JP2010164516A - Reaction card and automatic analysis apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a reaction card enabling to easily check whether the reaction card is kept at a determined temperature or lower and whether an inspection is performed at a temperature determined for the inspection by visual observation or an automatic analysis apparatus, and an automatic analysis apparatus. <P>SOLUTION: The reaction card 1 includes a reaction vessel 11 having an opening and housing a carrier C holding an aggregation caused by the aggregation reaction between an analyte and a reagent by changing the mobility according to the size of the aggregation; a body part 10 supporting the reaction vessel 11; and a temperature check member 16 disposed on the body part 10 and having a changing part 16a whose color irreversibly changes according to the temperature change. In the reaction card 1, the temperature control state can be easily checked by visual observation and also can be read out by an automatic analysis device since the changing part 16a irreversibly changes according to the temperature. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a reaction card for performing an immunological agglutination reaction and an automatic analyzer using the reaction card.

  Conventionally, in an analysis method for immunologically analyzing a sample such as plasma, blood cells, or serum, a reagent corresponding to the test content is mixed with the sample in a reaction container in a dedicated reaction card and reacted. After incubation, the presence or absence of agglutination is confirmed from the reaction image generated by centrifuging the reaction card with a centrifuge. The sample is negative for antibody or antigen based on the agglutination pattern of the sample and reagent. It is determined whether it is positive or not (for example, see Patent Documents 1 and 2).

  In addition, the above-mentioned reaction card performs negative or positive determination based on an agglutination pattern by an antigen or antibody to perform ABO blood group determination, and antibodies other than regular antibodies such as anti-A antibody and anti-B antibody (non-antibodies) Regular antibody), it is possible to determine the Rh blood group from the agglutination pattern by the erythrocyte membrane antigen and the presence or absence of an irregular antibody by the erythrocyte antigen. In particular, in blood transfusion testing, the accuracy of the test is important in order to prevent blood transfusion side effects.

Japanese Patent Publication No.8-7215 Japanese Patent No. 3299768

  However, since the reaction card shown in Patent Documents 1 and 2 cannot confirm the temperature management state of the reaction card, the reaction card stored in the environment of the specified temperature or higher is used, and a valid analysis result is obtained. There was no fear. Further, even when the reaction is performed at a temperature other than the predetermined temperature due to an abnormality in the apparatus being analyzed due to the unconfirmed temperature control state, there is a problem that the analysis is continued and an appropriate analysis result cannot be obtained.

  The present invention has been made in view of the above, and visually or automatically analyzes whether or not a reaction card is managed below a specified temperature, and whether or not an inspection with a specified temperature is performed at a specified temperature. An object of the present invention is to provide a reaction card and an automatic analyzer that can be easily confirmed by the apparatus.

  In order to solve the above-described problems and achieve the object, the reaction card according to the present invention has an opening, and the mobility is changed depending on the size of the aggregate due to the aggregation reaction between the specimen and the reagent. One or more reaction containers that contain the carrier for holding the agglomerates, a main body part that supports each reaction container, and a change part that is disposed in the main body part and changes color irreversibly in response to a temperature change. And a temperature confirmation member having the above.

  In the reaction card according to the present invention as set forth in the invention described above, at least the hue of the changing portion changes.

  The reaction card according to the present invention is characterized in that, in the above invention, at least the luminance of the changing portion changes.

  The reaction card according to the present invention is characterized in that, in the above invention, the changing portion changes irreversibly when a predetermined temperature is exceeded.

  The reaction card according to the present invention is characterized in that, in the above invention, a plurality of the changing portions are provided corresponding to different predetermined temperatures.

  Moreover, the automatic analyzer according to the present invention includes a temperature confirmation member that supports one or more reaction vessels in the above-described invention and includes a change portion in which the hue changes irreversibly in response to a temperature change. A reaction card having a main body, transport means for transporting the reaction card to a predetermined position, dispensing means for dispensing a sample and a reagent in the reaction container, and the sample dispensed in the reaction container; A rotation mechanism for centrifuging the reaction card containing a reaction liquid with the reagent, an imaging means for imaging the reaction card centrifuged by the rotation mechanism, and a hue change of the change portion imaged by the imaging means Determining means for checking and determining the validity of the reaction card.

  The automatic analyzer according to the present invention is characterized in that, in the above invention, the automatic analyzer further comprises a reading means for reading the hue change in the change portion of the reaction card before the start of analysis and / or after the end of analysis. .

  According to the present invention, since the temperature management state of the reaction card can be confirmed by the color change, it is possible to easily confirm whether or not each reaction card is in the optimum temperature management state.

  A reaction card according to an embodiment of the present invention will be described below with reference to the drawings. Note that the present invention is not limited to the embodiments. In the description of the drawings, the same parts are denoted by the same reference numerals. Note that the drawings referred to in the following description are schematic, and when the same object is shown in different drawings, dimensions, scales, and the like may be different.

  FIG. 1 is a perspective view schematically showing a reaction card 1 according to an embodiment of the present invention. The reaction card 1 is a card-shaped main body 10, a reaction container 11 having an opening at the upper flat surface of the main body 10, and a main body 10, which is attached to an identification bar code, lot number, and effective date. And the like, and a seal 14 having a column for describing specimen information and reaction results. The reaction vessel 11 has a substantially cylindrical shape, and is provided in communication with the reaction unit 12 for reacting the specimen and the reagent, and the bottom of the reaction unit 12, and a reaction for determining the presence or absence of aggregation according to the result of the reaction. It has an analysis unit 13 that holds gel, glass beads, or plastic beads filled as a carrier C for generating an image, and holds a reaction solution obtained by antigen-antibody reaction between a specimen and a reagent, which is centrifuged by a centrifuge. The reaction card 1 is formed using a translucent resin. The aggregated image in the analysis unit 13 is confirmed by visual observation or imaging. The upper flat surface of the main body 10 is sealed at the upper opening of each reaction vessel 11 by the sealing member 15, and the hermeticity inside each reaction vessel 11 is maintained. When the reaction card 1 is used, the specimen and the reagent are dispensed into the reaction container 11 by peeling off the sealing member 15 or perforating the opening.

  In addition, the sealing member 15 is comprised with an elastic material or metal foil. Examples of the elastic material include resins such as polyester, nylon, polypropylene, polyethylene, and polymethylpentene. Further, examples of the metal foil include an aluminum foil, and any other metal that can be perforated can be used.

  Here, a temperature confirmation member 16 is affixed to the surface of the main body 10 that supports the reaction vessel 11 in the axial direction of the reaction vessel 11. The temperature confirmation member 16 has a changing portion 16a at the center. When the change unit 16a senses that the ambient temperature of the change unit 16a exceeds a predetermined temperature, for example, exceeds 30 ° C., the color of the change unit 16a changes as shown in the schematic diagram of FIG. Here, the color to be changed may be any hue as long as the change can be visually confirmed, and the luminance may be changed. When the storage temperature of the unused reaction card 1 is 30 ° C. or less and the color of the changing portion 16a of the reaction card 1 is changed before use, the reaction card 1 is stored at the storage temperature or higher. Since there is a possibility that the accuracy of the analysis is lowered, it is possible to maintain high analysis accuracy by stopping the use of the reaction card 1. In addition, as a temperature confirmation member to be used, a melt mark MK-30 manufactured by NOF Corporation can be used.

  FIG. 3 is a perspective view showing a modified example 1a of the reaction card 1 shown in FIG. A temperature confirmation member 16 and a temperature confirmation member 17 disposed at a position symmetrical to the temperature confirmation member 16 are affixed to the surface of the main body 10 that supports the reaction container 11 in the axial direction of the reaction vessel 11. Here, the change part 16a of the temperature confirmation member 16 changes its color when the temperature around the change part 16a exceeds the storage temperature of 30 ° C., and the change part 17a of the temperature confirmation member 17 has the change part 17a ambient temperature. Is set so that the color changes when it exceeds 37 ° C., which is the reaction temperature between the sample and the reagent. If the color of the change part 16a of the reaction card 1 has changed before using the reaction card, the reaction card 1 is stored at a storage temperature or higher, so the use of the reaction card 1 is stopped and the analysis is completed. Later, when the color of the changing portion 17a of the reaction card 1 has not changed, the analysis result of the reaction card 1 is invalidated because the reaction card 1 has not been analyzed at 37 ° C. When temperature control is performed at 37 ° C. or higher, a temperature confirmation member set to a predetermined temperature may be added. In order to perform temperature control more strictly, the temperature is set every 2-3 ° C. within the set temperature range. A temperature confirmation member may be arranged.

  In the reaction card described above, the temperature check state of the reaction card before and after the analysis can be easily visually confirmed by the temperature confirmation member, and the accuracy of the analysis can be further improved.

  Next, Modification Example 2 of the reaction card according to the embodiment of the present invention will be described. FIG. 4 is a perspective view schematically showing Modification Example 2 of the reaction card according to the embodiment of the present invention. In the reaction card 1 shown in FIG. 4, a temperature confirmation member 18 is affixed near the center of the main body 10, and the temperature confirmation member 18 is provided with a change portion group 18 g having a plurality of change portions whose colors change according to the ambient temperature. It has been.

  Here, the temperature confirmation member 18 shown in FIG. 4 will be described with reference to FIGS. FIG. 5 is a schematic diagram showing the changing portion group 18g when the ambient temperature of the temperature confirmation member 18 shown in FIG. 4 is less than 30 ° C. FIG. 6 is a schematic diagram showing the changing portion group 18g when the ambient temperature of the temperature confirmation member 18 shown in FIG. 5 and 6, the temperature confirmation member 18 has change portions 18a to 18e, and each change portion 18a to 18e has a temperature corresponding to a numerical value described in the lower part, for example, 30 ° C. if the change portion 18a. The change parts 18a-18e change in steps between 30 degreeC-43 degreeC. Examples of the temperature confirmation member to be used include Wahl's temp plate P / N101-4V-037 (TEMP-PLATE (registered trademark)).

  Moreover, in FIG. 5, since the ambient temperature of the temperature confirmation member 18 is less than 30 degreeC, the color of each change part 18a-18e does not change. When the temperature change part 18 is confirmed before use, and no color change is seen in each change part 18a to 18e, especially the change part 18a, since it is controlled at 30 ° C. or less which is the storage temperature, Can be used. On the other hand, in the analysis process, since the reaction process between the sample and the reagent is performed at 37 ° C., the color of the change portions 18a, 18b, and 18c changes as shown in FIG. Here, if the color of the change part 18d or the change part 18e changes after the analysis process, there is a possibility that the reaction process is performed at a temperature higher than 37 ° C. Therefore, the person in charge of analysis analyzes the reaction card. The result can be determined to be invalid.

  The reaction card according to the second modification described above can check the temperature management state step by step based on the color change, and can be easily confirmed visually. In addition, even when the reaction card is imaged and the result is stored, the environmental temperature at which the analysis was performed can be stored by the color change, so that the accuracy of the analysis can be further improved.

  Next, Modification 3 of the reaction card 1 according to the embodiment of the present invention will be described. FIG. 7 is a perspective view schematically showing Modification 3 of the reaction card 1 according to the embodiment of the present invention. The reaction card 1 shown in FIG. 7 has a temperature confirmation member 19 attached in the vicinity of the center of the main body 10, and the temperature confirmation member 19 has a barcode 19 g. Correspondingly, a plurality of changing portions whose colors change are provided. In addition, the temperature confirmation member to be used is created from the temperature confirmation member mentioned above.

  Here, the barcode 19g of the reaction card 1 shown in FIG. 7 will be described with reference to FIG. FIG. 8 is a schematic diagram showing changes in the changing portions 19a to 19c with respect to the temperature during the reaction process of the barcode 19g of the reaction card 1 shown in FIG. In the temperature confirmation member 19 shown in FIG. 8, changing portions 19 a to 19 c are provided in some empty regions of the barcode 19 g, and the changing portions 19 a to 19 c correspond to the numerical values shown in the lower part. The color changes at temperatures of 30 ° C., 37 ° C., and 40 ° C. FIG. 8A shows the temperature confirmation member 19 when the ambient temperature is less than 30 ° C. before the reaction process between the specimen and the reagent, and the color of each of the changing portions 19a to 19c does not change. Thereafter, when the temperature rises and the ambient temperature of the temperature confirmation member 19 is not less than 30 ° C. and less than 37 ° C., the change portion 19a in which the ambient temperature changes corresponding to 30 ° C. changes color (FIG. 8B). When the temperature reaches 37 ° C., which is the set temperature for the reaction process, the change portion 19b of the temperature confirmation member 19 changes color (FIG. 8C). By confirming the temperature confirmation member 19 when the reaction process is completed and the analysis result is confirmed, it can be easily confirmed visually whether the reaction process has been performed at an appropriate temperature, and the accuracy of the analysis is further improved. It becomes possible. In addition, the storage temperature can be confirmed before the analysis process is started, and the analysis process can be performed by removing reaction cards inappropriate for the analysis before the analysis process.

  The barcode 19g of the temperature confirmation member 19 can be input with various information described on the reaction card information or the seal 14, and the information can be read with a reader such as a barcode reader. In addition, when reading the information of the barcode 19g with the reading device before starting the analysis, if there is a color change in the change units 19a to 19c, the use stop information of the reaction card is added, and the reaction from the information read by the reading device It is possible to eliminate the use of cards and improve the accuracy of analysis. Similarly, after the analysis process, if there is a color change in the change part 19c, or if there is no color change in the change parts 19a and 19b, information indicating that the processing temperature is abnormal is added to the information read by the reading device. By adding, it is possible to determine that the analysis result of the reaction card is abnormal.

  Moreover, you may arrange | position the change part of the temperature confirmation member 19 in the position shown in FIG. FIG. 9 is a schematic diagram showing a modified example 3a of the temperature confirmation member 19 shown in FIGS. In the temperature confirmation member 19 shown in FIG. 9, the changing portions 19d to 19f provided on the barcode 19g are arranged side by side. Compared with the bar code 19g shown in FIG. 8, since the area of the empty region is large, it is possible to more easily confirm the change of the changed portion.

  The temperature confirmation member shown in FIGS. 7 to 9 can visually check the temperature management state, and can manage various information concerning the reaction card and the analysis process with a barcode, and whether or not the analysis result is acceptable due to the change of the change part. Therefore, even easier and more accurate management can be performed in automated analysis processing.

  Note that the reaction card according to the present embodiment may check the temperature history by changing the luminance of the color. Further, the hue and luminance may be changed in combination.

  Here, the case where the reaction card 1 concerning embodiment of this invention is used with an automatic analyzer is demonstrated with reference to FIG. FIG. 10 is a plan view showing a schematic configuration of the automatic analyzer 2 using the reaction card 1 according to the embodiment of the present invention. The automatic analyzer 2 dispenses a sample and a reagent into the reaction container 11 respectively, and optically measures the reaction occurring in the dispensed reaction container 11 and the entire automatic analyzer 2 including the measurement mechanism 3. And a control mechanism 4 for analyzing the measurement results in the measurement mechanism 3.

  The sample transport mechanism 30 holds a sample rack 30c in which the sample container 30b is arranged, has a caterpillar 30a having an L-shaped attachment orthogonal to the transport direction, and the measurement mechanism 3, FIG. 10 includes a transport lane 30d that transports the sample rack 30c to the left carry-out lane, and a rack step claw 30e that is disposed on the transport lane 30d and moves on the transport lane 30d to transport the sample rack 30c. The sample rack 30c is transported in the direction of the arrow in the figure by the drive mechanism that does not. Also, a barcode is affixed to the sample container 30b, and sample information can be managed by reading it with a barcode reader (not shown).

  The measurement mechanism 3 includes a reagent storage 31, a reagent dispensing mechanism 32, a reaction table 33, card transfer mechanisms 34 and 38, a card outlet 35, a sample dispensing mechanism 36, a diluent bottle 37, and an imaging unit 39. The control mechanism 4 includes a control unit 41, an input unit 42, an analysis unit 43, a storage unit 44, an output unit 45, and a determination unit 46. These units included in the measurement mechanism 3 and the control mechanism 4 are electrically connected to the control unit 41.

  The reagent storage 31 can store a plurality of reagent containers 31 a in which reagents to be dispensed in the reaction container 11 are stored. In the reagent storage 31, a plurality of storage chambers are arranged at equal intervals, and a reagent container 31a is detachably stored in each storage chamber. The reagent store 31 can be rotated clockwise or counterclockwise about a vertical line passing through the center of the reagent store 31 as a rotation axis by driving a drive mechanism (not shown) under the control of the control unit 41. The desired reagent container 31a is transferred to the reagent suction position by the reagent dispensing mechanism 32. An openable / closable lid (not shown) is provided above the reagent storage 31 to suppress reagent evaporation, denaturation, and contamination.

  The reagent dispensing mechanism 32 includes an arm that freely moves up and down in the vertical direction and rotates around a vertical line passing through the base end of the reagent dispensing mechanism 32 as a central axis. A probe for aspirating and discharging the reagent is attached to the tip of the arm. The reagent dispensing mechanism 32 sucks the reagent in the reagent container 31a moved to a predetermined position on the reagent storage 31 with a probe, rotates the arm around the arrow in the figure, and is transported to the predetermined position on the reaction table 33. Dispense into the reaction vessel 11.

  The reaction table 33 arranges the reaction card 1 for dispensing the sample and the reagent into the reaction container 11 in a card holder provided at a predetermined position. The reaction table 33 is rotatable about a vertical line passing through the center of the reaction table 33 as a rotation axis by driving a drive mechanism (not shown) under the control of the control unit 41. An openable / closable lid and a thermostat (not shown) are provided above and below the reaction table 33, respectively. In the reaction table 33, the sample and the reagent are dispensed, and the sample and the reagent are reacted by incubation at a predetermined temperature and a predetermined time, and then the reaction table 33 is rotated by a drive mechanism (not shown). The reaction card 1 is driven and rotated, and centrifugal force is applied to separate the reaction solution in which the sample and the reagent contained in the reaction container 11 have reacted. Here, the card holding part of the reaction table 33 is a columnar member extending in the radial direction of the reaction table 33, has an opening in the upper end plane, and the reaction card 1 in the internal space formed in the vertical direction from the opening. Hold. Also, a hole for attaching the rotation shaft of the card holding portion is provided on the side surface of the card holding portion which is substantially parallel to the radial direction of the reaction table 33, and the reaction table 33 and the card holding portion are contacted by the rotation shaft. is doing. The card holder is rotated around the rotation axis by the centrifugal force applied by the rotation of the reaction table 33. In the reaction card 1, the centrifugal force generated by the rotation of the reaction table 33 is transmitted from the card holding unit, receives the force directed downward in the reaction card, and the reaction liquid contained in the reaction container is attracted downward in the card.

  The card transfer mechanism 34 includes an arm that freely moves up and down in the vertical direction and rotates around a vertical line passing through its base end as a central axis. At the tip of this arm, there is a card holding arm for holding the reaction card 1, and the reaction card 1 prepared in the card outlet 35 is transferred to the reaction table 33.

  The card outlet 35 has a card storage below the outlet, and the reaction card 1 necessary for analysis is placed in the card outlet 35 under the control of the control unit 41. A reading unit 35 a is provided in the vicinity of the card outlet 35, and the reading unit 35 a reads each change portion color information or barcode of the reaction card 1 shown in FIGS. 1 to 9 and transmits it to the determination unit 46.

  Similar to the reagent dispensing mechanism 32, the sample dispensing mechanism 36 includes an arm having a probe for aspirating and discharging the sample attached to the tip. The arm freely moves up and down in the vertical direction and rotates around the vertical line passing through its base end as a central axis. In the vicinity of the specimen dispensing mechanism 36, a cleaning pod 36a and a dilution pod 36b are provided. In the dilution pod 36b, the sample is aspirated by the probe from the sample container 30b transferred to the predetermined position on the sample transfer mechanism 30 described above, and the sample is discharged into the dilution pod 36b by rotating the arm. It is diluted with a diluent contained in 37. The diluent bottle 37 has a tube extending from above to the outside, communicates with the dilution pod 36b, and sends the diluent into the dilution pod 36b by a pump or a syringe (not shown). The sample dispensing mechanism 36 aspirates the sample or the sample diluted with the dilution pod 36b, and discharges the sample into the reaction container 11 to perform dispensing. Further, the probe is appropriately cleaned with the cleaning pod 36a.

  The imaging unit 39 measures the sample in the reaction container 11 of the reaction card 1 conveyed to a predetermined imaging position by the card transfer mechanism 38. The measurement result by the imaging unit 39 is output to the control unit 41 and analyzed by the analysis unit 43. The imaging unit 39 reads the color or barcode of the changing portion of the reaction card 1 shown in FIGS. 1 to 9 and transmits the read information to the determination unit 46. The reaction card 1 whose analysis has been completed is discarded by the card discarding unit 39a.

  Next, the control mechanism 4 will be described. The control unit 41 is configured using a CPU or the like, and controls processing and operation of each unit of the automatic analyzer 2. The control unit 41 performs predetermined input / output control on information input / output to / from each of these components, and performs predetermined information processing on this information.

  The input unit 42 is configured using a keyboard, a mouse, a communication function, and the like, and acquires various information necessary for analyzing the sample, instruction information for analysis operation, and the like from the outside. The analysis unit 43 performs processing based on the image data acquired from the imaging unit 39 and analyzes the sample. The storage unit 44 is configured using a hard disk that magnetically stores information and a memory that loads various programs related to the process from the hard disk and electrically stores them when the automatic analyzer 2 executes the process. Various information including the analysis result of the specimen is stored. The storage unit 44 may include an auxiliary storage device that can read information stored in a storage medium such as a CD-ROM, a DVD-ROM, or a PC card. The output unit 45 is configured using a printer, a communication mechanism, and the like, and outputs various information including the analysis result of the sample.

  The determination unit 46 determines whether or not the reaction card 1 has been processed at an appropriate temperature based on the information acquired by the reading unit 35 a or the imaging unit 39, and outputs the determination result to the control unit 41. . Based on the determination result, the control unit 41 determines whether to stop using the reaction card or invalidate the analysis result.

  In the automatic analyzer 2 configured as described above, the sample dispensing mechanism 36 dispenses the sample or the diluted sample in the dilution pod 36b to the plurality of reaction cards 1, and the reagent dispensing mechanism 32 After dispensing the reagent in the reagent container 31a, the imaging unit 39 performs an imaging process in a state where the reaction solution obtained by the reaction between the sample and the reagent is separated by centrifugation, and the analysis unit 43 analyzes the imaging data. Thus, the analysis of the specimen is automatically performed. In addition, when the reaction card 1 is taken out from the card outlet 35, the determination unit 46 that has received the information of the reading unit 35a determines the temperature management state of the reaction card 1 to confirm the validity of the reaction card 1 before analysis. After the analysis, the determination unit 46 that has received the information from the imaging unit 39 determines the validity of the analysis result of the reaction card 1 to confirm the validity of the reaction card for the analysis.

  Here, in the reaction card shown in FIGS. 1 to 6, it is preferable that the reading unit 35a and the imaging unit 39 measure the color change of each changing unit by an optical sensor or the like. In the reaction card shown in FIGS. Preferably, a barcode reader is arranged in the reading unit 35a and the imaging unit 39 to read barcode information. In addition, each change part can also confirm the reaction card imaged by the imaging part 39 visually.

  In the reaction card according to the present embodiment, the temperature history at which the reaction card has been exposed can be easily confirmed visually or by an automatic analyzer. It is possible to eliminate a reaction card that may be affected or a reaction card that has not been reacted at a predetermined temperature in an analysis process, and to perform a more accurate analysis process.

It is a perspective view which shows typically the reaction card concerning embodiment of this invention. It is a perspective view which shows typically the reaction card concerning embodiment of this invention. It is a perspective view which shows the modification 1a of the reaction card shown in FIG. It is a perspective view which shows typically the modification 2 of the reaction card concerning embodiment of this invention. It is a schematic diagram which shows the change part group in case the temperature of the surrounding atmosphere of the temperature confirmation member shown in FIG. 4 is less than 30 degreeC. It is a schematic diagram which shows the change part group in case the temperature of the surrounding atmosphere of the temperature confirmation member shown in FIG. 4 is 37 degreeC. It is a perspective view which shows typically the modification 3 of the reaction card concerning embodiment of this invention. It is a schematic diagram which shows the change of the change part with respect to the temperature at the time of the reaction process of the barcode shown in FIG. It is a schematic diagram which shows typically the temperature confirmation member of the modification 3a of the reaction card shown to FIG. It is a top view which shows schematic structure of the automatic analyzer using the reaction card concerning embodiment of this invention.

DESCRIPTION OF SYMBOLS 1 Reaction card 2 Automatic analyzer 3 Measurement mechanism 4 Control mechanism 10 Main body part 11 Reaction container 12 Reaction part 13 Analysis part 14 Seal 15 Sealing member 16, 17, 18, 19 Temperature confirmation member 16a, 17a, 18a-18e, 19a -19f Changing section 18g Changing section group 19g Barcode 30a Caterpillar 30b Sample container 30c Sample rack 30d Transport lane 30e Rack advance claw 31 Reagent storage 31a Reagent container 32 Reagent dispensing mechanism 33 Reaction table 34, 38 Card transfer mechanism 35 Card removal Exit 35a Reading unit 36 Sample dispensing mechanism 36a Washing pod 36b Dilution pod 37 Diluent bottle 39 Imaging unit 39a Card discard unit 41 Control unit 42 Input unit 43 Analysis unit 44 Storage unit 45 Output unit 46 Determination unit C Carrier

Claims (11)

One or more reaction containers having an opening and containing a carrier for holding the aggregate by changing mobility according to the size of the aggregate by the aggregation reaction between the specimen and the reagent;
A main body for supporting each reaction vessel;
A temperature confirmation member disposed on the main body portion and having a changing portion whose color changes irreversibly in response to a temperature change;
A reaction card characterized by comprising.   The reaction card according to claim 1, wherein at least the hue of the changing unit changes.   The reaction card according to claim 1, wherein at least the luminance of the changing unit changes.   The reaction card according to claim 1, wherein the change unit changes irreversibly when a predetermined temperature is exceeded.   The reaction card according to claim 1, wherein a plurality of the changing portions are provided corresponding to different predetermined temperatures.   The reaction card according to claim 1, wherein the temperature confirmation member includes one or more change portions and a plurality of the change portions are provided.   The reaction card according to claim 1, wherein the predetermined temperature is 30 ° C. or higher.   The reaction card according to claim 7, wherein the predetermined temperature is 30 ° C.   The reaction card according to claim 7, wherein the predetermined temperature is 37 ° C. A reaction card having a body portion supporting a one or more reaction vessels and having a temperature confirmation member provided with a change portion in which the hue changes irreversibly in response to a temperature change;
Transport means for transporting the reaction card to a predetermined position;
A dispensing means for dispensing the sample and the reagent in the reaction container;
A rotating mechanism for centrifuging the reaction card containing a reaction liquid of the sample and the reagent dispensed in the reaction container;
Imaging means for imaging the reaction card centrifuged by the rotation mechanism;
Determining means for confirming the hue change of the changing portion imaged by the imaging means, and determining the validity of the reaction card;
An automatic analyzer characterized by comprising:   The automatic analysis apparatus according to claim 10, further comprising a reading unit that reads the hue change in the change portion of the reaction card before the analysis is started and / or after the analysis is completed.

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