CA2582775C - Analytical test element with wireless data transmission - Google Patents

Abstract

The invention relates to a system for determining the concentration of an analyte in a body fluid, which comprises an analytical test element and an implement which is separate from said test element. At least a part of the electrical components of the system are polymer electronic components. The analytical test element carries an area comprising an analytical chemical for detection of the analyte and a transponder for the wireless transmission of batch-specific data and/or measured values. The implement is provided with a reading module for the wireless transmission of data and power to the test element and an evaluation unit for evaluating the data or measured values received by the transponder.

Description

A

Analytical test element with wireless data transmission Description The present invention concerns a system for determining the concentration of an analyte in a body fluid. Furthermore, the invention concerns a process for producing such a system.

In clinical diagnostics the examination of body fluids enables an early and reliable detection of pathological states as well as the targeted and well-founded monitoring of physical conditions. Nowadays individual analyses that are specifically directed towards one parameter often require a few microlitres of blood and even down to less than one microlitre. Blood is usually collected by piercing the skin of the person to be examined e.g. the finger pad or the earlobe with the aid of a sterile sharp lancet. This method is especially suitable when the analysis of the blood sample can be carried out directly after blood collection.

Carrier-bound rapid tests are well established for the chemical and biochemical analysis of body fluids in specialized laboratories for these analyses but in particular also for use outside permanent laboratories. Such carrier-bound rapid tests based on a specially developed dry chemistry can be carried out simply and in an uncomplicated manner even by laymen despite the often complex reactions involving sensitive reagents. The most prominent examples of carrier-bound rapid tests are test strips for determining the blood glucose content in diabetics.

In the diagnostic tests that are used nowadays for detecting an analyte (e.g.
blood glucose) in a body fluid (e.g. blood) the function of lancing to generate a skin opening and the detection function are usually divided among several components e.g. a lancing aid for lancing and generating a drop of blood and an analytical test element e.g. a test strip for receiving the drop of blood, passing the blood from the receiving site to the detection area and detecting an analyte e.g. blood glucose.

Lancets and suitable devices for them which enable a largely painless and reliable collection of blood are offered above all in the field of so-called "home-monitoring"
i.e. where medical laymen themselves carry out simple analyses of blood and in this case especially for the periodical blood collection by diabetics that has to be carried out several times daily to monitor the blood glucose concentration. Examples of lancets and lancing aids are the commercially available devices (lancing aids) and lancets Glucolet from Bayer AG and Soflclix from Roche Diagnostics GmbH.
Such lancets and devices are for example the subject matter of WO 98/48695, EP
0,565,970, US 4,442,836 or US 5,554,166.

The self determination of blood sugar is nowadays a world-wide method in diabetes monitoring. Blood sugar instruments in the state of the art such as the AccuChek Sensor (from Roche Diagnostics) consist of a measuring instrument into which a test element (test strip) is inserted. The test strip is for example brought into contact with a drop of blood which has been previously collected from the finger pad by means of a lancing aid. On the test strip the blood is transported into the area in which the detection chemistry is located. Here the analyte to be detected reacts with the detection chemistry and generates a measurable signal e.g. an electrical current impulse or a change in colour. The measurement signal is evaluated by the measuring instrument and the current blood sugar value is shown to the user on the display of the blood sugar instrument.

State of the art In order to rigorously monitor the blood sugar content it is necessary to regularly carry out glucose measurements for example several times daily. A new test strip which is provided in storage cans for example containing 50 strips is required for each measurement. In this connection it should be born in mind that the test strips can have a different quality and different properties depending on the batch which can influence the measured result. It is therefore necessary to calibrate the glucose measuring instrument before inserting the measurement strip. These variations are due to unavoidable tolerances during test strip manufacture and the sensitive detection chemistry. In order to compensate for this, a large number of samples of each production batch are measured and batch-specific calibration data are determined from these measurements. These data are delivered to the customer together with the test strips but are not visible to the customer. The set of data consists of a batch number and values which describe a correction function.

It is known that a number code is printed onto the storage container which has to be entered by means of an appropriate input unit on the glucose measuring instrument in order to adjust the glucose measuring instrument to the test strips in this storage can. It is also known that a film foil accompanies each test strip pack.
The transparent film foil contains a barcode which contains the coefficients of a polynoma of the nth order in binary code. In the case of the glucose measuring instruments Accu-Chek Compact and Accu-Chek Comfort from Roche Diagnostics GmbH, an electronic storage medium, a so-called ROM key, on which a complete set of the coefficients of a polynoma is stored (see US 5,053,199), is for example enclosed with the test strips. This ROM key is inserted into the measuring instrument, the data are read from the storage chip by the measuring instrument and used for the correction calculation. US 6,689,320 also describes an electronic data carrier which, however, is inserted into the measuring instrument in a so-called code carrier; in this case the data are transferred using a transponder.

A common feature of all aforementioned calibration methods is that the user has to carry out a large number of steps in order to calibrate the glucose measuring instrument to the test strip batch. There is a risk that errors may occur in the manual input or that one forgets to read-in the memory chip or insert the film foil with the batch code. Especially when the user is using several cans containing test strips, there is a risk that a calibration of the glucose measuring instrument to the current test strip batch may be forgotten. In order to avoid this risk, a batch identification in the form of a bar code or magnetic strip is nowadays applied to the test strips themselves in addition to the external data store which contains the calibration data. Furthermore, special care must be taken that despite the separate test strip and data carrier logistics, it is ensured that the correct correction values are enclosed with the test strips.

One method of avoiding the said risk of confusion is to directly connect the entire calibration data with the test strip. The test strip for the Reflochek from Roche Diagnostics GmbH for example has a bar code printed on, and a magnetic strip is glued onto the Reflotron strip (Roche Diagnostics GmbH).

However, as the development progresses towards smaller and smaller test strips and at the same time more and more calibration data, the data capacity of such miniaturized bar code or magnetic strips reaches its limits.

Hence DE 102 37 602 describes a system for blood glucose measurement in which a data carrier with adequate capacity is present on the test strip itself in order to store all required data on the strip. The calibration unit in this blood glucose measuring system is composed of a receiver unit which interacts with a transmitter unit on the test carrier for the wireless transmission of a signal which reflects the quality and/or the properties of the test strip. This wireless and non-contacting transmission of calibration data means that the user does not have to carry out any additional steps for calibration to the currently used test strip. It is only necessary that the test carrier is held near to the measuring instrument which is for example the case when it is inserted into the measuring instrument. The receiver unit and the transmitter unit in this case form a so-called transponder system.

R. Puers describes a transponder system which is used in orthopaedic implants (Linking sensor systems with telemetry: impact on the system design; Sensors and Actuators (1996) 169- 174).

J. Black et al describe an implantable amperometric glucose sensor with an integrated telemetry unit as an example for transmission of analogue data (Integrated sensor-telemetry system for in vivo glucose monitoring; Sensor and Actuators (1996) 147 - 153).

A heart pacemaker is described in WO 031 00942 which receives its energy via a transponder from an extracorporeal battery unit. In return the heart pacemaker transmits its charge state to the outside.

US 6,217,744 concerns a disposable for blood glucose measurement which transmits its measurement data via a transponder to the information device where the blood sample itself serves as an electrolyte for the battery in the disposable.

A transponder system comprises a reading system which in this case corresponds to the receiver unit in the instrument and the actual transponder which in this case is the transmitter unit on the test strip. The energy required for the measurement is brought into the test strip by the reading system i.e. the test strip does not have its own power supply. The transmitter unit on the test strip in return transmits the stored calibration data as well as the measured signals of the current measurement to the measuring instrument. Transponders are usually provided with microprocessors in silicon technology. Although the manufacturing costs for silicon chips have decreased considerably in recent years due to miniaturization, integration and optimization of the manufacturing processes, they are nevertheless still at such a high level that they would disproportionately raise the cost of a measurement if each individual test strip that is discarded after a single measurement would be equipped with such a silicon chip.
Summary of the Invention In accordance with the invention there is provided a A system for determining the concentration of an analyte in a body fluid comprising:

an analytical test element which has an area with reagent chemistry for detecting the analyte in a body fluid by generating a measurement signal from the reaction of the analyte with the reagent chemistry, - an instrument separate from said analytical test element, said instrument comprising an evaluation unit to evaluate the measurement signal and determine the concentration of the analyte in the body fluid, the analytical test element and the instrument being operatively connected in a contacting or a non-contacting manner;
wherein said analytical test element comprises electrical components at least in part comprising polymer electronics, the electrical components on the analytical test element comprising at least two electrodes in contact with the reagent chemistry and a plurality DOCSMTL: 4408289\1 -5a-of galvanically separated electronic circuits and a plurality of parallel transmitting modules configured for wireless transmission of data or data and energy, the instrument further comprising a plurality of parallel reading modules configured for the wireless transmission of data or data and energy.

In one embodiment of the invention, there is provided a system for determining the concentration of an analyte in a body fluid comprising: an analytical test element which has an area with detection chemistry for detecting the analyte in a body fluid, and several parallel transmitting modules for the wireless transmission of data or data and energy, said analytical test element comprising electrical components comprising an electronic circuit comprising several electrodes which are in contact with the detection chemistry area and several galvanically separated electronic circuits; and separate therefrom an instrument which has several parallel reading modules for the wireless transmission of data or data and energy, and an evaluation unit for evaluating data;
wherein the data transmitted in a wireless manner between the transmitting modules and the reading modules consists at least partially of analogue data; and wherein at least a part of the electrical components of the analytical test element are formed from a polymer having semi-conducting or conducting properties associated with polymer electronics.

Description of the Invention The invention describes a system which ensures that the correct calibration data are used for each measurement without the risk of a mix-up. Moreover, the quality of the measured values is improved by increasing the accuracy of the measurements by an improved measuring setup.

Security against a mix-up of the calibration is ensured by storing the batch identification and the calibration data on each test strip. The above-mentioned transponder technology is used to store the required amount of data and transmit it DOCSMTL: 4408289\1 to the measuring instrument. In this connection especially the electrical components on the analytical test element are at least partly formed on the basis of polymer electronics.

It was found that the application according to the invention of transponder technology to systems for determining an analyte in a body fluid utilizing polymer electronics is particularly advantageous.

Polymer electronics is based on the fact that certain polymers (e.g.
pentacene, polythiophene) have semi-conducting properties and thus can be used to make electronic circuits. Thus for example a binary data memory can be directly incorporated into the substrate of a test strip ("Vom organischen Transistor zum Plastik-Chip, Physik Journal 2 (2003) No. 2, p. 31-36). In this case spatially discrete zones either of a lower or of a higher conductivity extending through the conductive polymer substrate are generated by the pointwise application of electrical fields depending on the polarity. The state is retained after removing the voltage. The state can be restored again by reversing the polarity of the electrical voltage. Hence this enables writing/reading processes and the storage of information such as batch numbers and correction curves directly on the test substrate. The punctiform fields are for example formed by applying a voltage to column and line leads by means of a decoder circuit preferably made of semi-conducting polymers (Polymer Memory, Technology Review September 2003, p.
31). In addition it is also possible to use conductive polymers to form further components which are necessary for electrical transponder functions (transistors, diodes, resistors, capacitors, coils, leads, contacts) directly on the test strip (Fast polymer integrated circuits, American Institute of Physics 2002, p. 1735-1737).

Terms such as integrated plastic circuits (IPC), organic electronics, polytronics, electronic plastic, organic semi-conductors or conductive polymers are often used synonymously for this new technology. These polymers can for example be applied by simple printing techniques such as offset, tampon, screen printing or technologies similar to laser or ink-jet printing e.g. using polymers in solution (so-called electronic ink). This technology is especially advantageous for applications on flat carrier foils which is usually the case for analytical test elements.
Moreover, since printing and laminating techniques are already routinely used to manufacture analytical test elements, polymer electronics can be readily integrated into the existing production process. For example DE 102 53 154 describes how the electronics for a complete blood glucose measuring system in a credit card format consisting of a measuring unit and biosensor is applied in polymer electronics in a single printing process.

Test strips are usually produced in so-called endless processes (roll-to-roll processes). The rolls are subsequently cut into test strips and filled into packaging units (cans, magazines). At the same time samples are taken from each production batch and validated. The deviations from the target values are converted into a data set by means of an algorithm and stored on a data carrier. The packaged test strips are brought together with the data carriers and delivered in a confectioned form.
The use according to the invention of transponder technology combined with polymer electronics enables a transponder to be applied to the analytical test element in a simple process step that can be easily integrated into a roll-to-roll production. Furthermore, a transponder consisting of polymer electronics can be manufactured extremely cost-effectively which is of major importance especially for single measuring strips which are discarded after single use. The invention enables the analytical test elements to be provided with a batch identification during the roll-to-roll process and to transfer the calibration data in a non-contacting manner to the separated and packaged test elements. This means that it is not necessary to store the calibration data on a separate data carrier in order to ensure that the test strips have been correctly packaged with the appropriate data carrier. The transponder system can be used to write data onto the analytical test element as well as to read data stored on the test element or generated during the measurement.
Thus, for example the batch numbers of the test elements filled in a packaging unit can be firstly read by a special reading unit in the production process. The calibration data for the respective batch numbers are stored in the reading unit. The reading unit selects the matching calibration data and transfers them to the test elements. In order to check whether the calibration data have been correctly transmitted, it is possible for the stored data to be finally read. In this connection the number of response signals can for example be used to check whether the correct number of test strips have been packaged and whether all test strips have stored the correct data set. In addition it is possible to also provide the analytical test elements with an unequivocal identification number in addition to the batch number in order to thus be able to write and read each individual test strip.
In this manner the method according to the invention ensures that the correct calibration data are used for each measurement and a mix-up is excluded during the packaging in the production as well as when used by the customers.

The batch-specific calibration data can for example be a complete calibration curve or certain supporting points are defined to which a specified curve is fitted that is for example deposited in the instrument. Furthermore, the calibration curve can be shown as a polynomial function in which case for example either the entire function or preferably the variables of the polynomial serve as batch-specific calibration data while the polynomial function is stored in the instrument. The curve or the polynomial function can also be stored on a ROM key which accompanies the instrument and is inserted by the customer into the instrument, instead of directly in the instrument. If the curve has to be fitted at a later time, for example when a new generation of test strips with slightly changed measuring properties is launched, the instrument can be adapted to them by simply exchanging the ROM
key.

In a preferred embodiment the batch-specific calibration data are stored on the analytical test element or on its packaging and the calibration curve is stored in the instrument for example in the form of a polynomial function. As an alternative several calibration curves for example with different identification numbers can be stored on a ROM key and the identification number of the calibration curve which matches this batch is stored on the test strip.

Another feature of the combination according to the invention of transponder technology and polymer electronics is the ability to improve the measuring technology on the analytical test element. The measurement of electrochemical parameters is essentially based on electrolytic processes or electron mobilities in liquid phases. If several electrochemical sensor systems are used in a common liquid circuit, they are inevitably connected electrolytically or in an undefined electrical manner by common electrical circuits such as the power supply and earth leads or by parasitic conducting mechanisms. Electrochemical measurements are usually direct current or low frequency processes i.e. they are essentially galvanic i.e.
conductive mechanisms which lead to error currents which can falsify the measurements as well as the chemical reaction itself. Elaborate isolation amplifiers are often used nowadays to avoid these problems. These separate the electro-chemical measurement systems to such an extent that the only connection is via the unavoidable liquid electrochemical path. As a result of this "single connection" no superimposed electric circuit is present via which the parasitic electric current can flow. Transformer isolation amplifiers that are commonly used nowadays are usually expensive since small direct parameters (current, voltage) have to be converted into alternating parameters in a complicated manner. An additional power source that is galvanically separated from the remaining system would have to be provided for such an analytical test element. These are usually batteries or power supply units separated by transformers which have a relatively large installation size. There are also optical isolation systems as an alternative to electrical isolation amplifier systems. In this case the measurements obtained as electrical direct parameters are transmitted with light barriers according to the opto-electrical principle. However, in the case of optical isolation systems the supply energy can only be transmitted to a limited extent and with a relatively poor efficiency.

It was found that instead of isolation amplifiers, transponders in particular are also suitable for galvanically separating electrical systems. The combination according to the invention of transponder technology and polymer electronics enables an analytical test element to be provided cost-effectively and manufactured in large numbers in which parasitic creepage currents are avoided by galvanic decoupling.
In particular the required transmission of small measurements at high potential differences is possible with transponders without potential carry over. In this case the energy is transmitted in a wireless and non-contacting manner from the reading module located in the instrument to the transmitting module located on the analytical test element by a transformer in the form of an alternating voltage according to the induction principle. Especially the flat structures of polymer electronics applied to foils enable a good linear magnetic transmission of the signals via the transformer coils. The energy starts the measurement on the analytical test element. The electrical measurement signal is firstly obtained as a d.c.
parameter (current or voltage), subsequently converted into an a.c. parameter and then transmitted to the instrument by induction for example by magnetic field coupling in a near field by modulating the signal onto a carrier frequency. The system according to the invention thus enables a non-contacting, bidirectional data transmission.

Transmission coils applied using polymer electronics can be extremely closely adjacent to one another or on top of one another at a distance of about 0.1 mm.
This enables the use of small coil dimensions which is particularly advantageously for the miniaturization of the analytical test elements. Polymer electronic technology not only allows planar structures to be applied but also three-dimensional structures such as that of a field effect transistor can also be applied by using several layers (Organic field-effect transistors - the breakthrough at last, Chemphyschem 2001, 2, 163-165).

The invention concerns a system for determining the concentration of an analyte in a body fluid which comprises an analytical test element and an instrument that is separate therefrom wherein at least a part of the electrical components of the analytical test element is formed on the basis of polymer electronics. An area containing detection chemistry for detecting the analyte is located on the analytical test element and the instrument has an evaluation unit for evaluating data.

A preferred embodiment of the invention concerns a system described above, wherein a transmitting module is located on the analytical test element for the wireless transmission of data and the instrument has a reading module for the wireless transmission of data. The transmitting module and reading module employ the transponder technology described above.

The system according to the invention comprises the components that are necessary to determine the concentration of an analyte in a body fluid. The system at least comprises an analytical test element with detection chemistry and an instrument with an evaluation unit. In particular the system can additionally comprise for example a lancing aid and a display unit, where these two components can be integrated into the test element or instrument or be independent units.

Analyte is understood to mean a component of the body fluid which reacts with the detection chemistry in the detection area such that the reaction can be measured in a measuring arrangement above a certain amount of analyte. A preferred embodiment is to use blood as the sample liquid and to detect blood glucose as an analyte in the detection area and thus to determine the concentration of blood glucose.

It is possible to also use interstitial fluid and other endogenous fluids as body fluids in addition to blood. It is also possible to detect not only one analyte e.g.
blood glucose but also several analytes e.g. HbA1C and to detect them in a body fluid e.g.
blood as well as in a mixture of several body fluids e.g. blood plus interstitial fluid.
An analytical test element is understood as any form of carrier-bound rapid tests for diagnostics especially rapid tests in a strip form, so-called test strips, in this case especially for determining the blood glucose content in diabetics.

Instrument refers to the part of the system which receives the measurement signals which are generated in the analytical test element and evaluates them in the evaluation unit. The instrument can also comprise a holder in which an analytical test element or a package for one or more test elements e.g. a container or a magazine is positioned. Furthermore, a display unit e.g. a LCD display can also be integrated into the instrument. The instrument is usually a battery-driven hand-held device.

Nowadays the electric leads and contacts on the analytical test element are usually made of gold or similar inert metals and for example removed in a structured manner by laser ablation. According to the invention polymer electronics can be used instead of metal for the conductor paths and contacts. Thus for example a test strip that is currently available on the market having gold contacts and a data carrier (e.g. a magnetic strip or bar code) for identifying the strip can be replaced by an analytical test element in which the electrical leads and contacts are formed by polymer electronic conductor paths and contacts. The strip identification is preferably stored in a polymer electronic memory. In a particularly preferred manner a polymer electronic transponder for writing and reading the memory is also located on the analytical test element. Of course it is also possible to replace only the gold contacts or only the data carrier by polymer electronics.

According to the invention the polymer electronics can be used on the test element as well as in the instrument. In a preferred embodiment some or also all electrical components on the analytical test element are based on polymer electronics and conventional technology is used for the electronics in the instrument.

The transmitter module on the analytical test element serves as a transponder on which data such as for example identification data (batch number, strip type, optionally serial number), expiry date and batch-specific calibration data are stored during the production. It is also possible to store additional data after the production such as updated notes for customers, logistic data, information for the retail trade e.g. the pharmacy or others. As soon as the test strip is inserted into the instrument, identification data are for example transmitted to the instrument to check for example whether a test strip that is suitable for the instrument has been inserted or whether the expiry date has expired. Where appropriate it is also possible to display notes or information for the customer which had been stored in advance on the analytical test element. Subsequently the measurement signals generated during the measurement of the concentration of the sought-after analyte can be transferred from the test strip to the instrument.

The reading module converts the signals received from the transmitter module and passes them onto the evaluation unit in which they are evaluated. The result, for example the concentration of blood glucose, is shown to the user in the display unit e.g. a LCD display. The display unit is usually integrated into the instrument but it is also possible for the display to be an independent unit. For example the test element can be designed as an implant or partial implant, the instrument together with the reading module is accordingly worn over the test element directly on the skin or over the clothing, and the display unit can be a type of wristwatch which is attached to the wrist. A transponder system is also used to transmit the data from the evaluation unit to the display unit. In addition it is of course also possible in this manner to actuate further modules and in particular an insulin pump or an electronic diabetic diary.

The transponder system according to the invention for example uses frequencies in the region of 125 kHz with a range in the body of about 10 to 20 cm such as those used for example in implants to identify animals for wireless transmission from an implanted test element to an extracorporeal reading module. Frequencies in the region of 13.56 MHz which can cover a distance of approximately 1 m in air are for example used for transmission from a reading module to an independent display unit or other external system components e.g. an insulin pump or a data management system such as an electronic diary. If, in addition, it is intended to transmit data over large distances e.g. to secondary external instruments such as a PC for data management, it is possible to use frequencies in the range of 800 to 2000 MHz (UHF range) to cover distances of up to approximately 4 m.

The measured values which are generated during the measurement of the concentration of the sought-after analyte are transmitted in a wireless and non-contacting manner from the measuring module to the transmitting module. In this connection wireless and non-contacting should only be understood as the signal transmission and optionally the transmission of energy. The electrical components on the analytical test element or in the measuring instrument are of course wired with electrical circuits and of course it is also possible that the analytical test element touches the instrument especially when the test element is inserted into the instrument. Wireless and non-contacting data transmission has several advantages over contact-linked transmission: thus, depending on the dimensions of the transponder coils the positioning tolerance of the analytical test element relative to the measuring instrument is considerably larger. Moreover, the transmission resistance of electrical contacts is very critical for high-impedance, low-current signals such as those that are typical for the present application. Although one tries to design the contacts to be as reliable as possible e.g. by using inert materials such as gold and by giving the counter-contacts a pointed shape such that they dig into the flat contact surfaces in order to remove any deposits that may be present.
Nevertheless an insulating layer or a short-circuit or leakage current may be formed between the contacts that are in close proximity to one another due to hand perspiration during the handling of the test element or a contact may be interrupted by scratches or a leakage current to a neighbouring contact may occur.

These contact problems are solved by the transponder system according to the invention. In one embodiment at least the sensitive measurement data are for example transmitted in a wireless manner for example when the energy for conducting the measurement on the test element continues to be available via the electrical contacts or when the test element has its own energy source. In another preferred embodiment the measured data as well as the energy required for the measurement are transmitted by the transponder system in a non-contacting manner. In a third embodiment the polymer electronics are used for the contacts.
Polymers are insensitive even towards aggressive sweat. Moreover, by generating a voltage peak on the contact surfaces it is possible to spot-weld the contacts between the test element and measuring instrument and thus reproducibly generate a very low transition resistance.

Another preferred embodiment of the invention concerns a system for determining the concentration of an analyte in a body fluid which comprises an analytical test element which has an area with detection chemistry to detect the analyte in a body fluid as well as a memory for storing electronic data. In addition the system comprises an instrument which has an evaluation unit for evaluating the data and a display unit. The system is characterized in that at least a part of the electrical components of the system is based on polymer electronics.

The electronic data stored on the analytical test element, can comprise a test strip identification, batch-specific calibration data and the measured values generated in the concentration measurement. The identification e.g. batch number, strip type and possibly additionally the expiry date are preferably already stored on the test element during the manufacture of the test strip and are subsequently no longer altered. Hence this could also be achieved by hard wiring. Otherwise single or multiple rewritable software memories e.g. an EPROM or EEPROM can also be used for this. According to the invention a rewritable polymer electronic memory is especially preferred for this purpose.

A memory that can be written by a transponder system is necessary in order to store calibration data on already packaged analytical test elements. Furthermore, it may be expedient to store the measurement signals obtained during the concentration measurement on the analytical test element before the data are transmitted to the measuring instrument. In this manner it is possible to transmit the measurements several times as required e.g. when an error occurs in the transmission to the measurement instrument.

Furthermore, it is also possible that the transmitting module receives energy transmitted from the reading module e.g. as soon as the analytical test element is inserted into the instrument especially if the analytical test element does not have its own energy supply. In the case of a passive transponder system the transponder does not have its own energy supply and is thus only active while it is in contact with the reading unit. Transponders usually operate in the near field by magnetic field coupling i.e. the transponder has to be moved close enough to the reading unit. When writing the transponder, the data are stored in an electrically writable memory e.g. an EPROM or an EEPROM and are permanently stored after removing the energy.

In a preferred embodiment of the invention, the analytical test element does not have its own source of energy. In this case the electrical energy required for the measurement and possibly also for the storage is transmitted from the instrument to the test element by means of the transponder system. This embodiment is especially advantageous for implants since the residence period of the implant is then not limited by the lifespan of the power source e.g. a battery.
Especially in the case of analytical test elements which are used as disposables for a single in vitro measurement (so-called single use test strips) it may be advantageous for cost reasons when the test element does not require its own energy supply.

In addition it is possible to integrate a temporary energy store into the test element for example a capacitance or accumulator. This for example allows more flexibility with the contact time and thus for example a continuously measuring system with such an energy buffer can continue to measure over a long period irrespective of whether the instrument is permanently in the vicinity of the test element.

In a further embodiment according to the invention the analytical test element has its own energy supply. Such a so-called active transponder may be expedient especially when the test element can carry out several measurements. Thus for example such an e.g. (partially) implanted test element could carry out the required or preset measurements over 24 hours and the user only needs to transfer the measurement data once daily from the test element to the instrument. If the test element has a rechargeable energy supply (accumulator, capacitance) then the energy store can be charged as required during data transmission.

In another embodiment the analytical test element of the system according to the invention comprises several electrodes and in particular more than two electrodes which are in contact with the detection chemistry. The electrodes are connected to one or more electronic circuits and the electronic circuits are galvanically separated i.e. the circuits do not have a common energy source or common earth and are galvanically isolated from the outside to such an extent that the only connection is via the unavoidable liquid path of the detection chemistry itself. Since there is an electrical contact at only one site, it is not possible for any parasitic leakage current path to build up which could falsify the measurement. In order to achieve a galvanic separation each circuit must for example have its own power supply which would be very expensive. According to the invention the galvanic decoupling is achieved by the transponder system. All circuits on the analytical test element have a transponder and are separated galvanically from one another. A common reading module or individual reading module for each transponder transmits the energy to the circuits. In this case the reading module can be located in the instrument or also on the analytical test element. In the latter case energy can be transferred from the reading module which is located on the test strip to the instrument either by electrical contacts or by another transponder system consisting of a common transponder or again consisting of several transponders.

Simple electrochemical systems usually consist of two to three electrodes. So-called potentiostats with 3 electrodes (working, counter and reference electrode) are frequently used. In this connection a parasitic resistance from the counter electrode to the output of the potentiostat is particularly critical since this resistance has a direct effect on the signal amplification. It is therefore advantageous when the entire potentiostat except for the electrodes is hermetically sealed with an insulating layer.
In this embodiment the transponder for example processes and stores no digital information but rather processes the analogue signal current and transmits it to the reading module. The functions necessary for the measuring process are integrated into the transponder such as e.g. permanent supply of the working electrode with a potential (typically a few 100 mV, preferably -350 mV). In this case the transponder system is designed such that the required energy is provided by the instrument at suitable refresh intervals and is temporarily stored.

Especially in the case of a potentiostat which is designed as an implant or partial implant it is particularly important, e.g. for the continuous measurement of an analyte, that the electrical system can be hermetically encapsulated by the use according to the invention of transponder technology and nevertheless information and energy can be transmitted.

A preferred embodiment according to the invention concerns implanted analytical test elements. The use of transponder technology enables a test element to be implanted in the body and be operated from the outside without transcutaneous connections through the skin. Leads through the skin reduce the wearing comfort e.g. when showering and involve the inherent risk of an infection. Thus for example an analytical test element for the continuous measurement of blood glucose can be inserted into the subcutaneous adipose tissue in the abdominal region and the instrument is held outside on the skin either only temporarily in order to carry out a measurement or permanently by a belt or a plaster especially in the case of continuous measurements of the analyte in the minute range. In both cases the instrument can be removed at least briefly e.g. for showering. Even in the case of partially implanted analytical test elements, one end of which is for example integrated into a plaster whereas the other, usually lancet-shaped end is inserted into the abdominal wall, the relatively large and heavy instrument for the measurements can be positioned near to the test element and if necessary simply removed. Since the partial implant has no open electrical contacts, it is also in this case considerably less sensitive to environmental influences. Moreover, the instrument can also be worn over the clothes especially when it is also comprises a display unit. Irrespective of whether it is equipped with or without a display unit, the instrument can store a considerable amount of the received data, for example several hundred measurements.

A preferred method for transmitting data with the transponder system according to the invention is to convert the signals which are typically direct current or direct voltage signals into a frequency and to modulate a carrier frequency onto it which is for example used for energy transfer.

One variant of the invention describes the use of different carrier frequencies. These can be used to differentiate between the transponder systems. Especially when several transponders are addressed simultaneously for example when several parallel transponders are present on one analytical test element or when writing several test strips which are in one package, it may be advantageous to individually address each transponder. Each carrier frequency can be treated individually and crosstalk can be for example avoided by using narrow band filters.

Another feature of the invention is that the signals transmitted by the transponder system cannot only comprise digital data e.g. calibration data but in addition also analogue signals, in particular the measured values obtained during the measurement of the analyte concentration. Current transponder systems are usually used only to transmit digital data. DE 103 22 167 for example describes the use of transponders for the logistical backtracking of reusable load carriers; US
6,579,498 discloses a transponder-assisted transmission of digital data in an implanted blood glucose sensor. In the above-mentioned publication of J. Black the feasibility of a wireless transmission of analogue data for glucose measurement is for example demonstrated.

Usually the calibration and identification data of the analytical test element are present as digital data and the measured signals obtained in the measurement of the concentration of an analyte are in the form of analogue data. In the application according to the invention of transponder technology the digital data are for example transmitted by the above-mentioned amplitude modulation. The analogue data are either digitalized before transmission or they are transmitted as analogue signals by for example also using amplitude modulation.

The calibration and identification data which are stored on the analytical test element are either stored in an electronic memory e.g. made of polymer electronics or they are coded in a magnetic strip or barcode which is located on the test strip.
The measurement signals are either stored on an electronic data memory before they are transmitted to the instrument e.g. by a transponder system or they are directly transmitted to the instrument without temporary storage. The electronic memory on the analytical test element is preferably a non-transient memory, in particular the memory or memory area in which the calibration and identification data are stored.

In a preferred variant of the invention the analytical test element comprises a memory for storing electronic data where this memory is also writable when the analytical test element is in a package. The test strips are for example packaged in a container (single test magazine or tape magazine) and subsequently the calibration data are transmitted from the reading module located on the outside through the package to the transponder located on the test element and are stored there.
In this case the package is designed such that a wireless transmission of the data is possible in particular the packaging material preferably consists of plastic or cardboard which is almost completely permeable to the transmission radiation.

In another embodiment according to the invention the analytical test element has no electrical contacts with the instrument by which data or electrical energy can be transmitted between the test element and the instrument for example because all data and optionally the energy are transmitted by a transponder system.

For example the electric circuit on the analytical test element, such as the transponder antenna or the conductor paths and contacts, at least partially made of polymer electronics but the transponder itself is in the form of a silicon chip. The higher manufacturing costs of a silicon chip may be acceptable for complex analytical test elements which can for example carry out several measurements.
This embodiment can be advantageous when the transponder is not directly located on the analytical test element but on a package for one or more test elements. In this alternative embodiment the system additionally comprises such a package which can in particular be a container or a magazine for a plurality of test elements e.g. a drum. In addition it is possible to implement a so-called test counter on the package which stores the number of tests carried out or still to be carried out with this container in the memory on the container. In this manner the instrument can at any time enquire how many unused test elements are still in the package. If this information is only stored in the instrument, malfunctions may occur for example when a container that has been started on is removed from the instrument and replaced by another partially used or new container. Of course an indicator showing whether the test element has been already used or not can also be stored on the test element itself.

Another preferred embodiment of the invention concerns a system which comprises an analytical test element which has an area with detection chemistry for detecting the analyte wherein at least a part of the electrical components on the test element is formed on the basis of polymer electronics, and a package in which one or more analytical test elements are packaged where the package has a memory for storing electronic data and a transmitting module for the wireless transmission of data. The system additionally comprises an instrument which has an evaluation unit for evaluating the data and a reading module for the wireless transmission of data.
The test strips are for example packaged in a container (drum, magazine). The calibration and identification data are in this case stored on the container and not on the test elements. The container, e.g. a drum containing analytical test elements which is similar to that used in the Accu-Chek Compact , is inserted into the instrument and the transponder on the container transmits the data to the reading module in the instrument. The advantage of this variant is that for example only one transmitting module is necessary for several test strips especially when the measurement signals can be processed without a transponder (e.g. in the case of photo-optical test elements).

According to another embodiment according to the invention especially for single-use test strips, the analytical test element does not have its own energy supply. Batch number, strip type, expiry date and calibration data are for example stored on the test element. The test element is removed from the package by the user or automatically by the instrument and for example moved into a holder in the instrument. The positioning of the test element in the holder ensures a correct position of the transmitting and reading module. In particular the holder ensures that the analytical test element is positioned in the transmitting and receiving range of the reading module. The transmitting and receiving range describes the range within which electronic data can be exchanged in a wireless manner between the reading module and transmitting module. The extent of this range is defined in particular by the dimensions of the transponder coils, the energy and frequency of the transmitted electromagnetic waves and any shielding that maybe present e.g. by metal parts. For example the holder can be designed such that the transponder modules are brought very close together typically to a distance of 0.1 to 3 mm. Due to the small distance which has to be bridged, the transponder coils can be very small and only a small amount of energy is required for the wireless transmission for example in the range of 0.1 to 10 mJ. A low energy requirement is particularly advantageous for battery operated instruments. Furthermore, the transmitting and receiving area can be spatially considerably narrowed down to ensure that only the inserted test element is addressed and not additionally other test elements that are in the vicinity. Alternatively the transmitting and receiving area can also be designed such that the analytical test element can be positioned with or without a holder for example right next to or on the instrument for wireless data transmission. Furthermore, the holder for inserting the analytical test element into the transmitting and receiving area can be located in a package for several test elements and the package is appropriately positioned relative to the instrument for example by a holder for the package on the instrument or by a holder for the instrument on the package.

In another preferred embodiment the transmitting module is not on the test element but rather on a package which contains one or more test elements and a holder positions the package in the instrument such that the transmitting and reading module are brought very close together so that the transmitting module of the package is in the transmitting and receiving range of the reading module.
Another preferred embodiment of the invention concerns an analytical test element which has an area with detection chemistry for detecting an analyte wherein a transmitting module and a reading module are located on the analytical test element and data are transmitted in a wireless manner between these two modules within the test strip. Furthermore, electrical energy can also be transmitted in addition to the data. At least some of the electrical components on such an analytical test element are preferably formed on the basis of polymer electronics.
Such an analytical test element can in addition also transmit data or data and energy to the instrument in a wireless manner e.g. by means of a second transponder system with a transmitting module on a test strip and reading module in the instrument. Of course the data which are transmitted within the test strip using a transponder system can be digital as well as analogue data. For example such an internal transponder system on the test strip can be used to galvanically decouple the electric circuits on an electrochemical test strip wherein energy is transmitted from the instrument to the detection area and the measurement signals e.g. as analogue voltage or current values, are in turn transmitted from the detection area to the instrument.

In the system according to the invention it is possible to use an electrochemical as well as a photo-optical measuring procedure for the analytical determination especially when the measuring unit is on the test strip in the case of a photo-optical test strip and thus the electrical measurement signals are to be generated on the test strip as is the case for an electrochemical test strip and transferred to the instrument.

For example a light beam can be guided from the instrument onto the detection area and a photoelement located on the test strip e.g. a solar cell made of polymer electronics receives the optical measurement signal and converts it into an electrical signal. This signal can then be transmitted in a non-contact manner by the transponder system to the instrument.

The methods known in the prior art are used for the sensory detection of the analyte and in particular of blood glucose. Photo-optical and electrochemical methods are preferred. Photo-optical measuring procedures are for example reflection photometry, absorption measurement or fluorescence measurement.
Electrochemical methods are for example potentiometry, amperometry, voltammetry and coulometry.

Another subject matter of the invention is a process for producing an analytical test element which has an area with detection chemistry for detecting an analyte in a body fluid, a memory for storing electronic data and a transmitting module for the wireless transmission of data wherein the production comprises the steps:
storing a batch identification on the analytical element; packaging the analytical test element;
and storing calibration data on the packaged analytical test element.

Another subject matter of the invention is a process for producing an analytical test element which has an area with detection chemistry for detecting an analyte in a body fluid, wherein the production comprises the steps: storing a batch identification on a package which has a memory for storing electronic data and a transmitting module for the wireless transmission of data; packaging the analytical test element in the package; and storing calibration data on the package.

Another subject matter of the invention is a method for determining the concentration of an analyte in a body fluid which comprises the steps:
inserting an analytical test element which has an area with detection chemistry for detecting an analyte in a body fluid, a memory for storing electronic data and a transmitting module for the wireless transmission of the data, into an instrument which comprises an evaluation unit for evaluating the data and a reading module for the wireless transmission of the data; applying the body fluid to the analytical test element, wireless transmission of the data from the analytical test element to the instrument, and the evaluation of the data in the evaluation unit of the instrument.
Another subject matter of the invention is a method for determining the concentration of an analyte in a body fluid which comprises the steps:
inserting a package in which one or more analytical test elements with detection chemistry for detecting an analyte in a body fluid are packaged, and the package has a memory for storing electronic data and a transmitting module for the wireless transmission of data; providing an analytical test element from the package; applying the body fluid to the analytical test element; wireless transmission of data from the package to an instrument which comprises an evaluation unit for evaluating data and a reading module for the wireless transmission of data; and the evaluation of the data in the evaluation unit of the instrument.

Batch-specific calibration data are for example stored on the test strip. The test strip is inserted into the appropriate holder in the instrument by the user for example by hand or the test strip storage container has a removal device which transports the strips from the storage container into the instrument. The instrument preferably automatically switches on as soon as the test strip is inserted and is ready for measurement after a short self test. Subsequently the user applies the sample of body fluid to be measured. The sample reacts with the detection chemistry on the test strip and thus generates a measurement signal. In the case of photo-optical systems this can for example be a change in colour and in the case of electrochemical systems a current signal is for example generated.

The colour change is converted by the optical measuring system into an electrical signal. The optics is usually integrated into the instrument but it can, however, also be located on the test strip especially when the optical system is at least partially in the form of polymer electronics. The calibration data are transmitted in a wireless manner from the test strip to the instrument with the aid of the transponder system or if the optical system is on the test strip, energy is firstly additionally transmitted from the instrument to the test strip to drive the optical system and after the measurement the measurement signals are transmitted from the test strip to the instrument. The measurement signals are evaluated in the evaluation unit taking into account the batch-specific calibration data. The instrument preferably has a display unit e.g. an LCD display which shows the measurements to the user.

In an alternative embodiment one or preferably a plurality of test strips are arranged in a package e.g. a container. The batch-specific calibration data are stored on the package and the transponder is also located in the package. The package is inserted into the instrument by the user. The instrument is switched on for operation and it preferably automatically transports a test strip into a position in which the user can apply the sample. Subsequently the sample is applied and a photo-optical or electro-chemical measurement is carried out as described above. It is preferably a photo-optical test strip and the optical measuring system is located in the instrument. The calibration data are transmitted by the transponder on the package to the instrument in a wireless manner before or after the measurement, while the optical measurement signals are received by the optical system in the instrument and evaluated in the evaluation unit taking into account the calibration data and preferably displayed in a display unit. In the case of an electrochemical test strip, calibration data are also transmitted by the transponder on the package to the instrument in a wireless manner and for example the electrical measurement signals are transmitted via electrical contacts from the test strip to the instrument by means of which the energy required for generating the measurement signal is also fed in.
Description of the figures The invention is further elucidated by the following figures: Figures 1 to 23 show schematic diagrams for specific embodiments of the invention.

Figure 1 shows an analytical test element with a transponder system.
Figure 2 shows an analytical test element according to the invention inserted into an instrument.
Figure 3 shows the use of a conductive polymer substrate as a data memory.
Figure 4 shows the transmission of data on several analytical test elements using the transponder system according to the invention.
Figure 5 shows a drawing of a system comprising several galvanically separated circuits.
Figure 6 shows a schematic block diagram of a system comprising several galvanically separated circuits.
Figure 7 shows a multielectrode system with transponder.
Figure 8 shows a partially implanted analytical test element.
Figure 9 shows an implanted analytical test element.
Figure 10 shows a basic circuit of a potentiostat transponder.
Figure 11 shows an electrochemical test strip with a transponder made of polymer electronics.
Figure 12 shows a sectional view of the test strip of figure 11 inserted into an instrument.
Figure 13 shows a photo-optical test strip with a transponder made of polymer electronics.
Figure 14 shows a sectional view of the test strip from figure 13 inserted into an instrument.
Figure 15 shows a test element with several potentiostat sensor systems.
Figure 16 shows the test element of figure 15 inserted into an instrument.
Figures 17 and 18 show a partially implantable analytical test element.

Figures 19 to 21 show examples for data transmission on packaged test strips.
Figures 22 and 23 show a writing/reading memory made of polymer electronics.
An analytical test element 1 is shown in figure 1 which consists of a substrate 2 on which a detection area 3 for detecting an analyte in a body fluid and a transmitting module which comprises the transponder substrate 4, in or on which the transponder antenna 5 and the transponder electronics 6 are located, which are manufactured as polymer electronics.

Figure 2 shows a schematic drawing of an analytical test element 1 which is inserted into an instrument 7. The identification and calibration data of the test strip are stored in the transponder electronics 6 and are transmitted via the transponder antenna 5 to the reading module 8 which is also situated in the instrument 7.
The wireless data transmission is indicated by the arrow 9. The measurement signals determined in the detection area 3 are passed onto the instrument 7 via the electrical contacts 15. The test strip shown here can be suitable for an electro-chemical and for a photo-optical measurement. In the case of a photo-optical test element either the contacts 15 are omitted and the optical evaluation system is in the instrument 7, or the optical evaluation system is at least partially integrated on the test strip such that the optical measurement signals on the test element are converted into electrical quantities and the electrical signals are passed onto the instrument via the contacts 15.

Use of a conductive polymer substrate 14 as a binary memory for electronic data is shown schematically in figure 3. The control electronics 10 controls the electrode matrix 11 such that firstly high-resistance zones 12 become low-resistance zones 13 in a spot-wise manner.

Figure 4 shows the wireless transmission of data 9 between a reading module 8 and several analytical test elements 1. The transmitting modules on the test element are in this case represented by the transponder substrate 4 and the transponder electronics 6. This application can for example be used in the production. In this case the test strips 1 are packaged in a package e.g. a container which does not impede the electromagnetic field and a special reading module 8 in the production firstly reads the test strip identification from the test elements in order to read the batch numbers, it then transmits the batch-specific calibration data and finally checks by means of a new interrogation whether the data transmission was correct.
In a second application of the setup shown here, the test elements 1 are in a container in the instrument or in close proximity to the instrument and the reading module 8 which is located in the instrument reads the data from the test element.
These data are for example the type of strip, expiry date and calibration data.
Furthermore, it is also possible that used test elements are placed back in the container after the measurement. The use is for example stored on the test element e.g. together with the measured values and reported to the reading module, or directly transmitted to the reading module and stored there for example together with the measured values, or a test element for which a measured value has been stored on the test element or in the instrument, is automatically regarded as having been used.

Figure 5 shows a basic diagram of a system with galvanically separated circuits.
Several electrical circuits consisting of transponder antenna 5, transponder electronics 6 and measuring electrodes 16 extending into the electrochemical detection area 3 are located on the transponder substrate 4. The measurement signals are received by an equal number of antennae 17 arranged in parallel in the reading module 8.

Figure 6 shows a simplified block diagram of the example shown in figure 5 where it is also possible to transmit and/or receive signals from further modules 30 e.g. an electrochemical flow sensor.

Figure 7 shows a complex multielectrode system as a potentiostat transponder for the electrochemical measurement of for example blood glucose and blood coagulation using electrical supply lines 18 which extend from the transponder electronics and transponder antenna 6 and 5 respectively to the measuring electrodes 16 in the detection area 3. A cover layer 19 ensures a hermetic separation of the transponder system.

Figure 8 shows a partially implantable lancet-like test element 1 having a potentiostat transponder which is preferably used for a continuous glucose measurement. In this case the glucose concentration is determined regularly, the data are stored in the transponder and the signals are always transmitted to the instrument when the reading module 8 is in the vicinity. Thus the user can remove the instrument for brief periods e.g. to change his clothes or shower without problems. The test element 1 consists of a relatively stiff substrate 2 which is pointed at one end and on the tip of which the measuring electrodes 16 are situated.
Electrical conductor paths 18 lead from the electrodes 16 to the other transmitting module located outside the body consisting of transponder electronics and transponder antenna 6 and 5 respectively. The entire test element 1 is encapsulated in a water-tight manner with a cover layer 19 and only the measuring electrodes 16 have, of necessity, contacts that are open towards the outside. There may for example be a plaster 22 over the test element 1 and the reading module 18 can be worn comfortably above the clothing 22.

Figure 9 shows a potentiostat test element 1 similar to the example shown in figure 8 as a (fully) implanted version. The entire electronics except for the measuring electrodes 16, is hermetically encapsulated in a glass or polymer capsule 23.
In order to achieve higher penetration depths into the tissue layers, one preferably uses low frequency transponders in the range of 125 kHz. In order to achieve small antenna coils that are suitable for this, they are equipped with rod ferrite cores 24.

Figure 10 describes a basic circuit for a potentiostat transponder. The transponder electronics comprises among others a load modulator 25, an energy store 26 e.g. in the form of a capacitance and a voltage/frequency converter 27. The resting potential 28 is permanently applied to the working electrode 29. 30 and 31 denote the reference and counter electrode respectively. The reading module has among others a band pass filter 32, energy transmitter and writing unit 33, reading unit 34, memory 35 and control unit 36.

Figure 11 shows an analytical test element 1 with a transponder made of polymer electronics which operates according to an electrochemical measuring procedure. A

spacing foil 51 is located on the substrate 2 and forms a blood capillary 50 between the substrate 2 and cover foil 52 into which the measuring electrodes 16 for the electrochemical measurement extend. The transponder antenna 5, the transponder electronics 6 and the transponder memory 54 in the form of polymer electronics are in or on the transponder foil 4. In this case the transponder is used to transmit test strip identification and calibration data. The measurement signals are transmitted via the sensor contacts 15.

Insertion of the test strip 1 from figure 11 into an instrument positions the transmitting module 37 and in particular the transponder antenna 5 close to the reading module 55 and in particular close to the reading module antenna 17 (see figure 12). In this case the reading module 55 is located on the electronic printed circuit board 56 of the instrument 7 as are the instrument contacts 70 which contact the sensor contacts 15 on the test strip 1.

In the test element 1 in figure 13 the detection area 3 which is filled by the blood capillary 50 is located under the polymer electronic transponder module consisting of transponder substrate 4, transponder antenna 5, transponder electronics 6 and transponder memory 54. The blood capillary 50 is formed by the spacing foil 51 between the substrate 2 and cover foil 52.

When the test element 1 from figure 13 is inserted into an instrument 7, the transponder antenna 5 and reading module antenna 17 are very close above one another and thus ensure an easy data transmission over a short distance (see figure 14). The transponder module 37 is on the upper side of the test strip, the photo-metric detection area 3 is illuminated from the underside by the illumination and read by the optical reader 59. Printed boards 56 lying above and below are fitted with the reading module 55 and the optical modules 58 and 59 respectively.

The test element 1 in figure 15 has a detection area 3 in the form of a liquid channel through which the sample flows from the inlet 60 to the outlet 61 e.g. for continuous blood glucose measurement. Three measuring electrodes 16 of a potentiostat extend into the liquid channel. A polymer electronic transponder antenna 5 and the transponder electronics 6 which is composed of polymer electronics or (at least partially) silicon chips are located on the transponder substrate 4. In addition to the first potentiostat sensor system there is another parallel system of identical construction where both systems are galvanically separated from one another.

When inserted into an instrument 7 the parallel transponder antennae 5 on the test element 1 are aligned with the corresponding reading module antennae 17 which pass the data onto the reading module electronics 55 for a wireless data transmission 9 (see figure 16).

Another example of a continuously measuring analytical test element 1 is shown in figures 17 and 18. The substrate 2 has a needle-like end which is inserted through the skin 20 into the tissue 21 such that the measuring electrodes 16 can measure directly in the tissue 21. The potentiostat electronics and the transponder module 37 as polymer electronics or a silicon chip are situated on the flat extracorporeal part of the substrate 2. A cover layer 19 encapsulates the electronics with the exception of the measuring electrodes. A plaster 62 attaches the test element 1 to the skin.

Figures 19 to 21 show examples for data programming in production and logistics.
In figures 19 and 20 a reading module 8 writes batch-specific calibration data onto test strips 1 during the production where the test strips are already packaged in a drum 63 or a magazine 64. In figure 21 several test strip cans 63 are combined in a cardboard box 65 to make a package and are then written by a reading module 8 in the production or in the logistic chain. It is also possible to hard-wire data (e.g.
batch numbers or serial numbers of the test strips) during the manufacture of the polymer electronic transponder. The data then do not have to be read additionally onto the transponder but can also not be subsequently changed.

Figures 22 and 23 show a writing/reading memory made of polymer electronics as is for example used for a transponder memory 54. The polymer substrate 4 e.g.
made of PDOT (polyethylene dioxythiophene) has line leads 66 on the upper side and column leads 67 on the underside. By applying a voltage to a certain line lead 66 and a certain column lead 67, the polymer 4 changes its electrical conductivity at the crossing point from high-resistance 12 to low-resistance 13. The effect can be reversed by reversing the polarity of the voltage, when the voltage is removed the last resistance value is retained. In this manner a binary data memory is obtained.
lines and 10 columns are for example sufficient to store the calibration data of a blood glucose test strip. The data are read out again by measuring the resistances between defined column and line leads.

Claims (10)

1. A system for determining the concentration of an analyte in a body fluid comprising:

- an analytical test element which has an area with reagent chemistry for detecting the analyte in a body fluid by generating a measurement signal from the reaction of the analyte with the reagent chemistry, - an instrument separate from said analytical test element, said instrument comprising an evaluation unit to evaluate the measurement signal and determine the concentration of the analyte in the body fluid, the analytical test element and the instrument being operatively connected in a contacting or a non-contacting manner;

wherein said analytical test element comprises electrical components at least in part comprising polymer electronics, the electrical components on the analytical test element comprising at least two electrodes in contact with the reagent chemistry and a plurality of galvanically separated electronic circuits and a plurality of parallel transmitting modules configured for wireless transmission of data or data and energy, the instrument further comprising a plurality of parallel reading modules configured for the wireless transmission of data or data and energy.

2. A system according to claim 1, wherein said polymer electronics element are formed from a polymer having semi-conducting or conducting properties associated with polymer electronics.

3. A system according to claim 1 or 2, wherein the data which is transmitted in a wireless manner between the transmitting modules and the reading modules at least partially comprise analogue data.

4. A system according to any one of claims 1 to 3, wherein the analytical test element and the instrument are operatively connected in a contacting manner.

5. A system according to any one of claims 1 to 3, wherein the analytical test element and the instrument are operatively connected in a non-contacting manner.

6. A system according to any one of claims 1 to 5, wherein the reading modules have a memory for storing data.

7. A system according to any one of claims 1 to 5, further comprising a memory for storing data and the memory is also writable when the system is located in a package.

8. A system according to any one of claims 1 to 7, wherein the instrument comprises a holder for positioning the analytical test element.

9. A system according to any one of claims 1 to 8, wherein the analytical test element has a memory for storing data.

10. A system according to any one of claims 1 to 9, wherein a transmitting module of said plurality of parallel transmitting modules and a further reading module are located on the analytical test element and data or data and energy are transmitted in a wireless manner within the analytical test element between said transmitting module and said further reading module.