WO2019097984A1 - Inspection package - Google Patents

Inspection package Download PDF

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Publication number
WO2019097984A1
WO2019097984A1 PCT/JP2018/039848 JP2018039848W WO2019097984A1 WO 2019097984 A1 WO2019097984 A1 WO 2019097984A1 JP 2018039848 W JP2018039848 W JP 2018039848W WO 2019097984 A1 WO2019097984 A1 WO 2019097984A1
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WO
WIPO (PCT)
Prior art keywords
detection unit
inspection
base
holding member
claws
Prior art date
Application number
PCT/JP2018/039848
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French (fr)
Japanese (ja)
Inventor
正貴 松尾
Original Assignee
コニカミノルタ株式会社
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Publication date
Application filed by コニカミノルタ株式会社 filed Critical コニカミノルタ株式会社
Priority to JP2019553782A priority Critical patent/JP7237008B2/en
Publication of WO2019097984A1 publication Critical patent/WO2019097984A1/en

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N37/00—Details not covered by any other group of this subclass

Definitions

  • the present invention relates to inspection packages.
  • a small amount of a substance to be detected such as blood protein or DNA
  • a substance to be detected can be measured with high sensitivity and quantitative in a clinical examination or the like, it will be possible to grasp the patient's condition quickly and carry out treatment. Therefore, there is a need for a method that can measure a small amount of substance to be detected at high sensitivity and quantitatively.
  • SPR method Surface Plasmon Resonance (hereinafter abbreviated as "SPR method”) method and surface plasmon-field enhanced fluorescence spectroscopy (below) as methods capable of measuring trace amounts of substances to be detected with high sensitivity. (Abbreviated as “SPFS”) is known.
  • the detection chip used for the SPR method, SPFS, etc. is, for example, integrated with a detection part for detecting a substance to be detected and a storage part for storing a reagent used for detection of a substance to be detected (for example, , Patent Document 1).
  • Patent Document 1 describes a detection chip in which a detection unit for detecting a substance to be detected and a storage unit for storing a reagent to be used for detection of a substance to be detected are integrated in a snap fit method. There is.
  • the storage portion includes a housing portion for housing the detection portion, and two pairs of snap-fit claws. In the detection chip of Patent Document 1, the claw portion engages with the detection portion by pushing the detection portion into the housing portion.
  • the detection portion of the detection chip as described in Patent Document 1 is made of an optical resin such as cycloolefin polymer (COP), acrylic resin, polycarbonate (PC), etc., and it is necessary to detect a substance to be detected in a state of being precisely positioned. is there.
  • the storage section is made of a resin such as polypropylene (PP) which has no hygroscopic property and is excellent in chemical resistance, and does not have to be positioned as precisely as the detection section.
  • PP polypropylene
  • an object of the present invention is an inspection package including an inspection chip including a detection unit and a storage unit having a claw unit for holding the detection unit, and the inspection package includes It is an object of the present invention to provide an inspection package in which the claw portion is not easily damaged even when an impact is applied.
  • an inspection package is an inspection package having an inspection chip for detecting a substance to be detected and a tray for holding the inspection chip,
  • the inspection chip includes a substrate, and a reaction unit for reacting the substance to be detected and a reagent disposed on the substrate or in the substrate, and a detection unit for detecting the substance to be detected, and the detection And a reservoir for storing the reagent separately formed, wherein the reservoir is provided on the front and back sides of the base at a distance wider than the distance between the front and back of the base of the detection unit.
  • It has one or more pairs of claws for limiting movement of the detection unit in the front and back direction of the detection unit, and the tray is disposed on the front or back side of the detection unit, Said nail Having a holding member for holding the detector in order to reduce the load by the detection unit with respect to.
  • the present invention it is possible to provide an inspection package in which the claw portion is less likely to be damaged even when an impact is applied to the claw portion due to transportation, dropping, or the like.
  • FIG. 1 is a view showing the configuration of an inspection package according to an embodiment of the present invention.
  • FIGS. 2A and 2B are diagrams showing the relationship between the distance between one of the claws and the detector on the holding member side and the distance between the pair of claws.
  • FIG. 3 is a schematic view showing a configuration of an inspection package according to a modification.
  • FIG. 1 is a diagram showing the configuration of an inspection package according to the present embodiment.
  • FIGS. 2A and 2B are cross-sectional views taken along the line AA shown in FIG. 1, showing the positional relationship between the detection unit supported by the holding member and the claws of the storage unit.
  • FIG. 2A and B the relationship between the space
  • the inspection package 100 has an inspection chip 110 and a tray 150.
  • the inspection chip 110 is transported in a state protected by the tray 150.
  • the inspection chip 110 includes a detection unit 111 and a storage unit 112.
  • the detection unit 111 is used to react the substance to be detected and the reagent to detect the substance to be detected.
  • the detection unit 111 is configured to detect a substance to be detected by SPFS.
  • the shape of the detection unit 111 can be set as appropriate.
  • the planar view shape of the detection unit 111 is rectangular, and the shape of the detection unit 111 is a substantially rectangular parallelepiped shape.
  • the detection unit 111 includes a base 118 and a reaction unit 117.
  • the detection unit 111 has a prism 115 and a metal film 116 in addition to the base 118 and the reaction unit 117.
  • the prism 115 has an incident surface 121, a reflecting surface 122 and an emitting surface 123.
  • the incident surface 121 causes the light emitted from the light source to enter into the prism 115.
  • the reflecting surface 122 reflects the light incident on the inside of the prism 115.
  • the light reflected by the reflecting surface 122 is reflected light.
  • the emitting surface 123 emits the reflected light to the outside of the prism 115.
  • the shape of the prism 115 can be set as appropriate. In the present embodiment, the shape of the prism 115 is a cylindrical body having a trapezoidal bottom surface.
  • the surface corresponding to one base of the trapezoid is the reflecting surface 122
  • the surface corresponding to one leg is the incident surface 121
  • the surface corresponding to the other leg is the emitting surface 123.
  • the material of the prism 115 include cycloolefin polymer (COP), acrylic resin, optical resin such as polycarbonate (PC), and glass.
  • the material of the prism 115 is a resin having a refractive index in the range of 1.4 to 1.6 and a small birefringence.
  • the metal film 116 is formed on the reflective surface 122 of the prism 115.
  • the material of the metal film 116 include at least one metal selected from the group consisting of gold, silver, aluminum, copper, and platinum, and an alloy of these metals.
  • the thickness of the metal film 116 may be set as appropriate. For example, the thickness of the metal film 116 is 5 to 500 nm.
  • the reaction unit 117 causes the substance to be detected to react with the reagent.
  • the reaction portion 117 is disposed on the surface of the metal film 116 on which the prism 115 is not disposed.
  • the flow path 130 is formed by assembling the base 118 to the prism 115 on which the metal film 116 is formed.
  • the reaction unit 117 is a part of the bottom of the flow channel 130.
  • the reaction unit 117 includes, for example, a primary antibody for capturing a substance to be detected, and captures the substance to be detected.
  • the to-be-detected substance captured by the primary antibody is fluorescently labeled by the secondary antibody labeled with a fluorescent substance.
  • the reaction unit 117 is a SAM film (Self-Assembled Monolayer: also referred to as “self-assembled monolayer”) or a polymer material film to which a primary antibody is bound.
  • the primary antibody is bound to one side of these membranes.
  • the other side of these films is fixed directly or indirectly to the surface of the metal film 116.
  • SAM films include those formed with substituted aliphatic thiols such as HOOC- (CH 2 ) 11 -SH.
  • examples of the polymer material include polyethylene glycol and MPC polymer.
  • the base 118 is a substantially plate-like transparent member disposed so as to cover the reaction portion 117 on the surface of the metal film 116 on which the prism 115 is not disposed.
  • a first through hole 125 is formed at one end of the base body 118, and a second through hole 126 is formed at the other end.
  • a channel groove 127 connecting the first through hole 125 and the second through hole 126 is formed on the surface (rear surface) opposite to the metal film 116 of the base 118.
  • the substrate 118 is bonded to the metal film 116 to form the inlet 128, the outlet 129, and the flow channel 130 together with the metal film 116.
  • the material of the substrate 118 include cycloolefin polymer (COP), acrylic resin, optical resin such as polycarbonate (PC), and glass.
  • the storage unit 112 stores a reagent, a sample, and the like to be reacted with the substance to be detected.
  • the storage unit 112 is formed separately from the detection unit 111.
  • the configuration of the storage unit 112 can be set as appropriate.
  • the storage portion 112 has a plurality of wells 131 opened on one surface and a plurality of claw portions 113. Samples and reagents are stored inside the well 131.
  • the shape of the well 131 is not particularly limited.
  • the volume of the well 131 can be appropriately set according to the amount of sample or reagent to be stored.
  • the well 131 may be sealed by a sealing member or the like.
  • a through hole 132 for housing the detection unit 111 is formed.
  • the through hole 132 accommodates the detection unit 111, and restricts the movement of the detection unit 111 (the base 118) in the horizontal direction (direction orthogonal to the front and back direction).
  • the shape of the through hole 132 can be appropriately set as long as the detection unit 111 can be accommodated.
  • the plan view shape of the through hole 132 is formed in a shape similar to the plan view shape of the detection unit 111, that is, a rectangular shape. Further, the size of the through hole 132 is not particularly limited as long as the horizontal movement of the detection unit 111 (base 118) can be limited.
  • a plurality of claws 113 are arranged on the inner side surface of the through hole 132.
  • the plurality of claws 113 restrict, to some extent, the movement of the detection unit 111 (the base 118) accommodated in the through hole 132 in the front and back direction.
  • the plurality of claws 113 are arranged in pairs on the inner side surface of the through hole 132.
  • the pair of claw portions 113 is disposed so as to be located on the front side of the base 118 and the back side of the base 118 when the detection portion 111 is accommodated in the through hole 132.
  • the number of claws 113 is not particularly limited as long as the above-described function can be exhibited.
  • one claw 113 may be disposed on the front side of the base 118 and two may be disposed on the back of the base 118.
  • two claws 113 may be disposed on the front side of the base 118 and one may be disposed on the back of the base 118. Furthermore, one claw 113 may be disposed on each of the front and back sides of the base 118. As described above, the pair of claws 113 is disposed so as to sandwich the base 118 of the detection unit 111. The pair of claws 113 is disposed at a distance wider than the distance between the front and back surfaces of the base 118. The number of pairs of claws 113 may be one pair, but is preferably two or more. In the present embodiment, the four pairs of claws 113 are arranged so as to be positioned two by two on the inner side surface of the long side of the through hole 132 when the through hole 132 is viewed in plan.
  • the claw portion 113 is configured to be able to integrate the detection portion 111 and the storage portion 112 in a snap fit method.
  • the detection unit 111 is integrated with the storage unit 112 by being pushed toward the inside of the through hole 132 from the side where the well 131 is opened.
  • the detection unit 111 continues to operate on the front and back even after the detection unit 111 and the storage unit 112 are integrated. Some extent of direction can be moved.
  • the storage unit 112 restricts the horizontal movement of the detection unit 111 (base 118) by the inner surface of the through hole 132, and restricts the movement of the detection unit 111 (base 118) in the front and back direction to a certain extent.
  • the tray 150 protects the inspection chip 110 when transporting the inspection chip 110 or the like.
  • the shape of the tray 150 can be appropriately designed as long as the inspection chip 110 can be protected.
  • the tray 150 has a substantially rectangular parallelepiped shape whose upper surface is open. Further, in the present embodiment, the holding member 151 is integrally formed on the bottom surface of the tray 150.
  • the holding member 151 holds the detection unit 111 in order to reduce the load of the detection unit 111 with respect to the claw portion 113 on the holding member 151 side among the pair of claw portions 113.
  • the holding member 151 is disposed on the front side or the back side of the detection unit 111. That is, the holding member 151 may be disposed only on the front side of the detection unit 111, may be disposed only on the back side of the detection unit 111, or is disposed on both the front side and the back side of the detection unit 111. May be In the present embodiment, the holding member 151 is disposed only on the back side of the detection unit 111.
  • the detection unit 111 is biased toward the claw portion 113 by its own weight at the time of transportation, handling, and the like. Therefore, when the holding member 151 does not exist, when the inspection package 100 is dropped at the time of conveyance or handling, the claw portion 113 may be damaged by an impact. From the viewpoint of preventing such breakage of the claws 113, the holding member 151 is preferably formed as follows.
  • the holding member 151 preferably holds the detection unit 111 such that the following equation (1) is satisfied.
  • the holding member 151 preferably holds the detection portion 111 so as to satisfy the following formula (3).
  • A is a distance (mm) between one of the claws 113 and the base 118 on the holding member 151 side (A> 0 mm in FIG. 2B). 0 ⁇ A (3)
  • the load applied to the claw portion 113 can be eliminated by holding the detection portion 111 such that the base 118 and the claw portion 113 do not contact each other by the holding member 151.
  • the detection unit 111 is held by the holding member 151 so that the load on the claws 113 is reduced, breakage of the claws 113 can be prevented. .
  • the inspection package 200 according to the modification differs from the inspection package 100 according to the first embodiment only in the presence or absence of the package 260. Therefore, the same components as those of the inspection package 100 according to the first embodiment are denoted by the same reference numerals, and the description thereof is omitted.
  • FIG. 3 is a diagram showing the configuration of an inspection package 200 according to a modification. As shown in FIG. 3, the inspection package 200 according to the modification has a package 260 in addition to the inspection chip 110 and the tray 150.
  • the package 260 packages the test chip 110 and the tray 150, and prevents damage to the test chip 110 by maintaining the positional relationship between the test chip 110 and the tray 150 at the time of transportation or the like.
  • the material of the package 260 can be appropriately selected as long as it has a predetermined rigidity and can exhibit the above-described effects. Examples of materials of the package 260 include low density polyethylene (LDPE), medium density polyethylene (HDPE), linear low density polyethylene (L-LDPE), ethylene-vinyl acetate copolymer resin (EVA resin), etc.
  • biaxially oriented polypropylene film OPP
  • polyvinylidene chloride coated OPP KOP
  • polypropylene based films using non-oriented polypropylene CPP
  • PET polyethylene terephthalate
  • KPET polyvinylidene chloride coated PET
  • polyester films such as nylon (ON), polyvinylidene chloride coated ON (KON), cast nylon (CN), nylon films, aluminum (AL), aluminum vapor deposited film (VM), etc.
  • General packaging film and functional packaging films such as arm, hand and the like that the laminated film.
  • the thickness of the package 260 is about 10 to 300 ⁇ m.
  • the package 260 is sealed.
  • the influence on the inspection chip 110 due to the external environment such as temperature and humidity can be reduced.
  • the inside of the package 260 may be decompressed.
  • the package 260 is in close contact with the test chip 110 and the tray 150, and the positional relationship between the test chip 110 and the tray 150 can be maintained more reliably. Damage can be prevented more reliably.
  • Cuts 261 are formed in the package 260 so as to be easily opened.
  • the position where the cut 261 is formed can be selected as appropriate.
  • the position where the cut 261 is formed may be formed on the long side of the package 260 in plan view, or may be formed on the short side of the package 260 in plan view.
  • the notches 261 are respectively formed on the short sides of the package 260 in plan view.
  • the notch 261 When the notch 261 is disposed on the short side of the package 260, the length of the package 260 is in a state in which the inspection chip 110 and the tray 150 are brought close to one long side (left side in FIG. 3) of the package 260.
  • the package 260 is cut from the notches 261 in the direction along the side, it is preferable that the notches 261 be disposed on the short side so that the cut does not overlap the inspection chip 110.
  • the cut 261 is disposed on the long side so that the cut does not overlap the inspection chip 110 when the package 260 is cut from the cut 261. In these cases, when the package 260 is opened, no extra impact is applied to the test chip 110, so that the test chip 110 can be prevented from being damaged.
  • the inspection package 200 according to the modification of the present embodiment further includes the package 260, the inspection package 100 according to the first embodiment can further prevent breakage of the claw portion 113.
  • the inspection package according to the present invention can prevent damage to the inspection chip due to transportation, dropping or the like. Therefore, the improvement of the reliability of the inspection result and the cost reduction of each inspection are expected.

Abstract

This inspection package includes an inspection chip and a tray. The inspection chip includes a base body and a reaction portion, and includes a detecting portion for detecting a substance being detected, and a storage portion for storing a reagent, formed separately from the detecting portion. The storage portion includes, on a top side or a rear side of the base body, one pair or two or more pairs of hook portions for restricting movement in the front/back direction of the detecting portion base body, disposed with a spacing wider than a spacing between the top surface and the rear surface of the detecting portion base body. The tray includes a holding member which is disposed on the top side or the rear side of the detecting portion to hold the detecting portion in order to alleviate a load on the hook portions due to the detecting portion.

Description

検査パッケージInspection package
　本発明は、検査パッケージに関する。 The present invention relates to inspection packages.
　臨床検査などにおいて、血液のタンパク質やＤＮＡなどの微量の被検出物質を高感度かつ定量的に測定することができれば、患者の状態を迅速に把握して治療を行うことが可能となる。このため、微量の被検出物質を高感度かつ定量的に測定できる方法が求められている。 If a small amount of a substance to be detected, such as blood protein or DNA, can be measured with high sensitivity and quantitative in a clinical examination or the like, it will be possible to grasp the patient's condition quickly and carry out treatment. Therefore, there is a need for a method that can measure a small amount of substance to be detected at high sensitivity and quantitatively.
　微量の被検出物質を高感度に測定できる方法として、表面プラズモン共鳴（Surface Plasmon Resonance：以下「ＳＰＲ法」と略記する）法および表面プラズモン励起増強蛍光分光法（Surface Plasmon-field enhanced Fluorescence Spectroscopy：以下「ＳＰＦＳ」と略記する）が知られている。 Surface Plasmon Resonance (hereinafter abbreviated as "SPR method") method and surface plasmon-field enhanced fluorescence spectroscopy (below) as methods capable of measuring trace amounts of substances to be detected with high sensitivity. (Abbreviated as "SPFS") is known.
　ＳＰＲ法やＳＰＦＳなどに使用される検出チップは、例えば被検出物質を検出するための検出部と、被検出物質の検出に使用する試薬などを貯留する貯留部とが一体化されている（例えば、特許文献１参照）。 The detection chip used for the SPR method, SPFS, etc. is, for example, integrated with a detection part for detecting a substance to be detected and a storage part for storing a reagent used for detection of a substance to be detected (for example, , Patent Document 1).
　特許文献１には、被検出物質を検出するための検出部と、被検出物質の検出に使用する試薬を貯留するための貯留部とがスナップフィット方式で一体化された検出チップが記載されている。貯留部は、検出部を収容する収容部と、スナップフィット方式の二対の爪部とを含む。特許文献１の検出チップでは、収容部に検出部を押し込むことで、爪部が検出部に係合する。 Patent Document 1 describes a detection chip in which a detection unit for detecting a substance to be detected and a storage unit for storing a reagent to be used for detection of a substance to be detected are integrated in a snap fit method. There is. The storage portion includes a housing portion for housing the detection portion, and two pairs of snap-fit claws. In the detection chip of Patent Document 1, the claw portion engages with the detection portion by pushing the detection portion into the housing portion.
　特許文献１のような検出チップの検出部は、シクロオレフィンポリマー（ＣＯＰ）、アクリル樹脂、ポリカーボネート（ＰＣ）などの光学樹脂製であり、精度良く位置決めされた状態で被検出物質を検出する必要がある。一方、貯留部は、吸湿性がなく、かつ耐薬品性に優れているポリプロピレン（ＰＰ）などの樹脂製であり、検出部ほど精度良く位置決めされる必要はない。 The detection portion of the detection chip as described in Patent Document 1 is made of an optical resin such as cycloolefin polymer (COP), acrylic resin, polycarbonate (PC), etc., and it is necessary to detect a substance to be detected in a state of being precisely positioned. is there. On the other hand, the storage section is made of a resin such as polypropylene (PP) which has no hygroscopic property and is excellent in chemical resistance, and does not have to be positioned as precisely as the detection section.
特表２０１１－５０８２２３号公報JP 2011-508223 gazette
　しかしながら、特許文献１の検出チップ（検査チップ）では、輸送時やハンドリング時における落下などの衝撃により、検出部を支持していた爪部が破損するという問題があった。なお、爪部の剛性を向上させるために、爪部の形状を変更することも考えられるが、この場合検出チップが大型化するとともに、成形型が複雑化するという問題が想定される。 However, in the detection chip (inspection chip) of Patent Document 1, there is a problem that the claw portion supporting the detection portion is damaged by an impact such as falling during transportation or handling. Although it is conceivable to change the shape of the claws in order to improve the rigidity of the claws, in this case, there is assumed a problem that the size of the detection chip is increased and the molding die is complicated.
　そこで、本発明の課題は、検出部と、前記検出部を保持するための爪部を有する貯留部とを含む検査チップを有する検査パッケージであって、輸送や落下などで貯留部の爪部に衝撃が加わった場合であっても、爪部が破損しにくい検査パッケージを提供することである。 Therefore, an object of the present invention is an inspection package including an inspection chip including a detection unit and a storage unit having a claw unit for holding the detection unit, and the inspection package includes It is an object of the present invention to provide an inspection package in which the claw portion is not easily damaged even when an impact is applied.
　上記課題を解決するため、本発明の一実施の形態に係る検査パッケージは、被検出物質を検出するための検査チップと、前記検査チップを保持するためのトレイとを有する検査パッケージであって、前記検査チップは、基体と、前記基体上または前記基体内に配置された前記被検出物質および試薬を反応させる反応部とを有し、前記被検出物質を検出するための検出部と、前記検出部と別体に形成された前記試薬を貯留するための貯留部とを有し、前記貯留部は、前記基体の表側および裏側に、前記検出部の基体の表面および裏面の間隔より広い間隔で配置された、前記検出部の前記基体の表裏方向における移動を制限するための１対または２対以上の爪部を有し、前記トレイは、前記検出部の前記表側または前記裏側に配置され、前記爪部に対する前記検出部による荷重を軽減するために前記検出部を保持する保持部材を有する。 In order to solve the above problems, an inspection package according to an embodiment of the present invention is an inspection package having an inspection chip for detecting a substance to be detected and a tray for holding the inspection chip, The inspection chip includes a substrate, and a reaction unit for reacting the substance to be detected and a reagent disposed on the substrate or in the substrate, and a detection unit for detecting the substance to be detected, and the detection And a reservoir for storing the reagent separately formed, wherein the reservoir is provided on the front and back sides of the base at a distance wider than the distance between the front and back of the base of the detection unit. It has one or more pairs of claws for limiting movement of the detection unit in the front and back direction of the detection unit, and the tray is disposed on the front or back side of the detection unit, Said nail Having a holding member for holding the detector in order to reduce the load by the detection unit with respect to.
　本発明によれば、輸送や落下などで爪部に衝撃が加わった場合であっても、爪部が破損しにくい検査パッケージを提供できる。 According to the present invention, it is possible to provide an inspection package in which the claw portion is less likely to be damaged even when an impact is applied to the claw portion due to transportation, dropping, or the like.
図１は、本発明の一実施の形態に係る検査パッケージの構成を示す図である。FIG. 1 is a view showing the configuration of an inspection package according to an embodiment of the present invention. 図２Ａ、Ｂは、保持部材側における一方の爪部および検出部の間隔と、一対の爪部の間隔との関係を示す図である。FIGS. 2A and 2B are diagrams showing the relationship between the distance between one of the claws and the detector on the holding member side and the distance between the pair of claws. 図３は、変形例に係る検査パッケージの構成を示す模式図である。FIG. 3 is a schematic view showing a configuration of an inspection package according to a modification.
　以下、本発明の一実施の形態に係る検査パッケージについて、添付した図面を参照して詳細に説明する。 Hereinafter, an inspection package according to an embodiment of the present invention will be described in detail with reference to the attached drawings.
　図１は、本実施の形態に係る検査パッケージの構成を示す図である。図２Ａ、Ｂは、図１に示されるＡ－Ａ線の断面図であり、保持部材により支持されている状態の検出部と、貯留部の爪部との位置関係を示す図である。図２Ａ、Ｂでは、保持部材側における一方の爪部および検出部の間隔Ａと、一対の爪部の間隔Ｂとの関係を示している。図２Ａは、Ａ＝０の状態を示す図であり、図２Ｂは、Ａ＞０の状態を示す図である。 FIG. 1 is a diagram showing the configuration of an inspection package according to the present embodiment. FIGS. 2A and 2B are cross-sectional views taken along the line AA shown in FIG. 1, showing the positional relationship between the detection unit supported by the holding member and the claws of the storage unit. In FIG. 2A and B, the relationship between the space | interval A of one nail | claw part in a holding member side and a detection part and the space | interval B of a pair of nail | claw parts is shown. FIG. 2A is a diagram showing a state of A = 0, and FIG. 2B is a diagram showing a state of A> 0.
　図１に示されるように、検査パッケージ１００は、検査チップ１１０と、トレイ１５０とを有する。検査チップ１１０は、トレイ１５０によって保護された状態で輸送される。 As shown in FIG. 1, the inspection package 100 has an inspection chip 110 and a tray 150. The inspection chip 110 is transported in a state protected by the tray 150.
　検査チップ１１０は、検出部１１１と、貯留部１１２とを有する。 The inspection chip 110 includes a detection unit 111 and a storage unit 112.
　検出部１１１は、被検出物質および試薬を反応させて、被検出物質を検出するために使用される。本実施の形態では、ＳＰＦＳにより被検出物質を検出するように、検出部１１１は構成されている。検出部１１１の形状は、適宜設定できる。本実施の形態では、検出部１１１の平面視形状は、矩形であり、検出部１１１の形状は、略直方体形状である。検出部１１１は、基体１１８と、反応部１１７とを有する。本実施の形態では、検出部１１１は、基体１１８および反応部１１７に加え、プリズム１１５と、金属膜１１６とを有する。 The detection unit 111 is used to react the substance to be detected and the reagent to detect the substance to be detected. In the present embodiment, the detection unit 111 is configured to detect a substance to be detected by SPFS. The shape of the detection unit 111 can be set as appropriate. In the present embodiment, the planar view shape of the detection unit 111 is rectangular, and the shape of the detection unit 111 is a substantially rectangular parallelepiped shape. The detection unit 111 includes a base 118 and a reaction unit 117. In the present embodiment, the detection unit 111 has a prism 115 and a metal film 116 in addition to the base 118 and the reaction unit 117.
　プリズム１１５は、入射面１２１、反射面１２２および出射面１２３を有する。入射面１２１は、光源から出射された光をプリズム１１５の内部に入射させる。反射面１２２は、プリズム１１５の内部に入射した光を反射させる。反射面１２２で反射した光は、反射光となる。出射面１２３は、反射光をプリズム１１５の外部に出射させる。プリズム１１５の形状は、適宜設定できる。本実施の形態では、プリズム１１５の形状は、台形を底面とする柱体である。この場合、台形の一方の底辺に対応する面が反射面１２２であり、一方の脚に対応する面が入射面１２１であり、他方の脚に対応する面が出射面１２３である。プリズム１１５の材料の例には、シクロオレフィンポリマー（ＣＯＰ）、アクリル樹脂、ポリカーボネート（ＰＣ）などの光学樹脂およびガラスが含まれる。例えばプリズム１１５の材料は、屈折率が１．４～１．６の範囲内であり、かつ複屈折が小さい樹脂である。 The prism 115 has an incident surface 121, a reflecting surface 122 and an emitting surface 123. The incident surface 121 causes the light emitted from the light source to enter into the prism 115. The reflecting surface 122 reflects the light incident on the inside of the prism 115. The light reflected by the reflecting surface 122 is reflected light. The emitting surface 123 emits the reflected light to the outside of the prism 115. The shape of the prism 115 can be set as appropriate. In the present embodiment, the shape of the prism 115 is a cylindrical body having a trapezoidal bottom surface. In this case, the surface corresponding to one base of the trapezoid is the reflecting surface 122, the surface corresponding to one leg is the incident surface 121, and the surface corresponding to the other leg is the emitting surface 123. Examples of the material of the prism 115 include cycloolefin polymer (COP), acrylic resin, optical resin such as polycarbonate (PC), and glass. For example, the material of the prism 115 is a resin having a refractive index in the range of 1.4 to 1.6 and a small birefringence.
　金属膜１１６は、プリズム１１５の反射面１２２上に形成されている。金属膜１１６の材料の例には、金、銀、アルミニウム、銅、および白金からなる群から選ばれる少なくとも１種の金属と、これらの金属の合金とが含まれる。金属膜１１６の厚さは、適宜設定すればよい。例えば、金属膜１１６の厚さは、５～５００ｎｍである。 The metal film 116 is formed on the reflective surface 122 of the prism 115. Examples of the material of the metal film 116 include at least one metal selected from the group consisting of gold, silver, aluminum, copper, and platinum, and an alloy of these metals. The thickness of the metal film 116 may be set as appropriate. For example, the thickness of the metal film 116 is 5 to 500 nm.
　反応部１１７は、被検出物質と試薬とを反応させる。反応部１１７は、金属膜１１６の２つの面のうち、プリズム１１５が配置されていない面上に配置されている。流路１３０は、金属膜１１６が形成されたプリズム１１５に基体１１８を組み付けることで形成される。反応部１１７は、流路１３０の底面の一部である。反応部１１７は、例えば、被検出物質を捕捉するための１次抗体を含み、被検出物質を捕捉する。１次抗体に捕捉された被検出物質は、蛍光物質で標識された２次抗体により蛍光標識される。例えば、反応部１１７は、１次抗体を結合させたＳＡＭ膜（Self-Assembled Monolayer：「自己組織化単分子膜」ともいう）または高分子材料膜である。これらの膜の一方の面には、１次抗体が結合されている。また、これらの膜の他方の面は、直接または間接に金属膜１１６の表面に固定されている。ＳＡＭ膜の例には、ＨＯＯＣ－（ＣＨ２）１１－ＳＨなどの置換脂肪族チオールで形成された膜が含まれる。また、高分子材料の例には、ポリエチレングリコールやＭＰＣポリマーなどが含まれる。 The reaction unit 117 causes the substance to be detected to react with the reagent. The reaction portion 117 is disposed on the surface of the metal film 116 on which the prism 115 is not disposed. The flow path 130 is formed by assembling the base 118 to the prism 115 on which the metal film 116 is formed. The reaction unit 117 is a part of the bottom of the flow channel 130. The reaction unit 117 includes, for example, a primary antibody for capturing a substance to be detected, and captures the substance to be detected. The to-be-detected substance captured by the primary antibody is fluorescently labeled by the secondary antibody labeled with a fluorescent substance. For example, the reaction unit 117 is a SAM film (Self-Assembled Monolayer: also referred to as “self-assembled monolayer”) or a polymer material film to which a primary antibody is bound. The primary antibody is bound to one side of these membranes. Also, the other side of these films is fixed directly or indirectly to the surface of the metal film 116. Examples of SAM films include those formed with substituted aliphatic thiols such as HOOC- (CH 2 ) 11 -SH. Further, examples of the polymer material include polyethylene glycol and MPC polymer.
　基体１１８は、金属膜１１６の２つの面のうち、プリズム１１５が配置されていない面上に、反応部１１７を覆うように配置された略板状の透明部材である。基体１１８の一方の端部には第１貫通孔１２５が形成されており、他方の端部には第２貫通孔１２６が形成されている。基体１１８の金属膜１１６に対向する面（裏面）には、第１貫通孔１２５および第２貫通孔１２６を接続する流路溝１２７が形成されている。本実施の形態では、基体１１８は、金属膜１１６に接合されることにより、金属膜１１６と共に、注入口１２８、排出口１２９および流路１３０を形成する。基体１１８の材料の例には、シクロオレフィンポリマー（ＣＯＰ）、アクリル樹脂、ポリカーボネート（ＰＣ）などの光学樹脂およびガラスが含まれる。 The base 118 is a substantially plate-like transparent member disposed so as to cover the reaction portion 117 on the surface of the metal film 116 on which the prism 115 is not disposed. A first through hole 125 is formed at one end of the base body 118, and a second through hole 126 is formed at the other end. A channel groove 127 connecting the first through hole 125 and the second through hole 126 is formed on the surface (rear surface) opposite to the metal film 116 of the base 118. In this embodiment, the substrate 118 is bonded to the metal film 116 to form the inlet 128, the outlet 129, and the flow channel 130 together with the metal film 116. Examples of the material of the substrate 118 include cycloolefin polymer (COP), acrylic resin, optical resin such as polycarbonate (PC), and glass.
　貯留部１１２は、被検出物質と反応させる試薬や検体などを貯留する。貯留部１１２は、検出部１１１と別体に形成されている。貯留部１１２の構成は、適宜設定できる。本実施の形態では、貯留部１１２は、一方の面に開口した複数のウェル１３１と、複数の爪部１１３とを有する。ウェル１３１の内部には、検体や試薬などを保管する。ウェル１３１の形状は、特に限定されない。ウェル１３１容量は、保管する検体や試薬の量に応じて適宜設定されうる。ウェル１３１は、シール部材などで封止されていてもよい。また、貯留部１１２には、検出部１１１を収容するための貫通孔１３２が形成されている。 The storage unit 112 stores a reagent, a sample, and the like to be reacted with the substance to be detected. The storage unit 112 is formed separately from the detection unit 111. The configuration of the storage unit 112 can be set as appropriate. In the present embodiment, the storage portion 112 has a plurality of wells 131 opened on one surface and a plurality of claw portions 113. Samples and reagents are stored inside the well 131. The shape of the well 131 is not particularly limited. The volume of the well 131 can be appropriately set according to the amount of sample or reagent to be stored. The well 131 may be sealed by a sealing member or the like. In addition, in the storage unit 112, a through hole 132 for housing the detection unit 111 is formed.
　貫通孔１３２は、検出部１１１を収容し、検出部１１１（基体１１８）の水平方向（表裏方向に直交する方向）の移動を制限する。貫通孔１３２の形状は、検出部１１１を収容できれば適宜設定できる。本実施の形態では、貫通孔１３２の平面視形状は、検出部１１１の平面視形状と相似形状、すなわち矩形状に形成されている。また、貫通孔１３２の大きさは、検出部１１１（基体１１８）の水平方向の移動を制限できるのであれば特に限定されない。貫通孔１３２の内側面には、複数の爪部１１３が配置されている。 The through hole 132 accommodates the detection unit 111, and restricts the movement of the detection unit 111 (the base 118) in the horizontal direction (direction orthogonal to the front and back direction). The shape of the through hole 132 can be appropriately set as long as the detection unit 111 can be accommodated. In the present embodiment, the plan view shape of the through hole 132 is formed in a shape similar to the plan view shape of the detection unit 111, that is, a rectangular shape. Further, the size of the through hole 132 is not particularly limited as long as the horizontal movement of the detection unit 111 (base 118) can be limited. A plurality of claws 113 are arranged on the inner side surface of the through hole 132.
　複数の爪部１１３は、貫通孔１３２に収容した検出部１１１（基体１１８）の表裏方向の移動をある程度制限する。複数の爪部１１３は、対となって貫通孔１３２の内側面に配置されている。一対の爪部１１３は、貫通孔１３２内に検出部１１１を収容したときに、基体１１８の表側と、基体１１８の裏側とに位置するように配置されている。爪部１１３の数は、前述の機能を発揮できれば特に限定されない。例えば、爪部１１３は、基体１１８の表側に１つ配置され、基体１１８の裏側に２つ配置されていてもよい。また、爪部１１３は、基体１１８の表側に２つ配置され、基体１１８の裏側に１つ配置されていてもよい。さらに、爪部１１３は、基体１１８の表側および裏側にそれぞれ１つずつ配置されていてもよい。このように、一対の爪部１１３は、検出部１１１の基体１１８を挟み込むように配置されている。一対の爪部１１３は、基体１１８の表面および裏面の間隔より広い間隔で配置されている。爪部１１３の対数は、１対であってもよいが、２対以上が好ましい。本実施の形態では、４対の爪部１１３が、貫通孔１３２を平面視したときに、貫通孔１３２の長辺の内側面に２対ずつ位置するように配置されている。 The plurality of claws 113 restrict, to some extent, the movement of the detection unit 111 (the base 118) accommodated in the through hole 132 in the front and back direction. The plurality of claws 113 are arranged in pairs on the inner side surface of the through hole 132. The pair of claw portions 113 is disposed so as to be located on the front side of the base 118 and the back side of the base 118 when the detection portion 111 is accommodated in the through hole 132. The number of claws 113 is not particularly limited as long as the above-described function can be exhibited. For example, one claw 113 may be disposed on the front side of the base 118 and two may be disposed on the back of the base 118. Also, two claws 113 may be disposed on the front side of the base 118 and one may be disposed on the back of the base 118. Furthermore, one claw 113 may be disposed on each of the front and back sides of the base 118. As described above, the pair of claws 113 is disposed so as to sandwich the base 118 of the detection unit 111. The pair of claws 113 is disposed at a distance wider than the distance between the front and back surfaces of the base 118. The number of pairs of claws 113 may be one pair, but is preferably two or more. In the present embodiment, the four pairs of claws 113 are arranged so as to be positioned two by two on the inner side surface of the long side of the through hole 132 when the through hole 132 is viewed in plan.
　爪部１１３は、スナップフィット方式で検出部１１１および貯留部１１２を一体化できるように構成されていることが好ましい。検出部１１１は、ウェル１３１が開口した面側から貫通孔１３２の内部に向けて押し込まれることで、貯留部１１２と一体化される。ただし、前述のとおり、一対の爪部１１３の間隔は、基体１１８の厚み（表面および裏面の間隔）より広いため、検出部１１１および貯留部１１２を一体化した後も、検出部１１１は、表裏方向にある程度の範囲は移動することができる。このように、貯留部１１２は、検出部１１１（基体１１８）の水平方向の移動を貫通孔１３２の内面で制限し、検出部１１１（基体１１８）の表裏方向の移動を爪部１１３である程度制限する。 Preferably, the claw portion 113 is configured to be able to integrate the detection portion 111 and the storage portion 112 in a snap fit method. The detection unit 111 is integrated with the storage unit 112 by being pushed toward the inside of the through hole 132 from the side where the well 131 is opened. However, as described above, since the distance between the pair of claws 113 is wider than the thickness of the base 118 (the distance between the front and back surfaces), the detection unit 111 continues to operate on the front and back even after the detection unit 111 and the storage unit 112 are integrated. Some extent of direction can be moved. Thus, the storage unit 112 restricts the horizontal movement of the detection unit 111 (base 118) by the inner surface of the through hole 132, and restricts the movement of the detection unit 111 (base 118) in the front and back direction to a certain extent. Do.
　トレイ１５０は、検査チップ１１０の搬送時などにおいて、検査チップ１１０を保護する。トレイ１５０の形状は、検査チップ１１０を保護できれば適宜設計できる。本実施の形態では、トレイ１５０は、上面が開放した略直方体形状である。また、本実施の形態では、トレイ１５０の底面には、保持部材１５１が一体として形成されている。 The tray 150 protects the inspection chip 110 when transporting the inspection chip 110 or the like. The shape of the tray 150 can be appropriately designed as long as the inspection chip 110 can be protected. In the present embodiment, the tray 150 has a substantially rectangular parallelepiped shape whose upper surface is open. Further, in the present embodiment, the holding member 151 is integrally formed on the bottom surface of the tray 150.
　保持部材１５１は、各対の爪部１１３のうち保持部材１５１側の爪部１１３に対する検出部１１１による荷重を軽減するために検出部１１１を保持する。保持部材１５１は、検出部１１１の表側または裏側に配置されている。すなわち、保持部材１５１は、検出部１１１の表側のみに配置されていてもよいし、検出部１１１の裏側のみに配置されていてもよいし、検出部１１１の表側および裏側の両方に配置されていてもよい。本実施の形態では、保持部材１５１は、検出部１１１の裏側にのみ配置されている。 The holding member 151 holds the detection unit 111 in order to reduce the load of the detection unit 111 with respect to the claw portion 113 on the holding member 151 side among the pair of claw portions 113. The holding member 151 is disposed on the front side or the back side of the detection unit 111. That is, the holding member 151 may be disposed only on the front side of the detection unit 111, may be disposed only on the back side of the detection unit 111, or is disposed on both the front side and the back side of the detection unit 111. May be In the present embodiment, the holding member 151 is disposed only on the back side of the detection unit 111.
　検出部１１１は、搬送時やハンドリング時などに自重により爪部１１３に向かって付勢される。よって、保持部材１５１が存在しない場合、搬送時やハンドリング時に検査パッケージ１００を落下させてしまうと、衝撃により、爪部１１３が破損してしまうおそれがある。このような爪部１１３の破損を防ぐ観点から、保持部材１５１は、以下に示すように形成されていることが好ましい。 The detection unit 111 is biased toward the claw portion 113 by its own weight at the time of transportation, handling, and the like. Therefore, when the holding member 151 does not exist, when the inspection package 100 is dropped at the time of conveyance or handling, the claw portion 113 may be damaged by an impact. From the viewpoint of preventing such breakage of the claws 113, the holding member 151 is preferably formed as follows.
　図２Ａに示されるように、保持部材１５１は、以下の式（１）を満たすように、検出部１１１を保持することが好ましい。式（１）において、Ａは、保持部材１５１側における一方の爪部１１３および基体１１８の間隔（ｍｍ）である（図２Ａでは、Ａ＝０ｍｍ）。
　０≦Ａ　　　（１） As shown in FIG. 2A, the holding member 151 preferably holds the detection unit 111 such that the following equation (1) is satisfied. In the formula (1), A is a distance (mm) between one of the claws 113 and the base 118 on the holding member 151 side (A = 0 mm in FIG. 2A).
0 ≦ A (1)
　また、本実施の形態では、前述のとおり、一対の爪部１１３の間隔は、基体１１８の厚み（表面および裏面の間隔）より広いことから、上記式（１）が満たされる場合は、以下の式（２）が満たされる。式（２）において、Ａは、保持部材１５１側における一方の爪部１１３および基体１１８の間隔（ｍｍ）であり、Ｂは、一対の爪部１１３の間隔から基体１１８の表面および裏面の間隔を引いた値（ｍｍ）である。
　０≦Ａ≦Ｂ　　　（２） Further, in the present embodiment, as described above, since the distance between the pair of claws 113 is wider than the thickness of the base 118 (the distance between the front surface and the back surface), when the above equation (1) is satisfied, Formula (2) is satisfied. In equation (2), A is the distance (mm) between one of the claws 113 and the base 118 on the holding member 151 side, and B is the distance between the front and back of the base 118 from the distance between the pair of claws 113. It is the subtracted value (mm).
0 ≦ A ≦ B (2)
　このように、各対の爪部１１３のうち保持部材１５１側の一方の爪部１１３および基体１１８の間隔を０以上とすることで、衝撃により爪部１１３に掛かる荷重を減らすことができる。 As described above, by setting the distance between one of the claws 113 and the base 118 on the holding member 151 side in each pair of claws 113 to be 0 or more, the load applied to the claws 113 due to impact can be reduced.
　また、爪部１１３の破損をより確実に防ぐ観点からは、図２Ｂに示されるように、保持部材１５１は、以下の式（３）を満たすように、検出部１１１を保持することが好ましい。式（３）において、Ａは、保持部材１５１側における一方の爪部１１３および基体１１８の間隔（ｍｍ）である（図２Ｂでは、Ａ＞０ｍｍ）。
　０＜Ａ　　　（３） Further, from the viewpoint of more reliably preventing breakage of the claw portion 113, as shown in FIG. 2B, the holding member 151 preferably holds the detection portion 111 so as to satisfy the following formula (3). In the formula (3), A is a distance (mm) between one of the claws 113 and the base 118 on the holding member 151 side (A> 0 mm in FIG. 2B).
0 <A (3)
　また、上記式（３）が満たされる場合は、以下の式（４）が満たされることが好ましい。式（４）において、Ａは、保持部材１５１側における一方の爪部１１３および基体１１８の間隔（ｍｍ）であり、Ｂは、一対の爪部１１３の間隔から基体１１８の表面および裏面の間隔を引いた値（ｍｍ）である。
　０＜Ａ＜Ｂ　　　（４） Moreover, when the said Formula (3) is satisfy | filled, it is preferable that the following formula (4) is satisfy | filled. In equation (4), A is the distance (mm) between one of the claws 113 and the base 118 on the holding member 151 side, and B is the distance between the front and back of the base 118 from the distance between the pair of claws 113. It is the subtracted value (mm).
0 <A <B (4)
　このように、保持部材１５１によって、基体１１８と爪部１１３とが接触しないように検出部１１１を保持することによって、爪部１１３に掛かる荷重をなくすことができる。 As described above, the load applied to the claw portion 113 can be eliminated by holding the detection portion 111 such that the base 118 and the claw portion 113 do not contact each other by the holding member 151.
　以上のように、本実施の形態に係る検査パッケージ１００は、爪部１１３に対する荷重が軽減されるように検出部１１１が保持部材１５１によって保持されるため、爪部１１３が破損することを防止できる。 As described above, in the inspection package 100 according to the present embodiment, since the detection unit 111 is held by the holding member 151 so that the load on the claws 113 is reduced, breakage of the claws 113 can be prevented. .
　［変形例］
　次に、変形例に係る検査パッケージ２００について説明する。変形例に係る検査パッケージ２００は、包装体２６０の有無のみが実施の形態１に係る検査パッケージ１００と異なる。そこで、実施の形態１に係る検査パッケージ１００と同様の構成については、同様の符号を付して、その説明を省略する。 [Modification]
Next, an inspection package 200 according to a modification will be described. The inspection package 200 according to the modification differs from the inspection package 100 according to the first embodiment only in the presence or absence of the package 260. Therefore, the same components as those of the inspection package 100 according to the first embodiment are denoted by the same reference numerals, and the description thereof is omitted.
　図３は、変形例に係る検査パッケージ２００の構成を示す図である。図３に示されるように、変形例に係る検査パッケージ２００は、検査チップ１１０およびトレイ１５０に加えて、包装体２６０を有する。 FIG. 3 is a diagram showing the configuration of an inspection package 200 according to a modification. As shown in FIG. 3, the inspection package 200 according to the modification has a package 260 in addition to the inspection chip 110 and the tray 150.
　包装体２６０は、検査チップ１１０およびトレイ１５０を包装して、搬送時などにおいて、検査チップ１１０およびトレイ１５０の位置関係を維持することで、検査チップ１１０の破損を防止する。包装体２６０の材料は、所定の剛性を有し、かつ上記の効果を発揮できれば適宜選択できる。包装体２６０の材料の例には、低密度ポリエチレン（ＬＤＰＥ）、中密度ポリエチレン（ＨＤＰＥ）、直鎖状低密度ポリエチレン（Ｌ－ＬＤＰＥ）、エチレン－酢酸ビニル共重合樹脂（ＥＶＡ樹脂）などを使用したポリエチレン系フィルム、２軸延伸ポリプロピレンフィルム（ＯＰＰ）、ポリ塩化ビニリデンコートＯＰＰ（ＫＯＰ）、無延伸ポリプロピレン（ＣＰＰ）などを使用したポリプロピレン系フィルム、ポリエチレンテレフタラート（ＰＥＴ）、ポリ塩化ビニリデンコートＰＥＴ（ＫＰＥＴ）などを使用したポリエステル系フィルム、ナイロン（ＯＮ）、ポリ塩化ビニリデンコートＯＮ（ＫＯＮ）、キャストナイロン（ＣＮ）などのナイロン系フィルム、アルミニウム（ＡＬ）、アルミ蒸着フィルム（ＶＭ）などのアルミニウムフィルムなどの一般的な包装フィルムや機能性包装フィルム、またその積層フィルムなどが含まれる。また、包装体２６０の厚みは、１０～３００ｕｍ程度である。 The package 260 packages the test chip 110 and the tray 150, and prevents damage to the test chip 110 by maintaining the positional relationship between the test chip 110 and the tray 150 at the time of transportation or the like. The material of the package 260 can be appropriately selected as long as it has a predetermined rigidity and can exhibit the above-described effects. Examples of materials of the package 260 include low density polyethylene (LDPE), medium density polyethylene (HDPE), linear low density polyethylene (L-LDPE), ethylene-vinyl acetate copolymer resin (EVA resin), etc. -Based films, biaxially oriented polypropylene film (OPP), polyvinylidene chloride coated OPP (KOP), polypropylene based films using non-oriented polypropylene (CPP), etc., polyethylene terephthalate (PET), polyvinylidene chloride coated PET ( (KPET), polyester films such as nylon (ON), polyvinylidene chloride coated ON (KON), cast nylon (CN), nylon films, aluminum (AL), aluminum vapor deposited film (VM), etc. General packaging film and functional packaging films, such as arm, hand and the like that the laminated film. The thickness of the package 260 is about 10 to 300 μm.
　また、包装体２６０は、密閉されていることが好ましい。包装体２６０が密閉されていることにより、温度や湿度などの外部環境による、検査チップ１１０への影響を軽減できる。また、包装体２６０の内部は、減圧にしてもよい。包装体２６０の内部を減圧することで、包装体２６０が検査チップ１１０およびトレイ１５０に密着して、検査チップ１１０およびトレイ１５０の位置関係をより確実に維持することができるため、爪部１１３の破損をより確実に防止することができる。 Moreover, it is preferable that the package 260 is sealed. By sealing the package 260, the influence on the inspection chip 110 due to the external environment such as temperature and humidity can be reduced. The inside of the package 260 may be decompressed. By depressurizing the inside of the package 260, the package 260 is in close contact with the test chip 110 and the tray 150, and the positional relationship between the test chip 110 and the tray 150 can be maintained more reliably. Damage can be prevented more reliably.
　包装体２６０には、開封しやすいように、切り込み２６１が形成されている。切り込み２６１が形成される位置は、適宜選択できる。切り込み２６１が形成される位置は、包装体２６０を平面視したときの長辺上に形成されていてもよいし、包装体２６０を平面視したときの短辺上に形成されていてもよい。本実施の形態では、切り込み２６１は、包装体２６０を平面視したときの短辺上にそれぞれ形成されている。 Cuts 261 are formed in the package 260 so as to be easily opened. The position where the cut 261 is formed can be selected as appropriate. The position where the cut 261 is formed may be formed on the long side of the package 260 in plan view, or may be formed on the short side of the package 260 in plan view. In the present embodiment, the notches 261 are respectively formed on the short sides of the package 260 in plan view.
　切り込み２６１が包装体２６０の短辺上に配置されている場合、検査チップ１１０およびトレイ１５０を包装体２６０の一方の長辺側（図３において左側）に寄せた状態で、包装体２６０の長辺に沿う方向に切り込み２６１から包装体２６０を切ったときに、切り口が検査チップ１１０と重ならないように、切り込み２６１は短辺上に配置されることが好ましい。一方、切り込み２６１が包装体２６０の長辺状に配置されている場合、検査チップ１１０およびトレイ１５０を包装体２６０の一方の短辺側に寄せた状態で、包装体２６０の短辺に沿う方向に切り込み２６１から包装体２６０を切ったときに、切り口が検査チップ１１０と重ならないように、切り込み２６１は長辺上に配置されることが好ましい。これらの場合、包装体２６０を開封するときに検査チップ１１０に対して余分な衝撃が加わらないため、検査チップ１１０が破損することを防止できる。 When the notch 261 is disposed on the short side of the package 260, the length of the package 260 is in a state in which the inspection chip 110 and the tray 150 are brought close to one long side (left side in FIG. 3) of the package 260. When the package 260 is cut from the notches 261 in the direction along the side, it is preferable that the notches 261 be disposed on the short side so that the cut does not overlap the inspection chip 110. On the other hand, when the notches 261 are arranged in the long side of the package 260, the test chip 110 and the tray 150 are brought closer to one short side of the package 260, and the direction along the short side of the package 260 Preferably, the cut 261 is disposed on the long side so that the cut does not overlap the inspection chip 110 when the package 260 is cut from the cut 261. In these cases, when the package 260 is opened, no extra impact is applied to the test chip 110, so that the test chip 110 can be prevented from being damaged.
　以上のように、本実施の形態の変形例に係る検査パッケージ２００は、包装体２６０をさらに有するため、実施の形態１に係る検査パッケージ１００より、さらに爪部１１３の破損を防止できる。 As described above, since the inspection package 200 according to the modification of the present embodiment further includes the package 260, the inspection package 100 according to the first embodiment can further prevent breakage of the claw portion 113.
　本出願は、２０１７年１１月１５日出願の特願２０１７－２２００１８に基づく優先権を主張する。当該出願明細書および図面に記載された内容は、すべて本願明細書に援用される。 This application claims the priority based on Japanese Patent Application No. 2017-220018 filed on Nov. 15, 2017. The contents described in the application specification and drawings are all incorporated herein by reference.
　本発明に係る検査パッケージは、輸送や落下などによる検査チップの破損を防ぐことができる。したがって、検査結果の信頼性の向上と各検査のコスト軽減とが期待される。 The inspection package according to the present invention can prevent damage to the inspection chip due to transportation, dropping or the like. Therefore, the improvement of the reliability of the inspection result and the cost reduction of each inspection are expected.
　１００、２００　検査パッケージ
　１１０　検出チップ
　１１１　検出部
　１１２　貯留部
　１１３　爪部
　１１５　プリズム
　１１６　金属膜
　１１７　反応部
　１１８　基体
　１２１　入射面
　１２２　反射面
　１２３　出射面
　１２５　第１貫通孔
　１２６　第２貫通孔
　１２７　流路溝
　１２８　注入口
　１２９　排出口
　１３０　流路
　１３１　ウェル
　１３２　貫通孔
　１５０　トレイ
　１５１　保持部材
　２６０　包装体
　２６１　切り込み 100, 200 inspection package 110 detection chip 111 detection unit 112 storage unit 113 claw unit 115 prism 116 metal film 117 reaction unit 118 base 121 entrance surface 122 reflection surface 123 exit surface 125 first through hole 126 second through hole 127 passage groove 128 Inlet 129 Discharge Port 130 Flow Path 131 Well 132 Through Hole 150 Tray 151 Holding Member 260 Package 261 Notch

Claims (7)

  1. 　被検出物質を検出するための検査チップと、前記検査チップを保持するためのトレイとを有する検査パッケージであって、
    　前記検査チップは、
    　基体と、前記基体上または前記基体内に配置された前記被検出物質および試薬を反応させる反応部とを有し、前記被検出物質を検出するための検出部と、
    　前記検出部と別体に形成された前記試薬を貯留するための貯留部とを有し、
    　前記貯留部は、前記基体の表側および裏側に、前記検出部の基体の表面および裏面の間隔より広い間隔で配置された、前記検出部の前記基体の表裏方向における移動を制限するための１対または２対以上の爪部を有し、
    　前記トレイは、前記検出部の前記表側または前記裏側に配置され、前記爪部に対する前記検出部による荷重を軽減するために前記検出部を保持する保持部材を有する、
    　検査パッケージ。     An inspection package comprising: an inspection chip for detecting a substance to be detected; and a tray for holding the inspection chip,
    The inspection chip is
    A detection unit for detecting the to-be-detected substance, having a substrate, and a reaction unit for reacting the to-be-detected substance and a reagent disposed on or in the substrate;
    A storage unit for storing the reagent separately from the detection unit;
    The reservoirs are disposed on the front and back sides of the base at a distance wider than the distance between the front and back sides of the base of the detection unit, and are a pair for limiting movement of the base in the front and back directions of the detection unit. Or have two or more pairs of claws,
    The tray is disposed on the front side or the back side of the detection unit, and includes a holding member that holds the detection unit to reduce a load by the detection unit on the claws.
    Inspection package.
  2. 　前記保持部材は、以下の式（１）を満たすように、前記検出部を保持する、請求項１に記載の検査パッケージ。
    　０≦Ａ　　　（１）
    ［Ａは、前記保持部材側における一方の前記爪部および前記基体の間隔（ｍｍ）である。］     The inspection package according to claim 1, wherein the holding member holds the detection unit such that the following expression (1) is satisfied.
    0 ≦ A (1)
    [A is a distance (mm) between one of the claws and the base on the holding member side. ]
  3. 　前記保持部材は、以下の式（２）を満たすように、前記検出部を保持する、請求項１または請求項２に記載の検査パッケージ。
    　０≦Ａ≦Ｂ　　　（２）
    ［Ａは、前記保持部材側における一方の前記爪部および前記基体の間隔（ｍｍ）であり、Ｂは、一対の前記爪部の間隔から前記基体の表面および裏面の間隔を引いた値（ｍｍ）である。］     The inspection package according to claim 1, wherein the holding member holds the detection unit so as to satisfy the following formula (2).
    0 ≦ A ≦ B (2)
    [A is a distance (mm) between one of the claws and the base on the holding member side, and B is a value obtained by subtracting the distance between the front and back of the base from the distance between the pair of claws (mm ). ]
  4. 　前記保持部材は、以下の式（３）を満たすように、前記検出部を保持する、請求項１に記載の検査パッケージ。
    　０＜Ａ　　　（３）
    ［Ａは、前記保持部材側における一方の前記爪部および前記基体の間隔（ｍｍ）である。］     The inspection package according to claim 1, wherein the holding member holds the detection unit so as to satisfy the following formula (3).
    0 <A (3)
    [A is a distance (mm) between one of the claws and the base on the holding member side. ]
  5. 　前記保持部材は、以下の式（４）を満たすように、前記検出部を保持する、請求項１または請求項２に記載の検査パッケージ。
    　０＜Ａ＜Ｂ　　　（４）
    ［Ａは、前記保持部材側における一方の前記爪部および前記基体の間隔（ｍｍ）であり、Ｂは、一対の前記爪部の間隔から前記基体の表面および裏面の間隔を引いた値（ｍｍ）である。］     The inspection package according to claim 1, wherein the holding member holds the detection unit so as to satisfy the following formula (4).
    0 <A <B (4)
    [A is a distance (mm) between one of the claws and the base on the holding member side, and B is a value obtained by subtracting the distance between the front and back of the base from the distance between the pair of claws (mm ). ]
  6. 　前記検出部は、
    　前記基体と、
    　前記基体上または前記基体内に配置された前記被検出物質および試薬を反応させる反応部と、
    　前記基体の一方の面に配置されたプリズムと、を含み、
    　前記保持部材は、前記プリズムを保持する、
    　請求項１～５のいずれか一項に記載の検査パッケージ。     The detection unit is
    The substrate,
    A reaction unit for reacting the substance to be detected and a reagent disposed on or in the substrate;
    And a prism disposed on one side of the substrate,
    The holding member holds the prism.
    An inspection package according to any one of the preceding claims.
  7. 　前記検査パッケージおよび前記トレイを包装した包装体をさらに有する、請求項１～６のいずれか一項に記載の検査パッケージ。 The inspection package according to any one of claims 1 to 6, further comprising a package in which the inspection package and the tray are packaged.
PCT/JP2018/039848 2017-11-15 2018-10-26 Inspection package WO2019097984A1 (en)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006106870A1 (en) * 2005-03-30 2006-10-12 Shimadzu Corporation Method of dispensing in reaction vessel and reaction vessel processing apparatus
JP2009222555A (en) * 2008-03-17 2009-10-01 Konica Minolta Medical & Graphic Inc Injection device, specimen pretreatment apparatus and microinspection chip
WO2009131043A1 (en) * 2008-04-25 2009-10-29 コニカミノルタエムジー株式会社 Microchip
WO2011040504A1 (en) * 2009-09-30 2011-04-07 凸版印刷株式会社 Nucleic acid analyzer
WO2016117570A1 (en) * 2015-01-20 2016-07-28 コニカミノルタ株式会社 Analysis chip and analysis apparatus
WO2017082196A1 (en) * 2015-11-13 2017-05-18 コニカミノルタ株式会社 Inspection chip and inspection system
WO2018110344A1 (en) * 2016-12-14 2018-06-21 コニカミノルタ株式会社 Inspection cartridge and blood inspection device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006106870A1 (en) * 2005-03-30 2006-10-12 Shimadzu Corporation Method of dispensing in reaction vessel and reaction vessel processing apparatus
JP2009222555A (en) * 2008-03-17 2009-10-01 Konica Minolta Medical & Graphic Inc Injection device, specimen pretreatment apparatus and microinspection chip
WO2009131043A1 (en) * 2008-04-25 2009-10-29 コニカミノルタエムジー株式会社 Microchip
WO2011040504A1 (en) * 2009-09-30 2011-04-07 凸版印刷株式会社 Nucleic acid analyzer
WO2016117570A1 (en) * 2015-01-20 2016-07-28 コニカミノルタ株式会社 Analysis chip and analysis apparatus
WO2017082196A1 (en) * 2015-11-13 2017-05-18 コニカミノルタ株式会社 Inspection chip and inspection system
WO2018110344A1 (en) * 2016-12-14 2018-06-21 コニカミノルタ株式会社 Inspection cartridge and blood inspection device

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