Patent Publication Number: US-2004050694-A1

Title: Portable multi-functional electrochemical biosensor system

Description:
BACKGROUND OF THE INVENTION  
       [0001] 1. Field of the Invention  
       [0002] The present invention relates to a portable multi-functional biosensor system, and more particularly to a portable multi-functional biosensor system that is able to detect the concentration of various selected analytes. The portable multi-functional biosensor system of the present invention can utilize a set of sample cell and pluggable information memory each time to detect the concentration of a corresponding selected analyte, and to calculate the concentration of the corresponding selected analyte by using a multi-functional signal analysis processor, and output the detected result. Moreover, with the cooperation of a status detector, whether or not the status of the portable multi-functional biosensor system normally operates is detected.  
       [0003] 2. Description of the Related Art  
       [0004] Portable multi-functional biosensor system are used at specific detection sites that are difficult to reach for large precise detection equipment and operators, for example, remote fields for the purpose of researches, homes and specific places for self medicine care (such as blood sugar, cholesterol, hemoglobin and uric acid) measurements. The portable multi-functional biosensor system are generally classified into optical and electrochemical biosensor systems. Since optical detection is adopted by most large precise detection equipments, a portable optical biosensor system, such as an early developed blood sugar detector, is more widely used. However, the optical biosensor system must be equipped with a light source and a light detector, and thus cannot be further shrunk for easier portability, and the optical biosensor system easily becomes unstable in function due to aging. Furthermore, the optical biosensor system is easily interfered by an external light source, causing undesired inaccuracy. An electrochemical biosensor system can improve this shortcoming. In addition, an electrochemical sample cell is cheaper in manufacture cost than an optical sample cell. Therefore, the portable optical biosensor system is gradually replaced by the portable electrochemical biosensor system.  
       [0005] The portable electrochemical biosensor system has more advantages, but still has several disadvantages that need to be eliminated. Significantly, electrochemical signals sent from electrodes are different due to the different properties of the sample cells. The inaccuracy are caused by the preparations of each batch of agents or the activities of enzymes on the sample cell. As a result, after each batch of sample cells is manufactured, they may not generate the same electrochemical signal for the same concentration detection. Therefore, parameters for detection and calculation calibration for each batch of sample cells must be inputted from outside so that the same type of sample cells can be used in the same electrochemical biodetectror so as to reduce inaccuracy therebetween. Inputting the parameter from outside to control the electrochemical biosensor system which operates with an existing program and a processor and then outputs a result, is similar to inputting data stored on a computer diskette. For applications in minimization, it is similar to a palm card-inserted game machine. U.S. Pat. No. 4,975,647 relates to a bioanalyzer which is controlled by parameters input from the outside, and it is stated that a set of detectors cooperating with a blood analyzer builds parameters for defining calibration timing, volume and concentration of fluids in an externally inserted memory card having a parameter check-sum code, thereby attaining precise detection. U.S. Pat. No. 5,366,609 shows an example of a portable electrochemical biosensor system which is controlled by parameters input from the outside, and is characterized in that:  
       [0006] (1) a predetermined Cottrell current equation (also mentioned in U.S. Pat. No. 5,366,609 and U.S. Pat. No. 5,243,516) is used as follows:  
         Cottrell                 Current     =     i   =       n                 F          D                     CA         π          t                         
 
       [0007] n: number of transferred electrons  
       [0008] F: Faraday&#39;s constant  
       [0009] A: areas of measuring electrodes  
       [0010] C: concentration of the analyte  
       [0011] D: diffusion coefficient of electroactive species  
       [0012] t: time  
       [0013] The Cottrell current can be transformed and shown by the following equation:  
         i                t       =     K        C     t                       
 
       [0014] After continuously detecting an electrochemical analog signal for an analyte (glucose) and accumulating related data in a period of time, a processor converts the analog signal representing the concentration of the analyte (glucose) into a digital signal, and then outputs the digital signal;  
       [0015] (2) during detection, whether or not the externally inserted memory card which stores measurement-related parameters exists or is exchanged is repeatedly checked several times by using a processor connected to the externally inserted memory card, thereby preventing wrong parameters from being input. The above equations and safe check need more complex and precise software and hardware to operate. Consequently, the cost for achieving this object must not be greatly reduced.  
       [0016] In the current markets, portable electrochemical biosensor system, such as Boehringer Mannheim, Roche, MediSense and Matsushita&#39;s blood sugar detector and blood sugar concentration detecting strip, still have only one function for detection. Those manufacturers have not produced or marketed a multi-functional portable electrochemical biosensor system yet. By using various sample cells made by agents or enzymes for detecting concentrations, such as blood sugar concentration biosensor system (ROC Patent Nos. 1094661 and 1243321), uric acid concentration biosensor system (ROC Patent No. 1070731 and U.S. Pat. No. 6,258,230 B1), hemoglobin concentration biosensor system (ROC Patent Publication No. 466344 and U.S. patent application Ser. No. 09/771,634) in cooperation with corresponding parameters input from outside for the uses of detection and calculation calibrations, the present invention not only can simplify the designs of software and hardware, but also can precisely detect the concentration of a selected analyte. Moreover, the detection for the concentrations of various specific analytes can be achieved by a portable detector so as to reduce cost. With such an arrangement, a portable multi-functional electrochemical biosensor system is constructed.  
       [0017] After integration, an operator must be able to confirm frequently whether or not the status of the portable multi-functional electrochemical biosensor system is normal in operation. To meet this requirement, the present invention designs a fixed resistor status detector for simply detecting the status of the portable multi-functional electrochemical biosensor system so as to increase the accuracy thereof.  
       SUMMARY OF THE INVENTION  
       [0018] An object of the present invention is to integrate various detecting devices for detecting the concentrations of various analytes using an electrochemical principle to form a multi-functional biosensor system. In the multi-functional biosensor system of the present invention, a plurality of pluggable information memories corresponding to various sample cells are used to store parameter information required by the sample cells when detecting concentration for function switching. The pluggable information memories and the sample cells are integrated with a multi-functional signal analysis processor to construct a multi-functional electrochemical biosensor system which is light and portable for easy operations.  
       [0019] With a microprocessor and an electrically erasable programmable read/write memory in the multi-functional signal analysis processor, the parameters stored in each pluggable information memory are able to be transferred into the electrically erasable programmable read/write memory, so that the microprocessor only uses internal information for performing detection. The parameters stored in the electrically erasable programmable read/write memory are not updated until the parameters stored in another pluggable information memory are transferred. Moreover, the microprocessor uses a parameter check-sum code to identify whether or not the input parameters are correct, thereby ensuring that the parameter information is not lost.  
       [0020] An electrode of the sample cell is grounded to serve as a reference electrode, and the other electrode of the sample cell provided with a reference potential and having a signal to be amplified via an amplifier and a feed-back resistor serves as an working electrode. During detection, an electrochemical reaction signal output from the working electrode is sent to the multi-functional signal analysis processor for calculating the concentration of a selected analyte.  
       [0021] The multi-functional signal analysis processor comprises a gain adjustable amplifier. The inverting input terminal of the gain adjustable amplifier is connected to the working electrode which is applied with a specific potential. Once the selected analyte is reacted with a reactant in a time, the specific potential supply is terminated. After a detection waiting time designated by the multi-functional information memory lapses, a constant potential is further applied to the working electrode to establish an electrochemical reaction environment. At this time, the electrochemical reaction signal is output from the working electrode, and detected with the parameters stored in the multi-functional information memory. The signal detected from the working electrode is reasonably amplified, and the concentration of the selected analyte is calculated by using the calculation parameters designated in the information memory, and then the detected resultant is output.  
       [0022] Another object of the present invention is to provide a status detector in the portable electrochemical biosensor system to simply detect whether or not the status of the portable electrochemical biosensor system is normal in operation. This facilitates users to frequently detect the status of the biosensor system so as to increase the accuracy of the portable electrochemical biosensor system. 
     
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
     [0023]FIG. 1 is a graph showing the relationship between an electrochemical signal and a uric acid concentration for a conventional uric acid detector.  
     [0024]FIG. 2 is a schematic, perspective view showing a multi-functional electrochemical biosensor system according to the present invention.  
     [0025]FIG. 3 is a schematic view showing a structure of a pluggable memory card.  
     [0026]FIG. 4 is a schematic view showing structures of a concentration detector and a status detector, wherein the concentration detector includes a detected zone and electrodes, and the status detector includes a PCB having two electrodes and a resistor thereon.  
     [0027]FIG. 5 is a block circuit diagram showing a multi-functional signal analysis processor according to the present invention.  
     [0028]FIG. 6 is a circuit diagram showing a signal amplifying unit according to the present invention.  
     [0029]FIG. 7 is a circuit diagram showing an alternative signal amplifying unit according to the present invention.  
     [0030]FIGS. 8 a  and  8   b  are a flow chart of executing a program according to the present invention.  
     [0031]FIG. 9 is a graph showing blood sugar concentrations detected according to the present invention.  
     [0032]FIG. 10 is a graph showing uric acid concentrations detected according to the present invention.  
     [0033]FIG. 11 is a graph showing hemoglobin concentrations detected according to the present invention.  
     [0034]FIG. 12 is a graph showing cholesterol concentrations detected according to the present invention.  
     [0035]FIG. 13 is a graph showing lactic acid concentrations detected according to the present invention.  
                               REFERENCE NUMERALS OF MAJOR ELEMENTS                                        1   portable multi-functional biosensor system       2   Slot       3   Slot       4   Button       5   Display Panel       6   Pluggable memory card       7   Sample cell       8   Detection Zone       9   Electrode       10   Electrode       11   External Cover       12   External Cover       13   PCB       14   Pluggable Information Memory       15   Chip Capacitor       16   Conductive Lines       17   Status Detector                     18-1   Electrode       18-2   Electrode                     19   Fixed Resistor       20   Microprocessor       21   Electronic Erasable Programmable Read/Write Memory       22   Power Managing Device       23   Reference potential Unit       24   Concentration Detector Inserted Detecting Unit       25   Signal Amplifying Unit       26   Access Selecting Unit       27   Environmental Temperature Sensor       28   Analog-to-Digital Converter       29   Reading Unit Selecting Device       30   Display Device       31   Memory Reading Device       32   Bus       33   Amplifier       34   Connection Line       35   Connection Line       36   Connection Line       37   Switch       38   Feed-Back Resistor       39   Feed-Back Resistor       40   Connection Line       41   Connection Line       42   Connection Line       43   Connection Line       44   Amplifier       45   Feed-Back Resistor       46   Feed-Back Resistor       47   Feed-Back Resistor       48   Feed-Back Resistor       49   Switch       50   Switch       51   Switch       52   Switch       53   Connection Line       54   Connection Line       55   Connection Line       56   Connection Line       57   Connection Line       58   Connection Line       59   Connection Line       60   Connection Line       61   Connection Line       62   Connection Line       63   Arrow       64   Statement Box       65   Condition Box       66   Statement Box       67   Statement Box       68   Condition Box       69   Condition Box       70   Statement Box       71   Statement Box       72   Statement Box       73   Statement Box       74   Arrow                     S   Sample cell       L1   Conductive Line       L2   Conductive Line                  
 
    
    
     DETAILED DESCRIPTION OF THE PRESENT INVENTION  
     [0036] An electrochemical biosensor system having a microprocessor, which is controlled by parameters input from outside, pertains to a prior art. The present invention integrates detecting devices (such as a plurality of sample cells, a plurality of pluggable information memories and a multi-functional signal analysis processor) to form a multi-functional biosensor system, thereby being able to detect the concentrations of various objects using an electrochemical principle. Parameter information required by the plurality of sample cells when detecting concentrations of various selected analytes is stored in a plurality of pluggable information memories which correspond to the plurality of sample cells, respectively. In the present invention, the plurality of sample cells can be, for example, a blood sugar sample cell (see ROC Patent No. 1094661 and ROC Patent No. 1243321), a uric acid concentration biosensor system (see ROC Patent No. 1070731 and U.S. Pat. No. 6,258,230 B1), or a hemoglobin concentration biosensor system (see ROC Patent Publication No. 466344 and U.S. patent application Ser. No. 09/771,634). It is found that the relationship between an electrochemical current value and a waiting detected concentration can be derived by detecting an electrochemical current signal one time (for example, after electricity is supplied for 7 seconds) with a proper electrochemical reaction time (300 mV) by a BAS CV-50W V-A analyzer. For example, FIG. 1 is a graph showing a resultant of a uric acid sample cell by using a V-A analyzer. That is, the relationship between a current and a uric acid concentration can be expressed in a simple equation of two variables. Therefore, when detection and calculation calibration parameters input from the outside are set, the concentration of the selected analyte can be detected with  
     
       i=KC+d  
     
     [0037] wherein  
     [0038] i=electrochemical current  
     [0039] C=concentration of the selected analyte  
     [0040] k=correction coefficient 1 of the selected analyte  
     [0041] d=correction coefficient 2 of the selected analyte  
     [0042] The resultant is featured in that (1) the concentration of the selected analyte can be derived without using the Cottrell current equation; and (2) check and calculation can be done without continually detecting and accumulating data (as stated in U.S. Pat. Nos. 5,366,609 and 5,243,516). As a result, not only the designs of software and hardware can be simplified, but also the concentration of the selected analyte can be precisely detected. Moreover, the detection for the concentrations of various specific analytes can be performed all by the portable multi-functional electrochemical biosensor system of the present invention. In addition, the multi-functional integration of the present invention results in cost reducing.  
     [0043] As shown in FIGS. 2, 3 and  4 , a portable multi-functional electrochemical biosensor system comprises a plurality of sample cells  7 , each sample cell  7  having a reaction zone on which a substance is placed to react with a corresponding selected analyte, and having at least two independent electrodes  9  and  10  which are not connected to each other, wherein one of the two electrodes is a reference electrode, and the other is an working electrode, and when a detective reaction occurs, the electrodes output an electrochemical reaction signal; a plurality of pluggable information memories  14 , corresponding to the sample cells  7 , respectively, during detection, each pluggable information memory  14  included in a pluggable information card  6  and being able to provide parameters used for analyzing the concentration of the corresponding selected analyte; and a multi-functional signal analysis processor  1 , including a microprocessor, an electrically erasable programmable read/write memory and an environmental temperature sensor (not shown), the multi-functional signal analysis processor  1  having at least two input terminals which are connected to the sample cell  7  and the pluggable information memory  14 , respectively, the microprocessor transferring the parameters from the pluggable information memory  14  to the electrically erasable programmable read/write memory so that the concentration of the selected analyte is calculated by using the electrochemical reaction signal output from the sample cell  7  and the parameters provided by the electrically erasable programmable read/write memory, as well as a temperature compensation established by the environmental temperature sensor, when an electrochemical reaction occurs; and a status detector  17 , having two independent electrodes which are connected to a resistor  19  with a constant resistance, and the sample cell which is connected to the multi-functional signal analysis processor  1 , and whether the status of the multi-functional signal analysis processor is normal is based on whether the resistance of the resistor detected by the multi-functional signal analysis processor conforms to the built-in resistance of the processor. The biosensor system uses a set of sample cell  7  and pluggable information memory  14  to detect the concentration of a corresponding selected analyte each time, so that the concentrations for various selected analytes can be detected.  
     [0044] When the sample cell  7  is utilized in an enzyme catalysis system, the reactant can comprises (1) enzymes which are able to react with a selected analyte or a series of enzymes required for subsequent reactions; and (2) electronic intermediates having an oxidoreductase activity. However, if the sample cells  7  are utilized in a enzyme-free system, the reactant does not comprise the enzymes shown in item (1). The reactant is fixed on the electrochemical reaction zone of the sample cell by using a carrier formed of hydrophilic polymers. The reaction zone has at least two separate electrodes, one being a reference electrode; and the other being a working electrode. When a reaction occurs and is detected, an electrochemical reaction signal is output from the working electrode under this electrochemical reaction environment. In the present invention, the biosensor system can detect various selected analytes based on the types of the reactants fixed on the sample cell.  
     [0045] Referring further to FIG. 3, the pluggable memory card  6  comprises an pluggable information memory  14  storing detection parameters, such as a start threshold, the type of the selected analyte, detection steps, detection time, a temperature compensation and a method for calculation, which are provided for the use of the multi-functional signal analysis processor to calculate the concentration of a corresponding selected analyte. The pluggable information memory  14  can be a read only memory (ROM), an ultraviolet erasable programmable read only memory (UVEPROM) or an electrically erasable programmable read only memory (EEPROM).  
     [0046] The comparison of the sample cell  7  and the status detector  17  in structure is shown in FIG. 4. The pitch of the electrodes  9  and  10  is equal to that of the electrodes  18 - 1  and  18 - 2 . The status detector  17  is used to simply detect the status of the multi-functional signal analysis processor  1 .  
     [0047]FIG. 5 is a block diagram showing the function of the multi-functional signal analysis processor  1 . Data stored in the pluggable information memory  14  can be retrieved by the microprocessor  20  via a bus  32 . The retrieved data are stored in the electrically erasable programmable read/write memory  21 . A parameter check-sum cod is derived by calculating the data retrieved from the pluggable information memory  14 . Whether or not the data of the pluggable information memory  14  is wrong is determined by comparing the derived parameter check-sum code with the parameter check-sum code of the pluggable information memory  14 . A detecting unit  24  can check whether or not a sample cell  7  is inserted into a slot  3 . The microprocessor  20  receives a signal from the detecting unit  24  via a bus  32  to ensure whether or not the sample cell  7  is inserted into the slot  3 . If the received signal is at a low logic level, the multi-functional signal analysis processor  1  is woken up. The microprocessor  20  controls an access selecting unit  26  via the bus  32 . The access selecting unit  26  makes a potential level of the reference potential unit  23  be sent to an analog-to-digital converter  28 . The microprocessor  20  receives an output reading of the analog-to-digital converter  28  via the bus  32 , and determines whether or not the potential level of the reference potential unit  23  is abnormal. The sample cell  7  is able to receive a proper polarized potential level via the reference potential unit  23 . The reaction signal of the sample cell  7  is amplified by a signal amplifying unit  25 , wherein the gain of the amplifying unit  25  is determined by the access selecting unit  26 . The amplified signal is sent to the analog-to-digital converter  28  from the output of the signal amplifying unit via the access selecting unit  26 . The microprocessor  20  controls the analog-to-digital converter  28  via the bus  32 . After that, the output value of the analog-to-digital converter  28  is obtained and operated. The environmental temperature sensor  27  senses an environmental temperature, and then generates a corresponding value. The corresponding value is sent to the analog-to-digital converter  28  via the access selecting unit  26 . The microprocessor  20  controls the analog-to-digital converter  28  via the bus  32 . Then, an output value of the analog-to-digital converter  28  is obtained and operated to show whether the current environmental temperature is too high or too low. After the microprocessor  20  receives the data from the electrically erasable programmable read/write memory  21 , the microprocessor  20  controls the reference potential unit  23  via the bus  32  to provide a proper potential level to the sample cell  7 , the signal amplifying unit  25 , the analog-to-digital converter  28  and the environmental temperature sensor  27 . A power managing device  22  is used to manage the power sources of the units, such as the microprocessor  20 , the electrically erasable programmable read/write memory  21 , the pluggable information memory  14 , the reference potential unit  23 , the signal amplifying unit  25  and the analog-to-digital converter  28 . A user is provided with a reading unit selecting device  29  for selecting what unit is used to measure blood. The microprocessor  20  receives a signal from the reading unit selecting device  29  via the bus  32 . A display device  30  shows various information and test resultants via the bus  32 . The measured values stored in the electrically erasable programmable read/write memory  21  can be displayed by a reading memory device  31 .  
     [0048]FIG. 6 shows an electrochemical signal amplifying mechanism including an amplifier  33 , a switch  37 , a feed-back resistor  38 , a feed-back resistor  39  and an access selecting unit  26 . A detecting device S can be the sample cell  7  or the status detector  17 , a conductive line L 1  represents the electrode  10  of the sample cell  7  or the electrode  18 - 2  of the status detector  17 , and a conductive line L 2  represents the electrode  9  of the sample cell  7  or the electrode  18 - 1  of the status detector  17 . The inverting input terminal of the amplifier  33  is connected to the conductive line L 2  of the detecting device S via a conductive line  35 . A terminal of the switch  37  and a terminal of the feed-back resistor  39  are connected to the conductive line  35  via a conductive line  36 . The other terminal of the switch  37  is connected to the other terminal of the feed-back resistor  39  and a terminal of the feed-back resistor  38  via the a connection line  41 . The other terminal of the feed-back resistor  38  is connected to a connection line  42 . The control terminal of the switch  37  is connected to the access selecting unit  26  via a connection line  40 . The conductive line L 1  of the detecting device S is grounded via a connection line  43 . The reference potential unit  23  is connected to a connection line  34 , and provides a proper potential to the conductive line L 2  of the detecting device S. This potential causes a current flowing to the detected zone  8  of the sample cell  7  or the fixed resistor  19  of the status detector via the conductive line L 2  of the detecting device S, and then to the conductive line L 1  of the detecting device S (ground). The current is amplified by the amplifier  33  and the feed-back resistor  38  or the feed-back resistor  39 . The amplified signal is sent to the access selecting unit  26  via the conductive line  42 . Before the output signal of the amplifier  33  is measured, a potential level is sent from the access selecting unit  26  to the control terminal of the switch  37  via the connection line  40  to turn on or off the switch  37 . When the switch  37  is turned off to have only the feed-back resistor  38  included in the feed-back path, it is set to a blood sugar measuring mode. When the switch  37  is turned on to have the feed-back resistors  38  and  39  included in the feed-back path, it is set to a uric acid measuring mode. The access selecting unit  26  selects various analog signals and allows them to pass through, and then the selected various analog signals are sent to the analog-to-digital converter  28 . The microprocessor  20  controls the access selecting unit  26  via the bus  32 . When the sample cell  7  or the status detector  17  is inserted into the slot  3 , there are various currents generated and flowing to the detected zone  8  or the fixed resistor  19 , thereby determining the sample cell  7  or that the status detector is inserted. If the status detector is inserted into the slot  3 , the current flowing to the fixed resistor  19  is amplified. This reading is calculated by the microprocessor  20 , and then is compared with the standard upper and lower limits stored in the memory. If the status detector is normal, whether or not the multi-functional signal analysis processor  1  is abnormal can be simply determined when the test value goes beyond the scope of the standard upper and lower limits.  
     [0049]FIG. 7 shows an alternative electrochemical signal amplifying mechanism which is obtained by improving the signal amplifying mechanism of FIG. 6. The alternative electrochemical signal amplifying mechanism can be commonly used by various biosensors and allow signals to be reasonably amplified so as to enhance the resolution of the electrochemical signal when detection is performed. In FIG. 7, a terminal of a connection line  58  is connected to the non-inverting input terminal of an amplifier  44 , and the other terminal of which is connected to a reference potential terminal so as to make the potential at the non-inverting input terminal of the amplifier  44  be approximate to that at the non-inverting input terminal of the amplifier  44 . A connection line  57  is connected to the inverting input terminal of the amplifier  44  and the polarized terminal of the sensor. The inverting input terminal of the amplifier  44  is connected to a fixed resistor (Rn 1 )  45  and a switch (swn 1 )  49  via connection lines  57  and  59 . There are several feed-back resistors (Rn 1 )  45 ˜(Rnn)  48  connected in series between the connection line  59  and a connection line  62 . Similarly, there are several switches (swn 1 )  49 ˜(swnn)  52  connected in series between the connection line  59  and the connection line  62 . The output of the amplifier  44  is connected to the fixed resistor (Rnn)  48  and the switch (swnn)  52  via the connection line  62 . The joint terminal of the fixed resistor (Rn 1 )  45  and the fixed resistor (Rn 2 )  46  is connected to that of the switch (swn 1 )  49  and the switch (swn 2 )  50  via a connection line  60 , the joint terminal of the fixed resistor (Rn 2 )  46  and the fixed resistor (Rn 3 )  47  is connected to that of the switch (swn 2 )  50  and the switch (swn 3 )  51  via a connection line  61 , and so on. Connection lines  53 - 56  serve as the control lines of the switches (swn 1 -swnn)  49 - 52 . Different sensors use different sets of fixed resistors and switches, respectively if swn 1  is open. Meanwhile, if swn 2 -swnn are closed, the resistance between Rn 2 -Rnn is very small. At this time, only the Rn 1  is taken as a feed-back resistor for amplifying. If Rn 2  is taken as a feed-back resistor for amplifying, swn 2  is open while swn 1  and swn 3 -swnn are closed, and the like. The numbers of Rn 1 -Rnn and swn 1 -swnn are selectable.  
     [0050]FIGS. 8 a  and  8   b  show a flow chart of executing part of a program in the multi-functional signal analysis processor  1 . After initialization and power check of the multi-functional signal analysis processor  1  and the polarized potential check provided by the reference potential unit  23 , the detection of the concentration of a selected analyte, the measurement of the constant concentration of a quality liquid or the display of the internal reading memory is completed, or the signal analysis processor  1  is found to be abnormal, the signal analysis processor  1  enters a sleep mode, and the power managing device  22  powers down the devices of FIG. 5. In step  64 , the signal analysis processor is woken up by the sample cell or the status detector. Next, in step  65 , whether or not the pluggable memory card  6  is inserted into a slot  2  is determined. If so, the content of the pluggable information memory  14  mounted in the pluggable memory card  6  is read and stored into the electrically erasable programmable read/write memory  21  of the signal analysis processor  1  in step  66 . If not, the content of the pluggable information memory  14  isn&#39;t read and stored into the electrically erasable programmable read/write memory  21  of the signal analysis processor  1 . In step  67 , the signal analysis processor  1  detects what type of the selected analyte it is to switch to based on the “model selecting parameter value” of the electrically erasable programmable read/write memory  21 . The switching operation is to change the switch  37  of FIG. 6 into an “on” or “off” state. The model selecting parameter value of the electrically erasable programmable read/write memory  21  is stored into a rCOdeCardOption memory.  
     [0051] After that, the resistance reading is obtained through the sample cell or the status detector inserted into the slot  3 . Based on the resistance, which one of a status detector, a normal sample cell  7  and a poor sample cell is inserted into the slot  3  is detected. If an abnormal sample cell is detected, and the abnormal sample cell is determined to be a poor sample cell based on the value of the resistance in step  69 , then the process goes back to a sleep mode. If the status detector is inserted, it proceeds with step  70 . In step  70 , the signal analysis processor  1  selects a quality liquid mode with a constant concentration, and then the process goes to step  68 .  
     [0052] If a normal sample cell is detected in step  68 , the process goes to step  71 . In step  71 , the environmental temperature sensor  27  senses the environmental temperature and generates a calculation value to determine whether or not the environmental temperature is located within a test scope. If the environmental temperature is normal, in step  72 , an output potential measured value is obtained when the quality liquid having a constant concentration or a selected analyte is placed on the detected zone  8  of the sample cell  7 . If the measured value is greater than the threshold of the electrically erasable programmable read/write memory  21 , the microprocessor  20  controls the reference potential unit  23  via the bus  32  so that the reference potential unit  23  can determine whether to supply the potential of the sample cell. The test time is determined by a test time parameter stored in the electrically erasable programmable read/write memory  21 . When the detection is finished, the microprocessor  20  obtains a reaction measured value of the sample cell. Proceeding with step  73 , corresponding calculation parameters are obtained, and the reading of the concentration of the selected analyte is obtained through calculation. After comparing the reading with the upper and lower limits stored in the electrically erasable programmable read/write memory  21 , the reading or sign is displayed by the display device  30 . Next, the process returns to a sleep mode.  
     [0053] Embodiment 1  
     [0054] A whole-blood blood sugar concentration analysis is processed by using a blood sugar sample cell (see ROC Patent No. 124332I) together with the portable multi-functional electrochemical biosensor system of the present invention. Furthermore, YSI 2300 (electrochemical detecting method) is taken as a reference comparison method to ensure a best detection (shown in FIG. 9).  
     [0055] Embodiment 2  
     [0056] A whole-blood uric acid concentration analysis is processed by using a uric acid sample cell (see ROC Patent No. 107073I) together with the portable multi-functional electrochemical biosensor system of the present invention. Furthermore, EPAC 6140 biochemical analyzer and a set of Roche Uric Acid Plus tests (enzyme optical detecting method) are taken as a reference comparison method to ensure a best detection (shown in FIG. 10).  
     [0057] Embodiment 3  
     [0058] A whole-blood hemoglobin concentration analysis is processed by using a hemoglobin sample cell (see ROC Patent Publication No. 466344) together with the portable multi-functional electrochemical biosensor system of the present invention. Furthermore, Metertek SP-870 spectroscopic analyzer and a set of SIGMA Hemoglobin tests (high ferricyanide hemoglobin optical detecting method) are taken as a reference comparison method to ensure a best detection (shown in FIG. 11).  
     [0059] Embodiment 4  
     [0060] A total cholesterol standard solution concentration analysis is processed by using a total cholesterol sample cell made of cholesterol oxidase, cholesterol esterase, surfactants and electron mediator together with the portable multi-functional electrochemical biosensor system of the present invention. Furthermore, Metertek SP-870 spectroscopic analyzer and a set of Self-Prepared Total Cholesterol tests (enzyme optical detecting method) are taken as a reference comparison method to ensure a best detection (shown in FIG. 12).  
     [0061] Embodiment 5  
     [0062] A lactic acid concentration analysis for blood serum is processed by using a lactic sample cell formed of lactate oxidase and electron mediator together with the portable multi-functional electrochemical biosensor system of the present invention. Furthermore, EPAC 6140 biochemical analyzer and a set of SIGMA lactate tests (enzyme optical detecting method) are taken as a reference comparison method to ensure a best detection (shown in FIG. 13).  
     [0063] The technical function and features of the present invention become more fully understandable from the above stated embodiments. It&#39;s to be noted that various changes and modifications are apparent to those skilled in the art. Such changes and modifications are to be understood as included within the scoop of the present invention as defined by the appended claims unless they depart therefrom.