JP2011169603A - Specimen analyzing chip and method for manufacturing the same - Google Patents

Specimen analyzing chip and method for manufacturing the same Download PDF

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JP2011169603A
JP2011169603A JP2010030934A JP2010030934A JP2011169603A JP 2011169603 A JP2011169603 A JP 2011169603A JP 2010030934 A JP2010030934 A JP 2010030934A JP 2010030934 A JP2010030934 A JP 2010030934A JP 2011169603 A JP2011169603 A JP 2011169603A
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chip
sample
hole
analyte
tip
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JP5564972B2 (en
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Atsushi Araki
淳 荒木
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Toppan Inc
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Toppan Printing Co Ltd
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a specimen analyzing chip which has little risk of contamination or infection caused by an inspection target solution and has an improved mass productivity. <P>SOLUTION: The specimen analyzing chip which has an elongated flat board shape for analyzing a liquid sample and is constituted by laminating a plurality of sheet members, includes: a positioning hole when inserting the chip in a measuring instrument in the leading end part of the chip; a sample introducing hole at the side surface of the central part protruding therefrom; a sample flow channel for guiding the sample introduced into the chip to a sample storage part by a capillary phenomenon and a membrane filter for treating the sample introduced into the sample storage part; an inspection hole for taking out the treated inspection target solution to inspect under the surface of the chip; and an air hole for smoothing the penetration of the sample at the upper surface of the chip. The end part on the side opposite to the leading end part of the chip forms a grasping part for grasping the chip and water repelling treatment is applied to at least the peripheral part of the sample introducing port of the front and/or back of the chip. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

本発明は、血液等を被検体として種々の特性値について測定を行うための被検体分析用チップに関する。   The present invention relates to an analyte analyzing chip for measuring various characteristic values using blood or the like as an analyte.

血液を被検体として、種々の測定を簡便に行うための血液分析用チップとしては、さまざまな提案がなされている。これらのチップの中で、最も一般的に用いられているものは、血糖値の測定用チップである。   Various proposals have been made for blood analysis chips for easily performing various measurements using blood as a subject. Among these chips, the most commonly used chip is a blood sugar level measuring chip.

血液分析用チップは、その使用目的に従い、大きく2種類に分けられる。一つは個人が自分の血液の状態を測定するために使用するものであり、もう一つは病院や検査機関等において、不特定多数の人の血液を分析測定するために使用されるものである。   Blood analysis chips are roughly classified into two types according to the purpose of use. One is used by individuals to measure their own blood condition, and the other is used to analyze and measure the blood of an unspecified number of people in hospitals and laboratories. is there.

個人が自分の血液を測定するために使用するチップの場合は、汚染や感染の問題は殆ど問題とならないが、不特定多数の人の血液を取り扱う場合には、血液が測定器に付着することによって生じる汚染の問題や、検査者が検体である血液によって感染することを防止するための何らかの手段を講じることが必要である。   In the case of chips used by individuals to measure their own blood, contamination and infection problems are hardly a problem, but when handling blood from an unspecified number of people, blood will adhere to the measuring instrument. It is necessary to take some measure to prevent the problem of contamination caused by the blood pressure and the tester from being infected by the blood sample.

特許文献1に記載されたバイオセンサ検査ストリップは、視力が低下した糖尿病患者でも触覚によって扱うことができるように、側面に凹みを設けた血糖値分析用チップである。このような目的のために提供されるチップの場合、上記の汚染や感染に関する問題は生じないため、事実何等の対策もとられていない。この点に関しては、特許文献2に記載されたバイオセンサについても、同様である。   The biosensor test strip described in Patent Document 1 is a blood sugar level analysis chip having a dent on the side surface so that even a diabetic patient with reduced visual acuity can be handled by touch. In the case of a chip provided for such a purpose, no problem is actually taken because the above-mentioned problems relating to contamination and infection do not occur. The same applies to the biosensor described in Patent Document 2.

特許文献3に記載されたマイクロデバイスは、特許文献2に記載されたバイオセンサと同様の用途に使用するチップであり、特許文献2に記載されたバイオセンサの問題点である、「血液に接触させて血液を内部に取り込むための点着部の先端が矩形状であるため点着した際に血液が点着部以外のマイクロデバイスの外壁面に付着してしまう」という問題を解決するためになされたものである。特許文献3のマイクロデバイスにおいては、この問題を解決するための手段として、流路となる溝が掘られたベースプレートにカバープレートを重ね合わせて内部に毛細管キャビティを形成するとともに、基端が前記毛細管キャビティに接続され先端がカバープレートから突出した点着部を設け、点着部の先端が、ベースプレートの流路形成面から離れる方向に突出した半球状に形成したものである。   The microdevice described in Patent Document 3 is a chip used for the same application as the biosensor described in Patent Document 2, and is a problem of the biosensor described in Patent Document 2, “contact with blood” In order to solve the problem of "the blood sticks to the outer wall surface of the micro device other than the spotted portion when spotted" because the tip of the spotted portion for taking the blood into the inside is rectangular. It was made. In the microdevice of Patent Document 3, as a means for solving this problem, a capillary plate is formed by superimposing a cover plate on a base plate in which a groove serving as a flow path is dug, and the proximal end is the capillary tube. A spotting portion connected to the cavity and having a tip protruding from the cover plate is provided, and the tip of the spotting portion is formed in a hemispherical shape protruding in a direction away from the flow path forming surface of the base plate.

特許文献3に記載されたマイクロデバイスにおいては、点着部を突出させるとともに、点着部の周囲にカバープレートと一体に樹脂成形されたリブを設け、このリブが合成樹脂材料自身の撥水性で血液を弾くことにより、血液が点着部以外の部分に付着するのを防止している。   In the microdevice described in Patent Document 3, a spotted portion is projected, and a rib molded with a resin integrally with the cover plate is provided around the spotted portion, and this rib is the water repellency of the synthetic resin material itself. By playing the blood, the blood is prevented from adhering to a portion other than the spotted portion.

特許文献3に記載されたマイクロデバイスは、ベースプレートを樹脂成形によって形成し、また樹脂成形で形成した流路内を血液が円滑に流れるように、流路の内面に別途親水処理を行う必要があり、コストがかかる。また点着部周辺への血液の付着を防止する手段として、リブの材料自身の撥水性を利用しているため、撥水性が十分でなく、汚染や感染の防止効果において不十分であった。   In the microdevice described in Patent Document 3, it is necessary to form a base plate by resin molding and to separately perform hydrophilic treatment on the inner surface of the flow path so that blood smoothly flows in the flow path formed by resin molding. ,costly. Further, since the water repellency of the rib material itself is used as means for preventing blood from adhering to the periphery of the spotted portion, the water repellency is not sufficient, and the effect of preventing contamination and infection is insufficient.

特許文献4に記載された被検液分析用チップは、測定機器の内部の汚染と作業者の汚染を防ぐことを主な課題としてなされたものであり、チップの形状や構造を工夫することに
よってこの目的を達成しようとしたものである。
The test solution analysis chip described in Patent Document 4 has been made mainly to prevent the internal contamination of the measuring instrument and the contamination of the operator, and by devising the shape and structure of the chip. This is an attempt to achieve this goal.

特表2001-526388号公報Special table 2001-526388 特開2001-159618号公報Japanese Patent Laid-Open No. 2001-159618 特開2009-229243号公報JP 2009-229243 特開2009-175118号公報JP 2009-175118 A

特許文献4に記載された被検液分析用チップは、平板状の部材を3枚貼り合わせて形成する構造であるため、構造自体は比較的単純であるが、流路を形成するために、流路の形状に打抜いた両面粘着テープを使用している関係上、組み立てに当っては人の手作業に頼らざるを得ないため、量産性やコストの面で問題があった。また被検液である血液を導入する接触口の周縁に血液が付着しやすいという問題もあった。   Since the test liquid analysis chip described in Patent Document 4 has a structure in which three flat members are bonded together, the structure itself is relatively simple, but in order to form a flow path, Since double-sided adhesive tape punched into the shape of the flow path is used, there is a problem in terms of mass productivity and cost because it is necessary to rely on human manual work for assembly. There is also a problem that blood tends to adhere to the periphery of a contact port for introducing blood as a test solution.

本発明は、これらの課題を解決するためになされたものであり、被検液による汚染や感染の危険性が少なく、しかも量産性が良好な被検体分析用チップを提案するものである。   The present invention has been made in order to solve these problems, and proposes a sample analysis chip that is less likely to be contaminated or infected by a test solution and has good mass productivity.

上記の課題を解決するための手段として、請求項1に記載の発明は、液体状の被検体試料を分析するための細長い平板状の分析用チップであって、複数枚のシート部材を貼合せてなり、チップ先端部には、計測装置に挿入した際の位置決めを行うための位置決め孔を有し、チップ中央部側面には、チップ内部に被検体試料を導入するための、チップ側面から突出した試料導入孔を有し、チップ内部には、試料貯留部と、試料導入孔から導入された被検体試料を毛細管現象によって試料貯留部に導く試料流路と、試料貯留部に導入された被検体試料を処理するメンブレンフィルターを有し、チップ下面には、処理された被検液を取り出して検査するための検査孔を有し、チップ上面には、被検体試料の試料流路への進入を円滑にするための空気孔を有し、チップ先端部の反対側端部は、チップを把持するための把持部を形成し、チップ表面および/または裏面の、少なくとも試料導入孔周辺部分に撥水処理を施したことを特徴とする被検体分析用チップである。   As a means for solving the above-mentioned problems, the invention described in claim 1 is an elongated flat plate analysis chip for analyzing a liquid sample, and a plurality of sheet members are bonded together. The tip of the chip has a positioning hole for positioning when inserted into the measuring device, and the side of the center of the chip protrudes from the side of the chip for introducing the specimen sample into the chip. A sample reservoir inside the chip, a sample flow path for guiding the analyte sample introduced from the sample inlet hole to the sample reservoir by capillary action, and a sample introduced into the sample reservoir. It has a membrane filter that processes the sample, and has a test hole on the lower surface of the chip for taking out the processed test liquid and inspecting it, and the upper surface of the chip enters the sample channel of the test sample. To smooth the air The tip end of the tip opposite to the tip forms a grip for gripping the tip, and at least the periphery of the sample introduction hole on the tip surface and / or the back surface is subjected to water repellent treatment. This is an analyte analysis chip.

また、請求項2に記載の発明は、前記複数枚のシート部材が、透明で表面が親水性を有し、検査孔が穿孔されたA部材と、メンブレンフィルターと、基材の両面に粘着層を有し試料流路と試料貯留部となるべき部分が打抜かれて除去されたB部材と、透明で表面が親水性を有し空気孔が穿孔されたC部材と、透明で上面にヒートシーラブル材料層を有し空気孔が穿孔されたD部材と、透明で下面に印刷層とヒートシーラブル材料層を有し空気孔が穿孔されたE部材を少なくとも含み、前記A部材、メンブレンフィルター、B〜E部材が下からこの順序に積層され、位置決め孔が穿孔されてなることを特徴とする請求項1記載の被検体分析用チップである。   The invention according to claim 2 is that the plurality of sheet members are transparent, have a hydrophilic surface, and have an A member having a perforated inspection hole, a membrane filter, and adhesive layers on both surfaces of the substrate. B member from which the portion to serve as the sample flow path and the sample reservoir is punched and removed, a transparent C member having a hydrophilic surface and perforated air holes, and a transparent heat seal on the upper surface. At least a D member having a ruble material layer and air holes perforated, and an E member which is transparent and has a printed layer and a heat sealable material layer on the lower surface and perforated air holes, the A member, the membrane filter, 2. The analyte analyzing chip according to claim 1, wherein B to E members are laminated in this order from the bottom, and a positioning hole is drilled.

また、請求項3に記載の発明は、前記A部材の下面に撥水性ニスを塗布する工程、A部材に検査孔を穿孔し、検査孔に前記メンブレンフィルターを貼り付ける工程、前記B部材の試料流路と試料貯留部になるべき部分を打抜いて除去する工程、前記C部材とD部材を予め貼り合せ、さらにE部材と貼り合せて、空気孔を穿孔する工程、前記工程を経たA部材、B部材、C、D、E部材を貼り合せて一体化し、位置決め孔を穿孔し、外形を所定のチップ形状に打抜く工程を少なくとも含むことを特徴とする請求項2に記載の被検体分析用チップの製造方法である。   Further, the invention according to claim 3 is a step of applying a water-repellent varnish to the lower surface of the A member, a step of drilling an inspection hole in the A member, and affixing the membrane filter to the inspection hole, a sample of the B member A step of punching and removing a portion to be a flow path and a sample storage portion, a step of pasting the C member and a D member in advance, a step of pasting an E member, and perforating an air hole; 3. The analyte analysis according to claim 2, comprising at least a step of bonding and integrating the members B, C, D, and E, punching a positioning hole, and punching the outer shape into a predetermined chip shape. It is the manufacturing method of the chip | tip.

本発明に係る被検体分析用チップは、複数枚のシート部材を貼り合せた細長い平板状の形状であり、計測装置に挿入する先端部の反対側の端部が把持部となっており、先端部と把持部の中間に被検体試料を導入するための試料導入孔を有する構造であるため、チップに被検体試料を導入する際に、被検体に手を触れることなく分析操作を行うことができる。   The analyte analysis chip according to the present invention has an elongated flat plate shape in which a plurality of sheet members are bonded, and the end opposite to the distal end to be inserted into the measuring device is a gripping portion. Since the structure has a sample introduction hole for introducing the analyte sample between the head and the gripper, the analysis operation can be performed without touching the analyte when introducing the analyte sample to the chip. it can.

また、試料導入孔は、チップ側面から突出しており、さらに試料導入孔周辺部分に撥水処理を施したので、被検体が試料導入孔周辺に付着して、計測装置を汚染したりする問題が発生する恐れが少ない。このため、不特定の人の血液等を分析する病院や検査機関等においても、安全にまた清潔に分析処理をおこなうことができる。   In addition, the sample introduction hole protrudes from the side surface of the chip, and since the water repellent treatment is applied to the periphery of the sample introduction hole, there is a problem that the sample adheres to the periphery of the sample introduction hole and contaminates the measurement device. Less likely to occur. For this reason, it is possible to perform the analysis process safely and cleanly even in hospitals, inspection institutions, and the like that analyze blood of unspecified persons.

また本発明に係る被検体分析用チップは、複数枚のシート状部材を貼り合せて構成されており、それぞれの部材に必要な機能を分散して持たせることができるので、無駄のない設計が可能であり、材料コストを低くすることができる。   Further, the analyte analysis chip according to the present invention is configured by laminating a plurality of sheet-like members, and each member can be provided with necessary functions in a distributed manner. This is possible, and the material cost can be reduced.

請求項3に記載の製造方法によれば、すべての工程を人手によらずに機械化することが可能であるため、安定した品質の分析用チップを迅速かつ大量に供給することができる。   According to the manufacturing method of the third aspect, since all the steps can be mechanized without manpower, a stable quality analysis chip can be supplied quickly and in large quantities.

本発明に係る被検体分析用チップの一実施態様を示した説明図であり、(1)は表面側から見た状態を、(2)は裏面側から見た状態を示す。It is explanatory drawing which showed one embodiment of the chip | tip for analyte analysis based on this invention, (1) shows the state seen from the surface side, (2) shows the state seen from the back surface side. 図1に示した被検体分析用チップの断面構成を模式的に示した断面説明図であり、(1)は図1(1)のXX断面を、(2)は図1(1)のYY断面を示す。FIGS. 2A and 2B are cross-sectional explanatory views schematically showing a cross-sectional configuration of the analyte analyzing chip shown in FIG. 1, wherein FIG. 1A is a cross-sectional view taken along line XX in FIG. 1A, and FIG. A cross section is shown. 図1に示した被検体分析用チップの層構成を模式的に示した断面説明図である。FIG. 2 is an explanatory cross-sectional view schematically showing a layer configuration of the analyte analysis chip shown in FIG. 1. 図1に示した被検体分析用チップの試料導入孔部分の拡大図である。FIG. 2 is an enlarged view of a sample introduction hole portion of the analyte analysis chip shown in FIG. 1. 図1に示した被検体分析用チップの層構成を示した斜視図である。FIG. 2 is a perspective view showing a layer configuration of the analyte analyzing chip shown in FIG. 1.

以下図面を参照しながら、本発明に係る被検体分析用チップについて詳細に説明する。図1は、本発明に係る被検体分析用チップの一実施態様を示した説明図である。図1(1)は表面側から見た状態を、図1(2)は裏面側から見た状態を示している。また図2は、図1に示した被検体分析用チップの断面構成を模式的に示した断面説明図である。図2(1)は図1(1)のXX断面を、図2(2)は図1(1)のYY断面を示している。
本発明に係る被検体分析用チップ1は、液体状の被検体試料を分析するための細長い平板状の分析用チップであって、複数枚のシート部材A〜E部材を貼合せてなる。
Hereinafter, the analyte analysis chip according to the present invention will be described in detail with reference to the drawings. FIG. 1 is an explanatory view showing an embodiment of the analyte analyzing chip according to the present invention. FIG. 1 (1) shows a state seen from the front side, and FIG. 1 (2) shows a state seen from the back side. FIG. 2 is an explanatory cross-sectional view schematically showing a cross-sectional configuration of the analyte analyzing chip shown in FIG. 2 (1) shows the XX section of FIG. 1 (1), and FIG. 2 (2) shows the YY section of FIG. 1 (1).
An analyte analysis chip 1 according to the present invention is an elongated flat plate analysis chip for analyzing a liquid analyte sample, and is formed by bonding a plurality of sheet members A to E.

チップ先端部2には、計測装置に挿入した際の位置決めを行うための位置決め孔4を有し、チップ中央部側面には、チップ内部に被検体試料を導入するための、試料導入孔6を有する。試料導入孔6は、チップ側面から突出していることを特徴とする。
チップ内部には、試料貯留部8と、試料導入孔6から導入された被検体試料を毛細管現象によって試料貯留部8に導く試料流路7と、試料貯留部8に導入された被検体試料を処理するメンブレンフィルター71を有する。
チップ下面には、メンブレンフィルター71によって処理された被検液を取り出して検査するための検査孔5を有し、チップ上面には、被検体試料の試料流路7への進入を円滑に
するための空気抜きである空気孔9を有する。
The tip end portion 2 has a positioning hole 4 for positioning when inserted into the measuring device, and a sample introduction hole 6 for introducing a sample to be tested into the chip is provided on the side surface of the center portion of the chip. Have. The sample introduction hole 6 protrudes from the side surface of the chip.
Inside the chip, there are a sample reservoir 8, a sample flow path 7 for guiding the analyte sample introduced from the sample introduction hole 6 to the sample reservoir 8 by capillary action, and an analyte sample introduced into the sample reservoir 8. A membrane filter 71 to be processed is included.
The lower surface of the chip has an inspection hole 5 for taking out and inspecting the test liquid processed by the membrane filter 71, and the upper surface of the chip has a sample sample 7 for smoothly entering the sample channel 7. The air hole 9 is an air vent.

空気孔9は、被検体試料が試料流路7を伝って流入するのに伴って、逃げ場のなくなるチップ内部の空気をチップ上面側に逃がす働きをする。空気孔9は、試料流路7が試料貯留部8を通過して延長した部分に開口している。このため、試料導入孔6から進入した被検体試料は、試料流路7を進み、試料貯留部8を満たし、さらに空気孔9まで到達する。   The air holes 9 function to release the air inside the chip, where there is no escape space, to the upper surface side of the chip as the specimen sample flows along the sample flow path 7. The air hole 9 is opened at a portion where the sample channel 7 extends through the sample storage portion 8. For this reason, the subject sample that has entered from the sample introduction hole 6 proceeds through the sample flow path 7, fills the sample storage portion 8, and further reaches the air hole 9.

チップ先端部2の反対側端部は、チップを把持するための把持部3を形成し、チップ表面および/または裏面の、少なくとも試料導入孔6の周辺部分に撥水処理を施した撥水処理部10を設けたことを特徴とする。   The opposite end portion of the tip end portion 2 forms a grip portion 3 for gripping the tip, and a water repellent treatment in which at least the peripheral portion of the sample introduction hole 6 on the front surface and / or back surface of the tip is subjected to a water repellent treatment. The unit 10 is provided.

本発明に係る被検体分析用チップ1は、血液、尿などの液体状の被検体試料を分析するために使用されるチップであり、チップの把持部3を持って、被検体に試料導入孔6を接触させ、毛細管現象によって被検体を試料流路7に沿って導入する。この時、試料流路7の最奥には、空気抜きである空気孔9が設けられているので、被検体は円滑に導入される。導入された被検体は試料貯留部8に溜り、メンブレンフィルター71に接触する。   The analyte analysis chip 1 according to the present invention is a chip used for analyzing a liquid analyte sample such as blood, urine, etc., and has a tip holding portion 3 and a sample introduction hole in the analyte. 6 is brought into contact, and the analyte is introduced along the sample flow path 7 by capillary action. At this time, since the air hole 9 for venting air is provided in the innermost part of the sample channel 7, the subject is smoothly introduced. The introduced analyte is collected in the sample storage unit 8 and comes into contact with the membrane filter 71.

メンブレンフィルター71は、被検体試料中の測定対象成分のみを分離する働きをもっている膜である。例えば被検体が血液であれば、血液から血漿成分のみを分離する血球分離膜が使用される。メンブレンフィルター71を通過した被検液は、検査孔5から取り出され、計測装置によって分析される。   The membrane filter 71 is a membrane that has a function of separating only the measurement target component in the specimen sample. For example, if the subject is blood, a blood cell separation membrane that separates only plasma components from the blood is used. The test liquid that has passed through the membrane filter 71 is taken out from the test hole 5 and analyzed by a measuring device.

本発明に係る被検体分析用チップ1は、計測装置に挿入する先端部2とは反対側の端部に把持部3を設け、試料導入孔6をその中間に配置したので、被検体に一切手を触れることなく、分析操作を行うことが可能である。また試料導入孔6は、チップ側面から突出しているため、被検体に試料導入孔6を接触させる際に、試料導入孔以外の部分に不必要に被検体が付着することを防止することが容易にできる。またさらにチップ表面および/または裏面の、少なくとも試料導入孔6の周辺部分に撥水処理を施したので、被検体が試料導入孔6の周辺に付着してこれが計測装置などを汚染することを未然に防止する効果がある。撥水処理は、分析用チップの試料導入孔周辺の裏面および表面に施すことが好ましいが、いずれか一方の面に施しても十分な効果がある。なお計測装置内に挿入される必要がある検査孔5の部分は、試料導入孔6とチップ先端部2との中間に位置するので、試料導入孔6の部分は、計測装置内に挿入される必要がない。このため万一試料導入孔の周辺が被検体によって汚染されたとしても、計測装置内が汚染されることはない。   In the analyte analyzing chip 1 according to the present invention, the grip 3 is provided at the end opposite to the tip 2 inserted into the measuring apparatus, and the sample introduction hole 6 is disposed in the middle thereof. Analysis operations can be performed without touching. Further, since the sample introduction hole 6 protrudes from the side surface of the chip, it is easy to prevent the subject from unnecessarily adhering to a portion other than the sample introduction hole when the sample introduction hole 6 is brought into contact with the subject. Can be. Further, since water repellent treatment is applied to at least the peripheral portion of the sample introduction hole 6 on the front surface and / or back surface of the chip, it is possible to prevent the subject from adhering to the periphery of the sample introduction hole 6 and contaminating the measurement device or the like. Has the effect of preventing. The water-repellent treatment is preferably performed on the back surface and the surface around the sample introduction hole of the analysis chip, but even if applied to either one of the surfaces, there is a sufficient effect. Since the portion of the inspection hole 5 that needs to be inserted into the measuring device is located between the sample introduction hole 6 and the tip end portion 2, the portion of the sample introduction hole 6 is inserted into the measuring device. There is no need. For this reason, even if the periphery of the sample introduction hole is contaminated by the subject, the inside of the measurement apparatus is not contaminated.

撥水処理の方法としては、撥水性のニスを塗布または印刷する方法や、撥水性のフィルムを貼り付ける方法がある。印刷法によって必要な部分だけに撥水性のニスを施す方法が最も材料の無駄がなく、生産の効率も高い。
図4は、図1に示した被検体分析用チップの試料導入孔部分の拡大図である。
この実施態様においては、試料導入孔6の位置がチップの裏面側に近い位置にあるため、チップの裏面側のみに撥水処理部10を設けてあるが、上記の撥水効果は十分に発揮される。なおこの実施態様において裏面のみに撥水処理部10を設けた理由としては、裏面に用いたA部材が両面に親水処理を施した材料であることによる。
Examples of the water repellent treatment include a method of applying or printing a water repellent varnish, and a method of attaching a water repellent film. A method of applying a water-repellent varnish only to a necessary portion by a printing method has the least waste of material and high production efficiency.
FIG. 4 is an enlarged view of a sample introduction hole portion of the analyte analyzing chip shown in FIG.
In this embodiment, since the position of the sample introduction hole 6 is close to the back surface side of the chip, the water repellent treatment part 10 is provided only on the back surface side of the chip, but the above water repellent effect is sufficiently exhibited. Is done. In this embodiment, the reason why the water-repellent treatment part 10 is provided only on the back surface is that the A member used on the back surface is a material subjected to hydrophilic treatment on both surfaces.

試料導入孔6に接触した被検体試料は、毛細管現象によって試料流路7に沿って進入するが、被検体試料の進入を円滑にするために、試料流路7の内壁を被検体試料によって濡れやすいものとすることが効果的である。被検体が血液や尿であれば、試料流路7の内壁を親水性の表面にしてやることにより、この目的が達せられる。この時、試料流路内壁の全面を親水性にする必要は必ずしもなく、例えば床面と天井面のみを親水性にするだけでも、十分な効果が発揮される。   The analyte sample that has contacted the sample introduction hole 6 enters along the sample channel 7 by capillary action, but the inner wall of the sample channel 7 is wetted by the analyte sample in order to make the analyte sample enter smoothly. It is effective to make it easy. If the subject is blood or urine, this purpose can be achieved by making the inner wall of the sample channel 7 a hydrophilic surface. At this time, it is not always necessary to make the entire surface of the inner wall of the sample flow path hydrophilic. For example, a sufficient effect can be obtained only by making only the floor surface and the ceiling surface hydrophilic.

次に本発明に係る被検体分析用チップの層構成および構成材料について説明する。
図3は、図1に示した被検体分析用チップの層構成を模式的に示した断面説明図である。本発明に係る被検体分析用チップは、複数枚のシート部材を貼り合せてなる。図3に示した実施態様においては、A〜Eの5枚のシート部材とメンブレンフィルターからなっている。
Next, the layer configuration and constituent materials of the analyte analysis chip according to the present invention will be described.
FIG. 3 is an explanatory cross-sectional view schematically showing the layer structure of the analyte analyzing chip shown in FIG. The analyte analysis chip according to the present invention is formed by bonding a plurality of sheet members. In the embodiment shown in FIG. 3, it consists of five sheet members A to E and a membrane filter.

A部材(A)は、透明で表面が親水性を有する親水性フィルム11である。A部材には、検査孔5が穿孔されている。A部材は試料流路7の床面を構成する。A部材として用いられる材料としては、表面に親水性処理を施した親水処理PET(ポリエチレンテレフタレート樹脂)フィルムや親水処理アクリル樹脂フィルム、親水処理アセテート樹脂フィルム等の親水処理フィルムや、フィルム自体が親水性を有するポリビニルアルコールフィルム等が挙げられるが、特に限定されるものではない。親水性の程度としては、水をたらした時の接触角が30°以下となるようなものであれば良い。一般的に、市販されているこれらの材料は、両面に親水処理を施したものが多いが、試料流路7に接する側の面だけに親水処理を施したものでもよい。なおA部材を透明とする理由は、血液等の被検体試料が試料流路7中を進行する様子が見えるようにするためである。   The A member (A) is a hydrophilic film 11 which is transparent and has a hydrophilic surface. An inspection hole 5 is drilled in the A member. The A member constitutes the floor surface of the sample channel 7. As materials used as the A member, hydrophilic treatment films such as hydrophilic treatment PET (polyethylene terephthalate resin) film, hydrophilic treatment acrylic resin film, hydrophilic treatment acetate resin film, etc. having a hydrophilic treatment on the surface, or the film itself is hydrophilic. A polyvinyl alcohol film or the like having, is not particularly limited. The degree of hydrophilicity may be anything as long as the contact angle when dripping water is 30 ° or less. In general, many of these commercially available materials have been subjected to hydrophilic treatment on both sides, but may be those in which only the surface in contact with the sample flow path 7 has been subjected to hydrophilic treatment. The reason why the member A is transparent is to allow the specimen sample such as blood to be seen in the sample channel 7.

A部材の下面すなわち分析用チップ1の底面となる面には、少なくとも試料導入孔6周辺部分に撥水処理を施した撥水処理部10を設ける。撥水処理部を設ける理由は、既に説明した通り、被検体試料に試料導入孔部分を接触させた時に、チップ表面に試料が付着しないようにするためである。撥水処理部10を形成する方法としては、撥水性の粘着テープを貼る方法や、撥水性のニスを塗布する方法があるが、スクリーン印刷法やグラビア印刷法を用いて、必要な部分だけに撥水性のニスを印刷する方法が最も好ましい。撥水処理の程度としては、水をたらした時の接触角が100°以上であることが好ましい。   On the lower surface of the A member, that is, the surface serving as the bottom surface of the analysis chip 1, a water repellent treatment portion 10 is provided in which water repellent treatment is performed on at least a portion around the sample introduction hole 6. The reason for providing the water repellent treatment part is to prevent the sample from adhering to the chip surface when the sample introduction hole is brought into contact with the sample to be examined, as already described. As a method of forming the water repellent treatment portion 10, there are a method of applying a water repellent pressure-sensitive adhesive tape and a method of applying a water repellent varnish, but only a necessary portion using a screen printing method or a gravure printing method. A method of printing a water-repellent varnish is most preferable. As the degree of water repellent treatment, it is preferable that the contact angle when water is poured is 100 ° or more.

A部材に撥水処理を施すタイミングとしては、特に限定されるものではなく、他の部材と貼り合せて、分析用チップの形になってからでもかまわないが、他の部材と貼り合せる前に、予めA部材の下面に撥水処理を施しておいてもよい。   The timing at which the water repellent treatment is applied to the A member is not particularly limited, and it may be pasted with another member to form a chip for analysis, but before being pasted with another member. The water repellent treatment may be performed on the lower surface of the A member in advance.

メンブレンフィルター71は、A部材に穿孔された検査孔5を覆うようにA部材に貼り付けられる。従って高価なメンブレンフィルター71は、検査孔5を覆うだけの大きさがあれば十分である。   The membrane filter 71 is affixed to the A member so as to cover the inspection hole 5 drilled in the A member. Therefore, the expensive membrane filter 71 need only be large enough to cover the inspection hole 5.

B部材(B)は、基材21の両面に粘着層22、23を有し、試料流路7と試料貯留部8となるべき部分が打抜かれて除去された部材である。B部材を前記A部材と、次に述べるC部材とで挟むように接合することにより、試料流路7と試料貯留部8が一繋がりの空間として形成される。B部材としては、例えばPETフィルムベースの両面粘着テープや、PETフィルムの両面に両面粘着テープを貼り合せたような材料が使用できる。B部材は、打抜かれた側面が試料流路7の壁面を構成するので、ある程度の厚さを必要とすると共に親水性であることが望ましいが、必ずしも親水性である必要はない。またB部材は、打抜かれた部分が試料流路7となるので、透明である必要はなく、むしろ試料流路7の部分が他と区別されて明確に分るように、黒色などに着色されていても良い。この場合は、基材21として着色された基材を用いればよい。B部材は、試料流路等を打ち抜く途中工程においては、両面に離型紙や離型フィルムが付着した状態で取り扱われる。   The B member (B) is a member having the adhesive layers 22 and 23 on both surfaces of the base material 21, and the portions to be the sample flow path 7 and the sample storage portion 8 are punched and removed. By joining the B member so as to be sandwiched between the A member and the C member described below, the sample flow path 7 and the sample storage portion 8 are formed as a continuous space. As the B member, for example, a PET film-based double-sided pressure-sensitive adhesive tape or a material in which a double-sided pressure-sensitive adhesive tape is bonded to both surfaces of the PET film can be used. Since the punched side surface of the B member constitutes the wall surface of the sample channel 7, the B member needs to have a certain thickness and is desirably hydrophilic, but is not necessarily hydrophilic. In addition, since the punched portion becomes the sample channel 7, the B member does not need to be transparent, but rather is colored black or the like so that the portion of the sample channel 7 is clearly distinguished from the others. May be. In this case, a colored base material may be used as the base material 21. The B member is handled in a state in which a release paper or a release film is attached to both surfaces in a process in the middle of punching the sample flow path or the like.

C部材(C)は前記A部材と同様、透明で表面が親水性を有する親水性フィルム31である。C部材としては、前記A部材と同じ材料が使用できるが、撥水処理を施す必要はない。C部材は試料流路7の天井面を構成する。   The C member (C) is a hydrophilic film 31 which is transparent and has a hydrophilic surface, like the A member. Although the same material as said A member can be used as C member, it is not necessary to perform water-repellent treatment. The C member constitutes the ceiling surface of the sample channel 7.

C部材には、空気孔9が穿孔されている。空気孔9は、後に説明するD部材、E部材のチップの同じ位置にも存在し、被検体試料が試料流路7を伝って流入するのに伴って、逃げ場のなくなる空気をチップ表面側に逃がす働きをする。   Air holes 9 are perforated in the C member. The air holes 9 are also present at the same positions of the tips of the D member and E member, which will be described later, and air that does not escape as the analyte sample flows along the sample flow path 7 flows to the chip surface side. Work to escape.

D部材(D)は、分析用チップ1全体に剛性を持たせるための基板の役割をになっている。D部材の基材41としては、厚さ100〜200μm程度の剛性の高い透明なプラスチックシートが適している。材質としては、ポリプロピレン樹脂、ポリ塩化ビニル樹脂、ポリスチレン樹脂、PET樹脂、アクリル樹脂等の一般的な材料が使用できる。基材の上面には、ヒートシーラブル材料層42が設けられている。ヒートシーラブル材料層42は、加熱によって溶融し、接着する材料であり、公知のヒートシールニスやホットメルト接着剤、ヒートシーラブル樹脂、ヒートシーラブルフィルム等が使用できる。ヒートシーラブル材料層42は、材料に応じて、グラビア印刷法、押出しラミネート法、ドライラミネート法等の方法によって形成される。D部材には、前記C部材と同位置に空気孔9が穿孔されている。   The D member (D) serves as a substrate for giving rigidity to the entire analysis chip 1. As the base material 41 of the D member, a transparent plastic sheet having a high rigidity of about 100 to 200 μm is suitable. As a material, general materials such as polypropylene resin, polyvinyl chloride resin, polystyrene resin, PET resin, acrylic resin and the like can be used. A heat sealable material layer 42 is provided on the upper surface of the substrate. The heat-sealable material layer 42 is a material that melts and adheres by heating, and a known heat-seal varnish, hot-melt adhesive, heat-sealable resin, heat-sealable film, or the like can be used. The heat sealable material layer 42 is formed by a method such as a gravure printing method, an extrusion laminating method, or a dry laminating method depending on the material. An air hole 9 is drilled in the D member at the same position as the C member.

E部材(E)は、分析用チップ1の最上面を形成する部材である。E部材の基材51は、分析用チップとして使用する上で必要な情報である印刷層52を裏面に印刷形成するために、透明でかつ寸法精度の良い材質であることが求められる。E部材の基材51としては、D部材の基材41として用いたものと同じ材料を用いることができる。   The E member (E) is a member that forms the uppermost surface of the analysis chip 1. The base material 51 of the E member is required to be a transparent material with good dimensional accuracy in order to print and form the printed layer 52, which is information necessary for use as an analysis chip, on the back surface. As the base material 51 of the E member, the same material as that used as the base material 41 of the D member can be used.

印刷層52によって表示される情報としては、チップの名称や型番、把持部の位置やチップの挿入方向を示す表示、試料導入孔の位置を示す表示、被検体試料が導入されるべき終点位置等、チップを使用するに当たって必要な情報を表示する。   Information displayed by the print layer 52 includes the name and model number of the chip, the display indicating the position of the gripping part and the insertion direction of the chip, the display indicating the position of the sample introduction hole, the end point position where the specimen sample should be introduced, etc. Information necessary for using the chip is displayed.

印刷層52を形成する方法としては、オフセット印刷法、グラビア印刷法、スクリーン印刷法、インクジェット印刷法等、公知の印刷方法が用いられる。E部材の裏面には、印刷層52の上に、D部材に設けたものと同じヒートシーラブル材料層53が形成されている。E部材には、前記C部材、D部材と同位置に空気孔9が穿孔されている。   As a method for forming the printing layer 52, a known printing method such as an offset printing method, a gravure printing method, a screen printing method, or an ink jet printing method is used. On the back surface of the E member, the same heat-sealable material layer 53 as that provided on the D member is formed on the printing layer 52. In the E member, air holes 9 are formed at the same positions as the C member and the D member.

本発明に係る被検体分析用チップは、前記A部材、メンブレンフィルター、B〜E部材を下からこの順序に積層した後、位置決め孔4が穿孔されてなる。図5は、図1に示した被検体分析用チップの層構成を示した斜視図である。以後、図5と図3を併用しながら本発明に係る被検体分析用チップの製造方法について説明する。   The analyte analysis chip according to the present invention is formed by laminating the A member, the membrane filter, and the B to E members in this order from the bottom, and then the positioning hole 4 is drilled. FIG. 5 is a perspective view showing the layer structure of the analyte analyzing chip shown in FIG. Hereinafter, the method for manufacturing the analyte analyzing chip according to the present invention will be described with reference to FIGS.

まず前記A部材の下面に撥水性ニスを塗布して、撥水処理部10を形成する。撥水処理部10は、グラビア印刷法、スクリーン印刷法等を用いて、必要な部分だけに設けてもよい。次にA部材に検査孔5を穿孔し、検査孔5の上面側に前記メンブレンフィルター71を、接着剤やヒートシールによって貼り付ける。   First, a water-repellent varnish is applied to the lower surface of the A member to form the water-repellent treatment portion 10. The water repellent treatment unit 10 may be provided only in a necessary portion using a gravure printing method, a screen printing method, or the like. Next, the inspection hole 5 is formed in the A member, and the membrane filter 71 is attached to the upper surface side of the inspection hole 5 by an adhesive or heat seal.

次に前記B部材の試料流路7と試料貯留部8になるべき部分を打抜いて除去する。打ち抜き作業は、抜き金型を用いてB部材となるべき積層体シートを連続的に順次送りながら能率的に行なう事ができる。なお打ち抜き工程を経て、後に説明する貼り合わせ工程までは、図では省略しているが、B部材の両面に離型紙や離型フィルムが付着した状態とする。   Next, the portion of the B member that should become the sample flow path 7 and the sample storage portion 8 is punched and removed. The punching operation can be efficiently performed using a punching die while continuously and sequentially feeding the laminate sheets to be the B member. In addition, although it has abbreviate | omitted in the figure after the punching process to the bonding process demonstrated later, it is set as the state which the release paper and the release film adhered to both surfaces of B member.

次に、D部材の基材41の表面に、ヒートシーラブル材料層42を形成した後、前記C部材と貼合せる。貼合せは、接着剤を用いたドライラミネート法が適当である。図3に示したように、C部材である親水性フィルム31とD部材の基材41とがドライラミネート接着剤層61によって接着された状態となる。(以下これをCD部材と表記する。以下同様である)   Next, after the heat-sealable material layer 42 is formed on the surface of the base material 41 of the D member, it is bonded to the C member. For laminating, a dry laminating method using an adhesive is suitable. As shown in FIG. 3, the hydrophilic film 31 as the C member and the base material 41 of the D member are bonded by the dry laminate adhesive layer 61. (Hereinafter, this is referred to as a CD member. The same applies hereinafter.)

次にE部材の基材51の裏面に印刷層52を形成し、印刷層52面に前記D部材に用いたものと同じ材質のヒートシーラブル材料層53を形成する。次にこのヒートシーラブル材料層53と、前記CD部材のヒートシーラブル材料層42とを向かい合わせて全体を熱ラミネートして一体化する。この時のヒートシール強度は、1N/15mm以上とするのが好ましい。以上によって1枚のシートとなった貼り合わせ部材(CDE部材)の所定の位置に空気孔9を穿孔する。   Next, the printing layer 52 is formed on the back surface of the base member 51 of the E member, and the heat-sealable material layer 53 made of the same material as that used for the D member is formed on the printing layer 52 surface. Next, the heat-sealable material layer 53 and the heat-sealable material layer 42 of the CD member are opposed to each other, and the whole is heat-laminated and integrated. The heat seal strength at this time is preferably 1 N / 15 mm or more. The air holes 9 are perforated at a predetermined position of the bonding member (CDE member) formed as one sheet by the above.

前記B部材の表裏面の剥離紙を除去し、A部材、B部材、CDE部材を貼り合せて一体化する。次に位置決め孔4を穿孔し、外形を抜き型によって所定のチップ形状に打抜く。以上の工程によって、被検体分析用チップ1が完成する。   The release paper on the front and back surfaces of the B member is removed, and the A member, the B member, and the CDE member are bonded and integrated. Next, the positioning hole 4 is drilled, and the outer shape is punched into a predetermined chip shape by a punching die. The analyte analysis chip 1 is completed through the above steps.

上記の各工程は、いずれも人手によらずに、機械設備によって自動的に行いうる内容であり、このため上記の各工程からなる製造方法によれば、本発明に係る被検体分析用チップを、きわめて能率的に製造することができる。
以下実施例に基づき、本発明に係る被検体分析用チップについてさらに具体的に説明する。
Each of the above steps is a content that can be automatically performed by mechanical equipment without human intervention. Therefore, according to the manufacturing method including the above steps, the analyte analysis chip according to the present invention is provided. Can be manufactured very efficiently.
The analyte analysis chip according to the present invention will be described in more detail below based on examples.

厚さ188μmのPET樹脂フィルム(東レ社製 S10 片面処理品)の処理面にグラビア印刷法によって所定の印刷絵柄を印刷した後、さらにEVA樹脂系ホットメルト接着剤(DIC社製 DX−11C)を25g/m塗工し、115mm巾にスリットしてE部材を得た。 After printing a predetermined printed pattern on the treated surface of a 188 μm thick PET resin film (S10 single-sided product manufactured by Toray Industries Inc.) by gravure printing, an EVA resin hot melt adhesive (DX-11C manufactured by DIC) is further added. 25 g / m 2 was applied and slit to a width of 115 mm to obtain an E member.

厚さ188μmのPET樹脂フィルム(東レ社製 S10 片面処理品)の処理面にホットメルト接着剤(DIC社製 DX−11C)を塗工し、反対面にドライラミネート用接着剤(東洋モートン社製 ウレタン系接着剤 TM242A/B)を4g/m塗布し、親水性処理を施した厚さ100μmのPET樹脂フィルム(東レ社製 S10)と貼り合わせた。これを40℃の雰囲気中で2日間エージングした後、115mm巾にスリットしてCD部材を得た。 A hot melt adhesive (DX-11C manufactured by DIC) is applied to the treated surface of a 188 μm thick PET resin film (S10 single-side processed product manufactured by Toray Industries, Inc.), and an adhesive for dry lamination (manufactured by Toyo Morton Co., Ltd.) is applied to the opposite surface. Urethane adhesive TM242A / B) was applied at 4 g / m 2 and bonded to a 100 μm-thick PET resin film (S10 manufactured by Toray Industries, Inc.) subjected to hydrophilic treatment. This was aged in an atmosphere of 40 ° C. for 2 days and then slit to a width of 115 mm to obtain a CD member.

親水性処理を施した厚さ100μmのPET樹脂フィルム(東レ社製 S10)の片面に撥水性ニス(東洋インキ製造社製 PANNECOメジウム)を所定の場所にグラビア印刷方式によって印刷し、115mm巾にスリットしてA部材を得た。   A water-repellent varnish (PANNECO medium, manufactured by Toyo Ink Manufacturing Co., Ltd.) is printed on one side of a 100 μm-thick PET resin film (S10, manufactured by Toray Industries, Inc.) that has been subjected to a hydrophilic treatment, and is slit in a 115 mm width by a gravure printing method. A member was obtained.

以上によって得られたシート部材をチップ組み立て装置にセットし、以下の工程に従って、図1に示した被検体分析用チップ1を得た。
1、A部材に直径6mmの検査孔をあけ、この孔を覆うようにメンブレンフィルター(MACHEREY−NAGEL社製 PORAFIL PC、厚さ7μm)をヒートシールして貼り付ける。
2、CD部材とE部材をヒートシールして貼り合わせ、CDE部材とした後、直径0.5mmの空気孔をあける。この時のヒートシール強度は、1N/15mm以上とした。
3、厚さ125μmの黒色PETフィルム(三菱樹脂社製 B100)の両面に両面粘着テープ(日東電工社製 両面テープ No.5620BW)を貼った総厚200μmのシートに試料流路および試料貯留部の形状を打ち抜いてB部材を得る。
4、A部材とCDE部材をB部材を介して貼り合わせた後、直径2mmの位置決め孔をあける。
5、巾約10mm、長さ約75mmの所定の外形に打ち抜いて図1に示したような被検体検査用チップ1を得る。
The sheet member obtained as described above was set in a chip assembling apparatus, and the analyte analysis chip 1 shown in FIG. 1 was obtained according to the following steps.
1. An inspection hole having a diameter of 6 mm is formed in the A member, and a membrane filter (PORAFIL PC manufactured by MACHEREY-NAGEL, thickness 7 μm) is heat-sealed and pasted so as to cover the hole.
2. The CD member and the E member are heat sealed and bonded to form a CDE member, and then an air hole having a diameter of 0.5 mm is formed. The heat seal strength at this time was 1 N / 15 mm or more.
3. A 125 μm thick black PET film (B100 manufactured by Mitsubishi Plastics, Inc., B100) and a double-sided adhesive tape (double-sided tape No. 5620BW manufactured by Nitto Denko Corporation) on a sheet with a total thickness of 200 μm B shape is obtained by punching the shape.
4. After bonding the A member and the CDE member via the B member, a positioning hole having a diameter of 2 mm is formed.
5. It is punched into a predetermined outer shape having a width of about 10 mm and a length of about 75 mm to obtain a specimen inspection chip 1 as shown in FIG.

以上の工程に従って得られた被検体分析用チップは、血糖値測定用チップとして用いられ、従来の手作業によって組み立てられていた製品に比較して品質が安定すると共に生産性が大幅に向上した。   The analyte analysis chip obtained according to the above steps was used as a blood glucose measurement chip, and the quality was stabilized and the productivity was greatly improved as compared with a product assembled by a conventional manual operation.

1・・・被検体分析用チップ
2・・・チップ先端部
3・・・把持部
4・・・位置決め孔
5・・・検査孔
6・・・試料導入孔
7・・・試料流路
8・・・試料貯留部
9・・・空気孔
10・・・撥水処理部
A・・・A部材
B・・・B部材
C・・・C部材
D・・・D部材
E・・・E部材
11、31・・・親水性フィルム
21、41、51・・・基材
22、23・・・粘着層
42、53・・・ヒートシーラブル材料層
52・・・印刷層
61・・・ドライラミネート接着剤層
71・・・メンブレンフィルター
DESCRIPTION OF SYMBOLS 1 ... Analytical analysis chip 2 ... Chip tip 3 ... Holding part 4 ... Positioning hole 5 ... Inspection hole 6 ... Sample introduction hole 7 ... Sample flow path 8 ..Sample reservoir 9 ... Air hole 10 ... Water repellent treatment part A ... A member B ... B member C ... C member D ... D member E ... E member 11 , 31 ... hydrophilic films 21, 41, 51 ... base material 22, 23 ... adhesive layer 42, 53 ... heat sealable material layer 52 ... printed layer 61 ... dry laminate adhesion Agent layer 71 ... Membrane filter

Claims (3)

液体状の被検体試料を分析するための細長い平板状の分析用チップであって、複数枚のシート部材を貼合せてなり、
チップ先端部には、計測装置に挿入した際の位置決めを行うための位置決め孔を有し、
チップ中央部側面には、チップ内部に被検体試料を導入するための、チップ側面から突出した試料導入孔を有し、
チップ内部には、試料貯留部と、試料導入孔から導入された被検体試料を毛細管現象によって試料貯留部に導く試料流路と、試料貯留部に導入された被検体試料を処理するメンブレンフィルターを有し、
チップ下面には、処理された被検液を取り出して検査するための検査孔を有し、
チップ上面には、被検体試料の試料流路への進入を円滑にするための空気孔を有し、
チップ先端部の反対側端部は、チップを把持するための把持部を形成し、
チップ表面および/または裏面の、少なくとも試料導入孔周辺部分に撥水処理を施したことを特徴とする被検体分析用チップ。
It is an elongated flat plate analysis chip for analyzing a liquid specimen, and a plurality of sheet members are bonded together,
The tip of the tip has a positioning hole for positioning when inserted into the measuring device,
On the side surface of the center of the chip, there is a sample introduction hole protruding from the side surface of the chip for introducing the specimen sample into the chip,
Inside the chip, there are a sample reservoir, a sample channel for guiding the analyte sample introduced from the sample introduction hole to the sample reservoir by capillary action, and a membrane filter for processing the analyte sample introduced into the sample reservoir. Have
On the lower surface of the chip, there is an inspection hole for taking out and inspecting the processed test liquid,
The top surface of the chip has an air hole for smooth entry of the specimen sample into the sample flow path,
The opposite end of the tip of the tip forms a grip for gripping the tip,
An analyte analyzing chip, wherein a water repellent treatment is applied to at least a portion around the sample introduction hole on the front surface and / or back surface of the chip.
前記複数枚のシート部材は、
透明で表面が親水性を有し検査孔が穿孔されたA部材と、
メンブレンフィルターと、
基材の両面に粘着層を有し試料流路と試料貯留部となるべき部分が打抜かれて除去されたB部材と、
透明で表面が親水性を有し空気孔が穿孔されたC部材と、
透明で上面にヒートシーラブル材料層を有し空気孔が穿孔されたD部材と、
透明で下面に印刷層とヒートシーラブル材料層を有し空気孔が穿孔されたE部材を少なくとも含み、
前記A部材、メンブレンフィルター、B〜E部材が下からこの順序に積層され、位置決め孔が穿孔されてなることを特徴とする請求項1記載の被検体分析用チップ。
The plurality of sheet members are:
A member which is transparent and has a hydrophilic surface and a perforated inspection hole;
A membrane filter,
B member having an adhesive layer on both sides of the substrate and punched and removed the portion to be the sample flow path and the sample reservoir;
A transparent C member having a hydrophilic surface and perforated air holes;
D member which is transparent and has a heat-sealable material layer on its upper surface and has air holes drilled;
At least an E member that is transparent and has a printed layer and a heat-sealable material layer on the lower surface and has air holes drilled therein,
2. The analyte analyzing chip according to claim 1, wherein the A member, the membrane filter, and the B to E members are laminated in this order from the bottom, and a positioning hole is perforated.
前記A部材の下面に撥水性ニスを塗布する工程、A部材に検査孔を穿孔し、検査孔に前記メンブレンフィルターを貼り付ける工程、前記B部材の試料流路と試料貯留部になるべき部分を打抜いて除去する工程、前記C部材とD部材を予め貼り合せ、さらにE部材と貼り合せて、空気孔を穿孔する工程、前記工程を経たA部材、B部材、C、D、E部材を貼り合せて一体化し、位置決め孔を穿孔し、外形を所定のチップ形状に打抜く工程を少なくとも含むことを特徴とする請求項2に記載の被検体分析用チップの製造方法。   A step of applying a water-repellent varnish to the lower surface of the A member, a step of drilling an inspection hole in the A member, and affixing the membrane filter to the inspection hole; The step of punching and removing, bonding the C member and D member in advance, and further bonding to the E member to punch air holes, and the A member, B member, C, D, and E member having undergone the above step 3. The method for producing an analyte analyzing chip according to claim 2, comprising at least a step of pasting and integrating, punching a positioning hole, and punching an outer shape into a predetermined chip shape.
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