JP2012103097A - Reagent kit and autoanalyzer equipped with the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a reagent kit which alleviates burdens on a measurer in treating a measurement reagent to be used in an autoanalyzer, and is suitable for rationalization of design of a production facility of a supplier of the measurement reagent and the autoanalyzer.SOLUTION: The above problem is solved by a reagent kit equipped with: (1) a measurement container which stores a reaction reagent: (2) at least one or more of a measurement container which stores components of a stock item, a measurement container which stores components of an accuracy control sample, a measurement container which stores components of an analyte diluent, a measurement container which stores a pretreatment reagent for pretreating an analyte, in which all the outer shapes of the measurement container which stores the reaction reagent, the measurement container which stores the components of the stock item, the measurement container which stores the components of the accuracy control sample, the measurement container which stores the components of the analyte diluent, and the measurement container which stores the pretreatment reagent for pretreating the analyte are the same, and by an autoanalyzer equipped with the kit.

Description

  The present invention relates to a reagent kit including a reaction reagent for specifically analyzing a component contained in a sample (specimen) such as blood or serum, and an automatic analyzer including the kit.

  2. Description of the Related Art In recent years, analyzers used in clinical tests have contributed to the reduction of human costs related to clinical tests and the burden on measurers by the advancement of technology and automation related to various actuators, sensors and software installed. However, even if automation progresses, there is still work to be done manually. The higher the processing speed of the apparatus, the greater the influence of human operation errors such as sample and reagent misplacement and sample pretreatment on test results, and the psychological pressure on the measurer increases.

As a supply form of the test reagent (reagent kit) used in the automatic analyzer,
(A) Straight liquid form that can be used as is,
(B) The form of the concentrate used after diluting with water,
(C) frozen form to be used after thawing;
(D) a freeze-dried form to be used by adding a redissolved solution,
Can be illustrated. Among these, the form (a) can be used as it is and the burden on the measurer is light, but it is disadvantageous in terms of transportation in terms of volume and weight. On the other hand, in the forms (b) to (d), in order to use as a test reagent, a dilution operation is performed in the form (b), a thawing operation is performed in the form (c), and a re-dissolution operation is performed in the form (d). If it is necessary and the above operation is performed manually by the measurer, a burden on the measurer is generated.

  In general, when a reagent is placed on an automatic analyzer, an erroneous operation that may occur may be an erroneous operation in preparation or pretreatment and a reagent misplacement (or misplacement). Most of these artificial mistakes can be overcome by automating the apparatus. Among the misoperations in the preparation and pretreatment, the misoperation in the dilution operation in the form (b) and the re-dissolution operation in the form (d) can be partially solved by the dispensing means provided in the automatic analyzer. Further, the thawing operation in the form (c) can be solved by using the temperature control means provided in the automatic analyzer. A reagent misplacement or misplacement can be partially solved by attaching an identification code (dot code, bar code, etc.) to the reagent container and providing the automatic analyzer with a reading means capable of reading the identification code. . This is because the reading means generally reads the identification code and can store the coordinates of the reagent container by a displacement sensor, a pulse motor or the like.

In the case of an automatic analyzer that performs heterogeneous immunoassay, all or part of the following components are usually used as samples and reagents (reagent kits).
(1) a reaction reagent containing a specific binding agent such as an antibody bound to a solid phase carrier and another specific binding agent bound to a labeling substance (2) a measurement sample (specimen)
(3) A standard product for preparing a calibration curve containing a known amount of the target component (also called a standard solution if it is a calibrator or a liquid)
(4) Quality control sample (also called control)
(5) Specimen diluent added in common or common to the test item to dilute the sample containing the target component or excessive interfering component present at a concentration exceeding the measurement range (6) The target component in the sample before measurement Pre-treatment reagent (7) to be converted into a detectable form (7) Diluted water or buffer solution common to test items (in order to stabilize the measurement result by adding a predetermined amount to the sample to make the sample liquid and viscosity uniform) 8) Enzyme substrate or sensitizer used in detection reactions common to test items (9) Washing water used for B / F (Bound / Free) separation (washing) Of these, reagents common to test items (( 7) to (9)) can be regarded as consumables for the analyzer rather than a part of the reagent kit. These common reagents can be prepared in quantities sufficient for a plurality of tests, and if they are put in their respective characteristic containers, the operator's human error will not be a problem.

  The reaction reagent (1), which plays a central role in the measurement by the automatic analyzer, has been variously devised conventionally in consideration of the occurrence of human error when placed on the apparatus. For example, a reagent used for one measurement is stored in each reagent container and supplied in a form in which the reagent container is placed on a tray having a grid-like holding hole (see Patent Document 1). ). When only one reagent container of the same type is stored in one tray, an identification code (bar code) indicating the contents of the stored reagent container is attached to the edge of the tray. The measurer stores the tray in a predetermined place of the automatic analyzer. The reading means provided in the automatic analyzer also serves as a sensor for identifying the presence or absence of the reagent container, and can recognize the arrangement information of the reagent container. The transport means provided in the automatic analyzer selects and grasps a necessary reagent based on the recognized reagent container arrangement information and a separately provided test program, and then performs the next process (for example, a sample dispensing processing unit). Transport to. As another contrivance, an apparatus configuration is disclosed in which individual reagent containers and measurement containers are placed in a mixed state on a single transport means, rather than being placed in the storage means together with the tray on which the reagent containers are placed. (See Patent Document 2). In the above-described configuration, the room for the intervention of the misplacement of the reagent container or the like by the measurer is larger than the case where the tray is supplied to the supply unit. For this reason, the inspection program (work list) in which one or more specific components to be measured for the measurement sample are associated with the information on the contents of the reagent container read by the reading means installed along the transport path is collated. Therefore, the human error of the measurer is eliminated or detected. When the reaction reagent (1) is supplied in a container containing a reaction reagent (for example, a labeling reagent) for a plurality of measurements, the measurer usually places the container at a predetermined position of the automatic analyzer. The container is provided with an identification code so that the apparatus can recognize the contents of the container. The automatic analyzer can automatically dispense a part of the reagent in the container into the reaction container at a predetermined timing according to the measurement program.

  With respect to the measurement sample (2), in a facility that does not use means for automatically transporting the specimen, the specimen is placed in a predetermined place on the apparatus with a measurer intervening in a measuring tube dedicated to a blood collection tube or an automatic analyzer. There may be work to place. Usually, an identification code is attached to the blood collection tube or measurement container to be placed, and the location and information of the sample attached to the identification code can be automatically read by a reading means provided in the apparatus. For this reason, the measurer does not need to pay attention to the correspondence between the order of examination requests and the arrangement of specimens. On the other hand, in the case of a blood collection tube or a measurement container without an identification code, after the test request information including the sample ID, the test item, and the mounting position is input in the automatic analyzer in advance, the sample container is mounted at the input mounting position. Must be placed. For this reason, there is a risk of misplacement (placement error) during placement.

  For the standard product (3), when everything is supplied in a straight solution that can be used as it is regardless of the presence or absence of the target component, when all are supplied in lyophilized form, those that do not contain the target component are used as a straight solution. Those containing ingredients are supplied in various forms, such as when supplied in lyophilized form. When the standard product (3) is supplied in lyophilized form, the measurer adds a predetermined amount of redissolved solution (usually purified water) to make a solution, then transfers the solution to a dedicated measuring container for automatic analysis. Place it at the position specified by the device. In this case, mistakes and misplacements during preparation can occur.

  As for the quality control sample (4), when using a sample supplied in lyophilized form, after dispensing and dissolving a predetermined re-dissolved solution, the same as for the measurement sample (2) (for example, dedicated to an automatic analyzer) And place on the apparatus. The placed quality control sample (4) can be managed by reading the identification code attached to the label of the quality control sample (4) with a handy scanner or inputting the identification information of the quality control sample. The position of the sample (4) is recognized.

  The specimen dilution liquid (5) may be supplied as a straight liquid that can be used as it is or supplied as a concentrated liquid. When the liquid is supplied as a straight liquid, the container containing the liquid may be set at a predetermined position. When the concentrate is supplied, an operation of diluting and preparing from the concentrate is necessary, and the prepared specimen dilution liquid for a plurality of times of measurement is transferred to a dedicated container. The measurer places the container at a position designated by the apparatus. If the identification code is attached, the position and type of the sample diluent can be recognized by the reading means provided in the automatic analyzer. In either case, the apparatus automatically dispenses the sample diluent together with the measurement sample into the sample dilution container at a predetermined timing according to the measurement program. Also for the sample dilution liquid, errors and misplacements (placement errors) may occur during dilution preparation.

  As for the pretreatment reagent (6), a pretreatment reagent set composed of a plurality of reagents supplied in a freeze-dried form, a solution form, or a mixture thereof can be exemplified. As a pretreatment method, there is a method in which the constituent reagents are mixed with each other and then contacted with a specimen, or the contact is performed for a predetermined time and then treated with another pretreatment reagent. When the reagents are mixed with each other, manual work is required, and the reagent is manually placed on the apparatus. In this case, mistakes in the preprocessing operation and misplacements (placement mistakes) may occur.

  In order to avoid the reagent preparation and misplacement of the reagents as much as possible, and to advance automation of the automatic analyzer, there is a reagent cartridge that contains almost all of the reagents required for one measurement divided into multiple wells. (See, for example, Patent Documents 3 and 4). The cartridge is provided with a well containing a reagent, a well containing a sample diluent, a well containing a cleaning solution, a well containing an enzyme substrate, and the like.

Japanese Examined Patent Publication No. 3-58668 Japanese Patent No. 3988306 JP 2009-150912 A JP 2001-349896 A

  As described above, there are various forms of supply of the measurement reagent used in the automatic analyzer, and when a reagent is placed on the automatic analyzer, an artificial error that may occur is in preparation and pretreatment. There are misoperations and reagent misplacement (or mounting errors). Most of the human error can be overcome by automation of the apparatus. However, since the conventional reagent has various supply forms and container shapes, there is still room for erroneous operation. For this reason, the burden on the measurer is large, and the possibility of producing erroneous test results due to tension, fatigue, etc. cannot be ignored.

  A container containing the reaction reagent (1), a container containing the standard product (3), a container containing the quality control sample (4), a container containing the sample diluent (5), and a pretreatment reagent (6) If the shape and appearance of the container are different from those of the containers to be stored, it is preferable for the measurer to identify and operate them. However, for the supplier, production facilities must be diversified, which is economically inconvenient. Furthermore, when automation of measurement operations using automatic analyzers with variously shaped containers is required, it is necessary to diversify the transport means and storage means, which increases the number of component types and the size of the apparatus. Leading to

  Dedicated multi-well cartridges (see Patent Documents 3 and 4) with reagents necessary for one measurement are preferable for devices that measure specific target components exclusively, but various measuring reagents and measurements It is not necessarily suitable for general-purpose automatic analyzers that require a method (see Patent Document 4).

  The frequency of preparing a calibration curve using the standard product (3) and the frequency of measuring the quality control sample (4) are determined according to the quality control schedule in the laboratory where the automatic analyzer is installed. In many cases, the calibration curve is updated as the reagent lot is changed or the measurement conditions are changed. Furthermore, inspection items that require sample dilution and inspection items that require pretreatment are limited to some items. In any case, the standard product (3), the quality control sample (4), the sample diluent (5), and the pretreatment reagent (6), which are relatively infrequently used, are incorporated into the reagent cartridge of the reaction reagent (1). It is not preferable. For example, if the same type of reagent cartridge is used for an item that requires several dilutions and an item that does not require dilution, the dilution well is not used for the items that do not require dilution. Further, since the reagent cartridge is increased in size, the degree of freedom in designing the transport means provided in the automatic analyzer is limited.

  Therefore, the present invention provides a reagent kit that reduces the burden on the measurer when handling the measurement reagent used in the automatic analyzer, and that is suitable for rationalizing the design of the production facility of the measurement reagent and the automatic analyzer. For the purpose.

The present invention made to achieve the above object includes the following inventions:
The first invention is
(1) a measurement container containing a reaction reagent;
(2) Measurement container containing the standard component, measurement container containing the quality control sample component, measurement container containing the sample diluent component, measurement containing the pretreatment reagent for pretreatment of the sample At least one of the containers, and
A reagent kit comprising:
A measurement container containing the reaction reagent, a measurement container containing the components of the standard product, a measurement container containing the components of the quality control sample, a measurement container containing the components of the specimen diluent, and the sample In the kit, the external shapes of the measurement containers containing pretreatment reagents for pretreating are all the same.

The second invention is
(1) a measurement container storage tray on which a plurality of measurement containers containing reaction reagents are placed;
(2) Measurement container storage tray on which a plurality of measurement containers containing standard constituent components are placed, measurement container storage tray on which a plurality of measurement containers containing constituent components of a quality control sample are placed, and constituent components of a sample diluent And at least one of a measurement container storage tray in which a plurality of measurement containers containing a pretreatment reagent for preprocessing a sample are placed,
A reagent kit comprising:
A measurement container containing the reaction reagent, a measurement container containing the components of the standard product, a measurement container containing the components of the quality control sample, a measurement container containing the components of the specimen diluent, and the sample The external shape of the measurement container containing the pretreatment reagent to be pretreated is the same,
Measurement container storage tray for mounting a plurality of measurement containers containing the reaction reagent, measurement container storage tray for mounting a plurality of measurement containers storing the components of the standard product, components of the quality control sample A measurement container storage tray for mounting a plurality of measurement containers for storing the sample, a measurement container storage tray for mounting a plurality of measurement containers for storing the components of the sample diluent, and the sample in front In the kit, the external shapes of the measurement container storage trays for mounting a plurality of measurement containers for storing pretreatment reagents to be processed are the same.

  The third invention is the kit according to the first or second invention, wherein the contents of the measurement container are sealed with a seal, and a code for identifying the contents is attached to the surface of the seal. It is.

  A fourth invention is the kit according to any one of the first to third inventions, wherein the measurement container is a double container in which two wells are connected.

  A fifth invention is the kit according to any one of the first to fourth inventions, wherein the content of the measurement container is a lyophilized product.

The sixth invention is
Storage means for storing the measurement container;
Conveying means for conveying the measurement container;
Dispensing means for sucking / discharging liquid into the measuring container;
A reaction means for reacting the solution contained in the measurement container;
Detection means for detecting light from the solution contained in the measurement container;
An automatic analyzer equipped with
In the automatic analyzer, the measurement container stored in the storage means is the measurement container provided in the kit according to any one of the first to fifth inventions.

The seventh invention
Storage means for storing the measurement container provided in the kit according to any one of the first to fifth inventions;
First transport means for transporting the measurement container stored in the storage means;
Dispensing means for sucking / discharging liquid into the measuring container;
A reaction means for reacting the solution contained in the measurement container;
A second transport means for transporting the measurement container to the reaction means;
Detection means for detecting light from the solution contained in the measurement container;
A third transport means for transporting the measurement container to the detection means;
Accept the measurement container transported by the first transport means, position to transport the measurement container to the reaction means by the second transport means, position to transport to the detection means by the third transport means, and dispensing means Transport means capable of transporting the specimen and / or dispensed water to a position for aspirating / discharging;
It is an automatic analyzer equipped with.

The eighth invention is
The transport means is
A measurement container holding part for placing a measurement container containing a reaction reagent,
A measurement container containing a standard component, a measurement container containing a quality control sample component, a measurement container containing a sample diluent component, and a measurement container containing a pretreatment reagent for pretreating a sample A measurement container holding part for placing any one of them,
This is an automatic analyzer according to the seventh invention, which is means provided with the above.

  Hereinafter, the present invention will be described in detail.

  The reagent in the present invention means a chemical / biochemical product involved in measurement of a measurement sample (specimen). In other words, standard products and quality control samples may be handled as reagents. In addition, the measurement container in the present invention means not only a measurement container or reaction container for reacting a measurement sample (sample) and a reagent to measure a target component in the sample, but also a reagent container containing a reagent. Also means.

  With the reagent kit of the present invention, for the measurer, when placing the reagent in the storage means provided in the automatic analyzer, the standard product, the quality control sample, Reagents such as a sample diluent and a pretreatment reagent can be placed. On the other hand, since it is not necessary for the supplier to manufacture measurement containers of various shapes, it is possible to contribute to rationalization of reagent manufacturing facilities. Further, the automatic analyzer equipped with the reagent kit of the present invention (hereinafter simply referred to as the automatic analyzer of the present invention) can maximize the number of measurement containers that can be stored in the storage means, and transport the measurement containers. Since the means can also be made common, it can contribute to miniaturization and simplification of the automatic analyzer itself.

  In addition, when a code for identifying the contents is attached to the measurement container of the reagent kit of the present invention and reading means capable of identifying and reading the code is provided in the automatic analyzer, the automatic analyzer is in accordance with the assay program. It is possible to confirm whether there are reaction reagents, standard products, quality control samples, specimen diluents, and pretreatment reagents necessary for analysis, and if not, it is possible to prompt the measurer to place these samples. Further, by attaching a code for identifying the contents, a reaction reagent, a standard product, a quality control sample, a specimen diluent, and a pretreatment reagent can be placed at any location in the storage means. For this reason, it is possible to prevent an erroneous manual operation due to a reagent placement error by the measurer, and to flexibly cope with a change in the measurement frequency of the specimen, the standard product, or the quality control sample in each measurement item.

  The reagent kit of the present invention may be provided in the form of a measurement container storage tray in which a plurality of measurement containers containing reagents are placed in order to facilitate the handling of the measurement container by a measurer. Measurement container storage tray for mounting a plurality of stored measurement containers, measurement container storage tray for mounting a plurality of measurement containers storing standard components, and measurement for storing components of a quality control sample Contains a measurement container storage tray for mounting a plurality of containers, a measurement container storage tray for mounting a plurality of measurement containers for storing the components of the sample diluent, and a pretreatment reagent for preprocessing the sample If the external shapes of the measurement container storage trays for mounting a plurality of measurement containers are the same, the measurement containers can be mounted in the storage means without waste. Since it conveyed using a common transport means is also in transporting the container housing tray, in that it can contribute to miniaturization and simplification of the automatic analyzer, preferably.

  The measurement container containing the reaction reagent and the measurement container having the same external shape means that the internal shape may or may not be the same shape. For example, the shape of the bottom surface inside the measurement container can generally be various shapes such as a flat surface, a spherical surface, a conical surface, and a paraboloid. Since the internal shape of these measurement containers has more or less suitability for each operation (for example, liquid injection, suction, and stirring), an appropriate internal shape may be adopted according to the purpose. For example, a measurement container for effectively sucking a small amount of liquid preferably has a conical bottom surface, and a measurement container for stirring purposes preferably has a spherical bottom surface. In this case, it is preferable that the bottom is a flat surface and the container is deep. That is, in the reagent kit of the present invention, a measurement container containing a reaction reagent, a measurement container containing a standard component, a measurement container containing a quality control sample component, and a measurement diluent containing a sample diluent component The container and the measurement container that contains the pretreatment reagent for pretreating the sample need only have the same external shape, and the internal shape may be the most preferable shape for each measurement container. On the other hand, a measurement container containing a reaction reagent, a measurement container containing a standard component, a measurement container containing a quality control sample component, a measurement container containing a sample diluent component, and a sample Measurement containers containing pretreatment reagents to be processed may all have the same external shape and internal shape. In that case, rationalization of measurement reagent production facilities, such as sharing of molds for manufacturing measurement containers There is an advantage that can be promoted.

  Examples of the external shape of the measurement container in the reagent kit of the present invention include individual and independent concave wells (having one opening) such as tubes, cups, and cuvettes, and those in which two or more wells are connected. Although the material of the measurement container is not particularly limited, it is preferably made of a resin in terms of manufacturing a large number of the same shape. For example, an olefin resin, a styrene resin, a vinyl resin, a carbonate resin, a polyester resin, a polyamide resin A thermoplastic resin such as a resin can be exemplified. The measurement container containing the reaction reagent, standard product, quality control sample, specimen diluent or pretreatment reagent may be sealed at its upper end opening with, for example, an aluminum foil for heat sealing or a polymer film. When a code for identifying the contents (bar code, two-dimensional code, etc.) is printed on the seal surface with a laser marker or the like, an error in placing the measurement reagent is made by means of reading the code provided in the automatic analyzer. It is preferable at the point which can prevent etc.

  One embodiment of the external shape of the measurement container in the reagent kit of the present invention is a double container in which two wells are integrated. As an example of a measurement container comprising a double container in which two wells are integrated and containing a reaction reagent for measuring a specific target component, an antibody or the like bound to a solid phase carrier in one well of the double container Examples include a measurement container containing a solution containing a specific binding agent and a solution containing another specific binding agent having a labeling substance bound to the other well. An example of a measurement container comprising a double container in which two wells are integrated, each containing a sample dilution liquid, is a measurement container containing a sample dilution liquid or a solution containing the component in two wells of a double container. . When diluting a measurement sample (specimen) in the measurement container, first dilute the first stage in one well, then transfer a part of the dilute liquid in the first stage to the other well and dilute the second stage. Can be performed. Examples of the components of the specimen diluent include human serum components such as albumin and matrix components composed of proteins. In the case of a measurement container for pretreatment of a measurement sample (specimen) by adding a neutralizing agent after reacting with a protein-denaturing reducing agent for a certain period of time (for example, tens of minutes), a protein is added to one well of a double container. A measuring container containing a denaturing reducing agent and a neutralizing agent in the other well can be exemplified, and a set of (two types of) pretreatment reagents can be operated integrally by using a double container. it can.

  In the reagent kit of the present invention, the reaction reagent, the standard product, the quality control sample, the sample diluent, and the pretreatment reagent contained in the measurement container may be the liquid reagent as it is, but the lyophilized body of the liquid reagent, It is more preferable if the measurement reagent contains the liquid reagent component or a gel containing the liquid reagent component. As an example, when the sample diluent component or pretreatment reagent is contained in a measurement container in the form of a lyophilized product, powder or gel, the measurement sample (specimen) and / or dispensing water is placed in the measurement container. By dispensing, dilution operation or pretreatment operation can be performed in the measurement container. In particular, the aspect in which the reaction reagent, standard product, quality control sample, sample diluent, and pretreatment reagent are all lyophilized and stored in the measurement container improves the storage stability of the reagent stored in the measurement container, and the reagent kit. This is most preferable because it contributes to weight reduction. As a lyophilization method for reaction reagents, standard products, quality control samples, specimen diluents or pretreatment reagents, known methods can be used. For example, after a container containing a reaction reagent in the form of a solution or suspension is frozen at −40 ° C. for 2 hours and then raised to −20 ° C. in 1.5 hours under a reduced pressure of 0.1 to 0.01 Torr, Dry at −20 ° C. for 2 hours. Furthermore, after raising to 25 degreeC in 1.5 hours, a freeze-dried body is obtained by drying at 25 degreeC for 5 hours.

As one aspect of the automatic analyzer of the present invention,
Storage means for storing the measurement container provided in the reagent kit of the present invention;
Conveying means for conveying the measurement container;
Dispensing means for sucking / discharging liquid into the measuring container;
A reaction means for reacting the solution contained in the measurement container;
Detection means for detecting light from the solution contained in the measurement container;
Since the external shape of the measurement containers stored in the storage means is the same, the number of measurement containers that can be stored in the storage means can be maximized. Further, since the conveying means can be shared, the automatic analyzer itself can be reduced in size and simplified.

As a more specific aspect of the automatic analyzer of the present invention,
Storage means for storing the measurement container provided in the reagent kit of the present invention;
First transport means for transporting the measurement container stored in the storage means;
Dispensing means for sucking / discharging liquid into the measuring container;
A reaction means for reacting the solution contained in the measurement container;
A second transport means for transporting the measurement container to the reaction means;
Detection means for detecting light from the solution contained in the measurement container;
A third transport means for transporting the measurement container to the detection means;
Accept the measurement container transported by the first transport means, position to transport the measurement container to the reaction means by the second transport means, position to transport to the detection means by the third transport means, and dispensing means Transport means capable of transporting the specimen and / or dispensed water to a position for aspirating / discharging;
There is an automatic analyzer equipped with.

  When performing analysis using the automatic analyzer of the above aspect, when analyzing a trace component in a sample with a reaction reagent, only the measurement container containing the reaction reagent in the reagent kit of the present invention may be used. . On the other hand, when a specimen is diluted or pretreated and analyzed with a reaction reagent, or when a standard product or a quality control sample is analyzed with a reaction reagent, the reagent kit of the present invention includes a measurement container containing the reaction reagent and a standard product. The measurement is performed using two types, a quality control sample, a specimen diluent, and a measurement container containing any of the pretreatment reagents. Therefore, it is preferable that the transfer means in the automatic analyzer of the present invention is provided with at least two measurement container holders, and as one preferred transfer means, a measurement container holder for placing a measurement container containing a reaction reagent. And a measurement container containing the components of the standard product, a measurement container containing the components of the quality control sample, a measurement container containing the components of the sample diluent, and a measurement container containing the pretreatment reagent for pretreating the sample And a measuring container holding part for placing any of the above.

The reagent kit of the present invention comprises:
(1) a measurement container containing a reaction reagent;
(2) Measurement container containing the standard component, measurement container containing the quality control sample component, measurement container containing the sample diluent component, measurement containing the pretreatment reagent for pretreatment of the sample At least one of the containers, and
A measurement container containing the reaction reagent, a measurement container containing the components of the standard product, a measurement container containing the components of the quality control sample, and a measurement container containing the components of the sample diluent And the external shape of the measurement container containing the pretreatment reagent for pretreating the specimen is the same. Therefore, it is possible for the supplier to contribute to rationalization of the reagent kit manufacturing facility. In addition, the automatic analyzer equipped with the reagent kit of the present invention (the automatic analyzer of the present invention) can maximize the number of measurement containers that can be stored in the storage means, and can share the transport means for transporting the measurement containers. This can contribute to the miniaturization and simplification of the analyzer itself.

  Furthermore, the reagent kit of the present invention may be provided in the form of a measurement container storage tray in which a plurality of measurement containers containing reagents are placed. By making the external shape of the measurement container storage tray the same, the automatic analyzer Since the measurement container can be placed without waste in the storage means provided in the case, and the measurement container storage tray on which a plurality of measurement containers are placed can be transported using a common transport means, This is particularly preferable because it can contribute to miniaturization and simplification, and also facilitates the handling of the reagent kit for the measurer.

  The contents of the measurement container provided in the reagent kit of the present invention are sealed with a seal, and a code for identifying the contents is attached to the surface of the seal, and means for reading the code is an automatic analyzer of the present invention. The measurer places various reagents (reaction reagents, standard products, quality control samples, sample diluents, pretreatment reagents) in designated locations in the storage means provided in the automatic analysis means. In doing so, it is possible to reduce human error such as burden on the measurer and placement errors.

It is the figure which showed the one aspect | mode at the time of setting the concave resin container which has one opening part among the reagent kits of this invention as a measurement container. (A) is a reaction reagent, (b) is a standard product, (c) is a reagent container containing and enclosing a quality control sample in a freeze-dried state, and the reagent container is placed on a measurement reagent storage tray. An embodiment is shown. It is the figure which showed the one aspect | mode at the time of setting the concave resin container which has one opening part among the reagent kits of this invention as a measurement container. (A) shows a specimen diluent, (b) shows a reagent container containing and enclosing a pretreatment reagent in a lyophilized state, and a mode in which the reagent container is placed on a measurement reagent storage tray. It is the figure which showed the one aspect | mode at the time of making into a measurement container the resin-made double container which connected two wells among the reagent kits of this invention. (A) is a reaction reagent, (b) is a standard product, (c) is a reagent container containing and enclosing a quality control sample in a freeze-dried state, and the reagent container is placed on a measurement reagent storage tray. An embodiment is shown. It is the figure which showed the one aspect | mode at the time of making into a measurement container the resin-made double container which connected two wells among the reagent kits of this invention. (A) shows a specimen diluent, (b) shows a reagent container containing and enclosing a pretreatment reagent in a lyophilized state, and a mode in which the reagent container is placed on a measurement reagent storage tray. It is the figure which showed an example of the automatic analyzer of this invention. It is the figure which linked | related the step of the conveyance process and the dispensing process, and the operation | movement of a measurement container transfer block in the case of measuring a measurement sample (specimen) directly with a reaction reagent. It is the figure which correlated each step of a conveyance process and a dispensing process in the case of measuring a standard goods or a quality control sample, and operation | movement of a measurement container transfer block. It is a figure in which each step of a conveyance process and a dispensing process in the case of measuring after diluting a sample using a measurement container containing a sample diluent is associated with the operation of a measurement container transfer block. The figure which linked each step of a conveyance process and a dispensing process, and the operation | movement of a measurement container transfer block in the case of measuring, after measuring a measurement sample (specimen) using the measurement container which accommodated the pretreatment reagent. It is.

  Hereinafter, the present invention will be described in more detail with reference to the drawings.

  FIGS. 1 and 2 show an embodiment of the reagent kit of the present invention in which a concave resin container having one opening is used as a measurement container. 1 and 2, the measurement container 10 is a concave resin container having one opening having an inner diameter of 15 mm at the upper opening, an inner diameter of 7 mm at the bottom, and a height of 20 mm.

  FIG. 1A shows a measurement container 10 containing a reaction reagent capable of specifically analyzing a target component in a measurement sample (specimen), and measurement in which the measurement container 10 is provided with a grid-like measurement container holding hole. The mode which mounted in the reagent storage tray 20 is shown. The measurement container 10 in FIG. 1A includes a magnetic bead on which an antibody that recognizes a target component (for example, BMG (β2-microglobulin)) is immobilized, and another antibody that recognizes an enzyme-labeled target component (BMG). The solution containing is enclosed by an aluminum foil seal 11 in a lyophilized state. An inspection item name (BMG) and an identification code (dot code) 11a are attached to the surface of the aluminum foil seal 11. When measuring with the automatic analyzer, the measuring container 10 is placed on the measuring reagent storage tray 20 and provided in the automatic analyzer to perform an analysis operation. An identification code (bar code) 21 for identifying the contents of the measurement container 10 is attached to the upper right of the measurement reagent storage tray 20.

  FIG. 1 (b) shows a standard product set of target components (for example, BMG), in which standard products 1 to 6 containing target components (BMG) with contents corresponding to six levels of concentrations are freeze-dried as shown in FIG. The aspect which accommodated in the measurement container 10 of the same shape and the same dimension as the measurement container of a), and the aspect which mounted the said measurement container 10 in the measurement reagent storage tray 20 provided with the grid-like measurement container holding hole are shown. . On the surface of the aluminum foil seal in the measurement container 10, an identification code 11a capable of specifying each content is attached. The form of the measurement reagent storage tray 20 may be the same shape and the same size as in FIG. Note that S1 to S6 on the right side of FIG. 1B indicate standard products 1 to 6, respectively. An identification code (barcode) 21 for identifying the contents of the measurement container 10 (standard product of the target component (BMG)) is attached to the upper right of the measurement reagent storage tray 20.

  FIG. 1C shows, as a control set, a quality control sample (CTL-1 to CTL-3) containing a target component having a content corresponding to three levels of concentration in a freeze-dried state with the measurement container of FIG. An aspect in which the measurement container 10 is accommodated in the same shape and the same size and an aspect in which the measurement container 10 is placed on a measurement reagent storage tray 20 provided with a grid-like measurement container holding hole are shown. On the surface of the aluminum foil seal in the measurement container 10, an identification code 11a capable of specifying each content is attached. The form of the measurement reagent storage tray 20 may be the same shape and the same size as in FIG. Note that C1 to C3 on the right side of FIG. 1C indicate CTL-1 to CTL3, respectively. An identification code (barcode) 21 for identifying the contents (control set) of the measurement container 10 is attached to the upper right of the measurement reagent storage tray 20.

  FIG. 2 (a) shows a measurement of the same shape and the same dimensions as the measurement container of FIG. 1 (a) in a freeze-dried state using the sample dilution component of the target component (BMG) as the sample dilution solution of the target component (for example, BMG). The aspect accommodated in the container 10 and the aspect which mounted the said measurement container 10 in the measurement reagent storage tray 20 provided with the grid-like measurement container holding hole are shown. On the surface of the aluminum foil seal in the measurement container 10, an identification code 11a capable of specifying each content is attached. The form of the measurement reagent storage tray 20 may be the same shape and the same size as in FIG. An identification code (bar code) 21 for identifying the contents (sample dilution liquid) of the measurement container 10 is attached to the upper right of the measurement reagent storage tray 20.

  FIG. 2 (b) shows two types of pretreatment reagents (pretreatment reagents 1 and 2) of the target component (FOL) as a pretreatment reagent for the target component (for example, FOL (folic acid)) in a lyophilized state. (A) The aspect accommodated in the measurement container 10 of the same shape and the same dimension as the measurement container, and the aspect which mounted the said measurement container 10 in the measurement reagent storage tray 20 provided with the grid-like measurement container holding hole are shown. Yes. On the surface of the aluminum foil seal in the measurement container 10, an identification code 11a capable of specifying each content is attached. The form of the measurement reagent storage tray 20 may be the same shape and the same size as in FIG. Note that P1 and P2 on the right side of FIG. 2B indicate pretreatment reagents 1 and 2, respectively. Further, an identification code (bar code) 21 for identifying the contents (pretreatment reagent) of the measurement container 10 is attached to the upper right of the measurement reagent storage tray 20.

  FIGS. 3 and 4 show an embodiment of the reagent kit of the present invention in which a resin-made double container connecting two wells is used as a measurement container. 3 and 4, a measurement container 10 is a resin container in which cylindrical recesses having an inner diameter of 6 mm and an opening of 20 mm are arranged in parallel through a minimum thickness part of about 1 mm.

  FIG. 3A shows a measurement container 30 containing a reaction reagent capable of specifically analyzing a target component in a measurement sample (specimen), and measurement in which the measurement container 30 is provided with a grid-like measurement container holding hole. The mode which mounted in the reagent storage tray 40 is shown. In the measurement container 30 of FIG. 3A, for example, a solution (solid phase reagent) containing magnetic particles in which an antibody recognizing a target component (for example, BMG) is immobilized is provided in one well 32a, and the other well 32b. Each of them contains a solution (labeling reagent) containing another antibody recognizing the target component (BMG) labeled with an enzyme, and sealed in an aluminum foil seal 31 in a lyophilized state. An inspection item name (BMG) and an identification code (two-dimensional code) 31a are attached to the surface of the aluminum foil seal 31. When the measurement is performed by the automatic analyzer, the measurement container 30 is provided in the automatic analyzer in a state of being placed on the measurement reagent storage tray 40 to perform analysis work. An identification code (bar code) 41 for identifying the contents of the measurement container 30 is attached to the upper right of the measurement reagent storage tray 40. In the case of immunoassay by the sandwich method, a reaction in which a solid phase reagent is stored in one well 32a and a labeled reagent is stored in a lyophilized state in the other well 32b of the two wells 32a and 32b provided in the measurement container 30. Reagents can be used. By accommodating the solid phase reagent and the labeling reagent in separate wells, the labeling substance is prevented from adsorbing nonspecifically to the solid phase, which helps to reduce the background signal.

  FIG. 3B shows a standard product set of target components (for example, BMG), in which standard products 1 to 6 containing the target component (BMG) having a content corresponding to six levels of concentrations are freeze-dried as shown in FIG. The aspect which accommodated in the measurement container 30 of the same shape and the same dimension as the measurement container of a) and the aspect which mounted the said measurement container 30 in the measurement reagent storage tray 40 provided with the grid-like measurement container holding hole are shown. . An identification code 31a for identifying each content is attached to the surface of the aluminum foil seal in the measurement container 30. In FIG. 3B, the same standard components are contained in the two wells 32a and 32b provided in the measurement container 30, but the automatic analyzer can distinguish the positions of the two wells. May accommodate different standard products in the well 32a and the well 32b. The form of the measurement reagent storage tray 40 may be the same shape and the same size as in FIG. Note that S1 to S6 on the right side of FIG. 3B indicate standard products 1 to 6, respectively. An identification code (barcode) 41 for identifying the contents of the measurement container 10 (standard product of the target component (BMG)) is attached to the upper right of the measurement reagent storage tray 40.

  FIG. 3 (c) shows a control sample containing CTLs (CTL-1 to CTL-3) containing a target component with a content corresponding to three levels of concentration in a freeze-dried state with the measurement container of FIG. 3 (a). The mode which accommodated in the measurement container 30 of the same shape and the same dimension and the aspect which mounted the said measurement container 30 in the measurement reagent storage tray 40 provided with the grid-shaped measurement container holding hole are shown. An identification code 31a for identifying each content is attached to the surface of the aluminum foil seal in the measurement container 30. In FIG. 3C, the same quality control sample is accommodated in the two wells 32a and 32b provided in the measurement container 30, but the automatic analyzer can distinguish the positions of the two wells. May contain different quality control samples in the well 32a and the well 32b. The form of the measurement reagent storage tray 20 may be the same shape and the same size as in FIG. Note that C1 to C3 on the right side of FIG. 3C indicate CTL-1 to CTL3, respectively. An identification code (bar code) 41 for identifying the contents (control set) of the measurement container 30 is attached to the upper right of the measurement reagent storage tray 40.

  FIG. 4A shows the measurement of the same shape and the same dimensions as the measurement container of FIG. 3A in the lyophilized state, with the sample dilution component of the target component (BMG) as the sample dilution solution of the target component (for example, BMG). The aspect accommodated in the container 30 and the aspect which mounted the said measurement container 30 in the measurement reagent storage tray 40 provided with the grid-like measurement container holding hole are shown. An identification code 31a for identifying each content is attached to the surface of the aluminum foil seal in the measurement container 30. The two wells 32a and 32b provided in the measurement container 30 contain the same specimen diluent component assuming that the specimen is diluted in two stages. The form of the measurement reagent storage tray 40 may be the same shape and the same size as in FIG. An identification code (bar code) 41 for identifying the contents (sample dilution liquid) of the measurement container 30 is attached to the upper right of the measurement reagent storage tray 40.

  FIG. 4B shows two types of pretreatment reagents for the target component (FOL) as the pretreatment reagents for the target component (for example, FOL (folic acid)) in the same shape as the measurement container of FIG. -The aspect accommodated in the measurement container 30 of the same dimension, and the aspect which mounted the said measurement container 30 in the measurement reagent storage tray 40 provided with the grid-like measurement container holding hole are shown. The measurement container 30 contains a protein-denaturing reducing agent as a pretreatment reagent 1 in one well 32a and a neutralizing agent as a pretreatment reagent 2 in a lyophilized state in the other well 32b. An identification code 31a for identifying each content is attached to the surface of the aluminum foil seal in the measurement container 30. The form of the measurement reagent storage tray 40 may be the same shape and the same size as in FIG. An identification code (bar code) 41 for identifying the contents (pretreatment reagent) of the measurement container 30 is attached to the upper right of the measurement reagent storage tray 40.

  FIG. 5 shows an example of the automatic analyzer 100 of the present invention using the measurement container composed of the double container shown in FIGS. The measurement container storage means 110 is mounted with a measurement container that contains and encloses the contents in a freeze-dried state. Specifically, the measurement container storage means 110 stores a storage tray 111 of a measurement container (TC) that contains a reaction reagent, and a standard product. The storage tray 112 of the measured container (CAL), the storage tray 113 of the measurement container (CTL) containing the quality control sample, the storage tray 114 of the measurement container (DIL) containing the sample diluent, and the pretreatment reagent A storage tray 115 for the measurement container (PRE) is stored. The measurement container placed in the measurement container storage means 110 is transported to the receiving position A by the measurement container transport means 116. The measurement container transport means 116 can freely move in the XYZ axes composed of the X axis and Y axis perpendicular to each other in the horizontal plane that covers the entire measurement container storage means 110, and the Z axis in the vertical direction. A suction conveyance mechanism, a clamping mechanism, and other chuck mechanisms for picking up or placing are provided. Furthermore, the measurement container transport means 116 detects the presence or absence of a sensor (not shown in FIG. 5) and a sensor that optically reads the identification information of the inspection item and reagent type attached to the edge of each storage tray and each measurement container. Sensor (not shown in FIG. 5). Further, the measurement container transport means 116 also has a sensor function of a measurement container stock mapping means (not shown in FIG. 5) for storing arrangement information of each measurement container in the measurement container supply means 110. The automatic analyzer 100 searches the mapping means for a measurement container required by the work list in which the examination items to be analyzed for each sample are associated, and the measurement container transport means 116 finds the target measurement container at a predetermined receiving position A. Transport to.

  As shown in FIG. 5, the receiving position A is located at one end of a track that can be reached by both of the two measurement container holding portions 121 provided in the measurement container transfer block 120. In the measurement container transfer block 120, the measurement container placed on the measurement container holding part 121 is transferred from the receiving position A to the dispensing position B via the position E, and both of the two measurement container holding parts 121 reach. It is possible to move on a linear track that can reciprocate so as to be transferred to a transfer relay point C located at the other end of the possible track. Further, by providing a driving means (not shown in FIG. 5) for applying vibration to the measurement container transfer block 120, dissolution / mixing of the lyophilized material in the measurement container can be promoted. It is preferable that the driving means for applying the vibration is provided on the dispensing position B, the transfer relay point C, or the trajectory therebetween.

  As shown in FIG. 5, on the track between the receiving position A and the position E, an identification code reading means 130 and a seal breaking means 140 for finally confirming the identification code attached to the measurement container are provided. I have. The dispensing unit 150 includes a dispensing tip supply unit 151, a dispensing water supply unit 152, a sample supply unit 153, and a nozzle 154 that can freely move on a track connecting the dispensing positions B. The dispensing unit 150 transports the nozzle 154 to the dispensing tip supply unit 151, attaches the dispensing tip to the nozzle 154, sucks the dispensing water after transporting to the dispensing water supply unit 152. Thereafter, the sample is fed to the sample supply unit 153, the sample is aspirated, and the sample is transported to the dispensing position B, whereby the dispensed water and the mixed solution of the sample can be dispensed into the measurement container located at the dispensing position B. The measurement container into which the sample is injected at the dispensing position B is transferred to the transfer relay point C by the measurement container transfer block 120 and then moved to the position D on the reaction table 171 provided in the reaction means 170 by the measurement container transfer means 161. Be transported. The measurement container transported to the position D is transported by the reaction table 171 to the position of the first B / F separation means (cleaning means) 172a over a predetermined time under constant temperature control. The first B / F separation means (washing means) 172a separates excess specimen from the solid phase, and the labeling reagent dispensing means 173 subsequently dispenses the labeling reagent. The measurement container into which the labeling reagent has been dispensed is further transported to the position of the second B / F separation means (washing means) 172b over a predetermined time, and the excess labeling reagent is separated from the solid phase. The measurement container after the end of the immune reaction (second B / F separation end) is transported again to position D, and then the measurement container holding part of the measurement container transport block 120 on the transport relay point C by the measurement container transport means 161 It is conveyed to 121. The conveyed measurement container passes through the dispensing position B, and the substrate is dispensed at the position where the substrate dispensing means 180 is provided. The measurement container into which the substrate is dispensed is transferred to the position E by the measurement container transfer block 120 and then transferred to the detection means 190 by the measurement container transfer means 162.

  Next, each of the transporting step and the dispensing step when the measuring container comprising the double container shown in FIGS. 3 and 4 is used as the reagent kit of the present invention and the apparatus shown in FIG. Each step will be described in detail (FIGS. 6 to 9). Measurement samples (samples), standard products, quality control samples, diluted samples, and pre-processed samples are automatically measured by a combination of operation timings of the measurement container transfer block 120 and the dispensing means 150 provided in the automatic analyzer 100. Can be measured.

  FIG. 6 shows that when a measurement sample (specimen) is directly measured with a reaction reagent, the measurement container is placed at the receiving position A from the measurement container storage means, and then the measurement container is transferred to the position D on the reaction table 171. It is the figure which linked | related the operation | movement of the measurement container transfer block 120 with each step of a conveyance process and a dispensing process until. The operation steps of the identification code reading means and the seal breaking means are omitted.

  First, a measurement container (TC) containing a reaction reagent after transferring the measurement container transfer block 120 so that one of the two measurement container holding parts provided in the measurement container transfer block 120 is located at the receiving position A. Is placed on the measurement container holder (step S11). Next, after transferring the measurement container transfer block 120 so that the placed measurement container is positioned at the dispensing position B, the dispensing water and the sample are accommodated in the well containing the solid phase reagent in the TC, and the labeling reagent is accommodated. Dispensing water is dispensed to each well by the dispensing means 150, and the lyophilized reagent is dissolved (step S12). In addition, dissolution of the labeling reagent may be carried out by separately providing a dispensing water dispensing mechanism before and after the dispensing position B (for example, a position in parallel with the substrate dispensing means) or at an initial transfer position on the reaction table 171. . Then, after the measurement container transfer block 120 is transferred so that TC is positioned at the transfer relay point C (step S13), TC is picked up from the measurement container transfer block 120 by the measurement container transfer means and moved to position D on the reaction table 171. Transport (step S14).

  FIG. 7 shows the transport from when the measurement container is placed at the receiving position A from the measurement container storage means to when the measurement container is transported to the position D on the reaction table 171 when measuring a standard product or a quality control sample. It is the figure which linked | related the step of the process and the dispensing process, and operation | movement of the measurement container transfer block 120. FIG.

  First, a measurement container (CAL) containing a standard product after transferring the measurement container transfer block 120 so that the left holding part of the two measurement container holding parts provided in the measurement container transfer block 120 is positioned at the receiving position A. Alternatively, the measurement container (CTL) containing the quality control sample is placed on the left holding part (step S21). Next, after the measurement container transfer block 120 is transferred so that the right holding part of the two measurement container holding parts provided in the measurement container transfer block 120 is positioned at the receiving position A, the TC is mounted on the right holding part. (Step S22). Next, the measurement container transfer block 120 is transferred so that CAL or CTL (the left holding part) is positioned at the dispensing position B, and the lyophilized standard is obtained by dispensing dispensing water by the dispensing means 150. After the product or quality control sample is dissolved, the solution (measurement sample) is sucked by the dispensing means 150 (step S23). Next, the measurement container transfer block 120 is transferred so that the TC (the right holding part) is located at the dispensing position B, and the dispensing means 150 sucks the TC in the well containing the solid phase reagent. Dissolving solution (measurement sample) is discharged, and dispensing water is dispensed into the well containing the labeling reagent by the dispensing means 150 (step S24). As in the case of FIG. 6, the dissolution of the labeling reagent is performed separately before and after the dispensing position B (for example, a position in parallel with the substrate dispensing means) or at an initial transfer position on the reaction table 171. It may be provided and implemented. Then, after the measurement container transfer block 120 is transferred so that TC is positioned at the transfer relay point C (step S25), TC is picked up from the measurement container transfer block 120 by the measurement container transfer means and moved to position D on the reaction table 171. Transport (step S26). When measuring a standard product or a quality control sample, a plurality of standard products or quality control samples with different concentrations are measured, so that step S21 is executed again for another standard product or quality control sample (step S21). S27).

  FIG. 8 shows a case where the measurement container is placed in the receiving position A from the measurement container storage means when the measurement is performed after diluting the sample using the measurement container (DIL) containing the sample diluent. It is the figure which linked | related the step of the conveyance process and dispensing process until it conveys to the position D on the reaction table 171, and the operation | movement of the measurement container transfer block 120. FIG. When measuring a standard product or quality control sample, a lysate obtained by dispensing dispensed water into CAL or CTL was used as a measurement sample. However, when measuring a diluted sample, dispensed water and sample were added to DIL. A solution obtained by dispensing is used as a measurement sample.

First, after the measurement container transfer block 120 is transferred so that the left holding part of the two measurement container holding parts provided in the measurement container transfer block 120 is positioned at the receiving position A, the DIL is placed on the left holding part. (Step S31). Next, after the measurement container transfer block 120 is transferred so that the right holding part of the two measurement container holding parts provided in the measurement container transfer block 120 is positioned at the receiving position A, the TC is mounted on the right holding part. (Step S32).
Next, the measurement container transfer block 120 is transferred so that the DIL (the left holding part) is located at the dispensing position B, and the dispensing water and the sample are dispensed by the dispensing means 150 into one well of the DIL. In this way, after dissolving the freeze-dried sample diluent and diluting the sample, the diluted sample (measurement sample) is aspirated by the dispensing means 150 (step S33). In addition, when performing the second stage (additional) dilution, the sample dilution solution lyophilized by dispensing the diluted sample and the dispensing water into the other well of the DIL by the dispensing means 150. After the dissolution and re-dilution of the sample, the obtained re-diluted sample may be aspirated by the dispensing means 150. Next, the measurement container transfer block 120 is transferred so that the TC (the right holding part) is located at the dispensing position B, and the dispensing means 150 sucks the TC in the well containing the solid phase reagent. The diluted (or re-diluted) specimen (measurement sample) is discharged, and dispensing water is dispensed into the well containing the labeling reagent by the dispensing means 150 (step S34). As in the case of FIG. 6, the dissolution of the labeling reagent is performed separately before and after the dispensing position B (for example, a position in parallel with the substrate dispensing means) or at an initial transfer position on the reaction table 171. It may be provided and implemented. Then, after the measurement container transfer block 120 is transferred so that TC is positioned at the transfer relay point C (step S35), TC is picked up from the measurement container transfer block 120 by the measurement container transfer means and moved to the position D on the reaction table 171. Transport (step S36).

  FIG. 9 shows that the measurement container is placed in the receiving position A from the measurement container storage means when the measurement sample (specimen) is measured after pretreatment using the measurement container (PRE) containing the pretreatment reagent. 10 is a diagram in which each step of the transport process and the dispensing process until the measurement container is transported to position D on the reaction table 171 and the operation of the measurement container transfer block 120 are associated with each other. As an example of a method of measuring after pretreatment of a specimen, a specimen treated with pretreatment reagent 1 (denaturing agent) is reacted for a predetermined time on a reaction table provided in a reaction means, and then pretreatment reagent 2 (neutralization) There is a method of measuring after treatment with the agent, and FIG. 9 is an explanatory diagram in the case of performing the measurement by the method.

  First, after the measurement container transfer block 120 is transferred so that the left holding part of the two measurement container holding parts provided in the measurement container transfer block 120 is positioned at the receiving position A, the PRE is placed on the left holding part. (Step S41). Next, after the measurement container transfer block 120 is transferred so that the right holding part of the two measurement container holding parts provided in the measurement container transfer block 120 is positioned at the receiving position A, the TC is mounted on the right holding part. (Step S42). Next, the measurement container transfer block 120 is transferred so that the PRE (the left holding unit) is positioned at the dispensing position B, and the dispensing water and the sample are dispensed into the wells containing the pretreatment reagent 1 in the PRE. Dissolution of the pretreatment reagent freeze-dried by the means 150 and primary processing of the specimen are performed (step S43). Next, the measurement container transfer block 120 is transferred so that the PRE (the left holding unit) is located at the transfer relay point C (step S44). Next, the PRE is picked up from the measurement container transfer block 120 by the measurement container transfer means, conveyed to the position D on the reaction table 171 and then reacted for a predetermined time (for example, ten and several minutes) (step S45). Next, the PRE containing the reacted sample is placed on the left holding part of the measurement container transfer block 120 located at the transfer relay point C by the measurement container transfer means (step S46). Next, after transferring the measurement container transfer block 120 so that the PRE (the left holding unit) is again positioned at the dispensing position B, the sample primarily treated with the pretreatment reagent 1 is aspirated by the dispensing means 150, After the lyophilized pretreatment reagent is dissolved and the specimen is subjected to secondary treatment by discharging it to the well containing the treatment reagent 2, the secondary-treated specimen (measurement sample) is aspirated by the dispensing means 150. (Step S47). Next, the measurement container transfer block 120 is transferred so that the TC (the right holding part) is located at the dispensing position B, and the dispensing means 150 sucks the TC in the well containing the solid phase reagent. The secondary-treated sample (measurement sample) is discharged, and dispensing water is dispensed by the dispensing means 150 into the well containing the labeling reagent (step S48). As in the case of FIG. 6, the dissolution of the labeling reagent is performed separately before and after the dispensing position B (for example, a position in parallel with the substrate dispensing means) or at an initial transfer position on the reaction table 171. It may be provided and implemented. Then, after the measurement container transfer block 120 is transferred so that TC is located at the transfer relay point C (step S49), TC is picked up from the measurement container transfer block 120 by the measurement container transfer means and moved to position D on the reaction table 171. Transport (step S50).

  The TC transported on the reaction table 171 by the method of FIGS. 6 to 9 is subjected to the first B / F separation, the dispensing of the labeling reagent, the second B after the predetermined reaction time has elapsed under constant temperature control. The process of detecting the target component labeled through / F separation and substrate dispensing is reached. The above-described embodiment is an immunoassay of a two-step sandwich method, but the present invention is also applicable to a one-step sandwich method, a sandwich method prioritizing a liquid phase reaction, a competitive measurement method, and other known immunoassays. Clearly, reagent kits are useful.

10, 30: Measurement container 11: Aluminum foil seal 11a, 21, 31a, 41: Identification code 20, 40: Measurement container storage tray 32a, 32b: Well 100: Automatic analyzer 110: Measurement container storage means 111: Measurement container storage Tray (for reaction reagent)
112: Measuring container storage tray (for standard products)
113: Measuring container storage tray (for quality control sample)
114: Measurement container storage tray (for diluent)
115: Measurement container storage tray (for pretreatment reagent)
116, 161, 162: Measurement container transport means 120: Measurement container transfer block 121: Measurement container holding part 130: Identification code reading means 140: Seal breaking means 150: Dispensing means 151: Dispensing tip supply part 152: Dispensing water Supply unit 153: Specimen supply unit 154: Nozzle 170: Reaction means 171: Reaction table 172a, 172b: Washing means 173: Labeling reagent dispensing means 180: Substrate dispensing means 190: Detection means

Claims (8)

(1) a measurement container containing a reaction reagent;
(2) Measurement container containing the standard component, measurement container containing the quality control sample component, measurement container containing the sample diluent component, measurement containing the pretreatment reagent for pretreatment of the sample At least one of the containers, and
A reagent kit comprising:
A measurement container containing the reaction reagent, a measurement container containing the components of the standard product, a measurement container containing the components of the quality control sample, a measurement container containing the components of the specimen diluent, and the sample The kit described above, wherein the external shapes of the measurement containers containing the pretreatment reagents for pretreating are all the same. (1) a measurement container storage tray on which a plurality of measurement containers containing reaction reagents are placed;
(2) Measurement container storage tray on which a plurality of measurement containers containing standard constituent components are placed, measurement container storage tray on which a plurality of measurement containers containing constituent components of a quality control sample are placed, and constituent components of a sample diluent And at least one of a measurement container storage tray in which a plurality of measurement containers containing a pretreatment reagent for preprocessing a sample are placed,
A reagent kit comprising:
A measurement container containing the reaction reagent, a measurement container containing the components of the standard product, a measurement container containing the components of the quality control sample, a measurement container containing the components of the specimen diluent, and the sample The external shape of the measurement container containing the pretreatment reagent to be pretreated is the same,
Measurement container storage tray for mounting a plurality of measurement containers containing the reaction reagent, measurement container storage tray for mounting a plurality of measurement containers storing the components of the standard product, components of the quality control sample A measurement container storage tray for mounting a plurality of measurement containers for storing the sample, a measurement container storage tray for mounting a plurality of measurement containers for storing the components of the sample diluent, and the sample in front The kit, wherein the external shapes of the measurement container storage trays for mounting a plurality of measurement containers for storing pretreatment reagents to be processed are the same. The kit according to claim 1 or 2, wherein the contents of the measurement container are sealed with a seal, and a code for identifying the contents is attached to a surface of the seal. The kit according to any one of claims 1 to 3, wherein the measurement container is a double container in which two wells are connected. The kit according to any one of claims 1 to 4, wherein the content of the measurement container is a lyophilized product. Storage means for storing the measurement container;
Conveying means for conveying the measurement container;
Dispensing means for sucking / discharging liquid into the measuring container;
A reaction means for reacting the solution contained in the measurement container;
Detection means for detecting light from the solution contained in the measurement container;
An automatic analyzer equipped with
The automatic analyzer, wherein the measurement container stored in the storage means is the measurement container provided in the kit according to any one of claims 1 to 5. Storage means for storing the measurement container provided in the kit according to any one of claims 1 to 5,
First transport means for transporting the measurement container stored in the storage means;
Dispensing means for sucking / discharging liquid into the measuring container;
A reaction means for reacting the solution contained in the measurement container;
A second transport means for transporting the measurement container to the reaction means;
Detection means for detecting light from the solution contained in the measurement container;
A third transport means for transporting the measurement container to the detection means;
Accept the measurement container transported by the first transport means, position to transport the measurement container to the reaction means by the second transport means, position to transport to the detection means by the third transport means, and dispensing means Transport means capable of transporting the specimen and / or dispensed water to a position for aspirating / discharging;
Automatic analyzer equipped with. The transport means is
A measurement container holding part for placing a measurement container containing a reaction reagent,
A measurement container containing a standard component, a measurement container containing a quality control sample component, a measurement container containing a sample diluent component, and a measurement container containing a pretreatment reagent for pretreating a sample A measurement container holding part for placing any one of them,
The automatic analyzer according to claim 7, which is means provided with

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