Abstract:
A self contained diagnostic test device is provided for use in the collection and detection of a biological specimen or the like. The device comprises a tubular swab and reagent dispensing cap component for receiving specimens. The reagent dispensing cap component includes barrel, reagent chamber, and results window subcomponents, and delivers one or more selected reagents to a specimen testing chamber for contacting the collected specimen, upon the rotation of the reagent chamber component.

Description:
FIELD OF THE INVENTION 
     The present invention relates to diagnostic test devices and methods of using the same. More particularly, the present invention relates to diagnostic test devices used for detecting microorganisms in a body cavity, interior body space or an environmental setting. 
     BACKGROUND OF THE INVENTION 
     Medical swabs are generally known in the art for use in collecting biological specimens from a patient for further analysis. Such medical swabs commonly comprise a fibrous swab tip at one end of an elongated stick or shaft, which is manipulated to contact the swab tip with selected tissue cells, secretions, fluids or other biological specimens obtained, for example, from within the ear, nose, throat, vaginal opening or other body cavity/opening of a patient. As a result, some of the targeted biological specimen adheres to the swab tip. The swab tip then can be contacted with one or more chemical reagents to indicate the presence of infection or other information regarding patient condition. Such reagent testing may either be quantitative in character, in that it produces a quantifiable result, qualitative (as providing matter of degree of infection or contamination by using a scale system), or a positive/negative-type test result, in that it indicates the presence of a particular condition, but does not provide details as to degree. 
     Alternatively, such swab testing may be used as part of environmental condition monitoring. For instance, such swabbing may be done in a food service area to determine the presence or absence of environmental or food pathogens or contaminants. 
     Such medical swabs may be either used as part of a storage/transport unit for transporting a biological sample to a laboratory for further analysis, or alternatively, as part of a portable test detection device, designed to provide an immediate or relatively quick indication of a patient&#39;s or environmental condition at the time of the test. If the swab is part of a storage/transport unit, it is likely that such unit will include growth media or other chemistries to aid in maintaining the specimen in a viable state during transport. 
     Tests commonly performed with such patient specimens include, by way of example, fluorescent tests, enzymatic tests, monoclonal based tests, agglutination tests, and others. Moreover, swabs and similar reagent test methods are also used in a variety of nonmedical applications to determine the presence of biological organisms on a selected surface, such as a food preparation surface in a restaurant, a slaughterhouse surface or the like. 
     In accordance with standard specimen collection and test preparation techniques, the biological specimen is normally transferred from the swab tip to a slide or other laboratory apparatus such as a test tube or the like, for contact with the selected reagent or reagents and further analysis. The reagents are typically stored in a vial or other breakable container prior to use. However, it is frequently difficult to ensure transfer of a sufficient specimen quantity from the swab tip to the laboratory slide or test tube to ensure accurate test results. Moreover, in many instances, the collected specimen must be transported to an off-site laboratory for performance of selected assays. Delays between the time of specimen collection and actual test performance can result in partial or complete drying of the specimen, with a corresponding decrease in test reliability. In addition, such conventional handling of a biological specimen in the course of preparing and/or performing an analysis undesirably exposes personnel to direct contact with the collected organism, wherein direct contact with infectious or toxic organisms can be especially undesirable. 
     In this regard, a variety of swab-type specimen collection and test devices have been proposed in efforts to provide enhanced contact between a specimen and reagents, or to sustain the specimen in an improved manner during transport to a laboratory, while at the same time reducing or minimizing risk of direct personnel contact with the collected specimen. 
     For example, sampling/test kits are now abundantly available for providing transport or testing of specimens in both a hospital and medical office environment. While these tests may be used in the home of a patient, the kits often involve multiple steps or stages, breakable parts, and in many cases, assembly, making them less desirable for use by the general public. For instance it is not unusual for a kit to include three to four parts such as a swab, a collection dish/tray or chamber, in some cases vials of testing solutions or reagents, and an assay medium such as a test strip. In test devices involving multiple pieces, the various components used to conduct the test must be kept separated in order to avoid possible contamination of either the testing substrate or the reagents/growth media used in the test. 
     Typically, such kits involve mixing of test solutions, or causing the rupture of a vessel containing the test solution(s), filling a testing dish, tray or vessel with the testing solutions (most often in the form of a small test tube or test chamber), placing the swab in the testing dish, tray or vessel, and either waiting for the results to be observed on a test strip or indicator, or alternatively for a value to be generated. In some instances, such kits also require the removal of the swab, or dipping a testing strip into a testing dish in order to obtain an analysis result. Depending on the type of kit being used, such steps may involve the awkward placement of test solution vials next to the test tray, or the continuous possibility of exposure of biological specimens to the tester. 
     Further, as many of such test kits utilize a relatively flexible bulbous vessel for dispensing test solutions/reagents directly into a test vessel, upon being squeezed (application of pressure) or upon having an internal component ruptured, such kits present the possibility of inadvertent rupturing of the vessel, or initiation of the test, when such is not desired. Such tests may also present the possibility of injury to the tester as internal components to be ruptured may include glass, reagent containing ampoules. 
     There is therefore a need for a simplified test device that can be conveniently stored safely in either the home, medical office or other commercial environments, and that requires minimal to no assembly (with few pieces) prior to use. There is a further need for a test device which provides an immediate visual indication readily to a user, of the results of such a test, but which cannot easily be inadvertently initiated or compromised. There is also a further need for a test device which is relatively stable in use, and avoids the need for awkward solution storage vessels or breakable reagent-containing ampoules for operation. 
     Given the current rise in health care costs and a focus on preventative/preemptive medicine, the members of the general public are performing more preliminary medical testing in their home environments. Such medical testing allows the individual to make basic medical determinations (such as blood sugar levels, cholesterol levels, blood alcohol levels, pregnancy evaluations, and various urinalysis and breath analysis) prior to visiting a physician, offering vast potential savings in both dollars to the consumer, and in time for physicians who can devote more of their time to patients who truly require medical attention. There is therefore a need for diagnostic test devices which are “patient friendly”, in that they are easy to operate and relatively contained in their configuration, so as to allow for the efficient identification of possible medical conditions prior to the costly involvement of a medical practitioner. It is to such needs that the current invention is directed. 
     Finally, in the practice of gastrointestinal and gynecological medicine, numerous more invasive tests are performed in various internal body organs which require the taking of a specimen or sample/biopsy from an internal space. For instance, it is not uncommon for endoscopic procedures to be performed on patients in order to obtain specimens of stomach lining or stomach fluids, so as to detect ulcer-causing bacteria, or in the colon so as to obtain specimens to detect precancerous polyps, related fluids and the like. With such endoscopic procedures, it is not uncommon for the endoscopic devices to include brushes, forceps, snares or baskets to obtain specimens. The specimens from such procedures may then be sent off to a laboratory facility for further analysis. There is therefore a need for an endoscopic swab that could be used as part of a rapid diagnostic device (where appropriate) to detect a medical condition. It is also to such needs that the current invention is directed. 
     SUMMARY OF THE INVENTION 
     The present invention addresses problems associated with the prior art. In one embodiment of the invention, a diagnostic test device for detecting the presence of microorganisms includes a cap component. The cap component includes at least one barrel component for receiving a swab. The barrel component includes an inside surface and an outside surface, and defines an interior barrel space. The cap component also includes a results window component for viewing test results from a test strip. The results windows component includes at least one viewing window. The cap component also includes a reagent chamber component between the barrel component and the results window component. The reagent chamber component defines an interior reagent chamber space in spatial communication with the barrel component and the results window component and includes at least one reagent chamber for containing at least one reagent or test solution. The reagent chamber component is rotatably connected to the results window component and rotatable with respect to a core contained in the reagent chamber space. The core includes a test strip. The diagnostic test device may also include a swab component for removable insertion through the barrel component to the reagent chamber component. The swab component may encompass a pre-designed swab to be matingly fit within the barrel component prior to usage. Alternatively, the barrel component may include a rupturable seal over an opening, through which any variety of swabs may be inserted. 
     The reagent chamber component can be rotated from a pre-use position to a use position, such that when rotated, the reagent chamber moves from a closed position to an open position, thereby delivering reagent contained in the reagent chamber onto the test strip. 
     In an alternative embodiment of the diagnostic test device, the barrel component includes a first interlocking mechanism on the inside surface, and a pre-designed swab component includes a second interlocking mechanism, such that the first and the second interlocking mechanisms releasably lock with each other, upon insertion of the swab component into the barrel component. 
     In another alternative embodiment of the diagnostic test device the interlocking mechanism is selected from the group consisting of screw mechanisms, interlocking flange mechanisms, and tab and slot mechanisms. 
     In another alternative embodiment of the diagnostic test device, the barrel component includes a collar on the inside surface for directing the swab component to the reagent chamber component. 
     In still another alternative embodiment of the diagnostic test device, the results window component includes at least two windows. In still another alternative embodiment of the diagnostic test device, one of the two windows is a control window. 
     In still another alternative embodiment of the diagnostic test device, the results window component defines a results window interior space having at least one interior wall inclined toward the results window. 
     In still another alternative embodiment of the diagnostic test device, the reagent chamber component includes at least two reagent chambers. 
     In still another alternative embodiment of the diagnostic test device, the core includes structural extensions for directing a reagent to the test strip. 
     In still another alternative embodiment of the diagnostic test device, the barrel component includes at least one flat side, the results window component includes at least one flat side in alignment with the barrel component flat side, and the reagent chamber component includes at least one flat side, whereby as the reagent chamber component is rotated with respect to the results window component, the reagent chamber component flat side becomes aligned with the barrel and results window component flat sides, as the reagent chamber moves from a closed to an open position. 
     In still another alternative embodiment of the diagnostic test device, the barrel component includes at least one marking, the results window component includes at least one marking in alignment with the barrel component marking, and the reagent chamber component includes at least one marking, whereby as the reagent chamber component is rotated with respect to the results window component, the reagent chamber component marking becomes aligned with the barrel and results window component markings, as the reagent chamber component moves from a closed to an open position. In still another alternative embodiment of the diagnostic test device, the markings are selected from lines, patterns, symbols, flat and textured surfaces. 
     In still another alternative embodiment of the diagnostic test device, the test strip is an elongated test strip which is situated within both reagent chamber and results window components. 
     In still another alternative embodiment of the diagnostic test device, the core is U-shaped. In still another alternative embodiment of the diagnostic test device the core is circular. 
     In still another alternative embodiment of the diagnostic test device, the swab component includes a handle portion and the handle portion is of such a length that it always protrudes from the barrel component upon insertion into the barrel component. 
     In still another alternative embodiment of the diagnostic test device, the device is generally tubular/cylindrical in configuration. 
     In still another alternative embodiment of the diagnostic test device, the U-shaped core defines an interior core space, and the U-shaped core includes an opening into the core space defined by an inner arc in degrees, and further wherein the reagent chambers are defined by an outer arc in degrees, wherein the inner arc is greater in size than the outer arc. 
     In still another alternative embodiment of the diagnostic test device, the reagent chamber includes side walls, the core has an outer wall, and at least one reagent chamber is formed from the side walls and the outer wall. 
     In still another alternative embodiment of the diagnostic test device, the reagent chamber includes side walls of a certain height, the barrel component and the results window component include walls of a height greater than or equal to the reagent chamber side walls, and at least one reagent chamber is formed from the reagent chamber side walls, the barrel and results window component walls. 
     In still another alternative embodiment, a method for detecting the presence of microorganisms includes the steps of: a) providing a diagnostic test device having a cap component comprising at least one barrel component for receiving a swab, the at least one barrel component including an inside surface and an outside surface, and defining an interior barrel space, a results window component for viewing test results from a test strip, the results windows component including at least one viewing window, a reagent chamber component between the at least one barrel component and the results window component; the reagent chamber component defining an interior reagent chamber space in spatial communication with the at least one barrel component and the results window component and including at least one reagent chamber for containing at least one reagent or test solution, the reagent chamber component being rotatably connected to the results window component such that when rotated, the reagent chamber within the reagent chamber component moves from a closed position to an open position, a core situated within the reagent chamber component space, the core being independently rotatable from the reagent chamber component and including a test strip; and a swab component for removable insertion through the barrel component to the reagent chamber component, b) optionally removing the swab component from the device (as the swab may be designed in one embodiment to fit in the device during shipping to keep it sterile and therefore would be removed from the device before it can be used) c) swabbing the swab component onto a selected body cavity, space or environmental location, d) inserting the swab component through the barrel component and into the reagent chamber component (U-shaped core), thereby placing the swab of the swab component adjacent the test strip; e) rotating the reagent chamber component such that the reagent chamber moves from a closed to an open position, thereby delivering the reagent onto the swab and the test strip, and f) viewing the test strip through the window. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective illustration of a diagnostic test device in accordance with the invention. 
         FIG. 1A  is a perspective view of the swab component of the diagnostic test device of FIG.  1 . 
         FIG. 1B  is a perspective view of the barrel component in the diagnostic test device of FIG.  1 . 
         FIG. 1C  is a perspective view of the results window component of the cylindrical cap component of the diagnostic test device of FIG.  1 . 
         FIG. 1D  is a perspective view of the reagent chamber component of the cylindrical ap component of the diagnostic test device of FIG.  1 . 
         FIG. 1E  is a perspective view of the U-shaped core component of the present invention. 
         FIG. 1F  is a perspective view of an alternative embodiment of the reagent chamber component showing a recess locking mechanism. 
         FIG. 1G  is a perspective view of an alternative embodiment of the U-shaped core component showing a nib locking mechanism. 
         FIG. 2  is a cross sectional view of the diagnostic test device taken along the device length. 
         FIG. 2A  is a cross-sectional view of the diagnostic test device taken along the device width. 
         FIG. 2B  is a cross sectional view of an alternative embodiment of the diagnostic test device taken along the device length. 
         FIG. 3  is a perspective view of the results window and reagent chamber components of the cylindrical cap component of the diagnostic test device of  FIG. 1 , shown in the “pre-use”/closed storage position. 
         FIG. 3A  is a cross sectional view of the cap housing component of FIG.  3 . 
         FIG. 4  is a perspective view of the result window and reagent chamber components of the cylindrical cap component of the diagnostic test device of  FIG. 1 , shown in the “use” /open position. 
         FIG. 4A  is a cross sectional view of the cap housing component of FIG.  4 . 
         FIG. 5  is a perspective view of the results window and reagent chamber components of the cylindrical cap component of the diagnostic test device of  FIG. 1 , shown in the “use” position and with a swab inserted in the cap housing. 
         FIG. 6  is a perspective front/top view of the diagnostic test device of  FIG. 1  in the “use” position. 
         FIG. 6A  is a perspective back/bottom view of the diagnostic test device of  FIG. 1  in the “use” position. 
         FIG. 6B  is a partial perspective top view of the diagnostic test device of  FIG. 1  in the “pre-use” storage position. 
         FIG. 6C  is a partial perspective back view of the diagnostic test device of  FIG. 1  in the “use” position. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     A diagnostic test device  10  as shown in FIG.  1  and in accordance with the invention, includes a swab component  20  and cap component  35 . Such a swab diagnostic device can be used for a variety of test procedures, in both medical office and home/private commercial environments. For instance, such a device may be used for medical testing involving cavity culture testing i.e. throat cultures, rapid strep tests, nasal or vaginal swabs, other body cavity swabs, as well as for the detection of microorganisms in commercial establishments, such as in food service or food preparation industries. The device incorporates all functionality into a two, primary part system for simplicity of use. Essentially the device includes a swab portion and a cap portion that can be used together to form a closed testing environment, and one that reduces the likelihood of tester exposure to microorganisms, spillage of reactant solutions/agents, and the need to perform an awkward series of separate steps and procedures with numerous reagent vials, ampoules or containers. The cap component  35  includes all of the test solutions/reagents, a testing strip and the collections/test dish in one closed location. 
     While the diagnostic test device  10  is shown in a generally cylindrical tubular configuration, it should be appreciated that any of various shapes may be utilized as long as the functionalities of the two primary components are present. For the purposes of efficiency, a tubular housing configuration is illustrated so as to conform to the overall elongated shape of the swab component  20 . The overall diagnostic test device  10  has a length dimension (or longitudinal dimension)  31  and a width dimension  32  transverse to the longitudinal dimension. In a first embodiment, the length dimension  31  includes a proximal end (or swab handle end)  33  and a distal end (results window end)  34 . It includes a top (front surface) on which the windows are situated, and a bottom (back surface) opposite from the window surface. In one desirable embodiment, the back surface is a flat surface  61  (as seen in FIG.  6 A). 
     As previously stated, the diagnostic test device can be separated into at least two primary components during use. The first component (swab component)  20  includes the swab itself. The swab component  20  has a length dimension  23  having a proximal handle end  29 , as seen in  FIG. 1A , and a distal swab end  30 . The swab component  20  desirably includes a distinct handle portion  22 , which desirably includes along a portion of its circumference, a first interlocking mechanism such as a raised portion or flange  28  which functions as part of a cap component interface/interlocking system, that will lock the cap component  35  (having a second interlocking mechanism) in place around the swab component  20  either prior to use, during use, or after use. Alternatively to a flange  28 , the handle portion  22  may include screw-like channels (not shown) along the swab handle circumference, for screwing the swab component  20  into a second interlocking mechanism such as a mated screw portion (not shown) along the inside surface of the cap component  35 . In a further alternative embodiment, the handle portion  22  may include a recess (not shown) to receive a mated elevated ridge portion (not shown) on the inside of the cap component  35 . It should be understood that in the various embodiments of first and second interlocking mechanisms, either of the mating locking mechanisms may be situated on either of the swab or cap components. 
     A stem portion  24  of the swab component  20  is immediately connected to the handle portion  22  adjacent the flange  28 . At the distal end of the swab component  20 , a swab  26  is attached or mounted to the stem portion  24 , for collecting specimens for testing. The swab component  20  body is desirably of an injection molded polymer construction, such as a polyethylene or polypropylene. The swab  26  itself, may be constructed of materials typically found in current medical swabs, and may be made from for example, cellulosic materials, synthetic polymeric nonwoven materials, polymeric foams or a combination of such. 
     The cap component  35  is itself desirably constructed from at least three distinct polymeric components, each being desirably made through an injection molded process. The first cap component, or barrel component  60  has an inside  62  and an outside surface, and is designed to enclose/envelop the majority of the swab component  20  within an interior barrel space  100 . In particular, the barrel component  60  is designed to enclose (receive) much of the swab handle in the interior barrel space  100 , and much of the swab stem  24 , but not the swab  26  itself. A portion of the swab handle  22 , adjacent the proximal handle end  29  desirably extends beyond  21  the barrel component opening  67  to allow for ease of hand manipulation during use. In this regard, it is desirable that at least between about 0.75-1 inch of the handle  22  extend from the barrel component opening  67  to allow for easy grasp of the swab component  20  with a users thumb and forefinger. The barrel component  60  desirably includes a flat back/bottom surface  61 , seen in  FIGS. 1B ,  2 A and  6 A. The flat surface  61  is referred to herein as back or bottom since in use, the flat surface may rest on a relatively horizontal surface during testing or storage (such as a tabletop or lab bench) away from the users line of sight. While not required to be resting on such a surface, the diagnostic test device  10  is desirably maintained in a horizontal level position during use (for ease of operation), i.e generally parallel to level ground when in use. This position is not required for operation, but it is desirable, so as to allow the maximum amount of testing solutions/reagents to contact the swab and test strip during use. If a flat back surface  61  is present on the device, the flat surface should be the surface facing the ground/table top, when the device is being used and opposite from the window-side of the device. The remaining barrel component surface is desirably rounded in configuration, as can be seen in the various figure views. It should be appreciated that while such rounded configuration is preferred, any shape configuration is contemplated. For instance, the barrel may be in the shape of a cube or other box form. Having at least one side surface that is flat does offer the benefit that the device will be stable on a flat surface during usage, reducing risk of test solution spillage and subsequent reagent/specimen contamination. 
     A barrel interlocking component is desirably present along the inside surface  62  of the barrel component  60  for holding the swab component in place either during pre-use storage, or during usage, as will be explained in the following sections. The interlocking component is designed to interlock with a swab component  20  interlocking component as previously stated, upon receiving gentle pressure in a longitudinal direction  64  of the device either toward the distal (result window end) end  34  of the cap component  35 , while maintaining the cap component  35  in a non-moving position, by receiving gentle pressure in the longitudinal direction toward the proximal end  33  of the device while maintaining the swab component  20  in a non-moving position, or alternatively, by applying gentle pressure from both the swab and the cap components towards each other (after the swab has been inserted within the barrel component). 
     The barrel interlocking component is desirably an elevated protuberance or a continuous circumferential ridge/flange  63  (cross section seen in  FIG. 2B ) on the inside surface  62  of the barrel component  60 , over which the swab component flange  28  must pass while the swab component  20  is inserted into the cap component  35 . As previously indicated, the interlocking components of both the swab and barrel components may alternatively be screw-type grooves and channels, such that the swab is rotated into and out of position with respect to the barrel component, or alternatively, a mating ridge and recess arrangement. In either instance, the interlocking arrangement is desirably one so as to allow the easy insertion or removal of the swab component  20  into the barrel component  60  with some force (so as to avoid the inadvertent removal of the swab component), but one that would desirably provide a liquid seal once the swab component  20  has been inserted within the cap component  35  and the swab is firmly in its “testing” position. Essentially, the swab and cap interface coaxially and lock together, either by a frictional arrangement, such as in a pen cap, a screw interface, a tab and slot interface, or other suitable sealing system. 
     The barrel component  60  may itself comprise multiple sub-components in a variety of shapes, so long as it encloses at least a portion of the swab component  20  as previously described. The barrel component  60  desirably includes on its inside surface  62 , at the end  66  opposite the opening  65  through which the swab is inserted, an elevated collar structure  71  (as seen in  FIG. 2 ) for directing the swab to the test strip (as will be explained in the following sections). While not required for operation, the presence of an elevated collar structure  71  can achieve the multiple objectives of 1) directing the swab  26  to make contact with the test strip  69  in order to receive the maximum amount of test solution/reagents, 2) locking the swab  26  in place so that it is immoveable, or at least difficult to inadvertently move with respect to the cap component  35 , and  3 ) forcing specimen fluid or tissue samples which may be contained on the swab  26  following swabbing, to be squeezed or directed onto the test strip  69  for later testing. In one embodiment, the elevated collar structure  71  desirably includes a conical depression  95  such that the widest shoulder of the cone is positioned closest to the barrel component end  65 . The elevated collar structure  71  is desirable integrally connected to the end  66  of the barrel component  60 . The wall thickness (or height)  96  (in the width direction) of the elevated collar structure  71  is designed to serve as a side wall to the reagent chamber  76 , as will be later described. 
     A results window component  40 , as illustrated in  FIGS. 1 ,  1 C,  2 ,  3 ,  4 , and  5 , is situated at the distal end  34  of the diagnostic test device  10 . The results window component  40  includes at least one viewing window  48  (as the component name suggests), but may include several viewing windows and defines a results window interior space  120 . For instance, the results window component  40  may include two windows, one to provide viewing of the test result, the other to provide viewing of a control strip, indicating normal operation of the diagnostic test device  10 . An exterior flat outer side surface  43  is desirably present on the results window component  40  as well, and is present on an exterior surface opposite from the viewing window(s)  48 . The remaining exterior surface is desirably round, as with the barrel component  60 . Desirably, the flat sides  43 ,  61  of the barrel component  60  and results window component  40  are capable of being aligned, as are the rounded sides. The viewing window(s)  48  of the results window component  40  are desirably made from a clear polymer, but may likewise be made from glass or other clear material in order to provide unhindered viewing of the test strip/results. The viewing window(s)  48  should allow for the observation of either a color change, or the appearance of a symbol/numerical indicator on a test strip  69  which is situated beneath them, and originating from within the testing chamber  73  (as seen in FIG.  5 ). The interior of the results window component  40  desirably includes an inverted U-shaped opening  46  directly beneath the windows. An elongated test strip  69  is partly situated along the bottom surface  47  of the U-shaped opening. The interior of the result window component  40  may also include a filled polymer section having an angled interior wall  68 . The elongated test strip  69  may lie on the angled interior wall  68 , as seen in  FIG. 5 , such that as reagent(s) and organisms react on the test strip  69 , the indicator chemistry on the test strip will wick upwards (as part of a lateral flow) such that the test result can be viewed through the result window(s)  48 . An angled interior wall  68 , while not necessary for operation of the diagnostic test device, also provides the desirable attribute of maintaining either the test specimen or certain reagents within the testing chamber  73 , while allowing only specific reagents to wick along the strip to inform a viewer of a specific result. As with the barrel component  60 , the results window component  40  may itself be formed from a variety of subsections, and may be of a variety of shapes. For instance, while it is shown generally as cylindrical, it may be box-like in shape (having a square or rectangular cross-section in the width dimension) or prism-like in shape (having a triangular cross-section in the width direction). 
     As seen in  FIGS. 1D ,  3 ,  3 A,  4 ,  4 A and  5 , the reagent chamber component  70  of the cap component  35  (in the shape of a ring) is immediately adjacent the barrel component  60  and between the barrel component and the results window component  40 . As with the barrel chamber component  60 , the reagent chamber component  70  desirably includes an outer flat surface  77  on one side surrounded on either side by a round exterior surface. The reagent chamber component defines an interior reagent chamber space  110  in spatial communication with the barrel component  60  (and in particular the interior barrel space  100 ) and the results window component (interior space). By being in spatial communication, it is meant that a swab  26  or other object (such as the test strip) can either pass between, or is positioned from one cap component to another cap component. The inner walls  72  of the reagent chamber component  70  desirably have an interior wall thickness  74  of a certain dimension around the component circumference, with the exception of the interior wall opposite the interior wall immediately adjacent to the flat exterior surface. The walls help define an interior reagent chamber  76 . The thickness (or height)  79  of the interior wall  75  is desirably less than the remaining inner interior walls  72  of the reagent chamber  70 . This less thick wall area may be a single area or alternatively, may be sectioned via one or more divider walls  80 . If the less thick interior walls  75  are divided into sections, the divider walls  80  separating the sections are desirably of the same height  74  as the thicker inner walls  72 . As previously stated, it is desirable that the interior surface wall thickness be thinner (lower height) in the area opposite to that of the flat outer surface, as seen in FIG.  1 D. One or more reagent chambers  76  are thus created by the thinner interior walls  75 . If there are more than one reagent chambers present, they may be separated by divider walls  80  in a variety of configurations. It should be noted that any number of reagent chambers  76  may be present in the reagent chamber component  70 . However, each of the chambers should be situated such that their side walls  78  are directed to the outer flat side  77  of the component if there is one, or alternatively, to the center of the reagent chamber component  70  (center of the ring). The reagent chambers  76  are desirably situated adjacent each other along the ring inner surface, and desirably positioned in a close arc formation along the inner periphery of the ring. As will be discussed in later sections, the size of the arc (outer arc made up of reagent chambers), as measured in degrees, is desirably less than or equal to the size of the arc opening  56  (inner arc) formed in the U-shaped core  50  also to be discussed in a latter section. If the size of the outer arc is greater than the inner arc, then the test diagnostic test device  10  will not efficiently direct test solutions/reagents into the testing chamber  73  during use. Desirably, the size of the outer arc, defining the reagent chambers  76  is less than or equal to 180 degrees. More desirably, the size of the outer arc is between about 90 and 100 degrees. Even more desirably, the size of the outer arc is between about 95 and 99 degrees. 
     While in the figures the reagent chambers  76  are shown separated by a wall which runs in the longitudinal direction of the device, it is contemplated that such reagent chambers may likewise be situated with separation walls running in the width direction or the direction transverse to the longitudinal direction. In any event, the divider walls and/or side walls i.e.  80  and  78 , of the chambers should be directed/angled to the center of the reagent chamber component  70 , and if a flat outer side surface  77  is present on the reagent chamber component  70 , to the flat outer side surface  77  of the reagent chamber component  70 , so as to form a funnel-like opening that narrows towards the center of the reagent chamber component  70 . In an alternative embodiment, the reagent chambers  76  may be formed with pre-formed walls on five sides, and with one opening facing the flat side surface/center of the ring. As illustrated, the chambers are shown with two molded walls ( 78  and  80 ) from the reagent chamber component  70  and a third wall formed by the relatively thinner interior wall  75  of the reagent chamber component. The remaining chamber walls, which are created during operation of the device, are formed via mechanical rotation of the ring component  70 , from the interior walls of the results window component  40  and barrel  60  component. 
     It should be appreciated that while the majority of the reagent chamber component  70  inner wall  72  is shown as being thicker than the thinner interior wall section  75 , this is not necessary for operation of the diagnostic test device  10 . For instance, the inner walls  72  need only be thicker at locations immediately surrounding the reagent chamber(s)  76 , thereby creating a chamber enclosure. 
     As previously stated, the reagent chamber component  70 , is rotatable with respect to the results window component  40 . It may also be rotatable with respect to the barrel component  60 , or rotate with the barrel component  60 . However, the interior of the reagent chamber component includes a U-shaped core  50  as seen in  FIGS. 1E ,  3 ,  3 A,  4 ,  4 A, and  5 , which is integrally connected with either the results window component  40  or alternatively, the barrel component  60 , and desirably does not rotate. In an alternative embodiment, if it is integrally connected with the barrel component  60 , either the U-shaped core  50  or the barrel component  60  will be capable of joint mechanical rotation (as one unit) with respect to the reagent chamber component  70 , or no mechanical rotation with respect to the reagent chamber component  70 . The U-shaped core  50  is of a partial circular configuration in order to allow the reagent chamber component  70  to rotate around it. In this fashion, when the reagent chamber component  70  rotates in a particular direction, it rotates also with respect to the U-shaped core  50  contained therein. The reagent chamber component  70  rotates as a result of any number of rotational technologies known in the art. For instance, it may rotate as a result of a channel/insert between the sides adjacent the barrel and results window components, or it may rotate along screw-like channels such as are found on a multi-component pen. 
     In an alternative embodiment, it may rotate as a result of a groove and lock mechanism specifically contained between the U-shaped core  50  and the reagant chamber component  70 . In this embodiment, the reagent chamber component  70 , includes along its lower inside surface  81  a recess  91 . The recess  91  includes within its interior portion at least one nib or protuberance  93  to act as a locking mechanism. In a second alternative embodiment two such nibs are present close to each end of the recess  91 . A similar nib or protuberance  51  maybe found on the bottom outer wall of the U-shaped core  50 . As the device is manufactured, the U-shaped core  50  would be inserted into the reagent chamber component  70  such that the protuberance  51  will be initially situated in the recess  91  or track. In operation, when the U-shaped core  50  is rotated, the nib  51  on the outer surface of the core will be rotated within the recess  91  until it locks in place on either side of the respective nib  93  in the reagent chamber recess/track  91 . 
     The U-shaped core  50  is an insert that fits within the central opening  86  (reagent chamber space) of the reagent chamber component  70 , defined by the interior walls/surfaces  72 ,  81  of the reagent chamber component  70 . The U-shaped core  50  includes two arm-like extensions  52  (making up the arms of the circular “U”), which partially envelop an interior space  57  (forming part of a testing chamber  73 ), and a specimen sample shelf  58 . In a first embodiment, the height and dimensions of the arm-like extensions  52  are such that when the core  50  is inserted into the space of the reagent chamber component  70 , the arm-like extensions  52  are coaligned with the ledge (created by side walls  78 ) formed by the thicker interior wall portions  74  of the reagent chamber component  70 . This coaligned ledge forms a wall having an extended total thickness/height  98 , which directs/helps deliver reagents to the swab  26 . This can be clearly seen in  FIGS. 4 and 4A . In an alternative embodiment, the arm-like extensions  52  of the U-shaped core  50  include additional structural extensions  54  which are directed towards the center of the U-shaped core  50 . Such extensions  54  are designed to further direct test solutions/reagents from the reagent chambers  76  to a test strip  69  when the diagnostic test device  10  is in use. The extensions  54  serve the additional function of providing further enclosure of the swab  26  and exerting additional pressure on the swab  26  so as to squeeze specimen material from the swab  26  onto a test strip  69  lying on the specimen sample shelf  58  (when the swab  26  is in the testing position). The elongated test strip  69  is positioned such that it partially sits on the specimen sample shelf  58  within the testing chamber  73 . The test strip  69  sits on the specimen sample shelf  58 , but is also positioned such that it lies partly in the testing chamber  73  and partly within the results window component  40 , as can be seen in  FIGS. 3 ,  4 , and  5 . For the purposes of this application, the testing chamber  73  is defined as the open space under the reagent chamber(s)  76  and between the reagent chamber component  70  and the U-shaped core  50 , when the reagent chambers(s)  76  are in the in-use open/test position. 
     The arc opening  56  forms an inner arc of sorts between the arm-like elements  52  of the U-shaped core  50 . The size of the inner arc (in degrees of a circle), is desirably equal to or greater than the outer arc size (defined by the reagent chambers  76 ). If the inner arc size were to be smaller than the outer arc, it is possible that the test solutions/reagents would not fall directly onto the swab  26  or test strip  69  when in use, and would be caught up an interior ledge formed by the outer wall  53  of the core  50 . 
     The U-shaped core  50  is desirably integrally connected with the exterior wall  44  of the results window component  40 . In this fashion, the elongated test strip  69  may continue in an uninterrupted path from the upper surface of the specimen sample shelf  58  of the U-shaped core  50  of the reagent chamber component  70 , up the angled interior wall  68  of the results window component  40 . 
     As the reagent chamber component  70  (outer portion) is rotatable in a 360 degree fashion, or some degree less than a full circle, the reagent chamber(s)  76  of the reagent chamber component  70 , either aligns with the opening  56  of the U-shaped core  50 , or alternatively is blocked by some portion of the exterior wall  53  of the U-shaped component  50 . As can be seen in  FIGS. 3 ,  3 A,  4 , and  4 A, the position of the reagent chamber component  70  will determine whether materials contained in the reagent chambers  76  will be permitted to fall (via gravity) onto the swab  26  and test strip  69  situated immediately below them when in use (when the testing device in held in a relatively horizontal position parallel with the ground, and with the flat surface facing the ground/away from the user). This is best illustrated in  FIGS. 2 ,  2 B and  6  which illustrate the swab component  20  in a testing use position, where all of the flat outer surfaces i.e.,  43  and  77  (if present) on each of the barrel component  60 , reagent chamber component  70  and results window component  40  are aligned, facing downward. The interior space defined by the reagent chamber component is in spatial communication with both the interior space defined by the barrel component and the interior space defined by the results window component. 
     In forming the diagnostic test device  10  as described, the height of the interior walls (thickness) on the various components is desirably coordinated so as to avoid leakage of testing solutions/reagents from the various reagent chambers. For instance, the height of the reagent chamber walls, must be less than or equal to the height of the adjacent results window component walls  45  and  49 . Likewise, the height of the reagent chamber component walls must also be less than or equal to the height of the barrel component interior walls  94 ,  96 , depending on the presence or absence of the barrel elevated collar structure  71 . If the height of the adjacent results windows walls, or barrel component walls (thickness) was less than either of the reagent chamber walls, the reagent or test solutions could leak out from the reagent chambers  76  into the various compartments of either the barrel component  60  or the results window component  40 , jeopardizing the accuracy and viability of the diagnostic test device  10 . 
     Further, the frictional contact and/or materials which make up the various subcomponents of the cap component  35 , should be such that they encourage the fluid seal of the reagent chambers  76  when the reagent chambers  76  are in a pre-use storage position, and when they are between a pre-use storage position and the testing/use position. Therefore, manufacturing materials such as ultra high modulus polyethylene, polypropylene, syndiotactic polystyrene, cross-linked polyurethane, and polycarbonate may be used to create tight fluid seals, but also provide for the sufficient rotation of the reagent chamber component  70  in operation from a pre-use to a testing/use position. Such materials would not provide undue frictional resistance to the reagent chamber component  70 , thereby preventing its rotation with respect to adjacent cap components. Such materials may be injection molded and may be further treated in certain locations to increase hydrophobicity or other repellency around the reagent chambers  76 . For instance, Teflon coatings or silicone strips may be situated along the edges of the reagent chambers to encourage retention of solutions within the reagent chambers  76 . 
     Test solutions/reagents may be placed in the reagent chambers  76  either during the diagnostic test device  10  initial manufacture, or following the device manufacture. For instance, the regents may be inserted into the chambers while the device is in a pre-use storage position (when the chambers are entirely enclosed/sealed by six walls) through a port  83  which may be later sealed. Such a port  83  may be in the side exterior wall of the reagent chamber component  70  or other cap component. 
     In a further alternative embodiment of the diagnostic test device  10 , the device may allow for the use of a separately manufactured swab component  20 . For instance, the device may include a seal enclosing the opening of the barrel component end  65  (seal not shown) so as to maintain a sterile environment within the device. Such a seal may be manufactured from a polymeric film, or metallic foil for example. During insertion of a separately manufactured swab component  20 , the seal may be broken so as to allow the passage of the swab  20  through the barrel component  60  and into the reagent chamber component  70 , as previously described. 
     In still a further alternative embodiment of the diagnostic test device  10 , the swab  26  may be part of a separate endoscopic device, such as those endoscopic devices described in U.S. Pat. Nos. 4,700,694 and 5,146,928 and which are each incorporated by reference herein in their entirety. After an endoscopic swab is passed over desired tissue, it may be withdrawn into the endoscope, as with a forceps, snare, basket or brush, and then removed from a patient. The swab  26  may then be inserted into the diagnostic test device  10  as previously described, to provide for an immediate analysis of specific patient conditions. 
     In one such embodiment, a swab may be positioned with a swab cover at the end of a catheter. The catheter would be designed to be fed through the endoscope as with the previously described biopsy sample collection tools. The cover could be removed and the swab could be fed into the gut or colon for example. The desired tissue could then be swabbed to collect the organism/specimen of interest, and then the swab could be retrieved along with the catheter from the endoscope. For example, such a swab and diagnostic testing device could be utilized to test for the presence of H. Pylori (as part of an ulcer determination). 
     In performing a diagnostic test utilizing the diagnostic test device  10 , multiple steps of testing common to those devices of the prior art, have been reduced to two steps, those being sample collection and testing. Essentially, the mixing of test solutions and exposure of the specimen sample to a test strip has been combined into a two step operation. 
     In actual operation, the user of the diagnostic test device  10  is desirably provided with the device in a pre-use storage position (as seen in FIGS.  3 A and  6 B). Essentially, in the pre-use storage configuration, the swab component  20  (if a predesigned swab is contemplated) is held within the cap component  35 , the combination of which is desirably held in a hermetically sealed/sterile environment. In this configuration, if the cap components each include a flat outer surface, the flat surfaces of the barrel  60  and results window components  40  are aligned, while the flat surface of the reagent chamber component  70  is aligned with the windows  48  of the results window component  40 . Alternatively, the swab component  20  may be stored separately from the cap component  35 , each within a hermetically sealed sterile environment, such as a shrink-wrapped container (not shown). 
     It should be recognized, that in lieu of a flat outer side for alignment purposes, the device may include an alternative marking arrangement, such as a colored line or design element on these outer surfaces. As long as the reagent chamber component  70  marking (i.e. whether coloration, pattern, symbol, textured or flat surface) is not initially aligned with the same marking on the adjacent barrel and results window components,  60  and  40  respectively, the reagent chamber(s)  76  contained within the reagent chamber component  70  will be sealed either by walls within the reagent chamber component  70  itself in combination with the outer surface of the U-shaped core  50 , or in conjunction with the three walls within the reagent chamber component  70  and the additional side chamber walls provided by the thicker adjacent interior walls of the barrel component  60  and results window component  40  along with the outer wall of the U-shaped core  50 . The reagent chamber(s)  76  will be closed with respect to the testing chamber  73 . This configuration keeps the various reagents from mixing, as well as prevents contact of the reagents/test solutions with the elongated test strip  69  prior to use. 
     The swab component  20  is then either removed from the diagnostic test device cap component  35  and used to swab the environment to be tested, or removed from its own sealed packaging and used to swab. The swab component  20  is then inserted/reinserted into the cylindrical housing cap component  35 . The swab component  20  is inserted so that it desirably locks into place by the circumferential ridge/flange (interlocking mechanism)  63 , thereby reducing exposure of the user to any potential organisms contained on the swab  26 , and preventing the leakage of reagent/test solutions. Upon insertion into the cap component  35 , the swab  26  will be directed through the elevated collar structure  71  (if present) to the specimen sample shelf  58 . In pushing the swab component  20  into the cap component  35 , the swab  26  will move into the cap until it comes to rest upon, or immediately adjacent the test strip  69 , which is laying on the specimen sample shelf  58 . The rotatable portion of the cap (the rotatable portion of the reagent chamber component  70 ) is then rotated such that the outer flat side  77  (or marked side) of the reagent chamber component  70  is aligned with the outer flat sides (i.e.,  61  and  43 ) of the adjacent barrel and results window components  60  and  40 . As an alternative, the reagent chamber component  70  may include a tab or breaking mechanism in its rotational mechanics such as to require that the rotation stops in the designated position. At this position in the rotation, as represented by the arrow  59  in FIG.  3  and  FIG. 4 , the rounded sides of the reagent chamber component  70  become aligned with the respective rounded sides of the adjacent cap components. The reagent chambers  76  are essentially moved from a closed to an open position with respect to the testing chamber  73 . 
     The testing solutions/reagents contained in the reagent chambers  76  are dropped via gravity, into the testing chamber  73  and onto the swab  26  and underlying test strip  69 . The paths of the reagents are indicated by arrow  93  in FIG.  5 . It is therefore desirable that the diagnostic test device  10 , be held in a relatively horizontal/level orientation with the viewing windows  48  facing upward. The rotatable reagent chamber component  70  desirably finishes its rotation in a position in which the outer flat side  77  is aligned with the adjacent flat sides of the adjacent cap components, such that the device can desirably sit in a stable position on a horizontal flat surface without the risk of rolling along the surface, or being tipped over. 
     This directed dropping of reagents (in the testing/use position) causes the reagents to mix on the swab  26  and subsequently onto the underlying elongated test strip  69 . The test results generated by the various reagents will then wick/laterally flow up the test strip  69 , such that the end result appears in the viewing windows  48 . The test results may be the presence of a color change or indicator which appears on the test strip and which can be observed through the viewing windows  48 . Alternatively, the result can be a positive or negative indicator or a value/numerical indicator. It should be recognized that one or more viewing windows may be utilized in the results window component  40  as previously described. If a control window is utilized, the user may at this time also view a control reading, indicative of normal operation of the diagnostic test device  10 . Following reading of the test results, the entire diagnostic test device  10  can be discarded. 
     As a result of the sealing ridge or other interlocking mechanism around the inner surface of the barrel component  60  and swab component  20 , the cap is desirably liquid tight, thereby preventing release of the reagents or microorganisms contained on the swab  26  during disposal of the device. In this fashion, premeasured reagents/testing solutions are safely employed within the testing device, without risk of contamination of either the user, the surrounding environment or leading to the inadvertent initiation of the test. 
     Examples of various reagents which may be used to detect and identify microorganisms include one or more of various well known test reagents. Such reagents may be present in either liquid or solid/powder form. The particular test reagent used may be chosen on the basis of the particular type of microorganism species being identified or tissue cells being tested. For instance, commercially available reagents may be used. In one embodiment, a test reagent such as N,N,N,N tetra methyl-p-phenylenediamine dihydrochloride may be used for detecting gonorrhea. Other test reagents such as dimethyl amino-cinnaminaldehyde, beta d galactosidase substrates, gamma glutamylamino peptidase and prolylamine peptidase may also be used for detecting specific species of the genus  Neisseria . Further test reagents may include, but are not limited to, hippuric acid for detecting Group B  Streptococcus , L-pyrrolidonyl beta naphthylamide and esculin for detecting Group A  Streptococcus , and acid or mineral acids, such as citric, acetic, and hydrochloric acid and sodium nitrite, for detecting Group A  Streptococcus  antigen. In still a further embodiment, reagents such as those described in U.S. Pat. Nos. 4,748,113, 4,830,010, and WO 95/11672 (each incorporated by reference herein in their entirety) may be used to detect the presence of urease on a gastrointestinal swab inserted into the diagnostic test device  10 . For instance, a urea reagent may be used as a first reactant to generate ammonia on the test strip, in the presence of urease from the swab. A color indicator reagent may also be employed to create a color change on the test strip, based on an increase in pH resulting from the generation of ammonia. 
     In another example of the diagnostic test device  10 , the device may be used to perform a strep organism identification test. In such a test, the back of a patients throat is swabbed in a normal manner and the swab  26  is inserted within the cap component  35 , such that the swab  26  comes to rest upon the specimen sample shelf  58 , or is situated above/immediately adjacent the test strip  69 . The swab component  20  is locked in place via the swab and cap component interlocking system. An elevated collar structure  71  on the barrel component  60  helps direct any strep materials to the test strip  69 . The reagent chamber component  70  has within its multiple chambers  76  the reagents citric or acetic acid, and in a second chamber, either sodium nitrite or a similar nitrite compound. The cap component, or more specifically, the reagent chamber rotatable component, is rotated so as to dump the two chambers into a mixed stream over the swab  26 . The reagent solution mix is allowed to react with the specimen sample contained on the swab  26  and come into contact with the test strip. 
     The test strip  69  may comprise a porous paper-based element impregnated at predetermined points with additional agents such as a neutralizing buffer. An example of such a buffer includes trishydroxy-methylaminomethane (TRIS), for reacting with the treated specimen to yield a first color change indicating the presence of strep organism, or a second color change indicating the absence of strep organism. After a short period of time, the user of the diagnostic test device  10  can view the test results through the viewing windows  48 . Following the viewing of the results, the user can either bring the diagnostic test device  10  to his/her medical practitioner, or alternatively can dispose of the device, through acceptable medical waste disposal methods. 
     As will be appreciated by those skilled in the art, changes and variations to the invention are considered to be within the ability of those skilled in the art. Such changes and variations are intended by the inventors to be within the scope of the invention.