Abstract:
A fecal sample collecting device and method. The device of an embodiment includes a removable first layer, having primary and secondary apertures and a second layer having a releaseable adhesive on an inner surface that secures the first and second layers, a flap aligned with the primary aperture, and an integrally formed removable tab. The device also includes a sheet between the two layers. In a first configuration, the sheet is aligned with the primary aperture such that a sample is deposited thereon when the device is used to wipe one&#39;s anus, and the removable tab is aligned with the secondary aperture such that a second sample is deposited thereon. Subsequently, the first layer is discarded, thereby exposing the adhesive on the inner surface of the second layer. The device is placed in a second configuration by folding the inner surface upon itself. Thus, primary and secondary samples are enclosed.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates, generally, to specimen collection and more particularly, a device for collecting and determining the presence of occult blood in fecal matter, a method of testing using such a device and a test kit containing such a device. 
       BACKGROUND OF THE INVENTION 
       [0002]    Over 100,000 persons per year in the United States are afflicted with cancer of the colon and rectum. When the number of colon/rectal cancers occurring each year is combined with the number of cancers occurring in other digestive organs, including the esophagus and stomach, such cancers of the digestive system account for more occurrences of cancer than any other single form of the disease. Contrary to many other forms of cancer, early diagnosis and treatment of digestive tract cancer does result in a cure rate of 80% to 90%. If, however, the disease is not detected until the later stages, the cure rate drops significantly. Thus, early detection of the disease is important to successful treatment of digestive tract cancer. 
         [0003]    Most, but not all, cancers of the digestive tract bleed to a certain extent. This blood is deposited on and in fecal matter excreted from the digestive system. The presence of blood in fecal matter is not normally detected, however, until gross bleeding, that is, blood visible to the naked eye, occurs. Gross bleeding, however, is symptomatic of advanced cancers. 
         [0004]    Digestive tract cancers in the early stages, including pre-cancerous polyps, also tend to bleed, giving rise to occult (hidden) blood in the fecal matter. Other pathological conditions, such as Crohn&#39;s disease and diverticulitis, can also give rise to the presence of occult blood in the fecal matter. 
         [0005]    It is known that because of the relatively high fat content of fecal matter, blood, when present, is not distributed uniformly throughout it. For this reason, obtaining multiple samples from different areas of each bowel movement is desirable; but even a single positive test from any part of the feces should be considered a positive result. 
         [0006]    Accordingly, test equipment and test procedures have been developed for use by physicians in testing for the presence of occult blood in fecal matter. Such tests frequently employ an absorbent paper impregnated with a guaiac reagent and encased in a special test slide having openable flaps. To use the test slide, a sample of fecal matter is smeared onto the guaiac-impregnated paper by opening a panel on one side of the test slide. Thereafter, the panel is closed. A panel on the opposite side of the test slide is then opened and a non-aqueous developing solution is applied to the guaiac-impregnated paper. If occult blood is present in the fecal matter smeared on the opposite side of the paper, the guaiac reaction will dye the paper blue, providing a positive indication of the presence of blood in the fecal matter. 
         [0007]    Drawbacks of this type of test slide include risk of contamination from handling the test slides and a high percentage of false positives obtained from patients who in fact do not have a cancer or other condition for which occult blood is symptomatic. For example, certain foods, such as rare red meat and peroxidase enzymes as present in certain foods, such as horseradish, broccoli and cantaloupe, can cause a false positive result. 
         [0008]    To cut down on false positives, physicians place patients on specific diets designed to restrict the intake of animal proteins and other sources of false positives. Despite these efforts, large numbers of false positives still occur, as compliance with the restricted diet is unreliable. A false positive result in the test often results in expensive follow-up testing of patients who in fact have simply consumed a lot of meat or other undesirable foods just prior to the test. 
         [0009]    A specific test for human hemoglobin has been devised. This test, offered by SmithKline Diagnostics under the tradename HEMESELECT, theoretically registers only human hemoglobin and not animal blood from meat or other agents, and therefore, theoretically does not require the patient to be on a special diet. While the hemoglobin test has the advantage over guaiac tests of registering only human hemoglobin, the hemoglobin test is expensive for a screening test and requires specially trained individuals to perform and read the test. Furthermore, hemoglobin tests are typically very sensitive, capable of detecting as little as 0.3 micrograms of blood, which is in excess of what a healthy normal person loses in fecal matter daily. Thus, because even healthy individuals lose a small amount of blood, which can be detected, a positive result may itself be a false positive leading to further costly, unnecessary tests and procedures. 
         [0010]    Another drawback of this type of test is that follow-up tests commonly result in reduced patient compliance. Having already completed one test, a patient may be unwilling or unable to return in a timely fashion for follow-up tests. Consequently, the physician may be deprived of data necessary to accurately diagnose the patient. 
         [0011]    A need therefore exists for a relatively inexpensive test that has a minimal incidence of false positives and minimal manipulation of the sample. A further need exists for a test that improves patient compliance should follow-up testing be required. 
       SUMMARY OF THE INVENTION 
       [0012]    Embodiments of the present invention satisfy the foregoing and other needs. For example, a fecal sampling device according to one embodiment may be a sheet of paper with an adhesive, where one half of the sheet includes a flap and a removable tab. On top of the adhesive sheet of paper, there should be disposed at least two non-adhesive pieces of paper, one on each half. On the half of the adhesive sheet of paper that contains the flap and the tab portions, the non-adhesive piece of paper should cover the tab portion, and include a portion that may move with the tab portion. The non-adhesive piece of paper should also have a section that covers the tab portion and is configured to receive a fecal sample. Additionally, the non-adhesive sheet of paper preferably covers one of the borders of the first half. 
         [0013]    The non-adhesive piece of paper on the second half of the adhesive sheet preferably matches the first sheet such that when the device is folded along the boundary between the first and the second half of the adhesive sheet, the non-adhesive papers on the second half overlay the non-adhesive paper on the first half. Both pieces of non-adhesive paper should be configured so as not to cover the entire adhesive layer on the adhesive paper. 
         [0014]    Further, on top of the first half of the adhesive paper, above the non-adhesive piece of paper, there should be located, an absorbent piece of paper that is configured to receive a fecal sample and is sized to overlay the first piece of paper, and adhere to the adhesive on the first piece of paper. 
         [0015]    Additionally, overlaying all of the elements above, there is preferably a tissue paper that is the same size as the adhesive paper. The tissue paper should be placed so as to overlay the adhesive paper and adhere to the adhesive. The tissue paper should have separate apertures above the absorbent sheet and above the removable tab. 
         [0016]    In use, the patient should be able to take the device and wipe, after defecation, such that fecal matter gets deposited on the tissue paper, and through the tissue paper onto the removable tab and the absorbent sheet. Afterwards the patient should peel off the tissue paper, discard it, and fold the device along the border between the two halves. This should cause the enclosing of the fecal matter, deposited on the removable tab and the absorbent sheet, by the piece of paper located on the second half, and the sealing of the two halves of the device together, by the adhesive on the adhesive sheet. 
         [0017]    Subsequently the patient should deliver the device to a doctor who may in turn peel the tab portion to reveal the absorbent sheet underneath. The doctor may deposit a developing solution onto the absorbent sheet in order to determine presence of occult blood in the fecal sample. Additionally, the doctor may remove the tab that contains another fecal sample, and perform a different test on that sample. 
         [0018]    In an alternate embodiment, the fecal sampling device may be a sheet of paper with an adhesive, where one half of the sheet includes a removable tab section. On top of the adhesive sheet of paper, overlaying the removable tab section, there should be disposed a sheet of plain filter paper. The sheet of plain filter paper preferably adheres to the removable tab section and the half of the adhesive sheet of paper that contains the removable tab section. Both the removable tab section and the filter paper may contain complementary perforations such that removal of the removable tab section results in the removal of a section of the filter paper that overlies the removable tab section. It will be apparent to those skilled in the art that instead of filter paper any other material capable of receiving a fecal sample may be used. 
         [0019]    Additionally, overlaying all of the elements above, there is preferably a tissue paper that is the same size as the adhesive paper. The tissue paper should be placed so as to overlay the adhesive paper and adhere to the adhesive. The tissue paper should have an aperture over the removable tab section. 
         [0020]    In use, the patient should be able to take the device and wipe, after defecation, such that fecal matter gets deposited on the tissue paper, and through the aperture of the tissue paper onto the filter paper overlaying the removable tab. Afterwards the patient should peel off the tissue paper, discard it, and fold the device along the border between the two halves. This should cause the sealing of the fecal matter inside the fecal sampling device, by the adherence of the two halves of the device together, by the adhesive on the adhesive sheet of the device. Finally, the patient should deliver the sealed device to a doctor. 
         [0021]    The doctor may remove the tab section, along with the filter paper attached to that tab section, and the fecal sample disposed on the filter paper. Thereafter, the doctor may perform various test upon the fecal sample. After removing the tab, the doctor should dispose of the device. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]    The devices and methods according to various embodiments are explained in greater detail using the following exemplary drawings. The drawings are merely illustrative of the structure of devices and certain features that may be used singularly or in combination with other features. Thus, the invention is not limited to the embodiments shown or described. 
           [0023]      FIG. 1  is an exploded perspective view of one embodiment of a fecal sampling device according to the present invention; 
           [0024]      FIG. 2  is a top plan view of a portion of the fecal sampling device of  FIG. 1 ; 
           [0025]      FIG. 3  is a top plan view of the fecal sampling device of  FIG. 1 . 
           [0026]      FIG. 4  is a front plan view another embodiment of a fecal collection device according to the present invention; 
           [0027]      FIG. 5  is a back plan view of the embodiment of  FIG. 4 ; 
           [0028]      FIG. 6  is an exploded side view of the embodiment of  FIG. 4 ; and 
           [0029]      FIG. 7  is a front plan view of the embodiment of  FIG. 4 , with the removable layer partially removed. 
       
    
    
     DETAILED DESCRIPTION OF EMBODIMENTS 
       [0030]    Certain embodiments of the invention will now be described with reference to the drawings. In general, such embodiments relate to a fecal sampling device, including by way of non-limiting example, a device for collecting and determining the presence of occult blood in both a primary and secondary sample of fecal matter. The invention may have other applications and uses and should not be limited to the structure or use described and illustrated. 
         [0031]    As shown in  FIG. 1 , the fecal sampling device  5  according to one embodiment of the invention may include a tissue layer  10  and an outer layer  12 , with an absorbent sheet  14  and a plurality of barrier pieces  16   a ,  16   b  disposed between the outer layer  12  and tissue layer  10 . When device  5  is assembled for use, tissue layer  10  and outer layer  12  essentially overlay each other, with sheet  14  interposed therebetween. 
         [0032]    The tissue layer  10  generally includes a first portion  18  and a second portion  20 . In addition, the tissue layer  10  may include a plurality of metering holes  22  and an aperture  25  on one of the portions  18 ,  20  thereof (shown as the first portion  18 ), through which primary and secondary samples of a specimen may be received, respectively. The tissue layer  10  is preferably a moisture or liquid barrier, thus limiting the sample passing through to only the areas corresponding to the aperture  25  and holes  22 . As such, tissue  10  may be any suitable material, such as wax paper, polypropylene, biaxially oriented polypropylene (BOPP), and biaxially oriented polypropylene terephtalate polyester sold under the trademark MYLAR®. 
         [0033]    The outer layer  12  also generally includes a first portion  26  and a second portion  28 . When device  5  is assembled, the first portion  26  of the outer layer  12  overlays the first portion  18  of the tissue layer  10 , and the second portion  28  of the outer layer  12  overlays the second portion  20  of the tissue layer  10 . One of the portions  26 ,  28  (shown as the first portion  26 ) may include a first flap  34  dimensioned to align with the plurality of holes  22  in the tissue layer  10 , and a removable tab  32  dimensioned to align with the aperture  25  in the tissue layer  10 . Thus, the removable tab  32  forms a part of a well for receiving a sample through aperture  25 . The removable tab  32  is preferably formed from, and as a part of, the outer layer  12 . Tab  32  is integrally formed as part of the outer layer  12  by die cutting or other method and can be formed either entirely or partially by perforations in outer layer  12 . It should be understood that in certain embodiments the removable tab  32  may have a sheet overlaying and attached (e.g., adhered) to it, such that the sheet in fact receives the sample through aperture  25 , and the sheet is removable along with the removable tab  32  (in certain embodiments this sheet may be a separate sheet or a section of sheet  14 ). In the present embodiment, the outer layer  12  may be coated with adhesive on its inner surface (i.e., the surface facing tissue layer  10 ). As discussed in greater detail below, the adhesive may permit the outer layer  12  to bond to the plurality of pieces  16   a ,  16   b , the absorbent sheet  14 , and the tissue layer  10 . As shown in  FIG. 2 , the outer surface of outer layer  12  may preferably include a label  39  for patient information and/or instructions to the user. 
         [0034]    In the present embodiment, as illustrated in  FIG. 1 , the absorbent sheet  14  may be a single piece of filter paper generally dimensioned to align with or overlay, the plurality of holes  22  of the tissue layer  10  when device  5  is assembled. The sheet  14  may be impregnated with guaiac reagent or another indicator selected based on the particular application of the devices. The device  5  may further include a wax, glue or other moisture barrier, for example, disposed on the absorbent sheet  14  itself or around the perimeter of the absorbent sheet  14  on the first portion  26  of the outer layer  12 . This barrier separates the primary sample and sheet  14  from the secondary sample and the removable tab  32 , thereby reducing the risk of contamination of the secondary sample on removable tab  32  by the elements of the primary sample and the primary test, such as guaiac and developer solution. 
         [0035]    The plurality of pieces  16   a ,  16   b  are generally made of non-porous paper, such as, for example, wax paper, and function to define areas and prevent the adhesive disposed on the outer layer  12  from adhering to certain portions of the device  5 . The first set of pieces  16   a  may include first  40 , second  42  and third  44  pieces. As shown in  FIGS. 1 and 2 , the first piece  40  may be sized and configured to cover the flap  34  plus an additional area surrounding flap  34  of the outer layer  12 , such that the piece  40  adheres to the outer layer  12  (including when flap  34  is opened). Piece  40  includes a flap section  42  partially defined by a die cut, which generally corresponds to and adheres to the flap  34 . The adhesive on the inner surface of flap  34  allows it to removably adhere to a portion of the first piece  40 , thereby assisting flap  34  to stay shut until purposefully opened. 
         [0036]    The second piece  44  is generally dimensioned such that, when the device  5  is assembled, it aligns with and overlays the edge of the first portion  26  of the outer layer  12 . 
         [0037]    The device  5  may optionally include a generally positioned and dimensioned such that, when the device  5  is assembled, the third piece adheres the removable tab  32  of the outer layer  12 . Removal of the removable tab also removes the third piece which would carry the secondary sample. 
         [0038]    The second set of pieces  16   b  generally includes three pieces  46 ,  48  and  50  that adhere to the second portion  28  of the outer layer  12  when the device is assembled and, when the device is folded along median axis A-A, correspond to and align with the pieces  40  and  44  of the first set  16   a . More specifically, and as described below, when the device  5  is used, it is folded along axis A-A, which causes pieces  40  and  50  to generally, pieces  44  and  46  to generally along and piece  48  and removable tab  32  to generally align. As such, when the device  5  is used and folded along axis A-A, the primary sample deposited through holes  22  onto sheet  14  are preserved and prevented from adhering to the inner surface of outer layer  12  by piece  50 . Similarly, the secondary sample is preserved and protected from adhering to outer layer  12  by piece  48 . Pieces  44  and  46  provide non-adhesive grasping areas. 
         [0039]    In alternate embodiments the device may not be symmetrical along the median axis A-A, and the device may be any size or shape. For example, the first portion  18  may be smaller than the second portion  20 , and the second portion  20 , may fold over portion  18 , and around portion  18 , such that the perimeter of section  20 , adheres to the back of the first portion  26  to more securely seal the device. 
         [0040]    When the device  5  is assembled, the pieces  16   a ,  16   b  adhere to the adhesive on the inner surface of the outer layer  12 . Similarly, the sheet  14  adheres to the adhesive on the inner surface of the outer layer  12  along the edges of the sheet  14  that extend beyond the first set of pieces  16   a . The holes  22  in the tissue layer  10  in conjunction with the sheet  14  define wells for receiving the primary sample, the holes  22  providing a metering of the amount and configuration of sample deposited on the sheet  14 , and the aperture  25  in the tissue layer  10  in conjunction with the removable tab  32  (or any piece adhered thereto, if used) define a well for the secondary sample. In certain embodiments, the aperture  25  aligns with only a first portion of removable tab  32 , leaving a second portion of removable tab  32  specimen-free, which serves as a grasping area. Such specimen-free grasping area helps prevent contamination and cross-contamination when being handled. 
         [0041]    In use, a user, such as a patient, wipes after a bowel movement, grasping the second portions  20 ,  28  of the tissue and outer layers  10 ,  12  thereby depositing fecal samples on the first portion  18  of the tissue layer  10  and through the holes  22  and aperture  25 . The fecal sample that passes through the holes  22 —the primary sample—is deposited on the absorbent sheet  14 . The fecal sample that passes through the aperture  25 —the secondary sample—is deposited on the removable tab  32  of the outer layer  12 . It should be understood that reference to a sample being deposited on the removable tab, or other portion, includes the sample being deposited directly on the removable tab or on a dry sheet of paper adhered to it and forming a part of it. Pieces  44 ,  46  which align with and adhere to the distal edges of the first and second portions  26 ,  28  prevent the edges of the tissue layer  10  from adhering to the outer layer  12 , and hence permit the user to easily grasp and peel away the tissue layer  10  from the outer layer  12  after wiping. Removing the tissue layer  10  exposes the adhesive on the surface of outer layer  12 . The user may then dispose of the tissue layer  10  and fold the outer layer  12  along its medial axis A-A. This results in piece  50  overlapping the primary fecal sample that has been deposited on the absorbent sheet  14 , and piece  48  overlapping the secondary fecal sample that has been deposited on the removable tab  32 . Sections of the inner portion of the outer layer  12  which are not overlapped by one of the non-adhesive pieces  40 ,  42 ,  44 ,  46 ,  48 ,  52 ,  54  will subsequently adhere to either the absorbent sheet  14  or other sections of the outer layer  12 , thereby sealing the sampling device  5 . Because the outer layer  12  includes an adhesive folding device  5  along axis A-A creates sealed pockets containing fecal samples, which may be preserved until testing by a doctor. 
         [0042]    A physician receiving the device  5  may then peel back the flap  34  to perform a primary test to check for blood in the primary sample. For example, if the absorbent sheet is permeated with guaiac solution, the physician may drop hydrogen peroxide or other developing solution on the absorbent sheet. The presence of occult blood will be determined by a change in color of the absorbent sheet. The device may also include a control area on the sheet  14  to provide an indication of proper positive and/or negative results (e.g., confirming the effectiveness of the guaiac and/or developing solution). 
         [0043]    If the primary test is “positive,” a confirmatory, secondary test may be performed. If a secondary analysis is desired, the physician may subsequently remove the removable tab  32 , and conduct further analysis on the fecal sample deposited on the tab  32  using, for example a more specific immunological test. Such a test may involve removing the tab  32  and depositing it into a test tube or other container. Thus, the secondary test is performed off-device, whereas the primary test is performed on-device. 
         [0044]    It should be appreciated that the device provides several advantages over the prior art. For example, the removable tab is capable of being removed from the device (and particularly the exterior of the device) and used in its entirety in a subsequent, secondary analysis. Thus, there is no further manipulation of the removable tab once it has been pulled away from the device, thereby reducing the likelihood of sample cross-contamination and end-user (both patient and physician/laboratory technician) contamination. Furthermore, because the device obtains both a primary sample and a secondary sample at the same time and with a single act of the patient, there is no need to go back to a patient with a positive primary test for an additional sample, and patient non-compliance is avoided. 
         [0045]    In alternate embodiments the aperture  25  may include a plurality of holes, similar to holes  22 . In alternate embodiments of the invention, it is possible for all the non-adhesive pieces  16   a  to be integral as one sheet, in which case the tab  52 , will need to be cut out by a physician, alternatively, perforation may be provided in order to facilitate removal of tab  52 . 
         [0046]    It will be clear to one skilled in the art that different sizes, different types, and different numbers (including none) of pieces  16   a ,  16   b  may be used. Additionally, multiple removable tabs may be incorporated into the fecal sampling device in case more than two tests are expected to be performed. 
         [0047]    Turning now to  FIGS. 4-7 , an alternate embodiment for collecting fecal samples by wiping the device across a user&#39;s anus will now be discussed. As shown in  FIG. 4-7 , the fecal sampling device  100 , like the prior embodiments, may include a tissue layer  110  and an outer layer  112 , with a sheet of plain filter paper  114 , which is not impregnated with guaiac or other reagent for performing a test for the presence of blood, disposed between the outer layer  112  and tissue layer  110 . When device  100  is assembled for use, tissue layer  110  and outer layer  112  substantially overlay each other, with the filter paper sheet  114  interposed therebetween. 
         [0048]    The tissue layer  110  generally includes a first portion  118  and a second portion  120 . In addition, the tissue layer  110  includes an aperture  125  on one of the portions  118 ,  120  thereof (shown as the first portion  118 ), through which a sample may be received. The tissue layer  110  is preferably a moisture or liquid barrier, thus limiting the sample passing through to only the area corresponding to the aperture  125 . As such, tissue  110  may be any suitable material, such as wax paper, polypropylene, biaxially oriented polypropylene (BOPP), and biaxially oriented polypropylene terephtalate polyester sold under the trademark MYLAR®. In alternate embodiments, aperture  125  (like aperture  25  in the aforementioned embodiments) is replaced with a plurality of apertures for metering the amount of the sample received. 
         [0049]    The outer layer  112  also generally includes a first portion  126  and a second portion  128 . When device  100  is assembled, the first portion  126  of the outer layer  112  overlays the first portion  118  of the tissue layer  110 , and the second portion  128  of the outer layer  112  overlays the second portion  120  of the tissue layer  110 . One of the portions  126 ,  128  (shown as the first portion  126 ) may include a removable tab  132  that is dimensioned to align with the aperture  125  in the tissue layer  110 . As with the aforementioned embodiments, the aperture  125  may align with only a portion of removable tab  132 , thereby leaving a specimen-free grasping area to help prevent contamination. The removable tab  132  is preferably formed from, and as a part of, the outer layer  112 . Thus, tab  132  is integrally formed as part of the outer layer  112  for example, by die cutting or other method and can be formed either entirely or partially by perforations in outer layer  112 . It should be understood that in certain embodiments the removable tab  132  may have a sheet overlaying and attached to it, such that the sheet in fact receives the sample through aperture  125 , and the sheet is removable along with the removable tab  132 . The outer layer  112  may be coated with a releasable adhesive on all or a portion of its inner surface (i.e., the surface facing tissue layer  110 ). As discussed in greater detail below, the adhesive may permit the outer layer  112  to bond to the sheet of filter paper  114 , and the tissue layer  110 . 
         [0050]    In the present embodiment, as partially illustrated in  FIGS. 4-7 , the filter paper sheet  114  may be a single sheet of plain filter paper generally dimensioned to align with or overlay a portion of the removable tab section  132  that aligns with the aperture  125  when device  165  is assembled. The filter paper sheet  114  may further include a removable section  170 , that is sized and configured to overlay the removable tab section  132  and the aperture  125 . The removable section  170  of filter paper sheet  114 , may be integrally formed as part of the filter paper sheet  114 , for example, by die cutting or other method and can be formed either entirely or partially by perforations in the filter paper sheet  114 . Alternatively, the entire filter paper sheet  114  may be sized and configured to overlay the removable tab  132  (or a portion thereof) and the aperture  125  without substantially encroaching on the rest of the area of outer layer  112 , thus the entire filter paper sheet  114  may become removable with the removable tab  132 . 
         [0051]    In use, a user, such as a patient, wipes with device  100 , after a bowel movement, thereby depositing a fecal sample on the first portion  118  of the tissue layer  110  and through the aperture  125 . The fecal sample that passes through the aperture  125  is deposited on the removable section  170  of the filter paper  114 , which is attached to the removable tab  132 . The user may, after wiping, peel away the tissue layer  110  from the outer layer  112  and discard it. Removing the tissue layer  110  exposes the adhesive on the surface of outer layer  112 . The user may then fold the outer layer  112  along its medial axis A-A. This results in the adherence of section  126  of the outer layer  112  to section  128  of the outer layer  112 , thereby sealing the sampling device  100  with the sample being sealed and retained therein. In one embodiment section  128  of layer  112  includes an additional, non-adhesive piece adhered to layer  112  that, when the device  100  is folded, aligns with the removable tab  32  so that the deposited sample does not adhere to the adhesive. Such piece may be filter paper, tissue paper or any other specimen absorbing and/or capturing material. Alternatively, the area of layer  112  that aligns with the removable tab  132  when the device  100  is folded has no adhesive. 
         [0052]    A physician receiving the sealed device  100  may subsequently remove the removable tab  132 , thereby also removing the removable section  170  of the filter paper sheet  114  that is adhered to the removable tab  132 . The physician may then conduct analysis on the fecal sample deposited on the removable section  170  using any test such as H-Pylori, blood, etc. Such a test may involve depositing the removable tab  132 , along with the removable section  170  of the filter paper sheet  114  (in embodiments where it is used) and sample, into a test tube or other container. Thus, device  100  serves the function of collecting a sample for off-device testing (i.e., once the sample is removed from the device). 
         [0053]    In alternate embodiments, device  100  may include a plurality of non-adhesive pieces of material (not shown), similar to pieces  16   a  and  16   b  of  FIG. 1 , disposed between the tissue layer  110  and the outside layer  112 . These pieces may be used as barrier pieces around or on top of the filter paper sheet  114  in order to, for example, prevent sample loss or contamination. These non-adhesive pieces may also be used to provide gripping areas for the user of the device  100 . The non-adhesive pieces may further be positioned, as described above with reference to  FIG. 1 , such that folding of the device  100 , after the removal of the tissue layer  110 , creates a sealed pocket around a sample deposited on the removable portion  170  of filter paper sheet  114 . Those skilled in the art will appreciate that various configurations of non-adhesive pieces may be used to accomplish various goals of promoting sanitary use of the device  100  and preservation of samples collected by device  100 . 
         [0054]    To ease the removability of the removable tab  32  or  132 , second portions  28 ,  128  may be perforated or scored along its edge, where the second portion  28 ,  128  adheres to the removable tab  32 ,  132 . As such, removal if the removable tab  32 ,  132  takes with it the section of the second portion  28 ,  128  that adheres to the removable tab  32 ,  132 . 
         [0055]    It will be clear to one skilled in the art that different sizes, different types, and multiple numbers of removable tabs may be incorporated into the fecal sampling device in the even that more than one test is to be performed. 
         [0056]    While the foregoing description and drawings represent the preferred embodiments of the present invention, it will be understood that various additions, modifications and substitutions may be made therein without departing from the spirit and scope of the present invention as defined in the accompanying claims. In particular, it will be clear to those skilled in the art that the present invention may be embodied in other specific forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the spirit or essential characteristics thereof. One skilled in the art will appreciate that the invention may be used with many modifications of structure, arrangement, proportions, materials, and components and otherwise, used in the practice of the invention, which are particularly adapted to specific environments and operative requirements without departing from the principles of the present invention. In addition, features described herein may be used singularly or in combination with other features. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, and not limited to the foregoing description.