System for producing multiple diagnostic test elements

Abstract

A system for producing multiple diagnostic test elements has a support ( 1 ) with an analytical region ( 3 ) to which diagnostic test spots ( 8 ) are applied, one or several stop edges ( 11 - 13 ) for each direction in space for positioning the support, a first holding unit ( 10 I) into which the support is inserted and positioned by means of the one or more stop edges, a first printing head ( 20 I) arranged above the holding unit ( 10 ) for applying drops of a first liquid to the analytical region of the support ( 1 ), a first positioning unit which laterally displaces and positions the first holding unit, a second holding unit ( 10 II) into which the support is inserted and positioned by means of the one or more stop edges, a second printing head ( 20 II) arranged above the second holding unit for applying drops of a second liquid to the analytical region of the support ( 1 ), a second positioning unit which laterally displaces and positions the second holding unit, a transport unit ( 41 ) and a control unit.

1 . System for producing multiple diagnostic test elements comprising, 
 a) a support with an analytical region for applying diagnostic test spots and one or several stop edges for each direction in space to position the support,    b) a first holding unit into which the support is inserted and positioned by means of one or several stop edges,    c) a first printing head which is arranged above the holding unit and which is used to release fluid drops of a first liquid onto the analytical region of the support,    d) a first positioning unit which laterally displaces and positions the first holding unit,    e) a second holding unit into which the support is inserted and positioned by means of one or several stop edges,    f) a second printing head which is arranged above the second holding unit and is used to release fluid drops of a second liquid onto the analytical region of the support,    g) a second positioning unit which laterally displaces and positions the second holding unit,    h) a transport unit which transports the support into the holding units,    i) a control unit which controls the transport unit, the holding units and the positioning units and the release of liquid from the printing heads.    
     
     
         2 . System as claimed in  claim 1 , wherein the printing heads are not moved laterally in order to release the fluids onto the support.  
     
     
         3 . System as claimed in  claim 1  or  2 , wherein the control unit controls coordinated movements of the holding units and the release of fluid from the printing heads in such a way that a specified pattern of test spots is applied to the analytical region of a test element.  
     
     
         4 . System as claimed in  claim 1 , wherein the positioning accuracy of the support in the holding units and the positioning of the printing heads is so accurate that the individual test spots differ by less than 40 μm from the specified pattern.  
     
     
         5 . System as claimed in  claim 4 , wherein the deviation from the pattern is less than 25 μm.  
     
     
         6 . System as claimed in  claim 1 , wherein the transport unit comprises a conveyer device as well as a lifting device.  
     
     
         7 . System as claimed in  claim 6 , wherein the conveyer device comprises a conveyer belt on which holders for holding supports are located.  
     
     
         8 . System as claimed in  claim 7 , wherein the supports have a basal surface on the underside of which one or several cross-pieces are located which rest against the sides of the holder when the supports are located on the holders and the cross-pieces prevent the supports from sliding from the holders.  
     
     
         9 . System as claimed in  claim 1 , wherein the supports protrude over the holders on two opposite sides.  
     
     
         10 . System as claimed in  claim 6  or  9 , wherein the lifting device grips the underside of the support and lifts the support into the holding unit.  
     
     
         11 . System as claimed in  claim 1 , wherein the holding units are loaded with supports from below.  
     
     
         12 . System as claimed in  claim 11 , wherein the holding units have stop elements against which the support is pressed from below and is vertically positioned.  
     
     
         13 . System as claimed in  claim 1 , wherein the printing heads are held in adjusting devices which enable a lateral adjustment of the printing heads.  
     
     
         14 . System as claimed in  claim 13 , wherein the system has one or several quality assurance devices which optically examine the pattern and convert deviations from the specified pattern into signals which control an adjustment of the printing head positions by means of the adjusting devices.  
     
     
         15 . System as claimed in  claim 14 , wherein the optical examination is carried out with one or several CCD cameras.  
     
     
         16 . System as claimed in  claim 15 , wherein the first and/or second liquid contains one or several fluorescent dyes and the position of the test spots is determined by a fluorescent scanner.  
     
     
         17 . System as claimed in  claim 1 , wherein the entire system or parts of the system are closed from the environment by a housing in which a specified air humidity is adjusted.  
     
     
         18 . System as claimed in  claim 1 , wherein the liquid drops emerging from the printing heads have a speed of less than 5 m/s, preferably of less than 2 m/s and the distance of the printing head nozzles from the analytical region is less than 2 mm, preferably 500 μm or less during the printing process.  
     
     
         19 . System as claimed in  claim 18 , wherein the volume of an individual liquid drop is less than 1000 pl.  
     
     
         20 . Multiple diagnostic test element comprising a support with an analytical region in which a plurality of essentially circular test spots are applied in a specified pattern, the diameter of the test spots is less than 350 μm and the centres deviate by less than 40 μm from the specified pattern.  
     
     
         21 . Multiple diagnostic test element as claimed in  claim 20 , wherein the analytical region is surrounded by a continuous rim such that the rim and analytical region together form a well.  
     
     
         22 . Multiple diagnostic test element as claimed in  claim 20 , wherein the support has a basal surface which is parallel to the analytical region and is used to vertically position the support.  
     
     
         23 . Multiple diagnostic test element comprising a support with 
 a basal surface on which an analytical region is located,    a plurality of essentially circular test spots in a specified pattern which are applied to the analytical region,    a continuous rim which surrounds the analytical region such that rim and analytical region together form a well,    one or several cross-pieces which are attached to the basal surface and are essentially perpendicular to it and the cross-pieces form stop edges for two directions in space.    
     
     
         24 . Multiple diagnostic test element as claimed in  claim 23 , wherein it has two cross-pieces which each essentially have a U shape and the smallest distance between them is larger than the width of the well.  
     
     
         25 . Multiple diagnostic test element as claimed in  claim 20  or  23 , wherein the well has a holding capacity of 100 μl or less.  
     
     
         26 . Multiple diagnostic test element as claimed in  claim 20  or  23 , wherein the support has two or several stop edges which are perpendicular to the basal surface and are used to laterally position the support.  
     
     
         27 . Multiple diagnostic test element as claimed in  claim 26 , wherein the two or more stop edges and the well are on different sides of the basal surface.  
     
     
         28 . Multiple diagnostic test element as claimed in  claim 20  or  23 , wherein the analytical region has a surface whose defects are smaller than 10 μm in their longest dimension and the unevenness of the surface is less than or equal to 10 μm.  
     
     
         29 . Multiple diagnostic test element as claimed in  claim 20  or  23 , wherein the analytical region is hydrophobic.  
     
     
         30 . Production process for a multiple diagnostic test element in which a pattern of test spots is applied to a support comprising the following steps: 
 a) positioning a support in a first holding unit below a first printing head,    b) moving the first holding unit and the support positioned therein with a positioning unit into a position in which a first site of the analytical region is positioned below the first printing head,    c) release of one or several liquid drops from the first printing head onto the first site of the analytical region,    d) positioning the support in a second holding unit below a second printing head,    e) moving the second holding unit and the support positioned therein with a positioning unit into a position in which a second site of the analytical region is positioned below the second printing head,    f) release of one or several liquid drops from the second printing head onto the second site of the analytical region,    wherein steps a) to c) and d) to f) are repeated with the said printing head or with other printing heads so that a specified pattern of test spots is generated in the analytical region.    
     
     
         31 . Production process as claimed in  claim 30 , wherein the centres of the test spots deviate by less than 40 μm from the specified pattern.  
     
     
         32 . Production process as claimed in  claim 30 , wherein the support is inserted from below into the holding units.  
     
     
         33 . Production process as claimed in  claim 30 , wherein the pattern is monitored optically and when the test spots deviate from the specified pattern the printing heads are adjusted by adjusting devices.  
     
     
         34 . Production process as claimed in  claim 30 , wherein the supports are moved between the holding units with a transport device.  
     
     
         35 . Analytical method using multiple diagnostic test elements as claimed in  claim 20  or  23  comprising the following steps, 
 a) applying a sample liquid to the analytical region of a multiple test element,  
 b) recording an image of the analytical region with the pattern of test spots arranged therein,  
 c) evaluating the regions of the image in which test spots are located,  
 d) determining the presence and/or the concentration of one or several analytes.  
 
     
     
         36 . Analytical method as claimed in  claim 35 , wherein the image is generated by means of a fluorescence scanning method.  
     
     
         37 . Analytical method as claimed in  claim 35 , wherein immunological reactions occur between the test spots and the sample liquid.