五、新型說明： 【新型所屬之技術領域】 本^作係關於-種具有表面改質之生化感測試片 、以及其 貝處理之方法。-種電姆式檢啦極則，特別是， t種製作㈣、提高制精準，可·居家監測之生化感 測试片。 【先前技術】 近年來，由於電化學式生化感測試片以及其量測儀的製造 易*成本低、攜帶方便，而日趨普及化，因此，被成功地應用 於業上的各種生化值的檢測產品，例如企糖、尿酸、膽固醇、 血紅素、乳酸等各種生化檢測器。 ° 而電極是電化學反應中不可或缺的主要元件，而電極的活 性對於反應之進行速率、檢職準度皆有決定性影響。在習知 技藝上，大部分所提出之技術皆著重於如何避免金屬電極的腐 蝕，以延長電極的朞命與量測時的準確度；另外，對於一般製 造成本較低廉的碳電極而言，其f知的齡處理方式大多僅為 利用布料歧鮮直接拭_印後之碳電極上的油潰與雜質。 二而美國專利US 5,229,282揭示一種利用醇類以擦栻電 極^面的方法處理，其係可_清潔、並提錄基(_〇H基)之 功能。但在麵朗上仍具械關對人體/或魏的危害的 風險。另一方面，巾華民國第374116號發明專利揭示一種具 有載體之生化感測試片，係接露於該試片之電極上先塗佈—高 ’使得於反應區上的電極系統由疏水性變為親水性， 巧Π刀子細闕乾燥後，再塗佈―至少包含電子媒介物之 ί層調崎輯，細完反應叙製作，以此方法而 吕’為該反應層的塗佈需要至少二次或多次之製程。 ，而’ j隨著賴的進訂，有必要提供祕更簡易以及 f σ tL害、環保等問題之表面處理的電極式生化感測器。 【新型内容】 鑑於先前技術所存在的問題，本創作提供了一種製造容 易、成本低廉、且可提高生化感測試絲面潔淨度、均質化、 親水性，此外’亦提供了 __種可提升制鮮度、用於單次反 應層製程之—具表面改質之生化感測試片。 …根據本創作之一目的在於，提供了一種表面改質之生化感 測》式片其至少包含：絕緣基板、電極系統、絕緣墊高層、反 ，層、^及上蓋。射電極系、统，係設置在該絕緣基板之上； 、龙緣墊ilj層，覆蓋該絕緣基板的—部分，其巾該絕緣基板未被 該絕緣塾高層覆蓋之部分係形成—連接區及一反舰；反應層 則置於反應區中；上蓋置於該絕緣墊高層之上並覆蓋該反應 區’其中電極系統的一端曝露在該連接區，另一端曝露在該反 應區，且至少設置於該反應區的部分表面具有表面改質特性。 根據本創作之另一目的在於，提供了 一種表面改質之生化 感測試片，其至少包含：一絕絲板；設置在該絕緣基板之上 M378382 的電極系統；絕緣墊高層’覆蓋該絕緣基板的一部分，其中該 絕緣基板未被該絕緣墊高層覆蓋之部分係形成一連接區/及一' 反應區；反應層則置於反應區中；上蓋置於該絕緣墊高層之上 並覆蓋該反應區，其中電極系統的一端曝露在該連接區，另一 端曝露在該反應區，且至少設置於該反應區的部分表面具有表 面改質特性。 根據本創作之再一目的在於，提供了一種用於具單次性 反應層之生化感測試片，其至少包含：一絕緣基板，係具一 連接區及一感測區；一至少部份具有表面改質特性的電極系 統，其中該電極系統，係设置在該絕緣基板之上；一絕緣^ 高層，覆蓋該絕緣基板的一部分，其中該絕緣基板未被該絕 緣墊尚層覆蓋之部分係形成一連接區及一反應區；一反應層 則置於該反應區中，該反應層至少包含一反應層調配物包含 電子媒介物、介面活性劑，更可包含與待測物專一性的酵素、 或親水性載體；上蓋置於該絕緣墊高層之上並覆蓋該反應 區，其中電極系統的一端曝露在該連接區，另一端曝露在該 反應區，且至少設置於該反應區的部分表面。 【實施方式】 為了使本創作之敘述更加詳盡與完備，可參照下列描述 並配合圖-與_之圖式’其巾類似的元件符號代表類似的 元件。然以下實施例中所述，僅用以說明本創作，並非用以 限制本創作的範圍。 M378382 圖一為繪示一根據本創作之一具表面改質的生化感測試 片100的結構展開圖。該生化感測試片100其係至少包含： 一絕緣基板110、一電極系統12〇、一絕緣墊高層130、一反 應層140、以及一上蓋150。此外，生化感測試片1〇〇可依其 功能定義出一連接區112與一感測區113，其中該連接區112 係用以連接至一量測裝置(未繪示），而該感測區113係規劃以 形成容納一待測樣品的空間。在圖i中，則運用虛線表示各 元件相對應的位置，而該電極系統12〇，係設置在該絕緣基 板110之上。 在本文中所指的該絕緣基板110係指具有平直的表面及 電絕緣性質之薄層片。該絕緣基板110的材料可為此技藝中 任何已知適用於電化學式檢測電極試片之電絕緣基板的材 料，例如’但不限於聚亂乙稀板、玻璃纖板、聚I旨板、電木 板、聚對苯二甲酸乙二醇酯板、聚碳酸酯板、聚丁烯對苯二 曱酸醋樹脂、玻璃板或陶曼板。 而該電極系統120，係設置在該絕緣基板110之上，係 指包括至少二條分離且互不相接觸的一參考電極122、一工 作電極121 ’再此實施例中，更包含一感測電極124，在其他 實施例中，更可包含複數個用於其他功能的辨識電極。該導 電膜120的材料可為此技藝中任何已知適用於生化感測試片 之電極系統的材料，在此實施例中包含互相絕緣的，係使用 網印、壓印、熱轉印法、旋轉塗佈法、或噴墨印刷而形成於 該絕緣基板110上。其較佳係以網版印刷金屬膜或黏附金屬 膜之方式’塗覆於該電絕緣基板11〇之一面。適合之金屬腾 6 M378382 材料包括，但不限於金、銀、#絲，而適合網版印刷之 刷墨包括但祕於m墨、銀墨、碳墨與銀墨的混合 物、揮發性石墨、銅墨或以上的組合，如先印銀墨再印碳墨。 在本實施例之祕巾’射細版電極為—碳墨層。在其他 實施例中’該電極系統可為網版電極，其為-銀墨層與一碳 〜、扣…穴匁电、吧琢性買之材質 蓋該電極系統120之薄層，且絕緣塾高層⑽包 二在感測區113中的—開口 132，以暴露電極系統㈣之一 2…般而言’開口 132只要能夠暴露出部份的工作電極 132 的έ參考電極122即已足夠，本創作並不限制開口 ’狀。絕雜高層13G並減該連· 112，以使位於 電性】Π之電極系統120的一端可與一量測裝置(未繪示) =測===中任何已_於電V. New description: [New technical field] This is a method for measuring biochemical sensation with surface modification and its shell treatment. - A kind of electric meter test, especially, t production (four), improve the accuracy of the system, can be monitored by the home biochemical test film. [Prior Art] In recent years, since electrochemical biochemical test pieces and their measuring instruments are easy to manufacture, low in cost, and easy to carry, they are increasingly popular, and therefore, they have been successfully applied to various biochemical value detection products in the industry. For example, various biochemical detectors such as sugar, uric acid, cholesterol, heme, and lactic acid. ° The electrode is an indispensable main component in the electrochemical reaction, and the activity of the electrode has a decisive influence on the rate of reaction and the accuracy of the inspection. In the prior art, most of the proposed techniques focus on how to avoid corrosion of the metal electrode to prolong the accuracy of the electrode's life and measurement; in addition, for the carbon electrode which is generally cheaper to manufacture, Most of the methods of processing ages are only to directly wipe the oil from the carbon electrode and the impurities on the carbon electrode after printing. U.S. Patent No. 5,229,282, the disclosure of which is incorporated herein by reference in its entirety, the entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire entire all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all all However, there is still a risk of harm to the human body/or Wei in the face. On the other hand, the invention patent of the Chinese Patent No. 374116 discloses a biochemical test piece having a carrier which is attached to the electrode of the test piece and first coated-high so that the electrode system on the reaction zone is changed from hydrophobic to hydrophobic. For the hydrophilicity, after the knife is finely dried, it is coated with a layer containing at least the electron mediator, and the reaction is finished. This method requires at least two coatings for the reaction layer. One or more processes. And with the advancement of the company, it is necessary to provide an electrode-type biochemical sensor that is more simple and simple, as well as surface treatment of problems such as f σ tL and environmental protection. [New content] In view of the problems existing in the prior art, the present invention provides an easy-to-manufacture, low-cost, and improved biochemical test silk surface cleanliness, homogenization, and hydrophilicity, and also provides a __ Freshness, a biochemical test piece with a surface modification for a single reaction layer process. According to one of the purposes of the present invention, there is provided a surface-modified biochemical sensing film comprising at least: an insulating substrate, an electrode system, an insulating mat high layer, a reverse layer, a layer, and an upper cover. The emitter electrode system is disposed on the insulating substrate; the rim layer of the rim edge covers the portion of the insulating substrate, and the portion of the insulating substrate that is not covered by the high-rise layer of the insulating layer is formed. An anti-ship; the reaction layer is placed in the reaction zone; the upper cover is placed on the upper layer of the insulating mat and covers the reaction zone' wherein one end of the electrode system is exposed in the connection zone, and the other end is exposed in the reaction zone, and at least Part of the surface of the reaction zone has surface modification characteristics. According to another aspect of the present invention, there is provided a surface-modified biochemical test piece comprising: at least one wire plate; an electrode system disposed on the insulating substrate M378382; and an insulating pad high layer covering the insulating substrate a portion of the insulating substrate that is not covered by the upper layer of the insulating pad forms a connection region and a 'reaction zone; the reaction layer is placed in the reaction zone; the upper cover is placed on the upper layer of the insulating pad and covers the reaction a region, wherein one end of the electrode system is exposed to the connection region, and the other end is exposed to the reaction zone, and at least a portion of the surface disposed on the reaction zone has surface modification characteristics. According to another aspect of the present invention, there is provided a biochemical test strip for a single reactive layer, comprising at least: an insulating substrate having a connection region and a sensing region; and at least a portion having An electrode system having a surface modification property, wherein the electrode system is disposed on the insulating substrate; an insulating layer is disposed on a high layer covering a portion of the insulating substrate, wherein the insulating substrate is not formed by a portion covered by the insulating pad a reaction zone and a reaction zone; a reaction layer is disposed in the reaction zone, the reaction layer comprises at least one reaction layer formulation comprising an electron mediator, an interfacial surfactant, and an enzyme which is specific to the analyte, Or a hydrophilic carrier; an upper cover is placed on the upper layer of the insulating mat and covers the reaction zone, wherein one end of the electrode system is exposed in the connection zone, the other end is exposed in the reaction zone, and at least a part of the surface of the reaction zone is disposed. [Embodiment] In order to make the description of the present invention more detailed and complete, reference may be made to the following description, and the same reference numerals are used to represent similar elements. The descriptions in the following examples are merely illustrative of the present invention and are not intended to limit the scope of the present invention. M378382 Fig. 1 is a structural development view showing a biochemical sensing test piece 100 having a surface modification according to the present invention. The biochemical test strip 100 comprises at least: an insulating substrate 110, an electrode system 12A, an insulating mat high layer 130, a reaction layer 140, and an upper cover 150. In addition, the biochemical test strip 1 can define a connection area 112 and a sensing area 113 according to its function, wherein the connection area 112 is connected to a measuring device (not shown), and the sensing Zone 113 is planned to form a space for containing a sample to be tested. In Fig. i, the corresponding positions of the respective elements are indicated by broken lines, and the electrode system 12 is disposed above the insulating substrate 110. The insulating substrate 110 referred to herein means a thin layer having a flat surface and electrical insulating properties. The material of the insulating substrate 110 can be any material suitable for the electrically insulating substrate of the electrochemical detecting electrode test piece, such as, but not limited to, a polystyrene board, a glass fiber board, a poly-I board, and a battery. Wood board, polyethylene terephthalate board, polycarbonate board, polybutylene terephthalate resin, glass board or Tauman board. The electrode system 120 is disposed on the insulating substrate 110, and includes at least two reference electrodes 122 separated from each other and a working electrode 121 ′. In this embodiment, a sensing electrode is further included. 124. In other embodiments, a plurality of identification electrodes for other functions may be included. The material of the conductive film 120 can be any material known in the art to be suitable for the electrode system of the biochemical test piece, and in this embodiment, is insulated from each other by screen printing, imprinting, thermal transfer, and rotation. The insulating substrate 110 is formed by a coating method or inkjet printing. It is preferably applied to one side of the electrically insulating substrate 11 in a manner of screen printing a metal film or adhering a metal film. Suitable Metal Teng 6 M378382 Materials include, but are not limited to, gold, silver, #丝, and suitable for screen printing, including but m secret, m ink, silver ink, carbon ink and silver ink mixture, volatile graphite, copper Ink or a combination of the above, such as printing silver ink and then printing carbon ink. In the secret towel of the present embodiment, the thin plate electrode is a carbon ink layer. In other embodiments, the electrode system may be a screen electrode, which is a silver ink layer and a carbon layer, a buckle, a ceramic material, a thin layer of the electrode system 120, and an insulating layer. The upper layer (10) includes an opening 132 in the sensing region 113 to expose one of the electrode systems (4). [In general, the opening 132 is sufficient as long as the partial reference electrode 122 of the working electrode 132 can be exposed. Creation does not limit the opening' shape. Absolutely high-rise 13G and reduce the connection 112 so that one end of the electrode system 120 located in the electrical system can be combined with a measuring device (not shown) = measured ===
月之電，·，邑緣層的材料，例如，但不限於PVC 魏峨料光固化^ 根據ί:::::塗佈於該電極系統上。 001 M W /、體實樣’ f_層具有厚度為約約 口成H t此外，销造過W已裁切出開 上，二 :=絕緣墊高層__絕:板=: 132中的一反應厝 生化_試片】00更包含置於開口 7 140 ’係至少覆蓋於電化學反應區上之一膜層，其係由可與檢 測樣品進行反應之反應層調配物以滴加方式或以印刷方式於 電化學反應區上所形成，係可以單次製程形成一具有親水性 之反應層，無需如中華民國第374110號發明專利揭示之方 法。根據本創作之一具體實施態樣，該反應層調配物更包含 待測物之專一性酵素、水溶性高分子載體、電子媒介物及介 面活性劑；在另一實施例中，反應層調配物包含專一性酵素、 電子媒介物、介面活性劑；在其他實施例中，反應層調配物 僅包含電子媒介物 '介面活性劑。一般而言，反應層至 少覆蓋部份的工作電極121及參考電極122。反應層14〇之 材料係隨待測樣品不同而有所不同，例如可為一氧化還原酶 或一電子媒介物(如亞鐵類材料），用以與待測樣品產生化學反 應。其具有專一性辨識生物材料或訊號之能力。此外，本創 作之生化感測試片特別是在反應區的表面經過改質處理，可 使得反應層調配物固定的體積更均一，且形成反應層14〇亦 較不易因外力而脫落。 該水溶性高分子載體，係指可使電子媒介物乾燥後附著 於電絕緣基板上，並加強反應層與液態檢測樣品之間的接觸 作用之物質，使得水溶性高分子載體能均句地分佈於反應層 調配物中。適用於本創作中之水溶性高分子載體可為此技藝 中任何已知適用於電化學式檢測電極試片之水溶性高分子載 體’例如’但不限於聚乙烯醇(PVA)、聚乙烯吼洛嗣(pvp)、 聚乙二醇(PEG)、白明膠、羧曱基纖維素、曱基纖維素或其混 合物。根據本創作之一具體實施態樣，水溶性高分子載體之 含量為反應層調配物(以重量計)之約0 1%至約10〇/〇。 M378382 該電子媒介物係指可與全血巾檢測樣品反應後，本身可 由氧化狀,4還原成還原狀態之物質^當電子媒介物變成還原 狀態時，可藉由施加-外加龍於則上，促使電子媒介物 由還原狀態逆反應回復為氧化狀態，此時化學反應的電位、 電阻、或電流變化，可與反應層接觸之工作電極與參考電極 傳導至電極系統另一端之接頭。適用於本創作之電子媒介物 包括但不限定為鐵氰化鉀、黃素腺嘌呤雙核酸（flavin adenine di-nucleotide; FAD)、煙醯胺、或煙醯胺腺 嘌呤二核酸（nicotinamide adenine dinucleotide; NADH)、六銨基氣化釕，且電子媒介物之含 置為以反應層調配物(以重置計)之約1%至約6%。 本文中所稱之「介面活性劑」，為加強待測物質與電子媒 介物之反應強度之物質，其例如，但不限於十二烷基硫酸納 (sodium dociecyl sulfate)、十二烷基硫酸鈉(sodium d〇decyl sulfonate)、Tween 20、Triton X_ 100、膽鹽酸鈉或其衍生物， 且介面活性劑之含量為以反應層調配物（以重量計）之約 0.01%至約 1%。 上蓋150置於絕緣墊高層130之上，且覆蓋開口 132。 在此實施例中’上蓋150係暴露出連接區112。介於絕緣基板 110與上盍15〇之間的部份係形成一具毛細吸引力之取樣空 間（即反應區）。當取樣空間的面積固定時，其體積可取決於絕 緣墊高層130之厚度。一般而言，絕緣墊高層13〇之厚度介 於約0.005公釐至約0.3公釐，然不在此限。此外，在另一實r c : 9 施例中，本創作可更包含一中隔板(未繪示)設置於絕緣墊高層 130之上，此時取樣空間的體積將取決於中隔板與絕緣墊高 層130兩者的厚度。 本創作之上蓋150可為透明或半透明材質，以方便觀察 開口 132(即反應區)是否已填入樣品，避免樣品未填入前即進 行檢測，而導致錯誤的量測結果。此外，在其他實施例，該 上蓋150之接近反應區的下表面亦可塗佈如上文所述之一該 水溶性鬲分子載體，以加強反應區内部壁面的毛細作用，用 以更迅速有效地將樣品導入反應區中，上蓋15〇更包含相應 於開口 132的一通氣孔15卜用以排出反應區内的氣體，以 加強毛細作用，一般而言，通氣孔151係靠近開口 132内側 末端。本創作並不限制通氣孔151的形狀，舉例來說，通氣 孔151可為圓形、橢圓形、長方形、菱形等。 在本創作中，該表面改質處理係指電極系統表面均質化 之作用，乃以一定切削量、或一定磨損量而創造出均一的凹 凸表面，包含但不限於磨砂、喷砂、電漿等技術。請同時參 考圖二與圖三，其分別繪示本創作之—實施例生化感測試片 之電極系統於表面處理前與處理後之結構剖面圖。在圖二與 圖三中之生化感測試片2〇〇、300，為了能清楚說明，其僅^ 示絕緣基板210、310以及電極系統220、320。在此實施^ 中，電極系統220、320僅包含一工作電極221、321與一參 考電極222、322。如圖二所示，當該電極系統22〇形成於該 絕緣基板210上，其中該電極系統22〇的表面為一不平整^ 表面，該顆粒大小不均一，而生化感測試片3〇〇之電極系統 320 均 嘴昏糾雛大小較為 所示)，可增加與反麟接電極之表面積(如圓三，箭頭 則可職顧化之 又一方面 砂，其_粒：:為==:為：:磨 以及奴倾。而該微粒之顆粒直徑大小為約5〇至5_微米。 再-方面，在本創作中該表面改質處_指電極系統表 t Γ變域水性，其可為_賴技術。其機制乃 選擇之製程氣體而異，甚多不同類別之官能】; ，例如羥基(hydroxyl)、羰基(carb〇nyl)、竣基(carb〇xyl)、 (amine)、或過氧化基咖胃丨)官能基等。而在本創作中， 所指魏技術系可包含真空雜、氫魏、氦電漿、氧電漿 而 =常壓等技術’其中又以常壓電漿技術成本低廉， 吊壓電漿之強度大小約為500焦耳至2000焦耳。 β更進一步地，本創作亦可運用電漿技術、或是微粒磨砂 提供電極純之表Φ清潔之功效，使得該生化❹彳試片之反 應層固定性提高。其中該電漿清潔乃利用離子的動能轟擊該 電極系統，使其一表面的雜質擊出，達到清潔的效果，或可 藉由電漿中自由基或介穩態的高活性氣體分子，與該電極系 統表面的雜質進行化學反應後，產生氣體進入大氣中，將雜 質自表面移除。該電漿喷嘴喷出氣體光束可的溫度約為5〇。匚 11 Μΰ/ΟΟΟΔ Μΰ/ΟΟΟΔ 之範圍内 潔處施㈣，該_統表面清 η變物物賴編敍_申請專= 旦圖四為根據本創作之—具表面改質之生化感測試片搭配 一量測裝置所檢測出的讀值與—大型生化儀檢_值作比較 圖參考圖四’其中實驗組分別包含一利用微粒磨砂進行 改面改質後所製成之生化感測試片、一f漿轟擊進行改面改 質後所製成之生化感測試片、以及一利用習知技術所製作之 生化感測試片，在本實施例之中，代檢測物為含五個不同糖 濃度的血樣’該五個血樣以大型生化儀(YSI_230() STATPlus) 罝測的濃度分別為 51 mg/dL、125 mg/dL、220 mg/dL、330 mg/dL、以及450mg/dL，而在清潔步驟中利用電漿改值的試 片所量測的讀值則分別為53 mg/dL、124 mg/dL、223 mg/dL、 326mg/dL、以及452mg/dL ;而微粒表面處理後的讀值為5〇 mg/dL、124 mg/dL、215 mg/dL、335 mg/dL、以及 451 mg/dL ; 而以未具表面處理的試片當作對照組，其所量測之讀值則分 12 別為 42 mg/dL、105 mg/dL、180 mg/dL、301 mg/dL、以及 408 mS/dL，根據上述之試驗值而繪示出圖5，該LI為表示電漿 表面改質的試片；該L2為表示磨砂表面改質的試片；L3為 表示表面未經處理的試片。在圖5清楚地顯示LI、L2較L3 更精準的對應參考值(YSI-2300 STATPlus所檢測的結果），其 說明了，根據本創作的具表面處理的生化感測試片可增加反 應層的固定化’亦進一步地增加量測的精準性。 據上所述，本創作之生化感測試片，不但製程簡易、成 本低廉，更能有效提高習知試片之量測精準度，適合於居家 監控以及快速診斷用。雖然本創作已以較佳實施例揭露如 上，然其並非用以限定本創作，任何熟習此技藝者，在不脫 離本創作之精神範圍内，當可做些許之更動與潤飾，因此本 創作之保護範圍當視後附之申請專利範圍所界定者為準。 【圖式簡單說明】 圖一為本創作生化感測試片之一實施例的結構展開圖； 圖二為繪示本創作之生化感測試片之電極系統於表面處 理前一實施例的結構剖面圖； 圖三為繪示本創作之生化感測試片之電極系統於表面處 理後一實施例的結構剖面圖；以及 圖四為根據本創作之生化感測試片試驗結果圖。 【主要元件符號說明】 100、200、300 生化感測試片 13 M378382 110、210、310 絕緣基板 112 連接區 113 感測區 120、220、320 電極系統 121、221、321 工作電極 122 > 222 > 322 參考電極 123 感測電極 130 電絕緣層 132 開口 140 反應層 150 上蓋 151 通氣孔Month's electricity, ·, the material of the rim layer, such as, but not limited to, PVC Wei 峨 light curing ^ according to ί::::: coated on the electrode system. 001 MW /, the body sample 'f_ layer has a thickness of about ca. H t In addition, the pin has been cut W has been cut out, two: = insulation pad high __ absolutely: plate =: one of 132 The reaction 厝 biochemical _ test piece 00 further comprises a film layer placed on the opening 7 140 ′ at least covering the electrochemical reaction zone, which is in a dropping manner or by a reaction layer formulation which can react with the test sample The printing method is formed on the electrochemical reaction zone, and a hydrophilic reaction layer can be formed in a single process, without the method disclosed in the invention patent of the Republic of China No. 374110. According to one embodiment of the present invention, the reaction layer formulation further comprises a specific enzyme of the analyte, a water-soluble polymer carrier, an electron vehicle and an surfactant; in another embodiment, the reaction layer formulation A specific enzyme, an electron vehicle, an interfacial agent is included; in other embodiments, the reaction layer formulation comprises only an electron vehicle 'interfacing agent. In general, the reaction layer covers at least a portion of the working electrode 121 and the reference electrode 122. The material of the reaction layer 14〇 varies depending on the sample to be tested, and may be, for example, a oxidoreductase or an electron vehicle (e.g., a ferrous material) for chemically reacting with the sample to be tested. It has the ability to uniquely identify biological materials or signals. In addition, the biochemical test piece of the present invention is modified in the surface of the reaction zone in particular, so that the volume of the reaction layer formulation is more uniform, and the formation of the reaction layer 14 is less likely to fall off due to external force. The water-soluble polymer carrier refers to a substance which can make the electronic medium adhere to the electrically insulating substrate after drying and strengthen the contact between the reaction layer and the liquid detecting sample, so that the water-soluble polymer carrier can be uniformly distributed. In the reaction layer formulation. The water-soluble polymer carrier suitable for use in the present invention can be any water-soluble polymer carrier known in the art to be suitable for electrochemical detection electrode test pieces, such as, but not limited to, polyvinyl alcohol (PVA), polyethylene Phenol (pvp), polyethylene glycol (PEG), gelatin, carboxymethylcellulose, sulfhydryl cellulose or mixtures thereof. According to one embodiment of the present invention, the water-soluble polymer carrier is present in an amount of from about 0% to about 10% by weight of the reaction layer formulation (by weight). M378382 The electron mediator refers to a substance which can be reduced to a reduced state by oxidation after the reaction with the whole bloodsuckle test sample. When the electron mediator is in a reduced state, it can be applied by applying - plus a dragon. The electron medium is caused to return from the reverse state to the oxidized state, and the potential, resistance, or current of the chemical reaction changes, and the working electrode and the reference electrode which are in contact with the reaction layer are conducted to the joint of the other end of the electrode system. Electronic vehicles suitable for use in the present invention include, but are not limited to, potassium ferricyanide, flavin adenine di-nucleotide (FAD), nicotinamide, or nicotinamide adenine dinucleotide. ; NADH), hexammonium-based gasification ruthenium, and the content of the electron mediator is set to be from about 1% to about 6% of the reaction layer formulation (in terms of reset). The term "intercalating agent" as used herein is a substance which enhances the reaction strength of a substance to be tested and an electron vehicle, and is, for example, but not limited to, sodium dociecyl sulfate, sodium lauryl sulfate. (sodium d〇decyl sulfonate), Tween 20, Triton X 100, sodium bile salt or a derivative thereof, and the level of the surfactant is from about 0.01% to about 1% by weight of the reaction layer formulation (by weight). The upper cover 150 is placed over the upper layer 130 of the insulating mat and covers the opening 132. In this embodiment, the upper cover 150 exposes the connection region 112. The portion between the insulating substrate 110 and the upper crucible 15 is formed into a capillary suction sampling space (i.e., reaction zone). When the area of the sampling space is fixed, its volume may depend on the thickness of the upper layer 130 of the insulating mat. In general, the thickness of the upper layer of the insulating mat 13 is from about 0.005 mm to about 0.3 mm, although not limited thereto. In addition, in another real rc:9 embodiment, the present invention may further include a middle partition (not shown) disposed on the upper layer 130 of the insulating mat, and the volume of the sampling space will depend on the middle partition and the insulation. The thickness of both the upper layers 130 of the mat. The upper cover 150 can be a transparent or translucent material to facilitate observation of whether the opening 132 (ie, the reaction zone) has been filled with the sample, and to prevent the sample from being detected before it is filled, resulting in erroneous measurement results. In addition, in other embodiments, the lower surface of the upper cover 150 near the reaction zone may also be coated with one of the water-soluble hydrazine molecular carriers as described above to enhance the capillary action of the inner wall surface of the reaction zone for more rapid and effective use. The sample is introduced into the reaction zone, and the upper cover 15 further includes a vent 15 corresponding to the opening 132 for discharging the gas in the reaction zone to enhance capillary action. Generally, the vent 151 is adjacent to the inner end of the opening 132. This creation does not limit the shape of the vent 151. For example, the vent 151 may be circular, elliptical, rectangular, diamond-shaped or the like. In the present creation, the surface modification treatment refers to the effect of surface homogenization of the electrode system, and creates a uniform concave and convex surface with a certain amount of cutting or a certain amount of wear, including but not limited to frosting, sand blasting, plasma, etc. technology. Please refer to Fig. 2 and Fig. 3 at the same time, which respectively show the structural cross-section of the electrode system of the present invention - before and after the surface treatment of the biochemical test strip of the embodiment. In the biochemical sensing test pieces 2, 300 of Figs. 2 and 3, for the sake of clarity, only the insulating substrates 210, 310 and the electrode systems 220, 320 are shown. In this implementation, the electrode systems 220, 320 include only one working electrode 221, 321 and a reference electrode 222, 322. As shown in FIG. 2, when the electrode system 22 is formed on the insulating substrate 210, the surface of the electrode system 22 is an uneven surface, the particle size is not uniform, and the biochemical test piece 3 The electrode system 320 has the same size as the dizzy rectification), which can increase the surface area of the electrode with the reverse lining (such as the circle three, the arrow can be used for another aspect of the sand, its _ grain:: ==: :: grinding and slave pouring, and the particle diameter of the particle is about 5 〇 to 5 _ micron. Further, in the present creation, the surface modification _ refers to the electrode system table t Γ variable domain water, which can be _ Lai technology. The mechanism is different from the choice of process gas, many different types of functions]; such as hydroxyl, carb〇nyl, carb〇xyl, (amine), or Oxidized kiwi stomach) functional groups and the like. In this creation, the Wei technology system can include vacuum, hydrogen, kiln plasma, oxygen plasma and atmospheric pressure. Among them, the cost of the constant piezoelectric slurry technology is low, and the strength of the piezoelectric slurry is suspended. The size is approximately 500 joules to 2000 joules. Further, the creation can also use the plasma technology or the particle scrub to provide the electrode pure Φ cleaning effect, so that the reaction layer of the biochemical test piece is improved. Wherein the plasma cleaning utilizes the kinetic energy of ions to bombard the electrode system to cause impurities on one surface to be knocked out to achieve a cleaning effect, or may be caused by free radical or metastable high activity gas molecules in the plasma. After the impurities on the surface of the electrode system are chemically reacted, gas is generated into the atmosphere to remove impurities from the surface. The plasma nozzle can eject a gas beam at a temperature of about 5 angstroms.匚11 Μΰ/ΟΟΟΔ Μΰ/ΟΟΟΔ Within the range of cleaning (4), the _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ The reading value detected by a measuring device and the comparison value of the large biochemical instrument _ value are shown in Figure 4, wherein the experimental group respectively comprises a biochemical test piece made by modifying the surface with a particle scrub. A biochemical test piece prepared by modifying the surface and modifying the skin, and a biochemical test piece produced by using a conventional technique, in the present embodiment, the substitute test substance contains five different sugar concentrations. The blood samples of the five blood samples were measured by the large biochemical analyzer (YSI_230() STATPlus) at 51 mg/dL, 125 mg/dL, 220 mg/dL, 330 mg/dL, and 450 mg/dL, respectively. The readings measured by the plasma-modified test pieces in the cleaning step were 53 mg/dL, 124 mg/dL, 223 mg/dL, 326 mg/dL, and 452 mg/dL, respectively; The readings were 5〇mg/dL, 124 mg/dL, 215 mg/dL, 335 mg/dL, and 451 mg/dL; The test piece was used as a control group, and the measured values were determined to be 42 mg/dL, 105 mg/dL, 180 mg/dL, 301 mg/dL, and 408 mS/dL, according to the above test. 5, the LI is a test piece indicating the surface modification of the plasma; the L2 is a test piece indicating the modification of the matte surface; and L3 is a test piece indicating that the surface is not treated. Figure 5 clearly shows the more accurate reference values of LI and L2 than L3 (results detected by YSI-2300 STATPlus), which demonstrates that the biochemical test strip with surface treatment according to the present invention can increase the fixation of the reaction layer. 'further' also further increases the accuracy of measurement. According to the above, the biochemical test strip of this creation not only has simple process and low cost, but also can effectively improve the measurement accuracy of the conventional test piece, and is suitable for home monitoring and rapid diagnosis. Although the present invention has been disclosed in the above preferred embodiments, it is not intended to limit the present invention, and anyone skilled in the art can make some changes and refinements without departing from the spirit of the present invention. The scope of protection is subject to the definition of the scope of the patent application attached. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a structural development view of an embodiment of a biochemical test piece of the present invention; FIG. 2 is a structural cross-sectional view showing an embodiment of the electrode system of the biochemical test piece of the present invention before surface treatment. FIG. 3 is a structural cross-sectional view showing an embodiment of the electrode system of the biochemical test strip of the present invention after surface treatment; and FIG. 4 is a graph showing the results of the test of the biochemical test strip according to the present invention. [Main component symbol description] 100, 200, 300 Biochemical test piece 13 M378382 110, 210, 310 Insulating substrate 112 Connection area 113 Sensing area 120, 220, 320 Electrode system 121, 221, 321 Working electrode 122 > 222 > 322 Reference electrode 123 Sensing electrode 130 Electrically insulating layer 132 Opening 140 Reaction layer 150 Upper cover 151 Vent hole
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