JP2010185718A - Reaction card - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a reaction card capable of performing highly accurate analysis by suppressing collision of a reaction liquid against an air gap. <P>SOLUTION: This reaction card 1 includes: a body part 10 having a card shape; a reaction vessel 11 having an opening on an upper end plane part of the body part 10; and a seal 15 pasted on the body part 10, on which a bar code or a lot number for discrimination, an expiration date or the like are printed, and having a description column for specimen information or a reaction result. The reaction vessel 11 includes: a reaction part 12 having an approximately cylindrical shape, for reacting the specimen with a reagent; and an analysis part 13 provided in communication with a bottom part of the reaction part 12, and filled with a carrier C for generating a reaction image for determining existence of aggregation corresponding to the reaction result. Gas in the air gap of the reaction vessel 11 is exhausted by an exhaust pipe 14 connected to the analysis part 13, and thereby collision of the reaction liquid of the specimen and the reagent against the air gap can be prevented, to thereby enable highly accurate analysis. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a reaction card having a reaction vessel for performing an immunological agglutination reaction.

  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 reaction container of the above-described reaction card includes a reaction part that mixes a sample and a reagent to perform an immunological agglutination reaction, and a reaction solution that is connected to the lower part of the reaction part and that performs the immunological agglutination reaction. And an analysis unit containing a carrier whose mobility is changed according to the size of the aggregate. The sample contained in the analysis unit can be analyzed by changing the capture position according to the size of the aggregate in the reaction solution that moves from the reaction unit to the analysis unit by centrifugation. Here, in the space region between the reaction part and the carrier of the analysis part, there is an air gap that is a gas layer formed by the gas, and this air gap tensions the sample and the reagent dispensed to the reaction part. Alternatively, by holding the pressure inside the air gap, the sample and the reagent are prevented from contacting the carrier before the reaction between the sample and the reagent.

Japanese Patent Publication No.8-7215

  However, in the reaction card shown in Patent Document 1, when the reaction solution is moved from the reaction unit to the analysis unit by centrifugation, the reaction solution and the gas in the air gap are changed when the relative position of the reaction solution and the air gap is switched. Collided with each other to destroy aggregates formed by relatively weak bonds in the reaction solution, and the aggregates are destroyed, which may cause erroneous determination of analysis results.

  This invention is made | formed in view of the above, Comprising: It aims at providing the reaction card which makes it possible to obtain a highly accurate analysis result.

  In order to solve the above-described problems and achieve the object, the reaction card according to the present invention has one or more reaction vessels, and each reaction vessel is formed with an exhaust port for degassing the reaction vessel. It is characterized by that.

  The reaction card according to the present invention is the reaction card according to the above invention, wherein the reaction container contains a sample and a reagent, and performs agglutination reaction between the sample and the reagent, and is arranged at the lower part of the reaction unit. And an analysis unit that contains a carrier that retains the aggregate by changing the mobility depending on the size of the aggregate due to the aggregation reaction, and performs analysis of the sample, and the exhaust port of the analysis unit It is provided in the space area | region formed between an upper end part and the said support | carrier.

  The reaction card according to the present invention is characterized in that, in the above invention, an exhaust pipe connected to the exhaust port and extending to an upper plane of the reaction section is provided.

  In the reaction card according to the present invention as set forth in the invention described above, at least one or more exhaust ports are formed on a side surface of the analysis unit.

  In the reaction card according to the present invention, in the above invention, the inner diameter of the reaction vessel that passes through the exhaust port end on the carrier side is larger than the inner diameter of the reaction vessel that passes through the exhaust port end on the reaction unit side. It is characterized by becoming larger.

  In the reaction card according to the present invention, in the above invention, an inner tube inserted from the upper end of the reaction vessel to the vicinity of the upper end of the carrier is provided, and the exhaust pipe includes the inner wall surface of the reaction vessel and the outside of the inner tube. An annular space formed between the wall surface and the carrier-side end of the annular space is an exhaust port.

  The reaction card according to the present invention is characterized in that, in the above invention, an end of the inner tube on the carrier side is formed to be inclined with respect to a radial direction of the analysis unit.

  The reaction card according to the present invention is characterized in that, in the above invention, the upper opening of the reaction section and the other end of the exhaust pipe are sealed by a sealing member.

  According to the present invention, since the collision between the reaction liquid and the air gap when the reaction liquid is centrifuged is suppressed, an effect that a highly accurate analysis can be performed is achieved.

  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.

(Embodiment 1)
FIG. 1 is a perspective view schematically showing a reaction card 1 according to the first embodiment of the present invention. The reaction card 1 has a card shape, a main body portion 10 having a flat portion at the upper end, a reaction container 11 having an opening at the upper end flat portion of the main body portion 10, and a main body portion 10, and is attached with a bar code for identification. A lot number, effective date, and the like are printed, and a seal 15 having columns for specimen information and reaction results is provided. 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. Depending on the capture position of the reaction liquid in the carrier C of the analysis unit 13, it is determined as 4+ to 1+ (positive), − (negative), or unknown (when positive or negative cannot be determined), and the sample is analyzed. The reaction card 1 is formed using a translucent resin, and the aggregated image in the analysis unit 13 can be confirmed by visual observation. Further, the upper opening of each reaction vessel 11 is sealed by a sealing member 16 on the upper plane of the main body 10, 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 16 or perforating the opening.

  A substantially columnar exhaust pipe 14 connected to the upper plane of the main body 10 is connected to the upper surface of the carrier C on the side surface of the analysis unit 13. The upper part of the exhaust pipe 14 is also sealed by the sealing member 16, and when the sealing by the sealing member 16 on the upper part of the exhaust pipe 14 is released, the gas present in the reaction vessel 11 is released to the outside. Can do.

  In addition, the sealing member 16 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.

  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 16 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 16. Further, as shown in FIG. 2, a convex portion 10b is also provided on the upper surface of the main body 10 above the exhaust pipe 14, and the exhaust pipe 14 is hermetically sealed when the sealing member 16 and the convex portion 10b are in close contact with each other. . The exhaust pipe 14 has an exhaust port 141 at a connection portion with the reaction vessel 11 and an exhaust port 142 in an internal space formed by the convex portion 10 b of the main body 10.

  Here, the deaeration mechanism in the reaction vessel 11 will be described with reference to FIG. FIG. 3 is a schematic diagram showing a degassing mechanism of the reaction vessel 11. First, in FIG. 3 (a), the internal region formed by the convex portion 10a of the sealing member 16 is perforated with a needle or a dispensing probe to open the opening of the reaction vessel 11, and the sample and the reagent are dispensed. To do. The dispensed specimen and reagent are held in a space between the carrier C and the air gap A in the reaction vessel 11. Thereafter, the reaction solution M reacted for a predetermined time is centrifuged. Before performing the centrifugal treatment, the discharge port 142 is opened by perforating the space region formed by the convex portion 10b of the sealing member 16 using a needle or a dispensing probe. When the reaction card is centrifuged, a centrifugal force is applied in the direction indicated by the solid line in FIG. 3B, and the reaction solution M is also moved downward in FIG. 3B by the applied force. Due to the movement of the reaction liquid M, the internal pressure of the air gap A rises, and the gas in the air gap A is sent from the exhaust port 141 to the exhaust pipe 14. By continuing the centrifugation process, the gas in the air gap A is released to the outside from the discharge port 142 and the reaction solution M enters the carrier C as shown in FIG.

  By performing the above-described processing, the reaction between the air gap that holds the reaction liquid in which the specimen and the reagent have reacted and the reaction liquid is not rearranged by the centrifugal process, and thus the reaction caused by the impact when the reaction liquid and the air gap are switched. The influence of the liquid on the aggregate can be suppressed, and the analysis accuracy can be improved. Moreover, it is possible to make a more accurate determination in each determination of 4+ to 1+ (positive) and − (negative). Blood aggregation or hemolysis can be prevented.

  Here, the modification 1 of the reaction container 11 shown in FIG. 2 is demonstrated with reference to FIG. FIG. 4 is a cross-sectional view showing Modification 1 of the reaction vessel 11 shown in FIG. In the first modification shown in FIG. 4, the arrangement of the exhaust pipe 14 is inclined with respect to the radial direction of the reaction vessel 11, so that the reaction liquid M can be more reliably prevented from entering the exhaust pipe 14. Even when the reaction solution adheres to the vicinity of the exhaust port 141, the reaction solution can be returned to the analysis unit 13 by the force applied in the downward direction in FIG.

  Moreover, the modification 2 of the reaction container 11 shown in FIG. 2 is demonstrated with reference to FIG. FIG. 5 is a cross-sectional view showing a second modification of the reaction vessel 11 shown in FIG. In the second modification shown in FIG. 5, the diameter of the analysis unit 13 corresponding to the lower part of the exhaust port 141 is formed larger than the diameter of the analysis unit 13 corresponding to the upper part of the exhaust port 141. When the reaction solution is moved downward due to the difference in diameter, the reaction solution does not adhere to the exhaust port 141. Therefore, the reaction solution does not enter the exhaust pipe 14, and stable analysis is performed. Can be performed.

  Furthermore, Modification 3 of the reaction vessel 11 shown in FIG. 2 will be described with reference to FIG. FIG. 6 is a cross-sectional view showing a third modification of the reaction vessel 11 shown in FIG. In Modification 3 shown in FIG. 6, the above-described Modifications 1 and 2 are combined, and the reaction liquid that enters the exhaust pipe 14 can be more reliably prevented.

  Moreover, the modification 4 of the reaction container 11 shown in FIG. 2 is demonstrated with reference to FIG. FIG. 7 is a sectional view showing a fourth modification of the reaction vessel 11 shown in FIG. In the modified example 4 shown in FIG. 7, a plurality of exhaust ports 143a to 143c are provided. By providing the plurality of exhaust ports 143a to 143c, the gas in the air gap can be sequentially discharged from the exhaust port on the reaction part side while preventing the pressure of the air gap from increasing due to the pressure from the reaction solution by the centrifugal process. Smooth gas discharge can be performed.

  In the modification 4 shown in FIG. 7, the radial region of the reaction vessel 11 may be inclined as in the modification 1 shown in FIG. 4, and the exhaust port as in the modification 2 shown in FIG. The diameter of the analysis part 13 corresponding to the upper part and the lower part of 141 may be made different, and the exhaust pipe 14 is inclined as shown in FIG. 6 to correspond to the upper and lower parts of the exhaust port. You may make a difference in the diameter of the analysis part 13 to perform. Here, each of the exhaust ports 143a to 143c is preferably formed in parallel with the axial center of the reaction vessel 11 and in the same plane as the main body 10. With the arrangement described above, the volume occupied by the reaction card 1 can be minimized.

  In the above-described first embodiment, when the centrifugal treatment is performed by the exhaust pipe connecting the reaction container and the upper plane of the main body, the air gap present in the reaction container, the reaction liquid of the specimen and the reagent, Since the impact at the time of replacement can be prevented, the agglomerates in the reaction solution are not destroyed and more accurate analysis can be performed. In particular, a result that should be positive is not erroneously determined as negative, and blood aggregation or hemolysis after blood transfusion can be prevented.

  Here, in the exhaust of the reaction vessel 11 according to the first embodiment, as shown in FIG. 8, exhaust may be performed at the exhaust port 141 without providing the exhaust pipe 14. FIG. 8 is a cross-sectional view showing a fifth modification of the reaction vessel 11 shown in FIG. The exhaust port 141 is preferably sealed with a liquid-proof and moisture-permeable material 20 so that only gas can be released to the outside. The liquid-proof and moisture-permeable material 20 is sealed with a sealing member until just before use. . Only the gas in the air gap is released to the outside by pressing the reaction solution by the centrifugal treatment, and the same effect as in the first embodiment can be obtained. Further, since the sealing member is a separate body, the processing becomes easy particularly when the sealing member is peeled off for each processing.

  Further, when the reaction card 1 is centrifuged, the inside of the centrifuge may be set to a negative pressure so as to attract the gas in the air gap from the outside. By setting the inside of the centrifuge to a negative pressure, the exhaust efficiency is improved and the time required for centrifugation can be shortened.

(Embodiment 2)
Next, a second embodiment will be described. FIG. 9 is a perspective view schematically showing a reaction container of the reaction card according to the second embodiment of the present invention. FIG. 10 is a cross-sectional view schematically showing a cross section of the reaction vessel 11 shown in FIG. 9 and 10, an exhaust pipe 17 is disposed inside the reaction container 11, and the exhaust pipe 17 is supported in the internal space of the reaction container 11 by a support member 17a. The exhaust pipe 17 has a substantially columnar shape arranged on the axis of the reaction vessel 11, extends from the discharge port 172 provided in the upper plane formed by the convex portion 10 a to the lower side of the reaction vessel 11, and is an upper plane of the carrier C. An exhaust port 171 is provided in the vicinity.

  Moreover, the support member 17a is arrange | positioned in the position which does not overlap with the dispensing position P shown as an example. Consideration of the dispensing position P is necessary particularly when the dispensing probe of the automatic analyzer is automatically performed. When the reagent and the sample are dispensed from the dispensing position P into the space formed by the reaction vessel 11 and the outer periphery of the exhaust pipe 17, a space is formed between the reagent C and the carrier C by the air gap, and the reagent and specimen are centrifuged. The gas in the air gap is released to the outside through the exhaust pipe 17 through the exhaust pipe 17 by the processing, so that the reaction liquid can be sent into the carrier C.

  In the configuration of the reaction container and the exhaust pipe described above, the gas in the air gap in the reaction container can be more reliably exhausted by disposing the exhaust pipe in the reaction container. Further, by providing an exhaust pipe in parallel with the axial center of the reaction vessel, gas can be exhausted efficiently.

  Here, a modification according to the second embodiment of the present invention will be described with reference to FIGS. FIG. 11 is a perspective view showing a modification of the reaction vessel 11 according to the second embodiment of the present invention. Moreover, FIG. 12 is sectional drawing which shows the modification of the reaction container 11 concerning Embodiment 2 of this invention. In the modification shown in FIGS. 11 and 12, the sealing member 16 is attached to the upper plane of the plate-like member 10 c that is connected to the main body 10 and covers the opening of the reaction vessel 11. In addition, a discharge port 172 having a circular space is formed in the center of the plate-shaped member 10c, and a columnar member having a space inside that extends downward from the discharge port 172 on the axis of the reaction vessel 11. The exhaust pipe 17 is connected. An exhaust port 171 formed in the vicinity of the upper surface of the carrier C is the other end of the exhaust pipe 17. Furthermore, the plate-like member 10c has a cylindrical dispensing hole into which a dispensing probe can be inserted at a dispensing position P where a specimen or reagent is dispensed.

  When dispensing, the sample and reagent are dispensed into the space formed by the inner wall of the reaction vessel 11 and the outer wall of the exhaust pipe 17 by drilling the dispensing hole region of the sealing member 16 with a dispensing probe. . When dispensing is completed, the region of the discharge port 172 of the sealing member 16 is pierced with a needle or a probe, and the gas in the air gap is discharged to the outside via the exhaust pipe 17 by performing a centrifugal process. The liquid is fed into the carrier C.

  The reaction container of the reaction card according to the second embodiment described above has an exhaust pipe in the reaction container and is arranged in parallel with the axis of the reaction container. Accuracy stability can be improved.

  Further, in the modification according to the second embodiment, since the reaction container opening is the minimum necessary area by the plate member 10c, the reaction container can be easily and surely sealed, Contamination can be prevented and highly accurate analysis can be performed.

  The exhaust pipes according to the first and second embodiments may have a circular cross section, an ellipse, or a square as long as the exhaust pipe has a space inside.

(Embodiment 3)
Next, a third embodiment will be described. FIG. 13 is a perspective view schematically showing a reaction container of the reaction card according to the second embodiment of the present invention. FIG. 14 is a cross-sectional view schematically showing a cross section of the reaction vessel 11 shown in FIG. A reaction vessel 11 shown in FIGS. 13 and 14 is coaxial with the reaction vessel 11, has an exhaust pipe 18 having a slightly smaller diameter than the reaction vessel 11, and has an exhaust port 181 at the bottom. The upper part of the exhaust pipe 18 is flush with the upper plane of the convex part 10a, and a discharge port 182 is formed in an annular space formed by the convex part 10a and the exhaust pipe 18. The exhaust pipe 18 is supported by a support member 18a. The specimen and the reagent are dispensed by punching the sealing member 16 at the dispensing position P shown as an example, and held in the internal space of the exhaust pipe 18. The gas in the air gap located between the specimen and the reagent and the carrier C is taken into the exhaust port 181 by the pressure of the reaction liquid by centrifugal processing, and passes through the annular space formed by the reaction vessel 11 and the exhaust pipe 18. It is discharged from the discharge port 182 to the outside. In addition, the area | region concerning the discharge port 182 of the sealing member 16 is punctured with a dispensing probe etc. before centrifugation process, and the discharge port 182 is open | released. The perforation of the sealing member 16 is preferably performed at a plurality of locations, and may be opened using a perforation member corresponding to the shape of the discharge port 182, or the sealing member 16 may be peeled off and opened.

  By using the above-described configuration, the volume of exhaust is increased, and the gas in the air gap can be exhausted more efficiently. Further, since the reaction liquid of the specimen and the reagent pushes the gas in the air gap in the outer diameter direction, the exhaust can be surely performed by providing an exhaust port on the outer diameter side.

  Here, a modification according to the third embodiment of the present invention will be described with reference to FIGS. FIG. 15 is a perspective view showing a modification of the reaction vessel 11 according to the third embodiment of the present invention. Moreover, FIG. 16 is sectional drawing which shows the modification of the reaction container 11 concerning Embodiment 3 of this invention. In the modification shown in FIGS. 15 and 16, the exhaust pipe 19 supported by the support member 19 a has an exhaust port 191 at the lower portion and an exhaust port 192 at the upper portion, and the exhaust port 191 has the diameter of the reaction vessel 11. In contrast, an inclination is provided, and the gas in the air gap is exhausted at different heights when exhausting. Further, similarly to the reaction container shown in FIGS. 13 and 14, the sealing member 16 is pierced or peeled to open the discharge port 192 and exhaust.

  Since the reaction container of the reaction card according to the third embodiment described above exhausts the gas in the air gap through the space formed by the reaction container side surface and the outer periphery of the exhaust pipe, the exhaust capacity is high and the exhaust gas is more efficiently exhausted. It is possible to perform.

  In Embodiments 1 to 3 described above, the reaction card can also be applied to an automatic analyzer that automatically performs a dispensing process, a centrifugal process, and a photometric process. That is, the present invention can include various embodiments and the like not described herein, and various design changes and the like can be made without departing from the technical idea specified by the claims. Is possible.

It is a perspective view which shows typically the reaction card concerning Embodiment 1 of this invention. It is sectional drawing which shows typically the cross section of the reaction container of the reaction card | curd shown in FIG. It is a schematic diagram which shows the deaeration mechanism of the reaction container concerning Embodiment 1 of this invention. It is sectional drawing which shows the modification 1 of the reaction container shown in FIG. It is sectional drawing which shows the modification 2 of the reaction container shown in FIG. It is sectional drawing which shows the modification 3 of the reaction container shown in FIG. It is sectional drawing which shows the modification 4 of the reaction container shown in FIG. It is sectional drawing which shows the modification 5 of the reaction container shown in FIG. It is a perspective view which shows typically the reaction container of the reaction card concerning Embodiment 2 of this invention. It is sectional drawing which shows typically the cross section of the reaction container shown in FIG. It is a perspective view which shows the modification of the reaction container concerning Embodiment 2 of this invention. It is sectional drawing which shows the modification of the reaction container concerning Embodiment 2 of this invention. It is a perspective view which shows typically the reaction container of the reaction card concerning Embodiment 3 of this invention. It is sectional drawing which shows typically the cross section of the reaction container shown in FIG. It is a perspective view which shows the modification of the reaction container concerning Embodiment 3 of this invention. It is sectional drawing which shows the modification of the reaction container concerning Embodiment 3 of this invention.

DESCRIPTION OF SYMBOLS 1 Reaction card 10 Main-body part 10a, 10b Convex part 10c Plate-shaped member 11 Reaction container 12 Reaction part 13 Analysis part 14, 17, 18, 19 Exhaust pipe 141,171,181,191 Exhaust port 142,172,182,192 Exhaust Outlet 15 Seal 16 Sealing member 17a, 18a, 19a Support member 20 Liquid permeable and moisture permeable material A Air gap C Carrier M Reaction liquid P Dispensing position

Claims (8)

  A reaction card comprising one or more reaction vessels, wherein each reaction vessel is provided with an exhaust port for degassing the reaction vessel. 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 that is disposed in the lower part of the reaction unit, houses a carrier that holds the aggregate by changing mobility according to the size of the aggregate due to the aggregation reaction, and performs analysis of the specimen;
With
The reaction card according to claim 1, wherein the exhaust port is provided in a space region formed between an upper end portion of the analysis unit and the carrier.   The reaction card according to claim 1, wherein an exhaust pipe connected to the exhaust port and extending to an upper plane of the reaction unit is provided.   The reaction card according to claim 1, wherein at least one exhaust port is formed on a side surface of the analysis unit.   The inner diameter of the reaction vessel passing through the exhaust port end on the carrier side is larger than the inner diameter of the reaction vessel passing through the exhaust port end on the reaction side. 5. The reaction card according to any one of 4. An internal tube inserted from the upper end of the reaction vessel to the vicinity of the upper end of the carrier is provided,
2. The exhaust pipe is an annular space formed between an inner wall surface of the reaction vessel and an outer wall surface of the inner tube, and a carrier-side end portion of the annular space serves as an exhaust port. Or the reaction card of 2.   The reaction card according to claim 6, wherein an end portion of the inner tube on the carrier side is formed to be inclined with respect to a radial direction of the analysis unit.   The reaction card according to claim 1, wherein the upper opening of the reaction part and the other end of the exhaust pipe are sealed by a sealing member.

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