Abstract:
The present invention relates to an enhanced extracting and sampling device for collecting faeces samples, particularly suitable for performing laboratory diagnostic tests in a total laboratory automation, in particular for dosing one or more analytes, and allowing the screening of markers of diagnostic interest for purposes of prevention and treatment. 
     Such a device for sampling faeces may indeed be received and processed by robotic systems in highly automated analysis laboratories as the samples of body fluids (whole blood, plasma, serum, etc.) are processed.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to an extracting and sampling device for collecting faeces samples, particularly suitable for performing laboratory diagnostic tests in a total laboratory automation, in particular for dosing one or more analytes, such as for example hemoglobin,  Helicobacter pylori  and the like, and allowing the screening of markers of diagnostic interest for purposes of prevention and treatment. 
         [0002]    In fact, such a faeces sampling device may be received and processed by robotic systems in highly automated analysis laboratories as the samples of body fluids (whole blood, plasma, serum, etc.) are processed. These systems may implement the following pre-analytical steps on the sampling device, as required: identifying the sample by reading a bar code, de-capping (removing the test tube cap) or piercing (perforating the closure film of the test tube for the subsequent sampling by means of a specific probe), adding an appropriate extraction buffer, dissolving/dispersing the taken dry sample, centrifuging, transferring to the analysis station, hermetically sealing by means of a film and storing in specific, controlled temperature lockers for further analysis. 
       STATE OF THE ART 
       [0003]    It is known from Patent Application EP 1366715 to Sentinel C H. S.p.A. to employ an extracting and sampling test tube for collecting faeces samples which may be directly used on automated analysis systems. 
         [0004]    Such a test tube is practical for the patient who has a simple and practical collecting device, and easy to be used by the laboratory technician as it may be directly employed with several commercially available automated analysis systems, e.g. the automatic analyzers for immunological tests and clinical chemistry. 
         [0005]    Such a test tube for collecting faeces samples comprises an internally hollow container body which is open at the two ends. 
         [0006]    At a first end, the container body is equipped with a cap provided with a threaded stick for collecting faeces samples, said threaded stick axially protruding into the container body when the cap is applied to the first end of the container body. 
         [0007]    Furthermore, such a test tube comprises a partition in an intermediate position within said container body for separating an upper compartment from a lower compartment within the container body. Such a partition has an axial hole so as to allow the threaded stick to be introduced so as to retain the exceeding faeces in the upper compartment, and to permit the threaded zone of the stick to be introduced into said lower compartment. 
         [0008]    The body container is then opened at the second end, adapted to receive an extraction buffer solution, and is provided with a second cap removably applicable to the container body, so that said extracting test tube may be directly used as a primary sampling test tube to be fitted on a sample-holder plate of an automatic analyzer. 
         [0009]    In order to achieve this result consisting in being able to directly conduct the sample analysis on an automatic analyzer, placing the container body in a housing of the automatic analyzer with the first end cap facing downwards and removing the second cap is needed. In the body container zone closed by the second cap, a buffer solution is indeed contained or may be inserted at the laboratory. 
         [0010]    The user who should collect the faeces sample, unscrews the first cap connected to the stick and sinks the stick in the faeces, thus collecting the sample. Once the faeces sample has been dispersed in the buffer solution, possibly already present in the test tube or subsequently added, the test tube itself may be used as a primary sampling test tube to be directly fitted on the sample-holder plate of an automatic analyzer. 
         [0011]    Only at this point, the second cap is removed so as to allow the automatic analyzer probe to take an aliquot of the buffer solution, containing the dissolved/dispersed faeces sample, on which the analyte object of the research will be dosed. 
         [0012]    The test tube of known type and shown heretofore has however some drawbacks. A first drawback consists in that the test tube of known type has no grip to be handled by the robotic systems sorting the sampling devices (taking test tubes) to the various automatic analyzers once the expected pre-analytical steps have been carried out. This results in these steps being completed by the manual intervention of the laboratory technician. 
         [0013]    A further improvable aspect is that the second cap closing the zone of the test tube containing or which may then be fed with the buffer solution could be accidentally removed by the user, thus causing the dispersion of the buffer solution and therefore the non-availability of the test tube itself, which should be eliminated with the need of repeating the sampling with a new test tube. In fact, the user could get confused during the operations of sample collection and accidentally unscrew the wrong cap. 
         [0014]    Furthermore, the laboratory technician who receives the test tube containing the sample to be analyzed has no way to realize if such a cap has been opened and then closed, and therefore if part of the buffer solution has gone dispersed upon handling the test tube by the user. A part of the buffer solution could then be gone dispersed or it may have been somehow contaminated and the laboratory technician would have no way of realizing it. 
       OBJECT OF THE INVENTION 
       [0015]    Therefore, the primary task of the present invention is to solve the drawbacks that affect the collecting and sampling systems of the known type. 
         [0016]    Within this task, the object of the present invention is thus to provide a test tube for extracting and collecting faeces samples, suitable for being received and processed by the robotic systems in the highly automated analysis laboratories as the samples of body fluids (whole blood, plasma, serum, etc.) are processed. These systems may implement on the sampling device the pre-analytical steps needed for the overall automation of the process: identifying the sample by reading a bar code, centrifuging, de-capping or piercing, adding an appropriate extraction buffer and dissolving the taken dry sample, transferring to the analysis station, hermetically sealing by means of a film and possible storing in specific controlled temperature lockers for further analysis. 
         [0017]    Again, it is the object of the present invention to provide an extracting and sampling test tube which allows the faeces samples to be collected, both directly in the extraction buffer (existing in the device compartment intended therefor) and in dry conditions, the latter being particularly suitable for collecting and shipping biological origin materials by mail and the like. 
         [0018]    It is a further object of the present invention to provide an enhanced test tube for extracting and collecting faeces samples which allows the laboratory technician to effectively and immediately identify possible tampering of the test tube zone containing the buffer solution if the test tube is provided to the user when it already contains the buffer solution. 
         [0019]    It is a further object of the present invention to provide a test tube for extracting and collecting faeces samples that is provided with a cap which, in addition to the ability of effectively and immediately highlighting possible tampering, may be perforated by a specific-purpose probe existing on the automatic analyzer or processing module of the pre-analytical steps so as to avoid the operations of manually or non-automatically opening the individual test tubes by the technician. 
       SUMMARY OF THE INVENTION 
       [0020]    These objects are achieved, according to the invention, by a sampling test tube for collecting faeces samples of the type comprising:
       a container body, internally hollow and open at both ends, adapted to receive a buffer solution,   a first cap provided with a threaded stick for collecting faeces samples, said threaded stick axially protruding within the container body, when said first cap is applied to a first end of the container body,   a partition provided in an intermediate position within said container body in order to separate a first compartment from a second compartment within said container body.       
 
         [0024]    According to the invention said sampling test comprises gripping means integral with the second end of said container body facing said first end and suitable for forming a gripping striker for the automatic analysis machines that may therefore process the test tube in an automated manner. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]    Further features of the invention will be more apparent from the following detailed description, which refers to a merely exemplary embodiment thus not limiting the same, illustrated in the accompanying drawings, in which: 
           [0026]      FIG. 1  shows a sectional front view of an extracting and collecting test tube of the type known from the state of art; 
           [0027]      FIG. 2  shows a diagrammatic view of the container body of the test tube according to the present invention; 
           [0028]      FIG. 3  shows a detail of the sample collecting device of the test tube according to the present invention; 
           [0029]      FIG. 4  shows a detail of the test tube according to the present invention where the sample collecting device is shown to be inserted into the container body of said test tube; 
           [0030]      FIG. 5  shows a sectional assembly view of the test tube according to the present invention; 
           [0031]      FIG. 6  shows a sectional detail of the lower cap of the test tube in  FIG. 5 ; 
           [0032]      FIGS. 7A and 7B  show two views of a closure cap for one of the ends of the test tube according to the present invention; 
           [0033]      FIGS. 8A and 8B  show two views of a variant of the closure cap in  FIGS. 7A and 7B . 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0034]    The extracting test tube for collecting faeces samples according to the invention, indicated by numeral  1  as a whole, will now be described with the aid of the figures. 
         [0035]    Specifically,  FIG. 1  depicts the sample collecting test tube comprising a lower cap  6  of the type known from the state of the art. 
         [0036]    The test tube comprises a substantially cylindrical container  2 , a first cap  4  at a first end  2   a  of the container body  2 . In the case of a test tube of the known type, a second cap  6  is provided at the second end  2   b  of the test tube, which is substantially cylindrical and suitable for pressure-fitting within the end  2   b  of the container body  2 . 
         [0037]    Instead,  FIG. 2  shows, again in section view, just the cylindrical body  2  of the sample collecting test tube according to the present invention, from which the other members are disassembled. The test tube of the present invention may be seen as assembled in the section of  FIG. 5 . 
         [0038]    The container  2  comprises a substantially cylindrical body  20  which is internally hollow and open at the two ends end  2   a  and  2   b.  Within the cylindrical body  20 , a partition  21  is provided in an intermediate position, which divides the interior of the container  2  into a first compartment  22  and a second compartment  23 . 
         [0039]    The partition  21  comprises an annular flange  24  radially projecting towards the interior of the cylindrical container. A cylindrical ridge  25  axially protrudes from the side of the annular flange  24  facing towards the first compartment  22 . The partition  21  has an axial through hole  26  which axially passes through the cylindrical ridge  25  and the annular flange  24 . The hole  26  has at the top a conical-profiled, substantially tapered zone  26 ′ with an increasing diameter as compared to the lower zone. 
         [0040]    An internal thread  27  is provided in the internal surface of the container body  20 , within the end  2   a  of the first compartment  22 . 
         [0041]    As seen in  FIG. 3 , the first cap  4  according to the present invention comprises a body consisting of a substantially cylindrical middle zone  40  with an external diameter substantially equal to the external diameter of the container body  20 , a dome-shaped upper zone  41  placed above the middle zone, and a substantially cylindrical lower zone  42  provided with an appropriate thread  45  adapted to be fitted in the corresponding thread  27  provided within the end  2   a  of container  2 . 
         [0042]    A knurl  44  consisting of a plurality of ribs and grooves is provided on the external surface of the middle zone  40  of the body of the upper cap  4 . 
         [0043]    A shank or stick  46 , presenting a first substantially cylindrical section  47  with a diameter d 1  smaller than the diameter of the lower zone  42  of the cap  4 , axially protrudes from the lower zone  42  of the first cap  4 . 
         [0044]    Then, the stick  46  further tapers towards the end and presents a second portion  49  with a diameter d 2 , smaller than d 1 , with a conical joint  48  between the two cylindrical sections  47  and  49 . Finally, a third cylindrical section  50  with an even lower external diameter d 3  originates with an abrupt change in diameter and free from joints from the second portion  49  with a diameter d 2 . 
         [0045]    As seen from  FIG. 5  showing the test tube when assembled, the conical joint zone  48  between the sections  47  and  49  has a profile suitable for matching the conical-profiled tapered zone  26 ′ obtained on the partition  21  of the container body. 
         [0046]    The third cylindrical section  50  of the stick  46  comprises, at its free end zone, a thread consisting of a plurality of annular collars  51  spaced from one another so as to form as many annular spaces  52  between said collars  51 . 
         [0047]    According to the present invention, at the end  2   b  of the container body  2  opposite to the first end  2   a  with which said first cap  4  with the sampling stick  46  is associated, there are provided specific gripping means for automatic machines that allow the totally automated handling of the test tube. 
         [0048]    Specifically, according to the embodiment illustrated by way of example in  FIGS. 2 ,  5  and  6 , these gripping means consist of an annular profile  30  radially protruding outwards and adapted to be a striker for the grip by robotic arms adapted to automatically handle the test tube itself. 
         [0049]    According to the present invention, tamperproof closure means may advantageously be provided at the second end  2   b  of the test tube, the one facing the end  2   a  on which the first cap  4  is provided. 
         [0050]    According to a first embodiment illustrated in  FIGS. 5 and 6 , these tamperproof closure means may comprise a second cap  7  which comprises a cylindrical body having an internal diameter substantially equal to the external diameter of the container  2 , said second cap  7  having an internal thread  71  adapted to be screwed at the terminal end of said container body  2 , said terminal end of said container body  2  having in turn an external counter-thread  28  suitable for engaging said thread  71 . 
         [0051]    Two possible embodiments of the second cap  7  are shown hereinafter. A first embodiment of the second cap is indicated by  7   a  and it is shown in  FIGS. 7A and 7B . 
         [0052]    According to a first embodiment shown in  FIGS. 7A and 7B , the second cap  7   a  is closed at its central portion  70 . In this case, it will be necessary to unscrew the cap in order to open the test tube, which operation may also be carried out in an automatic manner by the analysis machines suitable for carrying out the de-capping of the test tubes. 
         [0053]    Again with reference to the figures, the second cap  7   a  may advantageously be provided with safety means  74  which prevent the accidental unscrewing thereof. 
         [0054]    Specifically, according to the preferred embodiment shown by way of example in  FIGS. 2 ,  6  and  7 A, these safety means may comprise an annular member  74  suitable for interacting with a specific striker  29  provided on the external surface of the container body  2  by means of a specific internal groove adapted to receive said striker  29 . 
         [0055]    A knurl, seen for example in  FIG. 7A  and consisting of a plurality of ribs and grooves, may advantageously be provided on the external surface of the second cap  7   a.    
         [0056]    Said annular member  74  is connected to the body of the second cap  7   a  in an unmatchable manner by means of one or more connecting members not depicted in the figures. 
         [0057]    Said one or more connecting members may consist of peduncles or tongues, for example, made of a material preferably consisting of the same plastic material as the second cap  7   a  and the annular member  74  itself. These peduncles retain said safety annular member  74  integral with the second cap  7   a  as long as it is completely screwed on said container body  2 . 
         [0058]    The safety annular member  74  operates as follows. 
         [0059]    When the second cap  7   a  is completely screwed to the container body  2 , the connecting members or peduncles (not depicted in the figures) connecting the cylindrical body of said second cap  7   a  to said annular member  74  prevent the cap  7   a  itself from accidentally open. In fact, the annular ring  74  prevents the cap  7   a  from unscrewing off the container body  2  and prevents the cap  7   a  itself from rotating and therefore unscrewing by striking against the striker  29  provided on said container body  2 . 
         [0060]    In fact, the rotation of the cap  7   a  in the unscrewing direction also causes an axial translation of the cap  7   a  in the direction along which the cap moves away from the container body, because of the presence of the helical thread. The member  74 , which is dragged by the presence of the connecting members or peduncles in the roto-translation of the cap  7   a,  prevents the cap itself from unscrewing since, striking against the striking member  29  integral with the container body  2 , it prevents the translating movement of the cap  7   a  in an axial direction towards the direction along which the cap  7   a  moves away from the container, thus ultimately preventing the cap itself from unscrewing. 
         [0061]    In order to unscrew the cap, a sufficient twisting torque need to be exerted on the cap  7   a  in the unscrewing direction so as to break said connecting members or peduncles, such an unscrewing operation may be manually performed by the laboratory technician or by an automatic machine. 
         [0062]    According to an alternative embodiment, the second cap  7  may be provided as shown in  FIGS. 8A and 8B , where it is indicated by the reference numeral  7   b.  In this case, the tamperproof closure means placed close to the test tube end  2   b  comprise a second cap  7   b  having, in an axial position on the bottom surface  70 , a through hole  73   b  hermetically sealed by a membrane or film made of polymeric material, e.g. aluminium-polythene. 
         [0063]    Thereby, it is possible for the automatic machine to take the buffer solution by means of a film piercing and picking up operation instead of preliminary unscrewing the cap itself, for example. 
         [0064]    According to a further embodiment of the test tube according to the present invention, a polymeric material film suitable for being perforated during the piercing operation may be directly applied to the second end  2   b  of the container body  2 . 
         [0065]    In each of these cases, the compartment  23  may comprise the buffer solution or may be dry. In all the shown examples, a test tube may be easily opened at one end only, the one closed by the first cap  4 , whereas the described safety means are provided at the opposite end, at the second cap  7 , with the major advantage of avoiding the patient from opening the wrong cap with the relating problems. 
         [0066]    In the second embodiment in which the second cap  7   b  is provided with a through hole closed by a film, the second cap  7   b  may advantageously be welded directly to the container body  2  by a welding operation by means of an ultrasonic method or similar known methods. By means of this further measure, the further benefit of preventing the user from accidentally opening the second cap  7   b  may be obtained, thus achieving an even greater safety. 
         [0067]    Therefore, it has been shown how the sampling test tube according to the present invention achieves the task and the intended objects. 
         [0068]    Specifically, it has been disclosed how the test tube according to the present invention is suitable for being directly placed into the sample-holder housing of an automatic machine with the end  2   b,  at which said gripping means  30  are provided, facing upwards. In order to be able to transfer, place or remove said test tube in an automatic manner, so as to further reduce the interventions by the laboratory technician, the test tube offers a striker member to the robotic arm or however to the gripping member provided on said automatic machine. 
         [0069]    Thereby, the sampling test tube may be received and processed by the robotic systems in the highly automated analysis laboratories as the samples of body fluids are processed. 
         [0070]    The possibility that the sampling test tube according to the present invention is handled in an automatic manner by the automated analysis systems allows to obtain several advantages in terms of process automation according to the above. 
         [0071]    Again, another advantage may be obtained if the test tube comprises tamperproof closure means suitable for closing the second end  2   b  of the container body  2 , where said tamperproof closure means comprise a second cap  7 . In this case, the robotic systems may perform the de-capping (i.e. providing for the removal of the cap) by also automating this step, and if the user is provided with the test tube when it already contains the buffer solution, the handling by an automatic machinery ensures that the test tube is moved without the risk of spilling the buffer solution contained in the test tube because of an error by the technician. 
         [0072]    The striker  30  allows the grip by the handler for transferring the test tube to the stations where the second cap  7   a  is unscrewed or the film is pierced in the case of a cap  7   b  provided with a through hole closed by a film or in the case of a film directly applied to the end  2   b  of the container body  2 , thus allowing a full automation of the operations before the analysis. 
         [0073]    The buffer solution, generally indicated by reference numeral  8  in  FIG. 1 , may be a solution with a pH suitable for storing the sample containing specific stabilizers, for example. The user who should collect a faeces sample, unscrews the upper cap  4  and takes it from the faeces by means of the stick  46 . Therefore, by extracting the stick  46  from the faeces, the faeces samples are retained in the annular spaces  52  made on the stick  46  and the exceeding faeces also remain about the stick  46 . 
         [0074]    Therefore, the collection of the sample may take place in complete safety both if the test tube is already provided to the user when it contains the buffer solution, and if said solution is subsequently added at the laboratory. In this second case, the sample is collected completely dry, thus allowing the test tube itself to be sent by mail, which is forbidden by the laws in force in many countries if the device contains a liquid, and the buffer solution may then be added at the laboratory manually or automatically by means of specific automated systems. 
         [0075]    Therefore, the second cap  7  is removed and the extracting test tube is placed in a specific housing of an automatic analyzer in order to perform the analysis on an aliquot of the buffer solution containing the faeces samples. In order to obtain this result, the external diameter of the container body  2  will be advantageously designed so as to match the size of the test tube-holder housings of the automatic analyzers. 
         [0076]    Therefore, it has been shown how, due to the test tube according to the present invention, the handling of the test tube may be completely automated, thus allowing the use of a robotic system that, in addition to the pre-analytical steps, also performs the steps of placing/loading the test tube in the test tube-holder housing of the automatic analyzer, unloading the test tube from the tube-holder plate, possibly closing by means of a film and storing in refrigerated lockers for possible analysis repetitions. 
         [0077]    Furthermore, the preferred embodiments of the test tube according to the present invention, comprise tamperproof closure means, such as the warranty collar  74  which is detached from the closure cap during the opening, thus allowing the laboratory technician to easily verify if the part of the test tube containing the buffer solution or however containing the end of the stick  46  for collecting the samples has been accidentally opened. 
         [0078]    In the case of the presence of the warranty collar  74 , the striker ring  30  also plays the role of striker for such a collar so that, once the collar  74  is detached from the cap  7  to open the same, said collar may not slip under gravity along the test tube. 
         [0079]    Either if it is used a second cap with a safety device, or it is used a film made of a pierceable material directly applied to the test tube, the further object to make the closure of the second end  2   b  of the test tube error-proof for the user is achieved, thus making possible tampering of such a closure immediately identifiable by the laboratory technician. 
         [0080]    This aspect makes the collecting system safer and more error-proof both if the test tube is supplied when it already contains the buffer solution, and if it is provided without a buffer solution, in this case the sample being stored when dry. 
         [0081]    Several modifications and detail variations within the reach of a person skilled in the art may be made to the present embodiment of the invention, without however departing from the scope of protection of the invention as set forth in the appended claims.