JP2012247231A - Inspection instrument - Google Patents

Inspection instrument Download PDF

Info

Publication number
JP2012247231A
JP2012247231A JP2011117471A JP2011117471A JP2012247231A JP 2012247231 A JP2012247231 A JP 2012247231A JP 2011117471 A JP2011117471 A JP 2011117471A JP 2011117471 A JP2011117471 A JP 2011117471A JP 2012247231 A JP2012247231 A JP 2012247231A
Authority
JP
Japan
Prior art keywords
liquid
detection
sealing member
small hole
matrix
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
JP2011117471A
Other languages
Japanese (ja)
Inventor
Taiji Inakubo
大治 稲窪
Hidenobu Anzai
秀伸 安齊
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fujikura Kasei Co Ltd
Original Assignee
Fujikura Kasei Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fujikura Kasei Co Ltd filed Critical Fujikura Kasei Co Ltd
Priority to JP2011117471A priority Critical patent/JP2012247231A/en
Publication of JP2012247231A publication Critical patent/JP2012247231A/en
Withdrawn legal-status Critical Current

Links

Images

Landscapes

  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

PROBLEM TO BE SOLVED: To provide means for accurately, efficiently and safely performing the apply operation of a detection object collected from a specimen to a matrix for detection.SOLUTION: Disclosed is an inspection instrument including (1) a fluid storage part for storing a fluid for extracting a specimen accompanied with an opening section at a front part and a small hole at a bottom part, (2) a first sealing member for sealing the opening section of the fluid storage part and a second sealing member for sealing the small hole at the bottom part, (3) a matrix for detection, and (4) one or more detection windows for visualizing the detection signal of the matrix for detection from the outside. The inspection instrument is configured such that the small hole at the bottom part of the fluid storage part and the matrix for detection are held so as to be interposed with the second sealing member, and that the second sealing member is formed so as to be directly or indirectly projected to the outside of the inspection instrument, and that when a tensile force is applied to the projecting section, the sealing section of the small hole in the second sealing member is peeled, and the matrix for detection and the small hole at the bottom part of the liquid storage part are directly brought into contact with each other. Disclosed is a method of using the inspection instrument.

Description

本発明は、免疫測定や腫瘍マーカーの測定等における検体中の測定対象物を検出するための検査器具と、当該器具の使用方法に関する発明である。   The present invention relates to a test instrument for detecting a measurement object in a sample in immunoassay, tumor marker measurement, and the like, and a method of using the instrument.

従来の検査器具として、測定対象物を抽出した試料液を調製した後、これを不織布等の検出用マトリックスを介した検出部への移送後、抗原抗体反応等のシグナルを利用し、測定対象物の検出を行うものが知られている。   As a conventional inspection instrument, after preparing a sample solution from which a measurement object is extracted, the sample liquid is transferred to a detection unit through a detection matrix such as a nonwoven fabric, and then a measurement object is obtained using a signal such as an antigen-antibody reaction. Those that perform detection are known.

本発明において提案する問題点は、検体から採取した検出対象物の検出用マトリックスへのアプライ操作である。この問題点を示唆する先行技術としては、例えば以下のものがある。   The problem proposed in the present invention is an operation of applying a detection object collected from a specimen to a detection matrix. Examples of prior art that suggests this problem include the following.

特許文献1には、検体液を検出器具に適性にアプライするための、検出器具とは別個の検体採取用容器が開示されている。また、特許文献2には、掃除機で収集したアレルゲンを器具に内蔵された液体で抽出して当該抽出液でのシグナルを検出する、アレルゲン検査キットが開示されている。   Patent Document 1 discloses a specimen collection container that is separate from the detection instrument for appropriately applying the specimen liquid to the detection instrument. Patent Document 2 discloses an allergen test kit that extracts allergens collected by a vacuum cleaner with a liquid contained in a device and detects a signal in the extract.

特開2010−38797号公報JP 2010-38797 A 特開平11−248705号公報JP-A-11-248705

上述したように本発明の課題は、検体から採取した検出対象物の検出用マトリックスへのアプライ操作を、確実、効率的、かつ、安全に行う手段を提供することにある。   As described above, an object of the present invention is to provide means for reliably, efficiently and safely applying an application of a detection object collected from a specimen to a detection matrix.

例えばベッドサイドで簡易的な検査を行う場合があり、その際に用いられる検査用器具において望まれるいくつかの課題がある。簡易的な検査を行う場合には、検体提供者への苦痛等を考慮して検体の採取量は最低限とすることが望ましい場合がある。よって、得られた検体は可能な限り無駄なく検査に供する必要がある。また、複数の検体を検査する場合には、検体の取り違えの防止を図る必要がある。さらに迅速な検査のためには、コンタミを防止して検査の正確性を向上させると共に、可能な限り簡便な手順で検査を行う必要がある。   For example, there is a case where a simple inspection is performed at the bedside, and there are some problems that are desired in an inspection instrument used at that time. When performing a simple test, it may be desirable to minimize the amount of sample collected in consideration of pain to the sample provider. Therefore, it is necessary to use the obtained specimen for examination as efficiently as possible. Further, when testing a plurality of samples, it is necessary to prevent sample mix-up. For a quicker inspection, it is necessary to prevent contamination and improve the accuracy of the inspection, and to perform the inspection with the simplest procedure possible.

特許文献1の検体採取用容器は、当該容器が検出器具とは別個の容器であり、検出器具を当該容器に着脱するための手間がかかり、しかもその過程において検体抽出液が漏出してしまうリスクが存在すると考えられる。また、特許文献2のアレルゲン検査キットでは、検出対象物がアレルゲン(ハウスダスト)のために掃除機による吸引操作が前提となり、開示された技術の構成を用いて、これを積極的な検体の抽出工程が必要な感染症検査等に応用することは困難である。   The sample collection container of Patent Document 1 is a container separate from the detection instrument, and it takes time and effort to attach and detach the detection instrument to and from the container, and the risk of the sample extract leaking out in the process Is considered to exist. Moreover, in the allergen test kit of patent document 2, since the detection target is an allergen (house dust), a suction operation by a vacuum cleaner is premised, and this is used to actively extract a specimen using the configuration of the disclosed technology. It is difficult to apply to infectious disease inspections that require processes.

本発明者は、採取された検体の抽出の場と、当該抽出物のクロマトグラフィーによる展開の場を一体化して、一連の検出作業を一つの検出器具で行うことにより、上記の課題を解決することを見出して本発明を完成した。本発明では、検出器具において検体抽出操作を行うことを可能とし、かつ、当該抽出操作を経た検体抽出液の検出用マトリックスへのアプライをワンステップで行うことを可能とした。   The present inventor solves the above problem by integrating a field for extracting a collected specimen and a field for developing the extract by chromatography, and performing a series of detection operations with a single detection instrument. As a result, the present invention was completed. In the present invention, the sample extraction operation can be performed in the detection instrument, and the sample extraction solution that has undergone the extraction operation can be applied to the detection matrix in one step.

すなわち第一に、本発明は、(1)表部における開口部分と底部における小孔を伴う、検体を抽出するための液体が収容されている液体収容部、(2)当該液体収容部の開口部分を封止する外力による剥離又は破断が可能な第一の封止部材と、底部小孔を封止する外力による剥離が可能な第二の封止部材、(3)検体が抽出された当該液体を浸潤力により移動させるための移動部と検出対象物を検出するための検出部が設けられている検出用マトリックス、及び、(4)当該検出部を外部から可視化するための1以上の検出窓、を具える検査器具であって、液体収納部の底部小孔と検出用マトリックスの移動部は第二の封止部材を挟んだ状態が保たれており、当該第二の封止部材は直接又は間接に検出器具の外部に突出し、当該突出部分に引っ張り力を加えることにより、第二の封止部材における前記の小孔の封止部分が剥離して、検出用マトリックスと液体収納部の底部小孔が直接接触する、検査器具(以下、本発明の検査器具ともいう)を提供する発明である。   That is, firstly, the present invention includes (1) a liquid storage section containing a liquid for extracting a specimen, with an opening portion at the front portion and a small hole at the bottom portion, and (2) an opening of the liquid storage portion. A first sealing member that can be peeled or broken by an external force that seals the portion, a second sealing member that can be peeled by an external force that seals the bottom small hole, and (3) the sample extracted A detection matrix provided with a moving part for moving the liquid by the infiltration force and a detecting part for detecting the detection object, and (4) one or more detections for visualizing the detecting part from the outside An inspection instrument comprising a window, wherein the bottom small hole of the liquid storage portion and the moving portion of the detection matrix are kept sandwiched between the second sealing members, and the second sealing member is Project directly or indirectly to the outside of the detection device and pull it By applying a tension force, the sealing portion of the small hole in the second sealing member is peeled off, and the detection matrix and the bottom small hole of the liquid storage unit are in direct contact with each other (hereinafter, the present invention). (Also referred to as an inspection instrument).

本発明の検査器具においては、検出用マトリックスの移動部は、液体収容部の底部小孔の横断面積よりも広い面積部分を有し、当該の広い面積部分と底部小孔により第二の封止部材が挟み込まれていることが、検体抽出液の無駄を防ぐ上で好適である。   In the inspection instrument of the present invention, the moving portion of the detection matrix has an area portion wider than the cross-sectional area of the bottom small hole of the liquid storage portion, and the second sealing is performed by the wide area portion and the bottom small hole. In order to prevent waste of the sample extract, it is preferable that the member is sandwiched.

また、液体収容部の底部小孔、第二の封止部材、及び、検出用マトリックスの移動部、による挟み込み部分が押圧部材による押圧力がかけられた状態であることが、検体抽出液の漏出の防止を行う上で好適である。そして、さらに第二の封止部材と検出用マトリックスの間における液体収容部の底部小孔の下部に相当する位置に、吸液浸潤部材が挟み込まれていることが、検体抽出液の漏出の防止をさらに完璧に行う上で好適である。   In addition, leakage of the sample extract is that the pressing portion by the pressing member is applied to the sandwiched portion by the bottom small hole of the liquid storage portion, the second sealing member, and the moving portion of the detection matrix. It is suitable for preventing the above. Further, the liquid absorption infiltrating member is sandwiched at a position corresponding to the lower part of the bottom small hole of the liquid storage part between the second sealing member and the detection matrix, thereby preventing the specimen extract from leaking out. It is suitable for carrying out the process more completely.

また、第二の封止部材における液体収容部の底部小孔に対する封止部分は、当該第二の封止部材の容器における突出部分と長さ方向において逆側の折り畳まれてなる端部であり、当該突出部分に引っ張り力をかけることにより当該の逆側端部の折り畳み状態が解除されて、底部小孔と検出用マトリックスが直接接触することが、第二の封止部材の小孔からの剥離を円滑に行う上で好適である。   Moreover, the sealing part with respect to the bottom small hole of the liquid storage part in the second sealing member is an end part that is folded on the opposite side in the length direction from the protruding part of the container of the second sealing member. By applying a pulling force to the projecting portion, the folded state of the opposite side end is released, and the bottom small hole and the detection matrix are in direct contact with each other from the small hole of the second sealing member. This is suitable for smooth peeling.

さらに、液体収容部の内壁面に、綿棒等の採取棒における検出対象物の付着部分(例えば、綿棒の頭)を擦り取ることが可能な場が設けることが可能であり、かつ、好適である。   Furthermore, it is possible and preferable to provide a place on the inner wall surface of the liquid storage portion where the attached portion (for example, the head of a cotton swab) of the collection target such as a cotton swab can be scraped off. .

また、マトリックスにおける水分の移動を促進する手段を設けることが可能である。具体的には、検出窓に対して検出用マトリックスの下流側に蒸散窓を設けることが例示される。   It is also possible to provide means for promoting the movement of moisture in the matrix. Specifically, providing a transpiration window on the downstream side of the detection matrix with respect to the detection window is exemplified.

第二に、本発明は、下記のステップ(1)〜(3)を含む本発明の検査器具の使用方法(以下、本発明の使用方法ともいう)を提供する発明である。
(1)液体収容部の第一の封止部材の一端を剥がして、又は、破断して、検体の付着した採取棒の先端を当該液体収容部に挿入して当該部中の液体に接触させて、検体の液中抽出を行うステップ、
(2)第二の封止部材の外部への突出部分に引っ張り力をかけて、当該封止部材を小孔から剥離させて、液体収容部における液中抽出物を検出用マトリックスの移動部に接触させるステップ、
(3)液中抽出物が検出用マトリックスに接触したことによる、当該液体の検出用マトリックスの移動部から検出部に向けての移動に伴う接触反応により顕れるシグナルを、検出窓を介して確認し、測定対象物の検出を行うステップ。
2ndly, this invention is invention which provides the usage method (henceforth the usage method of this invention) of the test | inspection instrument of this invention containing following step (1)-(3).
(1) One end of the first sealing member of the liquid container is peeled off or broken, and the tip of the collection rod to which the sample is attached is inserted into the liquid container and brought into contact with the liquid in the part A step of extracting the sample in the liquid,
(2) A tensile force is applied to the projecting portion of the second sealing member to the outside, and the sealing member is peeled off from the small hole so that the in-liquid extract in the liquid storage portion is moved to the moving portion of the detection matrix. Contacting step,
(3) Confirm through the detection window the signal that appears due to the contact reaction that accompanies the movement of the liquid detection matrix from the moving part toward the detecting part due to the extract in the liquid coming into contact with the detecting matrix. And detecting the measurement object.

本発明の検査器具には、付属物として、液体収容部の表部における開口部分を、第一の封止部材を剥離又は破断した後に封止するための蓋部材を備えることが、検査作業中の液中抽出物の飛散等による周辺環境への汚染の抑止を徹底することが可能となり好適である。すなわち、上記の本発明の使用方法において、ステップ(1)の検体の液中抽出の後に、前記蓋部材により液体収容部の表部における開口部分を封止するステップ[(2)’]を行うことにより、以降のステップ(2)と(3)を行うに際して、上記液体収容部の開口部分からの飛散等による周囲環境に対する汚染の抑止を徹底することが可能となる。当該蓋部材は「実質的に独立した付属物」として備えられることが通常であり、これは、実質的に検査器具の本体部分から独立して蓋部材が存在するという意味であり、例えば、検査器具本体と蓋部材が紐等により対になっている場合もこの「実質的に独立した」に含まれる。また、当初より上記表部開口部分が脱着可能な形態で当該蓋部材により封止されており、使用開始時に一旦取り外して、それを改めて必要時に再封止する形態を採ることも、この「実質的に独立した」に含まれる。   The inspection instrument according to the present invention includes, as an accessory, a cover member for sealing the opening portion in the front portion of the liquid storage portion after the first sealing member is peeled or broken, during the inspection operation. It is possible to thoroughly prevent contamination of the surrounding environment due to the scattering of the extract in the liquid. That is, in the above-described method of using the present invention, the step [(2) ′] of sealing the opening portion in the front portion of the liquid storage portion with the lid member is performed after the extraction of the specimen in the liquid in step (1). Thus, when performing the following steps (2) and (3), it is possible to thoroughly prevent contamination of the surrounding environment due to scattering from the opening portion of the liquid container. The lid member is usually provided as a “substantially independent accessory”, which means that the lid member is substantially independent of the body portion of the test instrument, eg, a test A case where the instrument main body and the lid member are paired with a string or the like is also included in this “substantially independent”. In addition, it is also possible to take a form in which the front opening portion is sealed by the lid member in a detachable form from the beginning, and is removed once at the start of use and re-sealed when necessary. Independence ".

上述した「採取された検体の抽出の場と、当該抽出物のクロマトグラフィーによる展開の場の一体化」は、第二の封止部材を外部からの引っ張り力により剥離することにより、本発明の検査器具において設けられた液体収容部において検体の抽出により得られた液中抽出物を、その下に載置された検出用マトリックスの移動部に液体収容部の底部の小孔を介して接触させることにより実現される。すなわち一つの検査器具において、「検体の液体収容部の液体における抽出→第二の封止部材の剥離と検出用マトリックスの前記液体への接触→検体液のマトリックス上流への移動→検出ゾーンにおける検出シグナルの確認」の一連のステップを行うことにより、上記の「場の一体化」が実現され、今般の課題を解決することができる。本発明の使用方法は、上記の一連のステップを規定するものである。   The above-mentioned “integration of the field of extraction of the collected specimen and the field of development of the extract by chromatography” is performed by peeling the second sealing member by an external pulling force. An in-liquid extract obtained by extraction of a sample in a liquid container provided in the inspection instrument is brought into contact with a moving part of a detection matrix placed thereunder through a small hole at the bottom of the liquid container. Is realized. That is, in one test instrument, “extraction of the specimen in the liquid in the liquid storage part → detachment of the second sealing member and contact of the detection matrix with the liquid → movement of the specimen liquid upstream of the matrix → detection in the detection zone” By performing a series of steps of “signal confirmation”, the above-mentioned “field integration” is realized, and this problem can be solved. The method of use of the present invention defines the above series of steps.

本発明は、臨床検査、食品検査、環境検査、犯罪調査等の分野において、特に抗原抗体反応に基づき検出可能な対象であれば、どのような対象でも適用範囲となる。また、例えば、PCR法による特定の生物種(細菌、ウイルス等)の遺伝子増幅産物を検体として、核酸同士のハイブリダイズを検出原理とする方法も可能である。   The present invention is applicable to any target in the fields of clinical testing, food testing, environmental testing, crime investigation, etc., as long as it is a target that can be detected based on an antigen-antibody reaction. In addition, for example, a method using a gene amplification product of a specific biological species (bacteria, virus, etc.) by a PCR method as a specimen and using a hybridization between nucleic acids as a detection principle is also possible.

本発明により、採取された検体の抽出の場と、当該抽出物のクロマトグラフィーによる展開の場を一体化して、一連の検出作業を一つの検出器具で行うことが可能な検体検査器具と、その使用方法が提供される。本発明の検査器具は、取り扱いや操作が容易であり、特に、イムノクロマトグラフィー法による検体検査を、簡便に、かつ、確実、迅速に行うことができる。また、周囲の環境に対する汚染も適切に防御することが可能である。   According to the present invention, a specimen inspection instrument capable of performing a series of detection operations with a single detection instrument by integrating a field for extraction of a collected specimen and a place for development by chromatography of the extract, A method of use is provided. The test instrument of the present invention is easy to handle and operate, and in particular, specimen testing by immunochromatography can be performed simply, reliably and rapidly. In addition, it is possible to appropriately prevent contamination of the surrounding environment.

本発明の検査器具の長さ方向の側面から見た分解図である。It is the exploded view seen from the side surface of the length direction of the inspection instrument of the present invention. 本発明の検査器具の第一の封止部材の平面図である。It is a top view of the 1st sealing member of the inspection instrument of the present invention. 本発明の検査器具の第二の封止部材の平面図である。It is a top view of the 2nd sealing member of the inspection instrument of the present invention. 本発明の検査器具の全体斜視図である。It is the whole inspection instrument perspective view of the present invention. 本発明の使用方法を示した長さ方向の側面方向から見た断面図である。It is sectional drawing seen from the side surface direction of the length direction which showed the usage method of this invention.

本発明の実施の形態を図1〜4を用いて説明する。ここに表された形態は一例であり、本発明の範囲内での必要に応じた設計変更を行うことも可能であり、無論のこと、当該設計変更がなされた態様もまた本発明の範囲内である。   An embodiment of the present invention will be described with reference to FIGS. The form shown here is an example, and it is possible to make a design change as necessary within the scope of the present invention. Of course, an aspect in which the design change is made is also within the scope of the present invention. It is.

図1は本発明の検査器具1の長さ方向の側面から見た分解図であり、図3は当該検査器具1の全体斜視図である。検査器具1を構成する部品は、下筐体部材10、バネ11、検出用マトリックス20、吸液浸潤部材30、第二の封止部材40、上筐体部材50、及び、第一の封止部材60である。下筐体部材10と上筐体部材50は、互いに係合固定可能な構造となっている。   FIG. 1 is an exploded view seen from the side surface in the length direction of the inspection instrument 1 of the present invention, and FIG. 3 is an overall perspective view of the inspection instrument 1. Components constituting the inspection instrument 1 are a lower casing member 10, a spring 11, a detection matrix 20, a liquid-absorbing infiltrating member 30, a second sealing member 40, an upper casing member 50, and a first sealing. This is the member 60. The lower housing member 10 and the upper housing member 50 have a structure that can be engaged and fixed to each other.

下筐体部材10にはバネ11と検出用マトリックス20を載置固定可能な場(図示せず)が設けられている。当該場は、例えば検出用マトリックス20が載置された際に嵌まり込むスペースを形成する連続的又は非連続的な凸構造を、下筐体部材10において設けることで形成される。当該場におけるバネ11と検出用マトリックス20の載置は、載置された位置が固定されている限りは接着を伴っても伴わなくても良い。上筐体部材50には、表部における開口部分511と底部における小孔512を伴い、検体を抽出するための液体514が収容される、液体収容部51が設けられている。さらに当該液体収容部51の内壁面に、採取棒2における検出対象物の付着部分を擦り取ることが可能な場513が設けられている。上筐体部材50の液体収容部51の近傍はその内容積を確保するために厚手の構造となっており、逆に検出窓52の近傍は検出用マトリックス20をより容易に目視可能とするために当該部分はテーパーを伴う凹構造となっている。一つ以上の検出窓52は検出用マトリックスの検出部22を目視することが可能であれば、窓部分に透明ガラスや透明プラスチック等の透明部材が伴っていても良いし、何も部材を伴わなくても良い。さらに上筐体部材50の厚手構造側の下筐体部材10との係合部分の中央端部には、第二の封止部材40のスライド部分44を外部から引っ張ることを可能とするスライド穴53が設けられている。スライド穴53は、当該スライド部分44の妻手方向幅よりも広く、かつ、当該第二の封止部材40の厚みよりも厚くなっている。このようなスライド穴53は、例えば、下筐体部材10側に設けることも可能であり、下筐体部材10と上筐体部材50の双方で係合形成するように設けることも可能である。   The lower housing member 10 is provided with a field (not shown) in which the spring 11 and the detection matrix 20 can be placed and fixed. The field is formed, for example, by providing a continuous or non-continuous convex structure in the lower housing member 10 that forms a space to be fitted when the detection matrix 20 is placed. The placement of the spring 11 and the detection matrix 20 in the field may or may not be accompanied as long as the placed position is fixed. The upper housing member 50 is provided with a liquid storage portion 51 that contains an opening 511 in the front portion and a small hole 512 in the bottom portion, and stores a liquid 514 for extracting a specimen. Further, a field 513 that can scrape off the portion of the collection rod 2 to which the detection target is attached is provided on the inner wall surface of the liquid storage unit 51. The upper casing member 50 has a thick structure in the vicinity of the liquid storage portion 51 in order to secure the inner volume, and conversely, the vicinity of the detection window 52 makes the detection matrix 20 more easily visible. In addition, the portion has a concave structure with a taper. As long as one or more detection windows 52 can visually detect the detection part 22 of the detection matrix, the window part may be accompanied by a transparent member such as transparent glass or transparent plastic, or anything. It is not necessary. Furthermore, a slide hole that allows the slide portion 44 of the second sealing member 40 to be pulled from the outside at the center end portion of the engagement portion of the upper housing member 50 with the lower housing member 10 on the thick structure side. 53 is provided. The slide hole 53 is wider than the width of the slide portion 44 in the thickness direction, and is thicker than the thickness of the second sealing member 40. Such a slide hole 53 can be provided on the lower housing member 10 side, for example, or can be provided so as to be engaged with both the lower housing member 10 and the upper housing member 50. .

検出用マトリックスは、毛細管作用を示す材料で構成され、例えば、不織布、ニトロセルロース、セルロース、ガラス繊維等が挙げられる。また、単一の素材であっても、複数の素材が接着されてなるものであってもよい。検出用マトリックス20はその典型例であり、検出部22、移動部23、及び、吸収部24が、検出部22の一端と移動部23の他端、検出部22の他端と吸収部24は互いに接触した状態で固定されている。この固定は、各々のパーツを透水可能な状態で接着させて行うことも可能であるが、粘着テープを底面に配置して当該テープの粘着力により各々のパーツを長さ方向に順次固定することにより完便に検出用マトリックス20を作成することができる。仮に、移動部23の一端に液体が接触すると、毛細管現象により、移動部23、検出部22、及び、吸収部24の順番で移動する。そして、その過程において当該液の中の特定成分の検出が検出部22において行われる。少なくとも移動部22は、小孔512の横断面積よりも広い面積部分を有していることが、検体抽出液の無駄を防ぐ上で好適である。   The detection matrix is made of a material exhibiting a capillary action, and examples thereof include non-woven fabric, nitrocellulose, cellulose, and glass fiber. Moreover, even if it is a single material, it may be formed by bonding a plurality of materials. The detection matrix 20 is a typical example, and the detection unit 22, the moving unit 23, and the absorption unit 24 include one end of the detection unit 22 and the other end of the movement unit 23, and the other end of the detection unit 22 and the absorption unit 24. They are fixed in contact with each other. This fixing can be done by adhering each part in a water-permeable manner, but placing the adhesive tape on the bottom and fixing each part sequentially in the length direction by the adhesive force of the tape Thus, the detection matrix 20 can be created completely. If the liquid comes into contact with one end of the moving unit 23, the moving unit 23, the detecting unit 22, and the absorbing unit 24 move in order due to capillary action. In the process, the detection unit 22 detects a specific component in the liquid. In order to prevent waste of the specimen extract, it is preferable that at least the moving unit 22 has an area portion wider than the cross-sectional area of the small hole 512.

検出用マトリックス20と下部筐体部材10の間に配置されるバネ11は、本発明の検出器具における選択的な構成要件として用いられる「押圧部材」であり、検出用マトリックス20とその上部に位置する構造を、液体収容部51の底部小孔512の下部入り口に対する押圧力を与える部材である限り、他のものであってもよい。例えば、弾力性を有するゴムやスポンジ等を用いることも可能である。バネ11は、その押圧力により液体収容部51に由来する検体抽出液の漏出の防止性能を向上させることができる。   The spring 11 disposed between the detection matrix 20 and the lower housing member 10 is a “pressing member” used as a selective constituent element in the detection instrument of the present invention, and is positioned on the detection matrix 20 and the upper part thereof. Any other structure may be used as long as it is a member that applies a pressing force to the lower entrance of the bottom small hole 512 of the liquid storage unit 51. For example, elastic rubber or sponge can be used. The spring 11 can improve the leakage preventing performance of the specimen extract derived from the liquid storage unit 51 by the pressing force.

図2は、シート状の第一の封止部材60(図2−1)と第二の封止部材40(図2−2)の各平面図を示している。第一の封止部材60は、液体収容部51の開口部分511を封止するためのシート状部材である。その一端部61は開口部分511の形状に合わせて、当該形状よりも一廻り大きな先尖形状となっており、他端62は引き剥がし開始部分であり、手力により引き剥がしをし易いように余裕を持った大きさとなっている。点線63は、選択的に採り入れることが可能な折り曲げ線又は切り取り線を示している。具体的には、当該点線部分の折り曲げ又は切り取りを容易にするための手段、すなわちミシン目等が施されていることにより、後述する本発明の使用方法におけるステップ(1)の液中抽出後、剥離された第一の封止部材60を液中抽出物の飛散防止を目的として再び元の封止状態に戻す場合に、当該点線部分63における折り曲げ又は切り取りが容易となる。折り曲げ又は切り取りは、第一の封止部材60の62部分による視界の妨げなく、検出窓52の目視を行うことを可能とするために行われる。なお当該点線を切り取り線とする場合には、他端62部分を引っ張って第一の封止部材60を剥ぎ取る際の引っ張り力を加えても容易には当該切り取り線が破れずに維持される程度の強度が要求される。また、第一の封止部材60を引っ張らずに綿棒2により破断する場合には、そもそも62部分自体の積極的な必要性は認められない。さらに、後述するように当該ステップ(1)の液中抽出後に、液体収容部51の表部における開口部分511を封止することが可能な蓋部材70を、当該開口部分に係合させることにより、液中抽出物の飛散防止と検出窓52の目視の容易化を実現することも可能である。   FIG. 2 shows respective plan views of the sheet-like first sealing member 60 (FIG. 2-1) and the second sealing member 40 (FIG. 2-2). The first sealing member 60 is a sheet-like member for sealing the opening portion 511 of the liquid storage unit 51. The one end 61 has a pointed shape that is slightly larger than the shape in accordance with the shape of the opening 511, and the other end 62 is a peeling start portion so that it can be easily peeled off by hand. The size has room. A dotted line 63 indicates a fold line or a cut line that can be selectively adopted. Specifically, the means for facilitating the bending or cutting of the dotted line portion, that is, perforations, etc. are applied, so that after extraction in the liquid of step (1) in the method of use of the present invention described later, When the peeled first sealing member 60 is returned to the original sealed state again for the purpose of preventing the extract in the liquid from scattering, the dotted line portion 63 can be easily folded or cut off. Bending or cutting is performed so that the detection window 52 can be visually observed without obstructing the field of view by the 62 portion of the first sealing member 60. When the dotted line is a cut line, the cut line is easily maintained without being broken even if the other end 62 portion is pulled to apply a pulling force when the first sealing member 60 is peeled off. A certain degree of strength is required. Further, when the first sealing member 60 is broken by the cotton swab 2 without pulling, the positive necessity of the 62 portion itself is not recognized. Further, as will be described later, after the extraction in the liquid in the step (1), the lid member 70 capable of sealing the opening portion 511 in the front portion of the liquid storage portion 51 is engaged with the opening portion. In addition, it is possible to prevent scattering of the extract in the liquid and facilitate visual inspection of the detection window 52.

第二の封止部材40の一端41近傍は、上筐体部材50の底部における小孔512を覆うための領域であり、好適な態様として当該小孔を覆うことが可能な十分な面積を有しており、他端42は手力により引っ張るための領域で摘みやすいように幅広になっている。なお、本例は上記の第二の封止部材の直接的な外部への突出態様であり、例えば、他端42近傍を本例のような第二の封止部材40の一部に替えて、他の部材、例えば引っ張りやすい形状や素材の紐部材等とする「外部への間接的な突出態様」とすることも可能である。さらに中間領域の一端41側にスライド穴53よりも幅広のストッパ領域43と他端42側に幅狭のスライド領域44が設けられている。第二の封止部材40の一端41は41’の状態へと折り込まれることにより、ループ状となって下部小孔512に接触している。この折り込みの方向は本例では下部小孔512の方向に向けて行っているが、逆に検出用マトリックス20側に向けて行ってもよい。剥離が前提の第一の封止部材と第二の封止部材は共に、薄くても丈夫であり、かつ、防水性と耐久性に優れている素材であることが好適である。このような素材としては、例えば、アルミ・ポリエチレンラミネートシート、アルミシート、プラスチックフィルム等を挙げることができる。第一の封止部材が剥離ではなく破断を行うことを前提とする場合には、押圧力により容易に破断する素材を用いることが必要である。実用性を鑑みると第一の封止部材は、本例のように剥離を前提とするものであることが好適である。   The vicinity of the one end 41 of the second sealing member 40 is a region for covering the small hole 512 at the bottom of the upper housing member 50, and has a sufficient area that can cover the small hole as a preferable aspect. The other end 42 is wide so that it can be easily picked in an area to be pulled by hand. In this example, the second sealing member directly protrudes to the outside. For example, the vicinity of the other end 42 is changed to a part of the second sealing member 40 as in this example. Also, it is possible to adopt an “indirect projecting aspect to the outside” which is made of another member, for example, a shape that is easy to pull or a string member made of a material. Furthermore, a stopper region 43 wider than the slide hole 53 is provided on one end 41 side of the intermediate region, and a narrow slide region 44 is provided on the other end 42 side. One end 41 of the second sealing member 40 is folded into a state 41 ′, thereby forming a loop and contacting the lower small hole 512. In this example, the folding direction is directed toward the lower small hole 512. However, the folding direction may be performed toward the detection matrix 20 side. Both the first sealing member and the second sealing member, which are premised on peeling, are preferably made of a material that is thin and strong and that is excellent in waterproofness and durability. Examples of such a material include an aluminum / polyethylene laminate sheet, an aluminum sheet, and a plastic film. When it is assumed that the first sealing member is not peeled but is broken, it is necessary to use a material that can be easily broken by a pressing force. In view of practicality, it is preferable that the first sealing member is based on peeling as in this example.

本例では、第二の封止部材40と検出用マトリックス20の間における液体収容部51の底部小孔512の下部に相当する位置に、吸液浸潤部材30を介在させることができる。この吸液浸潤部材30は、下部小孔512からの検体抽出液を吸水してトラップしつつ、効率良く検出用マトリックス20の移動部22に浸潤させる素材であることが好適であり、例えば、ポリビニルアルコール、ポリウレタン等を基にする多孔質部材や、セルロース、グラスウール等を基にする繊維部材等を例示することができる。このような吸液浸潤部材を用いることにより、検体抽出液の漏出の防止をさらに完璧に行うことができる。   In this example, the liquid-absorbing infiltrating member 30 can be interposed at a position corresponding to the lower portion of the bottom small hole 512 of the liquid storage portion 51 between the second sealing member 40 and the detection matrix 20. This liquid infiltrating member 30 is preferably a material that efficiently infiltrates the moving portion 22 of the detection matrix 20 while absorbing and trapping the specimen extract from the lower small hole 512, for example, polyvinyl Examples thereof include a porous member based on alcohol, polyurethane and the like, and a fiber member based on cellulose, glass wool and the like. By using such a liquid-absorbing infiltrating member, the leakage of the specimen extract can be prevented more completely.

さらに、上述した本発明の検査器具における各部分同士の、組み立て後の分解を防ぐために、必要に応じて分解防止手段を講ずることができる。例えば、上下の筐体部材が外れないように互いを係止することが可能な係止機構(例えば、凹構造と凸構造の組み合わせによる係止機構:図示せず)を設けることも可能である。また、上筐体部材50の検出用マトリックス20の吸収部24に対応する部位に蒸散窓(図示せず)を設けて、検出用マトリックス20における液体の移動をさらに促進することも可能である。さらに、必要に応じて本検査器具を用いやすくするためのデザイン上の工夫を行うこともできる。例えば、12にて表される細かい凹凸を伴う窪み形状は、本検査器具1を掴みやすくして、例えば、第一の封止部材60の引き剥がし時や第二の封止部材40の引っ張り時のスリップを防ぐための構造である。   Furthermore, in order to prevent the parts in the inspection instrument of the present invention described above from being disassembled after assembling, disassembly preventing means can be provided as necessary. For example, it is also possible to provide a locking mechanism (for example, a locking mechanism by a combination of a concave structure and a convex structure: not shown) that can lock the upper and lower housing members so as not to come off. . It is also possible to provide a transpiration window (not shown) at a portion of the upper housing member 50 corresponding to the absorption portion 24 of the detection matrix 20 to further promote the movement of the liquid in the detection matrix 20. Furthermore, a design device for facilitating the use of the present inspection instrument can be made as necessary. For example, the hollow shape with fine irregularities represented by 12 makes it easy to grasp the inspection instrument 1, for example, when the first sealing member 60 is peeled off or when the second sealing member 40 is pulled. It is a structure for preventing slipping.

図4は、当該検査器具1の使用方法の長さ方向の側面から見た断面解説図である。   FIG. 4 is a cross-sectional explanatory view seen from the side surface in the length direction of the method of using the inspection instrument 1.

図4(1)は、本発明の検査器具1の初期状態1において典型的な態様で使用する前の図3の全体斜視図に示した状態を示している。液体収容部51には検体を抽出するための液体514が収容されており、液体514と吸液浸潤部材30は第二の封止部材40により互いに隔離されて接触できない状態となっている。図4(2)は、綿棒2の差し込みを行った直後を示している。この差し込みを行う時点で、液体収容部51の第一の封止部材60は引き剥がされおり、綿棒2の差し込みが行われている。本図では、綿棒2を向かって右手方向から差し込んでいるが、その差し込みの方向は特に限定されない。例えば、第一の封止部材60の引き剥がしを行い、検体の抽出操作後に、当該第一の封止部材60で再び封止する場合は、第一の封止部材60はその一端部61を残して他端62のみ引き剥がしを行い、綿棒2を左手方向から差し込み、検体の抽出操作を完了して綿棒2を引き抜いた後に、前記部分剥離部分を再び元の状態に戻して再接着を行い再封止状態とすることができる。この場合には、第一の封止部材60の封止手段として用いられる接着剤は再封止可能な程度に、一回目の剥離後であっても相応の粘着力を発揮し得るものであることが必要である。またこのような第一の封止部材60による再封止を行う場合には、前述したように折り曲げ線又は切り取り線63が設けられていることにより、検出窓52の目視を行う際に妨げとなる62部分を、事前に折り曲げ又は除去することが容易となる。さらに上述のように、ここに図示した引き剥がしの他に、綿棒2により第一の封止部材60を破断して実質的に同一の検体抽出操作を行うことも可能である。   FIG. 4 (1) shows the state shown in the overall perspective view of FIG. 3 before being used in a typical manner in the initial state 1 of the inspection instrument 1 of the present invention. A liquid 514 for extracting a specimen is stored in the liquid storage unit 51, and the liquid 514 and the liquid-absorbing infiltrating member 30 are separated from each other by the second sealing member 40 and cannot contact each other. FIG. 4 (2) shows a state immediately after the cotton swab 2 is inserted. At the time of this insertion, the first sealing member 60 of the liquid storage unit 51 has been peeled off, and the cotton swab 2 has been inserted. In this figure, the cotton swab 2 is inserted from the right hand direction, but the insertion direction is not particularly limited. For example, when the first sealing member 60 is peeled off and sealed again with the first sealing member 60 after the specimen extraction operation, the first sealing member 60 has its one end portion 61 removed. Only the other end 62 is peeled off, the cotton swab 2 is inserted from the left-hand direction, the sample extraction operation is completed, and the cotton swab 2 is pulled out. Then, the partially peeled portion is returned to the original state and re-adhered. It can be set as a reseal state. In this case, the adhesive used as the sealing means of the first sealing member 60 can exhibit a suitable adhesive force even after the first peeling, to the extent that it can be resealed. It is necessary. Further, when re-sealing with the first sealing member 60 as described above, the bending line or the cut line 63 is provided as described above, which hinders visual inspection of the detection window 52. It becomes easy to bend or remove the 62 parts. Further, as described above, in addition to the peeling shown here, the first sealing member 60 can be broken by the cotton swab 2 to perform substantially the same specimen extraction operation.

これらの操作により液体収容部51中の検体を抽出するための液体514と、綿棒2の頭とが接触し、綿棒2の頭に付着した検体が当該液体514において抽出される。抽出される対象となる検体は特に限定されず、例えば、臨床検査用途に用いるのであれば、血液(全血、血清、血漿等)、リンパ液、尿、唾液、鼻汁、涙、糞便、肺洗浄液、骨髄液等、又は、これらの懸濁物や溶解物等が例示される。また、環境や食品の検査用途に用いるのであれば、検査対象となる土壌、水、食品等、又は、これらの懸濁物や溶解物等が挙げられる。さらに、細菌、ウイルス等の特定の生物種の核酸、特にPCR法等により得られた遺伝子増幅産物が挙げられる。また、液体514は、これらの検体を抽出するのに適した溶媒であれば限定されず、水、各種の緩衝液等の水性溶媒や、アルコール、アセトン、四塩化炭素等の有機溶媒等が例示される。液体収容部51の内壁面に凹凸構造513が設けられており、これにより綿棒2の頭を擦り取ることにより(矢印A)この頭部分に付着した検体の抽出を効率的に行うことができる。この凹凸構造513のような擦り取りを行うための場の位置と具体的な構造は、目的である検体の擦り取りの効率化を達成することが可能である限り特に限定されない。また、液体収容部51の底部近傍には綿棒2を差し込みやすくするための窪み構造(図示せず)を設けることができる。図4(3)は、上記の検体の抽出を終えて、液体抽出済みの綿棒2を液体収容部51から矢印Bの方向に抜き取る段階を示している。液体514’ は既に検出対象物を含有し得る状態となっている。以上の図4(1)〜(3)は、本発明の検出方法の「ステップ(1)」を示している。   By these operations, the liquid 514 for extracting the sample in the liquid storage unit 51 comes into contact with the head of the cotton swab 2, and the sample attached to the head of the cotton swab 2 is extracted in the liquid 514. The specimen to be extracted is not particularly limited. For example, if used for clinical laboratory use, blood (whole blood, serum, plasma, etc.), lymph, urine, saliva, nasal discharge, tears, feces, lung lavage fluid, Examples thereof include bone marrow fluid and the like, suspensions and lysates thereof, and the like. Moreover, if it uses for the test | inspection use of an environment or a foodstuff, the soil, water, foodstuffs etc. which become a test object, or these suspensions and melted substances are mentioned. Furthermore, the nucleic acid of specific biological species, such as bacteria and a virus, especially the gene amplification product obtained by PCR method etc. are mentioned. The liquid 514 is not limited as long as it is a solvent suitable for extracting these specimens, and examples thereof include water, aqueous solvents such as various buffer solutions, and organic solvents such as alcohol, acetone, and carbon tetrachloride. Is done. The concave-convex structure 513 is provided on the inner wall surface of the liquid storage unit 51, and by this, the sample attached to the head portion can be efficiently extracted by scraping the head of the swab 2 (arrow A). The position of the field and the specific structure for scraping such as the concavo-convex structure 513 are not particularly limited as long as the efficiency of scraping of the target specimen can be achieved. Further, a recess structure (not shown) for facilitating insertion of the cotton swab 2 can be provided in the vicinity of the bottom of the liquid storage portion 51. FIG. 4 (3) shows a stage in which the extraction of the sample is completed and the liquid-extracted swab 2 is extracted from the liquid container 51 in the direction of arrow B. The liquid 514 'is already in a state that can contain the detection target. 4 (1) to (3) above show “step (1)” of the detection method of the present invention.

図4(4)は、本発明の検出方法の「ステップ(2)((2)’を含む)とステップ(3)」を示している。すなわち、蓋部材70を液体収容部51の表部における開口部分の外縁515に嵌合させて(矢印C)、当該開口部分を再封止する。この蓋部材70による再封止は本例のような第一の封止部材を全て剥ぎ取る場合は無論のこと、上述したような第一の封止部材60が当該部分に存在している場合にも行うことができる。第二の封止部材40の他端42を引っ張り力によって引っ張って、一端41’を含むループを解すことにより第二の封止部材40による隔離状態が解除され、下部小孔512と吸液浸潤部材30は直接接触し、抽出済みの液体514’は当該部材30において含浸状態となり、当該液体514’はこれと接触する検出用マトリックス20の移動部23にアプライされる(矢印E1)。次いで、検出用マトリックス20における毛細管現象により、液体514’は矢印E2方向への移動し、検出部22に担持された検出要素との接触反応により顕れるシグナルを、検出窓52を介して確認することによる、測定対象物の検出段階を示している。前記シグナルとは、典型的には検出対象物に関する抗原抗体反応に伴うシグナルであり、例えば、移動部23に担持され、水分の移動に伴い移動可能な状態となっている測定対象物に特異的な標識抗体、例えば金コロイドが担持された標識抗体に検出対象物が結合した状態で、検出部22に固定化された測定対象物に対して特異的な第2抗体でトラップされ、これが検出ゾーン22において目視可能な状態に金コロイドが蓄積することにより、液体514’における検出対象物を測定することができる。さらに残りの液体514’は随時吸収ゾーン24に吸収されることにより、上記の水分の移動は維持される。なお、上記の抗原抗体反応のシグナルとしては特に限定されずに、例えば、発色酵素、蛍光色素等による発色や蛍光が挙げられる。また、核酸のハイブリダイズ反応を用いる場合には、上記の標識抗体の代わりに、検出対象となる核酸に相補的な核酸を検出ゾーン22に固定化し、当該の相補的な核酸には、ハイブリダイズすることにより発光又は消光する手段を設けることによって、所望する核酸の測定を行うことができる。   FIG. 4 (4) shows “Step (2) (including (2) ′) and Step (3)” of the detection method of the present invention. That is, the lid member 70 is fitted to the outer edge 515 of the opening portion in the front portion of the liquid storage portion 51 (arrow C), and the opening portion is resealed. This re-sealing by the lid member 70 is of course when all the first sealing member is peeled off as in this example, and when the first sealing member 60 as described above is present in the part. Can also be done. By pulling the other end 42 of the second sealing member 40 with a pulling force and releasing the loop including the one end 41 ′, the isolation state by the second sealing member 40 is released, and the lower small hole 512 and the liquid absorption infiltration are released. The member 30 is in direct contact, and the extracted liquid 514 ′ is impregnated in the member 30, and the liquid 514 ′ is applied to the moving part 23 of the detection matrix 20 in contact therewith (arrow E 1). Next, due to capillary action in the detection matrix 20, the liquid 514 ′ moves in the direction of the arrow E 2, and a signal that appears due to a contact reaction with the detection element carried by the detection unit 22 is confirmed through the detection window 52. Shows the detection stage of the measurement object. The signal is typically a signal that accompanies an antigen-antibody reaction related to a detection target, and is specific to, for example, a measurement target that is carried by the moving unit 23 and is movable along with the movement of moisture. In a state in which the detection target is bound to a labeled antibody carrying a colloidal gold antibody, for example, a colloidal gold, it is trapped by the second antibody specific to the measurement target immobilized on the detection unit 22, and this is detected in the detection zone. Since the colloidal gold accumulates in a visible state at 22, the object to be detected in the liquid 514 ′ can be measured. Further, the remaining liquid 514 ′ is absorbed into the absorption zone 24 as needed, so that the movement of moisture is maintained. The antigen-antibody reaction signal is not particularly limited, and examples thereof include color development and fluorescence using a chromogenic enzyme, a fluorescent dye, and the like. When using a nucleic acid hybridization reaction, a nucleic acid complementary to the nucleic acid to be detected is immobilized in the detection zone 22 instead of the labeled antibody, and the complementary nucleic acid is hybridized. Thus, by providing a means for emitting or quenching light, a desired nucleic acid can be measured.

上述した態様は本発明の一態様であって、適宜必要に応じて他の態様を採ることができる。   The above-described embodiment is one embodiment of the present invention, and other embodiments can be adopted as necessary.

上述したように、本発明の検査器具では、検体の液体への抽出が器具内に設けられた構造中で行われ、かつ、当該抽出液と検出用マトリックスとの接触を同一の器具内で一ステップにて行うことが可能となる。すなわち、採取した検体を全て用いることが可能となり、検体の採取量を最小限とすることができる。また、全ての操作を実質的に同一の器具内で行うことができるので、複数の検体を検査する場合の検体の取り違えを防止することができる。さらに液体収容部の再封止を行うことにより、検体抽出液の外部環境への飛散等による汚染の抑止を徹底することが可能となる。そして、全体として検査ステップが簡便化されて迅速な検査が可能となり、かつ、検査の確実性は全く損なわれない。よって、本発明の検査器具と、当該検査器具の使用方法における産業上の利用性が十分に認められる。   As described above, in the test instrument of the present invention, the extraction of the specimen into the liquid is performed in the structure provided in the instrument, and the contact between the extract and the detection matrix is made within the same instrument. This can be done in steps. That is, all the collected samples can be used, and the amount of collected samples can be minimized. In addition, since all operations can be performed in substantially the same instrument, it is possible to prevent sample mix-up when testing a plurality of samples. Furthermore, by re-sealing the liquid storage part, it becomes possible to thoroughly prevent contamination due to scattering of the specimen extract to the external environment. In addition, the inspection step is simplified as a whole, and a quick inspection is possible, and the reliability of the inspection is not impaired at all. Therefore, industrial applicability in the inspection instrument of the present invention and the method of using the inspection instrument is sufficiently recognized.

1 検査器具
2 綿棒
10 下筐体部材
11 バネ
20 検出用マトリックス
30 吸液浸潤部材
40 第二の封止部材
50 上筐体部材
51 液体収容部
511 液体収容部の表部における開口部分
512 液体収容部の底部における小孔
513 検出対象物の付着部分を擦り取ることが可能な場
514 検体を抽出するための液体
52 検出窓
60 第一の封止部材
70 蓋部材
DESCRIPTION OF SYMBOLS 1 Test | inspection instrument 2 Cotton swab 10 Lower housing | casing member 11 Spring 20 Detection matrix 30 Liquid absorption infiltrating member 40 2nd sealing member 50 Upper housing | casing member 51 Liquid accommodating part 511 Opening part in the front part of a liquid accommodating part 512 Liquid accommodating Small hole 513 in the bottom of the part 513 A place where the attached portion of the detection target can be scraped 514 Liquid for extracting the specimen 52 Detection window 60 First sealing member 70 Lid member

Claims (10)

(1)表部における開口部分と底部における小孔を伴う、検体を抽出するための液体が収容されている液体収容部、(2)当該液体収容部の開口部分を封止する外力による剥離又は破断が可能な第一の封止部材と、底部小孔を封止する外力による剥離が可能な第二の封止部材、(3)検体が抽出された当該液体を浸潤力により移動させるための移動部と検出対象物を検出するための検出部が設けられている検出用マトリックス、及び、(4)当該検出部を外部から可視化するための1以上の検出窓、を具える検査器具であって、液体収納部の底部小孔と検出用マトリックスの移動部は第二の封止部材を挟んだ状態が保たれており、当該第二の封止部材は直接又は間接に検出器具の外部に突出し、当該突出部分に引っ張り力を加えることにより、第二の封止部材における前記の小孔の封止部分が剥離して、検出用マトリックスと液体収納部の底部小孔が直接接触する、検査器具。   (1) A liquid storage part containing a liquid for extracting a specimen, with an opening part in the front part and a small hole in the bottom part, and (2) peeling by an external force that seals the opening part of the liquid storage part or A first sealing member that can be broken, a second sealing member that can be peeled off by an external force that seals the bottom small hole, and (3) for moving the liquid from which the specimen has been extracted by infiltration force An inspection instrument comprising a detection matrix provided with a detection unit for detecting a moving unit and a detection object, and (4) one or more detection windows for visualizing the detection unit from the outside. The bottom small hole of the liquid storage part and the moving part of the detection matrix are kept sandwiched between the second sealing members, and the second sealing member is directly or indirectly placed outside the detection instrument. By projecting and applying a tensile force to the projecting part Said by sealing portions peeling of pores in the second sealing member, the bottom pores of the detection matrix and the liquid containing portion is in direct contact, the inspection instrument. 検出用マトリックスの移動部は、液体収容部の底部小孔の横断面積よりも広い面積部分を有し、当該の広い面積部分と底部小孔により第二の封止部材が挟み込まれている、請求項1に記載の検査器具。   The moving part of the detection matrix has an area part wider than the cross-sectional area of the bottom small hole of the liquid storage part, and the second sealing member is sandwiched between the wide area part and the bottom small hole. Item 1. The inspection instrument according to Item 1. 液体収容部の底部小孔、第二の封止部材、及び、検出用マトリックスの移動部、による挟み込み部分が押圧部材による押圧力がかけられた状態である、請求項1又は2に記載の検査器具。   The inspection according to claim 1 or 2, wherein the sandwiched portion by the bottom small hole of the liquid storage unit, the second sealing member, and the moving portion of the detection matrix is in a state where a pressing force is applied by the pressing member. Instruments. 第二の封止部材と検出用マトリックスの間における液体収容部の底部小孔の下部に相当する位置に、吸液浸潤部材が挟み込まれている、請求項1〜3のいずれかに記載の検査器具。   The test according to any one of claims 1 to 3, wherein the liquid-absorbing infiltrating member is sandwiched at a position corresponding to a lower portion of the bottom small hole of the liquid storage portion between the second sealing member and the detection matrix. Instruments. 第二の封止部材における液体収容部の底部小孔に対する封止部分は、当該第二の封止部材の容器における突出部分と長さ方向において逆側の折り畳まれてなる端部であり、当該突出部分に引っ張り力をかけることにより当該の逆側端部の折り畳み状態が解除されて、底部小孔と検出用マトリックスが直接接触する、請求項1〜4のいずれかに記載の検査器具。   The sealing part for the bottom small hole of the liquid storage part in the second sealing member is an end part that is folded on the opposite side in the length direction from the protruding part in the container of the second sealing member, The inspection instrument according to any one of claims 1 to 4, wherein a folded state of the opposite end is released by applying a pulling force to the protruding portion, and the bottom small hole and the detection matrix are in direct contact. 液体収容部の内壁面に、採取棒における検出対象物の付着部分を擦り取ることが可能な場が設けられていることを特徴とする、請求項1〜5のいずれかに記載の検査器具。   The inspection instrument according to any one of claims 1 to 5, wherein a place capable of scraping off a portion to which the detection object is attached on the sampling rod is provided on the inner wall surface of the liquid storage unit. 検出窓に対して検出用マトリックスの下流側に蒸散窓が設けられていることを特徴とする、請求項1〜6のいずれかに記載の検査器具。   The inspection instrument according to any one of claims 1 to 6, wherein a transpiration window is provided downstream of the detection matrix with respect to the detection window. 液体収容部の表部における開口部分を、第一の封止部材を剥離又は破断した後に封止可能な蓋部材が、付属物として備わっている、請求項1〜7のいずれかに記載の検査器具。   The inspection according to any one of claims 1 to 7, wherein a lid member capable of sealing the opening portion in the front portion of the liquid storage portion after peeling or breaking the first sealing member is provided as an accessory. Instruments. 下記のステップ(1)〜(3)を含む、請求項1〜7のいずれかに記載の検査器具の使用方法。
(1)液体収容部の第一の封止部材の一端を剥がして、又は、破断して、検体の付着した採取棒の先端を当該液体収容部に挿入して当該部中の液体に接触させて、検体の液中抽出を行うステップ、
(2)第二の封止部材の容器外部への突出部分に引っ張り力をかけて、当該封止部材を小孔から剥離させて、液体収容部における液中抽出物を検出用マトリックスの移動部に接触させるステップ、
(3)液中抽出物が検出用マトリックスに接触したことによる、当該液体の検出用マトリックスの移動部から検出部に向けての移動に伴う接触反応により顕れるシグナルを、検出窓を介して確認し、測定対象物の検出を行うステップ。
The usage method of the test | inspection instrument in any one of Claims 1-7 containing following step (1)-(3).
(1) One end of the first sealing member of the liquid container is peeled off or broken, and the tip of the collection rod to which the sample is attached is inserted into the liquid container and brought into contact with the liquid in the part A step of extracting the sample in the liquid,
(2) A tensile force is applied to the projecting portion of the second sealing member to the outside of the container so that the sealing member is peeled from the small hole, and the in-liquid extract in the liquid storage portion is moved to the detection matrix moving portion. Contacting the step,
(3) Confirm through the detection window the signal that appears due to the contact reaction that accompanies the movement of the liquid detection matrix from the moving part toward the detecting part due to the extract in the liquid coming into contact with the detecting matrix. And detecting the measurement object.
下記のステップ(1)〜(4)を含む、請求項8に記載の検査器具の使用方法。
(1)液体収容部の第一の封止部材の一端を剥がして、又は、破断して、検体の付着した採取棒の先端を当該液体収容部に挿入して当該部中の液体に接触させて、検体の液中抽出を行うステップ、
(2)蓋部材により液体収容部の表部における開口部分を封止するステップ、
(3)第二の封止部材の容器外部への突出部分に引っ張り力をかけて、当該封止部材を小孔から剥離させて、液体収容部における液中抽出物を検出用マトリックスの移動部に接触させるステップ、
(4)液中抽出物が検出用マトリックスに接触したことによる、当該液体の検出用マトリックスの移動部から検出部に向けての移動に伴う接触反応により顕れるシグナルを、検出窓を介して確認し、測定対象物の検出を行うステップ。
The usage method of the test | inspection instrument of Claim 8 containing following step (1)-(4).
(1) One end of the first sealing member of the liquid container is peeled off or broken, and the tip of the collection rod to which the sample is attached is inserted into the liquid container and brought into contact with the liquid in the part A step of extracting the sample in the liquid,
(2) a step of sealing the opening portion in the front portion of the liquid storage portion by the lid member;
(3) A tensile force is applied to the projecting portion of the second sealing member to the outside of the container so that the sealing member is peeled from the small hole, and the in-liquid extract in the liquid storage portion is moved to the detection matrix moving portion. Contacting the step,
(4) Confirm through the detection window the signal that appears due to the contact reaction that accompanies the movement of the liquid detection matrix from the moving part to the detecting part due to the extract in the liquid coming into contact with the detecting matrix. And detecting the measurement object.
JP2011117471A 2011-05-25 2011-05-25 Inspection instrument Withdrawn JP2012247231A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2011117471A JP2012247231A (en) 2011-05-25 2011-05-25 Inspection instrument

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP2011117471A JP2012247231A (en) 2011-05-25 2011-05-25 Inspection instrument

Publications (1)

Publication Number Publication Date
JP2012247231A true JP2012247231A (en) 2012-12-13

Family

ID=47467818

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2011117471A Withdrawn JP2012247231A (en) 2011-05-25 2011-05-25 Inspection instrument

Country Status (1)

Country Link
JP (1) JP2012247231A (en)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104730229A (en) * 2015-03-27 2015-06-24 广州万孚生物技术股份有限公司 Electronic detection device
WO2016027782A1 (en) * 2014-08-20 2016-02-25 株式会社シン・コーポレイション Examination apparatus
JP2016045027A (en) * 2014-08-20 2016-04-04 株式会社シン・コーポレイション Testing device
KR20200070372A (en) * 2017-11-29 2020-06-17 옥스포드 나노포어 테크놀로지즈 리미티드 Microfluidic device
CN115227295A (en) * 2022-09-19 2022-10-25 深圳市雄帝科技股份有限公司 Pharynx swab sampling device
US11561216B2 (en) 2012-02-13 2023-01-24 Oxford Nanopore Technologies Plc Apparatus for supporting an array of layers of amphiphilic molecules and method of forming an array of layers of amphiphilic molecules
US11596940B2 (en) 2016-07-06 2023-03-07 Oxford Nanopore Technologies Plc Microfluidic device
US11789006B2 (en) 2019-03-12 2023-10-17 Oxford Nanopore Technologies Plc Nanopore sensing device, components and method of operation
US12121894B2 (en) 2017-11-29 2024-10-22 Oxford Nanopore Technologies Plc Microfluidic device

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11561216B2 (en) 2012-02-13 2023-01-24 Oxford Nanopore Technologies Plc Apparatus for supporting an array of layers of amphiphilic molecules and method of forming an array of layers of amphiphilic molecules
US11913936B2 (en) 2012-02-13 2024-02-27 Oxford Nanopore Technologies Plc Apparatus for supporting an array of layers of amphiphilic molecules and method of forming an array of layers of amphiphilic molecules
WO2016027782A1 (en) * 2014-08-20 2016-02-25 株式会社シン・コーポレイション Examination apparatus
JP2016045027A (en) * 2014-08-20 2016-04-04 株式会社シン・コーポレイション Testing device
JPWO2016027782A1 (en) * 2014-08-20 2017-06-01 株式会社シン・コーポレイション Inspection equipment
US9927433B2 (en) 2014-08-20 2018-03-27 Shin Corporation Test apparatus
CN104730229B (en) * 2015-03-27 2016-08-31 广州万孚生物技术股份有限公司 Electronic detecting device
CN104730229A (en) * 2015-03-27 2015-06-24 广州万孚生物技术股份有限公司 Electronic detection device
US11596940B2 (en) 2016-07-06 2023-03-07 Oxford Nanopore Technologies Plc Microfluidic device
JP7121124B2 (en) 2017-11-29 2022-08-17 オックスフォード ナノポール テクノロジーズ ピーエルシー microfluidic device
KR102503677B1 (en) 2017-11-29 2023-02-24 옥스포드 나노포어 테크놀로지즈 피엘씨 microfluidic device
JP2021504704A (en) * 2017-11-29 2021-02-15 オックスフォード ナノポール テクノロジーズ リミテッド Microfluidic device
KR20200070372A (en) * 2017-11-29 2020-06-17 옥스포드 나노포어 테크놀로지즈 리미티드 Microfluidic device
US12121894B2 (en) 2017-11-29 2024-10-22 Oxford Nanopore Technologies Plc Microfluidic device
US11789006B2 (en) 2019-03-12 2023-10-17 Oxford Nanopore Technologies Plc Nanopore sensing device, components and method of operation
CN115227295A (en) * 2022-09-19 2022-10-25 深圳市雄帝科技股份有限公司 Pharynx swab sampling device

Similar Documents

Publication Publication Date Title
JP2012247231A (en) Inspection instrument
JP6838127B2 (en) Test cartridge with integrated transfer module
US10119968B2 (en) Self-contained diagnostic test with advanceable test strip
JP4646147B2 (en) Sample collection and assay devices
US10041942B2 (en) Rotatable fluid sample collection device
US11026611B2 (en) Rotatable disk-shaped fluid sample collection device
US8216832B2 (en) Sanitary swab collection system, microfluidic assay device, and methods for diagnostic assays
CN103079704B (en) Sample testing apparatus and method
US20080003144A1 (en) Sampling device
US20040184954A1 (en) Lateral flow immunoassay devices for testing saliva and other liquid samples and methods of use of same
BRPI0717552A2 (en) CARTRIDGE SYSTEM, METHOD FOR FORMING A CARTRIDGE, CARTRIDGE, TEST SYSTEM, ANALYSIS METHOD FOR ONE OR MORE ANALYZES IN A SAMPLE, REAGENT COMPONENT TO STORE ONE OR MORE REAGENTS, AND, USE OF A CARTRIDGE SYSTEM, TEST AND / OR REAGENT COMPONENT
JP4913732B2 (en) Integrated analyzer that can be attached to a container that contains analysis samples
JP4938036B2 (en) Sample collection / testing device with pivot arm
JP2012230025A (en) Inspection instrument
EP3544734B1 (en) Lab-on-a-chip device for performing analyses
JP2009168667A (en) Microchip with built-in liquid reagent
JP6166938B2 (en) Microchip
US20180299433A1 (en) Sample collection device and method for urine and other fluids
WO2019131475A1 (en) Test device and test method
JP2001272397A (en) Specimen analyzing tool

Legal Events

Date Code Title Description
A300 Withdrawal of application because of no request for examination

Free format text: JAPANESE INTERMEDIATE CODE: A300

Effective date: 20140805