JP7237008B2 - inspection package - Google Patents

Description

The present invention relates to test packages.

In clinical examinations, etc., if minute amounts of substances to be detected such as blood proteins and DNA can be measured with high sensitivity and quantitatively, it will be possible to quickly grasp the patient's condition and provide treatment. Therefore, there is a demand for a method capable of quantitatively measuring a trace amount of a substance to be detected with high sensitivity.

Surface Plasmon Resonance (hereinafter abbreviated as "SPR method") and Surface Plasmon-field enhanced Fluorescence Spectroscopy (hereinafter referred to as Surface Plasmon-Enhanced Fluorescence Spectroscopy) are methods that can measure minute amounts of substances to be detected with high sensitivity. abbreviated as "SPFS") is known.

A detection chip used for the SPR method or SPFS, for example, integrates a detection unit for detecting a substance to be detected and a storage unit for storing a reagent used for detecting the substance to be detected (for example, , see Patent Document 1).

Patent Literature 1 describes a detection chip in which a detection portion for detecting a substance to be detected and a storage portion for storing a reagent used for detecting the substance to be detected are integrated in a snap-fit manner. there is The storage section includes a storage section that stores the detection section, 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 part of the detection chip as in Patent Document 1 is made of optical resin such as cycloolefin polymer (COP), acrylic resin, polycarbonate (PC), etc., and it is necessary to detect the substance to be detected while being positioned with high accuracy. be. On the other hand, the storage section is made of resin such as polypropylene (PP), which has no hygroscopicity and excellent chemical resistance, and does not need to be positioned as accurately as the detection section.

Japanese Patent Publication No. 2011-508223

However, the detection chip (inspection chip) of Patent Document 1 has a problem that the claws that support the detection section are damaged by impact such as dropping during transportation or handling. It is conceivable to change the shape of the claw in order to improve the rigidity of the claw.

Accordingly, an object of the present invention is to provide a test package having a test chip including a detecting portion and a storage portion having a claw portion for holding the detecting portion, wherein the claw portion of the storage portion may be damaged during transportation or dropping. To provide an inspection package in which a claw part is hardly damaged even when an impact is applied.

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 test chip has a base and a reaction section for reacting the substance to be detected and the reagent placed on or in the base, the detection section for detecting the substance to be detected, and the detection. and a storage portion formed separately for storing the reagent, and the storage portions are provided on the front and back sides of the substrate at intervals wider than the intervals between the front and back surfaces of the substrate of the detection portion. one or two or more pairs of claws for restricting the movement of the detection unit in the front-back direction of the substrate, the tray being arranged on the front side or the back side of the detection unit; A holding member for holding the detection section is provided to reduce the load of the detection section on the claw section, and the detection section includes the base and the substance to be detected disposed on or within the base. and a reaction section for reacting reagents, and a prism arranged on one surface of the substrate, and the holding member holds the prism on the back side of the detection section.

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 the claw portion is subjected to impact due to transportation, dropping, or the like.

FIG. 1 is a diagram showing the configuration of an inspection package according to one embodiment of the present invention. 2A and 2B are diagrams showing the relationship between the interval between one claw portion and the detection portion on the side of the holding member and the interval between the pair of claw portions. FIG. 3 is a schematic diagram showing the configuration of an inspection package according to a modification.

A test package according to an embodiment of the present invention will now be described in detail with reference to the accompanying drawings.

FIG. 1 is a diagram showing the configuration of an inspection package according to this embodiment. 2A and 2B are cross-sectional views taken along the line AA shown in FIG. 1, showing the positional relationship between the detecting portion supported by the holding member and the claw portion of the storing portion. 2A and 2B show the relationship between the interval A between one claw portion and the detection portion on the side of the holding member and the interval B between the pair of claw portions. FIG. 2A is a diagram showing the state of A=0, and FIG. 2B is a diagram showing the state of A>0.

As shown in FIG. 1, the test package 100 has a test chip 110 and a tray 150 . The test chip 110 is transported while being protected by the tray 150 .

The inspection chip 110 has a detection section 111 and a storage section 112 .

The detection unit 111 is used to react the substance to be detected and the reagent to detect the substance to be detected. In this embodiment, the detection unit 111 is configured to detect the substance to be detected by SPFS. The shape of the detection unit 111 can be set as appropriate. In the present embodiment, the plane view shape of the detection unit 111 is a rectangle, and the shape of the detection unit 111 is a substantially rectangular parallelepiped shape. The detection section 111 has a base 118 and a reaction section 117 . In this embodiment, detection section 111 has prism 115 and metal film 116 in addition to substrate 118 and reaction section 117 .

Prism 115 has an incident surface 121 , a reflective surface 122 and an exit surface 123 . The incident surface 121 allows the light emitted from the light source to enter the interior of the prism 115 . The reflective surface 122 reflects the light incident inside the prism 115 . The light reflected by the reflecting surface 122 becomes reflected light. The exit surface 123 emits the reflected light to the outside of the prism 115 . The shape of the prism 115 can be set appropriately. In this embodiment, the prism 115 has a columnar shape with 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 entrance surface 121 , and the surface corresponding to the other leg is the output surface 123 . Examples of materials for prism 115 include optical resins such as cycloolefin polymer (COP), acrylic resin, polycarbonate (PC), and glass. For example, the material of the prism 115 is a resin having a refractive index within the range of 1.4 to 1.6 and a small birefringence.

A metal film 116 is formed on the reflecting surface 122 of the prism 115 . Examples of materials for the metal film 116 include at least one metal selected from the group consisting of gold, silver, aluminum, copper, and platinum, and alloys 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 5-500 nm.

The reaction unit 117 causes the substance to be detected and the reagent to react. Of the two surfaces of the metal film 116, the reaction section 117 is arranged on the surface on which the prism 115 is not arranged. The channel 130 is formed by assembling the substrate 118 to the prism 115 on which the metal film 116 is formed. The reaction section 117 is part of the bottom surface of the channel 130 . The reaction section 117 contains, for example, a primary antibody for capturing the substance to be detected, and captures the substance to be detected. The substance to be detected captured by the primary antibody is fluorescently labeled with a secondary antibody labeled with a fluorescent substance. For example, the reaction section 117 is a SAM film (Self-Assembled Monolayer: also referred to as a “self-assembled monolayer”) or a polymeric material film to which a primary antibody is bound. A primary antibody is bound to one side of these membranes. Also, the other surfaces of these films are directly or indirectly fixed to the surface of the metal film 116 . Examples of SAM membranes include membranes formed of substituted aliphatic thiols such as HOOC-(CH ₂ ) ₁₁ -SH. Examples of polymeric materials also include polyethylene glycol, MPC polymers, and the like.

The substrate 118 is a substantially plate-like transparent member arranged so as to cover the reaction section 117 on one of the two surfaces of the metal film 116 on which the prism 115 is not arranged. A first through hole 125 is formed at one end of the base 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) of the substrate 118 facing the metal film 116 . In this embodiment, substrate 118 is bonded to metal film 116 to form inlet 128 , outlet 129 and channel 130 together with metal film 116 . Examples of materials for the substrate 118 include cycloolefin polymers (COP), acrylic resins, optical resins such as polycarbonate (PC), and glass.

The storage unit 112 stores reagents, specimens, and the like to be reacted with the substance to be detected. The storing portion 112 is formed separately from the detecting portion 111 . The configuration of the reservoir 112 can be set as appropriate. In the present embodiment, storage portion 112 has a plurality of wells 131 opened on one surface and a plurality of claw portions 113 . Samples, reagents, and the like are stored inside the well 131 . The shape of well 131 is not particularly limited. The capacity of the well 131 can be appropriately set according to the amount of samples and reagents to be stored. The well 131 may be sealed with a sealing member or the like. Further, a through hole 132 for accommodating the detecting portion 111 is formed in the storing portion 112 .

The through-hole 132 accommodates the detection unit 111 and restricts movement of the detection unit 111 (substrate 118) in the horizontal direction (direction perpendicular to the front-back direction). The shape of the through-hole 132 can be appropriately set as long as the detection unit 111 can be accommodated therein. In the present embodiment, the plan view shape of the through-hole 132 is similar to the plan view shape of the detection unit 111, that is, formed in a rectangular shape. Also, the size of the through-hole 132 is not particularly limited as long as it can restrict the horizontal movement of the detection unit 111 (substrate 118). A plurality of claw portions 113 are arranged on the inner surface of the through hole 132 .

The plurality of claw portions 113 restricts movement of the detecting portion 111 (substrate 118) accommodated in the through hole 132 in the front-back direction to some extent. The plurality of claw portions 113 are arranged in pairs on the inner surface of the through hole 132 . The pair of claws 113 are arranged so as to be positioned on the front side and the back side of the base 118 when the detection section 111 is housed in the through hole 132 . The number of claw portions 113 is not particularly limited as long as the above functions can be exhibited. For example, one claw portion 113 may be arranged on the front side of the base 118 and two claw portions 113 may be arranged on the back side of the base 118 . Also, two claw portions 113 may be arranged on the front side of the base 118 and one claw portion 113 may be arranged on the back side of the base 118 . Furthermore, one claw portion 113 may be arranged on each of the front side and the back side of the base 118 . Thus, the pair of claw portions 113 are arranged so as to sandwich the base 118 of the detection portion 111 . The pair of claws 113 are arranged at a larger interval than the interval between the front and back surfaces of the base 118 . The number of pairs of claws 113 may be one, but preferably two or more. In the present embodiment, four pairs of claw portions 113 are arranged so that two pairs of each of the claw portions 113 are positioned on the inner side surfaces of the long sides of the through hole 132 when the through hole 132 is viewed from above.

It is preferable that the claw portion 113 is configured so that the detection portion 111 and the storage portion 112 can be integrated by a snap-fit method. The detection unit 111 is integrated with the storage unit 112 by being pushed into the through-hole 132 from the side where the well 131 is opened. However, as described above, the gap between the pair of claws 113 is wider than the thickness of the base 118 (the gap between the front surface and the back surface). It can move in some direction. In this manner, the storing portion 112 restricts the horizontal movement of the detection portion 111 (substrate 118) by the inner surface of the through hole 132, and restricts the movement of the detection portion 111 (substrate 118) in the front-rear direction by the claw portion 113 to some extent. do.

The tray 150 protects the inspection chip 110 when the inspection chip 110 is transported. The shape of the tray 150 can be appropriately designed as long as the inspection chip 110 can be protected. In this embodiment, the tray 150 has a substantially rectangular parallelepiped shape with an open top. Further, in the present embodiment, a holding member 151 is integrally formed on the bottom surface of the tray 150 .

The holding member 151 holds the detecting portion 111 in order to reduce the load of the detecting portion 111 on the claw portion 113 on the holding member 151 side of each pair of claw portions 113 . The holding member 151 is arranged on the front side or the back side of the detection section 111 . That is, the holding member 151 may be arranged only on the front side of the detection section 111, may be arranged only on the back side of the detection section 111, or may be arranged on both the front side and the back side of the detection section 111. may In this embodiment, the holding member 151 is arranged only on the back side of the detection section 111 .

The detecting portion 111 is biased toward the claw portion 113 by its own weight during transportation, handling, or the like. Therefore, if the holding member 151 does not exist, if the test package 100 is dropped during transportation or handling, the impact may damage the claw portion 113 . From the viewpoint of preventing such damage to the claw portion 113, the holding member 151 is preferably formed as described below.

As shown in FIG. 2A, the holding member 151 preferably holds the detector 111 so as to satisfy the following formula (1). In formula (1), A is the distance (mm) between one claw portion 113 and the base 118 on the holding member 151 side (A=0 mm in FIG. 2A).
0≦A (1)

Further, in the present embodiment, as described above, 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 rear surface). Equation (2) is satisfied. In formula (2), A is the distance (mm) between one claw portion 113 and the base 118 on the holding member 151 side, and B is the distance between the pair of claw portions 113 and the front and back surfaces of the base 118. It is the subtracted value (mm).
0≦A≦B (2)

Thus, by setting the distance between one claw portion 113 of each pair of claw portions 113 on the holding member 151 side and the base 118 to be 0 or more, the load applied to the claw portions 113 due to the impact can be reduced.

Moreover, from the viewpoint of more reliably preventing damage to the claw portion 113, as shown in FIG. 2B, the holding member 151 preferably holds the detecting portion 111 so as to satisfy the following formula (3). In formula (3), A is the distance (mm) between one claw portion 113 and the base 118 on the holding member 151 side (A>0 mm in FIG. 2B).
0<A (3)

Moreover, when the above formula (3) is satisfied, it is preferable that the following formula (4) is satisfied. In equation (4), A is the distance (mm) between one claw portion 113 and the base 118 on the holding member 151 side, and B is the distance between the pair of claw portions 113 and the front and back surfaces of the base 118. It is the subtracted value (mm).
0<A<B (4)

In this way, the load applied to the claw portion 113 can be eliminated by holding the detecting portion 111 by the holding member 151 so that the base 118 and the claw portion 113 do not come into contact with each other.

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 as to reduce the load on the claw portion 113, damage to the claw portion 113 can be prevented. .

[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 descriptions thereof are omitted.

FIG. 3 is a diagram showing the configuration of an inspection package 200 according to a modification. As shown in FIG. 3 , the test package 200 according to the modification has a package 260 in addition to the test chip 110 and the tray 150 .

The package 260 wraps the test chip 110 and the tray 150 and maintains the positional relationship between the test chip 110 and the tray 150 during transportation, thereby preventing damage to the test chip 110 . The material of the package 260 can be appropriately selected as long as it has a predetermined rigidity and can exhibit the above effects. Examples of materials for 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), and the like. polyethylene film, biaxially oriented polypropylene film (OPP), polyvinylidene chloride coated OPP (KOP), polypropylene film using non-oriented polypropylene (CPP), polyethylene terephthalate (PET), polyvinylidene chloride coated PET ( KPET), nylon (ON), polyvinylidene chloride coated ON (KON), cast nylon (CN) and other nylon films, aluminum (AL), aluminum vapor deposition film (VM) and other aluminum films. general packaging films, functional packaging films, and laminated films thereof. Moreover, the thickness of the package 260 is about 10 to 300 μm.

Moreover, the package 260 is preferably hermetically sealed. By sealing the package 260, the influence of the external environment such as temperature and humidity on the test chip 110 can be reduced. Also, the inside of the package 260 may be decompressed. By decompressing the inside of the package 260, the package 260 is in close contact with the inspection chip 110 and the tray 150, and the positional relationship between the inspection chip 110 and the tray 150 can be more reliably maintained. Breakage can be prevented more reliably.

A notch 261 is formed in the package 260 so that it can be easily opened. The positions at which the cuts 261 are formed can be selected as appropriate. The position where the notch 261 is formed may be formed on the long side of the package 260 when viewed from above, or may be formed on the short side of the package 260 when viewed from above. In this embodiment, the cuts 261 are formed on the short sides of the package 260 in a plan view.

When the notch 261 is arranged on the short side of the package 260, the inspection chip 110 and the tray 150 are moved to one long side of the package 260 (left side in FIG. 3), and the length of the package 260 is adjusted. The cut 261 is preferably arranged on the short side so that the cut end does not overlap the inspection chip 110 when the package 260 is cut along the side. On the other hand, when the notch 261 is arranged along the long side of the package 260 , the inspection chip 110 and the tray 150 are placed near one of the short sides of the package 260 , and the direction along the short side of the package 260 is adjusted. The cut 261 is preferably arranged on the long side so that the cut end does not overlap the inspection chip 110 when the package 260 is cut from the cut 261 . In these cases, since an extra impact is not applied to the inspection chip 110 when the package 260 is opened, the inspection chip 110 can be prevented from being damaged.

As described above, since the inspection package 200 according to the modification of the present embodiment further includes the package 260, it is possible to further prevent the claw portion 113 from being damaged as compared with the inspection package 100 according to the first embodiment.

This application claims priority based on Japanese Patent Application No. 2017-220018 filed on November 15, 2017. All contents described in the specification and drawings are incorporated herein by reference.

The test package according to the present invention can prevent the test chip from being damaged due to transportation, dropping, or the like. Therefore, it is expected to improve the reliability of inspection results and reduce the cost of each inspection.

REFERENCE SIGNS LIST 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 flow channel 128 inlet 129 outlet 130 channel 131 well 132 through hole 150 tray 151 holding member 260 package 261 notch

Claims (6)

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 is
a detection unit for detecting the substance to be detected, which has a substrate and a reaction unit for reacting the substance to be detected and the reagent placed on or in the substrate;
a storage unit for storing the reagent formed separately from the detection unit;
The reservoir is arranged on the front side and the back side of the base body at a distance wider than the gap between the front side and the back side of the base body of the detection part, and is for restricting the movement of the detection part in the front and back direction of the base body. or having two or more pairs of claws,
The tray has a holding member arranged on the front side or the back side of the detection section and holding the detection section in order to reduce the load of the detection section on the claw section,
The detection unit is
the substrate;
a reaction unit that reacts the substance to be detected and the reagent placed on or in the substrate;
a prism disposed on one side of the substrate;
The holding member holds the prism on the back side of the detection unit ,
inspection package. The inspection package according to claim 1, wherein the holding member holds the detection unit so as to satisfy the following formula (1).
0≦A (1)
[A is the distance (mm) between one of the claws and the base on the holding member side. ] The inspection package according to claim 1 or 2, wherein the holding member holds the detection unit so as to satisfy the following formula (2).
0≦A≦B (2)
[A is the distance (mm) between one of the claws on the holding member side and the base, and B is the distance between the pair of claws minus the distance between the front and back surfaces of the base (mm) ). ] 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 the distance (mm) between one of the claws and the base on the holding member side. ] The inspection package according to claim 1 or 2, wherein the holding member holds the detection unit so as to satisfy the following formula (4).
0<A<B (4)
[A is the distance (mm) between one of the claws on the holding member side and the base, and B is the distance between the pair of claws minus the distance between the front and back surfaces of the base (mm) ). ] The inspection package according to any one of claims 1 to 5 , further comprising a package containing the inspection package and the tray.

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