JP2010156641A - Concentration measuring sensor - Google Patents
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Abstract
Description
本発明は、測定すべき物質の濃度に応じて色調が変化する判定部を備えた濃度測定センサに関する。 The present invention relates to a concentration measurement sensor including a determination unit whose color tone changes according to the concentration of a substance to be measured.
従来から、測定すべき物質の濃度に応じて色調が変化する判定部を備えた濃度測定センサは市場で販売されている。
具体的には、例えば、尿を使って尿糖、尿タンパク、尿潜血の濃度を測定する尿試験紙や、微量に尿中に排出されるアルブミンの濃度を測定する微量アルブミンセンサーおよび妊娠を判定する妊娠判定薬等がある。
上記した従来の濃度測定センサは、測定結果に応じた色調を表示する色調表がセンサ本体とは別に用意されており、使用者は、測定センサに尿等の試液を付けた後に、判定部の色と、色調表とを並べて見比べて、測定結果を判断する。
Conventionally, a concentration measurement sensor including a determination unit whose color tone changes according to the concentration of a substance to be measured has been sold in the market.
Specifically, for example, urine test paper that measures the concentration of urine sugar, urine protein, and urinary occult blood using urine, microalbumin sensor that measures the concentration of albumin excreted in the urine in small amounts, and pregnancy determination There are pregnancy determination drugs.
In the conventional concentration measurement sensor described above, a color tone table that displays the color tone according to the measurement result is prepared separately from the sensor body, and the user adds a test solution such as urine to the measurement sensor, The measurement result is judged by comparing the color and the color tone table side by side.
しかし、上記した従来の濃度測定センサのように、センサ本体と色調表とが別体に構成されていると、様々な問題が生じる。
具体的には、通常、色調表は複数の濃度測定センサに対して一つしか用意されていないため、色調表が紛失してしまったり、例えば、日の当たる場所においておいて色調表の色が変色してしまったりする等が原因で、色調表を用いた測定結果の判定を行うことができなくなるという問題がある。
また、使用に伴い、色調表が尿等で汚れてしまう可能性があるという問題もある。色調表が汚れないようにしようとすると、センサ本体を色調表から離して色を比べなければならないので判定が行い難いという問題もある。センサー本体が入っているケースに色調表が表示されている場合には、測定時にケースを用いて判定する手間があり、特にセンサーが冷蔵保存の場合には測定の都度、室温下に持ち出さなければならないという問題も生じる。
さらに、複数の判定部が一枚の試験紙に搭載されている場合には、判定に使用する色調表を間違って使用する問題点もある。
発明者は、上記したように、従来の濃度測定センサのように、センサ本体と色調表とが別体に構成されていると様々な問題が生じることを見出し、本願発明を発明するに至った。
本発明は、上記した従来の問題点を解決し、色調表の紛失、変色又は汚れ等の問題を生じさせずに、何時でも確実に色調表を用いた判定を行うことができる濃度測定センサを提供することを目的としている。
However, when the sensor main body and the color tone table are configured separately as in the above-described conventional density measurement sensor, various problems occur.
Specifically, since only one color chart is usually prepared for a plurality of density measuring sensors, the color chart may be lost or, for example, the color of the color chart may be changed in a sunny place. There is a problem that determination of the measurement result using the color tone table cannot be performed due to discoloration or the like.
In addition, there is a problem that the color tone table may become dirty with urine or the like with use. In order to prevent the color tone table from becoming dirty, there is also a problem that it is difficult to make a judgment because the sensor body must be separated from the color tone table and the colors must be compared. If the color tone table is displayed in the case containing the sensor body, there is the trouble of judging using the case at the time of measurement, especially if the sensor is refrigerated and stored, it must be taken out at room temperature each time it is measured There also arises the problem of not becoming.
Further, when a plurality of determination units are mounted on a single test paper, there is a problem that a color tone table used for determination is used incorrectly.
As described above, the inventor has found that various problems occur when the sensor main body and the color tone table are configured separately as in the case of the conventional concentration measurement sensor, and has invented the present invention. .
The present invention solves the above-described conventional problems, and provides a density measurement sensor that can reliably perform determination using the color tone table at any time without causing problems such as loss, discoloration, or contamination of the color tone table. It is intended to provide.
上記した目的を達成するために本発明に係る濃度測定センサは、測定すべき物質の濃度に応じて色調が変化する判定部を備えた濃度測定センサにおいて、判定部が設けられたテストストリップを、少なくとも判定部の色を外部から見ることができる窓部が形成されたハウジングに収容し、前記ハウジングの前記判定部に隣接した部分に、測定結果に応じた色調を表示する色調表を配置したことを特徴とする。
前記色調表は、判定部を挟んで判定部の両側に位置するように前記ハウジングに設けられ得る。
また、前記色調表を、判定部を囲むように前記ハウジングに設けてもよい。
さらに、前記色調表は、濃淡が漸次的に変化するように色が表示されて、かつ、スライド片に設けられ得、この場合、前記スライド片は、判定部に隣接してスライド可能に前記ハウジングに設けられ得る。
具体的には、例えば、前記テストストリップが、測定すべき物質の抗体に、その抗体の存在を可視化できる可視化物質を結合させた可視化物質結合抗体を保持した可視化物質結合抗体層と、試液中の前記測定すべき物質と前記可視化物質結合抗体とが抗原抗体反応するのに充分な大きさの展開層とを備え、前記展開層に、前記試液内の測定すべき物質と結合しなかった可視化物質結合抗体を結合させる抗原が固定された前記判定部を設け、試液が、毛細管現象により、可視化物質結合抗体層を通って展開層に入り、展開層で試液中の前記測定すべき物質と前記可視化物質結合抗体とが抗体抗原反応した後、判定部を通過するように各層が配置され、前記判定部の抗原に結合された可視化物質結合抗体における可視化物質の量によって試液中の測定すべき物質の量を測定することができるように構成され得る。
この場合、例えば、前記測定すべき物質は、8-ヒドロキシデオキシグアノシンであり得、測定すべき物質の抗体は8OHdG1B1(独立行政法人 産業技術総合研究所 特許生物寄託センター 受託番号FERM P-20122)(本願の出願人が特開2006-056859にて既に提案している抗体）であり得る。
In order to achieve the above-described object, the concentration measurement sensor according to the present invention is a concentration measurement sensor including a determination unit whose color tone changes according to the concentration of a substance to be measured. A color tone table for displaying a color tone according to a measurement result is disposed in a housing formed with a window portion in which at least the color of the judgment portion can be seen from the outside, and adjacent to the judgment portion of the housing. It is characterized by.
The color tone table may be provided in the housing so as to be positioned on both sides of the determination unit with the determination unit interposed therebetween.
The color tone table may be provided in the housing so as to surround the determination unit.
Further, the color chart may be provided with a color so that the gradation gradually changes and provided on the slide piece. In this case, the slide piece is slidable adjacent to the determination unit. Can be provided.
Specifically, for example, the test strip includes a visualization substance-binding antibody layer holding a visualization substance-binding antibody in which a visualization substance capable of visualizing the presence of the antibody is bound to the antibody of the substance to be measured; A visualization layer that has a development layer large enough for an antigen-antibody reaction between the substance to be measured and the visualization substance-bound antibody, and the development layer does not bind to the substance to be measured in the test solution. The determination unit to which an antigen that binds the bound antibody is fixed is provided, and the test solution enters the development layer through the visualization substance-binding antibody layer by capillary action, and the visualization is performed with the substance to be measured in the test solution in the development layer. After the antigen-antibody reaction with the substance-bound antibody, each layer is arranged so as to pass through the determination part, and the amount of the visualization substance in the visualization substance-bound antibody bound to the antigen of the determination part depends on the amount of the visualization substance in the test solution. It may be configured to be able to measure the amount of Teisu should substances.
In this case, for example, the substance to be measured can be 8-hydroxydeoxyguanosine, and the antibody of the substance to be measured is 8OHdG1B1 (National Institute of Advanced Industrial Science and Technology, Patent Biodeposition Center Accession No.FERM P-20122). The antibody already proposed in Japanese Patent Application Laid-Open No. 2006-056859 by the applicant of the present application.
本発明に係る濃度測定センサは、測定すべき物質の濃度に応じて色調が変化する判定部を備えた濃度測定センサにおいて、判定部が設けられたテストストリップを、少なくとも判定部の色を外部から見ることができる窓部が形成されたハウジングに収容し、前記ハウジングの前記判定部に隣接した部分に、測定結果に応じた色調を表示する色調表を配置しているので、判定部を有するテストストリップと色調表とが一体となり、色調表の紛失、変色及び汚れ等の問題が生じない。
また、本発明に係る濃度測定センサは、色調表を、ハウジングの前記判定部に隣接した部分に設けているので、使用者は常に判定部の色を色調表と並べて見ることができるので判定を行い易い。
また、前記テストストリップを、測定すべき物質の抗体に、その抗体の存在を可視化できる可視化物質を結合させた可視化物質結合抗体を保持した可視化物質結合抗体層と、試液中の前記測定すべき物質と前記可視化物質結合抗体とが結合するのに充分な大きさの展開層とで構成し、前記展開層に、前記試液内の測定すべき物質と結合しなかった可視化物質結合抗体を結合させる抗原が固定された前記判定部を設け、試液が、毛細管現象により、可視化物質結合抗体層を通って展開層に入り、展開層で試液中の前記測定すべき物質と前記可視化物質結合抗体とが抗体抗原反応した後、判定部を通過するように各層を配置し、前記判定部の抗原に結合された可視化物質結合抗体における可視化物質の量によって試液中の測定すべき物質の量を測定することができるように構成することによって、測定すべき物質と結合しなかった可視化物質結合抗体の量に基づいて、測定すべき物質の量を測定することが可能になる。従って、例えば、8-ヒドロキシデオキシグアノシンのように１：１の抗原抗体反応しかすることができない低分子物質であっても測定することが可能になる。また、試液が、毛細管現象により、可視化物質結合抗体層を通って展開層に入り、展開層で試液中の前記測定すべき物質と前記可視化物質結合抗体とが抗体抗原反応した後、判定部を通過するように各層を配置しているので、構造が簡単になり、センサそのものを安価に製造することができるようになり、8-ヒドロキシデオキシグアノシンのような低分子物質の量を手軽に測定することができるようになる。
The concentration measurement sensor according to the present invention is a concentration measurement sensor including a determination unit that changes in color tone according to the concentration of a substance to be measured. The test strip provided with the determination unit includes at least the color of the determination unit from the outside. Since the color tone table for displaying the color tone according to the measurement result is arranged in a portion adjacent to the judgment portion of the housing, which is accommodated in a housing in which a window portion that can be seen is formed, a test having a judgment portion The strip and the color tone table are integrated, and problems such as loss, discoloration, and contamination of the color tone table do not occur.
In addition, since the density measuring sensor according to the present invention is provided with a color tone table in a portion adjacent to the determination unit of the housing, the user can always see the color of the determination unit side by side with the color tone table. Easy to do.
Further, the test strip comprises a visualization substance-binding antibody layer holding a visualization substance-binding antibody in which a visualization substance capable of visualizing the presence of the antibody is bound to an antibody of the substance to be measured, and the substance to be measured in a test solution And an unfolded layer sufficiently large to bind the visualized substance-bound antibody, and an antigen that binds to the unfolded layer the visualized substance-bound antibody that did not bind to the substance to be measured in the test solution Is provided, and the test solution enters the development layer through the visualization substance-binding antibody layer by capillary action, and the substance to be measured in the test solution and the visualization substance-binding antibody are antibodies in the development layer. After the antigen reaction, each layer is arranged so as to pass through the determination unit, and the amount of the substance to be measured in the test solution is measured by the amount of the visualization substance in the visualization substance-bound antibody bound to the antigen of the determination part. By configuring so as to be able to, based on the amount of did not bind to the substance to be measured visualizing substance binding antibody, it is possible to measure the quantity of substance to be determined. Therefore, it is possible to measure even a low molecular weight substance capable of performing only 1: 1 antigen-antibody reaction such as 8-hydroxydeoxyguanosine. Further, the test solution enters the development layer through the visualization substance-bound antibody layer by capillary action, and after the substance to be measured in the test solution and the visualization substance-binding antibody react with each other in the development layer, the determination unit is Since each layer is arranged to pass through, the structure becomes simple, the sensor itself can be manufactured at low cost, and the amount of low molecular weight substances such as 8-hydroxydeoxyguanosine can be easily measured. Will be able to.
以下、添付図面に示した一実施例を参照して、本発明に係る濃度測定センサの実施の形態を説明していく。 Embodiments of a concentration measuring sensor according to the present invention will be described below with reference to one embodiment shown in the accompanying drawings.
図１は本発明に係る濃度測定センサの一実施例であるイムノクロマトセンサの分解展開図、図２は図１に示したイムノクロマトセンサの上面カバー以外の部分を組立てた部分分解展開図、図３は図１に示したイムノクロマトセンサの上面図を各々示している。
図中、符号１は土台となるベース基板を示しており、このベース基板１の上に、テストストリップ２及び試液吸収部３が設けられている。
テストストリップ２は、試液吸収部３に部分的に重ねて配置された試液展開層４と、前記試液展開層４に部分的に重ねて配置された可視化物質結合抗体保持層５と、可視化物質結合抗体保持層５に部分的に重ねて配置された展開層６とから成る。
可視化物質結合抗体保持層５には、測定すべき物質と特異的に反応する抗体に、その抗体の存在を可視化できる可視化物質を結合させた可視化物質結合抗体が保持されている。具体的には、例えば、測定すべき物質が8-ヒドロキシデオキシグアノシンの場合、その抗体は、8OHdG1B1(独立行政法人 産業技術総合研究所 特許生物寄託センター 受託番号FERM P-20122)（本願の出願人が特開2006-056859にて既に提案している抗体）であり、可視化物質としては金コロイドが挙げられる。この可視化物質結合抗体保持層５に保持された可視化物質結合抗体は、試液展開層４を介して試液が導入されると試液中に溶出する。このため、可視化物質結合抗体保持層５は、使用前（即ち、試液が通過する前）は、可視化物質（例えば、金コロイド）によって色付いているが、使用後、即ち、試液が正常に通過した後は、可視化物質が試液中に溶出してしまうため色が無くなる。具体的には、可視化物質結合抗体保持層５が白いメンブレンから成り、可視化物質が金コロイドである場合には、可視化物質結合抗体保持層５は、使用前は赤色であるが、使用後は白色になる。
展開層６は、前記可視化物質結合抗体保持層５に保持された可視化物質結合抗体と結合して、同抗体を捕捉する固定化用物質が固定された判定部７を有する。この判定部７は、展開層６において測定すべき物質と可視化物質結合抗体とが充分に抗体抗原反応することができるように、可視化物質結合抗体保持層５から充分に離れた位置に設けられている。
FIG. 1 is an exploded view of an immunochromatographic sensor which is an embodiment of a concentration measuring sensor according to the present invention, FIG. 2 is a partially exploded view in which parts other than the top cover of the immunochromatographic sensor shown in FIG. 1 are assembled, and FIG. The top view of the immunochromatographic sensor shown in FIG. 1 is shown respectively.
In the figure, reference numeral 1 denotes a base substrate that serves as a base, and a test strip 2 and a reagent solution absorbing portion 3 are provided on the base substrate 1.
The test strip 2 includes a reagent solution developing layer 4 that is partially overlapped with the reagent solution absorbing portion 3, a visualization substance binding antibody holding layer 5 that is partially overlapped with the reagent solution developing layer 4, and a visualization substance binding. And a spreading layer 6 disposed partially overlapping the antibody holding layer 5.
The visualization substance-bound antibody holding layer 5 holds a visualization substance-binding antibody in which a visualization substance capable of visualizing the presence of the antibody is bound to an antibody that specifically reacts with the substance to be measured. Specifically, for example, when the substance to be measured is 8-hydroxydeoxyguanosine, the antibody is 8OHdG1B1 (National Institute of Advanced Industrial Science and Technology, Patent Biodeposition Center Accession No.FERM P-20122) (the applicant of the present application). Is an antibody already proposed in Japanese Patent Application Laid-Open No. 2006-056859), and examples of the visualization substance include colloidal gold. The visualized substance-bound antibody retained in the visualized substance-bound antibody retaining layer 5 is eluted in the reagent when the reagent is introduced through the reagent developing layer 4. Therefore, the visualization substance-bound antibody holding layer 5 is colored by the visualization substance (for example, gold colloid) before use (that is, before the sample solution passes), but after use, that is, the sample solution has passed normally. After that, since the visualization substance is eluted in the test solution, the color disappears. Specifically, when the visualization substance binding antibody holding layer 5 is made of a white membrane and the visualization substance is a gold colloid, the visualization substance binding antibody holding layer 5 is red before use but is white after use. become.
The development layer 6 has a determination unit 7 to which an immobilization substance that binds to the visualization substance-binding antibody held in the visualization substance-binding antibody holding layer 5 and captures the antibody is fixed. The determination unit 7 is provided at a position sufficiently separated from the visualization substance-bound antibody holding layer 5 so that the substance to be measured in the development layer 6 and the visualization substance-bound antibody can sufficiently react with each other. Yes.
上記したように構成されたテストストリップ２及び試液吸収部３はベース基板１上に配置され、さらに基板１にカバー１０が取り付けられる。
この実施例では、カバー１０は、ベース基板１における試液吸収部３以外の部分を全て覆うように寸法決めされており、かつ、テストストリップ２に相当する部分には確認用窓１１が形成されている。
この確認用窓１１は、可視化物質結合抗体保持層５の一部と、展開層６における判定部７が露出するように形成されている。
また、カバー１０における判定部７に相当する部分には、判定部７を挟むように色調表１２が設けられている。この実施例では、図３における判定部７の左側に測定すべき物質の量が少ない時の色（即ち、濃い色）が、右側に測定すべき物質の量が多い時の色（即ち、薄い色）が印刷されている。
The test strip 2 and the test solution absorber 3 configured as described above are disposed on the base substrate 1, and a cover 10 is attached to the substrate 1.
In this embodiment, the cover 10 is dimensioned so as to cover all portions of the base substrate 1 other than the reagent solution absorbing portion 3, and a confirmation window 11 is formed in a portion corresponding to the test strip 2. Yes.
This confirmation window 11 is formed so that a part of the visualization substance binding antibody holding layer 5 and the determination part 7 in the development layer 6 are exposed.
A color tone table 12 is provided at a portion corresponding to the determination unit 7 in the cover 10 so as to sandwich the determination unit 7. In this embodiment, the color when the amount of the substance to be measured is small on the left side of the determination unit 7 in FIG. 3 (that is, the dark color) is the color when the amount of the substance to be measured is large on the right side (that is, the color is light). Color) is printed.
次に、上記したように構成されたイムノクロマトセンサの作用を説明していく。
本発明に係る濃度測定センサを構成するイムノクロマトセンサの作用を示す図であり、（ａ）は使用前の状態を、（ｂ）は使用後の状態を各々示している。
この説明では、測定すべき物質は、尿中に含まれている8-ヒドロキシデオキシグアノシンの量であり、従って、抗体は、8-ヒドロキシデオキシグアノシンに特異的に反応する抗体（8OHdG1B1(独立行政法人 産業技術総合研究所 特許生物寄託センター 受託番号FERM P-20122)であり、可視化物質は金コロイドである。また、判定層に固定されている固定化物質は8-ヒドロキシデオキシグアノシン(8-OHdG)である。
使用者が、尿を試液吸収部３にかけると、尿は試液吸収部３に含浸する。試液吸収部３に含浸した尿は、毛細管現象により試液展開層４に入り、試液展開層４の幅全体に広がりながら可視化物質結合抗体保持層５に進む。そして、尿が可視化物質結合抗体保持層５を通過する時に、尿中に、同層５に保持された金コロイドが結合した抗体（8OHdG1B1(独立行政法人 産業技術総合研究所 特許生物寄託センター 受託番号FERM P-20122）が溶出する。金コロイド結合抗体が溶出した尿は、そのまま展開層６へ進み、同層６で8-ヒドロキシデオキシグアノシンと金コロイド結合抗体とが抗体抗原反応して、尿中にある8-ヒドロキシデオキシグアノシンに金コロイド結合抗体が結合する。展開層６に入った尿は、さらに、毛細管現象により展開層６を判定部７に向かって進む。
尿が判定部７を通過する時に、既に8-ヒドロキシデオキシグアノシンと結合した金コロイド結合抗体は判定部７を通過するが、8-ヒドロキシデオキシグアノシンと結合していない金コロイド結合抗体は判定部７に固定された固定化物質と結合して判定部７に留まる。このため、判定部７は固定化物質と結合した金コロイド結合抗体の金コロイドの色の作用で着色される。
尿中に含まれている8-ヒドロキシデオキシグアノシンの量が多ければ多いほど、8-ヒドロキシデオキシグアノシンと結合しない金コロイド結合抗体の量は少なくなるので判定部７の色は薄くなり、逆に、尿中に含まれている8-ヒドロキシデオキシグアノシンの量が少なければ少ないほど、8-ヒドロキシデオキシグアノシンと結合しない金コロイド結合抗体の量が多くなるので判定部７の色は濃くなる。
使用者は、判定部７の両隣にある色調表１２の色と判定部７の色とを比較して、尿中に含まれている8-ヒドロキシデオキシグアノシンの量が多いか否かを判断する。
ところで、上記したように、このイムノクロマトセンサはカバー１０の窓部１１が、可視化物質結合抗体保持層５の一部が露出するように形成されている。このため、使用者は、窓部１１から見える可視化物質結合抗体保持層５の色の変化によって、尿が展開層６に入っているか否かを確認することができる。具体的には、可視化物質結合抗体保持層５は、使用前は、そこに保持されている可視化物質結合抗体の可視化物質、ここでは金コロイドの作用で色付いている。そして、可視化物質結合抗体保持層５は試液、ここでは尿が通過すると、可視化物質結合抗体が試液中に溶出するため同層５の色はなくなる。従って、試液導入部３から導入した尿が、何らかの原因で展開層６に進まなければ可視化物質結合抗体保持層５の色は変わらないが、試液吸収部３から導入した尿が、正確に展開層６に進めば可視化物質結合抗体保持層５の色が変わる。このため、使用者は、窓部１１から見える可視化物質結合抗体保持層５の色によって試液が正確に展開層６に進んでいるか否かを確認することができるため、判定結果を間違えて認識することがない。
Next, the operation of the immunochromatographic sensor configured as described above will be described.
It is a figure which shows the effect | action of the immunochromatography sensor which comprises the density | concentration measurement sensor which concerns on this invention, (a) has shown the state before use, (b) has each shown the state after use.
In this description, the substance to be measured is the amount of 8-hydroxydeoxyguanosine contained in the urine. Therefore, the antibody is an antibody (8OHdG1B1 (independent administrative agency) that specifically reacts with 8-hydroxydeoxyguanosine. The National Institute of Advanced Industrial Science and Technology, Patent Biological Deposit Center (Accession Number FERM P-20122), and the visualization substance is gold colloid.The immobilized substance immobilized on the judgment layer is 8-hydroxydeoxyguanosine (8-OHdG) It is.
When the user puts urine on the test solution absorption part 3, the urine impregnates the test solution absorption part 3. The urine impregnated in the test solution absorbing part 3 enters the test solution developing layer 4 by capillary action and proceeds to the visualization substance-bound antibody holding layer 5 while spreading over the entire width of the test solution developing layer 4. When the urine passes through the visualization substance-binding antibody holding layer 5, the antibody (8OHdG1B1 (Independent Administrative Institution National Institute of Advanced Industrial Science and Technology, Patent Biological Depositary Accession No.) The urine from which the gold colloid-bound antibody is eluted proceeds directly to the development layer 6 where 8-hydroxydeoxyguanosine and the gold colloid-bound antibody react with each other in the urine. The gold colloid-binding antibody binds to 8-hydroxydeoxyguanosine in the urine, and the urine that has entered the development layer 6 further proceeds toward the determination unit 7 through the development layer 6 by capillary action.
When the urine passes through the determination unit 7, the gold colloid-binding antibody already bound to 8-hydroxydeoxyguanosine passes the determination unit 7, but the gold colloid-binding antibody not bonded to 8-hydroxydeoxyguanosine determines the determination unit 7. It remains in the determination unit 7 by combining with the immobilized substance fixed on the surface. Therefore, the determination unit 7 is colored by the action of the colloidal gold color of the colloidal gold antibody bound to the immobilized substance.
The greater the amount of 8-hydroxydeoxyguanosine contained in the urine, the smaller the amount of colloidal gold-bound antibody that does not bind to 8-hydroxydeoxyguanosine, so the color of the determination unit 7 becomes lighter. The smaller the amount of 8-hydroxydeoxyguanosine contained in the urine, the greater the amount of colloidal gold-bound antibody that does not bind to 8-hydroxydeoxyguanosine, so the color of the determination unit 7 becomes darker.
The user compares the color of the color tone table 12 on both sides of the determination unit 7 with the color of the determination unit 7 to determine whether the amount of 8-hydroxydeoxyguanosine contained in the urine is large. .
By the way, as described above, in this immunochromatographic sensor, the window portion 11 of the cover 10 is formed so that a part of the visualization substance binding antibody holding layer 5 is exposed. For this reason, the user can confirm whether or not urine is in the spreading layer 6 by a change in the color of the visualization substance binding antibody holding layer 5 visible from the window portion 11. Specifically, the visualized substance-bound antibody holding layer 5 is colored by the action of the visualized substance of the visualized substance-bound antibody held therein, here, colloidal gold, before use. The visualization substance-binding antibody holding layer 5 disappears when the test solution, here urine passes, because the visualization substance-binding antibody is eluted in the test solution. Therefore, the color of the visualization substance-bound antibody retaining layer 5 does not change unless the urine introduced from the sample solution introduction unit 3 proceeds to the development layer 6 for some reason, but the urine introduced from the sample solution absorption unit 3 does not accurately represent the development layer. If it advances to 6, the color of the visualization substance binding antibody holding layer 5 will change. For this reason, since the user can confirm whether or not the test solution has advanced to the developing layer 6 accurately based on the color of the visualization substance-binding antibody holding layer 5 that can be seen from the window portion 11, the determination result is mistakenly recognized. There is nothing.
以上説明した実施例では、本発明に係る濃度測定センサをイムノクロマトセンサで構成した例を挙げて説明しているが、本発明に係る濃度測定センサはイムノクロマトセンサに限定されることなく、例えば、尿試験紙等のように一枚のベースシート上に尿糖や尿タンパク等の少なくとも一種類の物質と発色反応する濾紙をベースとした反応層が直列に設けられるように構成された試験紙であってもよい。 In the embodiments described above, the concentration measurement sensor according to the present invention is described as an example of an immunochromatography sensor. However, the concentration measurement sensor according to the present invention is not limited to an immunochromatography sensor, for example, urine This test paper is configured such that a reaction layer based on filter paper that develops color reaction with at least one substance such as urine sugar and urine protein is provided in series on a single base sheet, such as a test paper. May be.
また、ハウジングに対する色調表の配置は、本実施例に限定されることなく、例えば、判定部を囲むように設けてもよく、また、スライド状に設けてもよい。
図５は、判定部を囲むように色調表を配置した例を示す実施例であり、この実施例では、ハウジングのカバー１０に対して窓部１１が、判定部７のみが見えるように円形に形成されており、その円形窓部１１の周囲を囲むように色調表１２が設けられている。
また、図６は、色調表をスライド状に形成した例を示す実施例であり、この実施例では、カバー１０における判定部７の前方に、濃淡が漸次的に変化するように色が表示された色調表１２を有するスライド片１３が、カバー１０の長手方向に直交する方向にスライド可能に設けられている。図中、符号１３ａはカバー１０に設けられたスライド片用ガイド部材である。
Further, the arrangement of the color tone table with respect to the housing is not limited to the present embodiment, and may be provided so as to surround the determination unit, or may be provided in a slide shape.
FIG. 5 is an embodiment showing an example in which a color tone table is arranged so as to surround the determination portion. In this embodiment, the window portion 11 is circular with respect to the cover 10 of the housing so that only the determination portion 7 can be seen. The color tone table 12 is provided so as to surround the periphery of the circular window portion 11.
FIG. 6 is an example showing an example in which the color tone table is formed in a slide shape. In this example, colors are displayed in front of the determination unit 7 in the cover 10 so that the gradation changes gradually. A slide piece 13 having a color tone table 12 is provided so as to be slidable in a direction orthogonal to the longitudinal direction of the cover 10. In the figure, reference numeral 13 a denotes a slide piece guide member provided on the cover 10.
１ ベース基板
２ テストストリップ
３ 試液吸収部
４ 試液展開層
５ 可視化物質結合抗体保持層
６ 展開層
７ 判定部
１０ カバー
１１ 窓部
１２ 色調表
１３ スライド片
１３ａ ガイド部材
DESCRIPTION OF SYMBOLS 1 Base substrate 2 Test strip 3 Reagent absorption part 4 Reagent development layer 5 Visualization substance binding antibody holding layer 6 Development layer 7 Judgment part 10 Cover 11 Window part 12 Color tone table 13 Slide piece 13a Guide member
Claims (8)
判定部が設けられたテストストリップを、少なくとも判定部の色を外部から見ることができる窓部が形成されたハウジングに収容し、
前記ハウジングの前記判定部に隣接した部分に、測定結果に応じた色調を表示する色調表を配置した
ことを特徴とする濃度測定センサ。 In a concentration measurement sensor equipped with a determination unit whose color tone changes according to the concentration of the substance to be measured,
The test strip provided with the determination part is accommodated in a housing in which a window part capable of seeing at least the color of the determination part from the outside is formed,
A density measurement sensor, wherein a color tone table for displaying a color tone corresponding to a measurement result is arranged in a portion adjacent to the determination unit of the housing.
ことを特徴とする請求項１に記載の濃度測定センサ。 The density measurement sensor according to claim 1, wherein the color tone table is provided in the housing so as to be positioned on both sides of the determination unit with the determination unit interposed therebetween.
ことを特徴とする請求項１に記載の濃度測定センサ。 The concentration measurement sensor according to claim 1, wherein the color tone table is provided in the housing so as to surround the determination unit.
前記スライド片が判定部に隣接してスライド可能に前記ハウジングに設けられている
ことを特徴とする請求項１に記載の濃度測定センサ。 The color table is displayed with colors so that the gradation changes gradually, and is provided on the slide piece,
The concentration measuring sensor according to claim 1, wherein the slide piece is slidably provided adjacent to the determination unit.
測定すべき物質の抗体に、その抗体の存在を可視化できる可視化物質を結合させた可視化物質結合抗体を保持した可視化物質結合抗体層と、
試液中の前記測定すべき物質と前記可視化物質結合抗体とが抗原抗体反応するのに充分な大きさの展開層と、
を備え、
前記展開層に、前記試液内の測定すべき物質と抗原抗体反応しなかった可視化物質結合抗体を結合させる抗原が固定された前記判定部を設け、
試液が、毛細管現象により、可視化物質結合抗体層を通って展開層に入り、展開層で試液中の前記測定すべき物質と前記可視化物質結合抗体とが抗体抗原反応した後、判定部を通過するように各層が配置され、
前記判定部の抗原に結合された可視化物質結合抗体における可視化物質の量によって試液中の測定すべき物質の量を測定することができるように構成した
ことを特徴とする請求項１〜４の何れか一項に記載の濃度測定センサ。 The test strip is
A visualization substance-binding antibody layer holding a visualization substance-binding antibody in which a visualization substance capable of visualizing the presence of the antibody is bound to the antibody of the substance to be measured;
A development layer large enough for antigen-antibody reaction between the substance to be measured in the test solution and the visualization substance-bound antibody;
With
The development layer is provided with the determination unit on which an antigen that binds a visualization substance-bound antibody that has not reacted with an antigen-antibody with a substance to be measured in the test solution is fixed;
The test solution enters the development layer through the visualization substance-binding antibody layer by capillary action, and passes through the determination unit after the substance to be measured in the test solution and the visualization substance-binding antibody react with each other in the development layer. Each layer is placed as
The structure according to any one of claims 1 to 4, wherein the amount of the substance to be measured in the test solution can be measured by the amount of the visualization substance in the visualization substance-bound antibody bound to the antigen of the determination unit. The concentration measuring sensor according to claim 1.
ことを特徴とする請求項５に記載の濃度測定センサ。 The substance to be measured is 8-hydroxydeoxyguanosine, and the antibody of the substance to be measured is 8OHdG1B1 (National Institute of Advanced Industrial Science and Technology, Patent Organism Depositary Accession No.FERM P-20122) The concentration measuring sensor according to claim 5.
ことを特徴とする請求項５に記載の濃度測定センサ。 The concentration measuring sensor according to claim 5, wherein the visualization substance is gold particles.
ことを特徴とする請求項５又は６に記載の濃度測定センサ。 The concentration measuring sensor according to claim 5 or 6, wherein the visualization substance is latex particles, pigment molecules, or a fluorescent substance.
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