、M334325, M334325
案 97年1月23 E 俨丨月勹翁: : 96214873 修It-替換頁 八、新型說明： 【新型所屬之技術領域】 本創作係關於一種生化感測試片，特別是，關於一種 衣作簡單、操作方便、且可減少製程不良率的生化感測試 片。 【先前技術】 曰隨著醫學的進步與現代人對於健康護理觀念的曰益 提=，許多過去只有醫院才能檢測的試驗，今日大多趨於 居家醫療照護，例如血糖儀、電子耳溫搶、以及電子是血 壓計等。因此，此等檢測則趨向快速、便宜、體積小、以 及不需專業人員操作的自我檢驗產品。由於十分便捷，因 此居家的檢測系統也逐日普及化。而在此領域中，生化感 測試片的使用已經是—項極為純熟的技術，其中又以分析 血糖之應用最為廣泛。 參 白知的生化感测試片大多利用毛細原理將樣品由一 取樣口吸入反應區，使其與反應區内的物質進行化學反 應。接著’藉由誠片上的電極連結生物感測檢測裝置接收 =遽’再經過裝置中微處理器的計算而將訊號轉為檢測物 0度進而顯示於骏置的顯示器上。然而，其缺點為將樣 _ =吸入的時間太慢時，先進入的樣品已與反應區的物質進 行化學雙化，這將導致反應不一致，而得到一個不正確的 訊號。 M334325 旅；T：丨hirhZJTi 窠鉍：96214873 二：·Γ々 ί 97年1月23日膽^替換具二 此外’為使採樣量微小化， 間及其取樣口-般都具有报小的^感=片的反應區空 u 士制从士留Η、風i山人 然而，生化感測試 作中會在沖床程序或裁切程序時，因-瞬間所施予的壓力轉致採樣端封σ， 上 失誤，增加了生化感測試片的製作成、成衣私上的 高且製程不良率低 因此，有必要提供一種檢測準確率 之生化感測試片。Case January 23, 23 E 俨丨月勹翁: : 96214873 Repair It-Replacement Page VIII, New Description: [New Technology Area] This creation is about a biochemical test piece, especially about a simple clothing Biochemical sensory test piece with convenient operation and reduced process defect rate. [Prior Art] With the advancement of medicine and the benefits of modern people's concept of health care, many trials that were only tested by hospitals in the past tend to be home-based medical care, such as blood glucose meters, electronic ear thermometers, and The electron is a blood pressure monitor or the like. Therefore, such tests tend to be fast, inexpensive, small, and self-testing products that do not require professional operation. Because of its convenience, the home inspection system is also becoming popular every day. In this field, the use of biochemical test strips is already an extremely sophisticated technique, with the most widely used for analyzing blood sugar. Shen Baizhi's biochemical test strips mostly use the capillary principle to draw the sample from a sampling port into the reaction zone to chemically react with the material in the reaction zone. Then, the signal is detected by the electrode-connected biosensing detecting device on the tablet, and then the signal is converted to the detected object by the calculation of the microprocessor in the device, and then displayed on the display of Junji. However, the disadvantage is that when the sample _ = inhalation time is too slow, the first sample entered has been chemically doubled with the material in the reaction zone, which will result in inconsistent reactions and an incorrect signal. M334325 Brigade; T:丨hirhZJTi 窠铋:96214873 二:·Γ々ί January 23, 1997 Bold ^ Replacement with two additions 'To make the sampling volume miniaturized, and the sampling port - all have a small report ^ Sense = film reaction area empty u system from Shiliu, wind i mountain people However, the biochemical test will be in the punching program or cutting program, due to the pressure applied to the instantaneous transfer of the sampling end seal σ The mistakes have been made, the production of biochemical test strips has been increased, the garments have been privately high, and the process defect rate is low. Therefore, it is necessary to provide a biochemical test strip for detecting accuracy.
【新型内容】 鑑於先前技術所存在的問題’本創作提供了一種可提 南檢測正確性且可減少製程不良率的生化感測試片。 根據本創作之-方面，提供了一種生化感測試片，盆 包含-絕緣基板、-電極系統、一絕緣層、及一上蓋 極系統置於絕緣基板之上，而絕緣層置於電極系统之上。 •、絕緣層包含一開口，此開口暴露電極系統的-部分以定義 ，有-供應端之-反魅。上蓋置於絕緣層之上並覆蓋反 %、區’且具有對應反應區之—通氣孔以及對應供應端之一 缺口，其中缺口包含至少兩個凹槽。 本創作之上蓋的其中一特色在於，其材料係選自透明 =透明材料’且其下表面係塗佈—親水材料，以迅速有 ^地導入樣品。此外，上蓋的缺σ之其中一特色在於，包 s任意形狀的兩個凹槽’以增加樣品取樣的面 積，加速樣 -6- M334325 品吸入反應區的速率。 97年1月23 1VI _號：96214873 孑_;?^ 本創作之其他方面，部分將在後續說明中陳述，而部 ， 分可由說明中輕易得知，或可由本創作之實施而得知。本 ' . 創作之各方面將可利用後附之申請專利範圍中所特別指 出之元件及組合而理解並達成。需了解，先述的一般說明 及下列詳細說明均僅作舉例之用，並非用以限制本創作。 ⑩ 【實施方式】 本創作揭露一種生化感測試片，可增進取樣的效率進 而增加檢測的準確性，且可降低製造過程中產生失誤的可 能性。為了使本創作之敘述更加詳盡與完備，可參照下列 描述並配合圖丨至圖4之圖式，其中類似的元件符號代表 類似的元件。然以下實施例中所述之裝置、元件及程序步 驟，僅用以說明本創作，並非用以限制本創作的範圍。 • * • 圖1根據本創作一實施例，繪示一生化感測試片1〇〇 的結構分解圖，其中虚線是用以方便理解各元件間的相對 位置。本創作之生化感測試片100包含一絕緣基板110、 一電極系統120、一絕緣層130、一中隔板140、一反應層 150、及_上蓋16〇。 絕緣基板110具有電絕緣性，其材料可包含但不限 於·聚氣乙稀(PVC)、玻璃纖維(FR-4)、聚酯(polyester)、 電木板(bakelite)、聚對苯二甲酸二乙酯(PET)、聚破酸酯 M334325 (pc)、聚丙烯(PP)、聚乙歸 / .<>· -ίτ^ h 虎：96214873¾詞 97年1月雛頁名 )、聚笨乙烯(PS)或陶瓷等 包極系統120的材料可 銀膠、銅膠、碳銀混合膠、:彳何冷電物質，例如碳膠、 施例中，電極系統120^或其類似物及組合等。在一實 膠層之上的-導電碳粉層鄉層以及置於導電銀 電極系統120包含一蚤[New content] In view of the problems of the prior art, the present invention provides a biochemical test piece which can improve the correctness of the detection and can reduce the defect rate of the process. According to the aspect of the present invention, there is provided a biochemical test strip comprising an insulating substrate, an electrode system, an insulating layer, and an upper capping system disposed on the insulating substrate, wherein the insulating layer is placed on the electrode system . • The insulating layer contains an opening that exposes the - part of the electrode system to define, and the - supply end - anti-enchantment. The upper cover is placed over the insulating layer and covers the anti-%, zone' and has corresponding venting holes and one of the corresponding supply ends, wherein the notch comprises at least two grooves. One of the features of the upper cover of the present invention is that the material is selected from the group consisting of transparent = transparent material and the lower surface is coated with a hydrophilic material to rapidly introduce the sample. In addition, one of the features of the lack of σ of the upper cover is that the two grooves of any shape are included to increase the sample sampling area and accelerate the rate at which the sample -6-M334325 is inhaled into the reaction zone. January 23, 1997 1VI _: 96214873 孑 _;? ^ Other aspects of this creation, some of which will be stated in the following description, and the parts and points can be easily known from the description or can be known from the implementation of this creation. The various aspects of the present invention will be understood and achieved by means of the elements and combinations specifically recited in the appended claims. It is to be understood that the general description and the following detailed description are for illustrative purposes only and are not intended to be limiting. 10 [Embodiment] This work discloses a biochemical test piece, which can improve the efficiency of sampling and increase the accuracy of detection, and can reduce the possibility of errors in the manufacturing process. In order to make the description of the present invention more detailed and complete, reference is made to the following description in conjunction with the drawings to FIG. 4, wherein like reference numerals represent like elements. The apparatus, elements, and program steps described in the following examples are merely illustrative of the present invention and are not intended to limit the scope of the present invention. • Fig. 1 is a structural exploded view of a biochemical test strip 1〇〇 according to an embodiment of the present invention, wherein a broken line is used to facilitate understanding of the relative positions between the elements. The biochemical test strip 100 of the present invention comprises an insulating substrate 110, an electrode system 120, an insulating layer 130, a middle spacer 140, a reactive layer 150, and an upper cover 16A. The insulating substrate 110 has electrical insulation, and the material thereof may include, but is not limited to, polyethylene oxide (PVC), glass fiber (FR-4), polyester, bakelite, and polyethylene terephthalate. Ethyl ester (PET), polydeuterate M334325 (pc), polypropylene (PP), polyethylation / .<>· -ίτ^ h Tiger: 962148733⁄4 word January 1997 chick page name), poly The material of the inclusion system 120 such as ethylene (PS) or ceramic may be silver glue, copper glue, carbon silver mixed glue,: any cold electric substance, such as carbon glue, in the embodiment, the electrode system 120 ^ or the like and combination thereof Wait. The conductive carbon layer layer on top of a solid layer and the conductive silver electrode system 120 include a stack
127及-纽129，3極組123、—賴電極組 參考電極m及工作電極里/1電極組123包含互相絕緣的 1¾ 129 電極124，辨識電極組127包含由電 連接的弟一辨識電極126及第二辨識電極128。 U : 於電極系統⑽之上，且包含暴露電極 糸統m之-部分的第一開口m以及暴露電極系統⑼127 and - New 129, 3-pole group 123, - ray electrode group reference electrode m and working electrode 1/3 / electrode group 123 include mutually insulated 13⁄4 129 electrodes 124, and the identification electrode group 127 includes electrically connected buddies one identification electrode 126 And a second identification electrode 128. U : above the electrode system (10), and including the first opening m exposing the portion of the electrode system m and the exposed electrode system (9)
之另-部分的第-連接區134。第―開口 132只要能夠暴 露出電極系統12G部分即$足夠，本創作並不限制第 -開了 132及其供應端136的形狀。連倾134係用以使 電極系統120彳與-量測儀器（圖未示)電性相接。絕緣層 130的材料可包含但不限於PVC絕緣膠帶、pET絕緣膠 帶、熱乾燥型絕緣漆或紫外光乾燥型絕緣漆。 中隔板140置於絕緣層130之上，其具有電絕緣特性 且包含對應第一開口 132之一第二開口 142以及對應第一 連接區134的第二連接區144。上蓋160置於中隔板140 之上，且覆蓋第一開口 132與第二開口 142。介於絕緣基 M334325 •丨月祀t _號：96214873不\丨大: 97 年 1 月 23~&!(^£*"^^1頁一^一一一 板110與上蓋16〇之間的第一開口 132與第二開口丨42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，其體積可取決於中隔板14〇與絕緣層130 ， 之厚度。在另一實施例中，生化感測試片100可不包含中 、一 隔板14〇，而單以絕緣層130之厚度來決定取樣空間的體 積。一般而言，絕緣層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 切出第一開口 132及第一連接區134的絕緣層130放置於 絕緣基板110與電極系統120上，亦可以印刷的方式避開 第一凹槽132及第一連接區134的區域而直接形成絕緣層 130於部分的基板η〇與電極系統12〇之上。 在此實施例中，當液態樣品自供應端136注入反應區 W ’會依序會接觸到電極系統12〇中量測電極組123及辨 識電極組127。事實上，只要各電極組在反應區中的排列 順序如4述，且各電極之間彼此絕緣即已足夠，本創作並 • 不限制量測電極組123及辨識電極組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。當生化感測試片1〇〇置入一量測儀器（圖未示)後，透 過電阻129的連接，使得第一辨識電極126、第二辨識電 極128與量測儀器間形成一迴路，而啟動量測儀器。量測 • 儀器（圖未示)啟動後，可進一步的偵測第一辨識電極126 與第二辨識電極128間的阻抗值，再與電阻129的阻抗值 比較，而判斷生化感測試片是否置入正確的位置。在液態 樣品注入生化感測試片100的反應區後，將造成參考電極 M334325 I h , *5^ · 96214873 ；；„ 97 年 1 月 “ =2與工作電極124間的阻抗發生變化，因此檢視此阻抗 、交化可判斷液態樣品是否已進入反應區中。 本創作之生化感測试片100更包含置於第一開口 132 ^反應層15G，其具有專—性辨識生物材料或訊號之 ，其中反應層150之材料係隨樣品不_有所不同， 列=可為一氧化還原酶，用以與樣品產生化學反應。一般 =吕，反應層150至少覆蓋部份的工作電極122及部分的 參考電極124。 本創作之上蓋160可為透明或半透明材質，以方便觀 察反應區是否已填入樣品，避免樣品未填入前即進行檢 剩、，而導致錯誤的結果。上蓋16〇之接近反應區的下表面 可塗佈一親水材料，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由供應端136導入反應區。 上蓋160更包含相應於反應區的一通氣孔162，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 M2係靠近反應區末端。本創作並不限制通氣孔162的形 狀，舉例來說，通氣孔162可為圓形、橢圓形、長方形^ 菱形等。 此外，上蓋160更包含對應供應端136之一缺口 164, 以增加可吸入樣品的面積，幫助樣品吸入。缺口 164包含 至少兩個凹槽，其可具有不同的形狀或大小。在圖1所示 v;; ：M334325 -塒號：96214873 97年1月23 *0修正-替換貫一™ 的實施例中，缺口 164為二個半圓型的凹槽，在其他實施 例中，缺口 164可為二個半圓形、半橢圓形、方形、三角 形等。包含至少兩個凹槽的缺口 164不但增加樣品吸入面 積，更提供了多角度的取樣功能，不但可由試片侧面將樣 品吸入反應區，亦可由試片上方將樣品吸入反應區。因 此，試片不再侷限為單一角度取樣，因而可提高樣品吸入 反應區的速率。此外，藉由形成二個凹槽於反應區的供應 端，可降低在使用沖床或裁切等技術形成單一生化感測試 片之外型日守發生封口的可能性，而減少製程不良率。 圖2根據本創作一實施例而綠示圖丨之結構組裝後之 一生化感測試片200的俯視圖。由圖2可看出，電極系統 220係設置於絕緣基板210之上，且中隔板24〇暴露電極 系統220的一端以與一量測儀器電性連結，用以量測因樣 品與反應層（如圖1的元件150)產生化學反應後所造成的 阻抗變化。由圖1之第一開口 132及第二開口 142所形成 之反應區270與上蓋260之通氣孔262相接。在此實施例 中，上蓋260具有由兩個半圓型所形成之缺口 264，其設 置於反應區270的供應端以增加取樣面積，並避免製程時 的封口失誤。 圖3根據本創作另一實施例而綠示圖1之結構組裝後 之一生化感測試片300的俯視圖。在此實施例中，上蓋36〇 的缺口 364係由兩個三角形圖案所組成，且通氣孔362為 一方形通氣孔。此外，在上盍360之上可形成一箭頭圖案 -11 -The other-partial connection area 134. The first opening 132 is not limited to the shape of the first opening 132 and its supply end 136 as long as it is sufficient to expose the electrode system 12G portion. The continuous tilting 134 is used to electrically connect the electrode system 120彳 to a measuring instrument (not shown). The material of the insulating layer 130 may include, but is not limited to, PVC insulating tape, pET insulating tape, heat drying type insulating varnish or ultraviolet drying type insulating varnish. The intermediate spacer 140 is disposed over the insulating layer 130 and has electrical insulating properties and includes a second opening 142 corresponding to one of the first openings 132 and a second connecting region 144 corresponding to the first connecting region 134. The upper cover 160 is placed over the intermediate partition 140 and covers the first opening 132 and the second opening 142. Between the insulation base M334325 • 丨月祀t _号: 96214873不\丨大: January 23~&!(^£*"^^1 page one-to-one board 110 and upper cover 16〇 The first opening 132 and the second opening 丨 42 form a sampling space (ie, reaction zone) with capillary attraction. When the area of the sampling space is fixed, the volume thereof may depend on the intermediate partition 14 and the insulating layer 130. In another embodiment, the biochemical test strip 100 may not include a middle and a separator 14〇, and the thickness of the sampling space is determined by the thickness of the insulating layer 130. Generally, the thickness of the insulating layer 130 Between about 0.005 mm and about 0.3 mm, which is not limited thereto. Further, during the manufacturing process, the insulating layer 130 having the first opening 132 and the first connection region 134 cut out may be placed on the insulating substrate. 110 and the electrode system 120 can also directly form the insulating layer 130 on the portion of the substrate η 〇 and the electrode system 12 避 by avoiding the regions of the first recess 132 and the first connection region 134 in a printed manner. In the example, when the liquid sample is injected into the reaction zone W from the supply end 136, the electrode will be sequentially contacted. The system 12 〇 measures the electrode group 123 and the identification electrode group 127. In fact, as long as the arrangement order of the electrode groups in the reaction zone is as described above, and the electrodes are insulated from each other, it is sufficient. The arrangement of the measurement electrode group 123 and the identification electrode group 127 does not limit the number of electrodes, and other electrodes can be added according to the actual application. When the biochemical test piece is placed into a measuring instrument (not shown) After the connection of the resistor 129, a first loop is formed between the first identification electrode 126 and the second identification electrode 128 and the measuring instrument, and the measuring instrument is started. After the measuring instrument (not shown) is activated, the measuring instrument can be further activated. The impedance value between the first identification electrode 126 and the second identification electrode 128 is detected, and then compared with the impedance value of the resistor 129 to determine whether the biochemical test piece is placed in the correct position. The biochemical test piece 100 is injected into the liquid sample. After the reaction zone, the reference electrode M334325 I h , *5^ · 96214873 ;; „January 97 “ = 2 and the impedance between the working electrode 124 changes, so the impedance and the cross-linking liquid can be examined. Whether the sample has entered the reaction zone. The biochemical test strip 100 of the present invention further comprises a first opening 132 ^ reaction layer 15G, which has a specific identification of the biological material or signal, wherein the material of the reaction layer 150 is The sample is not different, column = can be a oxidoreductase for chemical reaction with the sample. Generally = Lu, the reaction layer 150 covers at least part of the working electrode 122 and part of the reference electrode 124. 160 can be transparent or translucent material to facilitate observation of whether the reaction zone has been filled with the sample, to avoid the sample remaining before filling, and lead to erroneous results. The upper surface of the upper cover 16 接近 close to the reaction zone may be coated with a hydrophilic material to enhance the capillary action of the inner wall of the reaction zone for more rapid and efficient introduction of the sample from the supply end 136 into the reaction zone. The upper cover 160 further includes a vent 162 corresponding to the reaction zone for venting the gas in the reaction zone to enhance capillary action. Generally, the vent M2 is adjacent to the end of the reaction zone. This creation does not limit the shape of the vent 162. For example, the vent 162 may be circular, elliptical, rectangular, diamond, or the like. In addition, the upper cover 160 further includes a notch 164 corresponding to the supply end 136 to increase the area of the inhalable sample to assist in sample inhalation. Notch 164 includes at least two grooves that may have different shapes or sizes. In the embodiment shown in Fig. 1, v:; M334325 - nickname: 96214873, January 23, *0 correction-replacement, the notch 164 is a two semicircular groove, in other embodiments, the notch 164 can be two semi-circular, semi-elliptical, square, triangular, and the like. The notch 164 comprising at least two grooves not only increases the sample suction area, but also provides a multi-angle sampling function, which not only draws the sample into the reaction zone from the side of the test piece, but also draws the sample into the reaction zone from above the test piece. Therefore, the test piece is no longer limited to single angle sampling, thus increasing the rate at which the sample is drawn into the reaction zone. In addition, by forming two grooves in the supply end of the reaction zone, the possibility of forming a single biochemical test piece in the form of a single biochemical test piece using a punching or cutting technique can be reduced, and the process defect rate can be reduced. Fig. 2 is a top plan view of a biochemical test strip 200 assembled in accordance with the structure of the green image according to an embodiment of the present invention. As can be seen from FIG. 2, the electrode system 220 is disposed on the insulating substrate 210, and the middle spacer 24 exposes one end of the electrode system 220 to be electrically connected to a measuring instrument for measuring the sample and the reaction layer. (Element 150 of Figure 1) produces a change in impedance caused by a chemical reaction. The reaction zone 270 formed by the first opening 132 and the second opening 142 of Fig. 1 is in contact with the venting opening 262 of the upper cover 260. In this embodiment, the upper cover 260 has a notch 264 formed by two semicircular shapes which are disposed at the supply end of the reaction zone 270 to increase the sampling area and avoid sealing errors during the process. Figure 3 is a top plan view of one of the biochemical test strips 300 assembled in accordance with another embodiment of the present invention. In this embodiment, the notch 364 of the upper cover 36 is composed of two triangular patterns, and the vent 362 is a square vent. In addition, an arrow pattern can be formed on the upper jaw 360 -11 -
M334325 380，用以指示樣品之進入方向，增加使用者在使用上的 便利性。箭頭圖案380可例如藉由印刷方式形成於上蓋 360上，然不在此限。此外，箭頭圖案380可使用任何不 會與所欲檢測之樣品產生反應的材料而形成。 # 化學反應，其中反應層的材料隨所欲檢測的樣品不同而有 所不同。在步驟S450中，塗佈一親水材料於一上蓋的表 面，並於上蓋上形成對應反應區之一通氣孔以及 < 端之-缺口，其中缺口包含至少兩個凹槽。接著;二 ， 1設置於中隔板之上，其中塗有親水材料的表面係朝下以 隔板。上蓋至少覆蓋住反應區，使得介於絕緣基板 圖4根據本創作之一實施例，繪示生化感測試片之製 造方法的流程圖。首先，在步驟S400中，提供—絕緣其^ 板。接著，在步驟S410形成一導電層於絕緣基板上，並 蚀刻導電層以形成具有至少兩個互相絕緣的參考電極及 工作電極的電極系統。在另一實施例中，步驟S4i〇所形 成的電極糸統更包含由一電阻連接的兩個辨識電極。在步 驟S420中，提供具有一開口的一絕緣層於電極系統之 上，其中此開口暴露電極系統之一部分而形成具有一供應 端之一反應區。此外，電極系統的其中一端也沒有被絕緣 層所覆蓋，以與一量測儀器電性連接。在步驟中， 提供對應絕緣層形狀之一中隔板·於絕緣層之上。接著，在 步驟S440中提供一反應層於反應區中，用以與樣品產生 與上蓋之間的反應區形成一 步驟S460中，使用例如沖 具毛細吸引力之取樣空間。在 中’使用例如沖床或裁切等技術，形成單一生 -12- M334325 jpf丨月巧日： Μ ： 9621487311¾ AV 'a,r ^ υ ^ α,ι » $ 1 月 2打3修正1 替顧-— 凹。由於在反應區供應端處具有至少兩個 凹I增加了取樣面積’因此在沖床或裁切過財 2端韻而導致無法將樣品吸人反應區的可能性將大 此外’形成上蓋之缺口的步驟可與形成上蓋之外 k虱孔的步驟-起進行，並不會增加製造的困難度。 本創作所揭示的生化感測試片不但可提高製程的良 =降低試片的製作成本’亦可迅速地將檢體樣品導入反 “片中此外，本創作之生化感 便利性。/、使用者了目視的辨識特徵，以增加使用上的 定太所為本創作之較佳實施例而已，並非用以限 1之中明專利範圍；凡其它未脫離本創作所揭示之 歧變或修飾，均應包含在下述之申請 【圖式簡單說明】M334325 380, used to indicate the direction of entry of the sample, increasing the convenience of the user. The arrow pattern 380 can be formed on the upper cover 360, for example, by printing, but is not limited thereto. Additionally, the arrow pattern 380 can be formed using any material that does not react with the sample to be detected. # Chemical reaction, in which the material of the reaction layer varies depending on the sample to be tested. In step S450, a hydrophilic material is applied to the surface of an upper cover, and a vent hole corresponding to one of the reaction zones and a gap of the end portion are formed on the upper cover, wherein the notch includes at least two grooves. Next, two, 1 are disposed on the intermediate partition, wherein the surface coated with the hydrophilic material faces downward to form a partition. The upper cover covers at least the reaction zone so as to be interposed between the insulating substrates. Figure 4 is a flow chart showing a method of manufacturing a biochemical test piece according to an embodiment of the present invention. First, in step S400, a board is provided-insulated. Next, a conductive layer is formed on the insulating substrate in step S410, and the conductive layer is etched to form an electrode system having at least two mutually insulated reference electrodes and working electrodes. In another embodiment, the electrode system formed in step S4i is further comprised of two identification electrodes connected by a resistor. In step S420, an insulating layer having an opening is provided over the electrode system, wherein the opening exposes a portion of the electrode system to form a reaction zone having a supply end. In addition, one end of the electrode system is not covered by the insulating layer to be electrically connected to a measuring instrument. In the step, a spacer in one of the shapes of the corresponding insulating layer is provided on the insulating layer. Next, a reaction layer is provided in the reaction zone in step S440 for forming a reaction zone with the sample generation and the upper cover in step S460, using, for example, a sampling space for the capillary attraction. In the 'use of techniques such as punching or cutting, the formation of a single birth -12- M334325 jpf 丨 巧 :: Μ : 96214873113⁄4 AV 'a,r ^ υ ^ α,ι » $ 1 2 2 3 correction 1 -— Concave. Since there are at least two concave I at the supply end of the reaction zone, the sampling area is increased. Therefore, the possibility of incapable of sucking the sample into the reaction zone in the punching or cutting of the end of the fuel 2 is large, and the gap of the upper cover is formed. The step can be carried out with the step of forming a k-hole outside the upper cover without increasing the difficulty of manufacture. The biochemical test strip disclosed in the present invention not only improves the process quality, but also reduces the production cost of the test piece. It can also quickly introduce the sample sample into the anti-" film. In addition, the biochemical convenience of the creation is convenient. The visual identification features are used to increase the use of the Dingtai Institute as a preferred embodiment of the present invention, and are not intended to limit the scope of the patent; any other deviations or modifications not disclosed in this creation should be The application included in the following [Simplified illustration]
圖1根據本創作一竇#A丨认 .t L 構分解囷. 貝苑例，繪示一生化感測試片的結 圖2根據本創作一實 生化感測試片的俯視圖 施例而繪示圖 之結構組裝後之 之一 圖3根據本創作另— 生化感測試片的俯視 貫施例而緣示圖1之結構組裝後 圖；以及 圖4根據本創作之一 實施例，繪示生化感測試片之製 M334325 m 97年1月23 號：96214873 < :狀」 造方法的流程圖。 【主要元件符號說明】 100 生化感測試片 110 絕緣基板 120 電極系統 122 參考電極 123 量測電極組 124 工作電極 126 第一辨識電極 127 辨識電極組 128 第二辨識電極 129 電阻 130 絕緣層 132 第一開口 134 第一連接區 136 供應端 140 中隔板 142 第二開口 144 第二連接區 150 反應層 160 上蓋 162 通氣孔 164 缺口 200 生化感測試片 -14- M334325 案號：9621487% 97 年 1 月 210 絕緣基板 220 電極糸統 240 中隔板 260 上蓋 262 通氣孔 264 缺口 270 反應區 300 生化感測試片 360 上蓋 362 通氣孔 364 缺口 380 箭頭圖案 -15 -Figure 1 is based on the creation of a sinus #A 丨 ..t L constitutive decomposition 贝. Bay Court example, showing a biochemical test piece of the knot Figure 2 according to the creation of a real biochemical test piece of the top view of the example FIG. 3 is a rear view of the structure of FIG. 1 according to the above-described embodiment of the biochemical test strip; and FIG. 4 shows a biochemical test according to an embodiment of the present invention. Film production M334325 m January 23, 1997: 96214873 < : shape" Flow chart of the method. [Main component symbol description] 100 Biochemical test piece 110 Insulating substrate 120 Electrode system 122 Reference electrode 123 Measuring electrode group 124 Working electrode 126 First identifying electrode 127 Identification electrode group 128 Second identifying electrode 129 Resistance 130 Insulation layer 132 First Opening 134 First connection area 136 Supply side 140 partition 142 Second opening 144 Second connection area 150 Reaction layer 160 Upper cover 162 Vent hole 164 Notch 200 Biochemical test piece-14- M334325 Case number: 9621487% January 1997 210 Insulation Substrate 220 Electrode System 240 Separator 260 Upper Cover 262 Vent 264 Notch 270 Reaction Zone 300 Biochemical Sense Test Strip 360 Upper Cover 362 Vent 364 Notch 380 Arrow Pattern -15 -