the transfer lever 232 and the cam 231 are rotated in the direction of the AR 17, and the “saliva transfer state” is released. The operation of returning the transfer lever 232 is very simple.

  According to the specimen temperature compensation mechanism provided in the enzyme activity measuring apparatus 200, since the detected amylase activity value is corrected by the specimen temperature correction data, an activity value with a small measurement error is obtained regardless of the temperature at the time of measurement. be able to.

  Further, according to the specimen temperature compensation mechanism, since the heater 260 is provided, the enzyme activity measuring apparatus 200 can be used in various temperature environments regardless of the measurement environment (for example, outdoors).

  As described above, the contents of the present invention have been disclosed through the first and second embodiments of the present invention. However, it should not be understood that the description and drawings constituting a part of this disclosure limit the present invention. Absent. From this disclosure, various alternative embodiments will be apparent to those skilled in the art.

  For example, the sample transfer unit 7 and the sample transfer unit 230 described above can be provided as a single sample transfer device, and the density measurement unit 9 and the density measurement unit 9 'can be provided as a single color measurement device.

  As described above, the present invention naturally includes various embodiments that are not described herein. Therefore, the technical scope of the present invention is defined only by the invention specifying matters according to the scope of claims reasonable from the above description.

It is a perspective view showing a schematic structure of an enzyme activity measuring device concerning a 1st embodiment of the present invention. It is a perspective view of the enzyme activity measuring apparatus from F2 direction shown in FIG. FIG. 3 is a cross-sectional view in the F3-F3 direction shown in FIG. 2. It is sectional drawing in the F4 direction shown in FIG. It is a schematic sectional drawing of the concentration measurement part of the enzyme activity measuring apparatus which concerns on 1st Embodiment of this invention. It is a graph which shows the relationship between the grade of enzyme reaction, and elapsed time when a substrate and amylase contact. It is a graph which shows the relationship between the output voltage converted based on reflected light, and elapsed time. It is a graph which shows the relationship between the density | concentration of a substrate when a substrate and amylase contact, and elapsed time. It is a block block diagram of CPU board | substrate provided in the enzyme activity measuring apparatus which concerns on embodiment of this invention. It is a figure which shows the block structure of the sensor board | substrate provided in the enzyme activity measuring apparatus which concerns on embodiment of this invention. It is a flowchart which shows the operation | movement which measures the activity value of amylase using an enzyme activity measuring apparatus. It is a flowchart which shows the operation | movement which measures the activity value of amylase using an enzyme activity measuring apparatus. It is a flowchart which shows the operation | movement which measures the activity value of amylase using an enzyme activity measuring apparatus. It is a perspective view of the enzyme activity measuring device concerning a 2nd embodiment of the present invention. It is a top view of the enzyme activity measuring device concerning a 2nd embodiment of the present invention. It is a top view (cover open state) of the enzyme activity measuring device concerning a 2nd embodiment of the present invention. It is sectional drawing of the F17-F17 direction shown in FIG. It is explanatory drawing for demonstrating operation | movement of the cover opening / closing mechanism provided in the enzyme activity measuring apparatus which concerns on 2nd Embodiment of this invention. FIG. 16 is a side view of the specimen transfer unit captured from the F19 direction shown in FIG. 15. It is explanatory drawing for demonstrating operation | movement of the sample transcription | transfer part provided in the enzyme activity measuring apparatus which concerns on 2nd Embodiment of this invention. It is a schematic block diagram of the concentration measurement part provided in the enzyme activity measuring apparatus which concerns on 2nd Embodiment of this invention. FIG. 5 is a graph showing a relationship (temperature characteristic) between the specimen temperature and the activity ratio of amylase contained in the specimen, and a chart showing a specimen temperature correction curve determined based on the temperature characteristic. It is a flowchart which shows a part of operation | movement performed in the enzyme activity measuring apparatus which concerns on 2nd Embodiment of this invention. It is a schematic block diagram of the base and heater which concern on 2nd Embodiment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Enzyme activity measuring device, 3 ... Cover, 5 ... Reagent / sample arrangement part, 7 ... Specimen transfer part, 9, 9 '... Concentration measurement part, 13 ... Reagent containing member, 13A ... Planar part, 15 ... Saliva collection Sheet, 15A ... Planar part, 17 ... Holder, 21 ... LED, 23 ... PD, 25 ... Optical fiber, 26 ... PD, 27 ... Base material, 29 ... Base, 29A ... Bottom, 31 ... Guide part, 33 ... Movable 35, guide portion, 37 ... spring holding portion, 39 ... coil spring, 41 ... cam, 41A ... transfer lever, 41r ... rotating shaft, 43 ... transfer pad, 45 ... hook, 47 ... substrate, 100 ... CPU substrate, DESCRIPTION OF SYMBOLS 101 ... CPU, 103 ... Oscillating unit, 105 ... Communication unit, 107 ... Clock unit, 109 ... Storage unit, 111 ... Buzzer output unit, 113 ... Power supply unit, 115 ... Backup power supply unit, 117 ... Liquid crystal display unit, 117A ... LCD Panel DESCRIPTION OF SYMBOLS 119 ... Switch part, 121 ... Sensor board | substrate, 123 ... Reference voltage generation part, 125 ... LED drive part, 127 ... PD amplifier part, 129 ... Temperature detection part, 131 ... Switch operation | movement detection part, 200 ... Enzyme activity measuring device, 210 ... Cover, 210a ... Insertion hole, 215 ... Hinge, 220 ... Housing, 225 ... Inner cover, 229 ... Base, 230 ... Specimen transfer part, 231 ... Cam, 231p ... Planar part, 232 ... Transfer lever, 233 ... Coil spring 234: Rotating shaft, 235: Coil spring, 237 ... Movable member, 237cp ... Cam contact surface, 237pp ... Pressing surface, 238 ... Guide rod, 239 ... Coil spring, 240 ... Transfer pad, 241 ... Base plate, 250 ... Cover Release button, 251 ... coil spring, 252 ... push rod, 253 ... lever, 254 ... rotating shaft 255 ... connection pin, 256 ... support shaft, 257 ... hook, 257E ... end, 260 ... heater, 270 ... LCD panel, 280 ... switching unit

Claims (17)

A reagent-containing member containing an enzyme activity measurement reagent for measuring the activity value of the enzyme, and a reagent / specimen placement unit that places the specimen apart from each other;
A sample transfer unit that brings the sample into contact with the reagent-containing member arranged by the reagent / sample arranging unit, and transfers a predetermined amount of the sample to the reagent-containing member;
A concentration measuring unit that measures the concentration of the color of the reagent contained in the reagent-containing member when a predetermined time has elapsed since the sample was transferred;
An enzyme activity measuring apparatus comprising: an enzyme activity detecting unit that detects an activity value of an enzyme contained in the sample based on the concentration measured by the concentration measuring unit. The reagent-containing member is a sheet-like member,
The specimen is included in a specimen-containing member that is a sheet-like member,
The reagent / specimen placement unit is arranged so that a reagent-containing member plane that is a planar portion of the reagent-containing member and a specimen-containing member plane that is a planar portion of the specimen-containing member are opposed to each other so as to be substantially parallel.
2. The enzyme activity measuring apparatus according to claim 1, wherein the specimen transfer unit brings the reagent-containing member plane and the specimen-containing member plane into contact with each other at a predetermined pressure for a predetermined time. The reagent / specimen arrangement unit uses the holder that holds the reagent-containing member and the sample-containing member to arrange the reagent-containing member and the sample-containing member apart from each other,
The enzyme activity measurement apparatus according to claim 2, wherein the specimen transfer unit presses the holder to bring the reagent-containing member plane into contact with the specimen-containing member plane. A cover that covers the concentration measuring unit and that opens and closes around a rotation axis;
The enzyme activity measuring apparatus according to claim 3, wherein the specimen transfer unit is provided on the cover. A projection member that moves in an orthogonal direction substantially orthogonal to a pressing direction in which the specimen transfer unit presses the holder;
The enzyme activity measuring apparatus according to claim 4, wherein the cover is provided with an insertion hole into which the protruding member is inserted in a state where the cover is closed. The protruding member is urged in the insertion direction into the insertion hole,
A protrusion member moving lever that engages with the protrusion member and moves the protrusion member in a direction opposite to the insertion direction by rotating about a rotation axis;
The enzyme activity measuring apparatus according to claim 5, further comprising a cover opening button portion that, when pressed, presses the protruding member moving lever to rotate the protruding member moving lever. The specimen transfer part is
A movable member having a pressing surface for pressing the holder and a cam abutting surface facing the pressing surface, and movable along a pressing direction for pressing the holder;
A cam having a flat portion on a part of the outer peripheral surface whose distance from the rotation axis is longer than that of the other portion;
A transfer lever that abuts the flat surface portion with the cam contact surface by rotating in a first direction;
A first urging member that urges the cam to rotate in a second direction that is opposite to the first direction;
The enzyme activity measuring apparatus according to claim 4, further comprising a second urging member that urges the movable member toward the cam.   The enzyme activity measuring apparatus according to claim 7, further comprising a third urging member that urges the transfer lever to rotate in the second direction. A temperature detection unit for detecting a sample temperature which is the temperature of the sample;
A sample temperature correction data storage unit for storing sample temperature correction data in which the sample temperature is associated with a correction ratio for correcting the activity value detected by the enzyme activity detection unit;
The enzyme activity measuring apparatus according to claim 1, further comprising an activity value correcting unit that corrects the activity value based on the sample temperature and the sample temperature correction data. A heater for heating the specimen to a predetermined temperature;
The enzyme activity according to claim 9, further comprising: a heater control unit that stops the operation of the heater when the temperature detection unit detects that the sample temperature has reached the predetermined temperature. measuring device.   The concentration measuring unit irradiates light substantially perpendicular to the reagent-containing member plane, and measures reflected light reflected from the reagent-containing member plane from an oblique direction with respect to the reagent-containing member plane. The enzyme activity measuring apparatus according to claim 1, wherein the concentration is measured.   The enzyme concentration measuring apparatus according to claim 11, wherein the concentration measuring unit receives and measures the reflected light through an optical fiber. The enzyme is an amylase;
The enzyme activity measuring apparatus according to claim 1, wherein the specimen is saliva. A reagent-specimen arrangement step in which a reagent-containing member containing an enzyme activity measurement reagent for measuring the activity of the enzyme and the specimen are arranged apart from each other;
A specimen transfer step of bringing the reagent-containing member placed in the reagent / sample placement step into contact with the specimen, and transferring a predetermined amount of the specimen to the reagent-containing member;
A concentration measuring step for measuring the color concentration of the reagent contained in the reagent-containing member when a predetermined time has elapsed since the specimen was transferred;
An enzyme activity detection step for detecting an activity value of an enzyme contained in the sample based on the concentration measured in the concentration measurement step;
In the reagent / sample placement step, the reagent-containing member plane which is a plane portion of the reagent-containing member and the sample-containing member plane which is a plane portion of the sample-containing member are arranged so as to be substantially parallel to each other,
In the specimen transfer step, the reagent-containing member plane and the specimen-containing member plane are brought into contact with each other at a predetermined pressure for a predetermined time. A reagent / specimen placement unit that separates and arranges a sheet-like reagent-containing member containing an enzyme activity measurement reagent for measuring enzyme activity and a sheet-like specimen-containing member containing a sample;
A specimen transfer section for bringing the reagent-containing member placed by the reagent / sample placement section into contact with the specimen and transferring a predetermined amount of the specimen to the reagent-containing member;
The reagent / specimen placement unit is arranged so that a reagent-containing member plane that is a planar portion of the reagent-containing member and a specimen-containing member plane that is a planar portion of the specimen-containing member are opposed to each other so as to be substantially parallel.
The specimen transfer device, wherein the specimen-containing member plane and the specimen-containing member plane are brought into contact with each other at a predetermined pressure for a predetermined time.   Irradiate light substantially perpendicular to the reagent-containing member plane, which is a planar portion of the sheet-like reagent-containing member containing the enzyme activity measurement reagent for measuring the enzyme activity, and reflect light reflected from the reagent-containing member plane A color measuring device comprising a concentration measuring unit that measures the color concentration of the reagent-containing member by measuring from an oblique direction with respect to the reagent-containing member plane. The color measuring apparatus according to claim 16, wherein the density measuring unit receives and measures the reflected light through an optical fiber.

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