201024721 六、發明說明： 【發明所屬之技術領域】 刚本料有關於—㈣㈣轉朗之㈣μ其檢測器 更有關於帛可偵測兩種血液標的物質之測試片以及 其***。 [先前技術] _慢性病患如糖尿病患者的血糖_，以往必須在醫院才 能進行，現在由於科技的進步，血糖濃度已可由病患在 ❹ 家自行檢測，方便病患進行自我徤康管理。目前市面上 有許多檢測器，配合對應的測試片可測量出正確的血糖 濃度，其中測試片用過一次後即可丟棄β [0003] 如第1圖所示，習用的測試片_1〇係在基板12的一面設有導 電層、反應區13及蓋板14，基板12的另一面為空白。導 電層係形成於基板12上，並由絕緣層零蓋部分的導電層 。未經絕緣層覆蓋之導電層至少可區分為兩部分：一部 分覆蓋有反應物質以形成耳應區13 ;另一部份形成端子 -4 r s 3 *· ' φ 部15可與外部檢測器之插槽連接。蓋板14可覆蓋絕緣層 以及部分導電層，避免使用者接觸。 [0004] 測試片10用於檢測血糖濃度時，其反應物質主要為葡萄 糖氧化酵素，其作用原理為：在血液樣品進入反應區13 時與其中的葡萄糖氧化酵素反應並產生電化學變化，當 測試片10***檢測器的插槽時，測試片1〇的端子部15將 和插槽中的接腳相連，檢測器藉由此電連接讀取其電流 變化，檢測器再將電流變化的訊號經過計算顯示為濃度 097150342 表單編號A0101 第3頁/共21頁 0972082054-0 201024721 [0005] 然而，糖尿病患者除了血糖濃度之外，亦需要定時注意 如微蛋白、總膽固醇或血酮濃度，以避免其他併發症的 發生。習用測試片10的設計僅能測得一種血液標的物質（ 即血糖），欲測量其他血液標的時，除了要利用另一種測 試片及對應的檢測器外，受測者必須另行採血進行檢測 ，亦影響受測者自行採血的意願。 [0006] 【發明内容】 本發明之目的在於提供一種用於電化學檢測器之測試片 〇 [0007] ，可同時達成兩種不同血液標的物質的檢測。 為達成此一目的，該測試片具有一基板，基板具有相對 之一第一面及一第二面。一第一導體層設於第一面；一 第二導體層設於第二面，一第一介電層，部分覆蓋第一 導體層；以及一第二介電層，部分覆蓋第二導體層。第 一介電層以及第二介電層分別具有一第一缺口及一第二 缺口分別使得第一及第二導體層裸露於其中。不同的試 劑層分別位於第一及第二缺口中。至少一試劑層包含用 ❹ 預測定血糖濃度的葡萄糖氧化酵素。第一缺口及第二缺 口分別由上蓋層覆蓋以分別形成一腔室。血液樣品可經 由毛細作用進入不同的腔室。 [0008] 為了同時達成以一滴血液樣品達成兩種不同血液標的物 質的檢測，缺口之邊緣設有與上蓋層切齊的切緣，亦可 不與上蓋層切齊。血液樣本經毛細作用分別進入缺口後 ，並不會有任何殘留連接，因此血液可分別與不同的試 劑層進行反應而不彼此干擾。 [0009] 本發明又一目的在於提供一種電化學檢測系統，可同時 097150342 表單編號A0101 第4頁/共21頁 0972082054-0 201024721 Ο [0010] [0011] ❹ [0012] 達成兩種不同血液標的物質的檢測。該電化學檢測系統 包括一測試片以及一檢測器。測試片具有：一基板，具 有相對之一第一面以及一第二面；一第一導體層，位於 該第一面且具有一第一端子部；以及一第二導體層，位 於該第二面且具有成一第二端子部對應於該第一端子部 。檢測器具有用以使該測試片***之一插槽，該插槽具 有：一第一接腳組，位於該插槽之一側且與該第一端子 部形成電連接；以及一第二接腳組，位於該插槽之另一 側且與該第二端子部形成電連接。 為避免可測得兩種金液樣品的測試片與接腳組的不當連 接，測試片在其一端的周緣設有一缺口或截角，且檢測 器的插槽中具有對應該缺口或截角之結構。此一缺口或 截角可避免測試片誤置***插槽中造成檢測器的不當動 作。 【實施方式】 以下將參照相關圖式，說明本發明實施例之一種電化學 檢測試片及其系統，其中相同的元件將以相同的符號加 以說明。 請參照第2Α及2Β圖所示，本發明其中一種實施例之測試 片S包含一基板2、一第一導體層31、一第二導體層32、 一第一介電層41、一第二介電層42、一第一試劑層51、 一第二試劑層52、一第一上蓋層61以及一第二上蓋層62 。基板2大體上呈矩形且具有一第一端21及一第二端22。 第一導體層31設置於基板2之一第一表面23，第一介電層 41係部份覆蓋第一導體層31使得第一導體層31在靠近第 097150342 表單編號Α0101 第5頁/共21頁 0972082054-0 201024721 [0013] ❹ ❹ 一端21及第二端22處裸露，以分別形成一第一端子區3ΐι 以及-第-電極區312。第-介電層41具有_第一切緣 411及對應形成的-第一缺口412使第一電極區312不至 於被覆蓋。第-試劑層51位於第—缺口412處並部份覆蓋 第一電極區312。第一上蓋層61覆蓋於第一缺口 412及第 -試劑層51上以形成-第-腔室，可令血液樣品由第一 切緣411進入第一腔室與第一試劑層51反應。 基板2之一第二表面24類似於第一表面23之結構，依序設 有第二導體層32、第二介電層42、第二試劑層52以及第 一上蓋層62。第A會電層42部分覆蓋第二導體層32使得 第二導體層'32在靠近第-麵二露分別形 成一第二端子區321以及一齡._€^2;齡二介電層 42具有一第二切緣421以及對應形成的一 ^二缺口 422， 使第二電極區322不至於被覆蓋。第二試劑層52位於第二 缺口 422處並部份覆蓋第二^電極區322。第一上蓋層62覆 盍第·一缺口 422及第一;試劑層52以形成一第二腔室，可令 金液樣品由第一切緣421進入第.二腔室-與第二試劑層μ反 應。 [0014] 在本實施例中’基板2可由聚氣乙烯（p〇iyvinyi chloride, PVC)、聚乙稀對苯二甲酸酯 (polyethylene terephthalate，PET)或高分子材料 所構成。第一介電層41及第二介電層42可為無機化合物 或高分子材料以貼附、塗佈或印刷的方式形成，以隔絕 使用者手持測試片時直接接觸第一導體層31及第二導艘 層32。第一介電層41及第二介電層42的厚度約為20-15〇 097150342 表單編號A0101 第6頁/共21頁 0972082054-0 201024721 β m ° [0015] 本實施例之第一試劑層51及第二試劑層52包含相異的酵 素以作為血液t不同生理標的測定。第一試劑層51或第 二試劑層52包含葡萄糖氧化酵素。 [0016] 請參照第3圖，為適用於本發明實施例之測試片S的檢測 器插槽100。插槽1〇〇之一侧設有對應於測試片S之第一端 子區311的一第一接腳組，插槽1〇〇之另一側設有對應於 測試片S之第二端子區321的一第二接腳組。第一接腳組 ❹ 包含接腳Al、A2、A3、A4及A5，可連接至對應於第一試 劑層51所包含酵素的電化學檢測電路，以及第二接腳組 包含接腳B1、B2、B3、B4及B5可連接至對應於第二試劑 層52所包含酵素的電化學檢測電路。由於‘液在不同腔 室分別與第一試劑層51及第二試劑層52產生化電化學反 應’因此產生的電流變化並不相同，藉由連接至不同的 電化學檢測電路可由檢測器經計算顯示血液樣品中不同 的生理標的濃度。 ，,.'' ^ ❹[0017] 由於血液樣品在不同試劑層之電化學反應所產生的電流 變化需經不同的檢測電路判讀，因此使用者需正確地將 測試片置入插槽中，以避免誤啟動檢測器。第4圖表示本 發明另一實施例之測試片S1，與第2B圖所示之測試片s的 差異在於測试片S1在基板2之第一端21具有一狹缝25。對 應此測試片S1的結構檢測器插槽1〇〇内有一突條（圖未示） 可對應於狹縫25。若使用者不慎將測試片S1反置***， 則第一端子區311無法與接腳A1至A5正確連接。 097150342 表單編號A0101 第7頁/共21頁 0972082054-0 201024721 [0018] 第5圖表示本發明再另一實施例之測試片S2，與第4圖所 示之測試片S1的差異在於係以截角26取代狹縫25。對應 此測試片S2的結構，檢測器插槽100内亦有對應此截角的 結構（圖未示），可避免測試片S2不當的反置***而誤啟 動檢測器。 [0019] ❹ 第6A圖表示依據本發明之測試片之第二端的側視圖，其 中第一切緣411與第二切緣412係分別與第一上蓋層61及 第二上蓋層62切齊。在使用測試片時，測試者依圖示的 箭頭方向令測試片與一滴血液樣品接觸時，血液會經毛 細作用經由第一切緣411及第二切緣421進入第一缺口 412及第二缺口 422以分別與第一試劑層51及第二試劑層 52進行反應。第6B至6D圖表示第6A圖所示之基板第二端 的上視圖變化。測試片的第二端具有圓角、雙截角、直 角或其他形狀。 [0020] ❹ 第7A圖表示依據本發明之測試片之基板第二端之另一變 化的侧視圖。不同於第6A圖的是第7A圖的第一上蓋層61 及第二上蓋層62略為内縮，使部分之第一介電層41及第 二介電層42露出，即第一切緣411與第二切緣421係不與 第一上蓋層61及第二上蓋層62切齊。如圖所示，測試者 依圖示的箭頭方向令測試片與一滴血液樣品接觸時，血 液會經毛細作用經由第一切緣411及第二切緣412進入第 一缺口 41 2及第二缺口 422以分別與第一試劑層51及第二 試劑層52進行反應。第7B至7D圖表示第7A圖所示之基板 第二端的上視圖變化。測試片的第二端具有圓角、雙截 角、直角或其他形狀。 097150342 表單編號A0101 第8頁/共21頁 0972082054-0 201024721 [0021] 如第6A至6D圖以及第7A至7D圖所示之測試片，血液樣本 經毛細作用分別進入第一缺口 412及第二缺口 422後，並 不會有任何殘留連接，因此血液可分別與第一試劑層51 及第二試劑層52進行反應而不彼此干擾，故本發明之單 一測試片同時可準確感測兩種以上之生化指標物質。 [0022] 以上所述僅為舉例性，而非為限制性者。任何未脫離本 發明之精神與範疇，而對其進行之等效修改或變更，均 應包括於後附之申請專利範圍中。 φ 【圖式簡單說明】 [0023] 第1圖係表示習知的檢測試片； 第2A及2B圖表示依據本發明之測試片之一實施例的分解 圖以及經組合後的上視圖； 第3圖表示本發明之電化學檢測器之插槽的實施態樣； 第4及5圖表示第2B圖所示之測試片實施例其端子區之變 化的上視圖； 第6A圖表示依據本發明之測試片之基板第二端的侧視圖 ❹ 第6B至6D圖表示第6A圖所示之基板第二端的變化上視圖 t 第7A圖表示依據本發明之測試片之基板第二端之另一變 化的侧視圖；以及 第7B至7D圖表示第7A圖所示之基板第二端的變化上視圖 〇 【主要元件符號說明】 [0024] 2，12:基板 097150342 表單編號A0101 第9頁/共21頁 0972082054-0 201024721 ❹201024721 VI. Description of the invention: [Technical field to which the invention pertains] Just as far as the material is concerned - (4) (4) Turning to the (4) μ detector is more about the test piece of the substance that can detect two blood markers and its system. [Prior Art] _ Chronic diseases such as blood sugar in diabetic patients _, in the past must be carried out in the hospital, and now due to advances in technology, blood glucose levels can be self-tested by patients at home, to facilitate patients to manage themselves. There are many detectors on the market, and the correct blood glucose concentration can be measured with the corresponding test piece. The test piece can be discarded after one use. [0003] As shown in Figure 1, the conventional test piece_1 A conductive layer, a reaction zone 13 and a cover plate 14 are provided on one surface of the substrate 12, and the other surface of the substrate 12 is blank. The conductive layer is formed on the substrate 12 and is covered by a conductive layer of the insulating layer. The conductive layer not covered by the insulating layer can be divided into at least two parts: one part is covered with the reaction substance to form the ear area 13; the other part forms the terminal - 4 rs 3 *· ' φ part 15 can be inserted with the external detector Slot connection. The cover 14 can cover the insulating layer and a portion of the conductive layer to avoid user contact. [0004] When the test piece 10 is used for detecting blood sugar concentration, the reaction substance is mainly glucose oxidase, and the principle of action is: reacting with the glucose oxidase and generating electrochemical changes when the blood sample enters the reaction zone 13 when testing When the chip 10 is inserted into the slot of the detector, the terminal portion 15 of the test piece 1 is connected to the pin in the slot, and the detector reads the current change by the electrical connection, and the detector passes the signal of the current change. The calculation shows the concentration of 097150342 Form No. A0101 Page 3 of 21 0972082054-0 201024721 [0005] However, in addition to blood glucose concentration, diabetic patients also need to pay attention to such as microprotein, total cholesterol or blood ketone concentration to avoid other The occurrence of complications. The design of the conventional test piece 10 can only measure one blood mark substance (ie, blood sugar). When measuring other blood mark, in addition to using another test piece and the corresponding detector, the test subject must separately collect blood for testing. Affect the subject's willingness to collect blood by himself. SUMMARY OF THE INVENTION [0006] The object of the present invention is to provide a test piece for an electrochemical detector [0007], which can simultaneously detect the detection of two different blood label substances. To achieve this, the test strip has a substrate having a first side and a second side opposite to each other. a first conductor layer is disposed on the first surface; a second conductor layer is disposed on the second surface, a first dielectric layer partially covering the first conductor layer; and a second dielectric layer partially covering the second conductor layer . The first dielectric layer and the second dielectric layer respectively have a first gap and a second gap, respectively, such that the first and second conductor layers are exposed therein. Different reagent layers are located in the first and second gaps, respectively. At least one reagent layer comprises glucose oxidase which predicts blood glucose concentration with ❹. The first notch and the second notch are respectively covered by the upper cover layer to form a chamber, respectively. Blood samples can enter different chambers via capillary action. [0008] In order to simultaneously achieve the detection of two different blood target substances with one drop of blood sample, the edge of the notch is provided with a cutting edge that is aligned with the upper cover layer, or may not be aligned with the upper cover layer. After the blood sample enters the gap by capillary action, there is no residual connection, so the blood can react with different reagent layers without interfering with each other. [0009] Another object of the present invention is to provide an electrochemical detection system capable of simultaneously 097150342 Form No. A0101 Page 4 / Total 21 Page 0972082054-0 201024721 Ο [0010] [0011] ❹ [0012] Two different blood labels are achieved Detection of substances. The electrochemical detection system includes a test piece and a detector. The test piece has: a substrate having a first surface and a second surface; a first conductor layer on the first surface and having a first terminal portion; and a second conductor layer on the second The surface has a second terminal portion corresponding to the first terminal portion. The detector has a socket for inserting the test piece into the slot, the slot having: a first pin set on one side of the slot and forming an electrical connection with the first terminal portion; and a second pin The set is located on the other side of the slot and is in electrical connection with the second terminal portion. In order to avoid improper connection of the test piece and the pin set of the two gold liquid samples, the test piece has a notch or a truncated angle at the periphery of one end thereof, and the slot of the detector has a corresponding notch or a truncated angle. structure. This notch or truncation prevents the test piece from being misplaced into the slot causing improper operation of the detector. [Embodiment] Hereinafter, an electrochemical test strip and a system thereof according to an embodiment of the present invention will be described with reference to the accompanying drawings, wherein the same elements will be denoted by the same reference numerals. Referring to Figures 2 and 2, the test piece S of one embodiment of the present invention comprises a substrate 2, a first conductor layer 31, a second conductor layer 32, a first dielectric layer 41, and a second The dielectric layer 42, a first reagent layer 51, a second reagent layer 52, a first upper cap layer 61 and a second upper cap layer 62. The substrate 2 is substantially rectangular and has a first end 21 and a second end 22. The first conductor layer 31 is disposed on one of the first surfaces 23 of the substrate 2, and the first dielectric layer 41 partially covers the first conductor layer 31 such that the first conductor layer 31 is near the 097150342 Form No. 1010101 Page 5 of 21 Page 0972082054-0 201024721 [0013] One end 21 and the second end 22 are exposed to form a first terminal region 3ΐ and a -electrode region 312, respectively. The first dielectric layer 41 has a first cutting edge 411 and a correspondingly formed first notch 412 such that the first electrode region 312 is not covered. The first reagent layer 51 is located at the first gap 412 and partially covers the first electrode region 312. The first upper cap layer 61 covers the first notch 412 and the first-reagent layer 51 to form a -th-chamber, which allows the blood sample to enter the first chamber from the first cutting edge 411 to react with the first reagent layer 51. The second surface 24 of the substrate 2 is similar to the structure of the first surface 23, and is provided with a second conductor layer 32, a second dielectric layer 42, a second reagent layer 52, and a first upper cap layer 62. The second electrical layer 42 partially covers the second conductor layer 32 such that the second conductor layer '32 forms a second terminal region 321 adjacent to the first surface and the second surface, and an age of two. There is a second cutting edge 421 and a correspondingly formed second gap 422 so that the second electrode region 322 is not covered. The second reagent layer 52 is located at the second gap 422 and partially covers the second electrode region 322. The first upper cap layer 62 covers the first notch 422 and the first; the reagent layer 52 forms a second chamber, so that the gold liquid sample enters the second chamber - the second reagent layer from the first cutting edge 421 μ reaction. [0014] In the present embodiment, the substrate 2 may be composed of polyethylene terephthalate (PVC), polyethylene terephthalate (PET) or a polymer material. The first dielectric layer 41 and the second dielectric layer 42 may be formed by attaching, coating or printing an inorganic compound or a polymer material to isolate the first conductor layer 31 and the first contact layer when the user holds the test piece. The second guide layer 32. The thickness of the first dielectric layer 41 and the second dielectric layer 42 is about 20-15 〇 097150342. Form No. A0101 Page 6 / Total 21 0972082054-0 201024721 β m ° [0015] The first reagent layer of this embodiment The 51 and second reagent layers 52 contain different enzymes as assays for different physiological targets of blood. The first reagent layer 51 or the second reagent layer 52 contains glucose oxidase. Referring to FIG. 3, a detector slot 100 suitable for the test piece S of the embodiment of the present invention. One side of the slot 1 is provided with a first pin group corresponding to the first terminal area 311 of the test piece S, and the other side of the slot 1 is provided with a second terminal area corresponding to the test piece S. A second pin set of 321 . The first pin set 包含 includes pins Al, A2, A3, A4, and A5, and is connectable to an electrochemical detection circuit corresponding to the enzyme contained in the first reagent layer 51, and the second pin set includes pins B1 and B2. B3, B4 and B5 may be connected to an electrochemical detection circuit corresponding to the enzyme contained in the second reagent layer 52. Since the 'liquid reacts electrochemically with the first reagent layer 51 and the second reagent layer 52 in different chambers respectively', the current changes are not the same, and can be calculated by the detector by connecting to different electrochemical detection circuits. Displays the concentration of different physiological targets in the blood sample. ,,.'' ^ ❹[0017] Since the current change caused by the electrochemical reaction of blood samples in different reagent layers needs to be interpreted by different detection circuits, the user needs to correctly place the test piece into the slot to Avoid accidentally starting the detector. Fig. 4 shows a test piece S1 according to another embodiment of the present invention, which differs from the test piece s shown in Fig. 2B in that the test piece S1 has a slit 25 at the first end 21 of the substrate 2. A protrusion (not shown) corresponding to the slit 25 is formed in the structure detector slot 1 of the test piece S1. If the user accidentally inserts the test piece S1, the first terminal area 311 cannot be properly connected to the pins A1 to A5. 097150342 Form No. A0101 Page 7 of 21 0972082054-0 201024721 [0018] FIG. 5 shows a test piece S2 according to still another embodiment of the present invention, which differs from the test piece S1 shown in FIG. 4 in that The corner 26 replaces the slit 25. Corresponding to the structure of the test piece S2, the detector slot 100 also has a structure corresponding to the truncated angle (not shown), which can prevent the test piece S2 from being improperly inserted and incorrectly start the detector. [0019] FIG. 6A is a side view showing the second end of the test piece according to the present invention, wherein the first cutting edge 411 and the second cutting edge 412 are respectively aligned with the first upper cover layer 61 and the second upper cover layer 62. When the test piece is used, when the tester touches the test piece with a drop of blood sample according to the direction of the arrow in the figure, the blood enters the first notch 412 and the second notch through the first cutting edge 411 and the second cutting edge 421 by capillary action. 422 is reacted with the first reagent layer 51 and the second reagent layer 52, respectively. Figures 6B to 6D show top view variations of the second end of the substrate shown in Figure 6A. The second end of the test piece has rounded corners, truncated angles, right angles or other shapes. [0020] FIG. 7A is a side elevational view showing another variation of the second end of the substrate of the test piece according to the present invention. Different from FIG. 6A, the first upper cap layer 61 and the second upper cap layer 62 of FIG. 7A are slightly retracted, so that a portion of the first dielectric layer 41 and the second dielectric layer 42 are exposed, that is, the first cutting edge 411. The second cutting edge 421 is not aligned with the first upper cover layer 61 and the second upper cover layer 62. As shown in the figure, when the tester touches the test piece with a drop of blood sample according to the direction of the arrow in the figure, the blood enters the first notch 41 2 and the second notch through the first cutting edge 411 and the second cutting edge 412 by capillary action. 422 is reacted with the first reagent layer 51 and the second reagent layer 52, respectively. Figures 7B through 7D show top view variations of the second end of the substrate shown in Figure 7A. The second end of the test piece has rounded corners, double cuts, right angles or other shapes. 097150342 Form No. A0101 Page 8 of 21 0972082054-0 201024721 [0021] As shown in Figures 6A to 6D and 7A to 7D, the blood sample enters the first gap 412 and the second by capillary action, respectively. After the gap 422, there is no residual connection, so the blood can react with the first reagent layer 51 and the second reagent layer 52 without interfering with each other, so that the single test piece of the present invention can accurately sense two or more types at the same time. Biochemical indicator substance. [0022] The foregoing is illustrative only and not limiting. Any equivalent modifications or alterations to the spirit and scope of the invention are intended to be included in the scope of the appended claims. [0023] Fig. 1 is a view showing a conventional test piece; and Figs. 2A and 2B are an exploded view showing an embodiment of a test piece according to the present invention and a combined upper view; 3 is a view showing an embodiment of a slot of the electrochemical detector of the present invention; FIGS. 4 and 5 are views showing a change of a terminal area of the test piece embodiment shown in FIG. 2B; FIG. 6A is a view showing the present invention. Side view of the second end of the substrate of the test piece ❹ FIGS. 6B to 6D show a variation of the second end of the substrate shown in FIG. 6A. FIG. 7A shows another variation of the second end of the substrate of the test piece according to the present invention. Side view; and Figs. 7B to 7D show changes in the second end of the substrate shown in Fig. 7A. [Main element symbol description] [0024] 2, 12: Substrate 097150342 Form No. A0101 Page 9 of 21 0972082054-0 201024721 ❹
10，S，Sl，S2:測試片 13:反應區 14:蓋板 15:端子部 21:第一端 22:第二端 23:第一表面 24:第二表面 25: 狹縫 26: 截角 31, 32:導體層 311, 321:端子區 312, 3 2 2 :電極區 41， 42:介電層 411， 4 21:切緣 412, 422 :缺口 51， 52:試劑層 61， 62:上蓋層 100:插槽10, S, Sl, S2: Test piece 13: Reaction zone 14: Cover plate 15: Terminal portion 21: First end 22: Second end 23: First surface 24: Second surface 25: Slit 26: Truncated 31, 32: conductor layer 311, 321: terminal region 312, 3 2 2 : electrode region 41, 42: dielectric layer 411, 4 21: cutting edge 412, 422: notch 51, 52: reagent layer 61, 62: upper cover Layer 100: Slot
A1~*A5，B1-B5:接腳 0972082054-0 097150342 表單編號A0101 第10頁/共21頁A1~*A5, B1-B5: Pin 0972082054-0 097150342 Form No. A0101 Page 10 of 21