201009331 九、發明說明： 【發明所屬之技術領域】 本發明係關於一種檢測試片、生化感測备祕、及 量測裝置，特別是，關於一種可免除密蝎卡需求之自 動辨識或权正之生化感測系統、量測裝置、及檢測試 【先前技術】 _ 隨著醫學的進步與現代人對於健康護理觀念的曰 益提升，定點照護.檢測(Point-of-Care ; POCT)的市場 普及化也大增。這類的檢測趨向快速、便宜、體積小、 以及不需專業人員操作的自我檢驗產品，例如血糖 儀、電子耳溫槍、以及電子式血壓計等。而在此領域 中，檢測試片的使用已經是一項極為純熟的技術，其 中又以分析血糖之應用最為廣泛。 ❸ 習知生化感測系統中，每一板檢測試片在生產過 程中都已設定獨特的變異參數或辨識碼。因此，在使 用1測裝置對該批檢測試片進行量測之前需藉由一密 碼卡(^code card)來對量測裝置進行辨識或校正，如美國 專利第5,366,609號以及PCT專利第wooo/33072號 所揭示。然而，密碼卡的燒錄和製備會增加人力與製 迈成本，而且也常發生使用者忘記插入或插錯密碼卡 導致杈正錯誤及數據判讀上的錯誤、或是密碼卡遺 等問題。 201009331 ★為了改善密碼卡使用上所造成的不便，美國專利 第6,814,844號揭露了 一種利用條碼(bar code)作為辨 識方式的試片。美國專利第6,814,844號利用高能量脈 衝雷射光轟擊已塗覆於基板上之金靶材的表面，使得 金靶材表面瞬間蒸發，而形成條碼圖形。然而，此條 碼的辨識方式為鮮式的檢測系統，需使_外的光 學元件丄例如使用CCD或LED進行偵測，因此製造 成本較高。再者，此種辨識條碼的再現性與準確度受 限於靶材表面材料，不但會造成製程上的限制亦$ 增加製造成本。 —此外’中華民國第M304662號新型專利揭示了另 種免费碼卡之生化感測系統，其在檢測裝置設置若 :按，，用以輸入一預定英文字母或是數字，此預定 ^文予母或疋數予係標示於檢測試片的包裝（外盒、膠 盒、說明書…等）上，且對應檢測裝置内部所預^的一 組參數。當輸入此預定英文字母或是數字後，Α所對 f的參數將傳送至檢測裝置中的一微處理器以對檢測 裝置進行一設定校正，而達到準確測試之目的。 中華民國第97208206號專利申請牵士报 ，馬卡的試片，其在試片上—端設置多』構:: 牛’迎對部分的構成元件進行打孔而形成〇或丨之電 性連接，以組合出多種圖碼。然而，此檢測系統具^ 201009331 多種限制，如打孔製程需要高精密度、量測裝置之各 感測端子與各構成元件之間的對位需要高精準度等， 且由於試片上之圖碼如齒狀，當置入量測裝置亦有斷 裂之風險。 因此’有必要提供一種免除密碼卡的辨識或校正 且具有檢測方便性之生化感測系統。 【發明内容】 鑑於先前技術所存在的問題，本發明提供了—種 可免除狺碼卡的使用、減少操作失誤、且可提高檢則 方便性的的自動辨識或校正之生化感測系統、駐 置及檢測試片。201009331 IX. Description of the invention: [Technical field of invention] The present invention relates to a test strip, a biochemical sensing preparation, and a measuring device, and in particular, to an automatic identification or right to eliminate the need for a security card. Biochemical sensing system, measuring device, and testing [previous technology] _ With the advancement of medicine and the improvement of modern people's concept of health care, the market penetration of point-of-Care (POCT) The number has also increased. Such tests tend to be fast, inexpensive, small, and self-testing products that do not require professional operation, such as blood glucose meters, electronic ear thermometers, and electronic sphygmomanometers. In this field, the use of test strips is already an extremely sophisticated technique, with the most widely used blood glucose analysis.习 In the traditional biochemical sensing system, each plate test piece has been set with unique variation parameters or identification codes during the production process. Therefore, the measurement device needs to be identified or corrected by a password card before the measurement of the batch of test strips by using the 1 test device, such as U.S. Patent No. 5,366,609 and PCT Patent No. WOOO/ Rev. 33072. However, the burning and preparation of the cryptographic card increases the labor and manufacturing costs, and it is often the case that the user forgets to insert or insert the wrong cryptographic card, causing errors in the correctness of the data and the interpretation of the data, or the cryptographic card. 201009331 ★ In order to improve the inconvenience caused by the use of the PIN card, a test piece using a bar code as an identification method is disclosed in U.S. Patent No. 6,814,844. U.S. Patent No. 6,814,844 utilizes high energy pulsed laser light to bombard the surface of a gold target that has been applied to a substrate such that the surface of the gold target evaporates instantaneously to form a bar code pattern. However, the identification method of this barcode is a fresh detection system, and the optical components such as CCD or LED are required to be detected, so that the manufacturing cost is high. Moreover, the reproducibility and accuracy of such identification bar codes are limited to the surface material of the target, which not only causes process limitations but also increases manufacturing costs. - In addition, the new patent No. M304662 of the Republic of China reveals a biochemical sensing system of another free code card, which is set in the detecting device to: press to input a predetermined English letter or number, the predetermined ^ text to the mother Or the number of lines is indicated on the package (outer box, plastic box, manual, etc.) of the test piece, and corresponds to a set of parameters pre-determined inside the detecting device. When the predetermined English letter or number is input, the parameter of f is transmitted to a microprocessor in the detecting device to perform a setting correction on the detecting device for accurate testing purposes. The patent application No. 97208206 of the Republic of China, the test piece of Maca, which is arranged on the test piece - the end of the test piece:: The cow's welcoming part of the component is punched to form an electrical connection of 〇 or 丨, To combine multiple graphic codes. However, this detection system has various limitations of 201009331. For example, the punching process requires high precision, the alignment between each sensing terminal of the measuring device and each component needs high precision, and the image on the test piece. If it is toothed, there is also a risk of breakage when placed in the measuring device. Therefore, it is necessary to provide a biochemical sensing system that is free of identification or correction of the PIN card and has the convenience of detection. SUMMARY OF THE INVENTION In view of the problems of the prior art, the present invention provides an automatic identification or correction biochemical sensing system capable of eliminating the use of a weight card, reducing operational errors, and improving the convenience of inspection. Set and test the test piece.
根據本發明之-方面，提供了一種檢測試片 檢測試片包含-絕緣基板、—電極組、及—辨識 電極組設置於_紐之上。_單元設置於某 板之一表面。辨識衫具有N個構成元件與二個連; 兀件，每- N個構成元件具有 其中-連結元件與各構成元件之-端連接= 連結元件所構成之—婢電性 牛及一 辨識碼 、-紐特徵蚊了檢測試片之— 根據本發明之再一方面 提供了一種生化感測系 201009331 統，其包含一檢測試片及一量測裝置。檢測試片具有 一絕緣基板、設置於絕緣基板上之一電極組、以及設 置於絕緣基板之一表面之一辨識單元。量測裝置具有 一微處理單元以及一連接器，其中連接器係用以柄合 至辨識單元以接收辨識單元所表示之一識別竭之—二 號’且微處理單元係耦合至連接器以接收來自連接^ 之信號。辨識單元具有N個構成元件與二個連、纟士^ 件，每一 N個構成元件具有一被動元件電性特徵，其 中一連結元件與各構成元件之一端連接，另—連纟士元 件與各構成元件之另一端連接。According to an aspect of the invention, there is provided a test strip test strip comprising an insulating substrate, an electrode set, and an identification electrode set disposed on the top. The _ unit is placed on one of the surfaces of a board. The identification shirt has N constituent elements and two connection members; each of the N constituent elements has a connection between the - connection element and each constituent element = a connection element - a battery and an identification code, - New characteristic mosquito test strip - According to still another aspect of the present invention, a biochemical sensing system 201009331 is provided, which comprises a test strip and a measuring device. The test strip has an insulating substrate, an electrode group disposed on the insulating substrate, and an identification unit disposed on one surface of the insulating substrate. The measuring device has a micro processing unit and a connector, wherein the connector is adapted to be coupled to the identification unit to receive one of the identification units indicated by the recognition unit - and the micro processing unit is coupled to the connector for receiving Signal from the connection ^. The identification unit has N constituent elements and two connected, gentlemen, each of the constituent elements has a passive component electrical characteristic, wherein one of the connecting elements is connected to one of the constituent elements, and the other is a gentleman element. The other ends of the constituent elements are connected.
根據本發明之另一方面，提供了一種量測裝置。 此量測裝置係用以搭配一檢測試片使用，其中檢測号 片具有一絕緣基板、設置於絕緣基板上之一電極組°、 以及设置於絕緣基板之一表面之一辨識單元。辨識單 個?ί元件與二個連結元件’每-N個構成 m-被動元件電性雜，其中一連結元件與各 另-：車i一端連接，另一連結元件與各構成元件之 另ί接。量測裝置包含一連接器及一微處 =連接益至少包含相應於賴單元 收來自連接器“?二處理單元輕合至連接器以接 所構成之—總電性=決定及二個連結元件 201009331 於一實施例中，N個構成元件之至少之一與二個 给結7〇件之間形成1路結構，且電極組包含相互絕 、’之一工作電極及一參考電極。在另一實施例中，電 極組包含相互絕狀-卫作電極、—參考電極、及一 則電極。在又—實施例中，電極組包含—工作電極、 參考電極、一感測電;^、及二個4貞測單元，其中二 ^貞測單元之-端分別連接至參考電極及二個連結元 件之其中之一。。 本發明之其他方面，部分將在後續說明中陳述， ，部分可由說财輕易得知，或可由本發明之實施而 :知。本發明之各方面將可利用後附之中請專利範圍 ▲所特別指出之元件及組合而理解並達成、需了解， =述的-般說明及下列詳細說明均僅作舉例之用 非用以限制本發明。 ❹ 【實施方式】 本發明揭露-種不需利用密碼卡即可進行辨識或 校正之生化感測系統、量測裝置、及檢測試片’其可 免除^碼卡製程、操作方便、防止忘記插人密碼 口番=密碼卡等失誤、且可降低使用過程中失誤發生的 可能性。為了使本發明之敘述更加詳盡與完備，可參 描述並配合圖1至圖6之圖式’其中類似的元 付k代表類似的元件。然以下實施例中所述之裝 置、凡件及程序步驟，僅用以說明本發明，並非用以 -10- 201009331 限制本發明的範圍。 圖1纷示本發明一實施例之檢測試片100,而圖2 則繪示檢測試片1〇〇的結構分解圖，並以虛線繪示出 各元組件之對應關係。本發明之檢測試片100包含一 絕緣基板110、一導電層12〇、一絕緣墊高層13〇、及 一上蓋150。導電層12〇包含一電極組122以及一辨 識單元127，其中辨識單元127包含構成元件組ι28 ❿ 及連結元件組129。在此實施例中’構成元件組128 包含 5 個構成元件 128a、128b、128c、128d、及 128e， 而連結元件組129包含二個連結元件129a及129b。 連結元件129a與各構成元件之的一端連接，而連結元 件129b則與各構成元件的另一端連接，如圖2所示。 在此實施例中，電極組122包含相互絕緣之一工作電 極123及一參考電極124。 ❹ 本發明並不限定辨識單元127中所含構成元件的 數量、形狀，且辨識單元127可設置於絕緣基板11〇 的任一表面，並不侷限與電極組122在同一表面。一 般來說，構成元件組128包含至少一個部分或完全貫 穿絕緣基板110的孔洞(如圖2中之元件η)於其中一構 成元件上，使得該構成元件與連結元件组129之間形 成一開路結構。在本實施例中孔洞Η係完全貫穿絕緣 基板110 ’其由絕緣基板11〇上之貫穿孔Μ、導電声 120中的貫穿孔h2、及絕緣墊高層13〇上的貫穿孔& -11- 201009331 所構成。藉由控制孔洞的數量及位置，可改變辨識單 元127的電性特徵(如二個連結元件12%及12卯之間 的阻抗值），並可據此而辨別檢測試片1〇〇。 絕緣基板110具有電絕緣性，其材料可包含但不 限於：聚氯乙烯（PVC)、玻璃纖維（fR-4)、聚酯 (polyester)、電木板(bakelite)、聚對苯二甲酸二乙酯 (PET)、聚碳酸酯(ρ〇、聚丙烯(pp)、聚乙歸(pE)、聚 ❹ 苯乙烯(PS)、或陶瓷等。 、 導電層120的材料可為任何導電物質，例如碳 膠、金銀膠、銅膠、碳銀混合膠、或其類似物及組合 等。在一實施例中，導電層12〇係由一導電銀膠層以 及置於導電銀膠層之上的一導電碳粉層所組成，一般 而言’導電碳粉層的阻抗遠大於導電銀膠層或其他金 屬膠層。辨識單元127可藉由導電銀膠層與導電碳粉 ❹ 層做搭配，以计算各個構成元件所組成之一阻抗值， 作為檢測試片之排列設計。各構成元件可分別具有不 同的長度或寬度以形成具有不同阻值的電阻，且各構 成元件與兩連結元件之間可選擇性地形成通路結構或 藉由孔洞而形成開路結構。一般來說，當N個構成元 件各自具有不同的阻抗值並搭配不同的孔祠數量及位 置’可組合出2N種阻抗值。當檢測試片1〇〇置入一 量測裝置時，量測裝置可根據兩連結元件之間的阻抗 值而辨別檢測試片100’亦可進而採行相對應校正象 •12- 201009331 數或拉式進行量測。需注意本發明之構成元件128不 限於電阻。 ^發明並不限制工作電極123、參考電極124、及 辨識單元127的安排方式，亦不限制電極的數量，可 根據實際應用所需而增加其他電極。一般來說，只要 各電極及辨識單元之間彼此絕緣即已足夠。 ▲絕緣墊高層130係置於導電層12〇之上，且絕緣 墊南層130包含一開口 132a，以暴露導電層12〇之一 部分。一般而言，開口 132a只要能夠暴露出部份的工 作電極123及部分的參考電極124即已足夠，本發明 並不限制開口 132a的形狀。此外’絕緣墊高層丨3〇之 设計亦暴露出導電層12〇的另一部份，以使導電層12〇 可與一量測裝置(如圖6之630)電性相接。絕緣墊高層 130的材料可包含但不限於PVC絕緣膠帶、PET絕緣 ❿ 膠帶、熱乾燥型絕緣漆或紫外光固化型絕緣漆。 上蓋150置於絕緣墊高層130之上，且覆蓋開口 132a。介於絕緣基板110與上蓋150之間的部份係形 成一具毛細吸引力之取樣空間（即反應區132)。當取樣 空間的面積固定時’其體積可取決於絕緣墊高層13〇 之厚度。一般而言’絕緣塾高層130之厚度介於約0.005 公釐至約0.3公釐，然不在此限。此外，在製造過程 中’可將已裁切出開口 132a的絕緣墊高層130放置於 -13- 201009331 絕緣基板110與導電層 開開口 及·的方1 接形成絕緣墊高層130於 ：之區域，而直 層120之上。 邛刀的絕緣基板110與導電 本發明之檢測試片100更 一反應層140，1具右A t置於開口 132at|7的 能力，装+ Θ =具有專一性辨識生物材料或訊號之 參 同，S應f140之材料係隨樣品不同而有所不 二料/、盘乳化還原酶或一電子媒介物(如亞鐵類 產生化學反應。—般而言，反應層 至夕覆蓋部份的參考電極I24及工作電極m。 本發明之上蓋15G可為透明或半透明材質，以方 便觀察反應區132是否已填入樣品，避免樣品未填入 前即進行檢測，而導致錯誤的結果。上蓋15〇之接近 反應區132的下表面可塗佈一親水材料，以加強反應 • 區132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132中。上蓋15〇更包含相應於開口 132a 末端的一通氣孔153，用以排出反應區132内的氣體 以加強毛細作用，一般而言，通氣孔153係靠近開口 132a末端。本發明並不限制通氣孔153的形狀，舉例 來說，通氣孔153可為圓形、橢圓形、長方形、菱形 等。 圖3、圖4、圖5A、及圖5B為根據本發明不同實 201009331 施例所繪示之檢測試片300、400、500a、及5〇〇b，須 /主思'到為方便說明並未繪' 示絕緣塾高層及上蓋。參考 圖3 ’檢測试片3 00包含·—絕緣基板310、以及相互絕 緣之一工作電極323、一參考電極324、一感測電極 325、二個偵測單元326及一辨識單元327,其中辨識 單元327包含構成元件組328及連結元件組329。在 此實施例中，構成元件組328包含五個構成元件 328a、328b、328c、328d、及 328e，而連結元件組 329 ❸ 包含連結元件329a及329b，其中各個構成元件之二 端分別與連結元件329a及329b連接，形成一並聯。 檢測試片300亦包含了兩個孔洞pi及p2於構成元件 328a及328d上，使得構成元件328a、328d分別與連 結元件組329之間形成一開路結構❶當檢測試片3〇〇 與一量測裝置(如圖ό所繪示之量測裝置630)電性連接 時，構成元件328b、328c、及328e可分別形成三個電 性迴路’而構成元件328a、328d則分別為斷路，因此 • 量測裝置將透過連結元件組329量測到由構成元件 328b、328c、及328e所形成之迴路的總電性特徵(如 一總等效阻抗值）’並藉此辨識檢測試片3〇〇。 在圖3所示的實施例中，感測電極325為一门字 型電極，其與工作電極323及參考電極324電性絕緣。 感測電極325設置於工作電極323及參考電極324之 間，用以感測檢測試片300與一量測裝置(如圖6所繪 . 示之量測裝置630)間的電性連接。一般來說，感測電 •15- 201009331 極325係透過-迴路產生—電訊號，而達到 之功效。舉例來說，當檢測試片3⑽置人 ^機 極325可與量測裝置間形成 ❹ 偵測單it 326的主要功能在於確認樣 ^地覆蓋反舰332。—般來說，勤i單元326 g 應反應區332的底部而設置，使得當-液態樣品注^ 反應區332時，將依序接觸到參考電極32心 極323、及侧單元326。一旦樣品到達反應區底2 一個偵測早兀326，此樣品可做為這二個偵測單元3 2 6 間的電性連接，而使其之間的阻抗值變小。偵測單元 326可藉由與基板上的其他電極或電性結構耦合而 達到在小面積之基板上實現多項檢測功能的目的。在 此實施例中，二個偵測單元326的一端分別與參考電 極324及連結元件329a連接。如此，量測裝置可提供 電壓於參考電極324及連結元件329a之間，一旦樣品 到達反應區332底部之彳貞測單元326，便可使參考電 極324及連結元件329a間有足夠的電流流通，而確認 樣品已適當地覆蓋反應區332。在其他實施例中，二 個偵測單元326的一端可分別連接至其他電極，例如 分別連接至工作電極323及連結元件329b。 參考圖4 ’檢測試片400包含一絕緣基板410、以 及相互絕緣之一工作電極423、一參考電極424、二個 -16- 201009331 偵測單元426及一辨識單元427，其中辨識單元427 包含構成元件428a、428b、428c及連結元件429a、According to another aspect of the present invention, a measuring device is provided. The measuring device is used for use with a detecting test piece, wherein the detecting chip has an insulating substrate, an electrode group disposed on the insulating substrate, and an identification unit disposed on one surface of the insulating substrate. Identifying a single component and two connecting components 'each-N constitutes an m-passive component, wherein one of the connecting components is connected to one end of each other, and the other connecting component is connected to each constituent component. . The measuring device comprises a connector and a micro-location = the connection benefit comprises at least the corresponding unit is received from the connector "the second processing unit is lightly coupled to the connector to form the connection - the total electrical quantity = the determination and the two connecting elements 201009331 In one embodiment, at least one of the N constituent elements forms a 1-way structure with the two junctions, and the electrode group comprises a mutual one, a working electrode and a reference electrode. In an embodiment, the electrode group comprises a mutually-shaped electrode, a reference electrode, and an electrode. In another embodiment, the electrode group includes a working electrode, a reference electrode, a sensing electrode, and two 4 measuring unit, wherein the ends of the two measuring units are respectively connected to one of the reference electrode and the two connecting elements. In other aspects of the invention, part will be stated in the following description, and part can be easily said It is to be understood that the various aspects of the invention may be understood and obtained by means of the elements and combinations particularly pointed out in the appended claims. And the following The detailed description is not intended to limit the present invention. ❹ [Embodiment] The present invention discloses a biochemical sensing system, a measuring device, and a test strip that can be identified or corrected without using a PIN card. 'It can eliminate the ^ code card process, easy to operate, prevent mistakes such as forgetting to insert passwords, password cards, etc., and can reduce the possibility of mistakes during use. In order to make the description of the present invention more detailed and complete, you can Illustrated and in conjunction with the drawings of Figures 1 through 6, wherein like reference numerals denote like elements, the devices, parts and program steps described in the following embodiments are merely illustrative of the invention and are not intended to be 10-201009331 Limits the scope of the present invention. Fig. 1 shows a test strip 100 according to an embodiment of the present invention, and Fig. 2 shows an exploded view of the test strip 1〇〇, and each element is shown by a broken line. The test strip 100 of the present invention comprises an insulating substrate 110, a conductive layer 12A, an insulating layer upper layer 13A, and an upper cover 150. The conductive layer 12 includes an electrode group 122 and an identification unit 127. among them The identification unit 127 includes a constituent element group ι28 ❿ and a connecting element group 129. In this embodiment, the constituting element group 128 includes five constituent elements 128a, 128b, 128c, 128d, and 128e, and the connecting element group 129 includes two links. The elements 129a and 129b. The connecting element 129a is connected to one end of each constituent element, and the connecting element 129b is connected to the other end of each constituent element, as shown in Fig. 2. In this embodiment, the electrode group 122 is insulated from each other. A working electrode 123 and a reference electrode 124. The present invention does not limit the number and shape of the constituent elements included in the identification unit 127, and the identification unit 127 can be disposed on any surface of the insulating substrate 11〇, and is not limited to the electrode. Group 122 is on the same surface. Generally, the constituent element group 128 includes at least one hole partially or completely penetrating through the insulating substrate 110 (such as the element η in FIG. 2) on one of the constituent elements, so that an open circuit is formed between the constituent element and the connecting element group 129. structure. In the present embodiment, the hole system completely penetrates the insulating substrate 110', the through hole 〇 on the insulating substrate 11, the through hole h2 in the conductive sound 120, and the through hole & -11- on the upper layer 13 of the insulating pad 201009331 constitutes. By controlling the number and position of the holes, the electrical characteristics of the identification unit 127 (e.g., the impedance values between the two connecting elements 12% and 12卯) can be changed, and the test strip 1 can be discriminated accordingly. The insulating substrate 110 has electrical insulation, and the material thereof may include, but is not limited to, polyvinyl chloride (PVC), glass fiber (fR-4), polyester, bakelite, polyethylene terephthalate. Ester (PET), polycarbonate (ρ〇, polypropylene (pp), polyethylene (pE), polyfluorene styrene (PS), ceramics, etc., the material of the conductive layer 120 may be any conductive substance, for example Carbon glue, gold silver glue, copper glue, carbon silver mixed glue, or the like and combinations thereof, etc. In one embodiment, the conductive layer 12 is made of a conductive silver paste layer and a layer placed on the conductive silver paste layer. The conductive carbon powder layer is composed of, generally speaking, the impedance of the conductive carbon powder layer is much larger than that of the conductive silver rubber layer or other metal glue layer. The identification unit 127 can be matched with the conductive carbon powder layer by the conductive silver rubber layer to calculate Each of the constituent elements constitutes an impedance value as an arrangement design of the test strips. Each of the constituent elements may have different lengths or widths to form resistors having different resistance values, and each constituent element and the two connecting elements may be selected. Forming a via structure or forming a hole Open circuit structure. Generally speaking, when N constituent elements have different impedance values and match different hole numbers and positions, 2N kinds of impedance values can be combined. When the test piece 1 is placed in a measuring device The measuring device can distinguish the detecting test piece 100' according to the impedance value between the two connecting elements, and can also perform the corresponding correction image number 12-201009331 number or pull type measurement. It should be noted that the constituent element 128 of the present invention The invention is not limited to the arrangement of the working electrode 123, the reference electrode 124, and the identification unit 127, and does not limit the number of electrodes, and other electrodes may be added according to actual application requirements. Generally, as long as each electrode It is sufficient to insulate each other between the identification units. ▲ The upper layer 130 of the insulating pad is placed on the conductive layer 12A, and the south layer 130 of the insulating pad includes an opening 132a to expose a portion of the conductive layer 12. In general, The opening 132a is sufficient as long as it can expose a portion of the working electrode 123 and a portion of the reference electrode 124. The present invention does not limit the shape of the opening 132a. The design also exposes another portion of the conductive layer 12〇 such that the conductive layer 12〇 can be electrically connected to a measuring device (such as 630 of FIG. 6). The material of the insulating pad high layer 130 can include but not It is limited to PVC insulating tape, PET insulating tape, thermal drying type insulating varnish or ultraviolet curing type insulating varnish. The upper cover 150 is placed on the upper layer 130 of the insulating pad and covers the opening 132a. Between the insulating substrate 110 and the upper cover 150 The part forms a sampling space with capillary attraction (ie, reaction zone 132). When the area of the sampling space is fixed, the volume may depend on the thickness of the upper layer of the insulating pad. Generally speaking, the thickness of the insulating layer 130 is high. It is between about 0.005 mm and about 0.3 mm, but not limited to this. In addition, during the manufacturing process, the upper surface 130 of the insulating pad 132 having the cut opening 132a can be placed on the surface of the insulating substrate 110 and the opening of the conductive layer and the surface of the insulating layer 110 is formed in the region of the insulating layer. Above the straight layer 120. The insulating substrate 110 of the boring tool and the conductive test strip 100 of the present invention are further provided with a reaction layer 140, and the right A t is placed at the opening 132at|7, and the + = Θ = specific identification of the biological material or the signal , S should be f140 material varies with the sample / / disk emulsified reductase or an electronic medium (such as ferrous metal to produce a chemical reaction. - Generally speaking, the reaction layer to the cover of the reference The electrode I24 and the working electrode m. The upper cover 15G of the present invention may be a transparent or translucent material to facilitate observation of whether the reaction zone 132 has been filled with the sample, and to prevent the sample from being detected before the sample is filled, resulting in erroneous results. The lower surface of the reaction zone 132 may be coated with a hydrophilic material to enhance the capillary action of the inner wall of the reaction zone 132, for more quickly and efficiently introducing the sample into the reaction zone 132. The upper cover 15 a vent 153 at the end of the opening 132a for discharging the gas in the reaction zone 132 to enhance capillary action. Generally, the vent 153 is adjacent to the end of the opening 132a. The present invention does not limit the shape of the vent 153. For example, the vents 153 may be circular, elliptical, rectangular, diamond-shaped, etc. Figures 3, 4, 5A, and 5B are test strips 300 according to different embodiments of the present invention 201009331, 400, 500a, and 5〇〇b, must be / thought to 'for the convenience of description, not shown' insulation 塾 high-rise and upper cover. Refer to Figure 3 'Test strip 3 00 contains · - insulating substrate 310, and insulation A working electrode 323, a reference electrode 324, a sensing electrode 325, two detecting units 326, and an identifying unit 327, wherein the identifying unit 327 includes a constituent element group 328 and a connecting element group 329. In this embodiment, the composition The component group 328 includes five constituent elements 328a, 328b, 328c, 328d, and 328e, and the connecting component group 329 包含 includes the connecting components 329a and 329b, wherein the two ends of the respective constituent elements are respectively connected to the connecting members 329a and 329b to form a The test strip 300 also includes two holes pi and p2 on the constituent elements 328a and 328d such that the constituent elements 328a, 328d and the joint element group 329 form an open circuit structure, respectively. One measurement When the measuring device 630 is electrically connected, the constituent elements 328b, 328c, and 328e can respectively form three electrical circuits ', and the constituent elements 328a and 328d are respectively open, thus The measuring device will measure the total electrical characteristics (e.g., a total equivalent impedance value) of the loop formed by the constituent elements 328b, 328c, and 328e through the connecting element group 329 and thereby identify the test strip 3〇〇. In the embodiment shown in FIG. 3, the sensing electrode 325 is a gate-shaped electrode that is electrically insulated from the working electrode 323 and the reference electrode 324. The sensing electrode 325 is disposed between the working electrode 323 and the reference electrode 324 for sensing the electrical connection between the detecting test strip 300 and a measuring device (as shown in FIG. 6). In general, the sensing power •15-201009331 pole 325 series through-loop generation - electrical signal, to achieve the effect. For example, when the test strip 3 (10) is placed, the mechanism 325 can be formed between the measuring device and the measuring device. The main function of the detecting unit is 326 is to confirm that the anti-ship 332 is covered. In general, the unit 326 g is disposed at the bottom of the reaction zone 332 such that when the liquid sample is injected into the reaction zone 332, it will sequentially contact the reference electrode 32 and the side unit 326. Once the sample reaches the bottom of the reaction zone 2, a sample early detection 326, this sample can be used as the electrical connection between the two detection units 3 26, and the impedance value between them becomes smaller. The detecting unit 326 can achieve multiple detection functions on a small-area substrate by coupling with other electrodes or electrical structures on the substrate. In this embodiment, one end of the two detecting units 326 is connected to the reference electrode 324 and the connecting element 329a, respectively. In this manner, the measuring device can provide a voltage between the reference electrode 324 and the connecting member 329a. Once the sample reaches the detecting unit 326 at the bottom of the reaction region 332, sufficient current can flow between the reference electrode 324 and the connecting member 329a. It is confirmed that the sample has appropriately covered the reaction zone 332. In other embodiments, one end of the two detecting units 326 can be respectively connected to other electrodes, for example, to the working electrode 323 and the connecting element 329b, respectively. Referring to FIG. 4, the test strip 400 includes an insulating substrate 410, and a working electrode 423, a reference electrode 424, two-16-201009331 detecting unit 426, and an identifying unit 427, wherein the identifying unit 427 comprises a component. Elements 428a, 428b, 428c and connecting element 429a,
429b’且各個構成元件之二端分別與連結元件429a及 429b連接。二個偵測單元426的一端分別與參考電極 424及連結元件429a連接，用以確認樣品是否已適當 地覆蓋反應區432。在其他實施例中，偵測單元426 中的一個或二個可為一獨立電極，並與其他電極相互 絕緣。檢測試片400亦包含了兩個孔洞ρι及p2於構 成元件428a及428c上，使構成元件428a及428c與 連結元件429間形成開路結構。孔洞P1及P2可為貫 穿絕緣基板41G的貫穿孔亦可為未貫穿絕緣基板4ι〇 的凹槽。在此實補中，以不同長度及形狀的導電碳 粉形成各構成元件’以產生具有不同阻抗值的構成元 件。-般來說’構成元件的阻抗值可利用導電碳粉的 ^度或寬度_整n步地，可搭配其他金 層（如銀膠層）來調整。429b' and the two ends of the respective constituent elements are connected to the connecting members 429a and 429b, respectively. One end of the two detecting units 426 is connected to the reference electrode 424 and the connecting member 429a, respectively, to confirm whether the sample has properly covered the reaction zone 432. In other embodiments, one or both of the detection units 426 can be a separate electrode and insulated from the other electrodes. The test strip 400 also includes two holes ρι and p2 on the constituting elements 428a and 428c to form an open structure between the constituting elements 428a and 428c and the connecting member 429. The holes P1 and P2 may be through holes penetrating through the insulating substrate 41G or grooves not penetrating through the insulating substrate 4ι. In this solid addition, each constituent element ' is formed of conductive carbon powders of different lengths and shapes to produce constituent elements having different resistance values. Generally speaking, the impedance value of the constituent elements can be adjusted by using the degree or width of the conductive carbon powder in n steps, and can be adjusted with other gold layers (such as a silver paste layer).
'戣片5(K)a具有一孔洞P1於一 、70件上’用以破壞該構成元件與連接元件間的電 ::路：其破壞方式可採部份或完成貫穿絕緣基板而 。在圖5B中’檢測試片5_具有二個孔洞ρι ㈣不同的構成元件上。因此，檢測試片500a 罝古知早元5273及檢夠試片5_的辨識單元527b將 不同的電性特徵，由此可辨別檢測試片500a及 。舉例來說’當檢測試片500a或500b置入 •17- 201009331 測裝置時，量測裝置可透過接收對應辨識單元527a或 527b之電性特徵的訊號，而得以辨別檢測試片5〇〇& 及500b，進而採行相對應校正參數或模式進行量測。 在本發明其他實施例中，可指定工作電極或量測 電極之不同位置而達到啟動量測裝置或其他之感測功 食b。舉例而δ，參考圖5A及5B，於參考電極 524a 或52扑之檢測端(將連接至量測裝置的端點)設置2個 9 檢測點以、S2，其中檢測點S2可用以接地，當二個 檢測點S卜S2與量測裝置連接成一電性迴路，則指定 啟動量測裝置。 本發明並不限制構成元件的數量，亦應了解到， 構成元件的數量、形狀、及電性可由設計者根據實際 應用自行設定，其中每一構成元件可選擇性地以孔洞 破壞其與連結元件組之間的電性連接，藉此可形成複 ❹ 數個不同的等效阻抗值。換言乏，當具有N個構成元 件時，最多將可組合出2N個識別碼。亦即，藉由選 擇性的破壞每一構成元件，並配合每個構成元件之阻 抗大小，即可組合成多個獨特的識別碼。辨識單元將 可藉此用以表示不同功能的檢測試片，或不同批次的 檢測試片。破壞構成元件迴路的方式可為貫穿絕緣基 板之貝穿孔或未貝穿絕緣基板的凹槽。本發明亦不限 制凹槽或貫穿孔的形狀與大小。需注意的是，本發明 之N個構成元件可為各種被動元件，如電阻、電感、 •18- 201009331 或電容等 圖6為根據本發明一實施例所纷示之一生化感測 系統600的方塊示意圖，其包含一檢測試片3〇〇及一 里測裝置630。檢測试片300包含一工作電極323、一 參考電極324、一感測電極325、二個偵測單元326、 一辨識単元327、及兩個孔洞pi、P2，其中辨識單元 327 包含構成元件 328a、328b、328c、328d、328e 及 連結元件329a、329b，且孔洞pi及P2分別位於構成 元件328a及328d上，如圖3所述。本發明之連結元 件329&、32%在於提供各構成元件3283、3281?、328(；、 328d、328e與量測裝置630電連接之途徑。 1測裝置630包含一連接器64〇及耦合至連接器 640的一微處理單元65〇,其中微處理單元65〇内建一 數位f料655，其可例如為校正參數、檢測模式、或 其他資訊f。麵H _具有對應錢極及辨識單元 327的連接端子，其中工作電極323、參考電極324、 感測電極325、债測單元326、及辨識單元327透過與 連接器640之連制子之_相接而與量職置_ 電性相連。 虽檢測試片300與連接器64〇連接，感測電極奶 器640之間將形成一迴路，而使微處理單元⑽ 啟動1測裝置630。此外’由於辨識單元％ -19- 201009331 構成元件分別有不同狀態，因此與連接器640間的連 接將有不同的形式’藉此而產生對應辨識單元327所 表示之識別碼的信號至微處理單元650。舉例來說， 當檢測試片300與量測裝置630電性連接時，構成元 件328a及328d無法與連接器640形成電性連接，僅 構成元件328b、328c、及328e可形成電性迴路。連接 器640可透過連結元件329a及329b接收對應此電性 特徵之一信號，並將此信號傳送至微處理器65〇。微 處理單元650則可將根據此信號進行辨識，並自資料 655中選擇相應此信號的參數或模式以執行。量測褒 置630更包含用以顯示各種量測結果之顯示器66〇 ^ 以及用以提供所需電源的一電源67〇β在另一實施例 中，顯示器660及電源670可為外接裝置，而不包含 於量測裝置630中。 簡言之，本發明之辨識單元係供辨識與指定在量 測裝置中所内建之資料’其中量測裝置内建有複數組 相應於試4上賴單元所麵之識料之校正參數、 檢測模式、或其他資訊。本發明所揭示的生化感測系 ，不=到無須密碼卡之目的並減少密碼卡製造成 本、^ 了檢測方便性、且可避免人為操作的疏失。 以上所述僅為本發明之較佳實施例而已，並 申物範圍;凡其它未脫離本發明 s神下所〜叙等狀變或修飾，均應包含 •20- 201009331 在下述之申請專利範圍内。 【圖式簡單說明】 圖1繪示本發明一實施例之檢測試片； 圖2繪示圖1之檢測試片的結構分解圖； 圖3及圖4為根據本發明不同實施例所繪示之檢 測試片； 圖5A及圖5B分別繪示具有感測功能之檢測試片 ❿ 之不同實施例；以及 • 圖6為根據本發明一實施例所繪示之一生化感測 系統的方塊示意圖。 【主要元件符號說明】 100 檢測試片 110 絕緣基板 120 導電層 122' 電極組 123 工作電極 124 參考電極 127 辨識單元 128 構成元件組 128a、128b、128c、128d、128e 構成元件 129 連結元件組 129a > 129b 連結元件 130 絕緣墊高層 -21 - 201009331 132 132a 140 150 153 300 310 323 ® 324 325 326 327 328 328a、328b、328c 329 329a、329b φ 332 400 410 423 424 426 427 428a 、 428b 、 428c 429a、429b 反應區 開口 反應 上蓋 通氣孔 檢測試片 絕緣基板 工作電極 參考電極 感測電極 偵測單元 辨識單元 構成元件組 328d、328e 構成元件 連結元件組 連結元件 ' 反應區 檢測試片 絕緣基板 工作電極 參考電極 偵測單元 辨識單元 構成元件 連結元件 -22- 201009331 432 反應區 500a、500b 檢測試片 524a、524b 參考電極 527a、527b 辨識單元 600 生化感測系統 630 量測裝置 640 連接器 650 微處理單元 © 655 數位資料 660 顯示器 670 電源 Η、M、h2、h3 貫穿孔 PI、P2 孔洞 SI ' S2 檢測點 ❹ -23-The cymbal 5 (K) a has a hole P1 on one of 70 pieces to break the electrical connection between the constituent element and the connecting element: the destruction mode can be partially or completed through the insulating substrate. In Fig. 5B, the test strip 5_ has two constituent elements having different holes ρι(4). Therefore, the test strip 500a and the discriminating unit 527b of the test strip 5_ have different electrical characteristics, whereby the test strips 500a and can be discriminated. For example, when the test strip 500a or 500b is placed in the 17-201009331 measuring device, the measuring device can discriminate the detecting strip 5〇〇& by receiving the signal corresponding to the electrical characteristic of the identifying unit 527a or 527b. And 500b, and then take the corresponding calibration parameters or modes for measurement. In other embodiments of the invention, different positions of the working or measuring electrodes may be designated to achieve the activation of the measuring device or other sensing function b. For example, δ, referring to FIGS. 5A and 5B, at the detecting end of the reference electrode 524a or 52 (which will be connected to the end point of the measuring device), two 9 detecting points are set, S2, wherein the detecting point S2 can be used to ground, when When the two detection points Sb and S2 are connected to the measuring device to form an electrical circuit, the starting measuring device is designated. The present invention does not limit the number of constituent elements. It should also be understood that the number, shape, and electrical properties of the constituent elements can be set by the designer according to the actual application, wherein each of the constituent elements can selectively break the connecting member with the hole. Electrical connections between the groups, whereby a number of different equivalent impedance values can be formed. In other words, when there are N constituent elements, at most 2N identification codes can be combined. That is, by selectively destroying each of the constituent elements and matching the impedance of each of the constituent elements, a plurality of unique identification codes can be combined. The identification unit can be used to indicate test strips of different functions or test strips of different batches. The manner in which the constituent element loops are broken may be a perforation through the insulating substrate or a recess that does not penetrate the insulating substrate. The invention also does not limit the shape and size of the grooves or through holes. It should be noted that the N constituent elements of the present invention may be various passive components, such as resistors, inductors, 18-201009331, or capacitors. FIG. 6 illustrates a biochemical sensing system 600 according to an embodiment of the invention. The block diagram includes a test strip 3 and a measuring device 630. The test strip 300 includes a working electrode 323, a reference electrode 324, a sensing electrode 325, two detecting units 326, an identifying unit 327, and two holes pi, P2, wherein the identifying unit 327 includes a constituent element 328a, 328b, 328c, 328d, 328e and joining elements 329a, 329b, and holes pi and P2 are located on constituent elements 328a and 328d, respectively, as described in FIG. The connecting element 329 & 32% of the present invention is to provide a means for electrically connecting each of the constituent elements 3283, 3281, 328 (;, 328d, 328e) to the measuring device 630. The measuring device 630 includes a connector 64A and is coupled to A micro processing unit 65A of the connector 640, wherein the micro processing unit 65 is internally provided with a digital f material 655, which may be, for example, a correction parameter, a detection mode, or other information f. The surface H_ has a corresponding money and identification unit The connection terminal of 327, wherein the working electrode 323, the reference electrode 324, the sensing electrode 325, the debt measuring unit 326, and the identification unit 327 are connected to the connector 640 through the connection with the connector 640 Although the test strip 300 is connected to the connector 64A, a circuit is formed between the sensing electrode milk 640, and the micro-processing unit (10) is activated to start the measuring device 630. Further, since the identification unit % -19-201009331 constitutes a component There are different states, respectively, so the connection to connector 640 will have a different form 'by thereby generating a signal corresponding to the identification code represented by identification unit 327 to microprocessing unit 650. For example, when detecting test strip 300 and Measuring When the electrical connection is made 630, the constituent elements 328a and 328d cannot be electrically connected to the connector 640, and only the constituent elements 328b, 328c, and 328e can form an electrical circuit. The connector 640 can receive the corresponding through the connecting elements 329a and 329b. One of the electrical characteristics is signaled and transmitted to the microprocessor 65. The microprocessor unit 650 can then identify the signal based on the signal and select a parameter or mode corresponding to the signal from the data 655 for execution. The device 630 further includes a display 66 for displaying various measurement results and a power source 67 〇 β for providing the required power. In another embodiment, the display 660 and the power source 670 can be external devices, and do not include In the measuring device 630. In short, the identification unit of the present invention is for identifying and specifying the data built in the measuring device. The measuring device has a complex array built therein corresponding to the test unit 4 Correction parameters, detection modes, or other information of the invention. The biochemical sensing system disclosed by the present invention does not have the purpose of eliminating the need for a password card and reduces the manufacturing cost of the password card, and the convenience of detection, and The above description is only for the preferred embodiment of the present invention, and the scope of the application; any other changes or modifications that do not deviate from the present invention should include • 20- 201009331 is within the scope of the following patent application. [FIG. 1 illustrates a test strip according to an embodiment of the present invention; FIG. 2 is a structural exploded view of the test strip of FIG. 1; FIG. 3 and FIG. Detecting test strips according to different embodiments of the present invention; FIG. 5A and FIG. 5B respectively show different embodiments of the test strip 具有 having a sensing function; and FIG. 6 is a diagram illustrating an embodiment of the present invention. A block diagram of one of the biochemical sensing systems. [Description of main component symbols] 100 test strip 110 insulating substrate 120 conductive layer 122' electrode group 123 working electrode 124 reference electrode 127 identification unit 128 constituent element group 128a, 128b, 128c, 128d, 128e constituent element 129 connecting element group 129a > 129b Connecting element 130 Insulation pad high-rise-21 - 201009331 132 132a 140 150 153 300 310 323 ® 324 325 326 327 328 328a, 328b, 328c 329 329a, 329b φ 332 400 410 423 424 426 427 428a, 428b, 428c 429a, 429b reaction zone opening reaction upper cover vent hole test piece insulating substrate working electrode reference electrode sensing electrode detecting unit identification unit constituting element group 328d, 328e constituting element connecting element group connecting element 'reaction zone detecting test piece insulating substrate working electrode reference electrode Detection unit identification unit constitutes element connection element-22- 201009331 432 Reaction area 500a, 500b Test strip 524a, 524b Reference electrode 527a, 527b Identification unit 600 Biochemical sensing system 630 Measuring device 640 Connector 650 Micro processing unit © 655 Digital data 660 display 670 power Η, M, h2, h3 through holes PI, P2 holes SI 'S2 detection point ❹ -23-