JPWO2010041595A1 - Bioactive substance measurement system - Google Patents

Abstract

To provide a physiologically active substance measuring system which has a simple structure, is suitable for POCT (Point of Care Testing), and can measure a physiologically active sample substance more simply and quickly. A reaction unit (including a reagent cartridge, a reaction material, a reagent cartridge setting unit, a reaction material setting unit, a dispensing pump, and a temperature control unit), a detection unit, a movable unit, a reading unit, a display operation unit, and a control unit. A physiologically active substance measuring system comprising: [Selection figure] None

Description

  The present invention relates to a physiologically active substance measurement system. More specifically, the present invention relates to a physiologically active substance measuring system that has a simple structure, is suitable for POCT (Point of Care Testing), and can measure a physiologically active sample substance more simply and quickly.

In recent years, the concept of POCT (Point of Care Testing) has permeated in the medical field, and a method for measuring a physiologically active substance more easily and rapidly has been demanded.
On the other hand, systems based on various principles are known as systems for measuring physiologically active substances. For example, as a system using an immunological measurement method, a method using an enzyme immunoassay method (Patent Document 1) using a porous filter or the like as a solid phase carrier, an immunochromatography method, a latex turbidimetric method, or the like is exemplified. The

JP 2001-235471 A

It is the figure which showed an example of schematic structure of the physiologically active substance measuring system which concerns on embodiment of this invention. It is the figure which illustrated the dotted-line part of FIG. 1 in further detail. It is the figure which illustrated the typical form of the reaction cartridge 11 of this invention. It is the figure which illustrated the typical form of the reaction material 12 of this invention. It is the figure which showed an example of the immunological measuring method applied by this invention. It is the figure which showed an example of the immunological measuring method applied by this invention. The correlation of the PSA measurement result by the physiologically active substance measurement system of this invention and the measurement result by another method is shown.

Generally, the following requirements are required for a measurement system suitable for POCT.
(1) Quickness from start of measurement to result display (2) Easy operability (3) Accuracy of measurement results (4) Ease of maintenance (5) Miniaturization of the apparatus An object of the present invention is to provide a suitable physiologically active substance measuring system.

  As a result of intensive investigations in view of the above problems, the present inventor measured a physiologically active substance reliably and quickly and simply by constructing a system having each configuration described later for a sample containing the physiologically active substance. The present inventors have found that the present invention can be accomplished and have completed the present invention.

That is, the present invention is as follows.
[Claim 1]
A physiologically active substance measuring system comprising all of the following (1) to (6): (1) Reaction section: means for mixing and reacting a sample and reagents, the following (a) (A) Reagent cartridge (b) Reactant (c) Reagent cartridge set part (d) Reactant set part (e) Dispensing pump (f) Temperature control part (2) Detection part : Means for detecting the progress of the reaction (3) movable part: means for moving each part of the above (1) to (2) in the directions of the X axis, the Y axis and the Z axis according to the purpose (4) Reading unit: means for reading information on the reagent from the outside according to the measurement item (5) display operation unit: means for grasping the status of the device or operating the device (6) control unit: the above Means for controlling each part of (1) to (5) [Section 2]
A member that can be used in the physiologically active substance measurement system according to Item 1, wherein the member is either of the following (a) or (b).
(A) Reagent cartridge (b) Reactant [Claim 3]
Item 2. A device that can be used in the physiologically active substance measurement system according to Item 1 and lacks the following configurations (a) and (b) among the components of the physiologically active substance measurement system according to Item 1.
(A) Reagent cartridge (b) Reactant [Item 4]
A method for measuring a physiologically active substance using the physiologically active substance measurement system according to Item 1.
[Section 5]
A method for producing measurement data of a physiologically active substance using the physiologically active substance measurement system according to Item 1.

  The physiologically active substance measuring system according to the present invention has a simple structure, is suitable for POCT (Point of Care Testing), and can measure a physiologically active substance more easily and quickly. It can be used in all industries that require measurement of physiologically active substances such as medical sites.

  In the following description, the numerals described after the noun correspond to the reference numerals of the drawings. For example, “reaction part 1” indicates that “reaction part” corresponds to the part indicated by reference numeral 1 in FIG.

[Configuration of Bioactive Substance Measurement System of the Present Invention]
The configuration of the physiologically active substance measurement system 100 according to the present invention includes a device and a reagent for solving the above problems.
Specifically, it includes all of the following (1) to (6).
(1) Reaction unit 1: Means for mixing and reacting sample and reagents (a) Reagent cartridge 11
(B) Reactive material 12
(C) Reagent cartridge setting unit 13
(D) Reactant setting part 14
(E) Dispensing pump 15
(F) Temperature controller 16
(2) Detection unit 2: Means for detecting progress of reaction (3) Movable unit 3: Each means of (1) to (2) described above in the directions of the X axis, the Y axis, and the Z axis depending on the purpose. (4) Reading unit 4: Means for reading information on reagent from outside according to measurement item to instrument (a) IC card reader 41 (and IC card)
(B) Bar code reader 42 (and reagent cartridge 11)
(C) Reactive material presence / absence sensor 43
(5) Display operation unit 5: Means for grasping the status of the device, or means for operating the device (6) Control unit 6: Means for controlling the above (1) to (5) If necessary,
(7) Communication port 7
May be included.

  The physiologically active substance measurement system 100 of the present invention is constructed so that a reaction material 12 (details will be described later) and a reagent cartridge 11 (details will be described later) necessary for a measurement (detection) reaction are mounted on a dedicated device for measurement. The Such a device is also included in the present invention.

  The physiologically active substance measurement system 100 of the present invention can be applied to various measurement principles. For example, it can be based on the immunological measurement method shown in FIGS.

The immunological measurement method in this system includes the following steps (A) (FIG. 5) or (B) (FIG. 6).
(A)
The immunoassay shown in FIG. 5 includes the following steps (a) to (e).
(A) A sample solution containing a physiologically active substance to be measured is brought into contact with a solution containing a conjugate (reagent 1) in which a ligand is bound to a first antibody that specifically binds to the target substance, Forming a complex of 1 and a substance to be measured in a solution.
(B) The solution containing the complex is dropped on the surface of the porous filter to which the ligand capturing agent is bound, and the ligand part of the complex is used as the ligand capturing agent. The process of combining.
(C) A solution of a second antibody (reagent 2) labeled with an enzyme that specifically binds to the substance to be measured is dropped on the surface of the porous filter of the reaction material 12, and the reagent 2 is added to the ligand. A step of binding to a complex of a first antibody and a substance to be measured that are bound to the porous filter of the reaction material 12 via a capturing agent and a ligand portion.
(D) A step of removing the unbound reagent by washing the porous filter of the reaction material 12. (E) The process of measuring the activity of the enzyme couple | bonded with the porous filter of the reaction material 12 using a luminescent substrate (reagent 3).

(B)
The immunological assay shown in FIG. 6 includes the following steps (a) to (d).
(A) a sample solution containing a physiologically active substance to be measured; a first antibody that specifically binds to the target substance; a ligand-bound conjugate (reagent 1); and the target substance specifically bound A second antibody that binds to the same or different part as the first antibody to be contacted with a second antibody (reagent 2) labeled with an enzyme, and a complex of reagent 1, reagent 2 and the substance to be measured Forming in solution.
(B) The solution containing the complex is dropped on the surface of the porous filter to which the ligand capturing agent is bound, and the ligand part of the complex is used as the ligand capturing agent. The process of combining.
(C) A step of removing the unbound reagent by washing the porous filter of the reaction material 12. (D) A step of measuring the activity of the enzyme bound to the porous filter of the reaction material 12 using a luminescent substrate (reagent 3).

  By adopting such a method, the reaction material 12 can be used in common regardless of the measurement item, and it is preferable. However, the present invention can be implemented even if a different reaction material 12 is used for each measurement item. It does not prevent.

In the above measurement method, the volume ratio between the sample solution and the solution containing the reagent 1 (expressed by a numerical value obtained by dividing the volume of the sample solution by the volume of the solution containing the reagent 1) is examined when the sample solution is smaller. From the viewpoint of reducing the burden on the subject and reducing the influence on the measurement by components other than the physiologically active substance to be measured contained in the sample solution, since the amount of sample that needs to be collected from the person can be reduced. It is preferable that it is less than 1/20. More preferably, it is less than 1 and 1/10 or more.
Further, when the concentration of the physiologically active substance to be measured in the sample solution is high, it is possible to perform dilution on the reagent cartridge and use a sample solution that has been diluted in advance.
On the other hand, when the concentration of the physiologically active substance to be measured is low, the volume ratio between the sample solution and the solution containing the reagent 1 (expressed by a numerical value obtained by dividing the volume of the sample solution by the volume of the solution containing the reagent 1). ) Is less than 20 and 1 or more considering the viewpoint of increasing the amount of the substance to be measured and the influence of the substance other than the physiologically active substance on the substance to be measured contained in the sample solution. Is preferred. More preferably, it is less than 10 and 1 or more.

The present invention is also a member that can be used in the physiologically active substance measurement system described above, and is any one of the following members (a) and (b).
(A) Reagent cartridge (b) Reactant

FIG. 4 illustrates a typical form of the reaction material 12, and FIG. 3 illustrates a typical form of the reaction cartridge 11.
The reaction material 12 includes a porous filter to which a ligand scavenger is bound. The material and structure of the porous filter are not particularly limited, and a glass fiber filter or the like can be used.
The combination of the ligand and the ligand capture agent in Reagent 1 is not particularly limited, and biotin and an anti-biotin antibody, or a combination of biotin and streptavidin can be used.
The ligand-trapping agent may be bound to the porous filter via a spacer. For example, when biotin is used as a ligand, when not using a spacer, as a ligand capture agent, an antibody against the ligand, that is, an anti-biotin antibody or streptavidin, and when via a spacer, an antibody against the ligand capture agent as a spacer, that is, It is preferable to overlay an anti-biotin antibody on an antibody against the anti-biotin antibody (“anti-goat antibody” is illustrated in FIG. 4). In addition, an anti-streptavidin antibody can be used as a spacer, or an anti-streptavidin antibody can be used as an overlay on an anti-streptavidin antibody.
The reaction material 12 may further include a water absorption plug. The water absorption plug is installed in the lower part of the porous filter (solid phase carrier) in order to make the solution pass quickly. The material and structure of the water-absorbing plug are not particularly limited, but those in which cellulose fibers such as tobacco filters are formed in a cotton shape (such as a cylinder) are preferable.
Examples of the reaction material 12 include the above-described porous filter to which a ligand scavenger is bound, and a water absorption plug, which are integrated in a reaction vessel. Although the form and the like are not limited, for example, reaction vessels such as those having an appearance as shown in the photograph of FIG. 4 and those described in FIGS. 4 and 5 of JP-A-7-218438 are exemplified. The

The measurement principle applied to the physiologically active substance measurement system 100 according to the present invention is not limited to the above example.
In the above description, an example was shown in which a measurement system based on an immunological measurement method was constructed using the specificity of an antigen-antibody reaction using a measurement target substance as an antigen. You may construct | assemble a measurement system using an effect | action suitably. Such interactions include, but are not limited to, hybridization of nucleic acids such as DNA and RNA, enzymes and their substrates (or substrate analogs, competitive inhibitors, etc.), and the like. The use of interaction newly found after the filing of the present application is naturally included in the scope of the present invention.
The combination of the ligand and the ligand capture agent is not limited to the above example, and an interaction suitable for the measurement target may be appropriately used. The use of interaction newly found after the filing of the present application is naturally included in the scope of the present invention.

The reaction material 12 applied to the physiologically active substance measurement system 100 according to the present invention is not limited to the above example.
In the above description, the reaction material 12 is configured to include a porous filter to which a ligand scavenger is bound, and a water absorption plug, and a sample and reagents are dropped onto the porous filter to bind them, and then An example of constructing a place for reaction by removing unnecessary components out of the system by using the porosity of the filter (more preferably by using the water absorption of the water absorption plug) was shown. The material and structure suitable for the measurement target may be used in appropriate combination to construct a place for reaction. The use of materials and structures (or combinations thereof) newly found after the filing of the present application is also included in the scope of the present invention.

The reaction cartridge 11 has a form in which several divided cells are combined. Although the shape is not particularly limited, in order to simplify the control operation of the support portion 34 that supports the reaction cartridge set portion 13, it is preferable that the coupling of each cell is in series in a one-dimensional direction. The size of each cell may not be the same. For example, the size of the cell into which the sample is dispensed may be changed as shown in FIG.
The reaction cartridge 11 is preferably sealed and sealed until just before use. Furthermore, it is preferable that the reaction cartridge is set in the reaction cartridge setting unit 13 while being sealed and is perforated by the dispensing tip 17 at the time of measurement. Although it does not specifically limit as a film suitable for such a structure, An aluminum film is illustrated.
Since the reaction cartridge 11 needs to appropriately change the type of antibody used in the reagent 1 and the reagent 2 according to the measurement target, it is necessary to fill a different reagent for each measurement target. In order to distinguish these, it is preferable to attach a barcode that can be read by the barcode reader 43 to the reaction cartridge 11.

  A physiologically active substance measuring system 100 of the present invention will be described with reference to the drawings. In the following, for convenience of explanation, a case based on the measurement principle shown in FIG. 5 will be described as an example, but the present invention is not limited to this.

FIG. 1 is a schematic configuration of a physiologically active substance measurement system 100 according to the present embodiment.
As shown in FIG. 1, the physiologically active substance measurement system 100 includes a reaction unit 1, a detection unit 2, a movable unit 3, a reading unit 4, a display operation unit 5, and a control unit 6. A separate communication port 7 may be provided.

FIG. 2 is a diagram illustrating the dotted line portions (reaction unit 1, detection unit 2, movable unit 3) of FIG. 1 in more detail.
The reaction unit 1 includes a reaction cartridge setting unit 13, a reaction material setting unit 14, and a dispensing pump 15. At the time of measurement, the reaction cartridge 11 is mounted on the reaction cartridge setting unit 13, the reaction material 12 is mounted on the reaction material setting unit 14, and the tip 17 is mounted on the dispensing pump 15. These “mounting” and “mounting” operations may be performed manually or may be automated.

The reaction cartridge setting unit 13 and the reaction material setting unit 14 are attached to a support unit 34 that supports the reaction cartridge and the reaction material. The dispensing pump 15 is controlled in the Z-axis direction by the motor 33 and in the X-axis direction by the motor 31. By movement in these XZ planes, dispensing and mixing of samples and reagents on the reaction cartridge 11, then dispensing of the sample / reagent mixture from the reaction cartridge 11 to the reaction material 12, The movement of the reaction material 12 to the detection unit 2 is controlled.
Further, the temperature control unit 16 is in contact with the reaction cartridge setting unit and the reaction material setting unit 14 (in contact with or placed in a very close position), or can be integrated with the setting unit.
As the motors 31 to 33, conventionally known driving means can be suitably used, and examples thereof include mechanically driven motors such as a servo motor, a stepping motor, and a linear motor.
An example of the dispensing pump 15 is a pencil pump. Moreover, what is necessary is just to use the chip | tip suitable for the chip | tip 17 for the dispensing pump 15 suitably.
Moreover, what is necessary is just to use a commercially available heat block for the temperature control part 16 suitably combining with a commercially available heater and thermistor, for example.

The moving directions of the reaction cartridge setting unit 13, the reaction material setting unit 14, and the dispensing pump 15 are not limited to the example in FIG. 2, and may be set so as to move in any direction.
In addition, the dimension of the motion direction may be one-dimensional or multi-dimensional, but for the downsizing and simplification of the equipment, each motion direction is one-dimensional as illustrated in FIG. And combining two dimensions.
It is preferable that the reaction cartridge setting part 13 and the reaction material setting part 14 are mounted on a common support part 34 and interlocked with each other. Furthermore, it is preferable for the downsizing of the device that the reaction material 12 and the arrangement of the cells of the reaction cartridge 11 are set in series in the forward direction and the operation direction of the support portion 34. Also, with such a structure, it is possible to easily set options such as changing the positions of the reaction cartridge setting unit 13 and the reaction material setting unit 14 according to the dominant hand of the person who uses the system.

In the system of the present invention, the reaction cartridge 11 and the reaction material 12 are divided.
Conventionally, those skilled in the art have not thought of dividing the reaction cartridge and the reaction material. This is because, in general, from the viewpoint of POCT, it was considered that the user's convenience was better when the reaction cartridge and the reaction material were integrated (hereinafter referred to as an integrated reaction material). I can say that.
However, in the case of an integrated reaction material, the present inventors have found that the porous filter part of the reaction material and each cell part of the reaction cartridge at the time of production are mutually dispensed with each other and when the reagent is bound to the porous filter (reduced pressure). It is thought that there is a risk of contamination due to aerosol scattering during drying, etc., and that there is a risk of contamination due to scattering when the user removes the hermetic seal immediately before use. It was conceived that these can be avoided by dividing the reaction cartridge and the reaction material. This is a configuration that cannot be easily conceived by those skilled in the art.

Note that the reaction material setting unit 14 is preferably configured to set a maximum of two reaction materials.
By adopting such a configuration, for example, it is also possible to measure different items such as influenza type A and type B at the same time.

The detection unit 2 functions as detection means for detecting a minute amount of light from the reaction material, and the specific configuration thereof is not particularly limited. For example, detection is possible by using a commercially available photomultiplier (also referred to as PMT or photomultiplier) and appropriately amplifying a minute output voltage from the photomultiplier tube.
In order to protect from a large amount of external light, it is preferable to process the temperature control unit 16 so that the light receiving surface is covered when the cover is opened.

The reading unit 4 functions as a reading unit that reads information from the outside, and the specific configuration thereof is not particularly limited. For example, a configuration including an IC card reader 42, a barcode reader 43, and a reaction material presence / absence sensor 44 is exemplified.
The IC card reader 42 is not particularly limited as long as it can read each data written in the user memory of the IC chip. Commercially available reader / writer modules and antennas can be used.
Each card necessary for measurement is read by preparing a card with an IC chip and inserting it into the insertion slot on the front of the device. Examples of data contents include item name, lot, expiration date, unit, dilution rate, adjustment temperature, temperature correction coefficient, calibration period, calibration data, measurement sequence, and the like.
The barcode reader 43 causes the limited reflection type sensor to detect a simple barcode of about 2 mm × 11 digits pasted on the reagent cartridge 11 in advance, and confirms the item and lot of the currently installed reagent cartridge 11. If the data read from the chip and the bar code are different, it is preferable to sound a warning sound or the like and display the error content on the display operation unit 5. These can use a commercially available thing.
The reaction material presence / absence sensor 44 is a sensor for confirming whether or not the reaction material 12 is set at each position. If it is not set at the position designated by the measurement of each item, it is preferable to sound a warning sound and display the error content on the display operation unit 5. These can use a commercially available thing.

The display operation unit 5 functions as a means for displaying information necessary for operation and the like to the operator and a means for transmitting the operator's intention to the device, and its specific configuration is particularly limited. It is not a thing. For example, a configuration including a liquid crystal display (also referred to as LCD) 51 and an operation switch substrate 52 is exemplified.
The liquid crystal display 51 is not particularly limited as long as it has an appropriate number of characters, display range, character size, display language, and the like, and a commercially available one can be used.
The operation switch board 52 is a board on which operation switches are mounted. The configuration is not particularly limited. For example, the number of switches can be set to about seven (↑, ↓, ←, →, Run, Menu, Enter). If necessary, add a function such as a buzzer to notify the operation sound or error sound, an LED indicating that the power is on and the measurement is in progress, or the measurement can be stopped by long pressing while the Run switch is operating. Is preferred.

The control unit 6 functions as a control unit that controls each unit of the physiologically active substance measurement system 100. Further, the control unit 6 may be provided with functions such as storage, processing, and determination of measurement data as necessary.
These control means are not particularly limited with respect to their specific configurations. For example, although it may be configured by hardware logic, it is preferably realized by software using a CPU.
That is, the physiologically active substance measuring system 100 includes a CPU (central processing unit) that executes instructions of a control program that realizes each function, a ROM (read only memory) that stores the program, and a RAM (random access) that expands the program. memory), a storage device (recording medium) such as a memory for storing the program and various data, and the like.
The object of the present invention is a record in which the program code (execution format program, intermediate code program, source program) of the control program of the physiologically active substance measurement system 100, which is software that implements the functions described above, is recorded so as to be readable by a computer. This can also be achieved by supplying a medium to the physiologically active substance measurement system 100 and reading and executing the program code recorded on the recording medium by the computer (or CPU or MPU).

In addition, the physiologically active substance measurement system 100 may be configured to be connectable to a communication network via the communication port 7, and the program code may be supplied via the communication network. The communication network is not particularly limited. For example, the Internet, intranet, extranet, LAN, ISDN, VAN, CATV communication network, virtual private network, telephone line network, mobile communication network, satellite communication A net or the like is available.
Further, the transmission medium constituting the communication network is not particularly limited. For example, even in the case of wired such as IEEE 1394, USB, power line carrier, cable TV line, telephone line, ADSL line, etc., infrared rays such as IrDA and remote control, Bluetooth ( (Registered trademark), 802.11 wireless, HDR, mobile phone network, satellite line, terrestrial digital network, and the like can also be used.
The present invention can also be realized in the form of a computer data signal embedded in a carrier wave in which the program code is embodied by electronic transmission.

  In addition to the above, the communication port 7 can be used as a means for achieving quality control and technical requirements such as ISO 15189, which is a specific requirement regarding the quality and capability of clinical laboratories.

[Specific Analysis Operation of Physiologically Active Substance Measurement System of the Present Invention]
Next, a specific operation of the physiologically active substance measurement system 100 of the present invention will be described. In the following, for convenience of explanation, a case based on the measurement principle shown in FIG. 5 will be described as an example, but the present invention is not limited to this.

(1) A card with an IC chip is set in the reading unit 4 and data is read. Based on this data, a calibration curve is created, and the reagent expiration date is collated. An error is displayed when the time limit is exceeded.
(2) The reaction cartridge 11, the reaction material 12, and the chip 17 are set at predetermined positions. At this time, a display for instructing setting is displayed on the liquid crystal display 51.
(3) Confirm and select the type of specimen, and operate the operation switch board 52 to start measurement and temperature control. Before starting, the default specimen type for each item is displayed on the liquid crystal display 51 to prompt confirmation. When you want to change the sample type, select and display the options.
(4) The reagent cartridge setting unit 13 reads the simple barcode of the cartridge and collates it with the data of the IC chip. For example, an 11-bit barcode (start bit is 1 bit) is read by a reflective beam sensor. The lot number read from the IC chip is collated with a simple barcode, and an error is displayed when the collation fails. Further, the presence or absence of the reaction material is detected in the reaction material setting unit 14, and an error is displayed if the reaction material is not at the designated position. During these verifications, a progress display may be displayed on the LCD 52.
(5) Wait until the temperature of the temperature control unit 16 (for example, heat block) reaches a specified temperature. Monitor the temperature of the heat block and wait until it reaches the specified temperature. When the specified temperature is reached, the dispensing operation is started, and the countdown of the assumed time set for each item is started according to the data read from the IC chip.
(6) Dispense the reagent / specimen in a specified volume, cause the reaction material to emit light, and measure the amount of light emitted by the detector 2 (for example, PMT). Dispense each solution according to the data read from the IC chip. For one or two (depending on the items) of the reaction material 12, the amount of luminescence is measured by the PMT, and during the measurement, the progress of the remaining measurement time is displayed on the LCD 52.
(7) The density is calculated from the relative light emission amount (RLU: Relative Light Unit), and the result is displayed and recorded on the display operation unit 5. The RLU measured by the PMT is substituted into the calibration curve, the concentration is obtained, and the results such as items and concentrations are displayed on the LCD 52. At the end of the measurement, the temperature of the temperature control unit 16 is set to the minimum control temperature.

In the calibration curve creation, a calibration curve is created by approximation of a function curve or a spline with a multi-check calibration curve (preferably about 10 points at maximum).
For calibration, store the measurement date and the coefficient to be multiplied by the calibration result slope for each item, and if the period specified by each item has elapsed from the measurement date, it will not be possible to perform normal measurement without recalibration. can do. At this time, the calibration period information is input to the IC tag, and it is possible to determine whether it is necessary from the previous measurement date and the current date at the time of reading. When two-point measurement is performed, two types of density measurement are performed. However, if the measurement is not performed according to the instruction, an error is generated and it is preferable to perform calibration again. An error also occurs when the measurement result is far from the data from the IC chip.
In addition, hematocrit correction (correction of measurement results during measurement using whole blood), temperature correction (correction of measurement results due to temperature in the device), data storage (recording of 500 test measurement results and error logs), calendar / clock function Etc. are preferably set.
Regarding various types of abnormality monitoring, the opening and closing of the cover can be monitored by a micro switch. During the measurement, it is preferable to lock with a manual ring handle to form a two-stage locking mechanism. Regarding the temperature, an error occurs if the specified temperature is not reached even after a certain time (for example, 5 minutes) has elapsed since the start of temperature control. In addition, it is preferable that the heater is turned off when the temperature becomes high due to poor control. As for various origin sensors, the origin of various motors is determined before starting the inspection.
It is preferable that various settings can be confirmed by pressing a menu button of the display operation unit 5.

The present invention also provides a method for measuring a physiologically active substance using the physiologically active substance measurement system as described above, or produces measurement data of a physiologically active substance using the physiologically active substance measurement system as described above. Is the method.
The specific principle and analysis operation of the system are as described above.

  The measurement in the physiologically active substance measurement system 100 according to the present invention will be described in detail with an example.

Using the physiologically active substance measurement system 100 described above, 50 samples of PSA (Prostate Specific Antigen) of human-derived serum were measured, and the correlation between the measurement results was confirmed.

(1) A glass fiber filter paper (manufactured by Advantech Toyo Co., Ltd.) is cut in a circular shape, laminated on an absorption plug, and stored in a polyethylene liquid-impermeable container as shown in FIG. a) 100 mM citrate buffer: 100 μl of pH 3.0, (b) goat anti-biotin polyclonal antibody 47 μg / mL (100 mM citrate buffer: pH 3.0), 50 μl, (c) 5% glycerol / 1% bovine serum 100 μl of albumin (BSA) solution (10 mM phosphate-saline buffer solution: pH 7.4) was sequentially supplied after the solution supplied immediately before was aspirated, and then lyophilized.
(2) Preparation of ALP-labeled anti-PSA antibody solution Using an anti-PSA antibody and bovine small intestine-derived alkaline phosphatase, label with EZ-Link Maleimide Activated Alkaline Phosphatase Kit (PIERCE) to 2.0 μg / mL The first antibody solution was prepared.
(3) Preparation of biotin-labeled anti-PSA antibody solution Anti-PSA antibody and biotinamide caproic acid-N-hydroxysuccinimide ester are reacted at 25 ° C. for 4 hours, and fractionated using NAP-5 (Amersham Biosciences). The second antibody solution was prepared to 8.0 μg / mL.
(4) Implementation of measurement A biological sample (40 μl) was mixed with 20 μl of the first antibody solution and 20 μl of the second antibody solution to prepare a reaction solution, which was then incubated at 40 ° C. for 5 minutes. 50 μl of physiological saline was added to the reaction container prepared in (1), and after 5 minutes, 50 μl of the reaction solution was added and incubated at 40 ° C. Two minutes later, physiological saline containing 0.05% Tween 20 was added twice by 80 μl, and after another 2 minutes, 30 μl of APS-5 (Lumigen) was added as a luminescent substrate. One minute after addition of the luminescent substrate, the amount of luminescence was read with a photomultiplier tube (manufactured by Hamamatsu Photonics).

[Comparative example]
The same serum specimen as in Example 1 was measured using E-plate 'Eiken' PSA (Eiken Chemical Co., Ltd.). The measurement was performed according to the package insert attached to the kit.

As shown in FIG. 7, a good correlation was confirmed.

  The physiologically active substance measuring system according to the present invention has a simple structure, is suitable for POCT (Point of Care Testing), and can measure a physiologically active substance more easily and quickly. It can be used in all industries that require measurement of physiologically active substances such as medical sites.

DESCRIPTION OF SYMBOLS 100 Bioactive substance measuring system 1 Reaction part 2 Detection part 3 Movable part 4 Reading part 5 Display operation part 6 Control part 7 Communication port 11 Reaction cartridge 12 Reaction material 13 Reaction cartridge setting part 14 Reaction material setting part 15 Dispensing pump 16 Temperature control unit 17 Chip 31 Motor (X-axis direction)
32 Motor (Y-axis direction)
33 Motor (Z-axis direction)
34 Supporting part

Claims (5)

A physiologically active substance measuring system comprising all of the following (1) to (6): (1) Reaction section: means for mixing and reacting a sample and reagents, the following (a) (A) Reagent cartridge (b) Reactant (c) Reagent cartridge set part (d) Reactant set part (e) Dispensing pump (f) Temperature control part (2) Detection part : Means for detecting the progress of the reaction (3) movable part: means for moving each part of the above (1) to (2) in the directions of the X axis, the Y axis and the Z axis according to the purpose (4) Reading unit: means for reading information on the reagent from the outside according to the measurement item (5) display operation unit: means for grasping the status of the device or operating the device (6) control unit: the above Means for controlling each part of (1) to (5) It is a member which can be used for the physiologically active substance measuring system according to claim 1, and is either the following member (a) or (b).
(A) Reagent cartridge (b) Reactant A device that can be used in the physiologically active substance measurement system according to claim 1, and lacks the following configurations (a) and (b) among the components of the physiologically active substance measurement system according to claim 1. machine.
(A) Reagent cartridge (b) Reactant   A method for measuring a physiologically active substance using the physiologically active substance measurement system according to claim 1. A method for producing measurement data of a physiologically active substance using the physiologically active substance measurement system according to claim 1.