201219779 六、發明說明: 【發明所屬之技術領域】 本發明係關於一種生化感測試片及其製造方法,關於一 種具有多功能的生化感測試片及其製造方法。 【先前技術】 以往僅有醫院才能提供身體狀況檢驗,隨著醫學科技的 進步與現代人的健康觀念日益提升,現今已能夠在家裡使用 各種生化感測裝置(例如血糖機)自行檢驗,市售的生化感 測裝置具有操作簡便、體積小、以及檢測速度快等的優點。 圖1顯示習知生化感測試片的外觀示意圖。圖2顯示圖 1之生化感測試片的分解圖。如圖1及圖2所示,生化感測 試片100為一血糖測試片,其包含有電極基板u〇、流道板 120以及頂板130。電極基板11〇係利用印刷技術於一基板 上印刷多個電極及電路所形成。流道板120界定出一缺口 122,其係由貫穿流道板120之上下表面來形成。為了使血 液能夠更順利地流動,可於頂板130之對應流道板12〇的缺 口 122的位置處設置一開口 135。 製造生化感測試片1〇〇時,需要將電極基板11〇、流道 201219779 板120以及頂板130貼合在一起。使流道板12〇位於電極基 板110及頂板130之間,且電極基板11〇、流道板12〇以及 頂板130共同定義出一流道15〇。流道15〇的位置對應流道 板120的缺口 122的位置,且具有一入口 125及一開口 135。 於操作時’使用者將檢體滴於入口 125處,血液從入口 125 進入流道150,因毛細現象血液會於流道15〇中流動,流道 150中的氣體則從開口 135排出。 鲁然而,依據習知技術之生化感測試片1〇〇尚存在有更一 步改善的空間。 【發明内容】 本發明一貫施例之目的在於提供一種生化感測試片及 其製造方法。一實施例之目的在於提供一種具有多功能的生 化感測試片及其製造方法。 依據本發明一實施例,提供一種生化感測試片包含一基 # 板、一電極結構及-頂板。基板界定有至少-凹槽,凹槽自 基板的表面向下延伸。電極結構自凹槽内部延伸至基板 的上表面。頂板設於基板上,並且頂板與基板界定出對應該 至y凹槽的至少一流道,且電極結構位於基板與頂板間。 依據本發明—實施例,提供—種生化感測試片的製造方 法其包含以下步驟。形成一基板,且基板界定有至少—凹 5 201219779 槽,該至少—凹槽自基板的-上表面向下延伸。對基板之一 即將形成電極_域進行雷射處理,其中該即將形錢極的 Μ係自該至少-凹槽内部延伸至基板的上表面。將一電極 結構形成於基板之該即將形成電極的輯,且電極結構係自 該至^凹槽内部延伸至基板的上表面。於基板上覆蓋一頂 板,藉以使基板及施界定出對應該至少1槽的至少一流 道。 本發明的其他目的和優料輯本發明所揭露的技術 特徵中得到進-步的了解。為讓本發明之上述和其他目的、 特徵和優點能更鶴祕,下文特舉實施舰配合所附圖 式,作詳細說明如下。 【實施方式】 圖3顯示依本發明一實施例生化感測試片之製造方法的 流程圖。圖4Α〜4D顯示依本發明一實施例生化感測試片之 製造方法各步驟的示意圖。如圖3及圖4Α〜4D所示,依本 發明一實施例生化感測試片之製造方法包含以下步驟。 如圖4Α所示,步驟S02 :形成一基板210,且基板210 界定有至少一凹槽211。於一實施例中,可以利用射出成型 (Injection molding )技術,將熱塑性的塑料射出成型成界定 有至少一凹槽211的基板210,較佳的情況是基板210為一 201219779 體成型。凹槽211自基板21〇的上表面叫向下延伸且沒有 貝穿至基板210的下表面,亦即凹槽211的底面係由基板, 的下半部所界定。 如圖4B所示,㈣簡:對基板21〇之-即將形成電 極的區域212 ’進行雷射處理,其中即將形成電極的區域212 係自凹槽2U _延伸至基板21〇的上表面。於一實施例 中,利用雷射粗糙化前述即將形成電極的區域212的表面, 更具體而言係於區域212的表面形成多孔結構(p〇r〇us)。於 一實施例中,依據雷射活化技術,添加特殊化學劑並以雷射 活化前述即將形成電極的區域212,使區域212的表面產生 物理化學反應而形成金屬核,較佳的情況是,除了對區域212 進行雷射活化處理外,更同時粗糙化區域212的表面。 如圖4C所示,步驟S06 :將一電極結構220形成於基 板210之一即將形成電極的區域212,其中電極結構22〇係 自凹槽211内部延伸至基板210的上表面。於一實施例中, 利用塗布技術,將電極結構220塗布於前述即將形成電極的 區域212 ’由於區域212的表面已被粗造化,因此電極結構 220能夠被固定於基板21〇的區域212上,更具體而言使電 極結構220錨固(adherent anchoring)於基板210的區域212 上。於一實施例中’係利用電鍍技術(Metallization),透過 區域212的表面上的該些金屬核,在即將形成電極的區域212 201219779 上電鍍一金屬層而形成電極結構220,相對於此基板21〇之 區域212以外的其他區域,沒有金屬核不易被電鑛上金屬 層’藉此僅將電極結構220形成於基板21〇之一即將形成電 極的區域212。此外,由於前述即將形成電極的區域212已 被粗造化且形成有多孔結構,因此電極結構220能夠被固定 (或被錨固)於基板210的區域212上。此外,於本發明不 限定金屬層的種類,其可以為例如金、鎳、銀或銅等。依本 發明一貫施例,利用雷射活化技術配合電錄技術,能夠於具 有凹槽的表面上形成電極結構220 ;此外還能夠製造出線寬 介於5〜8微米的電極結構220,相較於習知印刷技術,能夠 更進一步縮小化生化感測試片的尺寸。 如圖4C及圖4D所示,步驟s〇8 :於電極結構22〇的位 於凹槽211❸-端塗上測試用化學試劑,並覆蓋一頂板23〇, 藉以使基板210及頂板23〇定義出至少一流道,前述至少一 抓道的位置對應則述至少—凹槽211的位置。此步驟係於本 領域具有通常知識麵㈣成,且相目前已知或未來 發展之技術,因此省略其相關說明。 圖5顯不圖4C之形成有電極結構之基板的部分放大 圖。如圖4C及圖5所示’生化感測試片200包含-基板210' 電極結構22〇及-頂板23G。基板训係由熱塑性的塑料 射出成型且成-體成型,其界定有至少一凹槽211 。於本實 201219779 施例中,至少一凹槽211包含有一第一凹槽21a及一第二凹 槽21b。凹槽21a及21b皆係從自基板210的上表面214向 下延伸且沒有貫穿至基板210的下表面,亦即凹槽2H的底 面係由基板210的下半部所界定,於本實施例中,頂板23〇 被貼於基板210上’且基板21〇及頂板230界定出一第一流 道25a及一第二流道25b。 如圖5所示’電極結構220位於基板21〇與頂板23〇之 間且包含一第一工作電極2M、一第二工作電極23a、一第一 測量電極241及一第二測量電極242。於本實施例中,電極 結構220更包含一第三工作電極22b、一第四工作電極挪 以及-第三測量電極243。第一、二及三測量電極24ι、⑽ 及設於基板210的上表面214上。第一及二工作電極22& 及23a分別設於第一流道25以,更詳言之分別從第一凹槽 21a的底面延伸至基板21〇的上表面214,且第一工作電極 22a連接至第-測量電極241,而第二工作電極故連接至第 二測量電極242。第三及四工作電極创及现分別設於第 二流道25b内’更詳言之分別從第二凹槽训的底面延伸至 基板210的上表面214 ’且第三工作電極现連接至第三測 量電極243 ’而第四工作電極说連接至第二測量電極242。 當頂板230覆蓋於基板加時,露出第一、二及三測量電極 241、242及243至少-部分,用以電連於一生化感測試裝置。 201219779 頂板230上更定義有一第一開口 %及_第二開口祝。第 -開口 35a及第二開口 35b的位置分別對應第一流道仏及 第二流道25b的位置。於一實施例中,電極結構22〇還包含 有-第-化學觸及—第二化學試劑。第—化學試劑塗佈於 第工作電極22a及3亥第一工作電極23&。第二化學試劑塗 佈於第三工作電極22b及第四工作電極现,且當第一化學 試劑相異於第二化學試綱,即可形成具衫功能的生化感 測片200。於操作時’生化感測試裝置透過該些量測電極 241〜243使第-及二工作電極瓜與2如間形成一電壓差; 以及使第三及四1作電極22b與23b間形成—電壓差,生化 感測試裝置再_馳輕差,量_如錢等之檢體的一 測量值。 依據本發明-實施例’ φ於是彻詩活化技術配合電 鍍技術形成電極結構22〇,因此電極結構22()能夠形成於不 平整的表面上。藉由上述技術特徵,而能夠將電極結構22〇 形成於具有凹槽211之基板21G上。此外於一實施例中藉 由上述技術特徵,亦可以依據不同的目的,對凹槽2ιι的底 面進行表面處理而軸不伟的底面,例如為確紐測時能 夠有足夠的錢量而軸波錄、或者形脑多個狹縫等之 不平整的底面。相對於此’依據習知印刷技術,於不平整的 表面形成電歸構22G時,其製造良雜低,甚者無法形成 201219779 電極結構220。 此外,依據上述實施例所製得之電極結構22〇,能夠輕 易地增加工作電極的反應面積,而能夠提升檢測時的反應靈 敏度(Sensitivity)。 此外’依據上述實施例所製得之電極結構22〇的最小製 程線寬的財,能糾、於猶習知印職朗製得之電極結 構的最小製程線覓的尺寸而能夠縮小生化感測片2〇〇的尺 寸,並且便於形成多個流道250藉以再開發成具有多功能的 生化感測片200。多功能檢測是指能夠將不同檢測項目開發 於同一試片上進行檢測,具有多功能的生化感測片2〇〇即能 夠達成上述目的,該些檢測項目可以應用電化學原理方式進 行檢測’例如包括心血管疾病血脂檢測 '總膽固醇 (T-Cholesterol)檢測、高密度脂蛋白膽固醇檢測(high density lipoprotein cholesterol,HDL-C)、低密度脂蛋白膽固醇(i〇w density lipoprotein cholesterol,LDL-C )、三酸甘油脂 (Triglyceride ’ TG)、相關於心肌哽塞之 LDH、CK-MB、 CPK、GOT等檢測、相關於痛風指標的Uric acid檢測、以及 相關於肝功能的GOT,GPT檢測等。而且,多功能檢測的好 處之一在於能夠排除非特異性干擾(Non-Specific interaction)。 雖然本發明已以較佳實施例揭露如上,然其並非用以限 201219779 定本發明’任何熟習此技藝者,在不脫離本發明之精神和範 圍内’當可作些許之更動與潤飾,因此本發明之保護範圍當 視後附之巾請翻範_界定者鱗n本發明的任一 f關或巾請摘制不_成本發明簡露之全部目的 或優點或特點。此外,摘要部分和標題僅是用來輔助專利文 件搜尋之用,並義來_本發明之權利範圍。 【圖式簡單說明】 _ 圖1顯示習知生化感測試片的外觀示意圖。 圖2顯示圖1之生化感測試片的分解圖。 圖3顯示依本發明-實施例生化感測試片之製造方法的 流程圖。 圖4A〜圖4D顯示依本發明一實施例生化感測試片之製 造方法各步驟的不意圖。 圖5顯示圖4C之形成有電極結構之基板的部分放大圖。 Φ 【主要元件符號說明】 100 生化感測試片 110 電極基板 120 流道板 122 缺口 12 201219779 125 入口 130 頂板 135 開口 150 流道 200 生化感測試片 210 基板 211 凹槽 212 即將形成電極的區域 214 上表面 21a 第一凹槽 21b 第二凹槽 220 電極結構 22a 第一工作電極 22b 第三工作電極 230 頂板 23a 第二工作電極 23b 第四工作電極 241 第一測量電極 242 第二測量電極 243 第三測量電極 250 流道 13 201219779 25a 第一流道 25b 第二流道 35a 第一開口 35b 第二開口201219779 VI. Description of the Invention: [Technical Field] The present invention relates to a biochemical test piece and a method of manufacturing the same, relating to a biochemical test piece having a multifunctional function and a method of manufacturing the same. [Prior Art] In the past, only hospitals were able to provide physical condition tests. With the advancement of medical technology and the increasing health concept of modern people, it is now possible to self-test at home using various biochemical sensing devices (such as blood glucose meters). The biochemical sensing device has the advantages of simple operation, small volume, and fast detection speed. Figure 1 shows a schematic view of the appearance of a conventional biochemical test piece. Figure 2 shows an exploded view of the biochemical test strip of Figure 1. As shown in Figs. 1 and 2, the biochemical sensing test piece 100 is a blood glucose test piece including an electrode substrate u, a flow path plate 120, and a top plate 130. The electrode substrate 11 is formed by printing a plurality of electrodes and circuits on a substrate by a printing technique. The flow passage plate 120 defines a notch 122 which is formed by penetrating the upper surface above the flow passage plate 120. In order to allow the blood to flow more smoothly, an opening 135 may be provided at the position of the opening 122 of the corresponding flow path plate 12 of the top plate 130. When the biochemical test piece is manufactured, the electrode substrate 11A, the flow path 201219779 plate 120, and the top plate 130 need to be bonded together. The flow path plate 12 is placed between the electrode substrate 110 and the top plate 130, and the electrode substrate 11A, the flow path plate 12A, and the top plate 130 collectively define a first-class track 15〇. The position of the flow path 15A corresponds to the position of the notch 122 of the flow path plate 120, and has an inlet 125 and an opening 135. During operation, the user drops the sample at the inlet 125, and the blood enters the flow path 150 from the inlet 125. The blood flows through the flow path 15〇 due to capillary action, and the gas in the flow path 150 is discharged from the opening 135. However, according to the biochemical sensory test piece of the prior art, there is still room for further improvement. SUMMARY OF THE INVENTION The object of the consistent embodiment of the present invention is to provide a biochemical test piece and a method of manufacturing the same. An object of an embodiment is to provide a versatile biosensory test piece and a method of manufacturing the same. According to an embodiment of the invention, a biochemical test strip is provided comprising a base plate, an electrode structure and a top plate. The substrate defines at least a recess extending downwardly from the surface of the substrate. The electrode structure extends from the inside of the recess to the upper surface of the substrate. The top plate is disposed on the substrate, and the top plate and the substrate define at least the first pass corresponding to the y groove, and the electrode structure is located between the substrate and the top plate. According to the present invention - an embodiment, a method for producing a biochemical test piece is provided which comprises the following steps. A substrate is formed and the substrate defines at least a recess 5 201219779 slot that extends downwardly from the upper surface of the substrate. A laser treatment is performed on one of the substrates to be formed, wherein the enthalpy of the shape is extended from the inside of the at least groove to the upper surface of the substrate. An electrode structure is formed on the substrate to form an electrode, and the electrode structure extends from the inside of the groove to the upper surface of the substrate. A top plate is placed on the substrate to define the substrate and the at least one channel corresponding to at least one slot. Other objects and advantages of the present invention are further understood in the technical features disclosed herein. In order to make the above and other objects, features and advantages of the present invention more compelling, the following is a detailed description of the ship's cooperation. [Embodiment] Fig. 3 is a flow chart showing a method of manufacturing a biochemical test piece according to an embodiment of the present invention. 4A to 4D are views showing the steps of a method of manufacturing a biochemical test piece according to an embodiment of the present invention. As shown in Fig. 3 and Figs. 4 to 4D, a method of manufacturing a biosensing test piece according to an embodiment of the present invention comprises the following steps. As shown in FIG. 4A, step S02: forming a substrate 210, and the substrate 210 defines at least one groove 211. In one embodiment, the thermoplastic plastic can be injection molded into a substrate 210 defining at least one recess 211 by injection molding techniques. Preferably, the substrate 210 is a 201219779 body. The groove 211 extends downward from the upper surface of the substrate 21A and does not pass through to the lower surface of the substrate 210, that is, the bottom surface of the groove 211 is defined by the lower half of the substrate. As shown in Fig. 4B, (d) Simplified: laser processing is performed on the substrate 212 to which the electrode is to be formed, wherein the region 212 where the electrode is to be formed extends from the recess 2U_ to the upper surface of the substrate 21A. In one embodiment, the surface of the region 212 where the electrode is to be formed is roughened by laser, more specifically, the surface of the region 212 is formed into a porous structure (p〇r〇us). In one embodiment, according to the laser activation technique, a special chemical agent is added and the region 212 where the electrode is to be formed is activated by laser, so that the surface of the region 212 is subjected to a physicochemical reaction to form a metal core, preferably, except In addition to the laser activation treatment of the region 212, the surface of the region 212 is roughened at the same time. As shown in Fig. 4C, step S06: an electrode structure 220 is formed on a region 212 of the substrate 210 where the electrode is to be formed, wherein the electrode structure 22 extends from the inside of the recess 211 to the upper surface of the substrate 210. In one embodiment, the electrode structure 220 is applied to the region 212 to be formed by the coating technique. Since the surface of the region 212 has been roughened, the electrode structure 220 can be fixed on the region 212 of the substrate 21〇. More specifically, the electrode structure 220 is anchored to the region 212 of the substrate 210. In one embodiment, the electrode structure 220 is formed by electroplating, through the metal cores on the surface of the region 212, by electroplating a metal layer on the region 212 201219779 where the electrodes are to be formed, with respect to the substrate 21 In a region other than the region 212 of the crucible, no metal core is easily formed by the metal layer on the electric ore. Thus, only the electrode structure 220 is formed on the region 212 where the electrode is to be formed on one of the substrates 21 . Furthermore, since the aforementioned region 212 where the electrode is to be formed has been roughened and formed with a porous structure, the electrode structure 220 can be fixed (or anchored) to the region 212 of the substrate 210. Further, the type of the metal layer is not limited in the present invention, and it may be, for example, gold, nickel, silver or copper. According to the consistent embodiment of the present invention, the electrode structure 220 can be formed on the surface having the groove by using the laser activation technology and the electro-recording technology; and the electrode structure 220 having a line width of 5 to 8 μm can be manufactured. With the conventional printing technology, the size of the biochemical test piece can be further reduced. As shown in FIG. 4C and FIG. 4D, step s〇8: the test chemical is applied to the end of the electrode structure 22〇 at the end of the recess 211, and covers a top plate 23〇, thereby defining the substrate 210 and the top plate 23〇. At least the first-class track, the position of the at least one grab track corresponds to at least the position of the groove 211. This step is a technique that is generally known in the art and is currently known or developed in the future, and thus its related description is omitted. Fig. 5 is a partial enlarged view of the substrate on which the electrode structure is formed in Fig. 4C. As shown in FIG. 4C and FIG. 5, the biochemical test strip 200 includes a substrate 210' electrode structure 22A and a top plate 23G. The substrate train is injection molded from a thermoplastic plastic and is formed into a body that defines at least one recess 211. In the embodiment of the present invention, the at least one recess 211 includes a first recess 21a and a second recess 21b. The recesses 21a and 21b extend downward from the upper surface 214 of the substrate 210 and do not penetrate to the lower surface of the substrate 210, that is, the bottom surface of the recess 2H is defined by the lower half of the substrate 210, in this embodiment. The top plate 23 is attached to the substrate 210 and the substrate 21 and the top plate 230 define a first flow path 25a and a second flow path 25b. As shown in FIG. 5, the electrode structure 220 is located between the substrate 21A and the top plate 23A and includes a first working electrode 2M, a second working electrode 23a, a first measuring electrode 241 and a second measuring electrode 242. In this embodiment, the electrode structure 220 further includes a third working electrode 22b, a fourth working electrode, and a third measuring electrode 243. The first, second and third measuring electrodes 24, (10) and the upper surface 214 of the substrate 210 are disposed. The first and second working electrodes 22& and 23a are respectively disposed on the first flow path 25, and more specifically extend from the bottom surface of the first recess 21a to the upper surface 214 of the substrate 21A, respectively, and the first working electrode 22a is connected to The first measuring electrode 241 and the second working electrode are connected to the second measuring electrode 242. The third and fourth working electrode openings are respectively disposed in the second flow path 25b, respectively, and more specifically extend from the bottom surface of the second groove to the upper surface 214' of the substrate 210, and the third working electrode is now connected to the first The third measuring electrode 243' and the fourth working electrode are said to be connected to the second measuring electrode 242. When the top plate 230 covers the substrate, the first, second and third measuring electrodes 241, 242 and 243 are exposed to at least a portion for electrically connecting to a biochemical sensing device. 201219779 The top plate 230 is further defined with a first opening % and a second opening. The positions of the first opening 35a and the second opening 35b correspond to the positions of the first flow path 仏 and the second flow path 25b, respectively. In one embodiment, the electrode structure 22A further comprises a -th-chemical touch-second chemical reagent. The first chemical reagent is applied to the first working electrode 22a and the third working electrode 23& The second chemical reagent is applied to the third working electrode 22b and the fourth working electrode, and when the first chemical reagent is different from the second chemical test, the biochemical sensing sheet 200 having the shirt function can be formed. During operation, the biochemical sensing device forms a voltage difference between the first and second working electrodes and the second electrode through the measuring electrodes 241 to 243; and forms a voltage between the third and fourth electrodes 22b and 23b. Poor, biochemical sensation test device _ Chi light difference, quantity _ such as a measurement of the sample of money. According to the present invention - the embodiment φ is then formed by the Cushpod activation technique in combination with the electroplating technique to form the electrode structure 22, so that the electrode structure 22() can be formed on an uneven surface. With the above technical features, the electrode structure 22 can be formed on the substrate 21G having the recess 211. In addition, in an embodiment, according to the above technical features, the bottom surface of the groove 2 ι can be surface-treated according to different purposes, and the bottom surface of the shaft is not strong, for example, the axis wave can be sufficient when the measurement is performed. Recording, or an uneven bottom surface such as a plurality of slits in the brain. In contrast to the conventional printing technique, when the electrical structuring 22G is formed on an uneven surface, the manufacturing is low, and the 201219779 electrode structure 220 cannot be formed. Further, according to the electrode structure 22A obtained in the above embodiment, the reaction area of the working electrode can be easily increased, and the sensitivity at the time of detection can be improved. In addition, the minimum process line width of the electrode structure 22〇 obtained according to the above embodiment can correct the biochemical sensing by reducing the size of the minimum process line of the electrode structure prepared by the company. The size of the sheet is 2 inches, and it is convenient to form a plurality of flow channels 250 to be redeveloped into a multifunctional biochemical sensor sheet 200. Multi-function detection means that different test items can be developed on the same test piece for detection. The above-mentioned purpose can be achieved by a multi-functional biochemical sensor piece, which can be detected by electrochemical principle method, for example, including Cardiovascular disease lipid test 'total cholesterol (T-Cholesterol) detection, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), Triglyceride ' TG, LDH, CK-MB, CPK, GOT, etc. related to myocardial occlusion, Uric acid detection related to gout index, GOT and GPT detection related to liver function. Moreover, one of the benefits of multi-function detection is the ability to eliminate non-specific interactions. Although the present invention has been disclosed in the above preferred embodiments, it is not intended to limit the invention to the present invention, and it is intended that the invention may be modified and modified without departing from the spirit and scope of the invention. The scope of protection of the invention should be referred to as the attached towel. _ Defining the scales n Any of the inventions of the invention or the towel should be removed from the full purpose or advantages or features of the invention. In addition, the abstract sections and headings are only intended to aid in the search for patent documents and are intended to be within the scope of the invention. [Simple Description of the Drawing] _ Figure 1 shows a schematic view of the appearance of a conventional biochemical test piece. Figure 2 shows an exploded view of the biochemical test strip of Figure 1. Fig. 3 is a flow chart showing a method of manufacturing a biochemical test piece according to the present invention. 4A to 4D are views showing the steps of the steps of the method for producing a biochemical test piece according to an embodiment of the present invention. Fig. 5 is a partial enlarged view of the substrate of Fig. 4C in which the electrode structure is formed. Φ [Description of main component symbols] 100 Biochemical test piece 110 Electrode substrate 120 Flow path plate 122 Notch 12 201219779 125 Inlet 130 Top plate 135 Opening 150 Flow path 200 Biochemical test piece 210 Substrate 211 Groove 212 On the area where the electrode is to be formed 214 Surface 21a First groove 21b Second groove 220 Electrode structure 22a First working electrode 22b Third working electrode 230 Top plate 23a Second working electrode 23b Fourth working electrode 241 First measuring electrode 242 Second measuring electrode 243 Third measurement Electrode 250 flow channel 13 201219779 25a first flow channel 25b second flow channel 35a first opening 35b second opening