201142285 六、發明說明： 【發明所屬之技術領域】 本發明係有關生物感測試片結構，尤其是一種使用微量生物檢體即可 進行檢測之生物感測試片結構。 【先前技術】 有關於自我測試(Self-Test)的生物感測試片之技術，隨著曰新月異的科 技演變’試片體積要求欲逐漸縮小且輕薄，而同時在製造試片方面越考慮 其製程簡便及低成本等之gj素，因此對賊片的材料與結構設計，同業間 有各種不同研究與產品紛紛出爐。 目刖生物感測試片係利用一塑膠隔片製作形成一通道，利用通道所產 生的毛細現象將檢體導流進入反應檢測區，進而順利對檢體進行量測，而 利用塑膠隔片所製成的通道之厚度高，因此習知技術中通常試片檢測所需 的檢體量多，並且在製作塑膠隔片之通道時，需經過一段沖壓程序，其製 程手段較為繁複。 而為了達到提南試片製作效率以及檢體需求量減量等優點，台灣專利 公告號1239397揭露一種電化學網版印刷電極感測試片及其製法，如第^ 圆所示，此專利所揭示之試片結構係由一絕緣性底板1〇上印刷方式製成導 線12 ’並在導線12上印刷上電極14，而在印刷有電極14的底板1〇上黏 貼或網版印刷一含有溝槽161的絕緣中間層16,並有一上蓋片18貼合此絕 緣中間層16，以使溝槽161成為毛細導流通道。而由於絕緣中間層16可選 用絕緣性的介電材料印刷製成，或以黏貼方式覆蓋於電極表面，目的係為 了簡化試片的結構’然而此種技術的缺點在導流通道於絕緣中間層16内形 201142285 成’因此通道的南度不足所以吸收檢體的成功率降低，因而為了讓毛細導 流通道產生反應，通常在上蓋片18具有一凸起空間181，或直接將上蓋片 18開個孔洞(圖中未示）’來加強導流的效率’但是若增加了上蓋片18的模 具加工製程，相對的增加了整個製造流程的複雜度且降低提供其他彈性設 計的可能性。 另外’台灣專利公開號200823456所揭露的一種生物感測試片，為了 簡化加工程序的繁雜，提出-種生物感測試片結構，其係利用背勝的形狀 及厚度，在設有電極的絕緣基板上形成毛細通道，獨由於背膠為軟性材 質’導致其形成的毛細通道之厚度不穩定，料造成毛細通道碰縮變形， 也可能影響吸入檢體時的成功率與檢測的重複性。 因此為了簡化試片加工製程’且又同時確保試片品質，本發明提出一 種具有微通道之生物感職片結構，其結構特徵冀以簡化試片製程與 提高檢測成功率之優勢。 【發明内容】 本發明之主要目的係提出-種具有微通道之生物感測試片結構，試片 上具有-微通道，微通道之總體厚度可包括設於基板上的電極層加上絕緣 層與黏膠層之厚度，由於電極層與絕緣層材f為硬性材質所構成，所以足 以穩定構成微通道之整體結構，使其不綠縮變形而受到影響，因此試片 吸入檢體時保有毛細現象產生並成功進行檢測運作。 本發明之另-目的係提出-種具有微通道之生物感測試片結構，其微 通道内容積小，因此進行檢體量測時，僅需要微量的檢體量(約Ο·鋪 即可進行檢測。 201142285 本發明之再—目的係提出—種具有微通道之生物感測則結構，其結 構簡單’在具有電極層的基板上，印刷絕緣層以及黏膠層構成一微通道， 因此試片製程簡易且具彈性，並可節省成本。 為達到上述之目的，本發明係提出一種具有微通道之生物感測試片結 構’其係包括-下基板上設有—電極層’且在電極層上設有—絕緣層，其 具有第通道’在此第一通道中露出局部的下基板與局部的電極層；再者， 在絕緣層上在設有—黏縣，黏騎設有—第二通道，其位魏對應設於 #下層的第-通道上，進而第一通道與第二通道可形成一微通道，而微通道 中a又有-電化學檢測區域，微通道是包含至少兩個向外的開口；以及最上 層蓋上一上基板，係設於黏膠層上，以覆蓋此微通道並鞏固整體試片之結 構。 底下藉由具體貫施例配合所附的圖式詳加說明，當更容易瞭解本發明 之目的、技術内容、特點及其所達成之功效。 【實施方式】 φ 隨著生技產業的蓬勃發展，生化檢測的應用範圍亦隨生化檢測需求的 曰益普及而愈加廣泛，例如血糖、尿酸 '乳酸、膽固醇等其他生化檢測； 目前市場最大、最常見且應用最多的係以血糖檢測為主，而本發明不以血 - 糖為限。 為了提高檢體檢測之效率以及簡化製作試片流程，本發明結合軟性的 黏膠層以及硬性的絕緣層來製作微通道，利用電極層、黏膠層與絕緣層之 厚度作為整體微通道之厚度’使得本發明之試片所需的檢體可再次縮減其 檢體體積’並在此種僅吸入微量液體的通道内仍保有毛細效應，使試片檢 201142285 測可正常運作。 本發明係提出一種具有微通道之生物感測試片20，其結構如第2〜7圖 所示’其中第5 @係為第4圖之剖線AA’的結構剖面圖，帛6圖係為第4 圖之剖線BB，的結構剖面圖，第7圖係為第4圖之剖線cc，的結構剖面圖。 本發明之生物感測試片2〇結構係由一下基板22上設有一電極層Μ，其中， 電極層24之材f係為銀、銅、金、贼碳等金屬導f材質，此電極層24 係由至少-工作電極24卜一對電極242與一辅助電極243構成。在電極層 上覆蓋有-絕緣層26 ’其中，絕緣層26之材質為油漆、絕緣漆或w油墨 等硬性材質。而絕緣層26内具有—第—通道34，使下面部分的電極層24 與部分的·^板22露出，其中部分電極層24暴露於該第一通道％之内， 如第6圖所示’圖中部分的工作電極加及部分的對電極如係暴露於此 第一通道34〜另外在本實施例中’辅職極243作用在於支樓絕緣層26， 並且輔助電極243係由絕緣層26所覆蓋，而且第一通道別在絕緣層如側 面形成至少兩個之開口。而在絕緣層26上更設有-_層28，其中，黏膠 層28之材質為水膠或壓克力膠等軟性材料，黏膠層28對照著下層第一通 道34位置5χ有—第二通道36，其具有兩個開口於黏膠層μ側面，由第一 通道34與第一通道％結合進而形成一微通道3〇,而微通道中設有一電 化子檢測區域31 ’其中電化學檢顺域31係包含有反之生化反應催化 例如酵素4者是其他非生物催化物。且工作電極241及對電極如 之端分別與電化學檢測區域S1連接。在本實施例甲第一通道別與第 二通道36戶斤組成之微通道3〇的幾何形狀係為l形，如圖所示因第一通 道34與第—通道36之開口重疊設計，所以微通道％亦具有兩個向外為不 201142285 同方向之開口 ’其分別連通電化學檢顺域3ι，如圖所示。而本發明之具 有微通道之生物感測試片20結構中使用一上基板32覆蓋於黏膠㈣上與 /通C3〇_L以鞏固整體試片結構。再者，上基板η無膠層烈接觸的 那-面’還可預先進行親錢理，使該上基板32更具備加速檢體吸入的功 能性。 其巾，L型微通道3〇係具有兩端開口，如第*圖所示，其一者為吸入 σ 38 ’另-者為排氣口 4Q。生物感職片—般所採集的檢體通常為生物的 φ血液、唾液、淚液或尿液等，在此說明係以血液為例；在採集作為檢體之 血液時由吸入口 38接觸血液，透過毛細現象由排氣口 4〇排除氣體且吸 入血液並將其引人微通道3〇 _電化學檢測區域31，而吸人後的血液再與 反應催化舰生生化反應，而此生化反應的電荷量賊之喊會經由工作 電極241與對電極242之另—端傳送到所連接的電子生化檢測裝置㈤未示) 進行量測，即可得知血液的血糖濃度。 另外’本發明之輔助電極亦可變更設計，例如：將部分的輔助電極如 •暴露於第一通道34内，如第8、9圖所示，由於輔助電極243的位置接近 於排氣口 4G ’當檢體引人電化學檢灌域31而持續狀直到充滿微通道 30時，才會接觸到輔助電極243，因此這種設計可將輔助電極243作為偵 測檢體是否填滿微通道30之感應電極。 因此，本發明所揭露的具有微通道之生物感測試片結構，係利用絕緣 層與黏膠層結合來設計微通道結構，由於結構簡單，且在製作方面簡易， 其製程方式係在下基板上依序印刷電極層、絕緣層與黏膠層三層，最後再 以上蓋片覆蓋於黏膠層上，立即完成本發明。而且，本發明之生物感測試 7 201142285 片結構由於其微通道的容積小，因此試片所採集的檢體量只需約α2_〇3微 升，為目前自我測試(Self-Test)的生物感測試片結構所需檢體量最少的。更 值得注意的是，本發明之生物感測試片結構為了避免微通道過小無法載入 檢體的情況發生，構成試片微通道之材料係採用硬性材質的絕緣層作為構 成微通道主要的結構’因此微通道不易受到外力而變形，而再加上軟性材 質之黏膠層增加微通道之高度，以保證微通道吸收檢體時可產生毛細現 象’進而順利吸入檢體並成功完成檢測。 以上所述之實施例僅係為說明本發明之技術思想及特點，其目的在使 熟習此項技藝之人士能夠瞭解本發明之内容並據以實施，當不能以之限定 本發明之專利範圍’即大凡依本發明所揭示之精神所作之岣等變化咬終 飾’仍應涵蓋在本發明之專利範圍内。 【圖式簡單說明】 第1圖為先前技術之試片結構分解圖。 第2圖為本發明之較佳實施例之立體圖。 第3圖為本發明之較佳實施例之結構分解圖。 第4圖為本發明之較佳實施例之結構示意圖。 第5圖為第4圖之AA’剖線位置之剖視圖。 第6圖為第5圖之BB’剖線位置之剖視圖。 第7圖為第6圖之CC’剖線位置之剖視圖。 第8圖為本發明之另一實施例之結構示意圖。 第9圖為第8圖之BB’剖線位置之剖視圖。 【主要元件符號說明】 201142285 ίο絕緣性底板 12導線 14電極 16絕緣中間層 161溝槽 18上蓋片 181凸起空間 φ 20生物感測試片 22下基板 24電極層 241工作電極 242對電極 243輔助電極 26絕緣層 φ 28黏膠層 30微通道 31電化學檢測區域 32上基板 34第一通道 36第二通道 38吸入口 40排氣口201142285 VI. Description of the Invention: [Technical Field] The present invention relates to a biosensor test piece structure, and more particularly to a biosensor test piece structure which can be detected using a trace biological sample. [Prior Art] The technology of self-test (Self-Test) biosensing test piece, with the rapid development of technology, the test piece volume requirement is gradually reduced and light, and at the same time, the more consideration is made in manufacturing test pieces. The process is simple and low-cost, so the material and structure design of the thief film, there are various research and products in the industry. The biosensor test piece is formed by using a plastic spacer to form a channel, and the capillary phenomenon of the channel is used to guide the sample into the reaction detection area, thereby smoothly measuring the sample, and using the plastic spacer. The thickness of the formed channel is high. Therefore, in the prior art, the amount of the test piece required for the test piece is usually large, and when the passage of the plastic spacer is made, a punching process is required, and the process method is complicated. In order to achieve the advantages of the production efficiency of the sample film and the reduction of the sample demand, Taiwan Patent Publication No. 1239397 discloses an electrochemical screen printing electrode sensing test piece and a method for preparing the same, as shown in the first circle, which is disclosed in the patent. The test piece structure is formed by printing a wire 12' on an insulating substrate 1 and printing the upper electrode 14 on the wire 12, and pasting or screen printing a groove 161 on the substrate 1 on which the electrode 14 is printed. The insulating intermediate layer 16 has an upper cover sheet 18 attached to the insulating intermediate layer 16 to make the groove 161 a capillary flow guiding passage. The insulating interlayer 16 may be formed by printing with an insulating dielectric material or by adhering to the surface of the electrode in order to simplify the structure of the test piece. However, the disadvantage of this technique is that the flow guiding channel is in the insulating interlayer. 16 internal shape 201142285 becomes 'so the south of the channel is insufficient, so the success rate of the absorbed sample is reduced, so in order to make the capillary flow guiding channel react, usually the upper cover piece 18 has a convex space 181, or directly the upper cover piece 18 is opened. A hole (not shown) is used to enhance the efficiency of the flow guide. However, if the mold processing process of the upper cover sheet 18 is increased, the complexity of the entire manufacturing process is relatively increased and the possibility of providing other elastic designs is reduced. In addition, in order to simplify the complexity of the processing procedure, a biological sensing test piece is proposed in the 'Taiwan Patent Publication No. 200823456, and a biosensor test piece structure is proposed, which uses the shape and thickness of the back win on the insulating substrate provided with the electrode. The capillary channel is formed, and the thickness of the capillary channel formed by the adhesive is a soft material. The capillary channel is contracted and deformed, which may affect the success rate and the repeatability of the detection when the sample is inhaled. Therefore, in order to simplify the test piece processing process and at the same time ensure the quality of the test piece, the present invention proposes a biological sensor structure having a microchannel, and its structural features are to simplify the test piece process and improve the detection success rate. SUMMARY OF THE INVENTION The main object of the present invention is to provide a micro-channel biosensor test piece structure having a microchannel on the test piece. The overall thickness of the microchannel may include an electrode layer disposed on the substrate plus an insulating layer and a paste. Since the thickness of the adhesive layer is composed of the hard material of the electrode layer and the insulating layer f, it is sufficient to stably form the entire structure of the microchannel so as not to be affected by the green shrinkage deformation, so that the test piece retains the capillary phenomenon when sucking the sample. And successfully carried out the test operation. Another object of the present invention is to provide a biosensor test piece structure having a microchannel, wherein the microchannel has a small internal volume, so that only a small amount of sample is required for the measurement of the sample (about Ο· shop) 201142285 The invention again proposes a biological sensing structure with microchannels, which has a simple structure 'on a substrate having an electrode layer, a printed insulating layer and an adhesive layer forming a microchannel, so the test piece The process is simple and flexible, and can save cost. In order to achieve the above object, the present invention provides a biosensor test piece structure having a microchannel, which comprises an -electrode layer on the lower substrate and on the electrode layer. An insulating layer is provided, which has a first channel in which a partial lower substrate and a partial electrode layer are exposed in the first channel; further, an insulating layer is provided with a sticky county, and the sticky riding is provided with a second channel The Wei is correspondingly disposed on the first channel of the lower layer, and the first channel and the second channel can form a microchannel, and the microchannel has a-electrochemical detection region, and the microchannel includes at least two directions. Outside opening And the upper layer is covered with an upper substrate, which is disposed on the adhesive layer to cover the microchannel and consolidate the structure of the whole test piece. The bottom part is explained by the specific embodiment with the attached drawings. It is easy to understand the object, technical content, characteristics and the effects achieved by the present invention. [Embodiment] φ With the vigorous development of the biotechnology industry, the application range of biochemical detection has become more widespread with the popularization of biochemical detection requirements. For example, blood glucose, uric acid, lactic acid, cholesterol and other biochemical tests; the largest, most common and most widely used in the market is blood glucose testing, and the present invention is not limited to blood-sugar. In order to improve the efficiency and simplicity of sample testing In the process of preparing a test piece, the present invention combines a soft adhesive layer and a hard insulating layer to form a microchannel, and the thickness of the electrode layer, the adhesive layer and the insulating layer is used as the thickness of the entire microchannel, so that the test piece of the present invention is required The sample can reduce its sample volume again' and maintain the capillary effect in the channel that only inhales a small amount of liquid, so that the test piece can be tested normally. The present invention provides a biosensor test piece 20 having a microchannel, the structure of which is shown in the second to seventh figures, wherein the fifth embodiment is a cross-sectional view of the cross-sectional line AA' of the fourth figure, FIG. The structural cross-sectional view of the section line BB of Fig. 4, and Fig. 7 is a cross-sectional view of the section line cc of Fig. 4. The biosensor test piece 2〇 structure of the present invention is provided by the lower substrate 22 An electrode layer Μ, wherein the material f of the electrode layer 24 is made of a metal material such as silver, copper, gold or thief carbon, and the electrode layer 24 is composed of at least a working electrode 24 and a pair of electrodes 242 and an auxiliary electrode 243. The electrode layer is covered with an insulating layer 26', wherein the insulating layer 26 is made of a hard material such as paint, insulating varnish or w ink, and the insulating layer 26 has a first channel 34 for the lower portion of the electrode layer. 24 and a portion of the board 22 is exposed, wherein a portion of the electrode layer 24 is exposed within the first channel %, as shown in FIG. 6 'the portion of the working electrode of the portion of the working electrode is exposed to the first electrode a channel 34~ additionally in the present embodiment, the 'secondary pole 243 acts on the branch insulation layer 26, and The auxiliary electrode lines 243 are covered by an insulating layer 26, but not in the first channel insulating layer formed as side surfaces of the at least two openings. The insulating layer 26 is further provided with a layer _ 28, wherein the material of the adhesive layer 28 is a soft material such as water glue or acrylic glue, and the adhesive layer 28 is positioned at the position of the lower first channel 34. The second channel 36 has two openings on the side of the adhesive layer μ, and the first channel 34 is combined with the first channel % to form a microchannel 3〇, and the microchannel is provided with an electrochemical detection region 31' The detection domain 31 contains a biochemical reaction, such as enzyme 4, which is another non-biocatalyst. Further, the working electrode 241 and the counter electrode are connected to the electrochemical detection region S1, respectively. In the present embodiment, the geometry of the microchannel 3〇 composed of the first channel and the second channel 36 is 1 shape, and the first channel 34 and the first channel 36 are overlapped as shown in the figure, so The microchannel % also has two openings that are outwardly non-201142285 in the same direction's respectively connected to the electrochemical detection domain 3ι, as shown. In the structure of the biosensor test strip 20 having the microchannel of the present invention, an upper substrate 32 is used to cover the adhesive (4) and /C3〇_L to consolidate the overall test piece structure. Further, the side surface of the upper substrate η which is not in contact with the glue layer may be subjected to pro-intimacy, so that the upper substrate 32 has a function of accelerating the inhalation of the sample. The towel, the L-shaped microchannel 3 has both ends open, as shown in Fig. 6, one of which is suction σ 38 ' and the other is the exhaust port 4Q. The biological sensory film is generally collected from the biological blood ph blood, saliva, tears or urine. The blood is taken as an example. When the blood as the sample is collected, the blood is contacted by the suction port 38. Through the capillary phenomenon, the gas is exhausted from the exhaust port 4〇 and the blood is sucked and introduced into the microchannel 3〇 electrochemical detection zone 31, and the blood after inhalation reacts with the reaction catalytic ship biochemical reaction, and the biochemical reaction The charge of the thief is measured by measuring the blood glucose concentration of the blood by measuring the other end of the working electrode 241 and the counter electrode 242 to the connected electronic biochemical detection device (5). In addition, the auxiliary electrode of the present invention may also be modified in design, for example, by exposing a part of the auxiliary electrode to the first channel 34, as shown in FIGS. 8 and 9, since the position of the auxiliary electrode 243 is close to the exhaust port 4G. 'When the sample introduces the electrochemical detection field 31 and continues until the microchannel 30 is filled, the auxiliary electrode 243 is contacted. Therefore, the design can use the auxiliary electrode 243 as a detection sample to fill the microchannel 30. The sensing electrode. Therefore, the biosensor test piece structure with microchannels disclosed in the present invention uses a combination of an insulating layer and an adhesive layer to design a microchannel structure. Since the structure is simple and simple in fabrication, the manufacturing method is based on the lower substrate. The electrode layer, the insulating layer and the adhesive layer are sequentially printed, and finally the cover sheet is covered on the adhesive layer, and the present invention is completed immediately. Moreover, the biosensor test 7 201142285 piece structure of the present invention has a small volume of the microchannel, so the sample volume collected by the test piece needs only about α2_〇3 μl, which is the current self-test (Self-Test) organism. The test sample structure requires the least amount of sample. More importantly, the biosensor test piece structure of the present invention is formed in order to prevent the microchannel from being too small to be loaded into the sample. The material constituting the microchannel of the test piece is made of a hard material insulating layer as the main structure constituting the microchannel. Therefore, the microchannel is not easily deformed by external force, and the adhesive layer of the soft material increases the height of the microchannel to ensure that the microchannel can generate capillary phenomenon when the sample is absorbed, and the sample is smoothly inhaled and the detection is successfully completed. The embodiments described above are merely illustrative of the technical spirit and characteristics of the present invention, and the purpose of the present invention is to enable those skilled in the art to understand the contents of the present invention and to implement the invention. That is, the changes in the spirit of the invention disclosed in the present invention are still to be covered by the patent of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is an exploded view of a prior art test piece structure. Figure 2 is a perspective view of a preferred embodiment of the present invention. Figure 3 is an exploded view of the preferred embodiment of the present invention. Figure 4 is a schematic view showing the structure of a preferred embodiment of the present invention. Fig. 5 is a cross-sectional view showing the position of the line AA' of Fig. 4; Fig. 6 is a cross-sectional view showing the position of the line BB' of Fig. 5. Fig. 7 is a cross-sectional view showing the CC' line position of Fig. 6. Figure 8 is a schematic view showing the structure of another embodiment of the present invention. Fig. 9 is a cross-sectional view showing the position of the line BB' of Fig. 8. [Main component symbol description] 201142285 ίοInsulating base plate 12 wire 14 electrode 16 insulating intermediate layer 161 groove 18 upper cover piece 181 convex space φ 20 biosensor test piece 22 lower substrate 24 electrode layer 241 working electrode 242 counter electrode 243 auxiliary electrode 26 insulating layer φ 28 adhesive layer 30 microchannel 31 electrochemical detection region 32 upper substrate 34 first channel 36 second channel 38 suction port 40 exhaust port