JP2010169620A - Reaction card, method of manufacturing reaction card, and automatic analyzer using reaction card - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a reaction card easily confirming whether or not each reaction vessel of the reaction card is sealed up by visual observation or an automatic analyzer, and a method of manufacturing the reaction card. <P>SOLUTION: The reaction card 1 includes one or more reaction vessels 11 with an aperture and a sealing member 15 sealing the aperture and deforming depending on a pressure difference between inside and outside of the reaction vessels, in which sealed space within the reaction vessels 11 sealed with the sealing member 15 is set to a condition of plus or minus pressure to normal atmospheric pressure, the sealing member 15 deforms into a convex shape when the sealed space is under a condition of plus pressure and into a concave shape when the sealed space is under a condition of minus, thereby the sealed condition can be easily confirmed even by visual observation. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a reaction card that performs an immunological agglutination reaction, a reaction card manufacturing method, 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 Document 1).

  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, the accuracy of examination is important in order to prevent blood aggregation or hemolysis after blood transfusion. In order to improve inspection accuracy, inspect the container to improve the storage stability of the contents in the inspection container by measuring the degree of expansion by inspecting the inside of the inspection container in a sealed chamber with negative pressure and measuring the degree of expansion. A method is disclosed (for example, see Patent Document 2).

Japanese Patent Publication No.8-7215 JP 2006-8161 A

  However, since the reaction card shown in Patent Document 1 does not have a mechanism for confirming whether or not each reaction container is sealed, the test result is affected by evaporation of contents caused by the fact that the reaction container is not sealed. There was a risk of effects. In addition, the container inspection method shown in Patent Document 2 requires a dedicated airtightness inspection device, and the airtightness cannot be easily confirmed, and the user who actually uses the inspection container confirms the airtightness. It was difficult to do. Furthermore, there has been a problem that it is costly to incorporate the sealing tester into the automatic analyzer.

  The present invention has been made in view of the above, and is capable of easily confirming whether or not each reaction container of the reaction card is sealed with a visual or automatic analyzer, and manufacturing the reaction card and the reaction card. It aims to provide a method.

  In order to solve the above-described problems and achieve the object, a reaction card according to the present invention includes one or more reaction vessels having an opening, the opening being sealed, and the inside and outside of the reaction vessel. A sealing member that is deformed in accordance with the pressure difference between, and the sealed space in the reaction vessel sealed by the sealing member is set to a positive pressure or negative pressure state compared to normal pressure, The sealing member is deformed into a convex shape when the sealed space is in a positive pressure state, and is deformed into a concave shape when the sealed space is in a negative pressure state.

  In the reaction card according to the present invention as set forth in the invention described above, the sealing member is a metal or a resin.

  In the reaction card according to the present invention as set forth in the invention described above, at least a part of a portion of the sealing member covering the opening is deformed according to the pressure difference.

  In the reaction card according to the present invention as set forth in the invention described above, the metal is aluminum.

  The reaction card according to the present invention is the reaction card according to the above invention, wherein the reaction container contains a specimen and a reagent, and causes a reaction between the specimen and the reagent to cause an agglutination reaction; And an analysis unit for analyzing a sample, containing a carrier for holding the aggregate by changing the mobility depending on the size of the sample.

  The automatic analyzer according to the present invention is the above-described invention, wherein the reaction card in which the inside of the reaction container is held in a sealed state by a sealing member that seals the opening provided in the upper part of the reaction container, and the reaction Sealing determination means for determining whether or not the inside of the container is sealed by the sealing member, and when the sealing determination means determines that the inside of the reaction container is not sealed, informs that the container is not sealed. And an informing means.

  Further, the reaction card manufacturing method according to the present invention is the reaction card manufacturing method of the reaction card having one or more reaction containers in which the specimen and the reagent are dispensed to cause the immunological agglutination reaction in the above invention. And a charging step of charging the carrier accommodated in the reaction vessel, and a sealing step of sealing the reaction vessel containing the carrier under a negative pressure or a positive pressure with a sealing member. .

  According to the present invention, whether or not each reaction container of the reaction card is sealed can be confirmed by the shape of the sealing member, so that it is possible to easily confirm whether or not each reaction container is in a sealed state. Play.

  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. In addition, 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.

  Here, the inside of the reaction vessel 11 sealed by the sealing member 15 is maintained in a positive pressure state as compared with the external atmospheric pressure. Therefore, the sealing member 15 is deformed into a substantially spherical shape in the external direction by the pressure from the inside of the reaction vessel 11. Further, when the space between the sealing member 15 and the upper opening of the reaction vessel 11 is opened, and the hermeticity inside the reaction vessel 11 is lost, the deformation region of the sealing member 15 is between the inside of the reaction vessel 11 and the external atmospheric pressure. Corresponding to the pressure difference, when the vertical distance between the circular plane formed by the opening of the reaction vessel 11 and the top of the sealing member 15 changes, and the pressure in the reaction vessel 11 and the external atmospheric pressure become equal, The deformation region of the sealing member 15 returns to a circular plane shape. By confirming the presence or absence of deformation, it is possible to visually confirm the sealed state inside the reaction vessel 11. Here, the pressure applied to each reaction vessel 11 is preferably set to an equivalent pressure. By setting the pressure to be equal, it is possible to easily determine even when the sealing properties of some of the reaction vessels 11 of the same reaction card 1 are lost.

  The sealing member 15 is made of an elastic material or metal. Examples of the elastic material include resins such as polyester, nylon, polypropylene, polyethylene, and polymethylpentene. In addition, examples of the metal include aluminum, and any other metal that can be deformed by a pressure difference between the inside and the outside of the reaction vessel 11 can be applied.

  Moreover, FIG. 2 is sectional drawing which shows the cross section of the reaction container 11 of the reaction card | curd 1 shown in FIG. An upper portion of the main body 10 has a convex portion 10a along the opening of the reaction vessel 11, and the sealing member 15 seals the reaction vessel 11 by being affixed to the upper plane of the convex portion 10a. The convex portion 10 a is provided for each reaction vessel 11 and is sealed by a sealing member 15. As shown in FIG. 2, the sealing member 15 is deformed into a substantially spherical shape in the external direction because the pressure in the internal space formed by the reaction unit 12 and the analysis unit 13 is in a positive pressure state compared to the external atmospheric pressure. is doing. Due to the deformation of the sealing member 15, it is possible to easily confirm that the inside of the reaction vessel 11 is sealed visually.

  Next, the card sealing process of the reaction card 1 for sealing each reaction vessel 11 in the production of the reaction card 1 will be described with reference to FIG. FIG. 3 is a schematic diagram showing a card sealing process. First, a predetermined amount of carrier C is dispensed into each reaction vessel 11 and accommodated in the analysis unit 13 (FIG. 3A). When dispensing of the carrier C is completed, the reaction card 1 is accommodated in a sealed container 100 whose inside is set in a pressurized state, and a sealing member 15 is attached to the upper surface of the convex portion 10a of the reaction card 1 under a positive pressure. Then, the reaction vessel 11 is sealed (FIG. 3B). Thereafter, when the reaction card 1 is opened from the sealed container 100 to the outside, the sealing member 15 has the convex portion 10a of each reaction container 11 as a base end due to a pressure difference between the inside and the outside of the reaction container 11 of the reaction card 1. It is deformed into a substantially spherical shape that is convex upward (FIG. 3C).

  Using the sealing member 15 described above, it is easily confirmed whether or not each reaction vessel 11 is sealed by visually checking whether or not the sealing member 15 on the top of each reaction vessel 11 is deformed. It becomes possible to do. Further, since the sealing property can be confirmed without using an inspection apparatus, it is possible to continue the analysis with high accuracy without incurring costs.

  Here, sealing confirmation when the reaction card 1 is used in an automatic analyzer will be described with reference to FIG. FIG. 4 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 placed, has a caterpillar 30a having an L-shaped attachment orthogonal to the transport direction, and the measurement mechanism 3, FIG. 4 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. In addition, a sealing inspection part 35a is provided in the vicinity of the card outlet 35, and information for determining whether or not each reaction container 11 of the reaction card 1 is sealed by a sealing member using a sensor. The obtained information is transmitted 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. In addition, the reaction card 1 that has been analyzed is discarded by the card discard 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 1. 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 by 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 1 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.

  Further, the determination unit 46 determines whether or not each reaction container 11 of the reaction card 1 is sealed based on the information acquired by the sealing inspection unit 35 a, and outputs the determination result to the control unit 41. The control unit 41 stops using the reaction card 1 or the reaction container 11 based on the determination result.

  In the automatic analyzer 1 configured as described above, the specimen dispensing mechanism 36 dispenses the specimen or the diluted specimen 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, it is preferable to use a contact type or non-contact type sensor such as a reflection type sensor, a transmission type sensor, or a contact type sensor as the sensor used in the sealing inspection unit 35a. Alternatively, the determination unit 46 may determine the sealed state by imaging the deformation of the sealing member using a CCD image sensor.

  Moreover, the deformation | transformation of the sealing member 15 when the inside of the airtight container 100 shown in FIG. 3 is set to the negative pressure state is demonstrated with reference to FIG. FIG. 5 is a cross-sectional view showing a cross section of the reaction container 11 of the reaction card. As shown in FIG. 5, when the inside of the sealed container 100 is set to a negative pressure state, the inside of the reaction container 11 sealed in the sealed container 100 is in a negative pressure state as compared with the outside. The sealing member 15 is deformed into a substantially spherical shape in the inner direction with respect to the reaction vessel 11 having the convex portion 10a as a base end. In addition, when the space between the sealing member 15 and the upper opening of the reaction vessel 11 is opened and the hermeticity inside the reaction vessel 11 is lost, the deformation region of the sealing member 15 is between the inside of the reaction vessel 11 and the external atmospheric pressure. Corresponding to the pressure difference, when the vertical distance between the circular plane formed by the opening of the reaction vessel 11 and the top of the sealing member 15 changes, and the pressure in the reaction vessel 11 and the external atmospheric pressure become equal, The deformation region of the sealing member 15 returns to a circular plane shape.

  Here, with reference to FIG. 6, the modification 1 of the reaction card 1 shown in FIG. 1 is demonstrated. FIG. 6 is a perspective view showing a first modification of the reaction card 1 shown in FIG. As shown in FIG. 6, the sealing member 16 is affixed to the convex part 10a of the upper plane of the main-body part 10, and the inside of the reaction container 11 is sealed. A deformation portion 16a is provided in a region located in the convex portion 10a of the sealing member 16, and the deformation portion 16a is formed of the above-described elastic material or metal. Since the inside of the reaction vessel 11 shown in FIG. 6 is in a positive pressure state as compared with the external atmospheric pressure, the deforming portion 16a is deformed into a substantially spherical shape in the external direction with the end portion of the deforming portion 16a as the base end.

  The arrangement of the deforming part 16a may be any position as long as it is a region closed by the convex part 10a, and the area of the deforming part 16a can be inserted into each probe in the automatic analyzer 2 shown in FIG. It may be larger than the area where the deformation of the deformation portion 16a can be confirmed. Here, when using with the automatic analyzer 2, it is preferable that the deformation | transformation part 16a is arrange | positioned on the locus | trajectory which each probe can take.

  Moreover, with reference to FIG. 7, 8, the modification 2 of the reaction card 1 shown in FIG. 1 is demonstrated. 7 is a perspective view showing a second modification of the reaction card 1 shown in FIG. 1, and FIG. 8 is a cross-sectional view showing a second modification of the reaction card 1 shown in FIG. As shown in FIGS. 7 and 8, a sealing member 17 is affixed to the convex portion 10 a on the upper flat surface of the main body portion 10, and the inside of the reaction vessel 11 is sealed. Here, in the region closed by the convex portion 10a, the deformed portion 17b formed of the elastic member described above is disposed between the sealing materials 17a. 7 and 8, since the inside of the reaction vessel 11 is in a positive pressure state, the deforming portion 17b is deformed outward by the internal pressure, and the sealing member 17 is formed in a stepped shape. Here, the sealing material 17a may be made of a metal or resin having high hardness, and is preferably a material that has low stretchability and is difficult to deform as compared with the deformable member 17b. Further, when the reaction card 1 is used in the automatic analyzer 2 shown in FIG. 4, in dispensing, the deformed portion 17 b arranged on the upper plane of the sealing member 17 is drilled and a probe is inserted.

  Here, in the reaction card shown in the first and second modifications, the inside of the reaction vessel 11 may be in a negative pressure state. In the case of a negative pressure state, the deforming parts 16 a and 17 b are deformed in the internal direction of the reaction vessel 11. Further, the shape of the deforming portion may be any shape as long as the deformation can be confirmed. In addition, when using the modification 2, it is preferable that arrangement | positioning of the sealing material 17a and the deformation | transformation part 17b is arrange | positioned symmetrically with respect to the reaction container 11 opening plane.

  In the reaction card according to the present embodiment, the sealing member for sealing the reaction card is made of a deformable material, and the reaction container is brought into a positive pressure or negative pressure state to generate a pressure difference with the outside. By doing so, the sealing member is deformed, so that the sealed state can be easily confirmed visually. In addition, as shown in the first and second modifications, only a part of the sealing member is formed of a deformable material, thereby enhancing the resistance against the externally applied physical force of the sealing member and confirming the sealing. It can be done easily.

It is a perspective view which shows typically the reaction card concerning embodiment of this invention. It is sectional drawing which shows the cross section of the reaction container of the reaction card | curd of FIG. It is a schematic diagram which shows the card | curd sealing process concerning embodiment of this invention. It is a top view which shows schematic structure of the automatic analyzer using the reaction card concerning embodiment of this invention. It is sectional drawing which shows the cross section of the reaction container of the reaction card concerning embodiment of this invention. It is a perspective view which shows the modification 1 of the reaction card | curd of FIG. It is a perspective view which shows the modification 2 of the reaction card | curd of FIG. It is sectional drawing which shows the modification 2 of the reaction card | curd of FIG.

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 15,16,17 Sealing member 16a, 17b Deformation part 17a Sealing material 30 Sample conveyance mechanism 30a Caterpillar 30b Specimen container 30c Specimen 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 outlet 35a Seal inspection part 36 Specimen dispensing mechanism 36a Washing pod 36b Dilution Pod 37 Dilution Liquid Bottle 39 Imaging Unit 39a Card Discarding Unit 41 Control Unit 42 Input Unit 43 Analysis Unit 44 Storage Unit 45 Output Unit 46 Judgment Unit 100 Sealed Container C Carrier

Claims (7)

One or more reaction vessels having an opening;
A sealing member that seals the opening and deforms according to a pressure difference between the inside and the outside of the reaction vessel;
With
The sealed space in the reaction vessel sealed by the sealing member is set to a positive pressure or negative pressure state as compared to normal atmospheric pressure, and the sealing member is used when the sealed space is in a positive pressure state. A reaction card which is deformed into a convex shape and deforms into a concave shape when the sealed space is in a negative pressure state.   The reaction card according to claim 1, wherein the sealing member is a metal or a resin.   The reaction card according to claim 1, wherein at least a part of a portion of the sealing member that covers the opening is deformed according to the pressure difference.   The reaction card according to claim 2, wherein the metal is aluminum. The reaction vessel is
A reaction part that contains a sample and a reagent, and causes the agglutination reaction between the sample and the reagent;
An analysis unit for analyzing a specimen, containing a carrier for holding the aggregate by changing mobility according to the size of the aggregate by the aggregation reaction;
The reaction card according to any one of claims 1 to 4, further comprising: A reaction card in which the inside of the reaction container is held in a sealed state by a sealing member that seals an opening provided in the upper part of the reaction container;
Sealing determination means for determining whether or not the inside of the reaction container is sealed by the sealing member;
Informing means for notifying that the sealed state is not sealed when it is determined that the inside of the reaction vessel is not sealed,
An automatic analyzer characterized by comprising. In a reaction card manufacturing method for a reaction card having one or more reaction containers in which a specimen and a reagent are dispensed to cause an immunological agglutination reaction,
A charging step of charging a carrier accommodated in the reaction vessel;
A sealing step of sealing the reaction vessel containing the carrier under negative pressure or positive pressure with a sealing member;
The reaction card manufacturing method characterized by including this.

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