CN106053585A - Detection method for judging sample distribution status - Google Patents

Detection method for judging sample distribution status Download PDF

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Publication number
CN106053585A
CN106053585A CN201610656056.1A CN201610656056A CN106053585A CN 106053585 A CN106053585 A CN 106053585A CN 201610656056 A CN201610656056 A CN 201610656056A CN 106053585 A CN106053585 A CN 106053585A
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electrode
sample
reaction
voltage
value
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CN201610656056.1A
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黃椿木
徐振腾
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华广生技股份有限公司
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Priority to CN 200910141438 priority Critical patent/CN101887047A/en
Priority to CN201610656056.1A priority patent/CN106053585A/en
Publication of CN106053585A publication Critical patent/CN106053585A/en

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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, electro-chemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electro-chemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/416Systems
    • G01N27/49Systems involving the determination of the current at a single specific value, or small range of values, of applied voltage for producing selective measurement of one or more particular ionic species

Abstract

The invention relates to a detection method. The method is characterized in that a working voltage is provided between the first electrode and the second electrode of an electrochemical sensor to obtain a first current value and a second current value, wherein a ratio of the first current value to the second current value can represent the full distribution rate of samples fully distributed on the surface of the first electrode and the surface of the second electrode, and is used to judge the validity of test.

Description

一种判断样品布满状况的侦测方法 Sample detecting method for judging the condition of full

[0001 ] 本申请为2009年5月12日提交的申请号为200910141438.0且发明名称为"一种判断样品布满状况的侦测方法"的专利申请的分案申请。 [0001] This application is application No. 12 May 2009, and filed a divisional application 200910141438.0, entitled "Method for judging the sample to detect the status of full" patent application.

技术领域 FIELD

[0002]本发明系关于一种用于判断传感器测试有效性方法,尤指一种透过一系列电流值所取得之比值,藉以了解一待测样本于一电化学传感器之电极上之分布情形,并判断该电化学传感器之测试有效性的方法。 [0002] The present invention relates to a method of determining the effectiveness of a test sensor, especially a ratio of one kind accessed through a series of current values, in order to understand the distribution on the electrode of the electrochemical sensor a case where a test sample and determining the effectiveness of the electrochemical test sensors.

背景技术 Background technique

[0003] 电化学感测系统(Electrochemical Sensor Systems)目前已被广泛地应用在生物样本分析物的分析检测上,例如检测血液中的葡萄糖浓度、胆固醇浓度等等。 [0003] electrochemical sensing system (Electrochemical Sensor Systems) has been widely applied in the biological sample analysis and detection of analytes such as blood glucose concentration, cholesterol concentration and the like is detected. 一般来说, 这种电化学感测系统包含一感测试片和一测量仪,特别是该感测试片被设计为单一次使用、可抛弃式,以供民众居家生活方便使用。 In general, this electrochemical sensing system comprises a test strip and a measuring device, in particular the test strip is designed to be a single use, disposable, easy to use for people living at home.

[0004] 电化学传感器使用酵素电流方法(enzymatic amperometric methods)乃相当普遍,此种传感器具有覆盖含酵素的试剂的电极,该试剂和分析物反应而产生一电化学电流, 并可被该电极所感测。 [0004] Enzyme electrochemical sensors using current methods (enzymatic amperometric methods) is the quite common, such a sensor having electrodes covered with a reagent containing the enzyme, reaction of the analyte and the reagent to generate an electrochemical current of the electrode and can be sensed Measurement. 所使用的酵素具单一性,并与待测样本中的特定分析物有良好的专一性反应,这种专一性反应可降低其它分析物的干扰。 The enzyme used has unity, and in particular with the test sample analyte specific reaction is good, which can reduce the specificity of the reaction interfere with other analytes. 例如测试样本中的胆固醇浓度时,可使用含有对胆固醇具专一性之酵素的试剂,而测量血液中葡萄糖浓度时,则可使用含葡萄糖氧化酶(glucose oxidase)的试剂。 For example, when the concentration of cholesterol in a test sample, using cholesterol-containing reagent with specificity of enzymes, and measuring the concentration of glucose in the blood, may be a reagent containing glucose oxidase (glucose oxidase) is. 葡萄糖氧化酶不会和胆固醇作用,也不会和血液中的其它糖类作用。 Glucose and cholesterol oxidase will not, will not, and the role of other sugars in the blood. 一般来说,葡萄糖氧化酶对样本中的葡萄糖单一选择性可达99%,因此这种利用酵素方法的测量系统可产生相当精准的一测量结果。 Typically, glucose oxidase for glucose in the sample single selectivity 99%, so this method of using the enzyme measurement system may generate a relatively accurate measurement results.

[0005] 在以测量感测电流的方式来测定样品中分析物浓度之方法中,该感测电流称为柯特雷尔电流(Cottrell current),并可藉由以下公式得出: [0005] Analysis of the concentration in the sensing current to measure the measurement sample in a way, the sensing current is called a current Curt Trail (Cottrell current), can be obtained by the following equation:

[0006] i(t)=KnFACD0.5.t-0.5; [0006] i (t) = KnFACD0.5.t-0.5;

[0007]其中,i为感测电流的瞬间值; [0007] where, i is the instantaneous value of the sensing current;

[0008] K为一常数; [0008] K is a constant;

[0009] n为电子传递的数量; [0009] n is the number of electrons transferred;

[0010] F为法拉第常数; [0010] F is the Faraday constant;

[0011] A为工作电极的表面积; [0011] A is the surface area of ​​the working electrode;

[0012] C为样本中待测分析物的浓度; [0012] C is the concentration of analyte in the test sample;

[0013] D为试剂的扩散系数; [0013] D is the diffusion coefficient of the reagent;

[0014] t为一预设电压施加至电极后的一特定时间。 [0014] t is applied after a certain time to a predetermined voltage to the electrodes.

[0015] -般而言,于习知的抛弃式电化学感测试片的构造与量测程序上,包含如下: [0015] - In general, the structure and amount of the measurement on the conventional disposable electrochemical sensor strip, comprising the following:

[0016] 1 •-基体片(Base sheet)用为承载该试片的机构; [0016] 1 • - the base sheet (Base sheet) was carried by means of the test strip;

[0017] 2.至少有两分离的导电电极置放于该基体片上,其中第一导电电极的第一端做为一「工作电极(Working Electrode)」,而第一导电电极的第二端做为该工作电极的一引出端,该工作电极的引出端用于与一量表(measuring meter)做电的接触:另第二导电电极的第一端做为一「对电极(Counter Electrode)」,而第二导电电极的第二端做为一对电极的引出端,该对电极的引出端用于与该量表做电的接触。 [0017] 2. There are two separate conductive electrode disposed on at least the base sheet, wherein the first end as a "working electrode (Working Electrode)" a first conductive electrode, and the second end of the first conductive electrode do a lead electrode for the working end of the working electrode for the lead end and a scale (measuring meter) to make electrical contact: a first end of the other as a "pair of electrodes (Counter electrode)" second conductive electrode and the second end of the second conductive electrode as terminal electrode of one pair, the pair of terminal electrode is used to make electrical contact with the scale. 该工作电极与该对电极于机构上配置于临近的区域,以形成一电极测试区; The working electrode and the counter electrode is disposed on a region adjacent to the mechanism, to form an electrode test zone;

[0018] 3.-含酵素的化学试剂涂布于该电极测试区,用于与一待测流体的某分析物产生一化学反应; [0018] 3.- enzyme-containing chemical reagents applied to the test area of ​​the electrode, for generating a chemical reaction with an analyte of a fluid to be measured;

[0019] 4•由该量表施加一工作电压(Working voltage)于工作电极和对电极之间,此工作电压大小与电压极性用于让该化学反应工作于氧化(此时施加于工作电极的工作电压为正)或还原(此时施加于工作电极的工作电压为负)的工作状态,在此氧化(或还原)的反应工作电压状态下,量取该化学反应的电化学电流,其即为一柯特雷尔电流(Cottrell current); [0019] 4 • a scale applied by the operating voltage (Working voltage) to the working electrode and the counter electrode, the polarity of the operating voltage and the voltage magnitude so that the chemical reaction for the oxidation of work (when applied to the working electrode operating voltage is positive) or reducing (in this case applied to the working electrode, the working voltage is negative) the operating state, under the reaction the oxidation state of the operating voltage (or reduced), the amount of current through the electrochemical chemical reaction which a current that is Curt Trail (Cottrell current);

[0020] 5 •由该量测的电化学电流,再依照柯特雷尔电流公式(1(〇=1(.11.?^.(:.00.54-〇. 5 ),即可计算出该待测流体中某分析物的浓度。 [0020] 5 • electrochemical current measured by the amount, and then in accordance with the current formula Curt Trail (1 (billion = 1 (.11.? ^. (00.54 :.-square. 5), which can be calculated a concentration of an analyte in a fluid to be measured.

[0021] 其中,该「工作电极」上涂布一含酵素的化学试剂,用于与待测流体中的某分析物产生化学反应,并于化学反应过程中施加一反应的工作电压(含电压大小与电压极性)于该电极的表面上,使该化学反应工作于氧化区(或还原区)用以量取该化学反应中的电化学电流,此氧化区(或还原区)的电化学电流,即为柯特雷尔电流(Cottrell current);而该一「 对电极」用于产生量取电化学电流时的相对电流回路。 [0021] wherein a coating on the "working electrode" enzyme-containing chemical reagents for chemical reaction with the fluid to be measured in an analyte, and applying a chemical reaction in response to the operating voltage (voltage including magnitude and polarity of the voltage) on the surface of the electrode, so that chemical reactions in the oxidation zone of work (or reduction zone) to the current amount of the electrochemical chemical reactions, this electrochemical oxidation zone (or reduction zone) of current, i.e. current Curt Trail (Cottrell current); and that a "pair of electrodes" for the current loop when the relative amount of electrochemically generated current.

[0022]该反应的工作电压的选择,可由电化学中习知的循环伏安曲线(cyclic vo 1 tammograms)得知适切的氧化或还原电位,详细说明如下: [0022] select the operating voltage for the reaction, it may be in conventional electrochemical cyclic voltammetry curves (cyclic vo 1 tammograms) relevance that oxidation or reduction potential, are described below:

[0023] 1.改变并循环该工作电极的电压的大小,以量取不同工作电压时的电流,会得到一氧化波峰电流如图1 (A)的I点所示,于此氧化波峰电流时的电压大小,即为一最灵敏的" 氧化工作电压"VI,于此波峰电流点将获得最佳的"信号噪声比(S/N Ratio)",此工作点则具有最佳氧化反应工作电位,可获得最佳之一氧化柯特雷尔电流(Cottrell current)II, 而该信号噪声比将大于或等于一。 When [0023] 1 cycle changes and the magnitude of the voltage of the working electrode, the amount of current to different operating voltages, a point will be shown in the oxidation peak current I in FIG. 1 (A), the oxidation peak current thereto voltage magnitude, that is one of the most sensitive "oxidation operating voltage" Vl, the current peak point thereto optimum "signal to noise ratio (S / N ratio)", the operating point having the optimum working potential of the oxidation reaction , one of the best available oxidation current Curt Trail (Cottrell current) II, and the signal to noise ratio greater than or equal to one. 反之,若为图1(A)之II点所示,便无法得具最佳信号噪声比之一氧化柯特雷尔电流(Cottrell current)。 Conversely, if (A), the point II, can not be obtained with the best signal to noise ratio of a current one oxide Kurt Trail (Cottrell current) of FIG.

[0024] 2.相同的于还原曲线中的波峰电流点(参照图1(A)的III点所示),可获得一最灵敏的"还原工作电压" VIII,此工作点为最佳反应工作电位,可获得具最佳信号噪声比之一还原柯特雷尔电流(Cottrell current)IIII,而该信号噪声比亦将大于或等于一。 [0024] 2. The same reduction in peak current point of the curve (see FIG. 1 (A) represented by the point III), obtained one of the most sensitive "to restore the operating voltage" VIII, this optimum working point of the reaction work potential, the best signal to noise ratio is obtained with one of the current reduction Kurt Trail (Cottrell current) IIII, which will also be the signal to noise ratio is greater than or equal to one.

[0025] 3.由上所述选择适当电压极性与电压大小的工作电极电压,以量取待测体中某分析物与化学试剂于氧化(或还原)时的电化学的柯特雷尔电流(Cottre 11 current)。 [0025] 3. Select the working electrode by the voltage of an appropriate voltage polarity and magnitude of the voltage to when the amount of the electrochemical oxidation and chemical agents (or reducing) a body analyte to be measured Kurt Trail current (Cottre 11 current).

[0026]由柯特雷尔电流(Cottrell current)公式可知,待测物的浓度C与感测电流i成正比,故可以藉由量测电化学电流i(t)的大小,来计算一待测分析物的浓度C。 [0026] Equation apparent from Curt Trail current (Cottrell current), the concentration of C with a current proportional to the sensed analyte i, it is possible by measuring the electrochemical current i (t) is the size of a to be calculated C. measuring the concentration of analyte 因为该量测电流i(t)也和工作电极的表面积A成正比,故该浓度计算公式系以工作电极的面积为固定的前提为假设。 Since the measured current i (t) and the working electrode is also proportional to the surface area A, so that the concentration is calculated based in the area of ​​the working electrode is fixed premise hypothesis. 然,工作电极表面积A更精确的定义应为「于量取该电化学电流"当时"的工作电极表面积A是固定的」,故更进一步解释条件为「工作电极的表面积A于量测当时,需被该待测流体所完全布满,以确保该工作电极表面积A是固定的」,若工作电极表面积A因未被测试流体所布满,则由上述柯特雷尔电流(Cottre 11 current)公式所计算的该待测分析物的浓度C会是错误的。 However, the working electrode surface area A more precise definition should be "in the amount of electrochemical current" time "the working electrode surface area A is fixed", so that further explanation for the condition "working electrode surface area A at the measurement time, It needs to be completely covered with the fluid to be measured to ensure that the working electrode surface area a is fixed ", if the working electrode surface area a covered by the test fluid has not, by the above-described current Curt Trail (Cottre 11 current) the concentration of the analyte to be C equation calculated is wrong.

[0027] 藉此,待测物的浓度C可以被检测而得,且此浓度C与感测电流i成正比。 [0027] Accordingly, the concentration C of the analyte detected may be obtained, and this concentration C is proportional to the sense current i. 另外,因为感测电流也和工作电极表面积A成正比,因此对一准确的测量仪来说,感测试片中精确定义的工作电极表面积亦为一关键因素。 Further, since the sense current and also proportional to the surface area of ​​the working electrode A, therefore an accurate measuring instrument, the working electrode sense precisely defined surface area of ​​the test pieces is also a critical factor.

[0028] 判断待测物体积量于电化学传感器反应区是否已足够,则为另一与准确测量待测物浓度有关的关键因素。 [0028] It is determined whether the amount of analyte in the volume of the reaction zone is sufficient electrochemical sensors, and other factors critical to accurately measure the analyte concentration compared. 当已覆盖试剂之电化学传感器反应区有足够的待测物体积量时, 可根据柯特雷尔电流(Cottre 11 current)公式测量感测电流,藉以推算出待测物浓度;但是当待测物体积量不足时,根据公式所得之感测电流所推算出待测物浓度将因之不正确。 When the electrochemical sensor reagents of the reaction zone is covered with a sufficient volume of the analyte, according to current Curt Trail (Cottre 11 current) formula sensing current is measured, so as to calculate the analyte concentration; But when tested when the amount is less than the volume, according to the sensing current obtained from the formulas to calculate the concentration of analyte consequent incorrect. 因此当可精准控制工作电极表面积时,待测物体积于反应区内是否足够,则成为极重要的关键因素之一。 Therefore, when the working electrode surface area can be precisely controlled, the volume of analyte in the reaction zone is sufficient, become one of the very critical factor.

[0029] 诸如此类的传感器和测量仪在专利文件中例如:US 5,266,179,US 5,366,609或EP12728331中被揭露。 [0029] The sensors and measuring instruments like, for example, in the patent documents: US 5,266,179, US 5,366,609 or are disclosed in EP12728331.

[0030] 在上述文件中所揭露的测量仪操作方法大致相同。 [0030] The method of operation of the gauge disclosed in the above documents are substantially the same. 首先,插入一感测试片至测量仪中,感测试片是否已适当插入测量仪之中,是由机械式及/或电子式的开关及/或接触来侦测。 First, a test strip inserted into the meter, whether the test strip has been properly inserted into the meter, it is to detect by the mechanical and / or electronic switching and / or contact. 当感测试片被适当插入后,使用者被要求提供样本,典型地为一滴血。 When the test strip is properly inserted, the user is required to provide a sample, typically a drop of blood. 血液样本接着进入感测试片的一反应区,该反应区具有至少二电极,且该电极被适当的试剂所覆盖。 Then a blood sample into the test strip reaction zone, which reaction zone has at least two electrodes, and the electrodes are covered by a suitable reagent.

[0031] 为了侦测样本是否出现在该反应区,当感测试片适当插入时,即施加一电压至该电极,电极间试剂的电阻在没有样本出现时很高,但是只要样本一开始接触反应区,电极间的电阻就会下降。 [0031] In order to detect whether a sample is present in the reaction zone, when the test strip is properly inserted, i.e., applying a voltage to the electrodes, the resistance between the electrodes is high in the absence of reagent samples appear, but if a sample comes into contact with the reaction region, the resistance between the electrodes decreases. 此电阻的下降让一电流可被侦测到,以作为样本已存在于反应区的一指示, This drop resistance may allow a current to be detected, as already present in a sample indicates the reaction zone,

[0032] 为了更详细解释习知技术的检测方法,请参考图1(B)至图1(C)。 [0032] In order to more conventional detection technique explained in detail, referring to FIG 1 (B) to 1 (C).

[0033]图1(B)显示习知技术之测量仪所使用的方法,亦为美国专利US 5,366,609所揭露的内容。 [0033] FIG. 1 (B) The method of displaying content of conventional techniques used in the meter, U.S. Patent No. US 5,366,609 also disclosed. 图1(c)则显示于样本侦测期中因施加一电压而产生的电流、及范围S之放大图。 FIG 1 (c) detecting in the sample the current period by applying a voltage generated, and the enlarged view S is displayed.

[0034] 根据图1(B)所示,当感测试片于时间100被插入测量仪中,于样本存在侦测期101 施加一固定电压102,以侦测一待测样本是否存在于反应区。 [0034] According to FIG. 1 (B), at the time when the test strip 100 is inserted into a meter, to detect the presence of the sample 101 is applied to a fixed voltage 102, a test to detect whether a sample is present in the reaction zone . 一滴样本于时间108被加在感测试片上。 Drop of the sample at time 108 is applied to the test strip.

[0035] 请同时参阅图1(C),当电流达到一样本侦测门坎112,也就是一样本于时间116被侦测到存在时,开始一样本量延滞时期114。 [0035] Referring also to FIG. 1 (C), when the current reaches the same threshold detector 112 present, as is the present time to the present time is detected 116, the start delay time as the present amount of 114. 为了继续确认样本量是否足够,测量仪会继续施加该固定电压102至电极,直到一时点103 (请并参阅图1 (B))。 In order to continue to confirm the adequacy of sample volume, the meter will continue to apply the fixed voltage to the electrodes 102, 103 until a time point (and please refer to FIG. 1 (B)).

[0036] 接着,电流量109与时点115的一样本量门坎113相对照,定义出该样本量延滞时期114的终点。 [0036] Next, as the present amount of the current 109 and the point 115 the threshold 113 of contrast, the end point of the sample is defined delay period 114. 假如电流强度低于该样本量门坎113,测量仪将会发出警示表示感测试片中存在的样本量不足,然后测量过程将会停止。 If the current intensity is below the sample size threshold 113, the meter will send an insufficient amount of the sample indicates the presence of warning sense test pieces, and then measuring process stops.

[0037]假如已经有足够的样本量存在于反应区,也就是在时点115电流量已大于该样本量门坎113,测量仪就会继续下一个步骤,也就是静置期105的开始。 [0037] If a sufficient amount of sample has been present in the reaction zone, i.e. point 115 in the current sample is greater than the threshold 113, the meter will continue to the next step, that is, rest period 105 is started. 静置期105中,测量仪关闭该固定电压102而转成零电压104。 Rest period 105, voltage meter 102 and is fixed to close the switch 104 to zero voltage. 在静置期105期间,样本和试剂的混合溶化需要一特定、预设好的时间。 During the rest period 105, the mixed sample and the reagents required to melt a particular, predetermined good time. 在完成静置后,测量仪将会开始一测量期,为此测量目的,于一侦侧期106施加一预设电压107至电极,电极间的电流量110(请参阅图1(B)下方)将被测量。 After completion of standing, the meter will begin a measurement period, the measurement for this purpose, a predetermined voltage is applied to the electrode 107, current electrodes 110 to detect a side of 106 (see the bottom of FIG. 1 (B) ) to be measured.

[0038]待测分析物浓度的决定,是根据前述的柯特雷尔电流(Cottrell current),在测量期106依据柯特雷尔电流公式计算出来的浓度值会被显示于测量仪的显示器上。 [0038] determined analyte concentration to be measured, is displayed on the display on the meter of the preceding Kurt Trail current (Cottrell current), it is displayed on the basis of the calculated current formula Kurt Trail measured density value of 106 .

[0039]因此样本侦测门坎112的大小定义对于判断样本量是否足够极为重要。 [0039] Thus sample size threshold detector 112 is extremely important to define the sample volume adequacy determination.

[0040] 职是之故,申请人鉴于习知技术中所产生之缺失,乃经悉心试验与研究,并一本锲而不舍之精神,终构思出本案「一种判断样品布满状况的侦测方法」,以下为本案之简要说明。 [0040] Position is, therefore, in view of the conventional art, the applicant arising deletion, determined after careful testing and research, and a spirit of perseverance, the final detection method conceived in this case "condition for judging the sample covered "the following is a brief description of the case.

发明内容 SUMMARY

[0041] 本案之目的系为提供一种用于侦测流体待测样品覆盖于电化学传感器的电极表面积的布满率,其可于正式量测待测样品浓度前、或量测待测样品浓度之后,以本发明做此布满率的判断,用以判断该次测试的有效性。 [0041] The object of the present case is to provide a full line of the fluid sample to be tested to detect electrochemical sensor electrode covers the surface area for which can be tested before formal measurement sample concentration or sample under-test after concentration, the present invention is to make this determination full rate, for determining the validity of the test. 在样本存在侦测期施加一反应直流电压至至少具有第一电极与第二电极之电化学传感器,该施加反应电压大小系根据循环伏安法定义出可使样本发生电化学作用产生最佳氧化(还原)之氧化(还原)电压。 Detecting the presence of the sample by applying a DC voltage to the reaction electrochemical sensor having at least first and second electrodes, the oxidation reaction of the magnitude of the voltage applied to the best the system can define the role of the samples produced according electrochemical cyclic voltammetry (reduction) of the oxidation (reduction) voltage.

[0042] 为达上述目的,本发明提供一种判断一待测样品一布满状况的侦测方法,系应用于至少具有一第一电极与一第二电极之一传感器,其步骤包括:( a)提供该待测样品,使其从该第一电极流向该第二电极;(b)于一第一固定时间,施加一第一反应直流电压于该第一电极与该第二电极间,使该第一电极之电位高于该第二电极之电位,并记录该第一固定时间所产生之一第一Cottrell电流值;(c)移除该第一反应直流电压并停滞一第一期间;(d) 于一第二固定时间,施加一第二反应直流电压于该第一电极与该第二电极间,该第二反应直流电压之电压值与该第一反应直流电压之电压值相等,且使该第二电极之电位高于该第一电极之电位,并记录该第二固定时间所产生之一第二Cottrell电流值;(e)移除该第二反应直流电压并停滞一第二期间;(f)重复步骤(b)至步 [0042] To achieve the above object, the present invention provides a test sample for judging a full condition detection method, applied to a system of at least a first electrode and a second electrode of one of the sensors, comprising the steps :( a) providing the sample to be tested, so that from the first electrode to the second electrode; (b) at a first fixed time, applying a direct current voltage to a first reaction between the first electrode and the second electrode, the potential of the first electrode is higher than potential of the second electrode, the first fixed time and records the value of the first Cottrell current generated by one; (c) removing the first reaction a first DC voltage and a period of stagnation ; (d) in a second fixed time, a second reaction is applied to the DC voltage between the first and second electrodes, the voltage equal to the voltage value of the second reactive DC voltage of the DC voltage to the first reactor and that the potential of the second electrode higher than the potential of the first electrode, the second fixed time and records the value of the second Cottrell current generated by one; (e) removing the second reaction a second DC voltage and stagnation during the two; (f) repeating steps (b) to step 骤(e)至少两次,并各别累加该第一Cottrell电流值与该第二Cottrell电流值;及(g)计算该累加第一Cottrell电流值与该累加第二Cottrell电流值之一比值,其中该比值反映该待测样品在该第一电极及该第二电极之该布满状况。 Step (e) at least twice, and the respective first Cottrell current accumulated value and the second Cottrell current value; and (g) calculating a first accumulated value Cottrell current ratio of a second one of the Cottrell current accumulation value, wherein the ratio reflects the full condition of the first electrode and the second electrode of the sample to be tested.

[0043] 本发明重复施加的第一反应直流电压与第二反应直流电压,将分别使第一电极电位大于第二电极电位与第二电极电位大于第一电极电位,并将其所产生的第一Cottrell电流与第二Cottrell电流分别累加后计算其比值,用以判断样本是否足够,此方法可以克服习知技术以设定一样本侦测门坎电流的缺点。 [0043] The first reactor and the second reactor direct voltage direct voltage repeatedly applied to the present invention, respectively the first electrode potential greater than the potential of the second electrode and the second electrode potential than the first electrode potential, and it generates a first after a second Cottrell current and the Cottrell current are calculated accumulation ratio for judging the adequacy of the sample, this method can overcome the disadvantages of conventional techniques to set the detection threshold as the present current.

[0044] 根据上述方法,其中该第一反应直流电压与第二反应直流电压系透过循环伏安曲线(cyclic voltammograms)决定,且该第一反应直流电压与该第二反应直流电压之信号噪声比(S/N Ratio)大于或等于1。 [0044] According to the above method, wherein the first reaction is the reaction of the second DC voltage through a DC voltage based cyclic voltammetry (cyclic voltammograms) determined, and the first reactive noise DC voltage and the second reaction signal voltage DC ratio (S / N ratio) is greater than or equal to 1.

[0045] 根据上述方法,其中该第一电极与该第二电极位于同一基版。 [0045] According to the above method, wherein the first electrode is located at the same base plate and the second electrode.

[0046] 根据上述方法,其中该第一电极与该第二电极上具有一酵素及一电子传递中介物,其中该酵素对该待测样品进行氧化反应。 [0046] According to the above method, wherein the first electrode and the second electrode having an enzyme and an electron transfer mediator, wherein the oxidation reaction of the enzyme sample to be tested.

[0047] 根据上述方法,其中该第一电极与该第二电极上具有一酵素及一电子传递中介物,其中该酵素对该待测样品进行还原反应。 [0047] According to the above method, wherein the first electrode and the second electrode having an enzyme and an electron transfer mediator, wherein the reduction reaction of the enzyme sample to be tested.

[0048]根据上述方法,其中该第一固定时间为3ms至2s。 [0048] According to the above method, wherein the first fixed time of 3ms to 2s.

[0049] 根据上述方法,其中该第二固定时间为3ms至2s。 [0049] According to the above method, wherein the second fixed time of 3ms to 2s.

[0050] 根据上述方法,其中该第一固定时间与该第二固定时间相同。 [0050] According to the above method, wherein the first fixed time same as the second fixed time.

[0051]根据上述方法,其中该第一固定时间与该第二固定时间均为20ms。 [0051] According to the above method, wherein the first and second fixed time period are both fixed to 20ms.

[0052 ]根据上述方法,其中该第一期间为0ms至50ms。 [0052] According to the above method, wherein the first period of 0ms to 50ms.

[0053 ]根据上述方法,其中该第二期间为Oms至50ms。 [0053] According to the above method, wherein the second period is Oms to 50ms.

[0054]根据上述方法,其中该第一期间及该第二期间时间相同。 [0054] According to the above method, wherein the first period and the second period of the same time.

[0055]根据上述方法,其中该第一期间及该第二期间均为20ms。 [0055] According to the above method, wherein the first period and the second period are 20ms.

[0056]根据上述方法,其中该第一电极与该第二电极的电化学反应面积相同。 [0056] According to the above method, wherein the electrochemical reaction is the same as the area of ​​the first electrode and the second electrode.

[0057]根据上述方法,其中当该比值为1时,表示该待测样品布满该第一电极及该第二电极。 [0057] According to the above method, wherein when the ratio is 1, it indicates that the test sample covered with the first electrode and the second electrode.

[0058]根据上述方法,其中该第一电极的一电化学反应面积大于该第二电极的一电化学反应面积。 [0058] According to the method, an electrochemical reaction wherein the area of ​​the first electrode is greater than a second electrochemical reaction area of ​​the electrode.

[0059 ]根据上述方法,其中该第一电极的一电化学反应面积小于该第二电极的一电化学反应面积。 [0059] According to the method, an electrochemical reaction wherein the first electrode is smaller than the area of ​​an electrochemical reaction area of ​​the second electrode.

[0060] 根据上述方法,其中该传感器为一电化学传感器。 [0060] According to the above method, wherein the sensor is an electrochemical sensor.

[0061] 根据上述方法,其中该方法用以判断该传感器之一测试的有效性。 [0061] According to the above method, wherein the method is used to determine the effectiveness of one of the test sensors.

[0062] 根据上述方法,其中该方法可于一样品存在侦测期、一样品静置期或一样品测量期中任一时点进行。 [0062] According to the above method, wherein the method of detecting the presence in a sample, or a sample of a sample left to stand any point for the measurement period.

[0063] 根据上述方法,其中该比值为0.3至3.0时,代表该传感器之该测试为有效。 [0063] According to the method described above, wherein the ratio is 0.3 to 3.0, the test on behalf of the sensors is active.

[0064] 本发明亦提供一种判断一待测样品一布满状况的侦测方法,系应用于至少具有一第一电极与一第二电极之一传感器,其步骤包括:(a)提供一待测样品,使其从该第一电极流向该第二电极;(b)于一第一固定时间,施加一第一直流电压于该第一电极与该第二电极间,使该第一电极之电位高于该第二电极之电位,并记录该第一固定时间所产生之一第一Cottrell电流值;(c)移除该第一直流电压并停滞一第一期间;(d)于一第二固定时间,施加一第二直流电压于该第一电极与该第二电极间,该第二直流电压之电压值与该第一直流电压之电压值相等,且使该第二电极之电位高于该第一电极之电位,并记录该第二固定时间所产生之一第二Cottrel 1电流值;及(e)计算该第一Cottrel 1电流值与该第二Cottrel 1电流值之一比值,其中该比值反映该待测样品在该第一电极及 [0064] The present invention also provides a method of detecting Analyzing a sample to be tested in a filled condition, applied to a system of at least a first electrode and a second electrode of one sensor, comprising the steps of: (a) providing a the test sample, so that the second electrode from the first electrode to; (b) at a first fixed time, applying a first direct voltage to between the first electrode and the second electrode, such that the first electrode the potential higher than the potential of the second electrode, and one record of the first fixed time to generate a first Cottrell current value; (c) removing the first DC voltage during a first and a stagnation; (d) in a a second fixed time, a second DC voltage is applied to between the first electrode and the second electrode, the voltage value of the second DC voltage to the first voltage value of the DC voltage are equal, and the potential of the second electrode higher than the potential of the first electrode, a second fixed time and records the current value of a second one Cottrel 1 produced; and (e) calculating a first current value Cottrel 1 and one of said second current value ratio Cottrel 1 , which reflects the ratio of the test sample and the first electrode 第二电极之该布满状况。 A second electrode of the full condition. [0065]根据上述方法,其中该第一固定时间为3ms至2s。 [0065] According to the above method, wherein the first fixed time of 3ms to 2s.

[0066 ]根据上述方法,其中该第二固定时间为3ms至2 s。 [0066] According to the above method, wherein the second fixed time of 3ms to 2 s.

[0067]根据上述方法,其中该第一固定时间与该第二固定时间相同。 [0067] According to the above method, wherein the first fixed time same as the second fixed time.

[0068 ]根据上述方法,其中该第一固定时间与该第二固定时间均为2 0ms。 [0068] According to the above method, wherein the first and second fixed time period are both fixed 2 0ms.

[0069] 根据上述方法,其中该第一期间为0ms至50ms。 [0069] According to the above method, wherein the first period of 0ms to 50ms.

[0070]根据上述方法,其中该第一期间为20ms。 [0070] According to the above method, wherein the first period is 20ms.

[0071] 根据上述方法,其中该传感器为一电化学传感器。 [0071] According to the above method, wherein the sensor is an electrochemical sensor.

[0072] 根据上述方法,其中该方法用以判断该传感器之一测试的有效性。 [0072] According to the above method, wherein the method is used to determine the effectiveness of one of the test sensors.

[0073] 根据上述方法,其中该比值为0.3至3.0时,代表该传感器之该测试为有效。 [0073] According to the method described above, wherein the ratio is 0.3 to 3.0, the test on behalf of the sensors is active.

[0074]根据上述方法,其中该方法可于一待测样品侦测期、一待测样品静置期或一待测样品测量期中任一时点进行。 [0074] According to the above method, wherein the method of detecting in a test sample, a test sample or a test sample was allowed to stand in the measurement period for any point.

[0075] 本发明得藉由下列实施例及图示说明,俾得更深入之了解。 Invention is obtained by the following examples and illustrated embodiments [0075] present, to serve the more in-depth understanding.

附图说明 BRIEF DESCRIPTION

[0076] 图1(A)为一循环伏安曲线;图1(B)为习知测量仪所使用方法之示意图;图1(C)则为图1(B)之放大图; [0076] FIG 1 (A) is a cyclic voltammogram; FIG. 1 (B) is a schematic view of conventional apparatus used for measuring the known method; FIG. 1 (C), compared with FIG. 1 (B) of FIG enlarged;

[0077] 图2(A)为本发明之测量仪10的外观示意图;图2(B)则为电化学感测试片20放大后之正面视图及背面视图;图2(C)为习知测量仪之内部电路示意图; [0077] FIG. 2 (A) of the present invention the appearance of the meter 10 is a schematic diagram; FIG. 2 (B), compared with the electrochemical test strip 20 of the enlarged front view and back view; FIG. 2 (C) is a conventional measurement a schematic diagram of an internal circuit tester;

[0078] 图3(A)为电化学感测试片20沿A-A'截面线之剖面视图;图3(B)至图3(E)则为样本29在毛细管23流动之示意图; [0078] FIG. 3 (A) A-A 'cross-sectional view of the section line of an electrochemical test strip 20 along; FIG. 3 (B) to 3 (E) a schematic view of the flow of the sample in the capillary 29 was 23;

[0079]图4(A)至图4(C)为本发明之测量仪40的内部电路示意图; [0079] FIG. 4 (A) to 4 (C) inside a circuit diagram of the meter 40 of the present invention;

[0080]图5(A)至图5(G)为样本29流动而布满电极之示意图; [0080] FIG. 5 (A) to 5 (G) is a schematic view of a sample electrode 29 and the full flow;

[0081]图6(A)至图6(D)为本发明在样本29流动而布满电极之过程中所测得的电流及电压示意图;图6(E)至图6(1)则为本发明在样本29流动而布满电极之过程中所测得的循环伏安曲线; Compared to FIG. 6 (E) to 6 (1); [0081] FIG. 6 (A) to 6 (D) in the sample flow 29 is a schematic diagram of current and voltage electrodes in the process of the present invention is covered with measured the present invention sample 29 and the full flow process electrodes in the measured cyclic voltammogram;

[0082]图7(A)及图7(B)为本发明之测量仪40之另一内部电路示意图; [0082] FIG. 7 (A) and FIG. 7 (B) of another instrument 40 measuring the internal circuit schematic of the present invention;

[0083]图8为本发明之测量仪40之另一内部电路示意图; [0083] Figure 8 is a further measuring instrument 40 of the invention inside a circuit diagram;

[0084] 图9(A)为本发明电化学感测试片之另一实施例;图9(B)则为图9(A)之电化学感测试片沿BB '截面线之剖面视; [0084] FIG. 9 (A) an electrochemical test strip according to another embodiment of the invention; FIG. 9 (B), compared with FIG. 9 (A) of the electrochemical test strip 'cross-sectional view along the line BB;

[0085] 图10(A)为本发明电化学感测试片之另一实施例;图10(B)为图10(A)之电化学感测试片之分解图;图10(C)为图10(A)之电化学感测试片沿C-C'截面线之剖面视;图10(D)则为样本进入图10(A)之电化学感测试片之示意图及 [0085] FIG. 10 (A) an electrochemical test strip of another embodiment of the invention; FIG. 10 (B) is an exploded view of FIG. 10 (A) of the electrochemical test strip; FIG. 10 (C) of FIG. 10 (A) of the electrochemical sense C-C 'line cross-sectional view of a cross-sectional view along the test piece; FIG. 10 (D), compared with FIG. 10 is a schematic sample entry (A) of the electrochemical test strip and

[0086] 图11(A)为本发明电化学感测试片之另一实施例;图11(B)为图11(A)之电化学感测试片之分解图;图11(C)则为图11(A)之电化学感测试片沿D-D'截面线之剖面视。 [0086] FIG. 11 (A) an electrochemical test strip of another embodiment of the invention; FIG. 11 (B) is an exploded view of FIG. 11 (A) of the electrochemical test strip; FIG. 11 (C) was FIG 11 (A) of the electrochemical test strip along a D-D 'cross-sectional view of section line.

[0087] 主要组件符号说明 [0087] Description of Symbols major components

[0088] 1〇〇、1〇8、116时间101样本存在侦测期 [0088] 1〇〇, 1〇8,116 time 101 samples to detect the presence of

[0089] 102固定电压103、115时点 [0089] 102 fixed voltage point 103, 115

[0090] 104零电压105静置期 [0090] 104 105 zero-voltage rest period

[0091] 106侦侧期107默认电压 [0091] 106 after checking the default voltage of 107

[0092] 109、110电流量112样本侦测门坎 [0092] 109 current threshold detector 112 samples

[0093] 113样本量门坎114样本量延滞时期 [0093] The sample size threshold 113 114 sample delay period

[0094] 10测量仪11插槽 [0094] 10 gauge slot 11

[0095] 12显示器20电化学感测试片 [0095] 12 display an electrochemical test strip 20

[0096] 21、22、91、92 电极23 毛细管 [0096] 21,22,91,92 electrode capillary 23

[0097] 24、25 接触26、1009样本入口 [0097] 24, 25 contacting the sample inlet 26,1009

[0098] 27覆盖板28气孔 [0098] cover plate 28 hole 27

[0099] 29、1008样本210、1010 凹槽 [0099] Sample 210,1010 29,1008 recess

[0100] 211、212电极上表面213贯孔 [0100] surface of the through hole 213 on the electrodes 211 and 212

[0101] 214试剂41、701微处理器 [0101] Microprocessor 214 reagent 41,701

[0102] 42显示器43电源供应单元 [0102] The power supply unit 42 display 43

[0103] 44电流测量单元45电流 [0103] 44 current measuring unit 45 current

[0104] 46电流电压转换器47模拟数字转换器 [0104] 46 current-voltage converter 47 analog-digital converters

[0105] 48电流缓冲器49电压调节器 [0105] 48 voltage regulator current buffer 49

[0106] 410温度测量单元411、Vwc电极工作电压 [0106] 410 temperature measuring unit 411, Vwc operating voltage electrode

[0107] 412试片插入侦测单元SW、S1、S2、S3、S4开关 [0107] 412 test strip insertion detecting unit SW, S1, S2, S3, S4 switch

[0108] 415、715、815电压切换单元装置 [0108] 415,715,815 voltage switching unit means

[0109] 413、414、Vcl、Vc2 接点 [0109] 413,414, Vcl, Vc2 contacts

[0110] 416、716控制点417反向器 [0110] 417 inverter control point 416,716

[0111] 420切换开关组Vo模拟电压 [0111] 420 changeover switch set analog voltage Vo

[0112] Vw、Vc、Vx、Vy、Vr、Vref 电位 [0112] Vw, Vc, Vx, Vy, Vr, Vref potential

[0113] Vxy电压差R1、R2电阻 [0113] Vxy voltage difference R1, R2 resistor

[0114] X、Y输出点t0~t8时间 [0114] X, Y output time point t0 ~ t8

[0115] Ixa、Iya、Ixb、Iyb、Ixc、Iyc、Ixd、Iyd 电流值 [0115] Ixa, Iya, Ixb, Iyb, Ixc, Iyc, Ixd, Iyd current value

[0116] 93第三电极1104第三薄膜电极 [0116] The third electrode 93 of the third thin film electrode 1104

[0117] 1001、1101薄膜电极感测试片 [0117] sensing electrode film test strip 1001, 1101

[0118] 1002、1003、1102、1103、1104 薄膜电极 [0118] thin film electrode 1002,1003,1102,1103,1104

[0119] A-A'、B-B'、C-C'、DD' 截面线 [0119] A-A ', B-B', C-C ', DD' section line

具体实施方式 Detailed ways

[0120]本案之提供一种用于侦测流体待测样品覆盖于电化学传感器电极表面积布满率以判断测试有效性之方法,将可由以下的实施例说明而得到充分了解,并使得熟习本技艺之人士可以据以完成之,然而本案之实施型态并不限制于下列实施例中。 [0120] The case provides a method for detecting a fluid sample to be tested to cover the full surface area of ​​the electrode electrochemical sensor to determine the validity of the test method will be described by the following examples but well-understood, and so that one skilled in the those of skill in the completion of the data may, however, the case is not limited to the embodiment patterns the following examples.

[0121] 请参阅图2(A),其为本发明之使用电化学感测试片的一测量仪10的外观示意图。 [0121] Please refer to FIG. 2 (A), the appearance of which the present invention using an electrochemical test strip to a measuring device 10 of FIG. 测量仪10包含一具有一显示器12的外壳,用以显示测量结果,并包括一插槽11,用以插入一电化学感测试片20。 A measuring instrument 10 comprises a housing having a display 12 for displaying measurement results, and includes a slot 11 for inserting an electrochemical test strip 20. 图2(B)则为电化学感测试片20放大后之正面视图(图2(B)左)及背面视图(图2(B)右)之示意图,其中电化学感测试片20更包含电极21及22。 FIG 2 (B), compared with the electrochemical test strip 20 of the enlarged front view (FIG. 2 (B) left) and a rear view (FIG. 2 (B) right) of the schematic, where the electrochemical sensor strip further comprises an electrode 20 21 and 22.

[0122] 图2(C)为习知测量仪之示意图,该测量仪10包含一微处理器13、一显示器14、一电源供应单元15、一电流测量单元16、一电流17、一电流电压转换器18、一模拟数字转换器19、 一电流缓冲器120、一电压调节器121、一温度测量单元122、以及具有一开关SW之一试片插入侦测单元124,其中电流电压转换器18包含于电流量测单元16之中,用以将电极21、22之间的电流17转换成一模拟电压Vo (其中Vo = IX Rf ),再透过模拟数字转换器19将此模拟电压Vo转成电压的等效数字信号,以供微处理器13计算。 [0122] FIG. 2 (C) is a schematic diagram of a conventional meter, the meter 10 includes 13, 14, 15, 16, a current 17, a current measuring unit a voltage-current power supply a display unit a microprocessor converter 18, an analog to digital converter 19, a current buffer 120, a voltage regulator 121, a temperature measuring unit 122, a switch SW and a one test strip insertion detecting unit 124, wherein the current-voltage converter 18 among included in the current measuring unit 16 for converting current 17 between electrodes 21 and 22 into an analog voltage Vo (where Vo = IX Rf), and then through an analog to digital converter 19 to turn this analog voltage Vo equivalent digital voltage signal to the microprocessor 13 for computing. 而电压调节器121以及电阻R1、R2所构成的分压器,用以施加电压至接点Vcl,电流缓冲器120则具有一大电流驱动能力,用以在接点Vc2输出与接点Vcl相同的一电位。 And the voltage regulator 121, and resistors R1, R2 of the voltage divider consisting of, for applying a voltage to the contact Vcl, a current buffer 120 having a large current drive capability to an output potential of the junction point Vc2 at the same Vcl . 此时接点125之电位为Vw,接点126之电位为Vc,一电极工作电压123为Vwc,亦即等于Vw与Vc之间的电位差。 At this time, the contact point 125 is the potential Vw, to the contact potential Vc of 126, an electrode 123 for the operating voltage Vwc, i.e. equal to the potential difference between Vw and Vc. 此电极工作电压123被施加于接点125、126之间,而可被连接至感测试片20的输出接触24及25。 This working electrode 123 voltage is applied between the contacts 125, 126, and the output may be connected to the test strip 20 contacts 24 and 25.

[0123] 请续参阅图3(A)至(E),其为待测样本流入电化学感测试片20,并布满于电极21及22过程之示意图。 [0123] Please refer to FIG CONTINUED 3 (A) to (E), which flows into the electrochemical test strip as a sample to be tested 20, and covered in a schematic diagram of the process 22 and the electrode 21.

[0124] 图3(A)为电化学感测试片20沿A-A'之剖面视图,电化学感测试片20包含一毛细管23、输出接触24、25、一样本入口26、一覆盖板27、一气孔28、一样本29、一凹槽210、电极上表面211及212、贯孔213及试剂214。 [0124] FIG. 3 (A) is a cross-sectional view of an electrochemical test strip 20 along the A-A ', the electrochemical sensor strip 20 includes a capillary 23, output contacts 24 and 25, as this inlet 26, a cover plate 27 , a hole 28, 29, like the present, a recess 210, upper surface 211 and the electrode 212, through hole 213 and the agent 214. 其中电极21、22被设置于电化学感测试片20的凹槽210内的贯孔213中。 Wherein electrodes 21, 22 are disposed in the grooves 210 of the electrochemical test strip 20 of the through hole 213. 电极21、22的周围被贯孔213紧紧围绕而没有形成任何缺口。 Electrodes 21 and 22 around the through hole 213 is formed without any gaps focus. 贯孔213的直径被设计为稍小于电极21、22的直径,使电极21、22可以在贯孔213中被机械式地抓住。 The diameter of the through hole 213 is designed to be slightly smaller than the diameter of the electrodes 21 and 22, the electrodes 21 and 22 can be mechanically caught in the through hole 213.

[0125] 电极21、22的上表面211、212形成电极的工作面积,而上表面211、212的大小可以彼此相同或不同,而电极的下端则形成感测试片20的输出接触24、25,这些输出接触可分别与图2(C)中测量仪10的接点125、126连接。 An upper surface [0125] 211, 212 form electrodes 21 and 22 working area of ​​the electrode, and the size of the upper surface 211, 212 may be the same or different from each other, and the lower end of the output electrode of the test strip 20 into contact 24, 25, these contacts may be respectively output measuring instrument 10 of the contacts 125, 126 are connected (C) in FIG. 2. 而亲水性覆盖板27具有与外界相通的气孔28,并覆盖凹槽210以形成毛细管23,该毛细管23定义出一反应区,提供试剂214涂布在凹槽210 内,并覆盖电极21、22的电极上表面211、212。 And the hydrophilic cover plate 27 having a hole 28 communicating with the outside, and covering the groove 210 to form a capillary 23, the capillary tube 23 defining a reaction zone, there is provided a coating agent 214 in the recess 210, and to cover the electrodes 21, surfaces 211, 212 of the upper electrode 22. 试剂214包含一已知的氧化或还原酵素例如一葡萄糖氧化酶,一电子传递中介物例如亚铁氰化钾(Fe(CN)63-),以及一些亲水性的化学物质。 Agent 214 includes a known oxidation or reduction, for example, a glucose oxidase enzyme, an electron transfer mediator, for example, potassium ferrocyanide (Fe (CN) 63-), as well as some hydrophilic chemicals. 试剂的组成份为习知技术而非本发明的重点。 Parts of the composition agent technology rather than conventional focus of the present invention. 此外该感测试片20更提供样本入口26,用以置入样本29,例如一滴血。 In addition, the sensor strip 20 also provides a sample inlet 26 for the sample 29 into, for example, a drop of blood.

[0126] 请参阅图3(B),当样本29被放上样本入口26的开口时,因为毛细管作用或亲水作用,该血滴会自动被吸入毛细管23。 [0126] Refer to FIG. 3 (B), when the sample 29 is placed on the sample inlet opening 26, since the hydrophilic capillary action or effect, which will automatically drop of blood is drawn into the capillary tube 23. 而图3(B)至图3(E)则显示样本29在毛细管23内的流动情形。 And FIG. 3 (B) to 3 (E) is the case of the sample flow 29 in the capillary 23 is displayed. 当足够的样本29被滴入样本入口26时,便会如图3 (C)及(D)所示,开始沿着毛细管23 流动,直到如图3(E)所示完全覆盖电极,此时而毛细管23中的空气则会经由开口28排出。 When sufficient sample 29 is dropped into the sample inlet 26, will be shown in FIG 3 (C) and (D), began to flow along capillary 23 until as shown in FIG 3 (E) completely covering the electrode, the case and capillary 23 will be discharged through the air opening 28. 在图3(B)中,由于样本29尚未流动至电极22,故虽在样本存在侦测期101时已经施加电压至电极上,但因仍未导通所以尚未产生电流。 In FIG 3 (B), since the sample flow 29 to the electrode 22 yet, it has been applied to the upper electrode when a voltage detected despite the presence in the sample of 101, but has not yet turned on so that current is generated. 在图3(C),样本29已完全覆盖电极21并部分覆盖电极22,此时施加电压于电极上,将会有电流产生,测量仪10即需判断此电流是否已到达样本侦测门坎112,因此样本侦测门坎112的定义极为重要。 In FIG 3 (C), sample 29 has been completely covered by the electrode 21 and partially covers the electrode 22, when voltage is applied to the electrode, there will be a current generator, i.e., the meter 10 determines whether the required sample detected current has reached the threshold 112 thus defined detection threshold of 112 samples is extremely important. 由图3(C)可明显发现,此时样本29并未完全覆盖电极22,若样本侦测门坎112定义过小,则可能使测量仪10误判,而开始静置期105至测量期106的步骤,如此所得之样本浓度并不正确;反之,若样本侦测门坎312定义过大,因不同样本有不同的成分含量,如血液中的血球容积比(HCT )、含氧量、葡萄糖浓度或脂肪含量的不同,如图3(D)或(E),虽样本29已几乎完全充满于凹槽210,但样本存在侦测期101所产生之电流可能无法超过样本侦测门坎112,使得测量仪10无法进行静置期105至测量期106的步骤。 Found evident from FIG. 3 (C), the sample 29 at this time does not completely cover the electrode 22, if the sample is too small to detect the threshold 112 is defined, the gauge 10 can be false, rest period 105 to start measurement of 106 step, the concentration of the sample thus obtained is not correct; on the contrary, if the sample detecting threshold 312 is defined too large, because of different samples have different ingredients, such as hematocrit (HCT) in the blood, the oxygen content, the glucose concentration or a different fat content, FIG. 3 (D) or (E), although the sample 29 is almost completely filled in the groove 210, but the sample to detect the presence of current 101 may not be generated over the sample detection threshold 112, such that 10 gauge measurement of step 105 to 106 can not be allowed to stand on. 因此,提供一可正确判断待测物体积量于反应区是否足够,以获得有效之感测电流的方法,对此类测量仪而言极为重要。 Thus, a determination can be accurately measured volume of material in the reaction zone is sufficient to obtain an effective method of current sensing, measuring instrument is extremely important for such purposes.

[0127] 请参阅图4(A),其为本发明之使用电化学感测试片20的测量仪40的示意图,需特别强调的是,虽然图4(A)及其后所述的测量仪40与电化学感测试片20外观与习知者相同, 惟本发明在测量仪40的内部电路及其量测方法上,相较于前案已有大幅度之进步。 [0127] Please refer to FIG. 4 (A), a schematic view of an electrochemical test strip 40 of the meter 20 of the present invention which is used, particularly emphasized that although FIG. 4 meter (A) and after the 40 20 appearance by conventional electrochemical test strip is the same, but the present invention is in the internal circuit and the measuring method of measuring instrument 40, compared to the previous case of the prior substantial progress. 至于图4 (A)中之电化学感测试片20,已于图2(A)至(E)及其相对应之说明中详述,故于此将不再重复。 As an electrochemical sensing FIG. 4 (A), the test piece 20, has in FIG. 2 (A) to (E) and the corresponding detailed description, it will not be repeated herein.

[0128] 请续参阅图4(A),该测量仪40包含一微处理器41、一显示器42、一电源供应单元43、一电流测量单元44、一温度测量单元410、具有一开关SW之一试片插入侦测单元412、以及一电压调节器49,电流量测单元44包含一电流电压转换器46,用以将接点413、414之间一电流45转换成一模拟电压Vo(其中Vo = I XRf),再透过一模拟数字转换器47将此模拟电压Vo转成电压的等效数字信号以供微处理器41计算。 [0128] Please refer to FIG. Continued 4 (A), the meter 40 includes a microprocessor 41, a display 42, a power supply unit 43, a current measurement unit 44, a temperature measuring unit 410, a switch SW having the a test strip insertion detecting unit 412, and a voltage regulator 49, current measuring means 44 comprises a current-voltage converter 46 to the contacts 45 a current is converted into an analog voltage Vo (where Vo = between 413 and 414 I XRf), then through a digital-analog converter 47 this signal voltage Vo is converted into a digital equivalent of the analog voltage to the microprocessor 41 for computing. 电压调节器49以及电阻R1、R2所构成的分压器,用以施加电压至接点Vcl,一电流缓冲器48,具有一大电流驱动能力,用以在接点Vc2,输出一与接点Vcl相同的电位。 The voltage regulator 49, and resistors R1, R2 of the voltage divider consisting of, for applying a voltage to the contact Vcl, a current buffer 48 having a large current drive capability for Vc2 is at the contact, and the contact output of a same Vcl potential. 此时接点413之电位为Vw,接点414之电位为Vc,一电极工作电压411为Vwc (等于Vw与Vc之间的电位差)因此被施加于接点413、414之间。 At this time, the potential of the contact 413 is Vw, the potential of the contact 414 is of Vc, a voltage of the working electrode 411 is Vwc (equal to the potential difference between Vw and Vc) is thus applied to the junction between 413 and 414.

[0129] 图4(A)所示之本发明所使用的测量仪示意图,除了电压切换单元装置415之外,其它部分和电路的设计为习知技术。 [0129] FIG. 4 (A) a schematic view of the meter used in the present invention as shown, the apparatus in addition to the voltage switching unit 415, and other portions of the circuit design for the conventional technology.

[0130]电压切换单元装置415包含由S1、S2、S3及S4四个开关(Switches)组成的切换开关组420,此四个开关可由习知的机械式继电器(Relay)或电子式1C型的模拟开关(Analog Switch)或以电子式晶体管(MOSFET or Bipolar晶体管)组成的桥式开关来达成切换功能。 [0130] voltage switching means comprises a switch means 415 the group consisting of S1, S2, S3 and S4 four switches (Switches) consisting of 420, this switch may be four conventional mechanical relay (Relay) or electronic type 1C analog switches (analog switch) or electronic bridge switching transistors (MOSFET or Bipolar transistors) consisting of switching function to achieve. 而电压切换单元装置415更包含一控制点416,用以传送由微处理器41所传出之数字控制讯号,来加以控制切换开关组420中的S1及S4开关的闭合或开路;其中,当控制点416的信号为1时,则S1及S4开关同时闭合接通;反之,当控制点416的信号为0时,则S1及S4开关同时开路隔离。 Voltage switching unit 415 and the apparatus further comprises a control point 416 for the digital control signals transmitted from the microprocessor 41 came to be in the group 420 controls the switch S1 in a closed or open and switch S4; wherein, when a signal control point 416 is 1, while the switch S1 is closed and S4 is turned on; the contrary, when the control signal 416 is 0 point, while the switches S1 and S4 open isolation. 电压切换单元装置415更包含一反向器417,这是数字电路(逻辑电路)的基本组成之一,用以将输入讯号反向,就二进制逻辑来说,当输入〇时,输出为1,反之,当输入为1时,则输出为〇,其用于控制该开关组420中的S2及S3开关的闭合或开路,且让S2及S3的闭合时刻刚好与S1及S4的时刻相反,此两组开关只能于同一时刻选用一组为闭合状态。 Voltage switching unit 415 further comprises a counter means 417, which is one of the basic components of a digital circuit (logic circuit) for the inverted input signal, to binary logic, when the input square, the output is 1, Conversely, when the input is 1, the output is square, open or closed for controlling the switch group 420 and S2 switch S3, and S2, and S3 so that the closing timing coincides with the timing of S1 and S4, contrary to this only two sets of switches at the same time by using one of the closed state. 该电压切换单元装置415的控制说明如下: Means for controlling the voltage switching unit 415 is described as follows:

[0131] 如图4(B),当微处理器41给予控制点416-数字讯号1时, [0131] FIG. 4 (B), when 1 is given to the microprocessor 41 the control point 416 digital signal,

[0132] 此时输出点X经由S1的闭合与接点413接通而电位相同,输出点X与接点413之电位分别为Vx及Vw; [0132] At this time, the output point X of the same contact point S1 is closed via the potentiometer 413 is turned on, the potential of the output point X and point 413 and Vx and Vw respectively;

[0133] 而输出点Y经由S4的闭合与接点414接通而电位相同,输出点Y与接点414之电位分别为Vy及Vc; [0133] Y is output point S4 is turned on via the closing contact point 414 the same potential, the potential of the output point 414 of the contact point Y, respectively Vy and Vc of;

[0134] 此时Vx = Vw且Vy = Vc,故两输出点X及Y之间电位差,即为接点413及414之电位差411(Vwc), [0134] At this time, Vx = Vw and Vy = Vc, so that the potential difference between two output points X and Y, that is, the contact potential difference between the 413 and 414 411 (Vwc),

[0135] 因Vx>Vy,故此时与输出点X相连的电极21为工作电极。 [0135] because of Vx> Vy, so that the output at this time point X electrode 21 connected to the working electrode.

[0136] 另如图4(C),当微处理器41给予控制点416-数字讯号0时, [0136] Another in FIG 4 (C), the microprocessor 41 when the control point 416 given digital signal 0,

[0137]此时输出点X经由S2的闭合与414接通而电位相同,输出点X与接点414之电位分别为Vx及Vc; [0137] At this time, the output point X S2 is turned on via the closing of the same potential 414, the potential of the output point 414 of the contact point X respectively Vx and Vc of;

[0138] 而输出点Y经由S3的闭合与413接通而电压相同,输出点Y与接点413之电位分别为Vy 及Vw; [0138] Y is turned on via the output point S3 is closed the same voltage 413, the output point Y junction potentials Vy and 413 and Vw respectively;

[0139] 此时Vx = Vc且Vy = Vw,而两输出点X及Y之间电位差411仍为Vwc, [0139] At this time, the potential difference Vwc still between 411 and Vx = Vc Vy = Vw, and outputs two points X and Y,

[0140] 然因Vx〈Vy,故此时与输出点Y相连的电极22为工作电极。 [0140] However, because of Vx <Vy, so that the output at this time point Y electrode 22 connected to the working electrode.

[0141] 图5、图6为根据本发明的测量方法之一实施例,其中图5为图2(A)之局部放大俯视图,而所进行量测仪操作计有以下之步骤(请同时参阅图2(A)及图4(A)至(C))。 [0141] FIG. 5, FIG. 6 according to an embodiment one of the measuring method of the present invention, wherein FIG. 5 FIG. 2 (A) of a partially enlarged top plan view, and performed measurement instrument operation count following the steps (see simultaneously FIG 2 (A) and FIG. 4 (A) to (C)).

[0142] (1)插入电化学感测试片20至量测仪10的插槽11,将启动开关412,使微处理器41 开始循环的送出1与〇的讯号至控制点416。 [0142] (a) an electrochemical test strip 20 is inserted into the slot 1110 measuring instrument of the start switch 412, causes the microprocessor 41 starts sending the signal of 1 cycle and square to the control point 416. 此时输出点X与输出点Y电压分别如图6(A)与图6 (C)。 At this time, the output point X and point Y output voltage are shown in Fig 6 (A) and FIG. 6 (C).

[0143] (2)接着显示器12将显示请求供给样本29,典型为一血滴样本,亦为图5各图中之样本29。 [0143] (2) Next, the display 12 will display request supplied sample 29, typically a drop of blood samples, also FIG. 5 of the drawings the sample 29.

[0144] (3)当样本29被放上样本入口26时(请参阅图2(A)或图5(A)),因为毛细管作用或亲水作用,该样本29会被自动吸入毛细管23。 [0144] (3) when the sample 29 is placed on the sample inlet 26 (see FIG. 2 (A) or FIG. 5 (A)), since the hydrophilic capillary action or action, the sample 29 will automatically be sucked capillary 23. 图5(B)至图5(G)显示血滴样本29在毛细管23 内的流动情形。 FIG 5 (B) through 5 (G) show the case of a drop of blood sample 29 to flow within the capillary 23.

[0145] (4)此时微处理器41开始接收到反应电流: [0145] (4) then the microprocessor 41 starts to receive the current to the reaction:

[0146] (a)当时间为0~to时间时,样本29流动状况如图5(B)至图5(C),此时从输出点所接收到的电流分别如图6(B)、(D)所示。 [0146] (a) when is 0 to time to time, the flow state of the sample 29 as shown in FIG 5 (B) to 5 (C), received at this time from the current output point, respectively, to FIG 6 (B), As shown in (D). 可清楚显示,此时样本29尚未流动至电极表面212, 因此无任何电流产生;此时利用电化学之测试方法里的循环伏安法可得到如图6(E)所示的结果; Clearly it shows that, at this time the sample 29 to flow to the electrode surface 212 yet, so no current is generated; in this case an electrochemical test method using the cyclic voltammetry obtained in FIG. 6 (E) results shown;

[0147] (b)当时间为to~t2时,如图5(D),此时血液样本29已部分覆盖电极表面212,因此图6(D)清楚显示已有电流产生,此时从输出点X所接收到电流值为Ixa,而从输出点Y接收到电流值为Iya;然因此时样本29已完全覆盖电极上表面211,但只部分覆盖电极上表面212, 故Ixa远大于Iya;当时点为to~tl时,电极工作电压为Vwc,而此时工作电极为电极21,工作电极表面积为电极21的电极上表面211;当时点为11~t2时,电极工作电压仍为Vwc,但此时工作电极为电极22,工作电极表面积为电极22的部份电极上表面212;从柯特雷尔电流公式所得电流与工作面积成正比之结论,因此将得到此一较小电流Iya的结果;此时利用电化学之测试方法里的循环伏安法可得到如图6(F)所示的结果; [0147] (b) When the time to ~ t2, the FIG. 5 (D), at this time the blood sample 29 has been partially covering the electrode surface 212, and therefore FIG. 6 (D) clearly shows the existing current generated at this time from the output point X Ixa received current value, received from the output point to the current value of Y Iya; Therefore, when the sample 29 is then completely covers the surface of upper electrode 211, but only partially covers the surface of the upper electrode 212, it is much larger than Ixa Iya; At that time point to ~ tl, the working electrode voltage Vwc, the working electrode 21 at a time, the working electrode surface area of ​​the electrode surface 211 of the upper electrode 21; the time point of 11 ~ t2, the voltage of the working electrode is still Vwc, but this time the working electrode 22, the working electrode surface area of ​​the electrode upper portion 22 of the electrode surface 212; formulas resulting from Curt Trail current proportional to the current work area conclusions, thus resulting in this lower current Iya results; electrochemical test method of this case in the cyclic voltammetry obtained the results shown in (F) 6 in FIG;

[0148] (c)当时间为t2~t4时,如图5(E),输出点X、Y所接收到电流分别为Ixb及Iyb,其中Ixb约略等于Ixa,其原因为经过一小段时间后,已有小部分电流的消耗,但其值很小可忽略不计,而Iyb大于Iya,因此时样本29覆盖至电极22的电极上表面212面积较大所致;此时利用电化学之测试方法里的循环伏安法可得到如图6(G)所示的结果; [0148] (c) When the time t4, FIG. 5 (E), the output point X, after a short time lapse t2 ~ Y currents are received and Ixb IYB, wherein Ixb approximately equal Ixa, the reason for the , has been a small part of the current consumption, but its value is negligible small, but greater than Iyb Iya, so when the cover 29 to the surface of the sample 212 due to the larger area of ​​the upper electrode 22; in this case the use of an electrochemical test method the results shown in (G) 6 obtained in the cyclic voltammetry shown in FIG;

[0149] (D)当时间为t4~t6时,如图5(F),输出点X、Y所接收到电流分别为Ixc、IyC,其中Ixc约略等于Ixb,且Iyc大于Iyb,因此时样本29覆盖至电极22的电极上表面212面积又较前一时点更大所致;此时利用电化学之测试方法里的循环伏安法可得到如图6(H)所示的结果; [0149] (D) When the time t4 ~ t6, the FIG. 5 (F), the output point X, Y are received current Ixc, IYC, where Ixc Ixb approximately equal to, and greater than Iyc IYB, so when the sample 29 to cover the upper electrode 22 and a surface area of ​​212 points due to greater than one o'clock before; in this case an electrochemical test method using cyclic voltammetry in the results obtained. 6 (H) in FIG;

[0150] (E)当时间为t6~t8时,如图5(G),输出点X、Y所接收到电流分别为Ixd、Iyd,其中Ixd约略等于Ixc,Iyd大于Iyc,且Iyd几乎与Ixd相等,因为此时血液样本29已完全覆盖至电极22的电极上表面212,且电极上表面211、212面积相同;此时利用电化学之测试方法里的循环伏安法可得到如图6 (I)所示的结果。 [0150] (E) When the time t6 ~ t8, the FIG. 5 (G), the output point X, Y are received current Ixd, Iyd, IXD wherein approximately equal Ixc, Iyd greater than IYC, IYD and almost IXD equal, because the blood sample 29 to completely cover the upper surface 212 of the electrode 22, and the same area of ​​the surface of the electrode 211 and 212; in this case an electrochemical test method using the cyclic voltammetry in Fig. 6 can be obtained results (I) shown below.

[0151] (5)微处理器41接收到电流后,即开始运算并判断样本29于反应区内是否足够,有多种判断方式,例如:设定一时间范围,微处理器41不断的比较从输出点X、Y所接收到的电流值,当lx与Iy比值(Iy/Ix)大于或等于某一预定比值时(亦或当lx与Iy比值(Ix/Iy)小于或等于某一预定比值时),即可进行下一步骤,即为开始进入静置期305,反之即从显示器12 显示样本29体积(即血量)不足;也可设定一时间范围,微处理器41将所有lx与Iy值分别累加,并将累加之lx与Iy值加以计算,当此累加值经计算后之比值大于或等于(亦或小于或等于)某一预定比值时,即可进行下一步骤,反之即从显示器12显示样本29体积(即血量)不足。 After [0151] (5) a microprocessor 41 receives current, i.e., operation starts and determines whether a sufficient sample in the reaction zone 29, there is determined a variety of ways, for example: a setting time, the microprocessor 41 continuously compare the output current value from the point X, Y received, when the lx and Iy ratio (Iy / Ix) is greater than or equal to a predetermined ratio (or will lx and Iy when the ratio (Ix / Iy) is less than or equal to a predetermined when the ratio), to the next step, that is entered rest period 305, i.e., on the contrary from the display 12 to display the volume of the sample 29 (i.e., blood) is insufficient; a time range may be set, the microprocessor 41 will all when the lx and Iy values ​​are accumulated, and to calculate a cumulative value of lx and Iy, when this accumulated value of the calculated ratio is greater than or equal to a predetermined ratio (or will be less than or equal to), to the next step, Conversely i.e. from the display 12 to display a sample volume 29 (i.e., blood) is insufficient.

[0152] (6)当经微处理器41判断样本29于反应区内已足够,即可进行静置期至测量期的标准步骤,而获得一正确的测量电流,经微处理器41将所得测量电流经计算后之样本29中欲分析物浓度显示于显示器12上。 [0152] (6) When the sample is determined by the microprocessor 41 in reaction zone 29 is sufficient, can be left to the standard of measurement of the step, to obtain a correct measurement of current, the microprocessor 41 provides the resulting after the sample 29 was calculated in the current measuring analyte concentration to be displayed on the display 12.

[0153] 如何决定判断待侧样本之较佳布满状况之比值范围,系利用不同的样本体积去进行实验所得到之结果。 [0153] How to decide the range of the preferred ratio is determined to be the side of the full status of the sample, the sample volume with a different system to the experimental results obtained. 其说明如下: Which are described as follows:

[0154] 提供适用于一测量仪之一感测试片,该感测试片所需体积布满为0.7iU,且该感测试片上具有一第一电极及一第二电极,而该第一电极小于该第二电极。 [0154] providing a measuring device suitable for sensing one of the test piece, is filled with the desired volume 0.7iU the sensor strip, and having a first electrode and a second electrode on the test strip, and the first electrode is less than the second electrode.

[0155] 使样本由该第一电极流向该第二电极,该样本体积为0.3yl到0.8yl并进行多次实验。 [0155] The second electrode of the sample by the first electrode to the volume of sample to 0.8yl 0.3yl and many experiments.

[0156] 于一第一固定时间20ms,施加一第一直流电压0 . IV于该第一电极与该第二电极间,使该第一电极之电位高于该第二电极之电位,并记录该第一固定时间所产生之一第一Cottrell电流值。 [0156] a first fixed time to 20ms, applying a first DC voltage 0. IV in between the first electrode and the second electrode, the potential of the first electrode is higher than potential of the second electrodes, and recording a first one of the first Cottrell current value generated by the fixed time.

[0157] 移除该第一直流电压并停滞一第一期间20ms。 [0157] removing the first DC voltage and a stagnation during the first 20ms.

[0158] 于一第二固定时间20ms,施加一第二直流电压0.1 V于该第一电极与该第二电极间,使该第二电极之电位高于该第一电极之电位,并记录该第二固定时间所产生之一第二Cottrell电流值。 [0158] a second fixed time to 20ms, applying a second current to the 0.1 V thus between the first electrode and the second electrode, the potential of the second electrode higher than the potential of the first electrode, and the recording one of the second Cottrell current value generated by the second fixed time.

[0159] 计算该第一Cottre 11电流值与该第二Cottre 11电流值之一比值。 [0159] One of the current value 11 and the second current value Cottre 11 calculates a ratio of the first Cottre.

[0160] 上述每一种样本体积皆经过以上之步骤10次以上反复验证,并统计该比值范围, 并计算该第一Cottrell电流值之精确度,得一统计表格(表一),如下: [0160] The volume of each sample are to undergo more than 10 times of the repeated verification step, and counts the ratio range, and the accuracy of the calculation of the first Cottrell current value to obtain a statistical table (Table 1), as follows:

[0161] 表一: [0161] Table I:

[0162] [0162]

Figure CN106053585AD00151

[0163] 由上表一可知,当该样本体积过小时,如0.3yl,该第一Cottrel 1电流值无法量得, 因为此时样本体积不足以从该第一电极流至该第二电极。 [0163] From the above table a clear, when the sample volume is too small, such as 0.3yl, the first current value Cottrel 1 can not get the amount, because the sample volume is insufficient to flow from the first electrode to the second electrode. 当样本体积为〇.如1,虽已可量得该第一Cottrel 1电流值,但其电流精确度过差(CV> 10 % )。 When the sample volume is square as 1, may be the amount of the first Cottrel Although a current value obtained, but the difference in current through precise (CV> 10%). 增加样本体积至0.45yl~0.8yl 时,该第一Cottrell电流值的精确度较佳(CV〈5%),此时(第一/第二)Cottrell电流比值范围为0.3~1.7,反之(第二/第一)Cottrell电流比值范围为0.6~3.3,因此当电流比值落在0.3~3.3范围时,可代表待测样本于该感测试片中布满状况良好。 The sample volume is increased to 0.45yl ~ 0.8yl, the accuracy of the first preferred Cottrell current value (CV <5%), this time (first / second) Cottrell current ratio in the range of 0.3 to 1.7, and vice versa (the first two / first) ratio of the Cottrell current range is 0.6 to 3.3, and therefore when the current ratio falls outside the range of 0.3 to 3.3, to the test sample may represent a sense test pieces covered in good condition.

[0164] 图7(A)及(B)为本案另一实施例,于电压切换单元装置715所使用之方法与图4电压切换单元装置415有所不同,图7中之电压切换单元装置715由控制点716接收由微处理器701所发出命令进行S1、S2、S3间之切换,其说明如下。 [0164] FIG. 7 (A) and (B) of the case to another embodiment, the voltage switching unit 715 used in the method of FIG. 4 and the voltage switching unit 415 to vary the voltage switching unit of FIG. 7 715 716 received by the control command issued by the microprocessor 701 to switch between the S1, S2, S3, which is described below.

[0165] 当S1与S2相连接时,如图7(A)所示,此时: [0165] When S1 and S2 are connected, FIG. 7 (A), the case:

[0166] Vx = Vref = V1 =Vr [0166] Vx = Vref = V1 = Vr

[0167] Vy = V2 = [(R2+R3)/(R1+R2+R3)]Vr, [0167] Vy = V2 = [(R2 + R3) / (R1 + R2 + R3)] Vr,

[0168] Vxy = Vx-Vy = Vr-[(R2+R3)/(R1+R2+R3)]Vr [0168] Vxy = Vx-Vy = Vr - [(R2 + R3) / (R1 + R2 + R3)] Vr

[0169] =[Rl/(Rl+R2+R3)]Vr; [0169] = [Rl / (Rl + R2 + R3)] Vr;

[0170] 因此Vx>Vy,此时输出点X所连接之电极21即为工作电极。 [0170] Thus Vx> Vy, electrode output at this time of point X is connected is the working electrode 21.

[0171] 而当S1与S3相连接时,如图7 (B)所示,则: [0171] When S1 and S3 connected, FIG. 7 (B) as shown, then:

[0172] Vx = V3 = [R3/(R1+R2+R3)]Vr, [0172] Vx = V3 = [R3 / (R1 + R2 + R3)] Vr,

[0173] Vy = V2 = [(R2+R3)/(R1+R2+R3)]Vr, [0173] Vy = V2 = [(R2 + R3) / (R1 + R2 + R3)] Vr,

[0174] Vxy = Vx-Vy = [R3/(R1+R2+R3)]Vr-[(R2+R3)/(R1+R2+R3)]Vr; [0174] Vxy = Vx-Vy = [R3 / (R1 + R2 + R3)] Vr - [(R2 + R3) / (R1 + R2 + R3)] Vr;

[0175] =[-R2/(Rl+R2+R3)]Vr; [0175] = [- R2 / (Rl + R2 + R3)] Vr;

[0176] 因此Vy>Vx,此时输出点Y所连接之电极22即为工作电极。 [0176] Thus Vy> Vx, electrode output at this time of point Y is connected is the working electrode 22.

[0177] 于电路设计上,选用R1 = R2时,则会使当S1与S2相连接时的Vxy电压差与S1与S3相连接时的电压数值相同,只是其电压极性相反。 [0177] on the circuit design, R1 = R2 when selected, will cause the value when the voltage Vxy when voltage difference S1 and S3 connected at S1 and S2 is connected to the same, but opposite to the voltage polarity.

[0178] 根据此实施例于S1与S2、S3间相互切换,也可达成如图6所示,得到所欲计算之数值,进而判断血量是否足够。 [0178] According to this embodiment in S1 and S2, S3 each other switch, also shown in Figure 6 can be achieved, to obtain the desired value of the calculation, and then determine whether or not enough blood.

[0179] 图8为本案再另一实施例,于电压切换单元装置815与先前实施例又有所差异,于该实施例中Vx = Vr为一固定电压值,而电压切换单元装置815根据由微处理器801所发出命令进行数字讯号转换成模拟电压(Digital to Analoy Voltage Converter)输出至Vcl,经由电流缓冲器〇P2增强其电流的输出驱动力,此时电压不变仍为使Vy = Vcl,即由微处理器801所发出命令进行数字讯号来调整Vy的电压大小,以达到电压切换的功能。 [0179] FIG. 8 is the case yet another embodiment, the voltage switching unit 815 means there are differences with the previous embodiments, in this embodiment, Vx = Vr is a fixed voltage value, the voltage switching unit 815 according to the microprocessor 801 issues a command to the digital signal into an analog voltage (digital to Analoy voltage converter) output to Vcl, which outputs the driving force to enhance the current through the current buffer 〇P2, when the voltage remains constant so that Vy = Vcl , i.e., a command issued by the microprocessor 801 adjusts the digital signal voltage magnitude Vy to achieve the voltage switching function. 其控制程序如下: Control program is as follows:

[0180] 预先设计欲施加于输出点X与输出点Y间的电极工作电压Vxy的绝对值为Q; [0180] absolute value of the pre-designed to be applied to the working electrode output voltage Vxy between the point X and the point Y to the output Q;

[0181] 于第一时间,由微处理器801所发出命令进行数字讯号来调整Vcl,让 [0181] than the first time, the command issued by the microprocessor 801 adjusts the digital signal Vcl, so

[0182] Vcl =Vy = Vx-Q; [0182] Vcl = Vy = Vx-Q;

[0183] j/llJVxy = Vx-Vy = Vx- (Vx-Q) = Q; [0183] j / llJVxy = Vx-Vy = Vx- (Vx-Q) = Q;

[0184] 此时Vx>Vy,故输出点X所连接之电极21即为工作电极。 [0184] At this time, Vx> Vy, so the output of the X electrode 21 is the connecting point of the working electrode.

[0185] 于第二时间,由微处理器801所发出命令进行数字讯号来调整Vcl,让 [0185] in a second time, a command issued by the microprocessor 801 adjusts the digital signal Vcl, so

[0186] Vcl =Vy = Vx+Q; [0186] Vcl = Vy = Vx + Q;

[0187] 贝iJvXy = vx-Vy = vx-(vx+Q) =-Q; [0187] Pui iJvXy = vx-Vy = vx- (vx + Q) = -Q;

[0188] 此时Vx〈Vy,故输出点Y所连接之电极22即为工作电极。 [0188] At this time, Vx <Vy, so the output connection point of the Y electrode 22 is the working electrode.

[0189] 根据此实施例,于第一时间及第二时间由微处理器801所发出命令进行数字讯号改变来调整Vcl电压值的相互切换,也可达成如图6所示,得到所欲计算之数值,进而判断血量是否足够。 [0189] According to this embodiment, at a first time and a second time by the microprocessor 801 to issue commands to change the adjusted digital signal Vcl switching between the voltage value can be achieved also shown in FIG. 6, is calculated to give the desired the value, and then determine whether or not enough blood.

[0190] 透过本发明,更可当样本29进入样本入口26、而微处理器41、701、801接收到一电流时,依习知技术设定一样本侦测门坎112,当该电流到达该门坎后,即进入静置期105至测量期106之标准步骤,并于静置期105或测量期106中某一时点,进行本发明以上实施例之电压切换,以获得供微处理器41、701、801计算之lx与Iy,再进行本发明以上实施例之计算与判断之步骤,用以确定该测量期后所得之结果是否正确。 [0190] Through the present invention, but also when the sample 29 into the sample inlet 26, the microprocessor receives a current 41,701,801, according to conventional art is set as the present threshold detector 112, when the current reaches after this threshold, i.e., into the left of the standard steps 105 to 106 of the measurement period, and allowed to stand at a point in time of the measurement period 105, or 106, for the above embodiment of the present invention, the voltage switching embodiment, for the microprocessor 41 to obtain, calculation of lx 701, 801 and Iy, then the step of calculating the judgment of the above embodiment of the present invention, after the measurement period to determine the obtained result is correct.

[0191] 换句话说,本发明所述之方法,在样品存在侦测期101、静置期105或测量期106中某一时点均可以进行计算,用以判断该测量期后之计算结果有效性。 [0191] In other words, the method of the present invention, detecting the presence in the sample of 101, 105 or the left of the measurement of a point 106 can be calculated, for determining whether the calculation result of the measurement of the effective sex.

[0192] 请参阅图9(A)及(B),为图2电化学感测试片之另一实施例。 [0192] Please refer to FIG. 9 (A) and (B), FIG. 2 is another embodiment of an electrochemical test strip. 该结构包含电极91、 92,如前所述,电极91、92会于电压切换装置作动时,而于某一时点成为工作电极而产生所需计算用以判断之Cottrel 1电流,该实施例更佳为含有一第三电极93,该第三电极93可为一参考电极(reference electorde)。 The structure includes an electrode 91, 92, as described above, when the actuating means 91 and 92 are switched to the voltage electrode, and sometimes certain point becomes the working electrode to produce the desired current is calculated for the determination Cottrel 1, this embodiment more preferably 93 comprising a third electrode, the third electrode 93 may be a reference electrode (reference electorde). 当该电化学感测试片之测量仪确认血量样本已足够, 经静置期105后进入测量期106,该参考电极93可帮助于测量期106所需施加之预设电压107 更为稳定而得一更为精确之感测电流。 When the gauge of the electrochemical sensor strip is sufficient to confirm a sample of blood into the rest period 105 after the measurement period 106, the reference electrode 93 may be help to the preset voltage is applied to the desired measurement of 106 107 and more stable get a more accurate sense of the current.

[0193] 图10(A)至(D)及图11(A)至(C)所示分别为薄膜电极感测试片1001及1101,其成型与结构可参考如美国专利第5,997,817号、美国专利第5,985,116号、欧洲第EP 1,098,000 号专利等,该薄膜电极1002、1003、1102、1103及1104等,可用网版印刷、金属蒸镀等方法成型,而本发明于该薄膜电极感测试片之应用如图10。 [0193] FIG. 10 (A) to (D) and FIG. 11 (A) to (C) are shown in the thin film 1001 and the sense of the test strip 1101, which may be formed with reference to the structure as described in U.S. Patent No. 5,997,817 No., U.S. Pat. No. 5,985,116, European Patent No. EP 1,098,000, etc., the thin film electrode 1002,1003,1102,1103 and 1104, etc., can be screen printing, metal vapor deposition method for forming, the present invention is applied to the electrode film 10 of the test strip. 如图10(C)所示,当于提供一血量样本1008由样本入口1009进入至该感测试片1001时,其类似图2所述,当血量样本仅流至薄膜电极1002时,此时并无电流产生,待血量样本流至薄膜电极1003如图10(D)时,即可得到如图6 之结果而得到一所需计算用以判断之电流,以判断血量样本1008于凹槽1010内是否足够。 As shown in FIG. 10 (C), when provided in a blood sample enters the sample inlet 1008 to 1009 of the sensor strip 1001, which is similar to Figure 2, when the sample blood flows only to the thin film electrodes 1002, this when no current is generated, to be the blood flow of the sample to the thin film electrode 1003 in FIG. 10 (D), to obtain the results obtained in FIG. 6 for calculating a desired current is determined, the blood sample to determine at 1008 the adequacy of the recess 1010. 该实施例更佳如图11,包含一第三薄膜电极1104,可为一薄膜参考电极。 This embodiment better shown in FIG 11, comprising a third electrode film 1104, a film may be a reference electrode.

[0194] 纵使本发明已由上述之实施例所详细叙述,而可由在此领域具通常知识者任施匠思而为诸般修饰,然皆不脱如申请专利范围所欲保护者。 [0194] Even though the present invention has been described above in detail of the embodiments described embodiments, but may be applied to any person having ordinary knowledge in this field and Carpenter think of all sorts of modifications, however neither patent off as desired range protectors.

Claims (14)

1. 一种判断待测样品布满状况的侦测方法,是应用于包含分离的电极的传感器,所述分离的电极由第一电极与第二电极组成,所述第一电极与所述第二电极被试剂层覆盖,其特征在于,步骤包括: (a) 提供所述待测样品,使其从所述第一电极流向所述第二电极; (b) 提供微处理器及具有开关组的电压切换单元装置,当所述微处理器提供讯号使所述开关组中的第一电路接通且第二电路断开时,于第一固定时间,施加第一反应直流电压于所述第一电极与所述第二电极间,使所述第一电极的电位高于所述第二电极的电位,并记录所述第一固定时间所产生的第一Cottrell电流值,其中所述第一电极作为工作电极, 且所述第一Cottrell电流值与被所述待测样品覆盖的所述第一电极的表面积成正比,所述的第一固定时间为3ms至20ms; (c) 移除所述第一反应直流电压并停滞 A test sample is determined full condition detection method is applied to a sensor comprising electrodes separated, and the separated first electrodes and second electrodes composed of the first electrode and the second two electrodes are covered by the reagent layer, characterized in that, the step comprising: (a) providing the sample to be tested, so that from the first electrode to the second electrode; providing a microprocessor (b) and having a switch group the voltage switching unit of the device, the microprocessor providing the signal when the first switch circuit group and the second circuit is turned OFF, a first fixed time, a DC voltage is applied to the first reaction of between an electrode and the second electrode, the potential of the first electrode is higher than potential of the second electrode and the first recording Cottrell current value generated by the first fixed time, wherein the first as a working electrode, and the first Cottrell current is proportional to the value of the test sample of the first electrode covers the surface area of ​​said first fixed time 3ms to 20ms; (c) removing the a first DC voltage and said reaction stagnation 第一期间,所述的第一期间为0ms至20ms; (d) 所述微处理器提供讯号切换所述电压切换单元装置的所述开关组中的所述第一电路为断开且所述第二电路为接通,并于第二固定时间,施加第二反应直流电压于所述第一电极与所述第二电极间,所述第二反应直流电压的电压值与所述第一反应直流电压的电压值相等,且使所述第二电极的电位高于所述第一电极的电位,并记录所述第二固定时间所产生的第二Cottrell电流值,其中所述第二电极作为所述工作电极,且所述第二Cottrell 电流值与被所述待测样品覆盖的所述第二电极的表面积成正比,所述的第二固定时间为3ms至20ms; (e) 移除所述第二反应直流电压并停滞第二期间,所述的第二期间为0ms至20ms; (f) 循环的重复步骤(b)至步骤(e)至少两次,并各别累加所述第一Cottrell电流值与所述第二Cottrell电流值; (g) 计算所述 A first period, the first period of 0ms to 20ms; (d) providing the microprocessor circuit of the first switch group switching the signal voltage switching unit of the device is turned off and in the the second circuit is on, and fixed to the second time, a second reaction is applied to the DC voltage between the first electrode and the second electrode, the voltage value of the second reaction with the first DC voltage reaction is equal to the voltage value of the DC voltage, and the potential of the second electrode higher than the potential of the first electrode and the second recording Cottrell current value generated by a second fixed time, wherein the second electrode as a the working electrode, and a second surface area of ​​the Cottrell current is proportional to the value of the sample to be tested is covered by the second electrode, the second fixed time 3ms to 20ms; (e) removing the during the second DC voltage and said second reaction stalled, the second period of 0ms to 20ms; at least two repeating steps (b) (f) of the loop to step (E), and accumulating the respective first Cottrell Cottrell current value and the second current value; (G) calculating the 加第一Cottrell电流值与所述累加第二Cottrell电流值的比值,其中所述比值为0.3至3.3,用以反映所述待测样品在所述第一电极及所述第二电极的布满状况;及(h) 于样品体积大于0.45μ1时,判断所述待测样品是否足够,若是,则代表所述传感器对所述待测样品中欲分析物的浓度的测试为有效。 Applying a first Cottrell current value of the ratio of the second Cottrell current accumulated value, wherein said ratio is from 0.3 to 3.3, to reflect the full sample to be tested the first electrode and the second electrode in status; and (h) when the sample volume greater than 0.45μ1, determining whether the test sample is sufficient, if yes, to be representative of the concentration of an analyte sensor test sample for the test valid.
2. -种判断待测样品布满状况的侦测方法,是应用于至少具有第一电极与第二电极的传感器,其特征在于,步骤包括: (a) 提供所述待测样品,使其从所述第一电极流向所述第二电极; (b) 于第一固定时间,施加第一反应直流电压于所述第一电极与所述第二电极间,使所述第一电极的电位高于所述第二电极的电位,并记录所述第一固定时间所产生的第一Cottrell电流值; (c) 移除所述第一反应直流电压并停滞第一期间; (d) 于第二固定时间,施加第二反应直流电压于所述第一电极与所述第二电极间,所述第二反应直流电压的电压值与所述第一反应直流电压的电压值相等,且使所述第二电极的电位高于所述第一电极的电位,并记录所述第二固定时间所产生的第二Co t tre 11电流值; (e) 移除所述第二反应直流电压并停滞第二期间; (f) 重复步骤(b)至步骤(e)至少 2. - kind of the test sample is determined full condition detection method, is applied to at least the sensor having a first electrode and a second electrode, characterized in that, the step comprising: (a) providing the sample to be tested, so that from the first electrode to the second electrode; (b) at a first fixed time, a DC voltage is applied to the first reaction between the first electrode and the second electrode, the potential of the first electrode higher than the potential of the second electrode, and recording the first value of the first Cottrell current generated by the fixed time; (c) removing the first reaction period a first DC voltage and stagnation; (d) to the first two fixed time, a DC voltage is applied to the second reaction between the first electrode and the second electrode, the voltage value and the voltage value of the DC voltage of the second reaction DC voltage is equal to the first reactor, and so the the potential of said second electrode is higher than the potential of the first electrode and the recording current value t 11 Co tre second generated second fixed time; (e) removing the second DC voltage, and the reaction stagnation a second period; (f) repeating steps (b) to step (e) at least 次,并各别累加所述第一Cottrell电流值与所述第二Cottrell电流值;及(g)计算所述累加第一Cottrell电流值与所述累加第二Cottrell电流值的比值,其中所述比值反映所述待测样品在所述第一电极及所述第二电极的布满状况。 Times, and accumulating the respective first Cottrell current value and the second Cottrell current value; and (g) calculating a ratio of the first Cottrell current value and the accumulated value of the second Cottrell current accumulated, wherein said the ratio reflects the full condition in the test sample the first electrode and the second electrode.
3. 如权利要求2所述的方法,其特征在于,所述的第一反应直流电压与第二反应直流电压是透过循环伏安曲线(cyclic voltammograms)决定,且所述第一反应直流电压与所述第二反应直流电压的信号噪声比(S/N Ratio)大于或等于1。 3. The method according to claim 2, wherein the first reaction and the second reaction DC voltage is a DC voltage through cyclic voltammetry (cyclic voltammograms) determined, and the DC voltage of the first reactor the reaction with the second signal to noise ratio of DC voltage (S / N ratio) is greater than or equal to 1.
4. 如权利要求2所述的方法,其特征在于,所述的第一电极与所述第二电极位于同一基版。 4. The method according to claim 2, wherein said first electrode and said second electrode group in the same version.
5. 如权利要求2所述的方法,其特征在于, 所述的第一电极与所述第二电极上具有酵素及电子传递中介物,其中所述酵素对所述待测样品进行氧化反应;或所述的第一电极与所述第二电极上具有酵素及电子传递中介物,其中所述酵素对所述待测样品进行还原反应。 5. The method according to claim 2, characterized in that, with enzymes and electron transfer mediators to the first electrode and the second electrode, wherein the enzyme sample to be tested for the oxidation reaction; and the first electrode or the second electrode having the enzyme and an electron transfer mediator on the enzyme wherein the sample to be tested the reduction reaction.
6. 如权利要求2所述的方法,其特征在于, 所述的第一固定时间为3ms至2s;及/或所述的第二固定时间为3ms至2s。 6. The method according to claim 2, wherein said first fixed time 3ms to 2S; a second fixed time and / or is 3ms to 2s.
7. 如权利要求2所述的方法,其特征在于, 所述的第一固定时间与所述第二固定时间相同;及/或所述的第一固定时间与所述第二固定时间均为20ms。 7. The method according to claim 2, wherein said first fixed time and the same second fixed time; a first fixed time and / or with the second fixed time are 20ms.
8. 如权利要求2所述的方法,其特征在于, 所述的第一期间为〇ms至50ms;或所述的第二期间为〇ms至50ms。 8. The method according to claim 2, wherein said first period of 50ms to 〇ms; or to 〇ms second period is 50ms.
9. 如权利要求2所述的方法,其特征在于, 所述的第一期间及所述第二期间时间相同;及/或所述的第一期间及所述第二期间均为20ms。 9. The method according to claim 2, wherein said first period and said second time period the same; a first period and / or the second period and are 20ms.
10. 如权利要求2所述的方法,其特征在于,所述的第一电极与所述第二电极的电化学反应面积相同,其中当所述比值为1时,表示所述待测样品布满所述第一电极及所述第二电极。 10. The method according to claim 2, wherein the first electrode and the second electrode area of ​​the electrochemical reaction of the same, wherein when said ratio is 1, indicating that the test sample cloth over the first electrode and the second electrode.
11. 如权利要求2所述的方法,其特征在于, 所述的第一电极的电化学反应面积大于所述第二电极的电化学反应面积;或所述的第一电极的电化学反应面积小于所述第二电极的电化学反应面积。 11. The method according to claim 2, characterized in that the electrochemical reaction area of ​​the first electrode is larger than the area of ​​the second electrode of the electrochemical reaction; or the electrochemical reaction area of ​​the first electrode It is smaller than the area of ​​the second electrode of the electrochemical reaction.
12. 如权利要求2所述的方法,其特征在于,所述的传感器为电化学传感器。 12. The method according to claim 2, wherein said sensor is an electrochemical sensor.
13. 如权利要求2所述的方法,其特征在于,所述的方法用以判断所述传感器的测试的有效性,其中所述比值为0.3至3.3时,可代表所述传感器的所述测试为有效。 13. The test method according to claim 2, characterized in that, to test the effectiveness of the method of determination of the sensor, wherein the ratio is 0.3 to 3.3, the sensor may represent as valid.
14. 一种判断待测样品布满状况的侦测方法,是应用于至少具有第一电极与第二电极的传感器,其特征在于,步骤包括: (a) 提供所述待测样品,使其从所述第一电极流向所述第二电极; (b) 提供微处理器及具有开关组的电压切换单元装置,当所述微处理器提供讯号使所述开关组中的第一电路接通且第二电路断开时,于第一固定时间,施加第一反应直流电压于所述第一电极与所述第二电极间,使所述第一电极的电位高于所述第二电极的电位,并记录所述第一固定时间所产生的第一Cottrell电流值,其中所述第一电极作为工作电极, 且所述第一Cottrell电流值与被所述待测样品覆盖的所述第一电极的表面积成正比,所述的第一固定时间为20ms; (c) 移除所述第一反应直流电压并停滞第一期间,所述的第一期间为20ms; (d) 所述微处理器提供讯号切换所述电压切换单 Analyzing the test sample 14. A method of detecting full condition, is applied to at least the sensor having a first electrode and a second electrode, characterized in that, the step comprising: (a) providing the sample to be tested, so that from the first electrode to the second electrode; (b) providing a microprocessor device and a voltage switching unit having a switch group, when the microprocessor provides the signal switching circuit is connected to the first group and the second circuit is turned off, at a first fixed time, a DC voltage is applied to a first reaction between the first electrode and the second electrode, the potential of the first electrode is higher than the second electrode potential, and record the first value of the first Cottrell current generated by the fixed time, wherein the first electrode as the working electrode, and the first Cottrell current value and the test sample is covered with the first is proportional to the surface area of ​​the electrode, the first fixed time is 20ms; (c) removing the first reaction a first DC voltage and the stagnation period, the first period of 20ms; (d) the microprocessor provides the voltage switching signal switching unit 装置的所述开关组中的所述第一电路为断开且所述第二电路为接通,并于第二固定时间,施加第二反应直流电压于所述第一电极与所述第二电极间,所述第二反应直流电压的电压值与所述第一反应直流电压的电压值相等,且使所述第二电极的电位高于所述第一电极的电位,并记录所述第二固定时间所产生的第二Cottrell电流值,其中所述第二电极作为所述工作电极,且所述第二Cottrell 电流值与被所述待测样品覆盖的所述第二电极的表面积成正比,所述的第二固定时间为20ms; (e) 移除所述第二反应直流电压并停滞第二期间,所述的第二期间为20ms; (f) 循环的重复步骤(b)至步骤(e)至少两次,并各别累加所述第一Cottrell电流值与所述第二Cottrell电流值; (g) 计算所述累加第一Cottrell电流值与所述累加第二Cottrell电流值的比值,其中所述比值为0.3至3.3,用以反映所 The first group of said switching circuit means is turned off and in the second circuit is turned on, and fixed to the second time, a second reaction is applied to the first direct voltage electrode and the second between electrodes, the voltage value of the second DC voltage equal to the reaction of the direct current voltage of the first reactor, and the potential of the second electrode is higher than the potential of the first electrode and the second recording two second fixed time value Cottrell current generated, wherein the second electrode as the working electrode, and the second Cottrell current value is proportional to the surface area of ​​the sample to be tested is covered by the second electrode said second fixed time is 20ms; (e) removing the second reaction stalled and a second DC voltage during said second period is 20ms; repeating steps (b) (f) of the loop to step (e) at least twice, and the respective first Cottrell current accumulated value and the second Cottrell current value; (G) calculating a first Cottrell current accumulated value and the accumulated value of the second Cottrell current ratio , wherein the ratio is 0.3 to 3.3, to reflect the 待测样品在所述第一电极及所述第二电极的布满状况;及(h) 于样品体积大于0.45μ1时,判断所述待测样品是否足够,若是,则代表所述传感器对所述待测样品中欲分析物的浓度的测试为有效。 Availability covered sample to be tested the first electrode and the second electrode; and (h) in a sample volume greater than 0.45μ1, determining whether the test sample is sufficient, if it is the representative of the sensor said sample to be tested in the concentration of the analyte test to be valid.
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