JP2009095267A

JP2009095267A - Vessel for gene detection and examination, reagent kit for gene detection and examination, and method for gene detection and examination

Info

Publication number: JP2009095267A
Application number: JP2007268246A
Authority: JP
Inventors: Yuko Watai; 優子渡井
Original assignee: Olympus Corp
Current assignee: Olympus Corp
Priority date: 2007-10-15
Filing date: 2007-10-15
Publication date: 2009-05-07

Abstract

<P>PROBLEM TO BE SOLVED: To prevent artificial mistakes, such as, taking another biological sample by mistake which occurs, when a biological sample in a vessel for amplification is transferred to a vessel for detection. <P>SOLUTION: A vessel 1 for gene detection and examination is provided, including a vessel 10 for amplification to be used in an amplification step and a vessel 20 for detection to be used in a detection step, wherein these two vessels 10 and 20 are bendable and integrally formed via a connective member 30 provided with two perforated lines 31 and 32 enabling these two vessels 10 and 20 to be separated from each other by being cut off. Specifically, the connective member 30 connects these two vessels 10 and 20 to each other, in such a state as to set the respective vessels 10 and 20 apart from each other so that the opening of the vessel 10 and the opening of the vessel 20 stand against each other, when the connective member 30 is bent along the perforated lines 31 and 33. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

本発明は、生体試料中に含まれる検出対象の核酸を検出する遺伝子検出検査に用いる遺伝子検出検査用容器、遺伝子検出検査用試薬キットおよび遺伝子検出検査方法に関するものである。 The present invention relates to a gene detection test container, a gene detection test reagent kit, and a gene detection test method used for a gene detection test for detecting a nucleic acid to be detected contained in a biological sample.

従来から、免疫検査や生化学検査等のさまざまな分野で分析装置が用いられている。この分析装置は、試料と試薬とを反応させた反応液に所定波長の分析光を照射して反応液の特性を光学的に測定し、測定した特性をもとに試料の分析を行う装置であり、多試料を同時に検出処理することができ、かつ高精度で分析できる。 Conventionally, analyzers are used in various fields such as immunological tests and biochemical tests. This analyzer is an apparatus that optically measures the characteristics of a reaction solution by irradiating a reaction solution obtained by reacting a sample and a reagent with an analysis light having a predetermined wavelength, and analyzes the sample based on the measured properties. Yes, multiple samples can be detected at the same time and analyzed with high accuracy.

また、分析装置は、例えばＳＮＰ（一塩基多型）検査等、生体試料中に含まれる所定の塩基配列を有するＤＮＡ（デオキシリボ核酸）からなる遺伝子を検出する検査にも適している。ＳＮＰ検査等で用いる生体試料は、例えばＰＣＲ増幅装置等によって所定の塩基配列を有するＤＮＡを増幅させる処理を行ったＤＮＡ増幅液であり、抽出工程と増幅工程とを経て得られ、検出工程にて分析装置によって検出される。このような遺伝子検出に適用された場合には、分析装置は、増幅処理後の生体試料を試薬と反応させて反応液の特性を光学的に測定し、測定した特性をもとに試料中に含まれる所定の塩基配列を有するＤＮＡ等の検出を行う（例えば特許文献１，２を参照）。 The analyzer is also suitable for testing for detecting a gene made of DNA (deoxyribonucleic acid) having a predetermined base sequence contained in a biological sample, such as SNP (single nucleotide polymorphism) testing. The biological sample used in the SNP test or the like is a DNA amplification solution that has been subjected to a process of amplifying DNA having a predetermined base sequence using, for example, a PCR amplification device, and is obtained through an extraction process and an amplification process. Detected by the analyzer. When applied to such gene detection, the analyzer reacts the amplified biological sample with a reagent and optically measures the characteristics of the reaction solution, and based on the measured characteristics, Detection of DNA or the like having a predetermined base sequence is performed (see, for example, Patent Documents 1 and 2).

特開２００５−９５１３４号公報JP 2005-95134 A 特許第３５４５１５８号公報Japanese Patent No. 3545158

ところで、増幅工程から検出工程に移行する際、増幅処理用の容器（増幅用容器）に保持されている生体試料を、検出処理用の容器（検出用容器）へ移し替える必要があった。これは、増幅処理を行うＰＣＲ増幅装置で使用される増幅用容器の形状と、検出処理を行う分析装置で使用される検出用容器の形状とが異なるためである。このため従来は、例えばバーコード等の記録媒体を増幅用容器および検出用容器のそれぞれに付してこれらのバーコードを読み取り、読み取ったデータを管理することによって容器間での生体試料の移し替えを管理していた。しかしながら、この生体試料を移し替える作業は手作業で行われるため、生体試料を取り間違えてしまう等の人為的ミスが生じる恐れがあった。 By the way, when shifting from the amplification process to the detection process, it is necessary to transfer the biological sample held in the amplification processing container (amplification container) to the detection processing container (detection container). This is because the shape of the amplification container used in the PCR amplification apparatus that performs the amplification process is different from the shape of the detection container used in the analysis apparatus that performs the detection process. For this reason, conventionally, for example, a barcode or other recording medium is attached to each of the amplification container and the detection container, the barcode is read, and the biological data is transferred between the containers by managing the read data. Was managing. However, since the operation of transferring the biological sample is performed manually, a human error such as a mistake in the biological sample may occur.

本発明は、上記に鑑みなされたものであって、増幅用容器内の生体試料を検出用容器へ移し替える際に生じる生体試料の取り間違い等の人為的ミスを防止することができる遺伝子検出検査用容器、遺伝子検出検査用試薬キットおよび遺伝子検出検査方法を提供することを目的とする。 The present invention has been made in view of the above, and is a gene detection test capable of preventing human error such as a mistake in taking a biological sample that occurs when the biological sample in the amplification container is transferred to the detection container. It is an object to provide a container for detection, a reagent kit for gene detection test, and a method for gene detection test.

上述した課題を解決し、目的を達成するため、本発明にかかる遺伝子検出検査用容器は、遺伝子検出検査の増幅工程で使用され、生体試料を収容する増幅用容器と、前記増幅工程の後段の検出工程で使用され、前記増幅工程で増幅処理された生体試料を収容する検出用容器と、前記増幅用容器と前記検出用容器とを一体的に形成する接続部材と、を備え、前記接続部材は、折り曲げ可能な曲折部を有し、前記曲折部で折り曲げることによって前記増幅用容器の開口部と前記検出用容器の開口部とが対向可能に形成されていることを特徴とする。 In order to solve the above-mentioned problems and achieve the object, a gene detection test container according to the present invention is used in an amplification process of a gene detection test, and an amplification container that contains a biological sample, and a latter stage of the amplification process. A detection container that contains the biological sample that is used in the detection process and that has been amplified in the amplification process; and a connection member that integrally forms the amplification container and the detection container. Has a foldable bending portion, and the opening of the amplification container and the opening of the detection container are formed so as to face each other by being bent at the bending portion.

また、本発明にかかる遺伝子検出検査用容器は、上記の発明において、前記曲折部が分離可能に形成されていることを特徴とする。 Moreover, the gene detection test container according to the present invention is characterized in that, in the above invention, the bent portion is formed so as to be separable.

また、本発明にかかる遺伝子検出検査用容器は、上記の発明において、遺伝子検出検査の増幅工程で使用され、生体試料を収容する増幅用容器と、前記増幅工程の後段の検出工程で使用され、前記増幅工程で増幅処理された生体試料を収容する検出用容器と、前記増幅用容器と前記検出用容器とを一体的に形成する接続部材と、を備え、前記接続部材は、前記増幅用容器と前記検出用容器とを分離可能な分離部を有することを特徴とする。 In addition, the gene detection test container according to the present invention is used in the amplification process of the gene detection test in the above invention, and is used in an amplification container that contains a biological sample, and a detection process subsequent to the amplification process, A detection container that houses the biological sample amplified in the amplification step; and a connection member that integrally forms the amplification container and the detection container, wherein the connection member is the amplification container. And a separation portion capable of separating the detection container.

また、本発明にかかる遺伝子検出検査用容器は、上記の発明において、前記検出用容器の開口部が、前記増幅用容器の開口部より大きいことを特徴とする。 Moreover, the gene detection test container according to the present invention is characterized in that, in the above invention, the opening of the detection container is larger than the opening of the amplification container.

また、本発明にかかる遺伝子検出検査用容器は、上記の発明において、前記増幅用容器の開口部と前記検出用容器の開口部とが相互に接続可能であることを特徴とする。 The gene detection test container according to the present invention is characterized in that, in the above invention, the opening of the amplification container and the opening of the detection container can be connected to each other.

また、本発明にかかる遺伝子検出検査用容器は、上記の発明において、前記増幅用容器の開口部と前記検出用容器の開口部とが相互に嵌合可能であることを特徴とする。 The gene detection test container according to the present invention is characterized in that, in the above invention, the opening of the amplification container and the opening of the detection container can be fitted to each other.

また、本発明にかかる遺伝子検出検査用容器は、上記の発明において、内部に収容される生体試料に関する情報が記録され、前記検出用容器の外側面に装着された記録媒体を備えることを特徴とする。 Moreover, the gene detection test container according to the present invention is characterized in that, in the above-mentioned invention, information relating to a biological sample accommodated therein is recorded, and a recording medium mounted on an outer surface of the detection container is provided. To do.

また、本発明にかかる遺伝子検出検査用試薬キットは、上記構成の遺伝子検出検査用容器を備え、前記増幅用容器内に、遺伝子検出検査の検出方法に応じた修飾物質を有し、検出対象の核酸に対応したプライマーと、緩衝液と、ｄＮＴＰと、増幅用酵素とが注入されていることを特徴とする。 The reagent kit for gene detection test according to the present invention comprises a container for gene detection test having the above-described configuration, and has a modifying substance in the amplification container according to the detection method of gene detection test, A primer corresponding to a nucleic acid, a buffer solution, dNTP, and an amplification enzyme are injected.

また、本発明にかかる遺伝子検出検査用試薬キットは、上記構成の遺伝子検出検査用容器を備え、前記検出用容器内に、緩衝液と、前記増幅処理時に生体試料と反応させたプライマーの修飾物質と特異的に結合する抗体が標識された粒子とが注入されていることを特徴とする。 Further, a gene detection test reagent kit according to the present invention comprises a gene detection test container having the above-described configuration, and a buffer modifying solution in the detection container and a primer modifying substance reacted with a biological sample during the amplification process. And particles that are labeled with an antibody that specifically binds to.

また、本発明にかかる遺伝子検出検査方法は、遺伝子検出検査の増幅工程で使用され、生体試料を収容する増幅用容器と、前記増幅工程の後段の検出工程で使用され、前記増幅工程で増幅処理された生体試料を収容する検出用容器と、前記増幅用容器と前記検出用容器とを一体的に形成する接続部材とを備え、前記接続部材は、折り曲げ可能な曲折部を有し、前記曲折部で折り曲げることによって前記増幅用容器の開口部と前記検出用容器の開口部とが対向可能に形成された遺伝子検出検査用容器を用いて生体試料中に含まれる検出対象の核酸を検出する遺伝子検出検査方法であって、前記増幅用容器内に生体試料を分注する分注工程と、前記遺伝子検出検査用容器を増幅装置に設置して前記増幅用容器内の生体試料を増幅処理する増幅工程と、前記接続部材を前記折曲部で折り曲げて前記増幅用容器の開口部と前記検出用容器の開口部とを対向させ、前記増幅工程で増幅処理された前記増幅用容器内の生体試料を前記検出用容器へ移し替える移替工程と、前記検出用容器を分析装置に設置して前記検出用容器内の生体試料の検出処理を行い、前記検出対象の核酸を検出する検出工程と、を含むことを特徴とする。 The gene detection test method according to the present invention is used in an amplification process of a gene detection test, and is used in an amplification container that contains a biological sample and a detection process subsequent to the amplification process, and an amplification process is performed in the amplification process. And a connecting member that integrally forms the amplification container and the detecting container, the connecting member having a foldable bending portion, and the bending member. A gene for detecting a nucleic acid to be detected contained in a biological sample using a gene detection test container in which the opening of the amplification container and the opening of the detection container are formed to be able to face each other by being bent at a portion A detection test method, a dispensing step of dispensing a biological sample in the amplification container, and an amplification for amplifying the biological sample in the amplification container by installing the gene detection testing container in an amplification device Process The biological member in the amplification container amplified in the amplification step is formed by bending the connecting member at the bent portion so that the opening of the amplification container faces the opening of the detection container. A transfer step of transferring to a detection container; and a detection step of detecting the nucleic acid to be detected by performing detection processing of the biological sample in the detection container by installing the detection container in an analyzer. It is characterized by that.

また、本発明にかかる遺伝子検出検査方法は、上記の発明において、前記曲折部が分離可能に形成されており、前記移替工程の後、前記曲折部を切り離して前記増幅用容器と前記検出用容器とを分離する分離工程を含むことを特徴とする。 In the gene detection and testing method according to the present invention, in the above invention, the bent portion is formed so as to be separable, and after the transfer step, the bent portion is separated and the amplification container and the detection container are separated. It includes a separation step of separating the container.

また、本発明にかかる遺伝子検出検査方法は、遺伝子検出検査の増幅工程で使用され、生体試料を収容する増幅用容器と、前記増幅工程の後段の検出工程で使用され、前記増幅工程で増幅処理された生体試料を収容する検出用容器と、前記増幅用容器と前記検出用容器とを一体的に形成する接続部材とを備え、前記接続部材は、前記増幅用容器と前記検出用容器とを分離可能な分離部を有する遺伝子検出検査用容器を用いて生体試料中に含まれる検出対象の核酸を検出する遺伝子検出検査方法であって、前記増幅用容器内に生体試料を分注する分注工程と、前記遺伝子検出検査用容器を増幅装置に設置して前記増幅用容器内の生体試料を増幅処理する増幅工程と、前記分離部を切り離して前記増幅用容器と前記検出用容器とを分離する分離工程と、前記分離工程で分離された前記増幅用容器内の生体試料を前記検出用容器へ移し替える移替工程と、前記検出用容器を分析装置に設置して前記検出用容器内の生体試料の検出処理を行い、前記検出対象の核酸を検出する検出工程と、を含むことを特徴とする。 The gene detection test method according to the present invention is used in an amplification process of a gene detection test, and is used in an amplification container that contains a biological sample and a detection process subsequent to the amplification process, and an amplification process is performed in the amplification process. A detection container that accommodates the biological sample, and a connection member that integrally forms the amplification container and the detection container. The connection member includes the amplification container and the detection container. A gene detection and inspection method for detecting a nucleic acid to be detected contained in a biological sample using a genetic detection and inspection container having a separable separation unit, wherein the biological sample is dispensed into the amplification container. Separating the amplification container and the detection container by separating the separation part, an amplification step of amplifying the biological sample in the amplification container by installing the gene detection test container in the amplification device; Separator A transfer step in which the biological sample in the amplification container separated in the separation step is transferred to the detection container; and the detection container is installed in an analyzer and the biological sample in the detection container A detection step of performing detection processing and detecting the nucleic acid to be detected.

本発明によれば、接続部材の曲折部を折り曲げることによって増幅用容器の開口部と検出用容器の開口部とを対向させ、増幅用容器内の生体試料を検出用容器へ移し替えることができる。したがって、増幅処理後の増幅用容器内の生体試料を検出用容器へ移し替える際に生じる生体試料の取り間違い等の人為的ミスを防止することができるという効果を奏する。 According to the present invention, the bent portion of the connecting member is bent so that the opening of the amplification container and the opening of the detection container face each other, and the biological sample in the amplification container can be transferred to the detection container. . Therefore, it is possible to prevent an artificial error such as a mistake in taking the biological sample that occurs when the biological sample in the amplification container after the amplification process is transferred to the detection container.

以下、図面を参照し、本発明の好適な実施の形態について詳細に説明する。なお、本実施の形態により本発明が限定されるものではない。図１は、本実施の形態の遺伝子検出検査用容器１の一例を示す図である。本実施の形態の遺伝子検出検査では、例えば全血検体等の生体試料からＤＮＡを抽出する抽出工程と、抽出したＤＮＡのうちの所定の塩基配列を有するＤＮＡの一部（以下、適宜「特定部分」と呼ぶ。）を増幅する増幅工程と、増幅したＤＮＡを検出する検出工程とがこの順番で行われるが、遺伝子検出検査用容器１は、増幅工程および検出工程で用いられる。 DESCRIPTION OF EMBODIMENTS Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings. In addition, this invention is not limited by this Embodiment. FIG. 1 is a diagram illustrating an example of a container 1 for gene detection testing according to the present embodiment. In the gene detection test of the present embodiment, for example, an extraction step for extracting DNA from a biological sample such as a whole blood sample, and a part of the extracted DNA having a predetermined base sequence (hereinafter referred to as “specific part” as appropriate). The amplification step for amplifying the sample and the detection step for detecting the amplified DNA are performed in this order, and the gene detection test container 1 is used in the amplification step and the detection step.

図１に示すように、遺伝子検出検査用容器１は、増幅工程で使用される増幅用容器１０と、検出工程で使用される検出用容器２０とを備え、この増幅用容器１０および検出用容器２０は、折り曲げ可能であり、かつ切り離すことで増幅用容器１０と検出用容器２０とを分離可能な曲折部である２本のミシン目３１，３３を配した接続部材３０によって一体的に形成されている。具体的には、接続部材３０は、ミシン目３１，３３に沿って接続部材３０が折り曲げられたときに増幅用容器１０の開口部と検出用容器２０の開口部が対向するように、各容器１０，２０を離間させた状態で増幅用容器１０と検出用容器２０とを接続している。 As shown in FIG. 1, the gene detection test container 1 includes an amplification container 10 used in the amplification process and a detection container 20 used in the detection process. The amplification container 10 and the detection container 20 is integrally formed by a connecting member 30 provided with two perforations 31, 33, which are bendable and can be separated by separating the amplification container 10 and the detection container 20 from each other. ing. Specifically, the connection member 30 is formed so that the opening of the amplification container 10 and the opening of the detection container 20 face each other when the connection member 30 is bent along the perforations 31 and 33. The amplification container 10 and the detection container 20 are connected in a state where the distances 10 and 20 are separated from each other.

増幅工程では、増幅用容器１０内に抽出工程を経た生体試料であるＤＮＡ溶出液を分注し、遺伝子検出検査用容器１のままＰＣＲ増幅装置（増幅装置）に設置してＤＮＡ溶出液の増幅処理を行う。増幅用容器１０は、このＰＣＲ増幅装置で使用可能な形状を有する。例えば、容量が１〜２ｍＬ程度の略円筒形状を有し、底部が逆円錐形状に形成される。開口部は、口径が１０ｍｍ程度に成形され、検出用容器２０の開口部と相互に嵌合可能な形状に形成される。 In the amplification process, the DNA eluate, which is a biological sample that has undergone the extraction process, is dispensed into the amplification container 10 and placed in the PCR amplification apparatus (amplification apparatus) as it is in the gene detection test container 1 to amplify the DNA eluate. Process. The amplification container 10 has a shape that can be used in this PCR amplification apparatus. For example, it has a substantially cylindrical shape with a capacity of about 1 to 2 mL, and the bottom is formed in an inverted conical shape. The opening is shaped to have a diameter of about 10 mm and can be fitted to the opening of the detection container 20.

一方検出工程では、増幅工程で増幅処理された増幅用容器１０内の生体試料であるＤＮＡ増幅液を検出用容器２０へ移し替える作業を行う。そして、増幅用容器１０と切り離して検出用容器２０のみを分析装置に設置し、ＤＮＡ増幅液の検出処理を行う。検出用容器２０は、この分析装置で使用可能な形状を有する。例えば、容量が２〜３ｍＬ程度の略円筒形状を有する。開口部は、口径が増幅用容器１０と比較して大きい１２〜１３ｍｍ程度に成形され、増幅用容器１０の開口部と相互に嵌合可能な形状に形成される。また、検出用容器２０の外側面には、内部に収容される生体試料に関する情報を所定の規格に従ってコード化したバーコードが印刷（記録）された記録媒体であるバーコードラベル２３が貼付される。例えば、全血検体を提供した被験者の識別ＩＤ等がバーコードに記録される。 On the other hand, in the detection step, an operation of transferring the DNA amplification solution, which is a biological sample in the amplification container 10 amplified in the amplification step, to the detection container 20 is performed. Then, only the detection container 20 is separated from the amplification container 10 and installed in the analyzer to detect the DNA amplification solution. The detection container 20 has a shape that can be used in this analyzer. For example, it has a substantially cylindrical shape with a capacity of about 2 to 3 mL. The opening is shaped to have a diameter of about 12 to 13 mm, which is larger than that of the amplification container 10, and is formed into a shape that can be fitted to the opening of the amplification container 10. Further, a barcode label 23 which is a recording medium on which a barcode obtained by encoding information related to a biological sample accommodated in the detection container 20 according to a predetermined standard is printed (recorded) is attached to the outer surface of the detection container 20. . For example, the identification ID of the subject who provided the whole blood sample is recorded on the barcode.

この遺伝子検出検査用容器１は、例えば遺伝子検出検査用の検査キットとして提供される。すなわち、予め増幅用容器１０には増幅用試薬１５が、検出用容器２０には希釈液２５がそれぞれ適当量注入されており、増幅用容器１０はキャップ１１によって密封され、検出用容器２０はキャップ２１によって密封されている。 The container 1 for gene detection test is provided as a test kit for gene detection test, for example. That is, a suitable amount of the amplification reagent 15 is preliminarily injected into the amplification container 10, and a suitable amount of the diluent 25 is injected into the detection container 20. The amplification container 10 is sealed with the cap 11, and the detection container 20 is the cap. 21 is sealed.

増幅用容器１０に注入される増幅用試薬は、例えばプライマーと、核酸の伸長反応のための基質であるｄＮＴＰと、増幅用酵素と、酵素を活性化させるためのマグネシウム塩とを緩衝液中に添加したものであり、例えば３０μＬ注入される。ここで、プライマーは、遺伝子検出検査の検出方法に応じた修飾物質を有するものであり、検出対象の核酸（ＤＮＡ）を増幅するための人工的な配列を有するものが適宜用いられる。本実施の形態は、凝集による濁度を検出して遺伝子検出検査を行う場合の実施の形態であり、例えば抗原であるハプテンが修飾物質として用いられる。また、増幅用酵素とは、ＤＮＡを増幅させるための酵素であり、例えばＰＣＲ反応や等温増幅反応用のポリメラーゼである。具体的には、Ｔａｑ，ＫＯＤ，Ｔｆｉ由来のポリメラーゼが挙げられる。 The amplification reagent injected into the amplification container 10 includes, for example, a primer, dNTP which is a substrate for nucleic acid extension reaction, an amplification enzyme, and a magnesium salt for activating the enzyme in a buffer solution. For example, 30 μL is injected. Here, the primer has a modifying substance according to the detection method of the gene detection test, and a primer having an artificial sequence for amplifying the nucleic acid (DNA) to be detected is appropriately used. The present embodiment is an embodiment in the case where a gene detection test is performed by detecting turbidity due to aggregation. For example, a hapten that is an antigen is used as a modifying substance. The amplification enzyme is an enzyme for amplifying DNA, for example, a polymerase for PCR reaction or isothermal amplification reaction. Specific examples include polymerases derived from Taq, KOD, and Tfi.

検出用容器２０に注入される希釈液は、緩衝液中にプライマーの修飾物質と特異的に結合する抗体が標識された粒子が添加されたものであり、例えば２００μＬ注入される。本実施の形態では、ハプテンに対する抗体が表面に標識されたラテックス粒子が用いられ、この抗体結合ラテックス粒子の凝集を検出することによって検出対象のＤＮＡの有無が判定される。この希釈液は、例えば次のようにして得ることができる。すなわち先ず、濃度１ＭのＭＯＰＳＯ：２０ｍＬ、ＰＥＧ２０００：２２．４ｇ、濃度５ＭのＮａＣｌ：４０ｍＬを純水に溶解して１Ｌの水溶液とし、スターラーで混合して緩衝液を作製する。続いて、抗体ラテックス粒子溶液を作製する。先ず、濃度１ＭのＭＯＰＳＯ：２０ｍＬ、サリチル酸ナトリウム：４８ｇ、フィッシュスキンゼラチン（ＦＳＧ）の４５％溶液：４４．４ｍＬを純水に溶解して１Ｌの水溶液とし、スターラーで混合する。次いで、濃度５００ｍＭのＭＥＳ：１ｍＬを純水で９ｍＬにし、ラテックス粒子の１０％溶液１ｍＬと、所定濃度（Ｘｍｇ／ｍＬ）の抗体：所定量ＹｍＬとを添加し、抗体結合ラテックス粒子を調整する。抗体については、その種類に応じた濃度のものを添加する。そして、この抗体を結合させた抗体ラテックス粒子溶液を０．０５％の濃度でソニケーターにて懸濁する。 The diluent to be injected into the detection container 20 is obtained by adding particles labeled with an antibody that specifically binds to a primer modifying substance in a buffer solution. For example, 200 μL is injected. In the present embodiment, latex particles labeled with an antibody against a hapten are used, and the presence or absence of DNA to be detected is determined by detecting the aggregation of the antibody-bound latex particles. This diluted solution can be obtained, for example, as follows. That is, first, 1M MOPSO: 20 mL, PEG2000: 22.4 g, and 5 M NaCl: 40 mL are dissolved in pure water to form a 1 L aqueous solution, and mixed with a stirrer to prepare a buffer solution. Subsequently, an antibody latex particle solution is prepared. First, MOPSO at a concentration of 1M: 20 mL, sodium salicylate: 48 g, 45% solution of fish skin gelatin (FSG): 44.4 mL are dissolved in pure water to make a 1 L aqueous solution, and mixed with a stirrer. Subsequently, 1 mL of MES having a concentration of 500 mM is made 9 mL with pure water, and 1 mL of a 10% solution of latex particles and an antibody: predetermined amount YmL of a predetermined concentration (X mg / mL) are added to prepare antibody-bound latex particles. About an antibody, the thing of the density | concentration according to the kind is added. Then, the antibody latex particle solution to which this antibody is bound is suspended in a sonicator at a concentration of 0.05%.

ここで、所定の塩基配列（特定部分）を有するＤＮＡの検出原理について、図２を参照して説明する。増幅工程では、抽出工程を経て得られたＤＮＡ溶出液が、ハプテンで修飾されたプライマーを含む増幅用試薬が予め注入された増幅用容器１０に分注される。これにより、図２（ａ）に示すように、ＤＮＡ４０（４０−１，２）を含むＤＮＡ溶出液がハプテンで修飾されたプライマー５０ａ，５０ｂを含む増幅用試薬と混合され、増幅処理される。増幅処理では、抽出工程で抽出されたＤＮＡが特定部分を有する場合のみ増幅するような操作を行う。このため、被験者が特定部分を有するＤＮＡを持つ場合、図２（ｂ）に示すように、この増幅工程を経たＤＮＡ増幅液中には末端にハプテン５１ａ，５１ｂが結合した多量のＤＮＡ６０が含まれることとなる。被験者等が特定部分を有するＤＮＡを持たなければ、この増幅工程を経てもＤＮＡ増幅液中にはＤＮＡは含まれない。続く検出工程では、増幅工程を経て得られた増幅用容器１０内のＤＮＡ増幅液が検出用容器２０へと移し替えられる。検出用容器２０には、予めプライマーの修飾物質であるハプテンに対する抗体が表面に標識されたラテックス粒子を含む希釈液が注入されている。これにより、ＤＮＡ増幅液が希釈液によって希釈される。そして、図２（ｃ）に示すように、ＤＮＡ増幅液中にハプテン５１ａ，５１ｂが結合したＤＮＡ６０があれば、このＤＮＡ６０に結合したハプテン５１ａ，５１ｂと、ラテックス粒子７３の表面に標識されたハプテン５１ａ，５１ｂに対する抗体７１とが抗原抗体反応を起こして結合する。この結合によって、抗体結合ラテックス粒子７０の間をＤＮＡ６０が架橋し、抗体結合ラテックス粒子７０とＤＮＡ６０とは凝集物８０をつくる。凝集物８０がつくられると反応液は懸濁するため、この反応液の濁度をもとに検出対象のＤＮＡの有無を判定することができる。 Here, the detection principle of DNA having a predetermined base sequence (specific portion) will be described with reference to FIG. In the amplification step, the DNA eluate obtained through the extraction step is dispensed into the amplification container 10 into which an amplification reagent containing a hapten-modified primer has been previously injected. As a result, as shown in FIG. 2 (a), the DNA eluate containing DNA 40 (40-1, 2) is mixed with the amplification reagent containing the hapten-modified primers 50a, 50b, and amplified. In the amplification process, an operation is performed to amplify only when the DNA extracted in the extraction step has a specific portion. For this reason, when the subject has DNA having a specific portion, as shown in FIG. 2 (b), the DNA amplification solution that has undergone this amplification step contains a large amount of DNA 60 having haptens 51a and 51b bound to the ends. It will be. If the subject or the like does not have DNA having a specific portion, DNA is not contained in the DNA amplification solution even after this amplification step. In the subsequent detection process, the DNA amplification solution in the amplification container 10 obtained through the amplification process is transferred to the detection container 20. The detection container 20 is injected with a diluent containing latex particles whose surface is preliminarily labeled with an antibody against a hapten, which is a primer modifying substance. Thereby, the DNA amplification solution is diluted with the diluent. As shown in FIG. 2 (c), if there is DNA 60 to which haptens 51a and 51b are bound in the DNA amplification solution, haptens 51a and 51b bound to the DNA 60 and haptens labeled on the surface of latex particles 73 are present. The antibody 71 against 51a and 51b binds by causing an antigen-antibody reaction. By this binding, the DNA 60 crosslinks between the antibody-bound latex particles 70, and the antibody-bound latex particles 70 and the DNA 60 form an aggregate 80. Since the reaction solution is suspended when the aggregate 80 is formed, the presence or absence of DNA to be detected can be determined based on the turbidity of the reaction solution.

図３は、遺伝子検出検査を構成する抽出工程、増幅工程および検出工程の各工程を説明するフローチャートである。抽出工程では、全血検体からＤＮＡを抽出する。すなわち先ず、核酸抽出装置で使用可能な抽出用容器に全血検体を注入する（ステップＳ１１）。この抽出用容器には、被験者の識別ＩＤ等を記録したバーコードが印刷されたバーコードラベルが添付されており、次のステップＳ１３で抽出用容器に付されたバーコードを読み取る。そして、核酸抽出装置によって抽出用容器内の全血検体の抽出処理を行う（ステップＳ１５）。具体的には先ず、全血検体を溶解液に溶解する。続いて、例えばシリカビーズ等の磁性粒子にＤＮＡを吸着させる。続いて、洗浄液を用いてＢ／Ｆ分離を行い、不要物を除去する。そして、例えばＩ^-等のカイトロピックイオンを含む溶出液でＤＮＡを溶出させ、このＤＮＡを溶出させた溶出液からシリカビーズを除去してＤＮＡ溶出液を得る。 FIG. 3 is a flowchart for explaining the extraction process, amplification process, and detection process that constitute the gene detection test. In the extraction step, DNA is extracted from the whole blood sample. That is, first, a whole blood sample is injected into an extraction container that can be used in the nucleic acid extraction apparatus (step S11). The extraction container is attached with a barcode label on which a barcode recording the identification ID of the subject is printed, and the barcode attached to the extraction container is read in the next step S13. Then, the whole blood sample in the extraction container is extracted by the nucleic acid extraction apparatus (step S15). Specifically, first, a whole blood sample is dissolved in a lysis solution. Subsequently, DNA is adsorbed onto magnetic particles such as silica beads. Subsequently, B / F separation is performed using a cleaning liquid to remove unnecessary substances. Then, for example, DNA is eluted with an eluate containing a chiral ion such as I ^−, and silica beads are removed from the eluate from which the DNA has been eluted to obtain a DNA eluate.

増幅工程では、抽出工程で抽出したＤＮＡのうち、所定の塩基配列を有するＤＮＡの一部（特定部分）を増幅させる。すなわち先ず、抽出用容器内のＤＮＡ溶出液を遺伝子検出検査用容器１の増幅用容器１０に分注する（ステップＳ１７）。図４は、この分注作業について説明する図である。増幅工程では、図１に示して説明した増幅用容器１０と検出用容器２０が一体的に構成された遺伝子検出検査用容器１を用意する（図４（ａ））。そして、核酸抽出装置によって全血検体を抽出処理して得た抽出用容器９０内のＤＮＡ溶出液を、例えば使い捨てタイプのチップ１００を用いたピペット等で１０μＬ分取する（図４（ｂ））。続いて、遺伝子検出検査用容器１の増幅用容器１０のキャップ１１を外し、分取したＤＮＡ溶出液を増幅用容器１０に分注する（図４（ｃ））。続いて、増幅用容器１０にキャップを被せて密封し（図４（ｄ））、遺伝子検出検査用容器１をＰＣＲ増幅装置に設置する。ここで、ＰＣＲ増幅装置は、温度制御を行うことによって増幅用容器１０内の試料のＰＣＲ増幅を行う装置であるが、検出用容器２０内に注入されている希釈液は温度変化による影響を受けないため、ＰＣＲ増幅装置内に設置しても問題ない。ＰＣＲ増幅装置側の容器の設置部分は、遺伝子検出検査用容器１の載置が可能に構成されているものとする。 In the amplification step, a part (specific portion) of DNA having a predetermined base sequence is amplified from the DNA extracted in the extraction step. That is, first, the DNA eluate in the extraction container is dispensed into the amplification container 10 of the gene detection test container 1 (step S17). FIG. 4 is a diagram for explaining this dispensing operation. In the amplification step, a gene detection test container 1 is prepared in which the amplification container 10 and the detection container 20 described with reference to FIG. 1 are integrally formed (FIG. 4A). Then, 10 μL of the DNA eluate in the extraction container 90 obtained by extracting the whole blood sample with the nucleic acid extraction apparatus is collected with, for example, a pipette using a disposable tip 100 (FIG. 4B). . Subsequently, the cap 11 of the amplification container 10 of the gene detection test container 1 is removed, and the collected DNA eluate is dispensed into the amplification container 10 (FIG. 4C). Subsequently, the amplification container 10 is covered with a cap and sealed (FIG. 4D), and the gene detection test container 1 is installed in the PCR amplification apparatus. Here, the PCR amplification device is a device that performs PCR amplification of the sample in the amplification container 10 by performing temperature control. However, the diluted solution injected into the detection container 20 is affected by the temperature change. Therefore, there is no problem even if it is installed in the PCR amplification apparatus. It is assumed that the installation part of the container on the PCR amplification device side is configured to allow the placement of the gene detection test container 1.

遺伝子検出検査用容器１をＰＣＲ増幅装置に設置したならば、図３に示すように、ＰＣＲ増幅装置によって増幅用容器１０内のＤＮＡ溶出液の増幅処理を行う（ステップＳ１９）。例えば、ＰＣＲ増幅装置は、ＰＣＲ法による増幅処理を行う。ＰＣＲ法とは、例えばＤＮＡ中の特定部分の合成を繰り返し行うことによって検出対象のＤＮＡを検出する手法のことである。具体的には、ＰＣＲ増幅装置は、増幅用容器１０内のＤＮＡ溶出液と増幅用試薬の混合液を先ず高温下で熱変性させ、次いで温度を下げてプライマーとＤＮＡとを結合（アニーリング）させる。この熱変性とアニーリングを繰り返し行うことによって、ＤＮＡ中の特定部分を合成・増幅させる。このＰＣＲ増幅の反応条件は、例えば、増幅用容器１０を２分間９４℃に保って反応を開始させた後、９４℃で３０秒間、６４℃で１５秒間を１サイクルとして３０サイクル行う。なお、反応条件は、これに限定されるものではなく、使用する増幅用酵素の種類等によって適宜設定できる。例えば、アニーリングの後に７２℃で２分間伸張反応させる工程を追加することとしてもよい。 If the gene detection test container 1 is installed in the PCR amplification apparatus, the DNA eluate in the amplification container 10 is amplified by the PCR amplification apparatus as shown in FIG. 3 (step S19). For example, the PCR amplification apparatus performs amplification processing by the PCR method. The PCR method is a technique for detecting DNA to be detected by, for example, repeatedly synthesizing a specific portion in DNA. Specifically, the PCR amplification apparatus first denatures the mixture of the DNA eluate and the amplification reagent in the amplification container 10 at high temperature, and then lowers the temperature to bond (anneal) the primer and DNA. . By repeating this heat denaturation and annealing, a specific portion in DNA is synthesized and amplified. The PCR amplification reaction condition is, for example, that the amplification container 10 is kept at 94 ° C. for 2 minutes to start the reaction, and then 30 cycles are performed with 94 ° C. for 30 seconds and 64 ° C. for 15 seconds. In addition, reaction conditions are not limited to this, It can set suitably according to the kind etc. of the enzyme for amplification to be used. For example, a step of extension reaction at 72 ° C. for 2 minutes after annealing may be added.

検出工程では、増幅工程で増幅させた特定部分を有するＤＮＡを検出する。すなわち、先ずＰＣＲ増幅装置で増幅処理された増幅用容器１０内のＤＮＡ増幅液を検出用容器２０へ移し替える（ステップＳ２１）。図５は、増幅用容器１０から検出用容器２０にＤＮＡ増幅液を移し替える作業について説明する図である。検出工程では、ＰＣＲ増幅装置から遺伝子検出検査用容器１を取り外し、遺伝子検出検査用容器１の増幅用容器１０のキャップ１１および検出用容器２０のキャップ２１を外す（図５（ａ））。そして、ミシン目３１，３３に沿って接続部材３０を折り曲げて増幅用容器１０の開口部と検出用容器２０の開口部とを対向させ、嵌合させることによって増幅用容器１０内のＤＮＡ増幅液を検出用容器２０へ移し替える（図５（ｂ））。遺伝子検出検査は、検出対象のＤＮＡの有無を判定できればよく、定量の必要はない。このため、増幅用容器１０内のＤＮＡ増幅液が希釈液が注入されている検出用容器２０へ移し替えられればよい。続いて、検出用容器２０側のミシン目３１を切り離して増幅用容器１０と検出用容器２０とを分離し、検出用容器２０を分析装置に設置する（図５（ｃ））。一方、増幅用容器１０については廃棄する（図５（ｄ））。なお、増幅用容器１０と検出用容器２０とを分離した後、検出用容器２０に再度キャップ２１を被せて密封し、振とう作業をする等して攪拌した後で、キャップ２１を外して分析装置に設置することとしてもよい。 In the detection step, DNA having a specific portion amplified in the amplification step is detected. That is, first, the DNA amplification solution in the amplification container 10 amplified by the PCR amplification apparatus is transferred to the detection container 20 (step S21). FIG. 5 is a diagram for explaining the operation of transferring the DNA amplification solution from the amplification container 10 to the detection container 20. In the detection step, the gene detection test container 1 is removed from the PCR amplification apparatus, and the cap 11 of the amplification container 10 and the cap 21 of the detection container 20 of the gene detection test container 1 are removed (FIG. 5A). Then, the connecting member 30 is bent along the perforations 31 and 33 so that the opening of the amplification container 10 and the opening of the detection container 20 are opposed to each other, and the DNA amplification solution in the amplification container 10 is fitted. Is transferred to the detection container 20 (FIG. 5B). The gene detection test need only determine the presence or absence of the DNA to be detected, and does not require quantification. For this reason, the DNA amplification solution in the amplification vessel 10 may be transferred to the detection vessel 20 into which the diluent is injected. Subsequently, the perforation 31 on the detection container 20 side is separated to separate the amplification container 10 and the detection container 20, and the detection container 20 is installed in the analyzer (FIG. 5C). On the other hand, the amplification container 10 is discarded (FIG. 5D). After the amplification container 10 and the detection container 20 are separated, the detection container 20 is covered with the cap 21 again, sealed, stirred by shaking, and then analyzed. It is good also as installing in an apparatus.

検出用容器２０を分析装置に設置したならば、図３に示すように、分析装置によって検出用容器２０に付されたバーコードの読取処理を行い（ステップＳ２３）、検出処理を行う（ステップＳ２５）。ここで、分析装置は、反応容器内に検体（ここでは検出用容器２０内のＤＮＡ増幅液）を分注する検体分注部や、反応容器内に第１試薬を分注する第１試薬分注部、反応容器内に第２試薬を分注する第２試薬分注部、反応容器内に分注されたＤＮＡ増幅液と第１試薬および第２試薬とを攪拌させる攪拌部、反応容器に所定波長の分析光を照射し、透過した光を受光して吸光度測定を行う測定部等を備える。 If the detection container 20 is installed in the analyzer, as shown in FIG. 3, the barcode attached to the detection container 20 is read by the analyzer (step S23), and the detection process is performed (step S25). ). Here, the analyzer is configured to dispense a sample (here, a DNA amplification solution in the detection container 20) into the reaction container, or a first reagent dispenser to dispense the first reagent into the reaction container. An injection part, a second reagent dispensing part for dispensing the second reagent in the reaction container, a stirring part for stirring the DNA amplification solution dispensed in the reaction container, the first reagent and the second reagent, and the reaction container A measurement unit that irradiates analysis light having a predetermined wavelength, receives transmitted light, and measures absorbance is provided.

図６は、分析装置が行う検出処理の処理手順の一例を示すフローチャートである。本実施の形態では、第１試薬を緩衝液とし、第２試薬を抗体ラテックス粒子溶液とする。図６に示すように、分析装置では、先ず、反応容器内に緩衝液である第１試薬を８０μＬ分注する（ステップＳ２５１）。そして、この第１試薬が分注された反応容器内に、分析装置内の所定位置に設置された検出用容器２０内のＤＮＡ増幅液を２０μＬ分注する（ステップＳ２５２）。さらに、反応容器内に抗体ラテックス粒子溶液である第２試薬を１００μＬ分注する（ステップＳ２５３）。そして、反応容器内に分注された第１試薬、ＤＮＡ増幅液および第２試薬を攪拌して反応させた後（ステップＳ２５４）、反応容器に例えば８００ｎｍ付近の近赤外光を照射して、反応液を光学的に測定する（ステップＳ２５５）。反応容器内に抗体結合ラテックス粒子とＤＮＡの凝集物ができ、反応液が懸濁している場合、反応液に照射された分析光は散乱されるので吸光度が上昇する。これを利用し、例えば第２試薬を分注した直後の吸光度と、第２試薬を分注してから所定時間が経過した時点での吸光度とを測定する。そして、測定した吸光度の吸光度差をもとに検出対象のＤＮＡの有無を判定する（ステップＳ２５６）。吸光度差から反応液が懸濁していると判定した場合には、被験者の全血検体から抽出したＤＮＡが、所定の塩基配列である特定部分を有するＤＮＡを持つと判定する。 FIG. 6 is a flowchart illustrating an example of a processing procedure of detection processing performed by the analysis apparatus. In the present embodiment, the first reagent is a buffer solution and the second reagent is an antibody latex particle solution. As shown in FIG. 6, the analyzer first dispenses 80 μL of the first reagent, which is a buffer solution, into the reaction container (step S251). Then, 20 μL of the DNA amplification solution in the detection container 20 installed at a predetermined position in the analyzer is dispensed into the reaction container into which the first reagent has been dispensed (step S252). Further, 100 μL of the second reagent, which is an antibody latex particle solution, is dispensed into the reaction container (step S253). Then, after the first reagent, the DNA amplification solution and the second reagent dispensed in the reaction container are stirred and reacted (step S254), the reaction container is irradiated with near infrared light, for example, near 800 nm, The reaction solution is optically measured (step S255). When antibody-bound latex particles and DNA aggregates are formed in the reaction vessel, and the reaction solution is suspended, the analysis light irradiated to the reaction solution is scattered, so that the absorbance increases. Utilizing this, for example, the absorbance immediately after dispensing the second reagent and the absorbance when a predetermined time has elapsed after dispensing the second reagent are measured. Then, the presence / absence of the DNA to be detected is determined based on the difference in absorbance between the measured absorbances (step S256). When it is determined from the difference in absorbance that the reaction solution is suspended, it is determined that the DNA extracted from the whole blood sample of the subject has DNA having a specific portion having a predetermined base sequence.

以上説明したように、本実施の形態によれば、抽出工程で得たＤＮＡ溶出液を増幅用容器１０内に分注し、遺伝子検出検査用容器１のままＰＣＲ増幅装置に設置してＤＮＡ溶出液の増幅処理を行うことができる。そして、増幅処理の後、接続部材３０をミシン目３１，３３に沿って接続部材３０を折り曲げて増幅用容器１０の開口部と検出用容器２０の開口部とを対向させ、嵌合させることによって増幅用容器１０内のＤＮＡ増幅液を検出用容器２０へ移し替えることができる。そして、移し替えた後、ミシン目３１を切り離して増幅用容器１０と検出用容器２０とを分離し、検出用容器２０のみを分析装置に設置し、ＤＮＡ増幅液の検出処理を行うことができる。したがって、増幅処理後の増幅用容器内の生体試料を検出用容器へ移し替える際に生じる、例えば異なる被験者の識別ＩＤが記録されたバーコードのバーコードラベルが貼付された容器間で移し替えを行ってしまうといった生体試料の取り間違い等の人為的ミスを防止することができる。 As described above, according to the present embodiment, the DNA eluate obtained in the extraction process is dispensed into the amplification container 10, and the DNA detection elution container 1 is placed in the PCR amplification apparatus and remains in the DNA amplification test apparatus. The liquid can be amplified. After the amplification process, the connection member 30 is bent along the perforations 31 and 33 so that the opening of the amplification container 10 and the opening of the detection container 20 are opposed to each other and fitted. The DNA amplification solution in the amplification container 10 can be transferred to the detection container 20. After the transfer, the perforation 31 is cut off to separate the amplification container 10 and the detection container 20, and only the detection container 20 is installed in the analyzer, so that the DNA amplification solution can be detected. . Therefore, when the biological sample in the amplification container after the amplification process is transferred to the detection container, for example, transfer between the containers with barcode barcode labels on which the identification IDs of different subjects are recorded is attached. It is possible to prevent human error such as mistakes in taking a biological sample.

また、従来は、増幅工程で使用する増幅用容器および検出工程で使用する検出用容器にそれぞれバーコードを付し、増幅処理時および検出処理時にその都度バーコードの読み取りを行っていたが、本実施の形態によれば、増幅用容器１０と検出用容器２０とが一体的に形成されているため、検出用容器２０にのみバーコード等の記録媒体を付しておき、分析処理時にバーコードを読み取れば済む。このため、ＰＣＲ増幅装置側にバーコード等の記録媒体を読み取る読取装置を設ける必要もない。また、ＰＣＲ増幅装置では、増幅処理した増幅用容器１０からバーコードを読み取って被験者の識別ＩＤ等を管理する必要がない。あるいは、識別ＩＤを管理するための外部装置と通信接続する必要もないため、情報漏えいのリスクを低減できる。 In the past, barcodes were attached to the amplification container used in the amplification process and the detection container used in the detection process, and the barcode was read each time during the amplification process and the detection process. According to the embodiment, since the amplification container 10 and the detection container 20 are integrally formed, a recording medium such as a barcode is attached only to the detection container 20, and the barcode is used during analysis processing. Just read. For this reason, it is not necessary to provide a reading device for reading a recording medium such as a barcode on the PCR amplification device side. Further, in the PCR amplification apparatus, it is not necessary to read the barcode from the amplified amplification container 10 and manage the identification ID of the subject. Alternatively, since it is not necessary to establish communication connection with an external device for managing the identification ID, the risk of information leakage can be reduced.

また、増幅用容器１０から検出用容器２０へＤＮＡ増幅液を移し替える際にチップ等を用いないため生体試料間のコンタミネーションを防止できる。また、増幅処理によって得られるＤＮＡ増幅液は１０〜１００μＬ程度と少量であり、分析装置で検出処理を行うためには、検出処理の前にＤＮＡ増幅液を適当量に希釈する必要があるが、本実施の形態によれば、検出用容器内に予め希釈液が注入されているため、希釈に際してＤＮＡ増幅液が汚染されることがない。 Further, since no chip or the like is used when transferring the DNA amplification solution from the amplification container 10 to the detection container 20, contamination between biological samples can be prevented. In addition, the DNA amplification solution obtained by the amplification process is a small amount of about 10 to 100 μL, and in order to perform the detection process with the analyzer, it is necessary to dilute the DNA amplification solution to an appropriate amount before the detection process. According to this embodiment, since the diluent is injected into the detection container in advance, the DNA amplification solution is not contaminated during the dilution.

以上、この発明の好適な実施の形態について説明したが、この発明は、上記したものに限らず、発明の趣旨を逸脱しない限りにおいて適宜変更可能である。 The preferred embodiments of the present invention have been described above. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the spirit of the invention.

例えば、上記した実施の形態では、増幅用容器１０から検出用容器２０へのＤＮＡ増幅液の移し替えを、接続部材３０をミシン目３１，３３の部分で折り曲げることにより行う場合について説明したが、これに限定されるものではない。図７は、ＤＮＡ増幅液を移し替える作業の変形例について説明する図である。図７（ａ）に示すように、本変形例の遺伝子検出検査用容器１ｂは、増幅用容器１０ｂと検出用容器２０ｂとを備え、これらを分離可能な分離部である１本のミシン目３５ｂを配した接続部材３０ｂによって一体的に形成されている。増幅用容器１０ｂから検出用容器２０ｂにＤＮＡ増幅液を移し替える際には、先ず、ミシン目３５ｂを切り離して増幅用容器１０ｂと検出用容器２０ｂとを分離する（図７（ｂ））。そして、増幅用容器１０ｂのキャップ１１ｂおよび検出用容器２０ｂのキャップ２１ｂを外して増幅用容器１０ｂの開口部を検出用容器２０ｂの開口部に嵌合させることによって増幅用容器１０ｂ内のＤＮＡ増幅液を検出用容器２０ｂへ移し替える（図７（ｃ））。続いて、検出用容器２０ｂを分析装置に設置する（図７（ｄ））。一方、増幅用容器１０ｂについては廃棄する（図７（ｅ））。なお、本変形例は、上記した実施の形態の構成の遺伝子検出検査用容器１ｂでも実現できるが、事前にミシン目３５ｂに沿って増幅用容器１０ｂと検出用容器２０ｂとを分離した後でＤＮＡ増幅液の移し替え作業を行うため、各容器１０ｂ，２０ｂが分離可能であればよく、接続部材３０ｂによって接続される各容器１０ｂ，２０ｂの位置関係は特に限定されない。本変形例によれば、上記した実施の形態と同様の効果を奏することができる。すなわち、増幅処理後の増幅用容器内の生体試料を検出用容器へ移し替える際に生じる生体試料の取り間違い等の人為的ミスを防止することができる。また、検出用容器２０ｂにのみバーコード等の記録媒体を付しておき、分析処理時にバーコードを読み取れば済む。また、増幅用容器１０ｂから検出用容器２０ｂへＤＮＡ増幅液を移し替える際にチップ等を用いないため生体試料間のコンタミネーションを防止できる。さらに、検出用容器内に予め希釈液が注入されているため、ＤＮＡ増幅液の希釈に際して汚染の心配がない。 For example, in the above-described embodiment, the case where the DNA amplification solution is transferred from the amplification container 10 to the detection container 20 by bending the connection member 30 at the perforations 31 and 33 has been described. It is not limited to this. FIG. 7 is a diagram for explaining a modification of the operation of transferring the DNA amplification solution. As shown in FIG. 7 (a), the gene detection test container 1b of the present modification includes an amplification container 10b and a detection container 20b, and one perforation 35b which is a separation part capable of separating them. Are integrally formed by the connecting member 30b. When transferring the DNA amplification solution from the amplification container 10b to the detection container 20b, first, the perforation 35b is cut off to separate the amplification container 10b and the detection container 20b (FIG. 7B). Then, by removing the cap 11b of the amplification container 10b and the cap 21b of the detection container 20b and fitting the opening of the amplification container 10b into the opening of the detection container 20b, the DNA amplification solution in the amplification container 10b Is transferred to the detection container 20b (FIG. 7C). Subsequently, the detection container 20b is installed in the analyzer (FIG. 7D). On the other hand, the amplification container 10b is discarded (FIG. 7E). This modification can also be realized by the gene detection test container 1b having the configuration of the above-described embodiment, but the DNA after the amplification container 10b and the detection container 20b are separated in advance along the perforation 35b. In order to perform the transfer operation of the amplification solution, it is sufficient that the containers 10b and 20b are separable, and the positional relationship between the containers 10b and 20b connected by the connection member 30b is not particularly limited. According to this modification, the same effects as those of the above-described embodiment can be obtained. That is, it is possible to prevent a human error such as a mistake in taking the biological sample that occurs when the biological sample in the amplification container after the amplification process is transferred to the detection container. Further, a recording medium such as a barcode is attached only to the detection container 20b, and the barcode is read at the time of analysis processing. Further, since a chip or the like is not used when transferring the DNA amplification solution from the amplification container 10b to the detection container 20b, contamination between biological samples can be prevented. Furthermore, since the diluent is injected into the detection container in advance, there is no concern about contamination when the DNA amplification solution is diluted.

図８は、ＤＮＡ増幅液を移し替える作業の他の変形例について説明する図である。図８（ａ）に示すように、本変形例の遺伝子検出検査用容器１ｃは、図７に示した遺伝子検出検査用容器１０ｂと同様のものであり、増幅用容器１０ｃと検出用容器２０ｃとを備え、これらを分離可能な１本のミシン目３５ｃを配した接続部材３０ｃによって一体的に形成されている。増幅用容器１０ｃから検出用容器２０ｃにＤＮＡ増幅液を移し替える際には、先ず、増幅用容器１０ｃのキャップ１１ｃおよび検出用容器２０ｃのキャップ２１ｃを外す。そして、例えば使い捨てのチップ１１０を用いたピペット等で増幅用容器１０ｃ内のＤＮＡ増幅液を分取し、検出用容器２０ｃに分注することによって移し替える。続いて、ミシン目３５ｃを切り離して増幅用容器１０ｃと検出用容器２０ｃとを分離し（図８（ｂ））、検出用容器２０ｃを分析装置に設置する（図８（ｃ））。一方、増幅用容器１０ｃについては廃棄する（図８（ｄ））。なお、本変形例についても、上記した実施の形態の構成の遺伝子検出検査用容器１ｃでも実現できるが、チップ１１０を用いてＤＮＡ増幅液の移し替え作業を行うため、各容器１０ｃ，２０ｃが分離可能であればよい。本変形例によれば、増幅処理後の増幅用容器内の生体試料を検出用容器へ移し替える際に生じる生体試料の取り間違い等の人為的ミスを防止することができる。また、検出用容器２０ｃにのみバーコード等の記録媒体を付しておき、分析処理時にバーコードを読み取れば済む。また、検出用容器内に予め希釈液が注入されているため、ＤＮＡ増幅液の希釈に際して汚染の心配がない。 FIG. 8 is a diagram for explaining another modified example of the operation of transferring the DNA amplification solution. As shown in FIG. 8 (a), the gene detection test container 1c of the present modification is the same as the gene detection test container 10b shown in FIG. 7, and the amplification container 10c, the detection container 20c, And a connecting member 30c provided with a single perforation 35c capable of separating them. When transferring the DNA amplification solution from the amplification container 10c to the detection container 20c, first, the cap 11c of the amplification container 10c and the cap 21c of the detection container 20c are removed. Then, for example, the DNA amplification solution in the amplification container 10c is collected with a pipette using a disposable chip 110 and transferred to the detection container 20c for transfer. Subsequently, the perforation 35c is cut off to separate the amplification container 10c and the detection container 20c (FIG. 8B), and the detection container 20c is installed in the analyzer (FIG. 8C). On the other hand, the amplification container 10c is discarded (FIG. 8D). Although this modification can also be realized by the gene detection test container 1c having the configuration of the above-described embodiment, since the DNA amplification solution is transferred using the chip 110, the containers 10c and 20c are separated. If possible. According to this modification, it is possible to prevent human error such as a mistake in taking a biological sample that occurs when the biological sample in the amplification container after the amplification process is transferred to the detection container. Further, a recording medium such as a barcode is attached only to the detection container 20c, and the barcode is read at the time of analysis processing. In addition, since the diluent is previously injected into the detection container, there is no concern about contamination when the DNA amplification solution is diluted.

また、上記した実施の形態では、増幅用容器１０と検出用容器２０とを分離するためのミシン目３１，３３が接続部材３０の略中央に形成された場合について説明したが、ミシン目の位置はこれに限定されるものではない。図９は、遺伝子検出検査用容器１ｄの変形例を示す図である。図９（ａ）に示すように、本変形例の遺伝子検出検査用容器１ｄは、増幅用容器１０ｄと検出用容器２０ｄとが接続部材３０ｄによって一体的に形成されるとともに、接続部材３０ｄには、検出用容器２０ｄの外壁に沿うようにミシン目３７ｄが形成されている。本変形例の遺伝子検出検査用容器１ｄでは、増幅用容器１０ｄ内のＤＮＡ増幅液を検出用容器２０ｄへ移し替える直前または直後に、図９（ｂ）に示すように、接続部材３０ｄから検出用容器２０ｄのみを分離させることができる。 In the above-described embodiment, the case where the perforations 31 and 33 for separating the amplification container 10 and the detection container 20 are formed in the approximate center of the connection member 30 has been described. Is not limited to this. FIG. 9 is a view showing a modification of the gene detection test container 1d. As shown in FIG. 9 (a), in the gene detection test container 1d of this modification, the amplification container 10d and the detection container 20d are integrally formed by the connection member 30d, and the connection member 30d includes A perforation 37d is formed along the outer wall of the detection container 20d. In the gene detection test container 1d of this modification, as shown in FIG. 9 (b), immediately before or after the DNA amplification solution in the amplification container 10d is transferred to the detection container 20d, the detection is performed from the connection member 30d. Only the container 20d can be separated.

また、上記した実施の形態では、抗体結合ラテックス粒子の凝集を検出して検出対象の核酸（ＤＮＡ）の有無を判定する場合について説明したが、本発明の遺伝子検出用容器が適用可能な検出方法はこれに限定されるものではない。例えば、蛍光による検出を行う場合に適用できる。この場合には、蛍光色素等の蛍光物質を修飾物質として用い、検出対象の核酸を増幅する。修飾物質としては、例えばＦＩＴＣ，Ｃｙ３，Ｃｙ５等が挙げられる。続いて、得られた増幅液を、蛍光物質に対する抗体が標識された磁性粒子を用い、攪拌を行って蛍光物質と磁性粒子とを結合させる。そして、磁石によって磁性粒子を回収して洗浄した後、蛍光分析を行って検出対象の核酸の有無を判定する。あるいは、化学発光による検出を行う場合に適用できる。この場合には、化学発光のための基質を修飾物質として用い、検出対象の核酸を増幅する。修飾物質としては、例えばルシフェリンが挙げられる。続いて、得られた増幅液を、化学発光のための基質に対する抗体が標識された磁性粒子を用い、攪拌を行って基質と磁性粒子とを結合させる。そして、磁石によって磁性粒子を回収して洗浄した後、ホスファターゼ等の酵素溶液を添加し、蛍光分析を行って検出対象の核酸の有無を判定する。基質を含んだ第２試薬を供給すると化学発光の有無により検出対象の核酸の有無を判定することが可能となる。 In the above-described embodiment, the case where the presence of nucleic acid (DNA) to be detected is determined by detecting aggregation of antibody-bound latex particles has been described. However, the detection method to which the gene detection container of the present invention can be applied. Is not limited to this. For example, the present invention can be applied when detecting by fluorescence. In this case, a fluorescent substance such as a fluorescent dye is used as a modifying substance to amplify the nucleic acid to be detected. Examples of the modifying substance include FITC, Cy3, Cy5 and the like. Subsequently, the obtained amplification solution is stirred using magnetic particles labeled with an antibody against the fluorescent substance to bind the fluorescent substance and the magnetic particles. Then, after collecting and washing the magnetic particles with a magnet, fluorescence analysis is performed to determine the presence or absence of the nucleic acid to be detected. Alternatively, it can be applied in the case of performing detection by chemiluminescence. In this case, the substrate for chemiluminescence is used as a modifying substance, and the nucleic acid to be detected is amplified. An example of the modifying substance is luciferin. Subsequently, the obtained amplification solution is stirred using magnetic particles labeled with an antibody against the substrate for chemiluminescence to bind the substrate and the magnetic particles. Then, after collecting and washing the magnetic particles with a magnet, an enzyme solution such as phosphatase is added, and fluorescence analysis is performed to determine the presence or absence of the nucleic acid to be detected. When the second reagent containing the substrate is supplied, the presence or absence of the nucleic acid to be detected can be determined based on the presence or absence of chemiluminescence.

また、上記した実施の形態では、抽出工程において全血検体からＤＮＡを抽出する抽出処理を行い、この抽出工程で得られたＤＮＡ溶出液を増幅用容器１０に分注して増幅処理を行うこととしたが、抽出工程については適宜省略できる。従来から、ＤＮＡを精製して溶出させることなく、血液試料をそのままＰＣＲ増幅可能な前処理試薬が知られており、この前処理試薬を添加する場合には、抽出工程を省略することができる。この場合には、増幅用試薬が予め注入された増幅用容器内に、全血検体と前処理試薬とを分注する。そして、ＰＣＲ増幅装置によって増幅処理を行う。 In the above-described embodiment, an extraction process for extracting DNA from a whole blood sample is performed in the extraction process, and the DNA eluate obtained in this extraction process is dispensed into the amplification container 10 to perform the amplification process. However, the extraction process can be omitted as appropriate. Conventionally, a pretreatment reagent capable of PCR amplification of a blood sample as it is without purifying and eluting DNA is known. When this pretreatment reagent is added, the extraction step can be omitted. In this case, the whole blood sample and the pretreatment reagent are dispensed into the amplification container into which the amplification reagent has been previously injected. Then, amplification processing is performed by a PCR amplification device.

また、接続部材に増幅用容器と検出用容器とを分離するためのミシン目を形成する場合について説明したが、増幅用容器と検出用容器とを分離できればミシン目でなくても構わない。例えば、断続的なミシン目にかえて、接続部材に切り目のない切取線を形成してもよい。あるいは、例えば上記した実施の形態でミシン目３１，３３が形成された帯状の部分を分離し易い素材で形成してもよいし、分離し易いように他の部分よりも肉薄にして溝を形成することとしてもよい。 Moreover, although the case where the perforation for separating the amplification container and the detection container is formed on the connection member has been described, the perforation may not be provided as long as the amplification container and the detection container can be separated. For example, a continuous cut line may be formed on the connection member instead of the intermittent perforation. Alternatively, for example, the band-like portions in which the perforations 31 and 33 are formed in the above-described embodiment may be formed of a material that can be easily separated, or the groove is formed thinner than other portions so as to be easily separated. It is good to do.

また、上記した実施の形態では、分離可能なミシン目を配した接続部材によって増幅用容器と検出用容器とを一体的に形成し、増幅処理後に増幅用容器と検出用容器とを分離して検出用容器のみを分析装置に設置する場合について説明したが、分析装置に増幅用容器を設置するスペースが確保できる場合等、増幅用容器と検出用容器とが接続されたまま分析装置に設置可能な場合には、これらを分離する必要はない。例えば、折り曲げ可能な曲折部を有し、この曲折部で折り曲げることによって増幅用容器の開口部と検出用容器の開口部とが対向可能に形成された接続部材によって増幅用容器と検出用容器とを一体的に形成することとしてもよい。この場合には、増幅処理後、増幅用容器と検出用容器とが接続されたままの状態で分析装置に設置する。 In the above-described embodiment, the amplification container and the detection container are integrally formed by a connecting member having a separable perforation, and the amplification container and the detection container are separated after the amplification process. The case where only the detection container is installed in the analyzer has been described. However, when the space for installing the amplification container can be secured in the analyzer, the amplification container and the detection container can be installed in the analyzer. In these cases, it is not necessary to separate them. For example, the amplifying container and the detection container are connected to each other by a connecting member that has a bendable bending part and is formed so that the opening of the amplifying container and the opening of the detection container can be opposed to each other by bending the bent part. It is good also as forming integrally. In this case, after the amplification process, the amplification container and the detection container are installed in the analyzer while being connected.

本実施の形態の遺伝子検出検査用容器の一例を示す図である。It is a figure which shows an example of the container for a gene detection test | inspection of this Embodiment. 所定の塩基配列を有するＤＮＡの検出原理を説明する図である。It is a figure explaining the detection principle of DNA which has a predetermined base sequence. 遺伝子検出検査を構成する抽出工程、増幅工程および検出工程の各工程を説明するフローチャートである。It is a flowchart explaining each process of the extraction process, amplification process, and detection process which comprise a gene detection test | inspection. 増幅用容器にＤＮＡ溶出液を分注する作業について説明する図である。It is a figure explaining the operation | work which dispenses a DNA eluate to the container for amplification. 増幅用容器から検出用容器にＤＮＡ増幅液を移し替える作業について説明する図である。It is a figure explaining the operation | work which transfers DNA amplification liquid from the container for amplification to the container for detection. 検出処理の処理手順の一例を示すフローチャートである。It is a flowchart which shows an example of the process sequence of a detection process. 増幅用容器から検出用容器にＤＮＡ増幅液を移し替える作業の変形例について説明する図である。It is a figure explaining the modification of the operation | work which transfers DNA amplification liquid from the container for amplification to the container for detection. 増幅用容器から検出用容器にＤＮＡ増幅液を移し替える作業の他の変形例について説明する図である。It is a figure explaining the other modification of the operation | work which transfers a DNA amplification liquid from the container for amplification to the container for a detection. 遺伝子検出検査用容器の変形例を示す図である。It is a figure which shows the modification of the container for gene detection tests.

符号の説明Explanation of symbols

１遺伝子検出検査用容器
１０増幅用容器
１１キャップ
１５増幅用試薬
２０検出用容器
２１キャップ
２３バーコードラベル
２５希釈液
３０接続部材
３１，３３ミシン目 DESCRIPTION OF SYMBOLS 1 Gene detection test container 10 Amplification container 11 Cap 15 Amplification reagent 20 Detection container 21 Cap 23 Bar code label 25 Diluent 30 Connection member 31, 33 Perforation

Claims

遺伝子検出検査の増幅工程で使用され、生体試料を収容する増幅用容器と、
前記増幅工程の後段の検出工程で使用され、前記増幅工程で増幅処理された生体試料を収容する検出用容器と、
前記増幅用容器と前記検出用容器とを一体的に形成する接続部材と、
を備え、前記接続部材は、折り曲げ可能な曲折部を有し、前記曲折部で折り曲げることによって前記増幅用容器の開口部と前記検出用容器の開口部とが対向可能に形成されていることを特徴とする遺伝子検出検査用容器。 An amplification container that is used in the amplification process of the gene detection test and contains a biological sample;
A detection container used in a detection step subsequent to the amplification step and containing a biological sample amplified in the amplification step;
A connection member that integrally forms the amplification container and the detection container;
The connecting member has a foldable bending portion, and the opening of the amplification container and the opening of the detection container are formed so as to be able to face each other by being bent at the bending portion. Characteristic genetic detection test container.

前記曲折部が分離可能に形成されていることを特徴とする請求項１に記載の遺伝子検出検査用容器。 The container for gene detection testing according to claim 1, wherein the bent portion is formed so as to be separable.

遺伝子検出検査の増幅工程で使用され、生体試料を収容する増幅用容器と、
前記増幅工程の後段の検出工程で使用され、前記増幅工程で増幅処理された生体試料を収容する検出用容器と、
前記増幅用容器と前記検出用容器とを一体的に形成する接続部材と、
を備え、前記接続部材は、前記増幅用容器と前記検出用容器とを分離可能な分離部を有することを特徴とする遺伝子検出検査用容器。 An amplification container that is used in the amplification process of the gene detection test and contains a biological sample;
A detection container used in a detection step subsequent to the amplification step and containing a biological sample amplified in the amplification step;
A connection member that integrally forms the amplification container and the detection container;
And the connection member has a separation part capable of separating the amplification container and the detection container.

前記検出用容器の開口部が、前記増幅用容器の開口部より大きいことを特徴とする請求項１〜３のいずれか一つに記載の遺伝子検出検査用容器。 The gene detection test container according to any one of claims 1 to 3, wherein an opening of the detection container is larger than an opening of the amplification container.

前記増幅用容器の開口部と前記検出用容器の開口部とが相互に接続可能であることを特徴とする請求項１〜４のいずれか一つに記載の遺伝子検出検査用容器。 The container for gene detection testing according to any one of claims 1 to 4, wherein the opening of the amplification container and the opening of the detection container can be connected to each other.

前記増幅用容器の開口部と前記検出用容器の開口部とが相互に嵌合可能であることを特徴とする請求項１〜５のいずれか一つに記載の遺伝子検出検査用容器。 The gene detection test container according to any one of claims 1 to 5, wherein the opening of the amplification container and the opening of the detection container can be fitted to each other.

内部に収容される生体試料に関する情報が記録され、前記検出用容器の外側面に装着された記録媒体を備えることを特徴とする請求項１〜６のいずれか一つに記載の遺伝子検出検査用容器。 The information regarding the biological sample accommodated inside is recorded, The recording medium with which the outer surface of the said detection container was mounted | worn is provided, The gene detection test | inspection as described in any one of Claims 1-6 characterized by the above-mentioned container.

請求項１〜７のいずれか一つに記載の遺伝子検出検査用容器を備え、
前記増幅用容器内に、遺伝子検出検査の検出方法に応じた修飾物質を有し、検出対象の核酸に対応したプライマーと、緩衝液と、ｄＮＴＰと、増幅用酵素とが注入されていることを特徴とする遺伝子検出検査用試薬キット。 The container for genetic detection test according to any one of claims 1 to 7,
The amplification container has a modifying substance according to the detection method of the gene detection test, and a primer corresponding to the nucleic acid to be detected, a buffer solution, dNTP, and an amplification enzyme are injected. A reagent kit for gene detection test.

請求項１〜７のいずれか一つに記載の遺伝子検出検査用容器を備え、
前記検出用容器内に、緩衝液と、前記増幅処理時に生体試料と反応させたプライマーの修飾物質と特異的に結合する抗体が標識された粒子とが注入されていることを特徴とする遺伝子検出検査用試薬キット。 The container for genetic detection test according to any one of claims 1 to 7,
In the detection container, a buffer solution and particles labeled with an antibody that specifically binds to a primer modifying substance reacted with a biological sample during the amplification process are injected. Test reagent kit.

遺伝子検出検査の増幅工程で使用され、生体試料を収容する増幅用容器と、前記増幅工程の後段の検出工程で使用され、前記増幅工程で増幅処理された生体試料を収容する検出用容器と、前記増幅用容器と前記検出用容器とを一体的に形成する接続部材とを備え、前記接続部材は、折り曲げ可能な曲折部を有し、前記曲折部で折り曲げることによって前記増幅用容器の開口部と前記検出用容器の開口部とが対向可能に形成された遺伝子検出検査用容器を用いて生体試料中に含まれる検出対象の核酸を検出する遺伝子検出検査方法であって、
前記増幅用容器内に生体試料を分注する分注工程と、
前記遺伝子検出検査用容器を増幅装置に設置して前記増幅用容器内の生体試料を増幅処理する増幅工程と、
前記接続部材を前記折曲部で折り曲げて前記増幅用容器の開口部と前記検出用容器の開口部とを対向させ、前記増幅工程で増幅処理された前記増幅用容器内の生体試料を前記検出用容器へ移し替える移替工程と、
前記検出用容器を分析装置に設置して前記検出用容器内の生体試料の検出処理を行い、前記検出対象の核酸を検出する検出工程と、
を含むことを特徴とする遺伝子検出検査方法。 An amplification container used in the amplification process of the gene detection test and containing a biological sample; a detection container used in the detection process subsequent to the amplification process and containing the biological sample amplified in the amplification process; A connection member that integrally forms the amplification container and the detection container, the connection member having a foldable bending portion, and the opening of the amplification container by being bent at the bending portion. A gene detection test method for detecting a nucleic acid to be detected contained in a biological sample using a gene detection test container formed such that the opening of the detection container and the opening can be opposed to each other,
A dispensing step of dispensing a biological sample into the amplification container;
An amplification step of amplifying the biological sample in the amplification container by installing the gene detection test container in an amplification device;
The connection member is bent at the bent portion so that the opening of the amplification container faces the opening of the detection container, and the biological sample in the amplification container amplified in the amplification step is detected. A transfer process for transferring to a container for use;
A detection step of installing the detection container in an analyzer and performing a detection process of the biological sample in the detection container to detect the nucleic acid to be detected;
A gene detection test method comprising:

前記曲折部が分離可能に形成されており、
前記移替工程の後、前記曲折部を切り離して前記増幅用容器と前記検出用容器とを分離する分離工程を含むことを特徴とする請求項１０に記載の遺伝子検出検査方法。 The bent portion is formed to be separable,
The gene detection test method according to claim 10, further comprising a separation step of separating the bent portion and separating the amplification container and the detection container after the transfer step.

遺伝子検出検査の増幅工程で使用され、生体試料を収容する増幅用容器と、前記増幅工程の後段の検出工程で使用され、前記増幅工程で増幅処理された生体試料を収容する検出用容器と、前記増幅用容器と前記検出用容器とを一体的に形成する接続部材とを備え、前記接続部材は、前記増幅用容器と前記検出用容器とを分離可能な分離部を有する遺伝子検出検査用容器を用いて生体試料中に含まれる検出対象の核酸を検出する遺伝子検出検査方法であって、
前記増幅用容器内に生体試料を分注する分注工程と、
前記遺伝子検出検査用容器を増幅装置に設置して前記増幅用容器内の生体試料を増幅処理する増幅工程と、
前記分離部を切り離して前記増幅用容器と前記検出用容器とを分離する分離工程と、
前記分離工程で分離された前記増幅用容器内の生体試料を前記検出用容器へ移し替える移替工程と、
前記検出用容器を分析装置に設置して前記検出用容器内の生体試料の検出処理を行い、前記検出対象の核酸を検出する検出工程と、
を含むことを特徴とする遺伝子検出検査方法。 An amplification container used in the amplification process of the gene detection test and containing a biological sample; a detection container used in the detection process subsequent to the amplification process and containing the biological sample amplified in the amplification process; A gene detection test container comprising a connection member integrally forming the amplification container and the detection container, wherein the connection member has a separation part capable of separating the amplification container and the detection container; A gene detection test method for detecting a nucleic acid to be detected contained in a biological sample using
A dispensing step of dispensing a biological sample into the amplification container;
An amplification step of amplifying the biological sample in the amplification container by installing the gene detection test container in an amplification device;
A separation step of separating the separation section and separating the amplification container and the detection container;
A transfer step of transferring the biological sample in the amplification container separated in the separation step to the detection container;
A detection step of installing the detection container in an analyzer and performing a detection process of the biological sample in the detection container to detect the nucleic acid to be detected;
A gene detection test method comprising: