1294964 九、發明說明： 【發明所屬之技術領域】 本案為關於一電化學式感測試片的發明，尤指與一種拋棄式 的電化學式感測試片有關的發明。 、 【先前技術】 ^本發明為前申請專利序號第92131008號的延續。本發明延續 該專利之基本架構〈但已改變試片結構〉，以製造出另一種具有 金屬電極（Metal Electrode)的電化學式感測試片(Electr〇chemical1294964 IX. Description of the invention: [Technical field to which the invention pertains] The present invention relates to an invention of an electrochemical sensing test piece, and more particularly to an invention relating to a disposable electrochemical type test piece. [Prior Art] The present invention is a continuation of the prior patent number No. 92131008. The present invention continues the basic structure of the patent (but the test piece structure has been changed) to produce another electrochemical sensing test piece having a metal electrode (Electr〇chemical)
Sensor Strip)，其適用於測試一待測流體中某分析物的含量，例如： ，，血液中的血糖、尿酸、膽固醇濃度以及污水中的重金屬與農 ，等物質之濃度；換言之，由本發明所製成的拋棄式的電化學式 感測試片適用於各式的電化學式檢測器、生物感測器、流體生化 ^分感測II以及各式絲醫療細的檢測器（例如血糖檢測器） 等。 爾你f ί ΐΐ感測試片(Electrochemical Sensor Strip)已被成熟地應 =於各種^體的檢測上，而其基本架構乃包含：丨—個容置一 ===容器；2.-化學試賴Reagent)，祕與該制流體之一 作用’並產生—電性參數的輸出信號，此電 t 體之該分析物有關；3.複數侧試電 其包含對電極(CounterElectr〇de)、工作電極降㈣Sensor Strip), which is suitable for testing the content of an analyte in a fluid to be tested, for example: , blood glucose, uric acid, cholesterol concentration, and concentration of heavy metals and agricultural materials in sewage; in other words, by the present invention The disposable electrochemical sensing test piece is suitable for various types of electrochemical detectors, biosensors, fluid biochemical sensing II, and various fine medical detectors (such as blood glucose detectors). Electrochemical Sensor Strip has been matured to be tested on a variety of bodies, and its basic structure includes: 丨 容 容 容 = == container; 2. - Chemical test Lai Reagent), secretly interacts with one of the fluids of the system and produces an output signal of the electrical parameter, which is related to the analyte; 3. The complex side tester contains the counter electrode (CounterElectr〇de), working Electrode drop (4)
EleTdT EleCtr〇de^^^^^^ (Detecting l^trode)。其中，當待測流體為人的血液，而待分析物醣 麼葡萄糖氧化酵素及其他複合物來作為化學試劑。EleTdT EleCtr〇de^^^^^^ (Detecting l^trode). Among them, when the fluid to be tested is human blood, the analyte sugar glucose oxidase and other complexes are used as chemical reagents.
Iff ί寸且皆被覆〈CGating〉—層貴金屬WP^ln〉、的1 屬條作為絕緣基板上的金屬電極（1應 上）’但，因貴金肠的耗材較大二真正 質特性者只有在與電化反應層相接觸的部分=== 1294964 » » 3即可），故整個金屬電極表面皆被覆鈸金屬實為一種無謂的 例，if ϋ]ΐ5,985，116號則是—個抛棄式印刷電極的實 ί電3使^的糊狀導電膏之成分所左右；#以貴金屬作為糊狀 成‘具雜佳的敏感度與較低的化學干擾作用，但是 朽$的咼；反之，若是使用成本較低的導電碳膜來製作電 tit有效降低所需成本，但是所獲得的電極卻因 而易造成量號的誤差。 — 叫η 雖然各式電化學式感測試片已成為現今居家醫療檢測 例如：也糖 '尿酸、膽固醇的檢 -曰是、 測精2度與製作成本卻都存有可再改進的空間仁疋檢 盆第―圖’其為習用電化學式制試片的製作流程圖， 個絕緣基板；2.架設電極於該絕緣基板上； 上塗覆-化ϋ丨捕ΐ—反應凹槽;4.在該反應凹_及該電極 該3二”成—電化反應層;5.待化學試劑乾燥後封閉 反應凹槽，6·財刷方式在絕緣基板賴邊沖刷出一開口。 學式(Α) _ (〇 ’其中第二圖（Α)為習用之電化 ίΪΐ 33刷操作前之狀態圖，第二圖（B)為習用之電化 ίϊίΐΐΐ沖刷操作後之狀態圖，而第二圖（C)則為待測流 ^包制刻齡意目；其巾該魏學式感測試 乃匕3、、、邑緣基板丨丨、電極12、電化反應層13、反應凹 Ϊ- 。如第二圖(A)所示，該反應凹槽14於未沖:前 ί化槽，當—液體狀的化學試劑進人時（未圖示）， 5雷會流出反應凹槽14外’待化學試劑乾燥後即生成 後再;^沖_作來處理該電化學式感測i 一 /、/、有如弟一圖（B)所示的侧邊開口 16，其中往、、目丨札 經由位於電化學式感測試片1侧邊的該開口 16進入反廊凹禅 而與該電化反應層13發生電化反應，並引發—錢 1294964 處:感測試片1時’其亦會沖掉-部分的該電化反 ^生# 過程中’魏化反應層13將可賴受到沖刷Iff ί 且 〈 〈 CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG CG In the part that is in contact with the electrochemical reaction layer === 1294964 » » 3, so the entire metal electrode surface is covered with bismuth metal is a kind of unnecessary example, if ϋ] ΐ 5,985,116 is a discard The electrode of the printed electrode is made of the composition of the paste-like conductive paste of the ^; the use of precious metal as a paste to form a 'common sensitivity and low chemical interference, but the $ of the 咼; If a lower cost conductive carbon film is used to make an electrical titer, the required cost is reduced, but the obtained electrode is liable to cause a volume error. — η Although various electrochemical test strips have become the home medical test for today, for example: the test of uric acid, cholesterol, sputum, 2 degrees of measurement and production cost, there is room for improvement. Pot-图图' is a flow chart for the production of conventional electrochemical test strips, an insulating substrate; 2. erecting electrodes on the insulating substrate; upper coating-chemical enthalpy-reaction groove; The reaction concave_and the electrode of the electrode are formed into an electro-chemical reaction layer; 5. After the chemical reagent is dried, the reaction groove is closed, and the opening method is used to flush an opening on the insulating substrate. 〇 'The second picture (Α) is the state of the electrification Ϊΐ Ϊΐ 33 state diagram before the brush operation, the second picture (B) is the state of the electro-acupuncture ίϊίΐΐΐ scouring operation, and the second picture (C) is waiting The flow measurement method is used for the inspection of the age; the towel is tested by the Wei-style test, the 丨丨3,, the edge substrate 丨丨, the electrode 12, the electrochemical reaction layer 13, the reaction concave Ϊ - as shown in the second figure (A) As shown, the reaction recess 14 is unwashed: before the liquid chemical is introduced (not shown), 5 Ray will flow out of the reaction groove 14 'after the chemical reagent is dried and then generated; ^ _ _ to handle the electrochemical sensing i / / /, as shown in the figure (B) side opening 16. In the middle, the opening and exiting through the opening 16 on the side of the electrochemical sensing test piece 1 enters the anti-corridor and is electrically reacted with the electrochemical reaction layer 13, and is triggered - money 1294964: sensory test piece 1 When it's also washed away - part of the eliminator's reaction, the process of 'weihua reaction layer 13 will be washed away
If龜裂131位於魏極12的上方，則當使該伽i 麻寸Kp亩後’其可絲未與電化反麟13的化學試劑反 了雷極12接觸而發生了預期外的電化反應，進而將 降低了電化學核職片1的精確度。 棄式的電化學式感測器試片的金屬電極的製作成 t究測精销，本案發明人經過反覆實驗、測試及 =ί、=獲传—種拋棄式的電化學式感測試片的結構及其製 •Λ*处/女明除了可有效降低製作成本與簡化製作流程之外， =5;免感測試片在製作過程中遭受到不必 【發明内容】 本發明提供了—種電化學式感職片，該電化學式感測試片 0 3 —絕緣基板、一覆蓋部、一電化反應層以及電極裝置。豆中， 該絕緣，板具有至少—個反應凹槽，且該反應凹槽具有一第二區 域，-第二區域，該第二區域乃介於該第—區域與該絕緣基板的 一，緣之間，而該絕緣基板與該反應凹槽為一體成型，·該覆蓋部 覆蓋在該反應凹槽上，而該反應凹槽在該絕緣基板的邊緣留有開 口，該電化反應層則位於該反應凹槽内且為一電化反應發生的位 置。該電極裝置乃裝設於該反應凹槽中，用以檢測並傳輸該電化 反應所產生之一#號。其中，該第二區域的粗趟度乃低於該第一 區域的粗縫度。 ^ 根據上述構想，其中該第二區域的寬度乃為〇〇5_至4〇_。 根據上述構想，其中該第二區域的寬度乃為〇1_至2 〇_。 根據上述構想，其中該電極裝置的一端乃與該電化反應層相 連。 ^ 根據上述構想，其中該反應凹槽具有至少一貫孔。 1294964 根據上述構想，其中該電極裝置穿過該貫孔。 根據上述構想，其中該電極裝置包含複數個電極。 根據上述構想，其中該複數個電極選自於對電極、工作電極、 參考電極與檢測電極。 根據上述構想，其中該複數個電極分別由一導電素材覆 層金屬薄膜而形成。 一y根^上述構想，其中該電化反應層包括一化學試劑，用以與 一待测分析物（Analyte)發生該電化反應以引發該信號。 根據上述構想，其中該待測分析物由該開孔進入該反應凹槽。 一根據上述構想，其中該覆蓋部上至少具有一氣孔；該氣孔為 二毛細流動通道的對流孔，以便調節反應凹槽内的壓力，並進而 調整該待測分析物在該反應凹槽内的分佈。 型根據上述構想，其中該反應凹槽與該絕緣基板為塑膠射出成 根據上述構想，其中該絕緣基板在該開口處乃具有不平坦的 邊緣。 、再者，本案乃提出了一種電化學式感測試片，所述電化學式 感浪m片用於檢測-待測流體中的某一分析物。所述電化學式感 測忒片包&·一絕緣基板、一覆蓋部、一電化反應層以及電極裂 置。其中該絕緣基板具有至少一個反應凹槽，及至少一貫孔置於 該反，凹槽=，而該絕緣基板、該反應凹槽與該貫孔為一體成型。 該覆蓋部覆蓋在該反應凹槽上，而該電化反應層乃位於該反應凹 槽内，且為一電化反應發生的位置。該電極裝置乃裝設於該反應 ^的貫孔中，該電極裝置組裝於該貫孔而形成_第—電極面與 -第二電極面，該第—電極面與該化學反應層相接，用以檢測^ 電化學反應所產生之-信魏流，該第二電極面為該信號電流的 輸出端點。#中該覆蓋部於覆蓋於該反應凹槽後，使該反應凹槽 在該絕緣基板的邊緣處乃具有與外界相通的一開口，該開口為 待測流體的輸入口。 1294964 塑 膠射t據想’其中該絕緣基板、該反應凹槽與該貫孔為 根據上述構想，其中該電極襄置包含對電極。 f據上述構想，其中該雜裝置包含工作電極。 根據上述構想，其中該雜裝置包含參考電極。 f據上述構想，其中該電極裝置包含檢測電極。 薄二=該 的壓:氣 凋正該分析物在該反應凹槽内的分佈。 緣。根據上述構想，其巾舰緣紐在· σ處具有不平坦的邊 it外’本案也提供了—種製作電化學式感測試片的方法，盆 匕括如下步驟：提供—絕緣基板，其具有至少—反應凹槽，且^ 、，緣基板，該反應凹槽為—體成型；在該反應凹槽内形成二 套ί一ί域ί中該第二區域乃介於該第一區域與該絕緣 土板的，緣之間且該第二區域的粗糙度乃低於該第一區域的粗糙 度，架設至少-個電極裝置於該反應凹槽；在該反應凹槽内形= 一個與該電極裝置相接觸的電化反應層；以及以一覆蓋板覆蓋該 反應凹槽。其中，該反應凹槽在該絕緣基板的邊緣具有與外界相 通的開口。 、 根據上述構想，其中該電極裝置包含複數個電極。 根據上述構想，其中該複數個電極分別由一導電素材覆蓋一 層金屬薄膜而形成。 根據上述構想，其中該覆蓋板具有至少一氣孔，其用以調 該反應凹槽的壓力。 根據上述構想，其中該絕緣基板在該開口處乃具有不平坦的 邊緣。 1294964 【實施方法】 本案之電化學式感測試片的結構與製作方法，將可由以下的 =施例說明而得到充分瞭解，並使得熟f本技藝之人士可以據以 完成=，然^，之實施型態並不限制於下列實施例中。 =閱第三圖，為本發明之電化學式感測試片之製作流程 :處乂驟包含· L提供具有至少—反應凹槽的絕、緣*板；2·在該 形成—第一區域與—第二區域；3·架設至少一個電極裝 ί凹槽内塗佈—液體或膠狀的化學試 與該冑轉置相細㈣化反麟；以及 通的門口。應凹槽。其中’該反應凹槽有一與外界間相 型;:該第:區用塑膠射出而-體成 應層藉塗附、散佈粗糙度。其中該電化反 ===置，由複數個槽 當使用的貓缝3 、金白金、鈀、鍺、釕、銥。另外， -甲酸亞丁烯^ ^由聚氯乙婦、聚丙烯、聚碳酸醋、聚對苯 合==製，透過將： 驟，也因此可完全避免化學反 =白2冲刷步 請參閱第四圖（A)二應層：到非必要性之應力的破壞。 施例之電化學式感測試片爆炸圖’，n(^)d的-較佳實 如第四圖（A)-(c)所千士 f該電化學式感測试片之背面圖。 (C)所I’本案㈣ = 1294964 —具有一反應凹槽21的絕緣基板2、在該反應凹槽21内的一電化反 應層22、一覆蓋部23、一開口24以及一不平坦的邊緣25，其中該 覆蓋部23具有一氣孔231以及一觀察窗232。而當覆蓋部23遮蔽反 應凹槽21後’該反應凹槽21在該絕緣基板2的邊緣乃存有開口24 ; 另外，在反應凹槽21乃具有一第一區域214以及一第二區域215。 般而& ’第一區域215的寬度為〇.〇5mm至4.0mm，而其中又以 0.1mm至2.0mm為較佳。另外，該第一區域214的粗糙度乃大於第 二區域215的粗糙度，因此，當液狀化學試劑（未圖示）塗佈於反 應凹槽21的第一區域214與第二區域215之後，該液狀化學試劑與 該第一區域214之間所產生的附著力將會大於在該液狀化學試劑 與該第二區域215之間所產生的附著力，此將使得該液狀化學試劑 不易自該第一區域214中漏出流到開口24處，利用表面粗糙度不同 的兩區域使化學液體產生不同的表面張力而不致流出具有開口的 凹槽外。此有別於傳統作法，須先製作一封閉開口的凹槽，滴入 液體化學試劑經乾燥後再利用沖壓製造一待測流體的輸入開口， 於沖壓過程易造成乾燥的化學反應層龜裂而影響量測精確度。另 外’值得注意是，該第一區域214與該第二區域215間可存有一高 度差。再者’因為存有不平坦的邊緣25，因此開口24整個被待測 物質完全封住的機會將會降低而利於待測物質進入反應凹槽。 另外’在反應凹槽21底部乃具有二個貫孔211，而對電極 (^C=mter Electrode)212 與工作電極(Working Electr〇de)2 丨 3 可貫穿該 等貝孔211 ’其中對電極212與工作電極213的端點面各具有金屬薄 膜2^422、則以及2132(請參閱第四圖⑷與第四圖（cf)專 其中金屬薄膜2121與2131與該電化反應層22接觸，以便檢測來自 於電化反應層22内發生的電化反應。因為本發明提供了具有不平 坦的邊緣25以及開口24的電化學式感測試片Si，故，在製'作過程 中無須進行習用的沖刷步驟（用以產生一個可供待測物質進入反 應凹槽的入口），因此應用本發明將可確保電化反應層22的完整 性，並進而增進電化反應的精確度。另外，本案的反應凹槽21、 1294964 覆蓋部23以及開口 24的位置與形狀應並不受限於本實施例之實施 型態。 請參考第五圖（A) - (B)，其為利用本案之較佳實施例的電 化學式感測試片檢測一待測流體的某一分析物(例如檢測血液中的 血糖、尿酸值，或檢測污水中的汞含量等)的示意圖。當一待測物 質A由開口24進入反應凹槽21時，該待測物質a隨即與電化反應層 22内所含的化學物質發生該電化反應，而氣孔231除了可排除反應 凹槽21内的部分氣體而使待測流體a能順利分佈之外，其亦可用來 宣洩在該電化反應中所產生的氣體，進以確保反應凹槽21内外維 持在氣壓平衡的狀態下而使該反應凹槽21内的該電化反應不受到 非必要的影響。觀測窗232包含一透明膜，以便在待測物質a進入 反應凹槽22時觀察待測物質A是否完全佈滿反應凹槽21，若待測物 質未能佈滿時能及時補充，以免因待測物質A不足而產生不正常的 電化反應。於開口24處設計一不平坦的邊緣25，以避免當加入待 測物質A時該開口 24會被完全封住而使待測物質a無法流入凹槽 中，例如作居家血糖值測試時，在手指上扎一針，擠出一小滴血 於手私上，當手指緊緊靠進開口24時可能會將開口24完全封住， 使血液（即待測物質A)無法順利流入反應凹21槽中，使用者需注 意只能輕輕靠進開口24，開口24的不平坦的邊緣25設計可避免開 口24會被完全封住而引發待測物質a無法流入反應凹槽21的缺 =、，另外，因為氣孔231調節了反應凹槽内21的氣壓，因此亦使得 待測物體A可藉毛細現象而進入反應凹槽21。另外，在必要時，可 =參考電極取代該對電極212，並可多設置其他電極以作為檢測 Z極之用。目前常被絲製作電極或是金屬薄賴材料包含：銅、 e If;金、白金、鈀、鍺、釕、銀、鐵或鋁等金屬及其合金或 物質；而其中又以黃銅、無氧銅、青銅、翻1、洋白銅、 i二二目則較常見的材質。又，以金屬薄膜搭配電極作設計之主 可有效減少成本；因為真正需要具有高反應性與穩定 、邛刀僅在於電極裝置的端點，故，僅在該部分利用貴金屬材 1294964 質’並在其他部位使用其他金屬或是碳棒將可有 的成本。另外，本實施例之絕緣基板與反應凹槽為利用偷極裝置 :::成型而得，此可免除習用試片以層狀結構疊合時所 刷牛Ξ上ΐΐ，本發日猶過將特殊㈣何設相免除了習用的沖 t驟’其巧可有效避免感測試片内部結構在製作過程 2 必要之破壞而造成檢測精確度降低的缺點；更甚 ^ ίΐΓ中刷步驟’因此不論是在感測試片的製作複ί度Ϊ =====本案已由上述之實施例所詳 皆不二二者任施匠思而為諸_ ’然 【圖式簡單說明】 t圖’為制之電化制試狀製作流程圖； 第’為制之電化感測試片在進行沖刷操作前之狀態圖； 第’為習用之電化感測試片在進行沖刷操作後之狀態圖； 莖二θ (c) ’為待測物進入習用電化感測試片的示意圖； 第：:為本發明之電化感測試片製作的流程圖； 第四i ，為本案的一較佳實施例之電化感測試片爆炸圖； 第四i ，為本案的一較佳實施例之電化感測試片之組合圖； 以及回（c)，為本案的一較佳實施例之電化感測試片之背面圖； t圖iA) _⑻’為使用本案的-較佳實施例之電化感測試片 檢娜-待測物質的示意圖。 貝If the crack 131 is located above the Weiji 12, the expected electrochemical reaction occurs when the gamma is not Kp mu, and the chemical reagent of the electro-chemical anti-lin 13 is not in contact with the thunder electrode 12. Further, the accuracy of the electrochemical nuclear film 1 will be lowered. The metal electrode of the discarded electrochemical sensor test piece is made into a test, and the inventor of the present invention has undergone repeated experiments, tests, and the structure of the electrochemical test piece of the disposable type. In addition to being able to effectively reduce the production cost and simplify the production process, the system can not be used in the production process. [Inventive content] The present invention provides an electrochemical sensory function. The sheet, the electrochemical sensing test piece 0 3 - an insulating substrate, a covering portion, an electrochemical reaction layer, and an electrode device. In the bean, the insulation, the plate has at least one reaction groove, and the reaction groove has a second region, a second region, the second region is between the first region and the insulating substrate, and the edge And the insulating substrate is integrally formed with the reaction groove, the cover portion covers the reaction groove, and the reaction groove has an opening at an edge of the insulating substrate, and the electrochemical reaction layer is located in the reaction Inside the groove and a position where an electrochemical reaction occurs. The electrode device is installed in the reaction groove for detecting and transmitting one of the ## generated by the electrochemical reaction. Wherein, the roughness of the second region is lower than the roughness of the first region. ^ According to the above concept, wherein the width of the second region is 〇〇5_ to 4〇_. According to the above concept, the width of the second region is 〇1_ to 2 〇_. According to the above concept, one end of the electrode device is connected to the electrochemical reaction layer. ^ According to the above concept, wherein the reaction groove has at least a consistent hole. 1294964 According to the above concept, the electrode device passes through the through hole. According to the above concept, the electrode device comprises a plurality of electrodes. According to the above concept, the plurality of electrodes are selected from the group consisting of a counter electrode, a working electrode, a reference electrode and a detecting electrode. According to the above concept, the plurality of electrodes are respectively formed by coating a metal film with a conductive material. One of the above concepts, wherein the electrochemical reaction layer comprises a chemical reagent for reacting with an analyte to be detected to initiate the signal. According to the above concept, the analyte to be tested enters the reaction groove from the opening. According to the above concept, wherein the covering portion has at least one air hole; the air hole is a convection hole of the two capillary flow passages for adjusting the pressure in the reaction groove, and further adjusting the analyte to be tested in the reaction groove. distributed. According to the above concept, wherein the reaction recess and the insulating substrate are plastic injection according to the above concept, wherein the insulating substrate has an uneven edge at the opening. Furthermore, the present invention proposes an electrochemical sensing test piece for detecting an analyte in a fluid to be tested. The electrochemical sensing cymbal package & an insulating substrate, a cover portion, an electrochemical reaction layer, and an electrode split. Wherein the insulating substrate has at least one reaction groove, and at least a consistent hole is disposed in the opposite direction, and the insulating substrate, the reaction groove and the through hole are integrally formed. The covering portion covers the reaction recess, and the electrochemical reaction layer is located in the reaction recess and is a position where an electrochemical reaction occurs. The electrode device is disposed in the through hole of the reaction, and the electrode device is assembled in the through hole to form a first electrode surface and a second electrode surface, and the first electrode surface is in contact with the chemical reaction layer. It is used to detect the signal flow generated by the electrochemical reaction, and the second electrode surface is the output end point of the signal current. After the cover portion covers the reaction recess, the reaction recess has an opening at the edge of the insulating substrate that communicates with the outside, and the opening is an input port of the fluid to be tested. 1294964 Plastic injection is considered to be the insulating substrate, the reaction groove and the through hole according to the above concept, wherein the electrode arrangement comprises a counter electrode. f According to the above concept, wherein the hybrid device comprises a working electrode. According to the above concept, wherein the hybrid device comprises a reference electrode. f According to the above concept, wherein the electrode device comprises a detection electrode. Thin 2 = the pressure: gas is the distribution of the analyte in the reaction groove. edge. According to the above concept, the towel edge has an uneven edge at the σ. The present invention also provides a method for producing an electrochemical sense test piece. The basin includes the following steps: providing an insulating substrate having at least a reaction groove, and a substrate, the reaction groove is formed into a body; and two sets of the second region are formed in the reaction groove, and the second region is interposed between the first region and the insulating soil The roughness of the second region between the edges of the plate is lower than the roughness of the first region, and at least one electrode device is disposed in the reaction groove; and the electrode device is formed in the reaction groove Contacting the electrochemical reaction layer; and covering the reaction groove with a cover plate. Wherein, the reaction groove has an opening communicating with the outside at the edge of the insulating substrate. According to the above concept, the electrode device comprises a plurality of electrodes. According to the above concept, the plurality of electrodes are respectively formed by covering a metal thin film with a conductive material. According to the above concept, the cover plate has at least one air hole for adjusting the pressure of the reaction groove. According to the above concept, the insulating substrate has an uneven edge at the opening. 1294964 [Implementation method] The structure and manufacturing method of the electrochemical sensing test piece of the present invention can be fully understood by the following description of the example, and the person skilled in the art can complete the implementation of the method. The type is not limited to the following examples. = See the third figure, which is the manufacturing process of the electrochemical sensing test piece of the present invention: the step includes: L provides a permanent and edge plate having at least a reaction groove; 2. In the formation - the first region and - The second area; 3· erecting at least one of the electrodes to be coated with a liquid or gel-like chemical test and the 胄 transposed phase is fine (four) reversed; and the door is open. Should be grooved. Wherein the reaction groove has a phase relationship with the outside; the first: region is ejected with plastic and the body layer is coated and spread roughness. Wherein the electrification is reversed ===, and the plurality of slots are used when the cat is sewn 3, gold, platinum, palladium, rhodium, ruthenium, iridium. In addition, - butylene bromide ^ ^ is made of polychloroethylene, polypropylene, polycarbonate, polyparaphenylene == system, through: will also completely avoid chemical anti-white 2 flush step please refer to the fourth Figure (A) Two layers: damage to the non-essential stress. Explosion diagram of the electrochemical test strip of the embodiment ', n(^)d - preferably as shown in the fourth figure (A) - (c), the back view of the electrochemical test strip. (C) I' (4) = 1294964 - an insulating substrate 2 having a reaction recess 21, an electrochemical reaction layer 22 in the reaction recess 21, a cover portion 23, an opening 24, and an uneven edge 25, wherein the covering portion 23 has an air hole 231 and a viewing window 232. When the covering portion 23 shields the reaction groove 21, the reaction groove 21 has an opening 24 at the edge of the insulating substrate 2; in addition, the reaction groove 21 has a first region 214 and a second region 215. . The width of the first region 215 is 〇. 5 mm to 4.0 mm, and preferably 0.1 mm to 2.0 mm. In addition, the roughness of the first region 214 is greater than the roughness of the second region 215, and therefore, after the liquid chemical agent (not shown) is applied to the first region 214 and the second region 215 of the reaction groove 21 The adhesion between the liquid chemical and the first region 214 will be greater than the adhesion between the liquid chemical and the second region 215, which will result in the liquid chemical It is not easy to leak from the first region 214 to the opening 24, and the two regions having different surface roughness are used to cause the chemical liquid to generate different surface tensions without flowing out of the groove having the opening. This is different from the traditional method. It is necessary to make a groove with a closed opening. After the liquid chemical is dripped, the input opening of the fluid to be tested is formed by stamping, which is easy to cause cracking of the dried chemical reaction layer during the stamping process. Affects measurement accuracy. Further, it is worth noting that there may be a height difference between the first area 214 and the second area 215. Furthermore, since there is an uneven edge 25, the chance that the opening 24 is completely sealed by the substance to be tested will be lowered to facilitate entry of the substance to be tested into the reaction groove. In addition, there are two through holes 211 at the bottom of the reaction groove 21, and the counter electrode (^C=mter Electrode) 212 and the working electrode (Working Electr〇de) 2 丨3 can penetrate through the other holes 211 ' The end faces of the 212 and the working electrode 213 each have a metal thin film 2^422, then 2132 (refer to the fourth figure (4) and the fourth figure (cf), in which the metal thin films 2121 and 2131 are in contact with the electrochemical reaction layer 22, so that The electrochemical reaction occurring from the electrochemical reaction layer 22 is detected. Since the present invention provides an electrochemical sensing test piece Si having an uneven edge 25 and an opening 24, it is not necessary to perform a conventional scouring step during the manufacturing process ( It is used to generate an inlet for the substance to be tested to enter the reaction groove. Therefore, the application of the present invention can ensure the integrity of the electrochemical reaction layer 22 and further improve the accuracy of the electrochemical reaction. In addition, the reaction groove 21 of the present invention, 1294964 The position and shape of the cover portion 23 and the opening 24 are not limited to the embodiment of the embodiment. Please refer to the fifth figure (A) - (B), which is an electrochemical type using the preferred embodiment of the present invention. Sense test A schematic diagram of detecting an analyte of a fluid to be tested (for example, detecting blood glucose, uric acid value, or detecting mercury content in sewage, etc.). When a substance to be tested A enters the reaction groove 21 from the opening 24, the The substance to be tested a then undergoes the electrochemical reaction with the chemical substance contained in the electrochemical reaction layer 22, and the pores 231 can be used to remove the part of the gas in the reaction groove 21, so that the fluid to be tested can be smoothly distributed. The gas generated in the electrochemical reaction is vented to ensure that the internal and external reaction grooves 21 are maintained in a state of equilibrium of the gas pressure so that the electrochemical reaction in the reaction groove 21 is not unnecessarily affected. The observation window 232 includes a transparent film, so that when the substance to be tested a enters the reaction groove 22, it is observed whether the substance A to be tested completely fills the reaction groove 21, and if the substance to be tested fails to be filled, it can be replenished in time to avoid the shortage of the substance A to be tested. An abnormal electrochemical reaction is generated. An uneven edge 25 is designed at the opening 24 to prevent the opening 24 from being completely sealed when the substance A to be tested is added, so that the substance a to be tested cannot flow into the groove, for example. When testing the home's blood sugar level, put a needle on the finger and squeeze a small drop of blood on the palm. When the finger is pressed tightly into the opening 24, the opening 24 may be completely sealed, so that the blood (ie, the substance to be tested) A) can not smoothly flow into the reaction recess 21 slot, the user should pay attention to only gently lean into the opening 24, the uneven edge 25 of the opening 24 is designed to prevent the opening 24 from being completely sealed, causing the test substance a to flow in. The absence of the reaction groove 21, and, in addition, because the air hole 231 adjusts the air pressure in the reaction groove 21, the object A to be measured can also enter the reaction groove 21 by capillary phenomenon. In addition, if necessary, The reference electrode is substituted for the pair of electrodes 212, and other electrodes may be provided as the detection of the Z-pole. At present, the electrode or the thin metal material is usually made of copper, e If; metal such as gold, platinum, palladium, rhodium, iridium, silver, iron or aluminum and alloys or substances thereof; and brass and no Oxygen copper, bronze, turn 1, foreign copper, i or two are more common materials. In addition, the design of the metal film with the electrode can effectively reduce the cost; because it really needs to have high reactivity and stability, the boring tool only lies at the end of the electrode device, so only the precious metal material 1294964 is used in this part' Other parts that use other metals or carbon rods will cost. In addition, the insulating substrate and the reaction recess of the embodiment are obtained by using a stealing device:::, which can eliminate the use of the test strips when the laminated test pieces are stacked in a layered structure. Special (4) What is the principle of avoiding the disadvantages of the detection of the internal structure of the test piece in the production process 2 and causing the detection accuracy to be reduced; In the production of the test strips, the degree of re-measurement ===== This case has been exemplified by the above-mentioned examples, and both of them are for the sake of _ '然 [Simple description of the schema] t-graph The flow chart of the electro-chemical test pattern; the state diagram of the electro-sensitivity test piece before the flushing operation; the state chart of the electro-sensitivity test piece for the conventional use after the flushing operation; the stem two θ (c ' is a schematic diagram of the test object for the test object; a: a flow chart for the manufacture of the electrochemical test strip of the present invention; and a fourth i, an explosion diagram of the electrochemical test strip of a preferred embodiment of the present invention; Fourth i, the electrification of a preferred embodiment of the present invention a combined view of the test piece; and back (c), a rear view of the electrochemical test piece of a preferred embodiment of the present invention; tFig. iA) _(8)' is an electrochemical sense test piece using the preferred embodiment of the present invention Na - a schematic diagram of the substance to be tested. shell
Si、1 :電化學式感測試片 12 :電極 131 ·缺陷 【主要元件符號說明】 A ·待測物質 11 :絕緣基板 13 :電化反應層 13 1294964 14 ·•反應凹槽 15 :覆蓋板 16 :開口 17 :氣孔 2:絕緣基板 21 :反應凹槽 211 :貫孔電極 212 :對電極 2121、2122 ··金屬薄膜 213 :工作電極 2131、2132 :金屬薄膜 214 :第一區域 215 :第二區域 22 :電化反應層 23 :覆蓋部 231 :氣孔 232 :觀察窗 24 :反應凹槽 25 :邊緣Si, 1: electrochemical sensing test piece 12: electrode 131 · defect [description of main component symbol] A · substance to be tested 11 : insulating substrate 13 : electrochemical reaction layer 13 1294964 14 · • reaction groove 15 : cover plate 16 : opening 17: air hole 2: insulating substrate 21: reaction groove 211: through hole electrode 212: counter electrode 2121, 2122, metal film 213: working electrode 2131, 2132: metal film 214: first region 215: second region 22: Electrochemical reaction layer 23: cover portion 231: air hole 232: observation window 24: reaction groove 25: edge