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CN1916616A - Reusable bioassay test strips - Google Patents

Reusable bioassay test strips Download PDF

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CN1916616A
CN1916616A CNA2005100905705A CN200510090570A CN1916616A CN 1916616 A CN1916616 A CN 1916616A CN A2005100905705 A CNA2005100905705 A CN A2005100905705A CN 200510090570 A CN200510090570 A CN 200510090570A CN 1916616 A CN1916616 A CN 1916616A
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test piece
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李仁方
张裕宏
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3272Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels

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Abstract

A biological test piece which can be used repeatedly, the main structure is formed by pasting a plurality of layers of thin slices, and the space formed by punching holes on the thin slices can be used for placing biological reaction carriers, and the test piece can be easily broken off, so as to be beneficial to secondary and tertiary reuse; two positive and negative electrodes are arranged between the sheets to conduct electrochemical signals of reaction, and the electrode wires are designed to have the same resistance in each electrochemical reaction area, so that the test piece can be repeatedly used. The test piece and the chemical carrier contained in the test piece can be used for matching with a biological sensing detection device, and detecting the components of the detected product and measuring the concentration of the detected product according to the electrochemical effect of the detected product in biological reaction; furthermore, two or more test items, which may be the same or different, may be measured simultaneously for a drop of blood. Meanwhile, the invention discovers for the first time that the addition of the carbon nanotube in the chemical carrier can greatly increase the biological reaction rate and shorten the detection time.

Description

可多次使用的生物检测试片Reusable bioassay test strips

技术领域technical field

本发明涉及一种个人用的生物检测试片,尤其是指一种单一片可以多次使用的血液生物检测试片,以及可以以一滴血同时测量两种以上相同或不同检验项目的生物检测试片。The present invention relates to a biological detection test piece for personal use, in particular to a blood biological detection test piece that can be used multiple times in a single piece, and a biological detection test that can simultaneously measure two or more identical or different test items with one drop of blood. piece.

背景技术Background technique

目前所有市面上的血糖检测试片都是只能使用一次、用完即丢的试片。这种试片对于发展中或未发展国家的糖尿病患者来说,实在太过于昂贵、负担不起,而无法定期依据病情作血糖检测,甚而危及生命。他们非常需要一种更便宜的血糖检测试片。同时,目前市面上的血糖试片精确度也不够,限于他们使用的材质及方法,常常造成超过百分之三十以上的误差。而且,除了欧美少数品牌以外,都需要十五到三十秒的测量时间,测量时间比较长。At present, all blood glucose test strips on the market are test strips that can only be used once and are thrown away after use. Such test strips are too expensive and unaffordable for diabetic patients in developing or undeveloped countries, and cannot regularly test blood sugar according to their condition, and even endanger their lives. They desperately need a cheaper blood glucose test strip. At the same time, the blood glucose test strips currently on the market are not accurate enough, limited by the materials and methods they use, often resulting in an error of more than 30%. Moreover, except for a few brands in Europe and the United States, it takes fifteen to thirty seconds to measure, which is relatively long.

因此,需要提供一种便宜且测量更准确、测量时间短的血糖检测试片。或者,需要提供一种在单个一次性、用完即丢的生物检测试片上能多次使用的结构设计及方法,以减少使用者的经济负担。本案发明人在美国发明专利申请案号No.10/704,701中首次提出了在单一试片上能多次使用的电化学试片,但内容与本申请案不同,该在先美国申请案所述的试片有不容易折断的问题,以及在同一试片上的多数个反应区至电极导线电极头之间所产生的电阻都不相同,致其所测得的检侧值误差相当大,而存在改良的必要。Therefore, there is a need to provide a blood glucose test strip that is cheap, more accurate, and has a shorter measurement time. Alternatively, it is necessary to provide a structural design and method that can be used multiple times on a single disposable, disposable biological detection test piece, so as to reduce the economic burden of the user. The inventor of this case first proposed an electrochemical test strip that can be used multiple times on a single test strip in U.S. Patent Application No. 10/704,701, but the content is different from this application. The test piece has the problem that it is not easy to break, and the resistance generated between the multiple reaction areas on the same test piece and the electrode wire tip is not the same, resulting in a considerable error in the measured detection value, and there is an improvement necessary.

另,Shiro Nankai等人申请的美国专利5,120,420公开了一种在一片试片上有多条电极导线的方案,可以同时为多个检品检测其血糖浓度,再取其平均值,以增加准确度。但是这种方法需要比较多的血液量,对于病患在家自我检测而言,并不可行。同时,这种方法也无助于降低使用者的检测费用。In addition, U.S. Patent No. 5,120,420 applied by Shiro Nankai et al. discloses a scheme in which multiple electrode wires are placed on one test piece, which can detect the blood glucose concentrations of multiple test items at the same time, and then take the average value to increase the accuracy. However, this method requires a relatively large amount of blood, which is not feasible for patients to self-test at home. Simultaneously, this method also does not help to reduce the detection cost of the user.

再者,有很多研究报告及专利提出各种方法以提高测量的准确度或检测速度。例如,Thomas Y.S.Shen的美国专利6,491,803有提到采用纳米金属粉以增加导电度及减少反应时间,但仍然需要十五秒钟的测量时间。Hart(Biosensors & Bioelectronics,13:333-339,1996)发现在电极表面加入白金粉末可以增加导电度以改善测量的准确度,然而这些效果还不够好。C.D.Wisley等人的美国专利6,541,216指出利用等离子体处理银电极和碳电极的表面可以增加试片测量的准确度。但是,以上这些方法并不能达到所要求的经济上比较便宜、测量更准确、及测量速度更快的目标。Furthermore, there are many research reports and patents proposing various methods to improve measurement accuracy or detection speed. For example, US Patent No. 6,491,803 of Thomas Y.S.Shen mentions the use of nanometer metal powder to increase conductivity and reduce reaction time, but it still requires fifteen seconds of measurement time. Hart (Biosensors & Bioelectronics, 13:333-339, 1996) found that adding platinum powder to the surface of the electrode can increase the conductivity to improve the accuracy of the measurement, but these effects are not good enough. US Patent No. 6,541,216 to C.D. Wisley et al. states that plasma treatment of the surfaces of silver and carbon electrodes can increase the accuracy of test strip measurements. However, the above-mentioned methods cannot achieve the required goals of being economically cheaper, more accurate in measurement, and faster in measurement speed.

发明内容Contents of the invention

因此,本发明的主要目的就是能提供一种更便宜、测量更准确、测量时间更短的血糖检测试片。Therefore, the main purpose of the present invention is to provide a blood glucose test strip that is cheaper, more accurate and takes less time to measure.

本发明的另一个主要目的就是能提供一种血糖检测试片,只要采一滴血、痛一次,用一滴血就能测得多种相同或不同的检品读值;用一滴血就能测得多种相同的检品读值的目的是为了能多做几次血糖检测,取得平均值以增加准确度,但不必多次采血,可减少采血的疼痛;而用一滴血就能测得数种不同的检品读值的目的也可以是用于同时做不同项目的检测。Another main purpose of the present invention is to provide a blood glucose detection test piece, as long as one drop of blood is taken and one pain is taken, a variety of identical or different reading values can be measured with one drop of blood; multiple readings can be measured with one drop of blood The purpose of reading the same test product is to do more blood glucose tests and obtain the average value to increase the accuracy, but it is not necessary to collect blood many times, which can reduce the pain of blood collection; and several different blood glucose can be measured with one drop of blood The purpose of the reading value of the inspection product can also be used to test different items at the same time.

为达上述的目的,本发明提供了一种可多次使用的生物检测试片,其主要包含一种每片能多次使用的一次性、用完即丢式的电极试片的结构及所含的化学载体,用以配合生物感测检测装置使用,并根据检品于生物反应中所产生的电效应,检出该检品的成分及测定其浓度。本发明的一个具体结构是由四层的薄片粘贴而成,而薄片上有各种冲孔所形成的空间可以产生三个相同的反应区,并于各反应区上置有生物反应载体,仅需要2μl的血液量,藉由虹吸的原理,血液会被吸入反应区后随即与其上的生物反应载体起电化学反应,并且藉由分析该电化学反应的结果能得知该血液检品的血糖浓度。同时该薄片另有各种冲孔所形成的空间能使该试片因应力集中因素而能将用过的试片轻易折断,以利第二、三次再使用其它未使用的部分;在最底层的薄片上有两条正负极导电电极以传导反应的电化学讯号,且该电极导线被设计成使每个电化学反应区的正负电极与测量电极头上的正负电极间具有相同电阻,具有相同电阻是本发明所揭示的试片能多次使用的关键因素,也是不可或缺的要素,本发明首次采用这种方法。每个电化学反应区的正负电极会将其上的化学载体与血液反应所产生的电化学反应讯号传到测量电极头上的正负电极,然后可被血糖测试机判读其血液检品的血糖读值。至于本发明开发的化学反应物质的配方是含有羟丙甲基纤维素(hydroxypropyl methyl cellulose),以使其化学反应物质平均分布,这与美国专利5,120,420所采用的羧甲基纤维素(Carboxymethylcellulose),以及中国台湾TW374116号及美国专利6,413,394B1所采用的微晶纤维素(Microcrystalline cellulose)不同,是本发明首次采用。In order to achieve the above-mentioned purpose, the present invention provides a biological detection test piece that can be used repeatedly, which mainly includes a structure of a disposable, disposable electrode test piece that can be used multiple times and the structure of the electrode test piece The chemical carrier contained in it is used in conjunction with the biosensing detection device, and according to the electrical effect generated by the test product in the biological reaction, the composition of the test product is detected and its concentration is determined. A specific structure of the present invention is formed by pasting four layers of thin sheets, and the space formed by various punching holes on the thin sheet can produce three identical reaction zones, and a biological reaction carrier is placed on each reaction zone, only A blood volume of 2 μl is required. By the principle of siphon, the blood will be sucked into the reaction area and then electrochemically react with the biological reaction carrier on it, and the blood sugar of the blood sample can be obtained by analyzing the results of the electrochemical reaction concentration. At the same time, the thin sheet also has a space formed by various punching holes, so that the used test piece can be easily broken due to stress concentration factors, so as to facilitate the second or third use of other unused parts; There are two positive and negative conductive electrodes on the thin sheet to conduct the electrochemical signal of the reaction, and the electrode wire is designed so that the positive and negative electrodes of each electrochemical reaction zone have the same resistance as the positive and negative electrodes on the measuring electrode head , having the same resistance is the key factor for the multiple use of the test piece disclosed in the present invention, and it is also an indispensable element, and this method is adopted in the present invention for the first time. The positive and negative electrodes in each electrochemical reaction area will transmit the electrochemical reaction signal generated by the chemical carrier on it and the blood reaction to the positive and negative electrodes on the measuring electrode head, and then the blood glucose testing machine can interpret the blood sample. Blood glucose reading. As for the formula of the chemical reaction substance developed by the present invention, it contains hydroxypropyl methylcellulose (hydroxypropyl methylcellulose), so that its chemical reaction substance is evenly distributed, which is the same as the carboxymethylcellulose (Carboxymethylcellulose) adopted in U.S. Patent 5,120,420, It is different from the microcrystalline cellulose (Microcrystalline cellulose) used in Taiwan TW374116 and US Patent No. 6,413,394B1, which is used in the present invention for the first time.

除此之外,本发明还发现,还可以通过添加多壁及单壁(Multi-walled和single walled)纳米碳管以增加导电速率、减少检测时间,它可以将反应时间由一般的三十秒减少到四秒甚至二秒钟,并可提供适当的表面张力及表面能,以防止血液凝固。这样一来,本发明所提供的试片可以多次重复使用,而且可以很迅速地得到很准确的结果。In addition, the present invention also finds that by adding multi-walled and single-walled (Multi-walled and single walled) carbon nanotubes to increase the conduction rate and reduce the detection time, it can change the reaction time from the general thirty seconds Reduced to four seconds or even two seconds, and can provide appropriate surface tension and surface energy to prevent blood coagulation. In this way, the test strip provided by the present invention can be used repeatedly, and very accurate results can be obtained very quickly.

再者,若将上述四层所形成的试片于其最上层再加贴同样的四层或八层,但其虹吸进血位置皆在相同位置,则以一滴血可以被虹吸到两个或三个不同的、独立的反应区,做相同的或不同的生物反应检测,因此以一滴血可以同时测量两种以上的相同或不同项目。如果以一滴血同时测量两种以上的相同检品时,可以取其平均值以增加其准确度;但如果以一滴血同时测量两种以上的不相同项目时,则可以减少每一次采血的疼痛。Furthermore, if the test piece formed by the above four layers is pasted on the top layer with the same four or eight layers, but the blood siphoning positions are all at the same position, then one drop of blood can be siphoned to two or more Three different and independent reaction areas are used for the same or different biological reaction detection, so more than two same or different items can be measured at the same time with one drop of blood. If one drop of blood is used to measure two or more of the same test items at the same time, the average value can be used to increase its accuracy; but if one drop of blood is used to measure two or more different items at the same time, the pain of each blood collection can be reduced .

根据本发明的一具体实施方案,本发明提供了一种可多次使用的生物检测试片,主要由四层薄片、两条有两组以上工作电极及参考电极的导线、及置于反应区的化学载体所组成;所述四层薄片包含上贴有两条有两组以上工作电极及参考电极的电极导线的底层、有三小薄片上有三个独立的反应区冲孔的第二层、有三小薄片上有三个独立的血液虹吸内凹的第三层、及有三小薄片上有三个独立的出气口的第四层;其中所述两条有两组以上工作电极及参考电极的导线,其各个工作电极或参考电极到电极头的电阻相同。According to a specific embodiment of the present invention, the present invention provides a biological detection test piece that can be used multiple times, mainly consisting of four layers of sheets, two wires with more than two groups of working electrodes and reference electrodes, and a test piece placed in the reaction area. Composed of chemical carriers; the four-layer sheet includes a bottom layer on which two electrode wires with more than two groups of working electrodes and reference electrodes are pasted, a second layer with three independent reaction zone punching holes on three small sheets, and three There are three independent blood siphon concave third layers on the small sheet, and a fourth layer with three independent gas outlets on the three small sheets; wherein the two wires with more than two groups of working electrodes and reference electrodes, the Each working or reference electrode has the same resistance to the electrode tip.

根据本发明的另一具体实施方案,本发明还提供了另一种可多次使用的生物检测试片,主要由三层薄片、两条有两组以上工作电极及参考电极的导线、及置于反应区的化学载体所组成;所述三层薄片包含上贴有两条有两组以上工作电极及参考电极的电极导线的底层、有三小薄片上有三个独立的血液虹吸内凹的第二层、及有三小薄片上有三个独立的出气口的第三层;其中所述两条有两组以上工作电极及参考电极的导线,其各个工作电极或参考电极到电极头的电阻相同。According to another specific embodiment of the present invention, the present invention also provides another biological detection test piece that can be used repeatedly, mainly consisting of three layers of sheets, two wires with more than two groups of working electrodes and reference electrodes, and a set Composed of chemical carriers in the reaction area; the three-layer thin sheet includes the bottom layer with two electrode wires with more than two groups of working electrodes and reference electrodes on it, and the second layer with three independent blood siphon concaves on three small sheets. layer, and a third layer with three independent gas outlets on three small slices; wherein the two wires with more than two groups of working electrodes and reference electrodes have the same resistance from each working electrode or reference electrode to the electrode head.

根据本发明的另一具体实施方案,本发明还提供了另一种可多次使用的、且一滴血可检验三种相同或不相同检测项目的生物检测试片,主要由八层、十二层或十六层以上的薄片、及四条、六条或八条以上且每组导线具有两组以上工作电极及参考电极的导线、及置于反应区的化学载体所组成;所述八层、十二层或十六层以上的薄片包含上贴有两条有两组以上工作电极及参考电极的电极导线的底层、有三小薄片上有三个独立的反应区冲孔的第二层、有三小薄片上有三个独立的血液虹吸内凹的第三层、及有三小薄片上有三个独立的出气口的第四层;其中所述两条有两组以上工作电极及参考电极的导线,其各个工作电极或参考电极到电极头的电阻相同。According to another specific embodiment of the present invention, the present invention also provides another bioassay test strip that can be used multiple times, and one drop of blood can test three identical or different detection items, mainly composed of eight layers, twelve layer or more than sixteen layers, and four, six or more than eight wires with each group of wires having more than two sets of working electrodes and reference electrodes, and chemical carriers placed in the reaction zone; the eight layers, twelve Sheets with more than 16 layers include the bottom layer with two electrode wires with more than two sets of working electrodes and reference electrodes, the second layer with three independent reaction zone punching holes on three small sheets, and the upper layer with three small sheets. The third layer with three independent blood siphons and the fourth layer with three independent air outlets on three small slices; the two wires with more than two sets of working electrodes and reference electrodes, each working electrode Or the same resistance from the reference electrode to the electrode tip.

根据本发明的另一具体实施方案,本发明还提供了另一种可多次使用的、且一滴血可检验三种相同或不相同检测项目的生物检测试片,主要由六层、九层或十二层以上的薄片、及四条、六条或八条以上且每组导线具有两组以上工作电极及参考电极的导线、及置于反应区的化学载体所组成;六层、九层或十二层以上的薄片包含上贴有两条有两组以上工作电极及参考电极的电极导线的底层、有三小薄片上有三个独立的血液虹吸内凹的第二层、及有三小薄片上有三个独立的出气口的第三层;其中所述两条有两组以上工作电极及参考电极的导线,其各个工作电极或参考电极到电极头的电阻相同。According to another specific embodiment of the present invention, the present invention also provides another bioassay test strip that can be used multiple times, and one drop of blood can test three identical or different detection items, mainly composed of six layers and nine layers. or more than twelve layers of sheets, and four, six or more than eight wires, each group of wires has more than two sets of working electrodes and reference electrodes, and chemical carriers placed in the reaction area; six, nine or twelve layers The sheets above the first layer include the bottom layer with two electrode wires with more than two sets of working electrodes and reference electrodes, the second layer with three small sheets with three independent blood siphon concaves, and the three small sheets with three independent blood siphons. The third layer of the gas outlet; wherein the two wires with more than two groups of working electrodes and reference electrodes have the same resistance from each working electrode or reference electrode to the electrode head.

根据本发明的另一具体实施方案,本发明还提供了另一种可多次使用、且血液入口在侧面的生物检测试片,主要由三层薄片、两条有两组以上工作电极及参考电极的导线、及置于反应区的化学载体所组成;所述三层薄片包含上贴有两条有两组以上工作电极及参考电极的电极导线的底层、有三个独立的血液虹吸内凹的第二层、及有三个独立的出气口的第三层;其中所述两条有两组以上工作电极及参考电极的导线,其各个工作电极或参考电极到电极头的电阻相同。According to another specific embodiment of the present invention, the present invention also provides another bioassay test piece that can be used multiple times and has a blood inlet on the side. The lead wire of the electrode and the chemical carrier placed in the reaction area; the three-layer thin sheet includes the bottom layer with two electrode wires with more than two groups of working electrodes and reference electrodes on it, and the bottom layer with three independent blood siphons. The second layer, and the third layer with three independent gas outlets; wherein the two wires with more than two sets of working electrodes and reference electrodes have the same resistance from each working electrode or reference electrode to the electrode head.

根据本发明的另一具体实施方案,本发明还提供了另一种可多次使用、血液入口在侧面、且一滴血可检验三种相同或不相同检测项目的生物检测试片,主要由六层、九层或十二层以上的薄片,四条、六条或八条以上且每组导线具有两组以上工作电极及参考电极的导线、及置于反应区的化学载体所组成;所述六层、九层或十二层以上的薄片包含上贴有两条有两组以上工作电极及参考电极的电极导线的底层、有三个独立的血液虹吸内凹的第二层、及有三个独立的出气口的第三层;其中所述两条有两组以上工作电极及参考电极的导线,其各个工作电极或参考电极到电极头的电阻相同。According to another specific embodiment of the present invention, the present invention also provides another biological detection test strip that can be used multiple times, the blood inlet is on the side, and one drop of blood can test three identical or different detection items, mainly composed of six layer, nine or more than twelve layers of sheets, four, six or more than eight and each group of wires has more than two groups of working electrodes and reference electrodes, and chemical carriers placed in the reaction area; the six layers, Sheets with nine or more than twelve layers include the bottom layer with two electrode wires with more than two sets of working electrodes and reference electrodes, the second layer with three independent blood siphons, and three independent gas outlets The third layer; wherein the two wires with more than two groups of working electrodes and reference electrodes have the same resistance from each working electrode or reference electrode to the electrode head.

根据本发明的具体实施方案,本发明提供的可多次使用的生物检测试片中,所述薄片的基材可以为聚氯乙烯(PVC)板、玻璃纤维(FR-4)板、聚醚砜(polyether sulphone,PES)板、电木板、PET板、PC板、玻璃板或陶磁板(CEM-1)。所述电极导线的基材为用于网版印刷技术中的银胶或碳胶导线。该电极导线可以是以加成法(Additive Process)的化学反应方法产生所需导电电路;也可以是以减乘法(Subtractive process)的化学反应方法,将表面局部无用的导体去除;然后再以化学浸镀法(俗称化金)将贵金属(如金、白金等贵金属)通过化学置换反应置换在底材上。According to a specific embodiment of the present invention, in the reusable biological detection test piece provided by the present invention, the base material of the sheet can be polyvinyl chloride (PVC) board, glass fiber (FR-4) board, polyether Sulfone (polyether sulphone, PES) board, bakelite board, PET board, PC board, glass board or ceramic board (CEM-1). The base material of the electrode wire is silver glue or carbon glue wire used in screen printing technology. The electrode wire can produce the required conductive circuit by the chemical reaction method of the additive process; it can also remove the partially useless conductor on the surface by the chemical reaction method of the subtractive process; and then use the chemical reaction method The immersion plating method (commonly known as gold plating) replaces precious metals (such as gold, platinum and other precious metals) on the substrate through chemical displacement reactions.

根据本发明的具体实施方案,本发明提供的可多次使用的生物检测试片中,在该试片的每一反应区内的化学载体成分包含:羟丙甲基纤维素(Hydroxypropyl methyl cellulose)、柠檬酸(Citric acid)、磷酸氢二钾(Dibasic potassium phosphate)、非离子性表面活性剂Triton X-100、葡萄糖氧化酵素(Glucose oxidase)、赤血盐(Potassium ferricyanide)、去离子水(Deionized water)、纳米碳管(Nanotube carbon)。According to a specific embodiment of the present invention, in the reusable biological detection test strip provided by the present invention, the chemical carrier component in each reaction zone of the test strip comprises: hydroxypropyl methylcellulose (Hydroxypropyl methylcellulose) , Citric acid, Dibasic potassium phosphate, Non-ionic surfactant Triton X-100, Glucose oxidase, Potassium ferricyanide, Deionized water water), carbon nanotubes (Nanotube carbon).

优选地,其中所述羟丙甲基纤维素的含量为0.05%-2%。所述纳米碳管可以是多壁及单壁(Multi-walled和single walled)纳米碳管,其大小为10μm-200μm,含量为0.01%-2%。本发明的化学载体配方中其余各组分为一般血糖或其它检体测试的惯用载体,其含量范围是常规的。Preferably, the content of the hydroxypropylmethylcellulose is 0.05%-2%. The carbon nanotubes can be multi-walled and single-walled (Multi-walled and single walled) carbon nanotubes, the size of which is 10 μm-200 μm, and the content is 0.01%-2%. The rest of the components in the chemical carrier formulation of the present invention are commonly used carriers for general blood sugar or other specimen tests, and their content ranges are conventional.

根据本发明的另一具体实施方案,本发明还提供了另一种可多次使用的生物检测试片,包含在该一试片上设有数个具有化学载体的检测区,并在每二检测区之间设有折断缺口,以能用于光学方法检测检品,及达到每片能多次使用的血糖检测试片。According to another specific embodiment of the present invention, the present invention also provides another bioassay test strip that can be used repeatedly, comprising several detection zones with chemical carriers on the test strip, and each two detection zones There is a breaking gap between them, so that it can be used for optical detection of the inspection product, and each piece can be used multiple times for blood glucose detection test strips.

综上所述,本发明提供的生物检测试片,每片可以多次重复使用,其主要结构是由多数层的薄片粘贴而成,而薄片上由冲孔所形成的空间可以放置生物反应载体,且能使该试片能轻易折断,以利第二、三次再使用;薄片间的用以传导反应的电化学讯号的电极导线被设计成在每个电化学反应区有相同电阻,测量准确度高。本发明的试片及其所含的化学载体,可用以配合生物感测检测装置使用,并根据检品在生物反应中所产生的电化学效应,检出检品的成分及测定其浓度;而且,还可以一滴血同时测量两种以上相同或不同的检验项目。同时,本发明具有准确度高、测试时间短的优点。In summary, the biological detection test piece provided by the present invention can be reused many times, and its main structure is formed by pasting multiple layers of sheets, and the space formed by punching holes on the sheet can place biological reaction carriers. , and the test piece can be easily broken to facilitate the second or third reuse; the electrode wires used to conduct the electrochemical signal of the reaction between the sheets are designed to have the same resistance in each electrochemical reaction area, and the measurement is accurate high degree. The test piece of the present invention and the chemical carrier contained therein can be used in conjunction with a biosensing detection device, and detect the composition of the test product and determine its concentration according to the electrochemical effect produced by the test product in the biological reaction; and , It can also measure more than two identical or different inspection items at the same time with one drop of blood. At the same time, the invention has the advantages of high accuracy and short testing time.

附图说明Description of drawings

图1为本发明能多次使用的生物检测试片的立体组合示意图。FIG. 1 is a three-dimensional assembly schematic diagram of the multiple-usable biological detection test piece of the present invention.

图2与图2A分别为本发明能多次使用的生物检测试片的立体分解示意图,及设于基层薄片上的导线的另一实施例示意图。FIG. 2 and FIG. 2A are respectively a three-dimensional exploded schematic diagram of the multiple-usable biological detection test piece of the present invention, and a schematic diagram of another embodiment of the wires arranged on the base sheet.

图3A-图3D为本发明能多次使用的生物检测试片的剖面示意图。3A-3D are schematic cross-sectional views of the bioassay test piece that can be used multiple times in the present invention.

图4为本发明的一片可多次使用、且一滴血可检验三种相同或不相同检测项目的生物检测试片的立体组合示意图。Fig. 4 is a three-dimensional combination schematic diagram of a bioassay test piece of the present invention that can be used multiple times and can test three identical or different detection items with one drop of blood.

图5A、图5B为本发明的一片可多次使用、且一滴血可检验三种相同或不相同检测项目的生物检测试片剖面示意图。Fig. 5A and Fig. 5B are schematic cross-sectional views of a bioassay test strip of the present invention that can be used multiple times and can test three same or different test items with one drop of blood.

图6为本发明的一片可多次使用、且血液入口在侧面的生物检测试片的立体组合示意图。FIG. 6 is a three-dimensional assembly diagram of a biological detection test piece that can be used multiple times and has a blood inlet on the side of the present invention.

图7为本发明的一片可多次使用、且血液入口在侧面的生物检测试片中的导电电极实施例示意图。Fig. 7 is a schematic diagram of an embodiment of a conductive electrode in a biological detection test strip that can be used multiple times and has a blood inlet on the side of the present invention.

图8为本发明的一片可多次使用、血液入口在侧面、且一滴血可检验三种相同或不相同检测项目的生物检测试片的立体组合示意图。Fig. 8 is a three-dimensional combination schematic diagram of a biological detection test piece that can be used multiple times, the blood inlet is on the side, and one drop of blood can test three identical or different detection items.

图9为本发明的另一种实施例的示意图。Fig. 9 is a schematic diagram of another embodiment of the present invention.

图10为有加纳米碳管与没加纳米碳管的化学载体与血液的电化学反应图表。Fig. 10 is a graph of electrochemical reactions between chemical carriers with and without carbon nanotubes and blood.

图中主要组件符号说明:Explanation of main component symbols in the figure:

试片10、90;                薄片11、12、13、14;Test piece 10, 90; Thin slice 11, 12, 13, 14;

小薄片121、122、123、131、132、133、141、142、143;Small flakes 121, 122, 123, 131, 132, 133, 141, 142, 143;

冲孔201、202、203、401、402、403、404、405、406、17、18;Punching holes 201, 202, 203, 401, 402, 403, 404, 405, 406, 17, 18;

内凹19、191、192、193、194、195、196、301、302、303;Concave 19, 191, 192, 193, 194, 195, 196, 301, 302, 303;

化学载体251、252、253、91、92、93;血液40;chemical carrier 251, 252, 253, 91, 92, 93; blood 40;

血液进入口71、72、73、74、75、76、77、78、79;电极头51、52;Blood inlets 71, 72, 73, 74, 75, 76, 77, 78, 79; electrode heads 51, 52;

导线15、16;工作电极161、162、163;参考电极151、152、153。Lead wires 15, 16; working electrodes 161, 162, 163; reference electrodes 151, 152, 153.

具体实施方式Detailed ways

为使阅读者对本发明的构造及其特征能有更深一层的认识与了解,现列举可行实施例并配合附图详细说明如下:In order to enable readers to have a deeper understanding and understanding of the structure and features of the present invention, the feasible embodiments are listed below in detail with accompanying drawings:

请参阅图1、图2、图2A及图3A-图3D所示,本发明所述的能多次使用的生物检测试片10,是由四层薄片11、12、13、14所粘贴而成,并在薄片11、12之间放置有二条导线15、16,导线15连接到三个参考电极151、152、153,而导线16连接到三个工作电极161、162、163(如图2所示)。所述的工作电极161、162、163可设计成一个圆形,而参考电极151、152、153则设置于该工作电极161、162、163的缺口处且为互不接触的型态;或将工作电极161、162、163设计成一个H形(如图2A所示)或方形,而参考电极151、152、153则设置于该工作电极161、162、163的缺口处且为互不接触的型态。Please refer to Fig. 1, Fig. 2, Fig. 2A and Fig. 3A-Fig. and two wires 15,16 are placed between the sheets 11,12, the wire 15 is connected to three reference electrodes 151,152,153, and the wire 16 is connected to three working electrodes 161,162,163 (as shown in Figure 2 shown). The working electrodes 161, 162, 163 can be designed as a circle, while the reference electrodes 151, 152, 153 are arranged at the gaps of the working electrodes 161, 162, 163 and are not in contact with each other; or The working electrodes 161, 162, 163 are designed as an H shape (as shown in FIG. 2A ) or square, and the reference electrodes 151, 152, 153 are arranged at the gaps of the working electrodes 161, 162, 163 and are not in contact with each other. type.

薄片11上有两个冲孔17、18,可以产生应力集中以利试片折断,该薄片11上另有一个内凹19,以标明进血位置。There are two punch holes 17, 18 on the sheet 11, which can generate stress concentration to facilitate the test piece to break. There is also an indentation 19 on the sheet 11 to mark the position of blood entry.

薄片12分成三片小薄片121、122、123贴在导线15、16及薄片11上;该三片小薄片121、122、123中间有空隙是为了组合后的试片比较容易折断(如图3C所示),又该三片小薄片121、122、123上各有冲孔201、202、203以放置化学载体251、252、253于工作电极161、162、163和参考电极151、152、153上(如图3A所示)而成为三个不同的反应区,以及在该三片小薄片121、122、123端部各设有一个内凹191、192、193以标明进血位置。Thin slice 12 is divided into three small slices 121,122,123 and sticks on the wire 15,16 and thin slice 11; There is a gap in the middle of these three small slices 121,122,123 for the test piece after the combination is relatively easy to break (as shown in Figure 3C shown), and the three small slices 121, 122, 123 each have punching holes 201, 202, 203 to place chemical carriers 251, 252, 253 on the working electrodes 161, 162, 163 and reference electrodes 151, 152, 153 (as shown in FIG. 3A ) to form three different reaction zones, and an indentation 191, 192, 193 is respectively provided at the ends of the three small slices 121, 122, 123 to mark the position of blood entry.

薄片13分成三片小薄片131、132、133贴在薄片12上,同理,在该三片小薄片131、132、133中间有空隙是为了组合后的试片比较容易折断;且在其上具有三个内凹301、302、303可以让血液40藉由虹吸原理吸入与化学载体251、252、253起电化学反应(如图3A与3B所示)。因此,该试片每次检测仅需要2μl的血液量,藉由虹吸的原理,血液会被吸入反应区后随即与其上的生物载体起电化学反应,并且藉由分析该电化学反应的结果能得知该血液检品的血糖浓度。Thin slice 13 is divided into three small flakes 131,132,133 and sticks on the thin slice 12, likewise, there is a gap in the middle of the three small flakes 131,132,133 for the combined test piece is relatively easy to break; and on it Having three indentations 301 , 302 , 303 allows the blood 40 to inhale and react electrochemically with the chemical carriers 251 , 252 , 253 through the siphon principle (as shown in FIGS. 3A and 3B ). Therefore, the test strip only needs 2 μl of blood for each test. By the principle of siphon, the blood will be sucked into the reaction area and then electrochemically react with the biological carrier on it, and by analyzing the result of the electrochemical reaction, it can Know the blood glucose concentration of the blood sample.

薄片14分成三片小薄片141、142、143贴在薄片13上,其上有三个内凹194、195、196,是为了标明进血位置;其上另有冲孔401、402、403作为虹吸原理血液的出气口。The sheet 14 is divided into three small sheets 141, 142, 143 and pasted on the sheet 13, and there are three indentations 194, 195, 196 on it to mark the position of blood inflow; there are also punched holes 401, 402, 403 on it as siphons Principle blood outlet.

而导线15、16则被设计为参考电极151、152、153到电极头51需有相同的导线长度,亦即相同电阻,而且工作电极161、162、163到电极头52需有相同的导线长度,亦即相同电阻,这样,在这三个不同反应区的生物反应结果才会一致。如上述,各导线15与16具有相同电阻是本发明所揭示的试片能多次使用的关键因素,也是不可或缺的要素,在全世界范围内本发明首次采用了这种方法。And lead wire 15,16 is then designed as reference electrode 151,152,153 needs to have identical wire length to electrode head 51, namely same resistance, and working electrode 161,162,163 needs to have identical wire length to electrode head 52 , that is, the same resistance, so that the biological reaction results in the three different reaction zones will be consistent. As mentioned above, the same resistance of the lead wires 15 and 16 is a key factor and an indispensable element for the repeated use of the test piece disclosed by the present invention. This method is adopted in the present invention for the first time in the world.

上述的结构中,薄片11、12、13、14可以为聚氯乙烯(PVC)、聚醚砜(polyether sulphone,PES)、PET、PC等塑料板,或陶质基板、电木板、纸板或FRP(玻璃纤维强化塑料)材质;而导线15、16可以为用于网版印刷技术中的银胶或碳胶导线,也可以是以加成法(Additive Process),以化学反应的方法产生所需导电电路;也可以以减乘法(Subtractive process),以化学反应的方法将表面局部无用的导体去除;然后再以化学浸镀法(俗称化金)将贵金属(如金、白金等贵金属),通过化学置换反应置换在底材上,以这种方法在一次生产一百多片的大量生产时,贵金属的厚度才能平均,也就是每片试片上的三个反应区的电阻都能维持在百分之一以内的误差。本发明的方法与美国专利5,437,999不同,也与中国台湾TW 496110不同,因为后者是利用电镀法镀上贵金属,所有试片都需连到同一电极(本发明的方法不需要),会造成试片上的贵金属电镀厚度不均,而在三个反应区的电阻都超过百分之三十以上的误差,因此误差太大,不能适用。In the above structure, the sheets 11, 12, 13, 14 can be plastic plates such as polyvinyl chloride (PVC), polyether sulfone (PES), PET, PC, etc., or ceramic substrates, bakelite boards, cardboard or FRP (glass fiber reinforced plastics) material; and wires 15, 16 can be silver glue or carbon glue wires used in the screen printing technology, and can also produce the required chemical reaction method with the addition method (Additive Process). Conductive circuit; Subtractive process can also be used to remove local useless conductors on the surface by chemical reaction; and then precious metals (such as gold, platinum, etc.) The chemical replacement reaction is replaced on the substrate. In this way, the thickness of the precious metal can be averaged when more than 100 pieces are produced at a time, that is, the resistance of the three reaction areas on each piece of the test piece can be maintained at 100%. error within one. The method of the present invention is different from U.S. Patent 5,437,999, and is also different from China Taiwan TW 496110, because the latter utilizes the electroplating method to plate precious metals, and all test pieces need to be connected to the same electrode (the method of the present invention does not need), which will cause test The thickness of the precious metal plating on the chip is not uniform, and the resistances in the three reaction zones all exceed an error of more than 30%, so the error is too large to be applicable.

本发明如上述的构造在使用时,请再参阅图3A-图3D所示,显示了本发明于血液40进入试片10的使用过程。当血液40由试片10右侧端部的内凹301经虹吸作用进入并充满冲孔201内的反应区后(如图3A到图3B所示),经过数秒钟等血糖读值出现后,该使用过的第一反应区的试片即可折断(如图3C所示),而露出中间那个未使用的第二反应区(如图3D所示),随即可再进行下一次的血液检测。以此类推,等到第二反应区用完后,可再将第二反应区的试片折断,使其露出第三个未反应的反应区,随即可在该一试片10上再进行第三次的血液检测,达到同一试片可多次使用的目的。When the present invention is in use with the above-mentioned structure, please refer to FIGS. 3A-3D again, which show the application process of the present invention when blood 40 enters the test strip 10 . When the blood 40 enters and fills the reaction zone in the punching hole 201 through the siphon effect from the concave 301 at the right end of the test strip 10 (as shown in FIGS. 3A to 3B ), after a few seconds and the blood glucose reading value appears, The test piece of the used first reaction zone can be broken off (as shown in FIG. 3C ), and the unused second reaction zone in the middle (as shown in FIG. 3D ) is exposed, and then the next blood test can be carried out . By analogy, after the second reaction zone is used up, the test piece of the second reaction zone can be broken off to expose the third unreacted reaction zone, and then the third reaction zone can be carried out on this test piece 10. The same test piece can be used multiple times for multiple blood tests.

再请参阅图4、图5A及图5B所示,其中显示了将构造相同而长度不同的三组如图1所示的试片10重叠组合成一片使用的实施例图,其让进血的冲孔301的入口位置相同,且其中作为出气口的冲孔404、405、406是至少由上贯穿至最底层薄片,则可以以一滴血液同时做三个相同或不同项目的检测。本实施例使用时如图5A-图5B所示,当一滴血液40被吸入而充满其右侧端重叠设置的三个反应区a、b、c,各反应区里的化学载体251会同时与吸入各反应区内的血液40起电化学反应。而其中在三个反应区a、b、c中的化学载体251可以是同一种,以产生相同的读值,再取其平均值以得到较佳的准确度;也可以是不同种类,以一滴血得到三种不同读值。同样的,这种试片一样的在第一次测试用完后可以折断再使用。Please refer to Fig. 4, Fig. 5A and Fig. 5B again, which shows an embodiment diagram in which three groups of test strips 10 shown in Fig. 1 with the same structure and different lengths are overlapped and combined into one piece, which allows blood to enter The entrance positions of the punching holes 301 are the same, and the punching holes 404 , 405 , 406 serving as air outlets penetrate at least from the top to the bottom sheet, so three identical or different items can be tested simultaneously with one drop of blood. When this embodiment is used, as shown in Fig. 5A-Fig. 5B, when a drop of blood 40 is sucked and filled with three reaction zones a, b and c overlapped at its right side, the chemical carrier 251 in each reaction zone will be simultaneously with The blood 40 sucked into each reaction area initiates an electrochemical reaction. Wherein the chemical carrier 251 in the three reaction zones a, b, c can be the same, to produce the same reading value, and then get the average value to obtain better accuracy; also can be different types, with a drop Three different readings were obtained for the blood. Similarly, this test piece can be broken and reused after the first test.

以上所述的试片构造也可变化实施如图6及图7所示,如图6所显示的实施例,该试片10设计成由三层薄片11、12、13粘贴而成,其中内凹的血液入口71、72、73设于第二层薄片12,且都设计在延长度方向电极头51、52的另一侧,使血液可以由侧面的血液入口71、72、73进入,而冲孔404、405、406(至少贯穿至最底层的薄片)为血液虹吸的出气口。另,可因应不同的血液入口位置可改变其导线15、16的设计形式(如图7所示),并将化学载体251涂布于第一层薄片11的工作电极161、162、163和参考电极151、152、153所形成的反应区上;据而即可达到如图1所示的实施例中可以同一试片10作多次检测使用的目的。又,这种血液由侧面进入的试片另可设计成多重堆栈的实施方式(如图8所示),其中的血液进入口71、72、73、74、75、76、77、78、79是设于试片10的侧边,而冲孔404、405、406为血液虹吸的出气口,据而同样可达到如图4所示的实施例所述的以一滴血可作多种测试的试片功效。如上述,同样的在每一段的试片上可作进一步的堆栈至四组或五组以上的反应区。The test piece structure described above can also be changed and implemented as shown in Figure 6 and Figure 7. In the embodiment shown in Figure 6, the test piece 10 is designed to be formed by pasting three layers of sheets 11, 12, 13, wherein the inner Concave blood inlets 71, 72, 73 are arranged on the second layer of sheet 12, and are all designed on the other side of the electrode heads 51, 52 in the direction of extension, so that blood can enter through the side blood inlets 71, 72, 73, and Perforations 404, 405, 406 (through at least the bottommost sheet) are air outlets for the blood siphon. In addition, the design form of the wires 15, 16 can be changed in response to different blood inlet positions (as shown in Figure 7), and the chemical carrier 251 is coated on the working electrodes 161, 162, 163 of the first layer of sheet 11 and the reference On the reaction zone formed by the electrodes 151, 152, 153; according to this, the purpose that the same test piece 10 can be used for multiple detections in the embodiment shown in FIG. 1 can be achieved. Again, the test strip that this blood enters from the side can also be designed as a multi-stack implementation (as shown in Figure 8), wherein the blood inlets 71, 72, 73, 74, 75, 76, 77, 78, 79 It is located on the side of the test piece 10, and the punching holes 404, 405, 406 are the air outlets of the blood siphon, so it can also achieve multiple tests with one drop of blood as described in the embodiment shown in Figure 4 Efficacy of the test piece. As mentioned above, the test strips of each segment can be further stacked to more than four or five groups of reaction zones.

如上所述的一个试片可多次使用的试片结构,本发明也提出另一种适合市面上少数以光学方法检测血糖浓度的血糖测试仪(如:ROCHE)使用的设计的实施例,如图9所示,在一试片90上可设有三个具有化学载体91、92、93的反应区,并在每两个反应区之间的二侧边对应的设有二缺口94,以能轻易的将已用过的反应区折断。As mentioned above, the structure of a test piece that can be used multiple times, the present invention also proposes another embodiment of the design suitable for the few blood glucose testers (such as: ROCHE) on the market that use optical methods to detect blood glucose concentration, such as As shown in Figure 9, three reaction zones with chemical carriers 91, 92, 93 can be provided on a test piece 90, and two gaps 94 are correspondingly provided on two sides between every two reaction zones, so as to be able to Easily snap off the used reaction zone.

至于本发明中所采用的反应区内的化学载体配方,其组成可以由羟丙甲基纤维素(Hydroxypropyl methyl cellulose)、柠檬酸(Citric acid)、磷酸氢二钾(Dibasic potassium phosphate)、非离子性表面活性剂TritonX-100、葡萄糖氧化酵素(Glucose oxidase)、赤血盐(Potassiumferricyanide)、去离子水(Deionized water)、纳米碳管(Nanotube carbon)所组成。As for the chemical carrier formula in the reaction zone adopted in the present invention, its composition can be composed of hydroxypropyl methylcellulose (Hydroxypropyl methylcellulose), citric acid (Citric acid), dibasic potassium phosphate (Dibasic potassium phosphate), nonionic Composed of active surfactant TritonX-100, Glucose oxidase, Potassium ferricyanide, Deionized water, and Nanotube carbon.

其中羟丙甲基纤维素是本发明首次采用,用以使化学载体在干燥于试片上时能均匀地分布,其含量优选为0.05%-2%;柠檬酸是用来调整酸碱值,同时它也有抗凝血的作用;磷酸氢二钾是用来调整酸碱值;非离子性表面活性剂Triton X-100是用来降低水的表面张力,有助于添加物的溶解;葡萄糖氧化酵素则会与血液产生电化学反应;赤血盐则作为导电介质;纳米碳管也是本发明首次采用,用以增加反应速率、减少反应时间,请参阅图10所示。纳米碳管可以用,也可以不用;用了可以减少反应时间,不是绝对必要的元素。上述组分中,所述羟丙甲基纤维素的含量优选为0.05%-2%;所述纳米碳管可以是多壁及单壁纳米碳管,其大小优选为10μm-200μm,含量优选为0.01%-2%;其余各组分为一般血糖或其它检体测试的惯用载体,其含量范围是常规的。Wherein hydroxypropylmethyl cellulose is adopted for the first time in the present invention, in order to make the chemical carrier evenly distribute when drying on the test piece, its content is preferably 0.05%-2%; Citric acid is used to adjust the pH value, while It also has an anticoagulant effect; dipotassium hydrogen phosphate is used to adjust the pH value; non-ionic surfactant Triton X-100 is used to reduce the surface tension of water and help dissolve additives; glucose oxidase It will produce an electrochemical reaction with blood; red blood salt is used as a conductive medium; carbon nanotubes are also used for the first time in the present invention to increase the reaction rate and reduce the reaction time, as shown in FIG. 10 . Carbon nanotubes can be used or not; they can reduce the reaction time and are not absolutely necessary elements. Among the above components, the content of the hydroxypropylmethylcellulose is preferably 0.05%-2%; the carbon nanotubes can be multi-walled and single-walled carbon nanotubes, the size of which is preferably 10 μm-200 μm, and the content is preferably 0.01%-2%; the rest of the components are commonly used carriers for general blood sugar or other specimen tests, and their content ranges are conventional.

有关本发明反应区内的化学载体配方的一个具体实施例可以是:A specific embodiment of the chemical carrier formula in the reaction zone of the present invention can be:

1.羟丙甲基纤维素(Hydroxypropyl methyl cellulose),含量:0.4%1. Hydroxypropyl methyl cellulose (Hydroxypropyl methyl cellulose), content: 0.4%

2.柠檬酸(Citric acid),含量:0.085%2. Citric acid (Citric acid), content: 0.085%

3.磷酸氢二钾(Dibasic potassium phosphate),含量:0.43%3. Dibasic potassium phosphate, content: 0.43%

4.非离子性表面活性剂Triton X-100,含量:0.035%4. Nonionic surfactant Triton X-100, content: 0.035%

5.葡萄糖氧化酵素(Glucose oxidase),含量:0.7%5. Glucose oxidase, content: 0.7%

6.赤血盐(Potassium ferricyanide),含量:3.5%6. Red blood salt (Potassium ferricyanide), content: 3.5%

7.去离子水(Deionized water),含量:94.8%7. Deionized water (Deionized water), content: 94.8%

8.奈米碳管(Nanotube carbon),含量:0.05%8. Nanotube carbon, content: 0.05%

前述的化学载体251-253是以武藏牌(Musashi)精密点胶机点在冲孔201-203内的工作电极161-163及参考电极151-153上,用以吸附载体的生物活性物质及导电介质,并且使该电极部分由疏水性变为亲水性,以利检品的附着,更进而可以保护该生物活性物质在较高温的干燥过程不致受损;而前述的生物活性物质则是只包括经固定化或甚至未经固定化的酵素(如葡萄糖氧化酵素Glucose oxidase)、抗原、抗体、微生物细胞、动植物细胞、动植物组织具有生物性辨识能力的成分,用以与之接触的检品(如血液等生物组织)产生生物或化学反应;而前述的导电介质(如Potassiumferricyanide,quinones)含量3.5%,乃用以接收酵素与检品反应后所产生的电子,并再将此电子经由电极导线传给传感器转换为检品浓度。The aforementioned chemical carriers 251-253 are placed on the working electrodes 161-163 and reference electrodes 151-153 in the punching holes 201-203 with a Musashi precision dispenser to absorb the biologically active substances of the carrier and conduct electricity. Medium, and make the electrode part from hydrophobic to hydrophilic, so as to facilitate the adhesion of the sample, and further protect the biologically active material from being damaged during the drying process at a higher temperature; while the aforementioned biologically active material is only Including immobilized or even unimmobilized enzymes (such as glucose oxidase Glucose oxidase), antigens, antibodies, microbial cells, animal and plant cells, and components with biorecognition capabilities of animal and plant tissues. Products (such as blood and other biological tissues) produce biological or chemical reactions; and the above-mentioned conductive medium (such as Potassium ferricyanide, quinones) content of 3.5%, is used to receive the electrons generated by the reaction between the enzyme and the test product, and then pass the electrons through The electrode wire is passed to the sensor to convert the concentration of the test product.

Claims (15)

1, a kind of reused biological detecting test piece, mainly by four layers of thin slice, two by the lead of working electrode and reference electrode more than two groups and place the chemistry carrier of reaction zone to be formed; Described four layers of thin slice comprise post two bottoms that the electrode cable of two groups of above working electrodes and reference electrode arranged, have have on three flakelets three independently the reaction zone punching the second layer, have and have three independently the 3rd layer of blood siphon indent and have three independently the 4th layers of gas outlet are arranged on three flakelet on three flakelets; Wherein said two leads that two groups of above working electrodes and reference electrode are arranged, its each working electrode or reference electrode are identical to the resistance of electrode tip.
2, a kind of reused biological detecting test piece, mainly by three layers of thin slice, two by the lead of working electrode and reference electrode more than two groups and place the chemistry carrier of reaction zone to be formed; Described three layers of thin slice comprise post two bottoms that the electrode cable of two groups of above working electrodes and reference electrode arranged, have have on three flakelets three independently the second layer and having of blood siphon indent three independently the 3rd layers of gas outlet are arranged on three flakelet; Wherein said two leads that two groups of above working electrodes and reference electrode are arranged, its each working electrode or reference electrode are identical to the resistance of electrode tip.
3, a kind of reused and one bleed and can check the biological detecting test piece of three kinds of identical or test items inequality, mainly by eight layers, Floor 12 or the thin slice more than 16 layers, and four, more than six or eight and every group of lead has the lead of working electrode and reference electrode more than two groups and place the chemistry carrier of reaction zone to be formed; Described eight layers, Floor 12 or the thin slice more than 16 layers comprise post two bottoms that the electrode cable of two groups of above working electrodes and reference electrode arranged, have have on three flakelets three independently the reaction zone punching the second layer, have and have three independently the 3rd layer of blood siphon indent and have three independently the 4th layers of gas outlet are arranged on three flakelet on three flakelets; Wherein said two leads that two groups of above working electrodes and reference electrode are arranged, its each working electrode or reference electrode are identical to the resistance of electrode tip.
4, a kind of reused and one bleed and can check the biological detecting test piece of three kinds of identical or test items inequality, mainly by six layers, nine layers or thin slice more than the Floor 12, and four, more than six or eight and every group of lead has the lead of working electrode and reference electrode more than two groups and place the chemistry carrier of reaction zone to be formed; The above thin slice of six layers, nine layers or Floor 12 comprise post two bottoms that the electrode cable of two groups of above working electrodes and reference electrode arranged, have have on three flakelets three independently the second layer and having of blood siphon indent three independently the 3rd layers of gas outlet are arranged on three flakelet; Wherein said two leads that two groups of above working electrodes and reference electrode are arranged, its each working electrode or reference electrode are identical to the resistance of electrode tip.
5, a kind of can repeatedly use and blood inlet at the biological detecting test piece of side, mainly by three layers of thin slice, two by the lead of working electrode and reference electrode more than two groups and place the chemistry carrier of reaction zone to be formed; Described three layers of thin slice comprise post two bottoms that the electrode cable of two groups of above working electrodes and reference electrode arranged, have three independently blood siphon indent the second layer and three independently the 3rd layers of gas outlet are arranged; Wherein said two leads that two groups of above working electrodes and reference electrode are arranged, its each working electrode or reference electrode are identical to the resistance of electrode tip.
6, a kind ofly can repeatedly use, the blood inlet is in the side and one bleed and can check the biological detecting test piece of three kinds of identical or test items inequality, mainly by six layers, nine layers or thin slice more than the Floor 12, four, more than six or eight and every group of lead have the lead of two groups of above working electrodes and reference electrode and place the chemistry carrier of reaction zone to form; The above thin slice of described six layers, nine layers or Floor 12 comprise post two bottoms that the electrode cable of two groups of above working electrodes and reference electrode arranged, have three independently blood siphon indent the second layer and three independently the 3rd layers of gas outlet are arranged; Wherein said two leads that two groups of above working electrodes and reference electrode are arranged, its each working electrode or reference electrode are identical to the resistance of electrode tip.
7, as each described test piece of claim 1-6, the base material of wherein said thin slice is polyvinyl chloride panel, glass mat, polyethersulfone plate, bakelite plate, PET plate, PC plate, glass plate or ceramic plate.
8, as each described test piece of claim 1-6, the base material of wherein said electrode cable is elargol or the carbon paste lead that is used for screen printing technology.
9, as each described test piece of claim 1-6, the chemistry carrier composition in each reaction zone of this test piece comprises: HPMC, citric acid, dipotassium hydrogen phosphate, nonionic surfactant Triton X-100, glucose oxidase ferment, potassium ferricyanide, deionized water, CNT.
10, test piece as claimed in claim 8, wherein said electrode cable are that the chemical reaction method with addition process produces required conducting channel; Or to subtract the chemical reaction method of multiplication, the conductor that surface local is useless is removed; And then with electroless plated method with noble metal by chemical replacement reaction displacement on ground.
11, test piece as claimed in claim 9, wherein said chemistry carrier contains many walls and Single Walled Carbon Nanotube, and its size is 10 μ m-200 μ m, and content is 0.01%-2%.
12, test piece as claimed in claim 9, wherein said chemistry carrier contains HPMC, and content is 0.05%-2%.
13, a kind of reused biological detecting test piece, be included in this test piece and be provided with most detection zones with chemistry carrier, and between per two detection zones, be provided with the breach that fractures, detect the inspection product can be used for optical means, and reach the every nonexpondable blood sugar test test piece of energy.
14, as each described test piece of claim 1-6, wherein said working electrode is designed to circle, and reference electrode then is arranged at the indentation, there of this working electrode and is non-touching kenel.
15, as each described test piece of claim 1-6, wherein said working electrode is designed to H shape, and reference electrode then is arranged at the indentation, there of this working electrode and is non-touching kenel.
CNA2005100905705A 2005-08-17 2005-08-17 Reusable bioassay test strips Pending CN1916616A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103134838A (en) * 2011-11-30 2013-06-05 连伸科技股份有限公司 Biochemical enzyme test bare chip
CN101303347B (en) * 2007-04-20 2013-07-31 天津亿朋医疗器械有限公司 Biological sensor
CN103959051A (en) * 2011-10-31 2014-07-30 喜来健迈德斯 Multi-reaction biosensor

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101303347B (en) * 2007-04-20 2013-07-31 天津亿朋医疗器械有限公司 Biological sensor
CN103959051A (en) * 2011-10-31 2014-07-30 喜来健迈德斯 Multi-reaction biosensor
CN103134838A (en) * 2011-11-30 2013-06-05 连伸科技股份有限公司 Biochemical enzyme test bare chip

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