The invention provides a biosensing device to set up the parameters of a strip in the device so that the calibration can be completed at a lower cost and be more user friendly.
Biosensing instruments have been developed to detect a variety of biomolecular complexes including oligonucleotides, antibody-antigen interactions, hormone-receptor interactions, and enzyme-substrate interactions. In general, biosensors consist of two components: a highly specific recognition element and a transducer that converts the molecular recognition event into a quantifiable signal. Signal transduction has been accomplished by many methods, including fluorescence and interferometry. Biosensing instruments that employ disposable sample strips enjoy wide consumer acceptance. Such instruments are employed for the detection of analytes such as glucose and cholesterol levels in blood samples and, in general, provide accurate readings.
However, to obtain accurate detecting results, the information in association with the disposable strips (such as calibration parameters, strip type and expiration duration, etc.) must be entered in the biosensing instruments. Calibration of the biosensor must be done first before using it. The strips are different lot by lot. The strip manufacturers must provide the calibration code for each lot of strips. The users must perform a set-up procedure before using the strips according to the manufacturers' manual so that the biosensors can receive correct calibration information. There are two setting procedures known in the art for calibration. One is that the user selects a set of built-in calibration codes in the biosensor according to the corresponding calibration codes marked in the package of the strips. The other is that a code card is attached to each lot of strips in order to save the calibration parameters in a memory unit. In a further calibration of the sensor unit, a parameter setting card corresponding to a lot number of a sensor included therein is inserted into the main unit so that the sensitivity of the equipment is calibrated. In a still further calibration of the sensor unit, correction data is supplied to the main unit in accordance with bar codes labelled thereon to calibrate the sensitivity of the biosensing instrument.
U.S. Pat. No. 4,637,403 provides a hand-held shirt-pocket portable medical diagnostic system for checking measurement of blood glucose, urea nitrogen, hemoglobin, blood components or other body qualities. This prior reference describes an integrated system that provides a method by which the patient lances the finger to get a sample of blood which is then used by the device to provide a reading of the blood glucose or other analyte concentration. This system uses a complex reflectance system to read the analyte level in the sample.
European Patent No. 0351891 describes an electrochemical sensor system and electrodes which are suitable for measuring the concentration of an analyte in a body fluid sample. The system requires the use of expensive electrodes and a reader to determine the analyte concentration level.
U.S. Pat. No. 5,053,199 provides a device including an integrated circuit carrier and a socket for removably and longitudinally receiving the integrated circuit carrier. It describes a biosensing meter with a pluggable memory key. This device uses a pluggable memory key to control the operations of the meter.
U.S. Pat. No. 5,366,609 relates to biosensing meters for determining the presence of an analyte in a biological sample, and, more particularly, to a biosensing meter whose operation is controlled by data accessed from a removably pluggable memory module. It describes a biosensing meter with a pluggable read-only memory wherein data read from the read-only memory at sequential times during the use of the meter enables a determination to be made as to whether the read-only memory has been switched during a test procedure.
Although many improvements have been made, the cost and complexity needed for calibration are still significant. The need to match calibration of a meter to the strips leads to errors in analyte concentration readings. Currently, existing calibration mechanisms require loading a calibration chip or strip, or manually inputting a calibration code into the meter. These devices can be reused numerous times, resulting in errors by the patient who does not change to or enter the appropriate calibration data. An additional issue is the use of test strips which are out of date. Old test strips which are expired can lead to errors and inaccurate results. By providing a means to eliminate the use of expired test strips, the patients will not have to monitor the expiration date of the test strips, and patient errors from using old test strips are eliminated.
There remains an important need to develop rapid, simple, cheaper and reliable calibration for biosensing instruments.
The invention provides a biosensing device comprising the following units:
The invention provides a biosensing device to set up the calibration parameters of the strip in the device so that the calibration can be completed at a lower cost and be more user friendly.
The invention provides a biosensing device comprising the following units:
The biosensing device of the invention comprises four units that set parameters of the device for a strip used therein. The above-mentioned four units are the input unit, analysis unit, process unit and set unit, which are shown in the following scheme:
The input unit of the biosensing device of the invention comprises a parameter-setting card of a strip and a port of the biosensing device wherein the parameter-setting card connects with the port so that the circuit of the card and the signal-acquiring circuit of the biosensing device form a working circuit (see
The analysis unit of the biosensing device of the invention converts the electrical signal obtained from the input unit through an analog-to-digital converter (ADC) circuit.
The process unit of the biosensing device of the invention encodes the electrical signal obtained from the analysis unit to obtain the data numbers by pre-determining the maximum value (Pmax), minimum value (Pmin) and the resolution value (Pres) to be entered into the biosensing device and determining the minimum unit of measurement from the maximum value and minimum value of the characterizing method. Using the voltage difference as the method to characterize the electrical signal, the data numbers (Pn) can be obtained through the following equation:
In addition, the maximum value (Umax) and the minimum value (Umin) of the characterizing method to be used should be determined to obtain the minimum unit of measurement (step) through the following equation:
The data values (P) acquired can be calculated by the following equation: (Here Uin is the characterized value of signal)
The set unit of the biosensing device of the invention stores the resulting data numbers as the basis for the calibration of the biosensing device for the strip.
To enter the slope of the characteristic equation of the strip into the biosensing device, the configuration of the signal-acquiring circuit of the biosensing device and the parameter-setting card of a strip in the input unit of the invention are illustrated in
If the ADC reference voltage is 2.5V, the reference resistance (Rf) is 10 k Ω and the range of the voltage variation is limited between 0.1 V and 2.5 V, according to Eq. 2-2, the minimum unit of measurement (step) is as follows:
According to Eq. 2-3, the voltage and their equivalent impedances corresponding to the data numbers to be entered into the biosensing device can be calculated (see Table 1 below).
The characterized values of the signal voltage mapping to the slopes can be obtained by pointing out appropriate impedances. By using the amplifier circuit to acquire the signal from the parameter-setting card, the characteristic values can be obtained by the process of the analysis unit. In this example, the characteristic value is the strength of the voltage (ΔV). According to the encoding regulations, the setting data can be obtained through the set unit by an encoding and calculation series on the basis of the strength of the voltage and the corresponding parameters.
If the slope and intercept of the characteristic equation of the strip are entered into the biosensing device simultaneously, the configuration of the signal-acquiring circuit of the biosensing device and the parameter-setting card of a strip in the input unit of the invention are as illustrated in
If the ADC reference voltage is 2.5V, the reference resistance (Rf) is 10 k Ω and the range of the voltage variation is limited between 0.1 and 2.5, according to Eq. 2-2, the minimum unit of measurement (step) is as follows:
According to Eq. 2-3, the voltage values and their equivalent impedances corresponding to the data numbers to be entered into the biosensing device can be calculated (see Table 2 below).
The characterized values of the signal voltage mapping to the slopes can be obtained by pointing out appropriate impedances. By controlling the signal selection circuit, Ra, the reference resistance and the biosensing device can form the signal wave shape of the circuit output. The slope can be obtained by using the amplifier circuit to acquire the signal from the parameter-setting card and encoding the resulting data. After completion, Rb was chosen as the working resistance by the signal selection circuit, Ra exhibited an open-loop state and the signal generated on the basis of Rb was acquired by using the amplifier circuit, and the characteristic value of the strength of the voltage (ΔV) can be obtained by the process of the analysis unit. According to the encoding regulations, the setting data can be obtained through the set unit by an encoding and calculation series on the basis of the strength of the voltage and the corresponding parameters (see
The manufacturing date of a strip can be entered into the biosensing device to manage the expiration date of the strip. The characteristic methods of the invention can represent year and week numbers. The configuration of the circuit of the biosensing device and the parameter-setting card of a strip in the input unit of the invention are illustrated in
For example, if each week from 2007 to 2011 is to be entered into the biosensing device, the characteristic values are the voltage strength (ΔV) and time difference (ΔT), which represent week numbers and year, respectively. For the encoding of week numbers, since a year includes 52 weeks, the mapping data number (Pn) according to Eq. 2-1 is as follows:
If the ADC reference voltage is 2.5V, the reference resistance (Rf) is 470 k Ω and the range of the voltage variation is limited between 0.2 V and 1.73 V, according to Eq. 2-2, the minimum unit of measurement (step) is as follows:
According to Eq. 2-3, the voltage values and their equivalent impedances corresponding to the data numbers to be entered into the biosensing device can be calculated (see Table 3 below).
In addition, for the encoding of year, since the years to be entered range from 2007 to 2012, according to Eq. 2-1, the mapping data number (Pn) according to Eq. 2-1 is as follows:
If the ADC reference voltage is 2.5V, the reference resistance (Rf) is 470 k Ω and the range of the time reference (ΔT) variation is limited between 0.5 and 0.1, according to Eq. 2-2, the minimum unit of measurement (step) is as follows:
According to Eq. 2-3, the time difference (ΔT) and the equivalent capacitance value (CA) corresponding to the data numbers to be entered into the biosensing device can be calculated (see Table 3 above).