Abstract:
A measuring device for analyzing a sample liquid having at least one analyte is provided. A test field support housed in the device includes a number of individual test fields in communication with electrochemical measuring cells of the test field support. Reagents can be assigned to the electrochemical measuring cells which can react with a sample liquid. The reaction can lead to a measurable change of at least one quantity characteristic of the presence or concentration of an analyte in the sample. The measuring device includes evaluation electronics. The individual test fields on the test field support are accessible to the user after the measuring device has been opened.

Description:
RELATED APPLICATIONS  
       [0001]     This application is a continuation application of International Application PCT/EP2006/061449, filed Apr. 7, 2006, which claims priority to DE 10 2005 017 364, filed Apr. 14, 2005, which are hereby incorporated by reference in their entirety. 
     
    
     BACKGROUND  
       [0002]     The invention relates to an analysis device for the determination of concentration or presence of an analyte in a human body fluid, and more particularly, a device of this type that can be used several times in succession.  
         [0003]     U.S. Pat. No. 5,286,362 discloses a method and a sensor electrode system for electrochemical determination of an analyte or of oxidoreductase, as well as suitable substances for the electrochemical determination. Electrons are transferred in the presence of an oxidoreductase and a reducible substance, and are transferred in the course of the determination reaction from the oxidoreductase to an electrode. This produces a signal which allows determination of the analyte, the reducible substance being enzymatically reduced and oxidized at the electrode. The substance which is produced at the electrode by oxidation differs from the reducible substance originally used. A corresponding sensor electrode system and components suitable for it are furthermore disclosed. According to U.S. Pat. No. 5,286,362, a mixture of an oxidoreductase and a first reducible substance is used. The first reducible substance is reduced by the oxidoreductase and produces a reduced substance in an irreversible reaction. This reduced substance is oxidized to produce a second reducible substance which differs from the first reducible substance. Instruments are provided for holding the mixture of the oxidoreductase and the first reducible substance as well as for bringing the mixture in contact with a liquid sample which may contain the analyte. Contact instruments are also provided for electrical connection of the mixture upon contact with the sample to two electrical leads that are physically separate from each other. The contact instruments enclose an electrically conductive surface for receiving the electrodes from the first reducible substance when the first reducible substance is reduced by the oxidoreductase and the reduced substance is produced, and for oxidizing the reduced substance at the electrically conductive surface to form the second reducible substance.  
         [0004]     U.S. Pat. No. 6,027,689 discloses a test card for optical or electrical determination of the concentration of a substance in a liquid. The test card is used in a measuring device for evaluating the concentration of a substance in a liquid such as body fluid. The test card has layers of material that are suitable for being united in a continuous process during which the layers are unrolled from corresponding storage rolls. Each test card comprises a number of individually usable test sections that are joined together and arranged in a successive sequence along the length of the test card. The material layers of the test card cooperate to define at least one reaction layer and a cover layer covering it, the cover layer comprising an opening for receiving a sample drop in each test section. A distribution layer and a carrier material layer can likewise be incorporated in the test card, the carrier layer in each test section comprising a measurement opening which coincides with the opening for the sample drop. Weakened zones are provided in the material between neighboring test sections, allowing simple removal of a used test section from the remaining unused test sections.  
         [0005]     WO 2004/030822 discloses a multiple capillary sensor analysis system used to analyze a sample liquid for an analyte, in particular, for analyzing a human or animal body fluid. A capillary sensor is provided that includes a capillary channel enclosed by at least two wall parts and having an inlet opening for the sample liquid and a vent opening. The capillary channel contains reagents that react with the sample liquid, thereby causing a change in a parameter that can be measured. An evaluation device is provided that has a capillary sensor frame for positioning a capillary sensor in a measuring position in order to carry out an analysis. The capillary sensor is positioned such that the inlet opening of the capillary channel is accessible for contact with a liquid sample to be studied, the liquid sample entering and filling the capillary channel due to capillary forces. Measurement and evaluation electronics are also provided to measure the parameter and correlate it to the information being sought, e.g., glucose concentration of the liquid sample. The capillary sensors are provided as multiple capillary strips with successively arranged capillary sensors. A multiple capillary sensor strip is guided and held in the capillary sensor frame of the evaluation device so that one capillary sensor of the strip lies in the measuring position and its inlet opening is accessible for contact with sample liquid. The multiple capillary sensor strip can then be moved in the evaluation device to transport consecutive capillary sensors of the sensor strip to the measuring position. The evaluation device comprises a cutting instrument which, after carrying out each measurement, cuts the capillary sensor used for the measurement from the multiple capillary sensor strip. Capillary sensors of the multiple capillary sensor strip are provided as electrochemical capillary sensors, each of which have a working electrode, a counter electrode and sensor contacts which are connected to the electrodes via conductor tracks and are in contact with corresponding device contacts of the evaluation device during the measurement to electrically connect to the measurement and evaluation electronics.  
         [0006]     The above-discussed references describe arrangements of test field supports in which a plurality of individual test fields are arranged in a row on a band or a bar, and a new test field must be transported to the sample application position each time a new test is performed. The references teach that the successively used individual test fields are removed. Transporting a test cell or test section to a fixed application position in the device entails relatively high outlay, which is inherent to all the above-discussed references. The user of the above-discussed arrangements is offered only one test section at a time, the test section being arranged on a band-shaped or strip-shaped support. The user is thus restricted in terms of selection, and can use only the test section that is currently positioned in the application position.  
       SUMMARY OF THE INVENTION  
       [0007]     Embodiments incorporating the present invention address the disadvantages of the prior art and the problems mentioned above.  
         [0008]     One embodiment provides an analysis unit which allows simplified handling by an end-user, for example a diabetic, and is constructed more simply. A plurality of individual test fields or test sections are arranged in the form of a matrix on a test field support, so that the individual test fields can be used in any order, which can be arbitrarily selected by a user. According to other embodiments, the position of the individual test fields on the test field support, and therefore the position of the individual test fields with respect to the measuring system, is fixed. It is therefore possible to apply the sample at any of the available different positions of the individual test fields. The transport of a test field to a fixed application position, which can only be carried out with considerable expense, is therefore not required. This greatly simplifies the structure of the measuring device.  
         [0009]     In contrast to using an individual test field support for each test field, the amount of handling can be significantly reduced by using a test field support having a plurality of individual test fields. The plurality of individual test fields can be arranged in a matrix on a side of the test field support accessible to the user. The number of individual test fields arranged on a single test field support can be adapted, e.g., to the number of glucose measurements required over a day by a diabetic, and the test field support can be replaceable. This arrangement considerably simplifies carrying out a single measurement and also avoids the need to dispose of individual used test strips or individual test fields after each test is conducted. This is in contrast to the above-described references that require individual test strips to be disposed of once used and also be separated from a continuous material.  
         [0010]     In contrast to individual test fields or bars arranged in row form on bands that are transported through an analysis unit as described above, the embodiments disclosed herein avoid complex mechanical or electromechanical drives, which take up installation space, as well as the transport mechanisms necessary for them. The analysis units or analysis systems can therefore be much smaller, in particular, much flatter. Avoiding mechanical or electromechanical drives and transport mechanisms also makes it possible to produce such analysis units at much lower costs. Embodiments of the analysis units taught herein are less susceptible to malfunction and, compared with systems in which electrical drives are used, consume less power. Battery life will thus be longer, and smaller, less expensive batteries can be used.  
         [0011]     Embodiments of the analysis units having test field supports configured to be replaceable enable successive determination of the same parameter of a sample by use of the individual test fields arranged on the replaceable test field support.  
         [0012]     One embodiment provides an analysis unit having simplified handling. An electrical contact between the analysis unit and the test field support, which can be removably and replaceably inserted into the unit, can be established when the test field support is inserted into a housing depression or a differently configured housing facility. The electrodes of the electrochemical measuring cells of the individual test fields of a test field support can be connected simultaneously to a common electrical measurement and control circuit. The analysis unit can automatically detect which of the individual test fields on the test field support have recently been used. Interconnection of the individual test field recently used takes place electronically with the measurement and control circuit of the analysis unit to carry out the determination measurement. The individual test fields can be arranged on the test field support in the form of a matrix. After all the individual test fields of a given test field support have been used, the test field can be removed from the analysis unit and replaced with a new test field support.  
         [0013]     In another embodiment, the analysis unit having a replaceable test field support can be configured in the form of a fold-down case having an upper shell and a lower shell. In a housing depression or cavity formed on the lower shell, a substantially flat test field support (e.g., credit card shaped) having individual test fields can be inserted. After insertion, an electrical contact strip formed on the rear side of the test field support mates with and is electrically connected to an electrical contact strip formed on the lower shell&#39;s rear side. The electrical contact strip can be located in the housing depression in the lower side of the analysis unit which is provided in the form of a case. According to this embodiment, several individual test fields are arranged in a matrix on the upper surface of the test field support which is accessible to the user after opening the upper shell.  
         [0014]     In one embodiment, the test field support includes a support sheet on which at least two electrodes are formed at individual test field positions by methods such as laser ablation, lithography or screen printing. The support sheet includes a sufficient amount of rigidity or stiffness to support test fields or electrodes. These test fields and/or electrodes are connected by conductor tracks to electrical contact surfaces at the edge of the test field support. A reagent layer is applied over the surface of the base sheet at least partially onto the electrode and/or conductor track structures. The reagent layer can handle the reagents necessary for specific detection and measurement of the intended parameters from the sample. A spacer sheet located on the reagent layer can be, for example, adhesively bonded onto the reagent layer. The spacer sheet includes holes at the positions of the electrodes to form measuring chambers. A cover sheet is furthermore applied on the spacer sheet. The cover sheet can, for example, be adhesively bonded onto the spacer sheet and seals the measuring chambers. Openings are included to receive the sample at the measuring positions and to provide a vent hole. A sealing sheet is provided above the cover sheet to externally seal the capillary spaces in a substantially moisture-tight fashion.  
         [0015]     In order to carry out the measurement, one of the measuring chamber dosing openings is opened by the user. A ring-pull closure, a tab, or the like is provided for this purpose. A sample can then be applied to the measuring chamber for measurement.  
         [0016]     Before the first individual test field on the test field support can be used for the measurement, the test field support is inserted into a measuring device. The measuring device is provided in the form of a case including an end having an indentation, recess or cavity. In order to insert the test field support and to carry out a measurement, an upper shell of the case of the analysis unit is folded open. The case can include a display on its inside that the user can read when it is open. The test field support is then inserted into the recess or depression in the lower shell. After the measurement, the analysis unit can be deactivated by folding the upper shell to close the cases. Activation of the analysis unit can be carried out by folding the upper shell open.  
         [0017]     The electrodes of the individual test fields arranged on the upper side of the test field support can be simultaneously connected to the contacts of the analysis unit. A measuring cell can be selectively electrically connected to the measurement and control circuit of the device using an analog semiconductor switching matrix. After the analysis unit is activated, the measuring electrodes of the individual test fields can be serially electronically tested by a conductance measurement. The analysis unit can detect which of the individual test fields has been dosed with a sample, and then can carry out the electrochemical detection measurement on the corresponding electrodes. The result can be subsequently shown on the display located inside the upper shell.  
         [0018]     Another embodiment includes a test field support having a continuous band of capillary sensors. According to this embodiment, the individual capillary sensors are not cut into individual test strips, but are instead grouped together in blocks in a mutually adjacent or side by side arrangement to form a plurality of capillary sensors. The continuous band can be constructed from individual layers of materials held on a plurality of rolls. Such a band can include a plurality of layers. These multiple layers are sandwiched together and cooperate to define multiple electrochemical measuring cells, each having a sample receiving opening and a capillary channel configured to draw sample fluid into the measuring cell. Each sensor includes a base sheet in the form of a strip includes a conductive structure, an electrode surface, conductor tracks and contacts. A strip-shaped reagent film with the reagents necessary for the intended detection reaction can be applied onto a stiffer base sheet in the region of the electrodes. On this reagent film, a stamped spacer sheet forms a capillary and a measuring cell above the electrode surface on one side of the band. On the other side of the band, contact surfaces for electrical connection at the ends of the conductor tracks are exposed. A cover sheet which seals the capillaries on the upper side and forms a vent hole at the inner end of the capillary is adhesively bonded onto the spacer sheet for closure. A moisture-isolating seal can be used to protect the reagent layer. In this event, the band can be formed longer in front of the capillary side. In this case, a U-shaped stamping region around the front of the capillary can leave the capillary open on the dosing side, but simultaneously form a closed frame around the dosing opening. By sealing around the stamped region with a vapor-tight sheet, the capillary region with the reagents provided can be substantially protected against ingress of moisture. In order to expose the capillary opening, the frame can be bent down on the front edge so that a protective sheet can be removed from the dosing opening.  
         [0019]     Two band-shaped sections having layers are inserted opposite each other into an analysis unit. The sections can include, for example, five individual test fields, such as five capillary measuring cells. The analysis unit includes a lower part having a block-shaped test field support respectively placed on two opposite sides thereof. An upper part is connected to the lower part of the analysis unit by a hinge. The upper part is folded onto the lower part after insertion of the test field supports which fixes the test field supports inserted into the analysis unit. At the same time, resilient contacts arranged in a row correspondingly contact the measuring cell electrodes with electronics in the upper part.  
         [0020]     A display can be located on the upper side of the folded-shut device. Control buttons can be provided on the upper side. The analysis unit according to this embodiment can include openings for the sample application positions, i.e., the capillary openings of the block-shaped test field supports inserted into the analysis unit, which face out on both sides and are therefore readily accessible.  
         [0021]     The analysis unit may furthermore include an outer cover sleeve which can be slid over the analysis unit. In this position, the cover sleeve can form a handle for holding the analysis unit. Also, according to this alternative embodiment, the electrodes of the individual test fields of the test field support are simultaneously connected to the contacts of the analysis unit. An individual measuring cell can be selectively connected to the measurement and control circuit of the device electronically, for example, using an analog semiconductor switching matrix as discussed above. After the analysis unit is activated, the measuring electrodes of the individual test fields can be electronically tested in series by a conductance measurement. The analysis unit or a measuring algorithm implemented in the unit detects which of the individual test fields has been dosed with a sample. An electrochemical detection measurement can then be carried out, and the result subsequently shown on the display of the analysis unit. After all the individual test fields of the test field support have been used. The block or card including test fields can be removed from the analysis unit by folding open the unit.  
         [0022]     According to another alternative embodiment, a test field support can be slid into a module including a slot. The module including the slot can be slid into a complementary sleeve to be securely held thereby. The module includes, for example, a rectangular recess into which the card-shaped test field support containing a plurality of individual test fields can be inserted. Individual test fields or test sections, each have portions extending from a line, such as in the form of tongues, and have capillary openings on an outer edge thereof.  
         [0023]     The individual test fields or test sections can be in a mutually adjacent, i.e., side by side, arrangement. A light-emitting diode can be assigned to each individual test field. After having used all the individual test fields of a test field support card, the used test field support can be removed by unlatching on the card from the module. A new test field support having unused individual test fields or test sections can be inserted into the slot in the module. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0024]     The above-mentioned aspects of the present invention and the manner of obtaining them will become more apparent and the invention itself will be better understood by reference to the following description of the embodiments of the invention, taken in conjunction with the accompanying drawings, wherein:  
         [0025]      FIG. 1  is a perspective view of an analysis unit having a card-shaped test field support;  
         [0026]      FIG. 2A  is a cross-section of the card-shaped test field support shown in  FIG. 1 ;  
         [0027]      FIG. 2B  is a fragmentary plan view in partial cross section of an electrode structure;  
         [0028]      FIG. 3  is a schematic representation of an analog semiconductor switching matrix for electrical contact of the individual fields of the test field support of  FIG. 1 ;  
         [0029]      FIG. 4  is a perspective view of a test support showing an upper side of the test support with individual test fields arranged in a matrix with the first individual test field row being open;  
         [0030]      FIG. 5  is a perspective view of an analysis unit having a card-shaped test field support removed from a depression in a lower shell of the analysis unit;  
         [0031]      FIG. 6  is a perspective view of another embodiment of an analysis unit shown folded open;  
         [0032]      FIG. 7  is a perspective view of the analysis unit of  FIG. 6  shown before sliding into a cover sleeve;  
         [0033]      FIG. 8  is a perspective view of the analysis unit of  FIG. 6  shown slid into a cover sleeve;  
         [0034]      FIG. 9  is a perspective view of another embodiment of an analysis unit;  
         [0035]      FIG. 10  is a perspective view of the analysis unit of  FIG. 9  shown with the module partially removed from a box and with a card-shaped test field support inserted;  
         [0036]      FIG. 11  is a fragmentary perspective view of the module of  FIG. 10  with the card-shaped test field support inserted;  
         [0037]      FIG. 12  is a perspective view of the module of  FIG. 10  with the card-shaped test field support removed from the module;  
         [0038]      FIG. 13  is an exploded perspective view of a layer arrangement of an individual test strip of the card-shaped test field support; and  
         [0039]      FIGS. 14A  to  14 E are perspective views of a test field support in the form of a card having individual test strips, with and without a protective sheet in the region of the terminal electrodes and in the region of the capillary openings. 
     
    
     DETAILED DESCRIPTION  
       [0040]     The embodiments of the present invention described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of the present invention.  
         [0041]     The terms “measuring devices” or “analysis units” include portable devices which a user can carry with them on their person. Such transportable measuring devices or analysis devices can contain a long-term energy storage device to supply energy to evaluation electronics of the portable measuring devices or the portable analysis unit. The test field supports, which can be inserted into the portable measuring devices or analysis units, can be a medical consumable material. The test field supports can be removed from the device after use and replaced by new ones. It is also possible, however, to employ multi-use test field supports that can be regenerated after each use so that they can be reused.  
         [0042]      FIG. 1  shows an analysis unit having a card-shaped test field support inserted in an analysis unit  10 . The analysis unit or measuring device  10  includes a lower shell  12  and an upper shell  14  connected by an articulated connection  16 . An indentation in the form of a depression or cavity (see reference number  21  in  FIG. 5 ) is formed in the lower shell  12 , into which the flat card-shaped test field support  26  can be inserted. The boundary of the cavity in the lower shell  12  is identified by the reference numeral  20 . A first display  22  and a second display  24  are located in the upper shell  14  of the analysis unit  10 .  
         [0043]     The substantially flat card-shaped test field support  26  includes a test support surface  28  having a test field array  30  arranged in the form of a matrix. After the upper shell  14  of device  10  is opened, the individual test fields of the test field array  30  are accessible. Each individual test field of the test field array  30  is initially closed, and can be opened by a user as will be described in more detail below.  
         [0044]     After the upper shell  14  is opened, the user can select any of the individual test fields of the test field array  30 . For diabetics, for example, the device provides a simple and user-friendly procedure since the number of blood sugar measurements required daily for diabetics can be carried out simply with the individual test fields. Once a corresponding individual test field from the test field array  30  has been used, it can remain inside the test field support  26 . The environmental burden resulting from discarded test strips which occurs in other devices can be avoided or at least delayed.  
         [0045]     It can be seen from the sectional representation of  FIG. 2A  that the test field support  26  can be substantially flat in the form of a card and can have a layered structure or arrangement. A support sheet  34  is applied onto a base sheet  32  and is covered by a reagent layer  40 . A column-shaped hole or void  44  is formed between the support sheet  34  and the reagent layer  40 . Conductor tracks  36  for the connection of electrodes  38  ( FIG. 2B ) extend inside the void  44 . The aforementioned reagent layer  40  lies adjacent to or above the conductor tracks  36 . Between the reagent layer  40  and a spacer sheet  42  that covers the reagent layer  40  in individual regions, electrochemical measuring chambers or cells  46  (measuring capillary spaces) are formed. The electrochemical measuring cells  46  are covered by a hydrophilic layer  50 , which is in turn covered by a cover sheet  48 . In order to vent the electrochemical measuring cells  46 , both the cover sheet  48  and the hydrophilic layer  50  that is arranged adjacent to or below cover sheet  48  include apertures to provide a vent  52 .  
         [0046]     The electrochemical measuring cell  46  is formed on a lower side of an individual test field  68  having a reception well  80 . A cover or lid  78 , which can close and seal the individual test field  68 , is shown in its open position in  FIG. 2A . On the side facing the reception well  80 , the cover  78  includes a sealing edge  82 .  
         [0047]     As seen in  FIG. 2B , the electrochemical measuring cell  46 , bounded by the spacer sheet  42 , the reagent layer  40  and the hydrophobic layer  50 , includes electrodes  38  arranged mutually opposite or side by side. The electrodes  38  include a counter electrode CE and a further electrode WE. The ends of the electrodes CE and WE are interleaved and protrude into each other in the form of a comb. A pair of sample sufficiency electrodes FSE, which can detect the filling level of the electrochemical measuring cell  46 , are provided at an individual electrochemical measuring cell  46 . The filling level electrodes, FSE, detect the level to which the electrochemical measuring cell  46  is filled with a sample liquid. The electrodes FSE protrude into the electrochemical measuring cell  46  in the region of the electrodes CE and WE.  
         [0048]      FIG. 3  shows an analog semiconductor switching matrix  54  in a schematic representation. The electrodes  38 , CE and WE represented in  FIG. 2 , as well as the electrodes FSE that detect the filling level of the electrochemical measuring cell  46 , are integrated into an analog semiconductor switching matrix  54 . Each electrochemical measuring cell  46 , and therefore each individual test field  68  of the test field support  26 , can include four electrodes. An evaluation component includes a CE terminal  56  that receives a voltage for the CE electrode and a WE terminal  58  that receives a voltage for the WE electrode. Each of the terminals  56 ,  58  can be coupled to a switch  64  or  66 . The first switch  64  switches between the CE electrode and a terminal  60  of the first filling level electrode, whereas the second switch  66  switches between the WE electrode and the terminal of the second filling level electrode  62 . This arrangement ensures the particular test field  68  that is wetted by a sample and deliberately selected by the user to be evaluated by the evaluation component which receives voltages conveyed by the electrodes. The result recorded by the evaluation component can be correspondingly shown graphically on the first display  22  or the second display  24 . The electrodes CE, WE and the two FSE electrodes can detect the filling level of a body fluid such as whole blood, thinned blood, or plasma in the electrochemical measuring cell  46 . These electrodes are assigned to each of the individual test fields  68  in the card-shaped test field support  26 . The two filling level electrodes FSE detect the filling level in the electrochemical measuring cell  46  to ensure that a measurement is carried out with a sufficient liquid content in the electrochemical measuring cell  46 . The two FSE electrodes also can ensure that both the CE electrode and the WE electrode are fully wetted by the liquid containing the analyte.  
         [0049]     The electrodes CE, WE and the two FSE electrodes are connected to the electrical contact strip  72  which can be located on the shell side as shown in  FIG. 5 . When the test field support  26  is inserted into the lower shell  12  of the analysis unit  10 , the electrical contact strip  72  is connected to a complementarily configured electrical contact strip  70  located on the lower side of the test field support  26 . In this way, the individual test fields  68  arranged as a test field array  30  are electrically connected when the test field support  26  is inserted into the lower shell  12 . A microprocessor coupled to the analog semiconductor switching matrix  54  switches through the analog semiconductor switching matrix  54  to check to which of the individual test fields  68  an electrically conductive connection has been made. The check is made based on filling the electrochemical measuring cell respectively assigned to this individual test field  68 . In order to ensure a reliable measurement result, the filling level of a raw liquid in the relevant electrochemical measuring cell  46  is determined via the FSE electrodes.  
         [0050]      FIG. 4  shows an upper side of the flat test field support  26  in the form of a card that can be removed from the depression-shaped indentation in the lower shell  12  of the measuring device  10 . In  FIG. 2 , a majority of the individual test fields  68  in the test field array  30  are closed, whereas one row of the individual test fields  68  is represented in the open state. In the closed state, each individual test field  68  is closed by a cover  78 , each of the covers  78  having a sealing edge  82 . In the closed state of the cover  78 , the sealing edge  82  seals a reception well  80  on the flat test field support  26 . In order to open the covers  78 , the covers include a ring-pull closure  76 , the tab of which protrudes slightly beyond the cover  78  when a reception well  80  is closed by a cover  78 . In order to open an individual test field  68  and introduce a body fluid sample, for example, blood, the user pulls on a recloseable ring-pull closure  76  and brings the cover  78  into an upright position as represented in  FIG. 4 . The ring-pull closure  76  can then be reclosed, so that the individual test field  68  is sealed.  
         [0051]      FIG. 5  shows a test field support  26  which is removed and spaced away from the indentation or recess  20  provided in the lower shell of the analysis unit in the folded-open state.  FIG. 5  shows the depression-shaped indentation or cavity  21 , which is formed in the lower shell  12  of the measuring device  10  delineated by border  20 . The replaceable test field support  26  includes individual test fields  68 , some of which are accessible because the cover  78  is open. The majority of the individual test fields  68  formed on the upper side of the flat test field support  26  are shown as sealed by closed covers  78 . The electrical contact of the flat test field support  26  is made by a contact strip  72  formed in recess  21  contacting a complementary electrical contact strip formed on the lower side of the test field support  26 . Thus, when the test field support  26  is inserted into the cavity of the lower shell  12 , contact with the flat test field support  26  takes place directly.  
         [0052]      FIG. 6  shows another embodiment including a lower part  142  and an upper part  144  connected together at a hinge  146  and a corresponding measuring device or analysis unit  140  in the open state. A capillary sensor support  100  can be inserted into the lower part  142  and can include five or more capillary sensors  104  arranged next to one another as shown.  
         [0053]     A band assembled from rolls comprises a plurality of layers to create an electrochemical capillary sensor  104  when laminated together. The capillary sensor support  100 , containing a plurality of layers in its final assembled state, includes a stiffer base sheet having a conductive structure, electrode surfaces, conductor tracks and contacts. A strip reagent film with the reagents necessary for the intended measurement reaction is applied over the more stiffly designed base sheet by, e.g., flow coating in the region of the electrodes. A further layer is in turn applied on top of the base sheet in the form of a stamped spacer sheet, for example, adhesively bonded. A capillary  108  is located on one side of the capillary sensor support  100 . An electrochemical measuring cell is placed over respective electrode surfaces. On the other side of the band a conductor track includes contact surfaces upon which electrical contact can take place. A cover sheet, which seals the capillary  108  at the top and forms a vent hole at the inner end of the capillary  108  is adhesively bonded onto the reagent sheet.  
         [0054]     Sealing of the reagent layer against moisture can also be achieved by making the band wider on the capillary side, in which case a U-slot-shaped stamping around the front of the capillary  108  leaves it open on the dosing side. This simultaneously forms a closed frame around the dosing opening. By sealing around the stamped region with a thin vapor-tight sheet, the capillary region with the reagents can be protected against ingress of moisture.  
         [0055]     In order to expose the capillary  108 , a frame (not shown in  FIG. 6 ) can be bent up on the front edge of the capillary sensor support  100 , after which a protective sheet can be removed from the opening of the capillary  108 . Two of these sections, for example, each having five individual test fields (capillary measuring cells), can be inserted opposite each other into the analysis unit  140 . The lower part  142  and the upper part  144  are closed so that the inserted capillary sensor support  100  can be immobilized. Contact takes place with strip-shaped contact regions  110 ,  112  of the capillary sensor support  100  so that the measuring cell electrodes can be coupled to electronics, which are accommodated in the upper part  144  of the measuring device  140  by resilient contacts  148  arranged in a row. The two contact regions  110  and  112  extending parallel to one another also run parallel to the first long side  102  or the second long side  106  of the capillary sensor support  100 . The electronics test the individual test fields of the capillary sensor support  100 . When the capillary sensors  104  have been selected for use by the user, a conductive connection is set up in the assigned electrochemical measuring cell  46  in the capillary sensor  104  being used, due to the sample liquid entering the cell.  
         [0056]     Once the upper part  144  of the analysis unit  140  is folded down about the hinge  146 , then the contact regions  110 ,  112  are connected to resilient contacts  148  which are complementarily designed with the profile of the contact regions  110 ,  112 . When the upper part  144  is folded down, an electrical connection is established between the resilient contacts  148  and the contact regions  110 ,  112  of the capillary sensor support  100 . The openings of the capillaries  108  protrude laterally beyond the folded-down upper part  144 . The user of the connected capillary sensor support  100  can therefore select which of the capillary sensors  104  is to be used and, in contrast to the solutions known from the prior art, is not restricted to successive presentation of sensors.  
         [0057]      FIG. 7  shows the measuring device  140  folded together, or the analysis unit  140  folded together, before sliding into a cover sleeve. The lower part  142  and the upper part  144  of the measuring device  140  connect with the capillary sensor support  100 . The upper side of the upper part  144  includes a display  150  and optional control buttons, which are identified by reference numerals  152 . In the folded-together state, the measuring device  140  can be slid into the cover sleeve  154  (See  FIG. 8 ). In the slid-on state  156 , the cover sleeve  154  can also be used as a handle for holding the measuring device  140 .  
         [0058]     The electrodes of the individual test fields or capillary sensors  104  of the capillary sensor support  100  are simultaneously connected to the resilient contacts  148 . Determination of the respectively used electrochemical measuring cell for the measurement and control circuit of the measuring device  140  is carried out electronically via an analog semiconductor switching matrix  54  such as depicted in  FIG. 3 . After activation of the measuring device  140 , all of the measuring electrodes of the individual test fields are serially electronically tested repeatedly by a conductance measurement. Consequently, the measuring device  140  detects with the aid of a measurement algorithm, for example, which of the individual test fields has been dosed with a liquid sample. Electrochemical detection measurement is then carried out on the electrodes. The result can be subsequently shown on display  150  on the upper side of upper part  144 .  
         [0059]     Once all the individual test fields or capillary sensors  104  of the capillary sensor support  100  have been used, the latter is removed from the measuring device  140 . The cover sleeve  154  is then slid completely off the measuring device  140 . A latch between the upper part  144  and the lower part  142  is then released. After opening the upper part  144  and the lower part  142 , the capillary sensor supports  100  can be taken out and replaced by unused, new usable capillary sensor supports  100 .  
         [0060]      FIG. 9  shows another embodiment module including a slot which can be slid into a box. An arrangement  200  comprises a module  202  including a slot and a box  204  to receive the module  202 . Gripping pieces  206  can be externally applied on the box  204 . A latching/unlatching device  208  with a latching element  238  is located at one end of the box  204 . Gripping surfaces  210  are formed on the extraction side of the module  202  to extract the box  204  after actuation of the latching/unlatching device  208 .  
         [0061]      FIG. 10  shows the arrangement  200  with the module  202  removed from the box  204 . A recess  212 , into which a substantially flat test field support  214  is slid, is formed on the module  202 . The test field support  214  contains a plurality of test sections  250  which can be separated from one another by free spaces  240 , provided in the form of prongs. Each test section  250  has a capillary opening  218  for receiving a sample liquid. Light-emitting diodes  216  are located on the upper side of the module  202 , each of which is assigned to a test section  250 . The test field support  214  is slid into the module  202  in a slot  220  formed on the side surfaces of the recess  212 . After the module  202  is extracted from the box  204 , the individual capillary openings  218  are freely accessible. The user of the arrangement  200  can therefore select which of the test sections  250  of the test field support  214  to use since use is not restricted to successive presentation of the individual test sections  250 .  
         [0062]     As shown in  FIG. 11 , the module  202  can include a control field  226  having a plurality of buttons  228  on its upper side in the vicinity of the light-emitting diodes  216 . The flatly designed test field support  214  can be slid laterally into the module  202  in the recess  212  bounded by a bounding wall  224 , its outer edge  234  being freely accessible. Connection of the test field support  214  to the module  202  can be carried out by fully sliding it into the slot  220  of the module using the side opposite from the outer edge  234 . Protruding edges of a guide surface  222  below the outer edge  234  of the test field support  214  facilitate the lateral sliding of the test field support  214  into slots  220  which extend perpendicularly to the bounding wall  224 . Each test section  250  of the test field support  214  includes a capillary opening  218 . The test sections  250  can be separated from one another by, for example, triangularly designed free spaces  240 , as noted above. When the test field support  214  is slid laterally into the recess  212  and electrically connected to the module  202  at the end of the slots  220 , the user can expose and use the capillary openings  218  arranged on the outer edge  234 . The capillary openings  218  can be freely exposed before insertion or sliding into the module  202  by removing a sheet which seals and closes the capillary openings  218 . Sealing elements may furthermore be provided on the module  202 , with which it is possible to seal the capillary openings  218 .  
         [0063]     The user can select any of the test sections  250  of the test field support  214 . Test field supports  214  can be application-specific by, e.g., providing reagent chemistry that is specific to a particular analyte of interest. Consequently, depending on the particular analyte for which the sample liquid is to be studied, a wide variety of values, such as cholesterol values, lactate values as well as blood sugar values and the like, can be shown in the display  230  by means of the control field  226  and the keypad  280  arranged for viewing by the user.  
         [0064]      FIG. 12  shows module  202  without a test field support  214  slid into the recess  212 . A guide surface  222  extends between the slots  220  inside the recess  212 . Below the bounding wall  224 , the test field support  214  (not shown in  FIG. 12 ) or the test sections  250  formed thereon can be electrically connected in the module  202 . The electrical contact region lies below the bounding wall  224  in the module  202  and is indicated by the reference numeral  236 . A display  230  is arranged on the upper side of the module  202 . Various values can be shown on the display  230  after actuating the keypad  228 , for example, values for cholesterol content, lactate, blood sugar and the like.  
         [0065]     The displays  24 ,  150  and  230  of the embodiments described above can furthermore show which of the individual test fields  38  of the respective test field support  26 ,  100  and  214  have been used and/or which of the individual test fields  68 ,  104  and  250  are still available for use.  
         [0066]      FIG. 13  shows an exploded representation of a multi-layer test section or test field  250  of a test field support designed in the form of a card. A reagent coating  254  can be applied on a support sheet  252  which can extend to inside the head region of the test section  250 . Above or adjacent to the reagent coating  254  there is a first adhesive layer  256  on which a spacer sheet  258  is in turn applied. A second adhesive layer  260  is applied above the spacer sheet  258 , and a hydrophilic layer  262  is likewise applied thereto in the head region of the test section  250 . A cover layer  264  is applied on top.  
         [0067]     A capillary channel  266 , the opening of which is denoted by the reference numeral  270 , can be formed in the first adhesive layer  256  and the spacer sheet  258  lying above it. For example, a body fluid such as whole blood or plasma can enter the capillary channel  266  at the capillary opening  270  and travel into an electrochemical measuring cell  268  due to the capillary forces acting there. The electrochemical measuring cell  268 , which can be formed both in the first adhesive layer  256  and in the spacer sheet  258 , is bounded on its upper side by the hydrophilic layer  262  and on its lower side by the reagent coating  254 . For economic reasons and in order to save material, the hydrophilic layer  262  and the reagent coating  254  may lie only in the head region of the test section  250 , which is part of a card-shaped test field support  214  according to the preceding figures.  
         [0068]      FIGS. 14A-14E  show the structure of a test field support designed in the form of a card.  FIG. 14A  shows that the card-shaped test field support  214  can include a plurality of test field sections  250  arranged next to one another. In the representation according to  FIG. 14A , the test field support  214  can include five test sections  250  lying next to one another. Each of the test sections  250  includes a capillary opening  270  on an application side  272 . As seen in  FIG. 14A , these are closed by a separable section of the test field support  214 . Electrode terminals for contact with the test field support  214  when it is slid into the slot  220  of the module  202  are included on the contact side  274 .  
         [0069]      FIG. 14B  furthermore shows a test section  250  separated from the test field support  214 . In the upper region of the test section  250 , the capillary opening  270  is represented as being open, and the capillary channel  266  extends from it to the electrochemical measuring cell  268 . The reference numeral  272  denotes the user side on which the capillary opening  270  is also located; the reference numeral  274  denotes the contact side of the test section  250 .  
         [0070]      FIG. 14C  likewise shows a test field support designed in the form of a card, although its contact and application sides are protected. A material projection  276  is included on the application side  272  on the card-shaped test field support  214 . The same applies to the contact side  274 , on which a material projection  278  is likewise formed. The material projection  276  protects the capillary openings  270  on the application side  272 , so as to substantially prevent contaminants from entering the capillary channel  266  before use by the user. The material projection  278  can be used in order to stabilize the contact side  274  of the test field support  214 . The material projections  276  and  278  shown in  FIG. 14C  may, for example, be separated simply by bending them before the test field support  214  is inserted into the slot-in module  202 . This can be necessary, on the one hand, in order to electrically connect the test field support  214  designed in the form of a card to the slot-in module  202  and/or in order to permit use of the individual test sections  250  arranged next to one another.  
         [0071]     On the contact side  274  of the test field support  214 , a material projection  278  can protect the individual electrodes FSE, CE and WE (See  FIG. 2 ) which electronically connect the individual test sections  250  to the module  214  and which can be evaluated according to the analog semiconductor switching matrix  54  of  FIG. 3 . Reference is made to the description of the electrodes FSE, CE and WE in connection with  FIG. 2 .  
         [0072]      FIG. 14D  shows a test field support designed in the form of a card, the application side of which and the contact side of which are exposed. The representation according to  FIG. 14D  shows the material projection  276  is provided on the application side  272  in  FIG. 14C  being removed, as indicated by the region identified by the reference numeral  280 . The same applies to the removal of the material projection  278  on the contact side  274  of the test field support  214 . This provides a multilayer structure  284 , reference being made to the exploded representation of  FIG. 13 . After separation of the material projection  276  on the application side  272 , the capillary openings of the capillary channel  266  which connects with the electrochemical measuring cell  268  are open. Such openings can be activated by wetting with a body fluid such as whole blood or plasma.  FIG. 14E  furthermore shows an individual test section  250 , in which the capillary opening  270  and the electrodes FSE, CE and WE have been exposed by separating the material projections  276  and  278  (compare  FIG. 14C ).  
         [0073]     While exemplary embodiments incorporating the principles of the present invention have been disclosed hereinabove, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.  
       LIST OF REFERENCE NUMERALS  
       [0000]    
       
           10  measuring device  
           12  lower shell  
           14  upper shell  
           16  articulated connection  
           18  folding case  
           20  cavity boundary  
           21  cavity or recess  
           22  1 st  display  
           24  2 nd  display  
           26  flat test field support  
           28  test field support surface  
           30  test field array  
           32  base sheet  
           34  support sheet  
           36  conductor tracks  
           38  electrodes  
          CE counter electrode  
          WE wettable electrode  
          FSE 1 st  filling level electrode  
          FSE 2 nd  filling level electrode  
           40  reagent layer  
           42  spacer sheet  
           44  hole  
           46  measuring chamber/measuring capillary space  
           48  cover sheet  
           50  hydrophilic layer  
           52  vent  
           54  analog semiconductor switching matrix  
           56  CE terminal  
           58  WE terminal  
           60  terminal of 1 st  FSE  
           62  terminal of 2 nd  FSE  
           64  1 st  switch  
           66  2 nd  switch  
           68  individual test field  
           70  electrical contact strip  
           72  shell-side electrical contact strip  
           74  closed individual test field  
           76  ring-pull closure  
           78  cover  
           80  reception well (sample receiving well)  
           82  sealing edge  
           100  capillary sensor support  
           102  1 st  long side  
           104  capillary sensor  
           106  2 nd  long side  
           108  capillary with opening  
           110  1 st  contact region of capillary sensor support  
           112  2 nd  contact region of capillary sensor support  
           140  measuring and analysis device  
           142  lower part  
           144  upper part  
           146  hinge  
           148  resilient contacts arranged in a row  
           150  display  
           152  control buttons  
           154  cover sleeve  
           156  retracted state  
           158  slid-on state  
           200  slot-in arrangement  
           202  slot-in module  
           204  slot-in box (cover)  
           206  gripping piece  
           208  latching/unlatching  
           210  gripping side  
           212  recess  
           214  test field support  
           216  light-emitting diodes  
           218  capillary opening  
           220  slot-in slot  
           222  guide surface  
           224  bounding wall  
           226  control field  
           248  keypad  
           230  display  
           234  edge of test field support  
           236  contact region of test field support  214   
           238  latching element  
           240  free space  
           242  slot-in position of test field support  214   
           250  test section  
           252  support sheet  
           254  reagent coating  
           256  1 st  adhesive layer  
           258  spacer sheet  
           260  2 nd  adhesive layer  
           262  hydrophilic layer  
           264  cover layer  
           266  capillary channel  
           268  measuring chamber  
           270  capillary opening  
           272  application side  
           274  contact side  
           276  material projection on application side  
           278  material projection on contact side  
           280  extent of detached material projection  276   
           282  extent of detached material projection  278   
           284  layer structure of test section