TW416005B - Biosensor with multiple sampling ways - Google Patents

Biosensor with multiple sampling ways Download PDF

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Publication number
TW416005B
TW416005B TW88119683A TW88119683A TW416005B TW 416005 B TW416005 B TW 416005B TW 88119683 A TW88119683 A TW 88119683A TW 88119683 A TW88119683 A TW 88119683A TW 416005 B TW416005 B TW 416005B
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Taiwan
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layer
biochemical sensor
patent application
item
reaction
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TW88119683A
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Chinese (zh)
Inventor
Ying-Je Huang
Jiun-Lung Shie
Yan-Shr Shen
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Apex Biotechnology Corp
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Priority to TW88119683A priority Critical patent/TW416005B/en
Priority to DE2000118959 priority patent/DE10018959B4/en
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Publication of TW416005B publication Critical patent/TW416005B/en
Priority to US10/023,279 priority patent/US6923894B2/en

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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12QMEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001Enzyme electrodes
    • C12Q1/002Electrode membranes
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54373Apparatus specially adapted for solid-phase testing involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
    • G01N33/5438Electrodes

Abstract

A biosensor for detecting the composition of bio-components in a detected body comprises an electric insulating substrate; an anode portion located on the substrate, the two ends of which separately forming a working electrode and an anode connector; a cathode portion located on the substrate, the two ends of which separately forming a reference electrode and a cathode connector; a reaction layer located on the working electrode and the reference electrode, which is used to contact with the detected body to generate a chemical reaction; an electrical insulating layer on the substrate, which has a chip for containing the detected body to the reaction layer and an opening end of the chip; and a net cover layer located on the reaction layer, which at least cover a portion of the chip. The detected body can use the capillary force generated between the net cover layer and the reaction layer to add sample from the chip on the side so as to make sampling easy. If the net cover is a hydrophilic layer, the sample can be added from above the specimen by hydrophilic property from the net cover.

Description

A7 416005 -- .—__B7 五、發明說明(I ) 發明之背景 1.發明之領域 本發明係關於一種生化感測器,更具體而言,係關於一 種用以檢測檢體中生化成分含量或濃度之電流式片狀生化 感測器。 1先前技藝之說明 生化分析儀一般可分為濕式、乾式及生化感測器三種; 濕式主化刀析儀是將檢品與試劑(通常含顯色劑)混合, 進仃化學反應以光學判讀裝置例如比色計,分光光度 汁等測凟前後的顏色變化。以此種方式測試的檢品不能使 :全血’因此須經前處理,且儀器較昂貴,以及非專業人 貝無法操作等限制,因A,常用在醫院及檢驗所。乾式生 化分析儀則是在試片表面塗佈化學試劑,酵素或抗體等, 直接與檢品接觸,來進行分析,省去了試劑配製且操作方 法簡化,但仍然是以呈色法之原理來測定;這種分析儀之 4片春易氧化隻色,易受檢品顏色干擾,因此亦無法使用 全血。 生化感測器係由生物元件'薄膜元件及傳感器所組成, 其中的生物元件是一種包括了微生物、細胞'組織、酵素 、柷原或抗體等具有專一性辨識能力的生物材料;薄膜元 件一般為高分子材料,用以固定前述的生物元件及篩除干 擾物質;傳感器則包括電極,離子選擇性場效晶體、熱敏 電阻器'壓電裝置、光纖、光電管及聲波計數器等,其中過 氧化氫電極是目前應用最廣的生化感測器用傳感器之—。 t國囵家標準(CNS)A4規袼(210 κ 297公》) ·--^--------訂---------線 (請先閱讀背面之注意事項再填寫本頁} 416005 A7 搜濟部智慧財產局BKT,消f合作杜印tlc B7 五、發明說明(2 ) 以分析血糖之生化感測器為例,其原理是將葡萄糖氧化 酵素固定於薄膜上並將此薄膜緊套於柱狀的過氧化氫電極 表面,再於白金陽極和銀/氣化銀陰極施予極化電位,經由 葡萄糖氧化酵素催化葡萄糖氧化反應使產生過氧化氫,過 氣化風可繼續在陽極表面附近被氧化成水,且同時釋出電 子’依據電子之釋出量可推算出檢品中之葡萄糖濃度。 前述的柱狀電極須經常拋光,且套膜不易、清洗困難, 因此易交叉污染,不易校正,不易作成丟棄型,以及製作 成本偏髙等缺點,實際使用不便,因此便有試片狀電極之 閗發,以克服柱狀電極之缺點,利於工業化製作。 美國專利號碼第5,1 20,42〇號揭示一種片狀生化檢測電極 ’包括電極部份、絕緣層、作用層,以及位於該作用層上 方的以樹脂板及親水性質上蓋板造成檢體承載空間,其中 通檢體承載空間須具有一個檢體吸入口與—個氣體排出口 :其中該作用層之形成,乃是依序於該電極基板部份覆上 叛基甲基纖維素(c a r b 0 x y m e t h y 1 c e 1 u丨1 0 s e,c M C )水溶 液,乾燥後形成一層(:“〇層,繼續在其上噴覆葡萄糖氧 化酵素落液(G 0 D ),然後乾燥,再於其上喷覆含有導 私介的有機相懸浮液,予以乾燥便完成生化反應區,最 後於基板上覆上造成檢體承載空間之樹脂板及親水性材料 之上蓋板以完成該板狀生化檢測電極。 該生化檢測電極的缺點在於:第―,完成作用反應區需 要二個步騾:形成c M c層用以改善碳質電極表面之疏水 性、形成G〇D層以及形成導電介質,且每一步驟完成前 -5- ------------^---農--------訂--------- {請先閱讀背面之注意事項再填寫本頁) 'ώ tf * / } ! r - * /* y 蛵蒂部智慧时產局員工演費合作社印Μτκ 416005 A7 —_______2Z------ 五、發明說明(3 ) 須先經乾燥,步驟繁雜;第二,取樣方式為接觸電極試片 的尖端後’將檢品導入反應區,取樣口只有一個位置。 美國專利號碼第5,6 2 8,8 9 0號揭示另一種片狀生化檢測電 極,包括一電極部份、一絕緣層、一作用層’位於該作用 層上方的親水性雙層網,以及覆蓋雙層網的上蓋層。其電 極為三極式,先印製破層再印製銀層。反應區中之工作極 、參考極與對極分別再覆上生物活性物質 '銀/氣化銀及導 電介質°隨後再披覆兩層網布,該雙層網布必須為親水處 理,以便利於樣品之導入,蓋血液樣品加入親水雙層網, 易被親水網之親和力作用而限制在作用層上,之後於網布 上再貼合一層上蓋,於上蓋層留下一取樣口 D上述之檢測 電極不僅製作裎序繁複、網布多層且需要親水處理、取樣 口只有一個,血樣加入試片時無法判別是否已確實導入反 應區’而且血樣需求量高,高達丨〇微升(以L )以上= 發明之概述 本發明即針對前述先前技藝的缺點,將反應成分混合在 —起’一次加入反應層,並於試片樣品吸入缺口上面,加 上一層網狀覆蓋層,可在網狀覆蓋層與反應層間產生毛細 σ及引力’由試片旁邊之缺口加入樣品,使取樣容易,或若 網狀覆蓋為親水層樣品可由網狀覆蓋藉親水性由試片上方 加入,因此提供一種製作簡單、檢測方便且有效的生化感 測器「 本發明之一目的在提供一種生化感測器,其具有多元之 取樣位置,可以檢體滴放、或使試片靠近檢體·如靠近人體 -6 - 本纸張尺度適用中國國家標準(CNS)A4規格(210 X 297公釐) -------Γ! :--'^i ------訂--------·線 (請先閲讀背面之注意事項再填寫本頁> 416005 經濟部智慧財產局—工消費合作社印製 A7 B7_____ 五、發明說明(4 ) 耳下垂處·的方式進行檢體的取樣,因此非常方便取樣。 本發明之又一目的在於提供一種生化感測器,其可以輕 易且迅速地將檢體導入反應層,以有效取得檢體進行檢測 反應3 本發明之另一目的在於提供—種生化感測器,其可以減 少檢體的取樣量》採血量在5微升以下,進一步減少病患的 痛楚。 本發明之更一目的在提供一種製造簡便的生化感測器, 其不須分層乾燥,即可在表面形成一均句平整的生物性反 應層,而且依然可以達到準確性的要求。 為達成上述目的並避免先前技藝的缺點,本發明揭示一 種生化感測器,用以檢測檢體中生化成分之含量,包含: 一電絕緣基板;一位於該基板上之陽極部份’其兩端分別 形成一工作電極以及—陽極接頭;一位於該基板上之陰極 邵分,其兩端分別形成—參考電極以及一陰極接頭;一位 於該工作電極以及該參考電極上之反應層,其係用以與檢 'm接觸以產生化學反應;一位於該基板上之電絕緣層,其 具有一用以容納該檢體至該反應層之缺口以及—缺口的開 口端;以及一位於該反應層片上之網狀覆蓋層,其至少覆 盍姊分該缺口;藉此,該檢體可以藉由該網狀覆蓋層之親 水性由網狀覆盍層上面加入樣品或藉由網狀覆蓋層與反應 層間所產生之毛細吸引力由該缺口的開口端到達反應層。 其中琢反應層係由酵素、3觀體以及電子#介物及界面活性 劑之配方所組成。 本紙张尸v度適用中國國家標準(CNS)A4規格(21〇 X 297公釐) 1111 — I ΙΓ I I Γ I . I I — 111— <1111111 - - (請先閱讀锡面之注意事項苒填寫本頁) 416005 A7 B7 經濟部智慧財產局員工消費合作社印货· 五、發明說明(5 ) 本發明生化感測器之網狀覆蓋層係親水性網狀材科或炉 水性網狀材料或金屬網,其提供毛細作用力以輕易且迅速 有效地將檢體由生化感測器旁邊缺口之開口端導入反應層 進行檢測。 該缺口的開口端係作為檢體的接觸點,其可用以靠近並 接觸病患身上的檢體取樣處,使檢體由該缺口的開口端進 入反應層進行檢測;只要將生化感測器靠近病患,就可以 有效取得檢體,取樣方便》於一較佳具體實施例中,該基 板於該缺口的開口端下緣處更具有一半圓形的突出部,以 作為檢體的接觸點,該半圓形的突出部不僅易於辨識且能 更接近取樣點以方便取樣,並且舒缓病患接觸感測器時的 感覺σ 藉由本發明的揭示,製造廠商得以方便進行生產生化感 測器 '檢驗人員得以簡便且有效地取得檢體進行檢測、病 患的不便減到最低、而且能夠得到準確的檢測結果,可謂 一舉數得。 本發明之前述和其他目的、優點以及如何達成之技術内 容,將根據下列詳細說明配合圖式作進一步說明,其中: 圖式簡單說明 圖1係根據本發明之一具體實施例的生化感測器之結構分 解圖; 圖2係該具體實施例之結構外觀圖; 圖3係該具體實施例之上視圖; 圖4係該具體實施例在圖3之Α斷面的剖面圖;_以及 ^1 I n 1 · I n n n H «^1 ί n n I i (請弁閱讀背面之注意事項再填寫本頁) 本紙張尺度適用t國國家榫準(CNS)A4規格(210 X 297公釐) 經濟部智慧財產局員工消費合作社印 1 生化感測器 2 電絕緣基板 3 陽極部份 4 工作電極 5 陽極接頭 6 陰極部分 7 參考電接 8 陰極接頭 9 反應層 10 、1CT 電絕緣層 11 缺口 12 缺口的開口端 13 網狀覆蓋層 14 突出部 a 第一檢體導入方向 b 第二檢體導入方向 416005 A7 B7 五、發明說明(6 ) 圖5係根據本發明之一具體實施例的生化感;.則為與丫^丨血 糠分析儀檢測血液中血糖濃度的結果比較圖。 圖式元件符號說明 較佳具體實例之說明 請參考圖丨至4,根據本發明之一具體實施例的生化感測 器1 ’其係用以檢測檢體中生化成分之含量,包含:一電絕 緣基板2 ; —位於該基板2上之陽極部份3,其兩端分別形成 一工作電極4 (如圖3所示)以及一陽極接頭5 ; —位於該基 板2上之陰極部分6 ’其兩端分別形成一參考電極7 (如圖3 所示)以及一陰極接頭8。 孩基材2具有平直的表面、電絕缘的特性以及可耐4〇t〜 200 C加溫處理的耐熱能力,以便於加溫處理以及增加該陽 極邵分3以及陰極部分6導電度及附著性,適用之基材㈣材 料包括但不限於PVC板、聚醋、電木板、坡璃纖維板( FR-4)fe、pET^、pc、pp pE、pA、ps 板、玻璃板、或陶瓷板(◦ E Μ _丨)。 用㈣國家標準-———·~- -------.------ 装---I----訂--------- - 一 · (請先閱讀背面之注咅?事項再填寫本頁) 416005 Λ7A7 416005-.__ B7 V. Description of the invention (I) Background of the invention 1. Field of invention The present invention relates to a biochemical sensor, and more specifically, to a method for detecting the content of biochemical components in a specimen or Current-type chip biochemical sensor for concentration. 1 Description of previous techniques Biochemical analyzers can generally be divided into three types: wet, dry, and biochemical sensors; wet main chemical analyzers are used to mix test substances with reagents (usually containing chromogenic reagents), and perform chemical reactions to Optical reading devices such as colorimeters, spectrophotometric juices, etc. measure the color change before and after the measurement. Specimens tested in this way cannot make: Whole blood ’therefore requires pre-treatment, and the equipment is expensive, and non-professionals cannot operate because of restrictions such as A, which is often used in hospitals and laboratories. The dry-type biochemical analyzer is to apply chemical reagents, enzymes or antibodies on the surface of the test strip, and directly contact the sample for analysis, eliminating the need for reagent preparation and simplifying the operation method, but it is still based on the principle of color rendering. Determination; 4 springs of this analyzer are easy to be oxidized, and are susceptible to interference with the color of the test product, so whole blood cannot be used. Biochemical sensors are composed of biological elements, thin film elements and sensors. The biological element is a kind of biological material that includes microorganisms, cells, tissues, enzymes, ligogens, or antibodies, and has the ability to specifically identify; thin film elements are generally Polymer materials used to fix the aforementioned biological elements and screen out interfering substances; sensors include electrodes, ion-selective field-effect crystals, thermistor's piezoelectric devices, optical fibers, photoelectric tubes, and acoustic counters, among which hydrogen peroxide Electrode is one of the most widely used sensors for biochemical sensors. National Standards (CNS) A4 Regulations (210 κ 297) "-^ -------- Order --------- line (Please read the precautions on the back before Fill in this page} 416005 A7 BKT of the Intellectual Property Bureau of the Ministry of Search, cooperation with Duyin tlc B7 V. Description of the invention (2) Take the biochemical sensor for analyzing blood glucose as an example, the principle is to fix glucose oxidase on the film The thin film was tightly sleeved on the surface of the columnar hydrogen peroxide electrode, and then a polarization potential was applied to the platinum anode and the silver / gasified silver cathode. The glucose oxidation enzyme catalyzed the glucose oxidation reaction to produce hydrogen peroxide and over-gasified The wind can continue to be oxidized into water near the surface of the anode, and at the same time, it can release the electrons. Based on the amount of electrons released, the glucose concentration in the test product can be calculated. Therefore, it is easy to cross-contaminate, difficult to correct, not easy to make discarded types, and the production cost is biased, and the actual use is inconvenient. Therefore, there are bursts of test strip electrodes to overcome the shortcomings of columnar electrodes and facilitate industrial production. Patent No. 5,1 20,42 Shown is a sheet-shaped biochemical detection electrode, which includes an electrode part, an insulating layer, and an active layer, and a specimen carrying space is formed by a resin plate and a hydrophilic upper cover plate located above the acting layer, wherein the specimen carrying space must have one Specimen suction port and a gas discharge port: The formation of the active layer is sequentially covered with the electrode substrate part (carb 0 xymethy 1 ce 1 u 丨 1 0 se, c MC) aqueous solution, dried to form a layer (: "0 layer, continued to be sprayed with a glucose oxidase falling liquid (G 0 D), and then dried, and then sprayed with an organic phase suspension containing a guide agent, After drying, the biochemical reaction zone is completed, and finally, a resin plate and a cover plate of a hydrophilic material which is the specimen carrying space are covered on the substrate to complete the plate-shaped biochemical detection electrode. The disadvantage of the biochemical detection electrode is: Two steps are required to complete the reaction zone: forming a c M c layer to improve the hydrophobicity of the carbonaceous electrode surface, forming a GOD layer, and forming a conductive medium, and before each step is completed -5- ----- - ------ ^ --- Agriculture -------- Order --------- {Please read the notes on the back before filling in this page) 'FREE tf * /}! R -* / * y 蛵 Ministry of Wisdom and Time Production Bureau staff performance co-operative cooperative printing Μτκ 416005 A7 —_______ 2Z ------ 5. Description of the invention (3) must be dried first, complicated steps; Second, the sampling method is contact After the tip of the electrode test strip, the test sample is introduced into the reaction zone, and the sampling port has only one position. US Patent No. 5, 6 2 8, 8 9 0 discloses another sheet-shaped biochemical detection electrode, including an electrode part, a An insulating layer, an active layer 'a hydrophilic double-layer network above the active layer, and an upper cover layer covering the double-layer network. Its electrode is a three-pole type, and a broken layer is printed before a silver layer is printed. The working electrode, the reference electrode and the counter electrode in the reaction zone are respectively covered with the biologically active substance 'silver / gasified silver and a conductive medium ° followed by two layers of mesh cloth, which must be treated hydrophilically to facilitate The introduction of the sample, the blood sample is added to the hydrophilic double-layer mesh, which is easily restricted to the active layer by the affinity of the hydrophilic mesh, and then a layer of the cover is attached to the mesh, leaving a sampling port D on the cover. The electrode is not only complicated to produce, multiple layers of mesh, and requires hydrophilic treatment. There is only one sampling port. When a blood sample is added to the test strip, it cannot be determined whether it has been actually introduced into the reaction zone. = Summary of the Invention The present invention addresses the shortcomings of the previous techniques by mixing the reaction components together-adding the reaction layer at one time, and sucking the sample on the test sample into the gap, and adding a mesh cover layer to the mesh cover layer. Capillary σ and gravitational force between the reaction layer and the sample are added to the sample from the gap next to the test piece to facilitate sampling, or if the mesh is covered with a hydrophilic layer, the sample can be borrowed by the mesh It is added from the top of the test strip, so it provides a biochemical sensor that is simple to make, convenient to detect, and effective. "An object of the present invention is to provide a biochemical sensor with multiple sampling positions, which can be used to drip the specimen, or Keep the test piece close to the specimen, such as close to the human body-6-This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) ------- Γ!:-'^ I- ---- Order -------- · Line (Please read the notes on the back before filling in this page> 416005 Printed by the Intellectual Property Bureau of the Ministry of Economy—Industrial and Consumer Cooperatives A7 B7_____ V. Description of Invention (4) It is very convenient to sample the specimen in the manner of the ear drop. Another object of the present invention is to provide a biochemical sensor, which can easily and quickly introduce the specimen into the reaction layer to effectively obtain the specimen. Detection reaction 3 Another object of the present invention is to provide a biochemical sensor which can reduce the sample sampling volume. The blood collection volume is less than 5 microliters, which further reduces the pain of patients. A further object of the present invention is to provide A simple-to-manufacture biochemical sensor, which The layered drying is required to form a uniform biological reaction layer on the surface, and the accuracy requirement can still be achieved. In order to achieve the above purpose and avoid the disadvantages of the prior art, the present invention discloses a biochemical sensor, which uses To detect the content of biochemical components in the specimen, it includes: an electrically insulating substrate; an anode portion on the substrate; two ends of which respectively form a working electrode and an anode connector; a cathode on the substrate; A reference electrode and a cathode terminal are formed at both ends of the electrode respectively; a reaction layer on the working electrode and the reference electrode is used for contact with the detector to generate a chemical reaction; an electrical insulation layer on the substrate It has a gap for accommodating the sample to the reaction layer and an open end of the gap; and a mesh cover layer on the reaction layer sheet, which at least covers the gap; thereby, the inspection The body can be added to the sample by the hydrophilic property of the mesh cover layer or by the capillary attraction between the mesh cover layer and the reaction layer. Open port reaches the reaction layer. Among them, the reaction layer is composed of the enzyme, the three-viewer body, the electron mediator and the surfactant formulation. The paper's v-degree applies to the Chinese National Standard (CNS) A4 specification (21〇X 297 mm) 1111 — I ΙΓ II Γ I. II — 111— < 1111111--(Please read the precautions for tin surface first 苒(This page) 416005 A7 B7 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs · V. Description of the invention (5) The net-like covering layer of the biochemical sensor of the present invention is a hydrophilic net-like material or a furnace-based net-like material or metal Net, which provides capillary force to easily and quickly and efficiently introduce the specimen from the open end of the gap next to the biochemical sensor to the reaction layer for detection. The open end of the notch serves as the contact point of the specimen, which can be used to approach and contact the specimen sampling site of the patient, so that the specimen enters the reaction layer for detection through the open end of the notch, as long as the biochemical sensor is close to The patient can effectively obtain the specimen, and the sampling is convenient. In a preferred embodiment, the substrate has a semi-circular protrusion at the lower edge of the open end of the notch as the contact point of the specimen. The semi-circular protrusion is not only easy to identify and can be closer to the sampling point to facilitate sampling, and also eases the patient's feeling when the sensor is in contact with the sensor. People can easily and effectively obtain specimens for testing, minimize the inconvenience of patients, and obtain accurate test results. The foregoing and other objects, advantages, and technical contents of the present invention will be further described in accordance with the following detailed description in conjunction with the drawings, wherein: The drawings briefly illustrate FIG. 1 is a biochemical sensor according to a specific embodiment of the present invention Structure exploded view; Figure 2 is a structural external view of the specific embodiment; Figure 3 is a top view of the specific embodiment; Figure 4 is a cross-sectional view of the specific embodiment in the section A of Figure 3; I n 1 · I nnn H «^ 1 ί nn I i (Please read the notes on the back and fill in this page) This paper size is applicable to the national tenon standard (CNS) A4 (210 X 297 mm) of the Ministry of Economic Affairs Printed by the Intellectual Property Bureau employee consumer cooperative 1 Biochemical sensor 2 Electrically insulated substrate 3 Anode part 4 Working electrode 5 Anode connector 6 Cathode part 7 Reference electrical connection 8 Cathode connector 9 Reaction layer 10, 1CT Electrical insulation layer 11 Notch 12 Notch Open end 13 Mesh cover 14 Protrusion a First sample introduction direction b Second sample introduction direction 416005 A7 B7 V. Description of the invention (6) Figure 5 is a biochemical sense according to a specific embodiment of the present invention; It is a comparison chart with the blood glucose concentration test result of blood bran analyzer. Refer to Figures 1-4 to 4 for a description of the preferred specific examples of the diagrammatic component symbols. According to a specific embodiment of the present invention, a biochemical sensor 1 ′ is used to detect the content of biochemical components in a specimen, including: Insulating substrate 2;-an anode portion 3 on the substrate 2, which has a working electrode 4 (as shown in Fig. 3) and an anode terminal 5 at its two ends;-a cathode portion 6 'on the substrate 2 A reference electrode 7 (as shown in FIG. 3) and a cathode terminal 8 are formed at both ends. The substrate 2 has the characteristics of flat surface, electrical insulation, and heat resistance capable of withstanding 40t to 200 C heating treatment, so as to facilitate the heating treatment and increase the conductivity and adhesion of the anode 3 and cathode 6 Suitable materials, including but not limited to PVC board, polyacetate, bakelite, sloped fiberboard (FR-4) fe, pET ^, pc, pp pE, pA, ps board, glass board, or ceramic board (◦ E Μ _ 丨). Use ㈣ national standard ------ ~--------.------ equipment --- I ---- order ----------one (please first Read the note on the back? Please fill in this page for more information) 416005 Λ7

經濟部智慧財產局員工消f合作杜印S B7 五、發明說明(7 ) 該陽極部份3以及陰極部份6係二條分離且互相不接觸的 導電膜,用以連接於感測裝置(未圖示)。 陽極部份3於部分覆蓋一電絕緣層1 〇及1 〇1之後,裸露兩 端分別是用以連接感測裝置的陽極接頭5以及其上覆蓋有一 作為反應層9的生物活性層之工作電極4 (請參考圖3 ),用 以傳導檢體在化學或生化反應時所誘發之電效應至該感測 裝置。陰極部份6於部分覆蓋一電絕緣層丨〇及1 〇 '之後,裸 露兩端則分別是該用以連接感測裝置的陰極接頭8以及其上 復蓋有一作為反應層9的生化活性層之參考電極7 (請參考 圖3 )’用以配合工作電極4對檢體的電效應進行檢測。 本發明之生化感測器丨另包含一位於該工作電極4以及該 參考電極7上之反應層9 (請參考圖4 ),其係一生化活性層 ’用以與檢體接觸以產生化學反應D其中該反應層並不與 前述之電絕緣層重疊。 該反應層9係由一生化活性物質的組成配方置於基板2之 陰陽電極上後所形成,該反應層係由酵素、載體、電子媒 介物及界面活性劑之配方所組成。於具體實施例中,該載 體使用量為配方的重量百分之〇 0 5至百分之丨5,可使用之 載體有超微粒纖維素、甲基纖維素(methyIcelluI〇se,M c )、羧基甲基纖維素(carboxyimethyl_ceUui〇se,c M C )、興粉(starch )、乙浠醇(Wnyialc〇h〇1 )、乙 蹄基五園酮(vi nylpyrr〇H done )、聚乙烯醇(p V A ) 、聚乙烯咯酮(p V P )、聚乙二醇(p e G )或白明膠 (gelatin)等。 -10- 本纸張尺度適用中國國家標準(CNS〉A4規格x 297公釐) -I I I ! I i I —1111、 I------ I « — — — — III — - i (請先閱讀腎面之注意事項再填寫本頁) 經濟部智慧財產局Μτ-消費合作社印制ίΛ 416005 A7 ____ B7_________ 五、發明說明(8 ) 可選用的組成配方如下: 酵素’如葡萄糖氧化酵素,使用量2 〇 〇〜1 2 0 0 U /in 1 ; 酵素保護劑,使用量為配方的重量百分之〇. 1至百分之 1 .(),可用之保護劑有:白蛋白、糊精、葡萄聚糖、氨基酸 等’上述之保護劑可單獨使用一项或多項混合使用; 電子媒介物,使用量為配方的重量百分之2.0至百分之 10.0 ’可用之導電介質有赤血鹽(p〇taSsium ferricyanide ); 界面活性劑’佔配方重量的百分之〇丨以下,可使用之界 面活性劑有 polyethylene glycol alkyl phenyl ether(TritonX-lOO)、TritonX-405、TritonX-114、十 一;i元硫酸納落液(s 0 d i u m 1 a u r y 1 s u 1 f a t e )、 polyoxyethylenesorbitan monolaurate(Tween20) ' Tween40、Tweeu60、Tween80或其它水溶性界面活性劑 或清潔劑。 本發明之生化感測器1另包含一位於該基板2上之電絕緣 層1 0及1 01 ’其具有一用以容納該檢體至該反應層9之缺口 1 1 (高度0.2 5 - 0.3毫末)以及一缺口的開口端n ^該電絕 緣層可選自PP、PVC、PET、PC或PE。 該電絕緣層1 0及丨0’於覆蓋上基板2之後,除了使裸露的 一端陽極部分3以及陰極部分6分別形成陽極接頭5以及陰極 接頭8 ’更於另一端由該缺口 1 1所侷限的區域分別形成工作 電極4以及參考電極7。於較佳實施例中,該工作電極4之面 積為參考電極7之面積的2至3倍》 -11 ^ 本紙張反度適用中國國家標準<CNS)A4規格(2〗0 X 297公釐) --------------装—------訂---------線 - - (請先閱讀背面之注意事項再填寫本頁) 416005 A7 _______B7 ___ 五、發明說明(9 ) 由該缺口丨丨所侷限的區域與該缺口】丨以下的反應層9形成 所謂的反應區域,以容納檢體並進行反應。反應區域上方 之電絕緣層1 0的厚度一般為〇 . 2 5至0.3 0毫米。 本發明之生化感測器1更包含一位於該電絕緣片丨0上之網 狀覆蓋層1 3,用以保護反應層以及促進與檢體的毛細作用 ,其至少覆蓋部分該缺口丨丨;藉此,該檢體可以藉由該網 狀覆蓋層丨3與反應層9之間所產生之毛細吸引力由該缺口的 開口端丨2到達反應膜層9。 該網狀覆蓋層1 3可選自親水性網狀材料或疏水性網狀材 料或金屬網,其網目數目包括但不限於6 0至3 0 0目。當網狀 覆蓋層1 3係由親水性網狀材料所組成時,對親水性的檢體 而言,檢體可由缺口開口端1 2導入或由網狀覆蓋層開口上 方,如圖4之a方向導入。當網狀覆蓋層1 3係由疏水性網狀 材料所組成時,對於親水性的血液檢體而言,其親和性較 弱,因此檢體主要是由缺口的開口端1 2藉毛細現象導入。 該網狀覆蓋層亦可為經過界面活性劑處理之疏水性網狀材 料,使檢體可經由圖4之a或b方向導入;其中該界面活性劑 係選自 Triton X-H30,TritonX-405,Triton X-114 ,十 二 硫酸納溶液(sodium lauryl sulfate )、 polyoxyethylenesorbitan motiolaui. ate(Tween20) > T w e e n 4 0,T w e e n 6 0 ’ T w e e n 8 0或其它水溶性界面活性劑 或清潔劑。 本發明生化感測器]將檢體導入反應層9的方式有二,當 網狀復蓋層為親水性時,由於親水性網狀覆蓋層1 3所提供 -12 - 本^-_張尺度適用申國國家標準(CNS)A4規格(2.10 x 297公餐) -II--I J— I 1 I ' . I I I I I I 訂— — — — — — —I* (請先閱讀背面之注音¥項再填寫本頁) 416005 經濟部智慧財產局員工消費合作杜印Μ A7 Β7 五、發明說明(10 ) 的親水性作用,檢體可以由如圖4所示之第一檢體導入方向 滴放’或由第二檢體導入U方向b藉毛細作用導入,由此 方向導入’生化感測器可直接靠近檢體,檢體得以迅速而 全面地被吸往反應層9,不僅得以確保有效的檢測結果,而 且可以減少檢體的滴放量;再者,若網狀覆蓋層為疏水性 時’檢體也可以由第二檢體導入方向b進入反應層9,這種 方式係將生化感測器直接靠近病患身體,例如於病患耳下 以細針穿刺使滴出小血滴,而將生化感測器靠近該血滴, 使A滴由第二檢體導入方向b進入反應層9,如此檢體的採 樣量可以降到最低。 糖尿病患者在使用血糖試片時採血量多,尤其是較嚴重 的患者’一天内常要進行多次的採樣以進行監控,若能在 血液需求量上減少’便能使用較纖細的採血針,使患者的 傷口及疼痛減到最低。再者’血樣加到電極試片上時容易 因為血量少而塗抹試片’進而造成量測上的誤差。本發明 可降低血糖電極試片在量測時的血液需求量,以及改良採 血樣的方式= 於一較佳具體實施例中,該生化感測器1之基板2於該缺 口的開口端1 2下緣處更具有一半圓形的突出部1 4,以作為 檢體的接觸點。該半圓形的突出部不僅使能更接近取樣點 以万便取樣’並且舒緩病患接觸感測器時的感覺。 不同於先前技藝美國專利號碼第5, 120,420及5,628,890 號者’本發明採用單層網布結構材料附著於反應區上方, 由夫網布材料上有很多孔洞在反應區之缺口開口端1 2處容 —- 13 _ 不、狀厂又過用中國國家標準(CNSM4規格(210 X 297公髮) ----------*---- 裝----1---訂--I---!線 (請先閱讀背面之注意事項再填寫本頁)Employees of the Intellectual Property Bureau of the Ministry of Economic Affairs cooperate with Du Yin S B7 V. Description of the invention (7) The anode part 3 and the cathode part 6 are two separate and non-contact conductive films for connecting to the sensing device (not Icon). After the anode part 3 is partially covered with an electrically insulating layer 10 and 100, the exposed ends are respectively connected to the anode connector 5 for the sensing device and a working electrode covered thereon with a bioactive layer as a reaction layer 9 4 (please refer to FIG. 3), which is used to conduct the electrical effect induced by the specimen during the chemical or biochemical reaction to the sensing device. After the cathode part 6 is partially covered with an electrical insulation layer 丨 0 and 10 ′, the exposed ends are respectively the cathode connector 8 for connecting the sensing device and a biochemical active layer covered thereon as a reaction layer 9 The reference electrode 7 (refer to FIG. 3) is used to detect the electrical effect of the specimen in cooperation with the working electrode 4. The biochemical sensor of the present invention further includes a reaction layer 9 (refer to FIG. 4) on the working electrode 4 and the reference electrode 7, which is a biochemical active layer for contacting the specimen to generate a chemical reaction. D wherein the reaction layer does not overlap the aforementioned electrical insulating layer. The reaction layer 9 is formed by a composition formula of a biochemical active material placed on the yin and yang electrodes of the substrate 2. The reaction layer 9 is composed of a formula of an enzyme, a carrier, an electronic medium and a surfactant. In specific embodiments, the amount of the carrier used is from 0.05 to 5 percent by weight of the formula. The carriers that can be used include ultrafine cellulose, methyl cellulose (methyIcelluose, Mc), Carboxymethylcellulose (carboxyimethyl_ceUuiose, c MC), starch (starch), acetohydrin (Wnyialcoh), ethinyl pentone (vi nylpyrroH done), polyvinyl alcohol (p VA), polyvinyl ketone (p VP), polyethylene glycol (pe G), or gelatin. -10- This paper size applies to Chinese national standards (CNS> A4 size x 297 mm) -III! I i I —11111, I ------ I «— — — — III —-i (please first Read the notes on the kidney side and fill out this page) Printed by the Intellectual Property Bureau of the Ministry of Economic Affairs, Mτ-Consumer Cooperative, ΛΛ 416005 A7 ____ B7_________ V. Description of the invention (8) The optional composition formula is as follows: Enzyme such as glucose oxidase, the amount used 2 00 ~ 1 2 0 U / in 1; Enzyme protection agent, the amount used is 0.1% to 1.% of the weight of the formula (), the available protection agents are: albumin, dextrin, Glycans, amino acids, etc. 'The above-mentioned protective agents can be used alone or in combination; electronic media, the amount used is 2.0% to 10.0% by weight of the formula. The available conductive medium is red blood salt ( p〇taSsium ferricyanide); surfactants account for less than 0% of the weight of the formula. Available surfactants include polyethylene glycol alkyl phenyl ether (TritonX-100), TritonX-405, TritonX-114, eleven; i-yuan sodium sulfate solution (s 0 dium 1 aur y 1 s u 1 f a t e), polyoxyethylenesorbitan monolaurate (Tween20) 'Tween40, Tweeu60, Tween80 or other water-soluble surfactants or detergents. The biochemical sensor 1 of the present invention further includes an electrical insulating layer 10 and 1 01 'on the substrate 2 which has a notch 1 1 (height 0.2 5-0.3) for accommodating the sample to the reaction layer 9 No end) and a notched open end n. The electrically insulating layer may be selected from PP, PVC, PET, PC or PE. After the electrical insulation layers 10 and 0 ′ are covered with the upper substrate 2, in addition to the exposed ends of the anode portion 3 and the cathode portion 6, the anode joint 5 and the cathode joint 8 ′ are respectively limited by the gap 11 at the other end. The working electrode 4 and the reference electrode 7 are respectively formed in the regions. In a preferred embodiment, the area of the working electrode 4 is 2 to 3 times the area of the reference electrode 7 "-11 ^ The paper's inversion applies the Chinese National Standard < CNS) A4 specification (2) 0 X 297 mm ) -------------- install ------- order --------- line--(Please read the precautions on the back before filling this page) 416005 A7 _______B7 ___ V. Description of the invention (9) The area confined by the gap 丨 丨 and the gap] The following reaction layer 9 forms a so-called reaction area to accommodate the specimen and perform the reaction. The thickness of the electrically insulating layer 10 above the reaction region is generally from 0.25 to 0.30 mm. The biochemical sensor 1 of the present invention further includes a mesh covering layer 13 on the electrical insulating sheet 丨 0 for protecting the reaction layer and promoting capillary action with the specimen, which covers at least part of the gap 丨 丨; Thereby, the specimen can reach the reaction film layer 9 from the open end of the notch by the capillary attractive force generated between the mesh cover layer 3 and the reaction layer 9. The mesh covering layer 13 may be selected from a hydrophilic mesh material or a hydrophobic mesh material or a metal mesh, and the number of meshes includes, but is not limited to, 60 to 300 mesh. When the mesh covering layer 13 is composed of a hydrophilic mesh material, for a hydrophilic specimen, the specimen can be introduced through the notched open end 12 or above the opening of the mesh covering layer, as shown in FIG. 4a. Direction import. When the net-like covering layer 13 is composed of a hydrophobic net-like material, for hydrophilic blood specimens, its affinity is weak, so the specimens are mainly introduced by the open end 1 2 of the gap by capillary phenomenon. . The net-shaped covering layer may also be a hydrophobic net-like material treated with a surfactant, so that the specimen can be introduced in the direction a or b of FIG. 4; wherein the surfactant is selected from Triton X-H30, Triton X-405 Triton X-114, sodium lauryl sulfate, polyoxyethylenesorbitan motiolaui. Ate (Tween20) > T ween 4 0, T ween 6 0 'T ween 8 0 or other water-soluble surfactants or cleaning agents . The biochemical sensor of the present invention] There are two ways to introduce the specimen into the reaction layer 9. When the mesh covering layer is hydrophilic, the hydrophilic mesh covering layer 13 provides -12-present ^ -_ Zhang scale Applicable to the National Standard of China (CNS) A4 (2.10 x 297 meals) -II--IJ— I 1 I '. IIIIII Order — — — — — — —I * (Please read the phonetic ¥ on the back before filling (In this page) 416005 Consumer cooperation of Intellectual Property Bureau of the Ministry of Economic Affairs Du Yin M A7 B7 V. Hydrophilic effect of invention description (10), the specimen can be dripped from the first specimen introduction direction as shown in Figure 4 or by The second specimen is introduced in the U direction b by capillary action. From this direction, the biochemical sensor can be directly approached to the specimen, and the specimen can be quickly and comprehensively sucked into the reaction layer 9, which not only can ensure an effective detection result, Moreover, the dripping amount of the specimen can be reduced; further, if the mesh covering layer is hydrophobic, the specimen can also enter the reaction layer 9 from the second specimen introduction direction b, in this way, the biochemical sensor is directly approached The patient's body, for example, a small needle puncture under the patient's ear to make small blood drip The biochemical sensor is brought close to the blood drop, so that the A drop enters the reaction layer 9 from the second sample introduction direction b, so that the sample sampling amount can be minimized. Diabetics use more blood samples when using blood glucose test strips, especially for more severe patients. 'Sampling is often performed multiple times a day for monitoring. If the blood demand can be reduced', a thinner blood collection needle can be used. Minimize patient wounds and pain. Furthermore, when a 'blood sample is applied to the electrode test strip, it is easy to smear the test strip because of the low blood volume', which causes measurement errors. The present invention can reduce the blood demand of blood glucose electrode test strips during measurement, and improve the way of taking blood samples. In a preferred embodiment, the substrate 2 of the biochemical sensor 1 is at the open end 1 2 of the gap. The lower edge further has a semicircular protruding portion 14 as a contact point of the specimen. This semi-circular protrusion not only enables closer to the sampling point to take a sample, and soothes the patient's feeling when touching the sensor. Different from the previous art US Patent Nos. 5, 120,420 and 5,628,890, the present invention uses a single layer of mesh fabric structure material to attach above the reaction area. There are many holes in the mesh material on the open end of the reaction area. —- 13 _ No, the factory has adopted the Chinese National Standard (CNSM4 specification (210 X 297)) ---------- * ---- Equipment ---- 1 --- Order- -I ---! Line (Please read the precautions on the back before filling this page)

416005 Λ7 Β7 五、發明說明(η ) 易產生毛細現象,因此造成採血容易,不論是疏水性戈觀 水性網布結構材料均可使用於作為生化感側器之電挺試片 反應區上面。若網狀覆蓋層為疏水性時,樣品可由b方向吸 入’若為親水性,樣品可由a方向或b方向吸入》 本發明生化感測器1之片狀電極的製程簡化,更能提高〇 質:其製作流程之步驟依序如下: 步驟一,首先在一片平板狀基板2之任一平直表面上,、 網版印刷技術印出一層包含有一陽極部分3與一陰極部分6 的導電膜’導電膜的材質可以是適合網版印刷的導電性嘴 狀材質’如碳膠、銀勝、金膠、或銀碳混合膝、或其級八 (如印銀膠後再印碳膠),然後在40〜!50 t:之下烘乾, 步驟二,以薄膜貼合技術,在前述印製有導電膜的同〜 表面’被覆一層厚度為0.1至丨.0毫米之電絕緣層1〇,,遊 於反應區位置上被覆一層厚度為0.25〜0.30毫米,且具 有一缺口 Η以及一缺口的開口端1 2之電絕緣層丨〇,並且 保留部份裸露且為該缺口 1 1所限制的區域之導電膜用以介 成工作電極4與參考電極7,而此工作電極4與參考電極7 部份形成之區域即稱為反應區; 步驟二’在前述之反應區之區域痛加生物活性物後,於 40〜60 °C之環境下乾燥,以形成一反應層9 ;以及 步鄉四’再將網狀覆蓋層1 3被覆於該反應層9之上。 以下’以具體實施例詳細說明本發明。 實施例一 在一 P C板基材之一平直表面上以網版印出獨立不連接 -14 - 本紙張尺度適用中國國家標準(CNS)A4蜆格(210 X 297公釐) 1! ^-----I--^----I--! I (靖先閱讀背面之注意事項再填寫本頁} 經濟部智慧財產局員工消費合作社fp#Jc; ---—----- 137416005 Λ7 五、發明說明(12 ) 之一陽極與一陰極的碳膠導電膜,然後在丨3 〇 之下烘乾 5隨即在印有導電膜的同一側表面被覆上一層厚度為 0.2 7 m m的P E T電絕緣層,且保留部份裸露的導電膜以形 成陽極接頭、陰極接頭、工作電極及參考電極。該工作電 極及參考電極所形成之區域即為反應區域。 之後將含下列配方成份及比例之材料滴加於該反應區域 表面以形成一反應層: 葡萄糖軋化酵素(glucose oxidase ) 0.63% 白蛋白(a丨b u m i η ) 0.5% 赤血鹽(potassium ferricyanide ) 6% 甲基纖維素(methyl cellulose ) 0.5 % Tiiton X-100 ( t-Octylphenoxyp〇lyethanol ) 0.07 % 磷酸鹽緩衝液(pH5.0 ) 9 2.3 0% 於反應區中點加上述之生物活性物質後 ,將試片置於5 0 t下烘乾丨5分鐘,隨即在反應層上被覆一層網狀材料(特 多龍,Tl2〇-54 ),完成一電流式電極試片之生化感測器 --------------裝--------訂---------線 (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合作社印以 所製得之可拋棄式電流式電極試片,由圖4之b方向吸入 樣品’以全血進行血液中血糖之含量測試,結果如圖5 ,以 本發明之試片與Y S I血糖分析儀檢測血液中血糖濃度之 比較’本發明之試片c V值在5 %以下,檢測所需之血量在 4微公升(# L )以下。由此可知,本發明生化感測器的量 測結果準確 ^15- 本紙張尺度適用中國國家標準(CNS)A4規格(210x 297公釐) Λ7 416005 ------- -B7__ 五、發明說明(l3 ) 實施例二 如貧施例—而更改配方如下: 葡萄糖礼化酵素(glucose oxidase ) 0.63% 白蛋白(albumin ) 0.5% 赤-紅鹽(P 〇 t a s s i um fe ri.i cy an i d e ) 6 % 錢·基甲基纖維素(c a r b 〇 x y m e t h y 1 c e丨丨ιΠ o s e ) 0.5 %416005 Λ7 Β7 V. Description of the invention (η) It is easy to produce capillary phenomenon, so it is easy to collect blood. Regardless of the hydrophobic Geguan water-based mesh fabric structure material can be used on the reaction zone of the test strip of the biochemical sensor. If the mesh cover is hydrophobic, the sample can be sucked in the direction b. If it is hydrophilic, the sample can be sucked in the direction a or b. "The process of the sheet electrode of the biochemical sensor 1 of the present invention is simplified, and the quality can be improved. : The steps of the manufacturing process are as follows: Step 1. First, on any flat surface of a flat substrate 2, a screen printing technology is used to print a conductive film including a positive electrode portion 3 and a negative electrode portion 6. The material can be a conductive mouth-shaped material suitable for screen printing, such as carbon glue, silver win, gold glue, or silver-carbon mixed knee, or its grade eight (such as silver glue and then carbon glue), and then at 40 ~! 50 t: drying underneath, step two, using a thin film bonding technology, the same surface with the conductive film printed thereon is coated with an electrical insulating layer 10 having a thickness of 0.1 to 丨 0 mm, and swims in the reaction The area is covered with an electrically insulating layer having a thickness of 0.25 to 0.30 mm, having a notch Η and a notched open end 12, and retaining a part of the conductive film that is exposed and is the area restricted by the notch 11 It is used to mediate the working electrode 4 and the reference electrode 7, and the area formed by the working electrode 4 and the reference electrode 7 is called the reaction area; Step 2 'After adding the biological active substance in the area of the aforementioned reaction area, Dry at 40 ~ 60 ° C to form a reaction layer 9; and then, cover the reaction layer 9 with a mesh covering layer 13. Hereinafter, the present invention will be described in detail with specific examples. The first embodiment is printed on a flat surface of a PC board substrate with a screen and independently connected. -14-This paper size applies the Chinese National Standard (CNS) A4 grid (210 X 297 mm) 1! ^- ---- I-^ ---- I--! I (Jing first read the precautions on the back before filling out this page} Employee Consumer Cooperatives, Intellectual Property Bureau, Ministry of Economic Affairs, fp # Jc; --------- -137416005 Λ7 V. Description of the invention (12) One of the anode and the cathode is a carbon rubber conductive film, and then dried under 3 〇 5 Then the surface of the same side printed with the conductive film is coated with a layer of 0.2 7 mm thickness PET electrical insulation layer, and part of the bare conductive film is retained to form the anode joint, cathode joint, working electrode and reference electrode. The area formed by the working electrode and reference electrode is the reaction area. The following formula ingredients and A proportion of material is dropped on the surface of the reaction area to form a reaction layer: glucose oxidase 0.63% albumin (a 丨 bumi η) 0.5% potassium ferricyanide 6% methyl cellulose ( methyl cellulose) 0.5% Tiiton X-100 (t-Octylphenoxyp lyethanol) 0.07% phosphate buffer solution (pH 5.0) 9 2.3 0% After adding the above-mentioned bioactive substance at the midpoint of the reaction zone, the test piece is dried at 50 t for 5 minutes, and then on the reaction layer Cover with a layer of mesh material (Tedlon, Tl20-54) to complete the biochemical sensor of a current-type electrode test strip ---------------------------- -Order --------- Wire (please read the precautions on the back before filling out this page) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs on the disposable electric current electrode test strips, as shown in the figure Inhale the sample in the direction b of “4” to test the blood glucose content in the blood with whole blood, and the result is shown in FIG. 5. The comparison between the test strip of the present invention and the blood glucose concentration detected by the YSI blood glucose analyzer is used. Below 5%, the blood volume required for the test is below 4 microliters (# L). It can be seen that the measurement result of the biochemical sensor of the present invention is accurate ^ 15- The Chinese paper standard (CNS) A4 Specifications (210x 297 mm) Λ7 416005 ------- -B7__ V. Description of the Invention (l3) The second embodiment is as poor as the example—but the formula is changed as follows: glucose Glucose oxidase 0.63% albumin 0.5% red-red salt (P 〇tassi um fe ri.i cy an ide) 6% carb xymethy 1 ce 丨 丨ιΠ ose) 0.5%

Triton X-loo ( t-OctylphenoxypolyethanoI ) 0.07 % 鱗酸鹽緩衝液(p H 5,0 ) 92.30% 實施例三 如實施例一而更改配方如下: 葡萄糖氧化酵素(glucose oxidase) 0.63% 白蛋白(albumin) 0.5% 永血鹽(potassium fen'icyanide ) 6% 葡萄聚糖(dextran) 0.5%Triton X-loo (t-OctylphenoxypolyethanoI) 0.07% phosphonium salt buffer (p H 5,0) 92.30% Example 3 The same formula as in Example 1 was used to modify the formula as follows: glucose oxidase 0.63% albumin ) 0.5% potassium fen'icyanide 6% dextran 0.5%

Triton X-100 ( t-Octylphenoxypolyethanol ) 0.07 % 磷酸鹽緩衝液(p H 7.0 ) 92.30% 實施例四 如實施例一而更改配方如下: 葡萄糖氧化酵素(glucose oxidase ) 0.63% 白蛋白(a 1 b u m i η ) 0.5% 赤血鹽(p 〇 t a s s i u in f e l. r i c y a n i d e ) 6 % -16- 本紙張反度遶闬中國國家標準(CNS)A4規格(210 x 297公釐) ---------i -裝--------訂---------線 (請先閱讀背面之注意事項再填寫本頁)Triton X-100 (t-Octylphenoxypolyethanol) 0.07% Phosphate buffer (p H 7.0) 92.30% The fourth embodiment is modified as in the first embodiment as follows: glucose oxidase 0.63% albumin (a 1 bumi η ) 0.5% red blood salt (p 〇tassiu in fe l. Ricyanide) 6% -16- The inversion of this paper revolves around the Chinese National Standard (CNS) A4 specification (210 x 297 mm) -------- -i -install -------- order --------- line (please read the precautions on the back before filling this page)

經濟部智慧財產局員工消費合作杜印SS 416005 A7 經濟部智慧財產局員.工消f合作社印智 _______B7 _五、發明說明(Η ) 魅:夫胺酸(g | u t a in i c a c i tl ) 0 1 % 聚乙二醇(PEG) 0,3% Tween20(po]yOXyethy|enes〇rbjtall Inon〇iaurate) 0. 1 % 磷酸鹽緩衝液(p H 6.0 ) 9 2.3 7 % 實施例五 如實施例一而以疏水性網狀材料聚脂纖維(p〇lyestei.) PES-37丁代替。其製作程序如實施例一,反應層固定完成 後,將網狀材料PES-3 7T黏附於電絕緣層上,完成—電極 試片。 實施例六 如贫施例一而以網狀材料不鏽鋼絲網(1 〇 〇目至3 〇 〇目 )代替。試片製作程序如實施例一,反應膜層固定完成後 ,將網狀材料不鏽鋼絲網黏附於電絕緣層上,完成一電極 試片。 實施例七 如貫施例一而以p v C板代替P c板,及以疏水性之網狀 材料聚脂纖維(ρ 0 1 y e s t e r ) p E s _ 4 2 τ代替。試片製作程 序如實施例一,反應膜層固定完成後,將網狀材料PEs _ 4 2 Γ黏附於電絕緣層上,完成一電極試片。 實施例八 如實施例一而以疏水性之網狀材料p E T - 4 3 T經由浸泡 1 Τ 1‘ I ί 〇 n X - 1 〇 〇處理,使成為親水性。反應膜層固定完成 後,將l%TritonX-100親水處理之網狀材料P£T_43T黏 _______ - 17- 本紙張尺度ligfiV國國家標準(CNS)A4規格⑵G χ 297 ) ' ~~~~ — — — — — —————111« * — — — — ill — — — — —— (請先閱讀背面之注意事項再填寫本頁) Α7 B7 五、發明說明(Ι5 附於電絕緣層上,完成一電極試片, 入樣品d 由W4之…方向吸 本發明所揭示的生化感測器僅 忒,拍' ir β k間便、檢測結果準 ^ ΜΑ置,可以檢體滴放、或靠近檢 ,^ 万便取樣;檢體可以輕易且 速地導入反應層…效取得檢體進行檢測反應;並且可 以減少檢體的取樣量,以進—+卩 . .、 少减少涡患的痛楚。對於製 造趿两、檢驗人_以及病4而专 、⑴。’都能夠提供最方便且 效的解決方案。 本叙月的方法和特欲,已充分揭示於上述實例說明中 應了解的是’任何不脫離本發明精神下所為之修飾或改 ’皆應涵蓋於本發明之保護範園中。 迅 可 有 ------.— —III — · ---I — I I I ^ - — — —— III — (請先閱讀背面之注意事項再填寫本頁) 經濟部智慧財產局員工消費合,/±社印^. -18. 本紙張尺度適用中國國家標準(CNS>A4規格(210 X 297公釐)Consumers' cooperation of Intellectual Property Bureau of the Ministry of Economic Affairs, Du Yin SS 416005 A7 Member of the Intellectual Property Bureau of the Ministry of Economic Affairs, Industrial Consumers, Cooperative Society, Yinzhi _______B7 _V. Description of Invention (Η) Charm: Fusine (g | uta in icaci tl) 0 1 % Polyethylene glycol (PEG) 0,3% Tween20 (po) yOXyethy | enes〇rbjtall Inon〇iaurate) 0.1% phosphate buffer solution (p H 6.0) 9 2.3 7% The hydrophobic mesh polyester fiber (polyestei.) PES-37 D was used instead. The manufacturing procedure is the same as in Example 1. After the reaction layer is fixed, the mesh material PES-3 7T is adhered to the electrical insulation layer to complete the electrode test piece. Example 6 As a poor example 1, a stainless steel wire mesh (100 mesh to 300 mesh) with a mesh material was used instead. The test piece production procedure is as in Example 1. After the reaction film layer is fixed, a stainless steel wire mesh material is adhered to the electrical insulation layer to complete an electrode test piece. Embodiment 7 As in the first embodiment, a p v C plate is used instead of a P c plate, and a hydrophobic mesh polyester fiber (ρ 0 1 y e s t e r) p E s _ 4 2 τ is used instead. The test piece production procedure is the same as in Example 1. After the reaction film layer is fixed, the mesh material PEs _ 4 2 Γ is adhered to the electrical insulation layer to complete an electrode test piece. Example 8 The hydrophobic net-shaped material p E T-4 3 T was treated by soaking 1 T 1 ′ I 〇 〇 X-1 〇 〇 as in Example 1 to make it hydrophilic. After the reaction film layer is fixed, the 1% TritonX-100 hydrophilically treated mesh material P £ T_43T is adhered _______-17- The paper standard ligfiV National Standard (CNS) A4 Specification ⑵G χ 297) '~~~~ — — — — — ————— 111 «* — — — — ill — — — — — (Please read the precautions on the back before filling out this page) Α7 B7 V. Description of the invention (Ι5 attached to the electrical insulation layer , Complete an electrode test strip, insert the sample d and suck the biochemical sensor disclosed by the present invention in the direction of W4, take a photo of ir β k, the test result is accurate, and the sample can be dropped, or When you are close to the sample, you can take a sample; the sample can be easily and quickly introduced into the reaction layer ... to obtain the sample for the detection reaction; and you can reduce the sample sampling volume to reduce the pain of the vortex. . For the manufacture of the two, the inspector_, and the disease, the special and the ⑴. Can provide the most convenient and effective solution. The method and special desires of this month have been fully revealed in the above example description. What should be understood is 'Any modification or alteration without departing from the spirit of the present invention' Covered in the protection scope of the present invention. Xun may have ------.-- —III — · --- I — III ^-— — — III — (Please read the notes on the back before filling in this Page) Consumption of employees of the Intellectual Property Bureau of the Ministry of Economic Affairs, / ± Social Printing ^. -18. This paper size applies to the Chinese national standard (CNS > A4 specification (210 X 297 mm)

Claims (1)

416005 Λ8 B8 C8 D8 六、申請專利範圍 1. 一種生化感測器’用以檢測檢體中生化成分之含量,包 含: 一電絕緣基板; 一位於該基板上之陽極部份’其兩端分別形成一工作電 極以及一陽極接頭; 一位於該基板上之陰極部分,其兩端分別形成一參考電 極以及一陰極接頭; ―位於该工作電極以及該參考電極上之反應層,其係用 以與檢體接觸以產生化學反應; —位於該基板上之電絕緣層’其具有—用以容納該檢體 至該反應層之缺口以及一缺口的開口端;以及 —位於該反應層上之網狀覆蓋層,其至少覆蓋部分該缺 2 .如申請專利範圍第丨項之生化感測器,其中該網狀覆蓋 層係親水性網狀材料或疏水性網狀材料或金屬網。 3 .如申請專利範圍第2項之生化感測器’其中該網狀覆蓋 層具有60至300目。 ""'部智"·"產馬員工消費合作社印製 ^^^1 —^n n ^^^1 HI t-ϋ —^n 一y (請先閱讀背面之注意事項再填寫本頁) 4 .如申請專利範園第丨項之生化感測器,其中該網狀覆蓋 層係經過界面活性劑處理之疏水性網狀材料。 5 .如申請專利範圍第4項之生化感測器,其中該界面活性 劑係選自 Triton χ_100 ,Trit0ilX_4()5 ,Tl.it〇11X- 114 ,十二燒硫酸鈉落液(s〇(jium iaury丨 sulfate)、 polyoxyethylenesorbiUm m ο η ο 1 au r a t e (T w e e η 2 0)' Tween40,Tween6{),Tween8()或其它水溶性界面活 -19- 本A乐尺度適用中國國系標率(CNS ) Λ4規格(297公4 j * -- ABCD 416005 六、申請專利範圍 性劑或清潔劑。 6 .如申請專利範圍第1項之生化感測器,其中該基板於該 H (n ^n· n 1^1 (HI ^^^1 n^l --. - (請七閱讀背面之注意事項再填寫本頁) 缺口的開口端「緣處更具有一半圓形的突出部,以作為 檢體的接觸點。 7 '如申請專利範圍第丨項之生化感測器,其中該反應層係 由酵素、載體、電子媒介物及界面活性劑之配方所組成 β 8 .如申請專利範圍第7項之生化感測器,其中該载體為超 微粒纖維素 '甲基纖維素、複基甲基纖維素、殿粉、乙 締醇、乙烯基五園酮、聚乙晞醇(ρ V A )、聚乙烯咯酮( PVP)、聚乙二醇(PEG)或白明膠(gelatin)。 9 .如申請專利範®第8項之生化感測器,其令該載體組成 估配方重量的百分之〇 〇5至百分之15 1 〇.如申請專利範圍第7項之生化感測器,其中該之電子媒 介物為赤血鹽。 1丨.如申請專利範圍第7項之生化感測器,其中該界面活性 經^部皙^財是^員工-^費合作社印^. 劑係選自 Triton X-100,Triton C-405,Triton X-114 ’ 十二坑疏酸鈉溶液(s〇dium lauryl sulfate)、 p ο I y o x y e t li y 1 e n e s o r b i t a n monolaurate (Tween 20) ’ Tween 4 0 ’ Tween 60,丁ween 80 或其它水溶性 界面活性劑或清潔劑。 1 2 .如申請專利範圍第7項之生化感測器,其中該界面活性 劑佔配方重量的百分之0.丨以下。 1 3 .如申請專利範圍第1項之生化感測器,其中該工作電極 -20- 本紙ft尺度適用中國國家標準(CNS ) Λ4規格(210X297公釐) 416005 A8 B3 C8 D8 六、申請專利範圍 之面積為參考電極之面積的2至3倍。 1 4 .如申請專利範圍第1項之生化感測器,其中該電絕緣層 係P P、P V C、P E T、P C、P E或其它絕緣塑膠 材質= 1 5 .如申請專利範圍第】項之生化感測器,其中該電絕緣層 之厚度在0.25至0,35mm之間。 II - - I - I - I ^^1 - - —I. - I K. I: - - \—* - ,τ (請先閲讀會面之注意事項再填寫本頁) 經濟部智慧时產笱員工消費合作杜印嗲 -21 - 本紙張尺度逡用中國國家橾準(CNS ) Α4規格(210X297公釐)416005 Λ8 B8 C8 D8 VI. Patent application scope 1. A biochemical sensor 'for detecting the content of biochemical components in a specimen, including: an electrically insulating substrate; an anode portion on the substrate', with two ends respectively Forming a working electrode and an anode terminal; a cathode portion on the substrate, a reference electrode and a cathode terminal being formed at two ends of the cathode portion respectively;-a reaction layer on the working electrode and the reference electrode, which is used for contacting The specimen is contacted to produce a chemical reaction;-the electrically insulating layer 'on the substrate' has-a notch for accommodating the specimen to the reaction layer and an open end of the notch; and-a mesh shape on the reaction layer The covering layer covers at least a part of the defect 2. The biochemical sensor according to item 丨 of the patent application scope, wherein the mesh covering layer is a hydrophilic mesh material or a hydrophobic mesh material or a metal mesh. 3. The biochemical sensor according to item 2 of the patent application, wherein the mesh cover layer has 60 to 300 meshes. " " '部 智 " · " Printed by the Horse Production Consumer Cooperative ^^^ 1 — ^ nn ^^^ 1 HI t-ϋ — ^ n y (Please read the notes on the back before filling in this Page) 4. The biochemical sensor according to item 丨 of the patent application park, wherein the net-shaped covering layer is a hydrophobic net-like material treated with a surfactant. 5. The biochemical sensor according to item 4 of the patent application scope, wherein the surfactant is selected from Triton χ_100, TritolX_4 () 5, Tl.it〇11X-114, sodium dodecyl sulfate sodium sulfate (s〇 ( jium iaury 丨 sulfate), polyoxyethylenesorbiUm m ο η ο 1 au rate (T wee η 2 0) 'Tween40, Tween6 {), Tween8 () or other water-soluble interface activities-19- This A scale applies to the Chinese national standard (CNS) Λ4 specification (297 male 4 j *-ABCD 416005 6. Apply for a patent scope agent or cleaner. 6. For the biochemical sensor of item 1 of the patent scope, wherein the substrate is in the H (n ^ n · n 1 ^ 1 (HI ^^^ 1 n ^ l-.-(Please read the precautions on the back and fill out this page) The open end of the notch "the edge has a semi-circular protrusion, as The contact point of the specimen. 7 'As in the biochemical sensor of item 丨, the reaction layer is composed of a formula of enzymes, carriers, electronic media and surfactants. 8 Biochemical sensor of item 7, wherein the carrier is ultrafine cellulose 'methyl cellulose, complex Cellulose, cellulose powder, ethylenol, vinylpentanolone, polyvinylacetone (ρ VA), polyvinylpyrrolidone (PVP), polyethylene glycol (PEG) or gelatin. 9. For example, the biochemical sensor of item 8 of the patent application, which makes the carrier constitute 0.05% to 15% of the weight of the formula. If the biochemical sensor of item 7 of the patent application scope, Wherein, the electronic medium is red blood salt. 1 丨. For example, the biochemical sensor of the seventh scope of the patent application, wherein the interface activity is ^ Ministry of Finance ^ wealth is printed by ^ staff-^ fee cooperatives ^. From Triton X-100, Triton C-405, Triton X-114 'sodium lauryl sulfate, p ο I yoxyet li y 1 enesorbitan monolaurate (Tween 20)' Tween 4 0 'Tween 60, Ding Ween 80 or other water-soluble surfactants or cleaning agents. 1 2. As in the biochemical sensor of the 7th scope of the patent application, wherein the surfactant accounts for 0% of the formula weight. 丨 below. 1 3. The biochemical sensor according to item 1 of the patent application scope, wherein the working electrode is -20- ft. Applicable to Chinese National Standard (CNS) Λ4 specification (210X297 mm) 416005 A8 B3 C8 D8 6. The area of patent application is 2 to 3 times the area of the reference electrode. 1 4. If the biochemical sensor of item 1 in the scope of patent application, wherein the electrical insulation layer is PP, PVC, PET, PC, PE or other insulating plastic materials = 1 5. If the biochemical sensor in item of scope of patent application] The measuring device, wherein the thickness of the electrical insulating layer is between 0.25 and 0,35 mm. II--I-I-I ^^ 1--—I.-I K. I:--\ — *-, τ (Please read the notes before meeting and then fill out this page) Employees of the Ministry of Economic Affairs Consumption Cooperation Du Yin 嗲 -21-This paper size uses China National Standard (CNS) Α4 size (210X297mm)
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CN102445471A (en) * 2010-10-09 2012-05-09 华广生技股份有限公司 Electrochemical sensing specimen
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EP1225449A1 (en) * 2001-01-19 2002-07-24 Apex Biotechnology Corporation Non-enzymatic disposable electrode strip comprising a surfactant for detecting uric acid or hemoglobin; method for producing the same and its use
EP1936375A1 (en) * 2001-01-19 2008-06-25 Apex Biotechnology Corporation Non-enzymatic disposable electrode strip comprising a surfactant for detecting uric acid or hemoglobin; method for producing the same and its use
CN101339154B (en) * 2007-07-05 2013-03-27 五鼎生物技术股份有限公司 Composite modified electrode test piece
TWI399538B (en) * 2009-05-13 2013-06-21 Univ Nat Yunlin Sci & Tech Calcium ion sensing units and fabrication method thereof, and sensing systems comprising the same
US8845869B2 (en) 2010-09-23 2014-09-30 Bionime Corporation Electrochemical sensor strip
CN102445471A (en) * 2010-10-09 2012-05-09 华广生技股份有限公司 Electrochemical sensing specimen
CN102445471B (en) * 2010-10-09 2014-04-09 华广生技股份有限公司 Electrochemical sensing specimen

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