Abstract:
A specimen collection and testing unit is provided for use in the collection, exact volume extraction and delivery of said exact volume for testing with a reagent. The specimen collector may include a scoop/mechanism having a flexible head that flips from a concave shape (for scooping specimen) to a convex shape to ensure the exact amount of specimen is being treated.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application claims the benefits under 35 U.S.C. § 119(e) of U.S. Provisional Application No. 60/800,273 filed May 15, 2006, titled STOOL SPECIMEN COLLECTION AND TESTING APPARATUS, in the name of Kenneth A. Alley.  
         [0002]     U.S. Provisional Application No. 60/800,273 filed May 15, 2006, is hereby incorporated by reference as if fully set forth herein. 
     
    
     FIELD OF THE INVENTION  
       [0003]     This invention relates generally to a specimen collection and testing apparatus and, more particularly, to a specimen collection and testing apparatus having an integrated specimen volume control and dispensing mechanism.  
       BRIEF DESCRIPTION OF THE PRIOR ART  
       [0004]     Specimen collection devices are well known in the industry. These include stool specimen collection tubes, containers, vials and/or swabs that may incorporate reagents and dispensing means. With a typical specimen collection apparatus, a collection container is given to a patient for stool samples. The patient fills the container with a specimen then returns the collection container to the laboratory. The specimen is then tested in the laboratory.  
         [0005]     Typically, the technician opens the container and removes a small portion of the specimen, placing the specimen into a test tube to perform various types of tests. In some cases, the test assays require a very specific amount of specimen to be tested. The lab technician must weigh the specimen or use precision equipment to measure the exact amount of the required specimen before he began testing the specimen.  
         [0006]     In addition to collection containers returned to a lab, there are a number of specimen test kits that include reagents and dispensers. These kits typically provide a swab that mixes with a reagent. For example, U.S. Pat. No. 5,879,635 describes a “reagent dispenser and related test kit for biological specimens.” The &#39;635 patent discloses the use of a swab along with reagents. The swab is used to collect a specimen such as stool, and by breaking the membrane a reagent is mixed with stool sample for later dispensing. Another example is U.S. Pat. No. 5,266,266 which describes a specimen test unit. This particular device also discloses the use of a swab along with some reagents. The swab is used for collecting a selected specimen for later testing and dispensing.  
         [0007]     There are numerous tests that require a specific or predetermined amount of specimen, and therefore the lab technician needs to handle the specimen in order to weigh it or measure it to perform the test. Needless to say, handling these biological specimens is undesirable and great caution must be used.  
         [0008]     As previously mentioned, both of the aforementioned patents provide a swab that is incorporated into a tube along with the reagent. In some cases, the technician may simply dispense the reagent/specimen sample to perform a test. Although, in many cases the testing assays require a predetermined and or a specific amount of specimen in order to perform the biological test. The prior art does not provide the ability to precisely control the amount of specimen collected, therefore, these devices cannot be used for a test where a quantitative sample is required. Such a test requires well-trained technicians to handle the specimens and perform the test.  
         [0009]     Additionally, there are numerous biological tests that could be performed by a consumer, thus lowering the cost of medical care if there was a device that had the ability to accurately control the specimen collected with the given a reagent. In order to sell over-the-counter biological testing devices, they must be deemed easy to use and have the ability to meet specific guidelines, with regard to function simplicity and accuracy.  
       SUMMARY OF THE INVENTION  
       [0010]     The testing apparatus includes the means to control a predetermined or required amount of specimen for specific test. The collection and testing apparatus includes an upper section and a lower section. The upper section is designed to receive a specimen by utilizing a scoop, applicator and or a specialized plunging/scoop mechanism. The lower section is designed to incorporate a reagent and or reagents. Between the upper section, and the lower section of the apparatus, there is a port which is designed to receive an interchangeable plug. The plug is designed to close off the lower section from the upper section and simultaneously communicate with both the upper and lower sections. Specifically, the specialized plug incorporates a cavity (predetermined volume) that is mated with the upper section of the apparatus. When a specimen is put into the upper section of the apparatus, the predetermined cavity on the plug will be filled with a predetermined and controlled amount of the specimen. The specialized plunging mechanism will force any type of solid specimen into the cavity thus assuring that the cavity of the plug is filled appropriately. The specialized plug may then be rotated or moved to align the cavity containing the specimen adjacent to the lower section, thereby mixing the specimen with a reagent. The lower section of the device may include a dropper tip for dispensing the controlled test portion mix (specimen/reagent) required for a specific test.  
         [0011]     The subject invention provides the means to precisely control the amount of specimen required for any given test. The invention also provides a collection device with means to isolate and mix a predetermined amount of specimen with a reagent and dispense it without having to re-open the collection container. More specifically, the following invention is a Specimen Collection and Testing Apparatus with an Integrated Specimen Volume Control and Dispensing Mechanism which is designed to be used in both vivo and vitro environments.  
         [0012]     The present invention is a collection and or testing apparatus which includes an integrated and interchangeable specimen volume control means and a reagent/specimen dispensing mechanism. The testing apparatus includes the means to control a predetermined amount of a specimen for specific test. The collection and testing apparatus may include an upper section and a lower section. The upper section is designed to receive a specimen by utilizing a scoop, applicator and or a specialized plunging/scoop mechanism. The lower section is designed to incorporate a reagent and or reagents. Between the upper section, and the lower section of the apparatus, there is a port which is designed to receive an interchangeable and rotatable (i.e., movable) plug. The specialized plug is designed to close off both; the interior openings of the lower section from the upper section and simultaneously communicate with both the upper section and lower sections. Specifically, the specialized plug incorporates a predetermined cavity that is mated with the upper section of the apparatus. When a specimen is put in the upper section of the apparatus the predetermined cavity on the plug will be filled with a predetermined and controlled amount of the specimen. The specialized plunging/scoop mechanism will force any types of solid/liquid specimen into the cavity thus assuring that the cavity of the plug is filled appropriately. The specialized plug may then be rotated or moved to align the cavity with the adjacent or lower section, thereby mixing the specimen with a reagent. The lower section of the device may include a dropper tip for dispensing the controlled test portion required for specific tests. The dropper tip in the lower section could be replaced or adapted to fit a testing cassette or other devices which may be desired (such as a swab, a test cassette with test strips etc).  
         [0013]     The apparatus disclosed herein could be used as a collection device, testing device, or any combination, depending on the particular application. One of the applications would be to make a test specific device, thus, providing the entire test platform, via assay, in a single device which may be used over the counter, and/or in a laboratory environment.  
         [0014]     The subject apparatus is especially well-suited for use as a (stool or specimen) collection container. Typically, stool collection containers include a container and a scoop. The patient collects a stool sample and sends it to the physician&#39;s office and/or laboratory where it is later tested for various pathogens and/or agents. A lab technician must then open the container and utilizing another applicator and/or swab, remove a portion of the specimen to be tested. As previously mentioned, some tests require specific amounts of specimen to be utilized. Therefore, the technician would need to weigh it or precisely measure the specimen. (Note: tests that require precise and or specific amounts of a specimen are typically deemed to be too complicated for public use and therefore are not usually sold over-the-counter.)  
         [0015]     If the present apparatus (invention) were used in place of standard collection containers, the interchangeable, predetermined plug cavity could be adapted to the apparatus for specific tests prescribed by the physician. When the technician is ready to perform the test, they simply rotate and/or move the interchangeable plug to align the cavity containing the measured specimen with the adjacent chamber. The adjacent chamber could include a reagent and or reagents that would automatically mix with the specimen. The specimen-reagent mix could then be dispensed into test cassettes or other test platforms. The adjacent chamber could also remain empty so that the technician could use it for any numerous tests that are later to be determined. In this case, the technician would never need to open the apparatus, but instead simply rotate or manipulate the movable plug to an adjacent chamber. With slight modifications, the described apparatus could be adapted to existing specimen collection containers such as stool collection containers and blood vacuum tubes. There are numerous applications for such an apparatus, including but not limited to biological (saliva, urine, stool, etc) and environmental testing.  
         [0016]     One of the main benefits of the described apparatus is that the plug can be interchanged with alternate plugs that incorporate different volume cavities. This feature would allow the device to be used for specific platforms (by color coding the plugs during manufacturing for different uses). The plug could also be used as a bypass (open/closed) closing off the upper section from the lower section and when desired, by manipulating the plug (opening) so that the upper section may communicate directly with the lower section thereby, mixing multiple reagents and/or specimens. The plug cavity could also be designed to incorporate reagents.  
         [0017]     Another important feature of the present apparatus is that either the upper and/or lower sections could be adapted to incorporate various types of applicators including a swab with and/or without a dropper. A typical test cassette could also be incorporated into either section of the apparatus.  
         [0018]     The described apparatus could also include a plug with multiple cavities adjacent to one another, and multiple lower sections. The cavities in the lower sections may or may not be isolated from one another. That would depend on the particular application. Although, the described apparatus includes an upper section, along with the lower section, it is conceivable that there are applications where the lower section is replaced with an adjacent section and the movable interchangeable plug is pushed (or twisted) horizontally instead of rotated (moving the cavity vertically). This particular configuration could be adapted as a top cover for a typical test cassette. There are numerous combinations and/or configurations that could be incorporated in to the described invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0019]     The foregoing summary, as well as the following detailed description may be better understood when read in conjunction with the accompanying drawings, which are incorporated in and form a part of the specification. The drawings serve to explain the principles of the invention and illustrate embodiments of the present invention that are preferred at the time the application was filed. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.  
         [0000]     In the drawings:  
         [0020]      FIG. 1  is an isometric view of a specimen collection and testing apparatus in accordance with the present invention. In this particular view the plunging/scoop mechanism is only partially seated in the device.  
         [0021]      FIG. 2A  is an exploded side view of the special plunging/scoop mechanism. Additionally, the plug is shown with the cavity aligned with the upper section of the apparatus. In this particular view the plunging/scoop is in a static position. When the closure of the upper section is completely tightened, the plunger/scoop will be flexed from its concave shape towards more of a convex shape thus, remaining in a dynamic position as shown in  FIG. 2B .  
         [0022]      FIG. 2B  is an exploded front view of the plunging mechanism and the plug cavity feature of the device. In this particular view, the plunging/scoop mechanism is pushed completely downward (in a dynamic position). In this particular view, the cavity of the plug is filled with the specimen and the excess specimen is shown in the upper chamber displaced around the plunging/scoop mechanism.  
         [0023]      FIG. 3  is a perspective isometric view of an alternative embodiment of a specimen and collection and testing apparatus in accordance with the present invention. In this particular design, the movable plug communicates with the upper and lower section of the apparatus by moving horizontally. Instead of rotating the plug, as in  FIG. 1 , this particular plug is designed to move horizontally thus, communicating with both upper and lower sections of the apparatus.  
         [0024]      FIG. 4  is an isometric view of an alternative apparatus. In this particular design, the rotate able or movable plug is designed to move horizontally by twisting the plug. Similar to the apparatus in  FIG. 3 , the upper section and the lower sections both have respective openings that are designed to communicate with a plug, although, in this case the plug is aligned to the respective openings by mechanically being rotated or twisted horizontally.  
         [0025]      FIG. 5  is a perspective exploded side view of the specialized plug with the cavity (predetermine volume) described in the apparatus of  FIG. 1 . The plug incorporates a cavity with a predetermined volume control that is designed to be filled with a specimen. As described in the apparatus of  FIG. 1 , the specimen will be compressed into the cavity of the plug. When the plug is rotated within its port or housing, the excess specimen is wiped clean from the surrounding areas. Once the cavity is positioned or aligned to the lower chamber, the contents of the cavity will be exposed to the contents of the lower section of the apparatus. In this position the desired testing can take place.  
         [0026]     Additionally, the apparatus described in  FIG. 1  could incorporate multiple cavities (each of a predetermined volume). Once the plug is rotated, the multiple cavities would simultaneously be repositioned from one chamber to a secondary chamber. The secondary chamber could also include multiple chambers isolated from one another. Each of these chambers may include reagents unique to a specific test.  
         [0027]      FIG. 6  represents a side view of an alternative plug. In this particular example, the plug is designed to be pushed horizontally. This particular plug also includes a cavity (which also provides a closed off position) and it includes an open bypass. This particular plug could be utilized for blood collection tubes. More specifically, if a blood vacuum tube incorporated such a plug feature, the plug could be used to isolate blood serum from the blood cells. Some of these applications will be discussed later.  
         [0028]      FIG. 7  is a front view of the apparatus described in  FIG. 1 . In this particular illustration, the plunging/scoop mechanism has been replaced with a swab or spooned style scoop and the lower section is open ended and can be used to be adapted to additional devices. This particular configuration could be used to replace the existing stool collection containers. A patient would fill the chamber with a specimen and send it to the physician&#39;s office. All the physician or technician would need to do, is rotate the plug with the cavity (predetermine volume) to access the specimen for testing.  
         [0029]     It should be noted that, after reading the present disclosure, a person skilled in the art could adapt certain novel features of the present invention into existing stool collection containers. By incorporating the plug/port and cavity feature/mechanism into a closure along with the plunging mechanism, a typical stool collection container could be utilized to take advantage of the invention described in  FIG. 1 .  
         [0030]      FIG. 8  is an alternative concept of a diagnostics swab/applicator holder and dispenser. The unique feature of this diagnostics swab/applicator is that the applicator includes a dropper tip dispenser within the swab handle. Unlike existing swab applicators this particular applicator incorporates a dropper tip that becomes the swab or applicator holder. It also may include a moldable filter and an over cap (or one piece flip top cap) that seals the entire contents of the swab and the test tube (or device) that it is adapted to. One of the unique benefits of this design is that the diagnostic swab applicator in  FIG. 8  could be incorporated onto a closed-end test tube and still provide the means to dispense the specimen without removing the applicator after its been contaminated with a specimen.  
         [0031]     The diagnostic swab/applicator holder and dispenser described in  FIG. 8  could also be incorporated and or adapted to the described invention. The apparatus shown in  FIG. 7  could include the “diagnostic swab applicator holder and dispenser” onto the lower section and or the upper section of the device. This particular design could be incorporated into numerous devices.  
         [0032]     The prior art applicator or swab holders do not have the ability to also dispense the specimen. For example: as previously mentioned in U.S. Pat. No. 5,879,635 which describes a “reagent dispenser and related test kit for biological specimens” the applicator or swab holder does not incorporate means to dispense the specimen and reagent mix. In order to dispense the specimen mix there is a dropper tip at the opposite end of an open ended tube. The alternative concept described in  FIG. 8 , would provide the means to dispense the specimen/reagent mix through the applicator holder and could be adapted to closed-ended test tubes that are commonly used today, or the concept could be adapted to the apparatus described in this invention.  
         [0033]      FIG. 8B  is an alternative concept of a dispenser/closure with a swab/applicator holder and a molded filter. The unique feature of this dispenser is that it includes a molded filter that communicates with an applicator to control the diameter of the dispensing exit port. It also holds and aligns the applicator (or diagnostics swab/applicator).  
         [0034]      FIGS. 9, 10 ,  11 ,  12  are perspective front views of and alternative application of the apparatus described in  FIG. 1 , where the apparatus is used as a blood vacuum tube. Typical blood vacuum tubes are used to drawl the blood out of the person&#39;s veins. Once the blood is drawn, the blood serum is typically separated from the blood cells by using a centrifuge. One of the problems is that the serum does not stay separated from the blood cells for long periods of time. There are density barriers that are added into typical blood tubes, although these are not permanent either. By incorporating the plug described in  FIGS. 9, 10 ,  11  and  12  the upper section of the blood vacuum tube apparatus could be closed off from the lower section of the after the blood serum is separated. The plug in  FIGS. 9 and 10  are designed to be pushed horizontally and the plug described in  FIGS. 11 and 12  are designed to be rotated. 
     
    
       [0035]     Another added advantage of incorporating a movable plug into vacuum tube containers is that there are numerous analytical analyzers/equipment that could automatically access the upper section of the container. By incorporating a small cavity into the plug along with a bypass, a needle can enter through the upper section and retrieve a specified amount of specimen to be tested. Additionally, by incorporating a plug and transfer mechanism for use with vacuum tubes there would be no need to pour off the serum specimen into alternative tubes and it would be less likely mix up or lose the specimen containers. Also, by incorporating the movable plug with either a bypass and/or cavity into the vacuum tube, the original sample is always available when needed. And there is no need to pour off serum samples into additional containers. This could provide a cost savings and a logistical advantage in handling specimens.  
       DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0036]     Referring now to  FIG. 1 , an isometric view of the described claimed invention/apparatus is shown. Specimen collection and testing apparatus  10  includes an upper section  14 , and lower section  9 . It will be appreciated that certain terms (e.g., upper, lower, left and right) are used when viewing the drawings for the sake of clarity and are not meant to be taken literally). Between the upper and lower section of apparatus  10 , there is a receptacle  5  that is designed to receive a plug  6 . Receptacle  5  includes opening  18  to the upper section  14 , and opening  8  to the lower section  9 . The specialized plug  6  is designed to close off upper section  14 , from lower section  9 . Additionally, plug  6  is designed to communicate with both the upper section  14  and lower section  9  of the apparatus  10 . Plug  6  includes cavity  7  (with a predetermined volume control). When plug  6  is placed into receptacle  5 , cavity  7  is aligned with the upper section  14  and frictionally sealed with the upper opening  18  of receptacle  5 . Simultaneously, the lower section opening  8  of receptacle  5  is also closed and frictionally sealed off from lower section  9 .  
         [0037]     Apparatus  10  also includes a dispensing tip  12  and an outer cover or closure  11 . The upper section of device  10  is adapted to receive closure  2 . Closure  2  includes applicator shaft  3  and plunging scoop mechanism  4 . The plunging/scoop mechanism  4  is designed to perform two functions, first it is used to collect a specimen; and second, it is designed to deliver the specimen into the upper section  14  and eventually compress a portion of the specimen into cavity  7 . Plunging/scoop mechanism  4  may be made of a flexible material, such that the flexible plunging/scoop mechanism may be concave shape as illustrated in  FIG. 2A , to scoop up a stool specimen, and then flips to a convex shape to ensure the compression of the specimen into cavity  7 , as illustrated in  FIG. 2B .  
         [0038]     For example, when the specimen is placed into upper section  14  of apparatus  10  and the closure  2  is securely attached to the upper section&#39;s open end, the plunging/scoop mechanism  4  will be forced downward thus, compressing the specimen between the plunging/scoop mechanism and into the aligned cavity  7  of plug  6 . The plunging/scoop will be flexed from a concave shape to a convex shape and will be fully seated against the bottom of the upper section  14  once the closure is completely attached to apparatus  10 . As a result of this action, cavity  7  of plug  6  will be filled with a predetermined and controlled amount of the specimen. Note: The specialized plunging/scoop will force any type of solid/liquid specimen into cavity  7  thus; insuring that cavity  7  is filled appropriately. Any excess specimen will be vented around the plunging scoop (i.e., towards the closure  2 ). Depending on the specimen, additional venting could be adapted to the device.  
         [0039]     Plug  6  may be adapted with a finger grip  17  or a slot  51  for receiving a flat-head screwdriver. The finger grip  17  or screwdriver slot assists a user in rotating the plug once the specimen has been compressed into cavity  7 . Once the cavity  7  is filled with the specimen, plug  6  may then be rotated or moved to align cavity  7  with the adjacent or lower section receptacle opening  58 , thereby mixing the specimen with a reagent that may be stored in the lower section  9 .  
         [0040]     The lower section may include a dropper tip  12  for dispensing the controlled test portion required for specific tests. The dropper tip in the lower section could be replaced, or adapted to fit a testing cassette or other devices which may be desired such as, the swab described in  FIG. 8 . It is important to note that plug  6  prevents any reagent from escaping into the upper compartment and simultaneously prevents any additional specimen from entering the lower compartment.  
         [0041]      FIGS. 2A and 2B  illustrate an exploded side view of the plunging/scoop mechanism  4 . Additionally, the plug  6  is shown frictionally engaged into receptacle  5  with cavity  7  aligned with the upper section of the apparatus. Plug  6  closes off or isolates the lower section from the upper section.  
         [0042]     In  FIG. 2A , the plunging/scoop  4  is in a static position. When closure  2  is completely tightened, the plunger/scoop  4  will be flexed from its concave shape towards more of a convex shape thus, remaining in a dynamic position as shown in  FIG. 2B .  
         [0043]     Referring again to  FIG. 2B , the scoop mechanism  4  is shown in its convex position. Plug  6  is still in its initial state in which cavity  7  is in position to receive the specimen. In this particular view, the plunging/scoop mechanism  4  is pushed completely downward (in a dynamic position). Cavity  7  is filled with the specimen  13  and the excess specimen is shown in the upper chamber displaced around the plunging/scoop mechanism. The plunging/scoop mechanism  4  is also fully seated against the upper receptacle opening  18  thus, sealing and compressing the specimen within cavity  7 .  
         [0044]     Referring now to  FIG. 3 , a perspective view of another embodiment in accordance with the present invention. Apparatus  30  includes upper section  31  and lower section  35 . In this particular design, the movable plug  33  communicates with the upper and lower section of the apparatus via cavity  32 . The size of well  32  determines the amount of specimen to be tested, (i.e., cavity  32  is analogous to cavity  7  of plug  6 ). Lower section  35  is substantially closed at the end proximate plug  33 , except for opening  39 . When a specimen is placed into the upper section  31 , plug  33  closes off upper section  31  from lower section  35 . When plug  33  is moved horizontally, well  32  aligns with opening  39  thereby plug  33  transferring the specimen within the well to the lower section  35 . Instead of rotating the plug, as in  FIG. 1 , this particular plug is designed to move horizontally thus, communicating with both upper and lower sections of the apparatus.  
         [0045]     Referring now to  FIG. 4 , an isometric view of another preferred embodiment is shown. Apparatus  40  includes upper section  41  and lower section  45 . In this particular design, a movable plug  43  communicates with the upper and lower section of the apparatus  40 . When a specimen is placed into the upper section  41 , plug  43  closes off upper section  41  from lower section  45 . In this embodiment, lower section  45  is closed proximate the plug  43  except for opening  39 . When plug  43  is twisted in a circular motion horizontally (similar to a lipstick tube), plug  43  transfers the specimen within its cavity  42  to align with opening  39  deliver the specimen to the lower section  45 . Similar to the apparatus in  FIG. 3 , the upper section and the lower sections both have respective openings that are designed to communicate with a plug, although, in this case the plug is aligned to the respective openings by rotating the plug radially (twisting in the horizontal plane).  
         [0046]     Referring to  FIG. 5 a  perspective exploded side view of the specialized plug  6  described in the apparatus of  FIG. 1  is shown. Plug  6  incorporates cavity  7  (with a predetermined volume control) which is designed to be filled with a specimen. As described in the apparatus of  FIG. 1 , the specimen will be compressed into cavity  7  of the plug. When the frictionally sealed plug  6  is rotated within its receptacle (or housing)  5 , the excess specimen is wiped clean from the surrounding areas. Once the cavity is positioned or aligned with the lower (or an adjacent) section, the contents of the cavity will be exposed to the contents of the lower section of the apparatus. In this position the desired testing can take place.  
         [0047]     Additionally, plug  6  could incorporate multiple cavities (each with predetermined volumes). Once the plug is rotated, the multiple cavities would simultaneously be repositioned from one chamber to a secondary chamber. The secondary chamber could also include multiple chambers isolated from one another. Each of these chambers may include reagents unique to a specific test.  
         [0048]     The testing apparatus is accordance with the present invention can be shipped with different plugs  6 , each having a different size well. The selection of plug  6  will be determined by the type of test. The manual manipulation of the plug  6  along with a pre-determined sized well  7  will deliver a precise amount of specimen to the secondary chamber.  
         [0049]     Referring to  FIG. 6 , a side view of an alternative plug is shown. In this particular example, the plug is designed to be pushed horizontally. This particular plug also includes cavity  62  (which can also be used as a shut off feature) and an open bypass  63 . This particular plug could be utilized for blood collection tubes. More specifically, if a blood vacuum tube incorporated such a plug feature, the plug could be used to isolate blood serum from the blood cells.  
         [0050]     Referring to  FIG. 7 , a front view of an alternative apparatus is described. In this particular illustration, apparatus  70  includes closure  72 . The plunging/scoop mechanism described in  FIG. 1 , has been replaced with a swab or spooned style scoop  75 . The lower section is open-ended and incorporates attachment means  74  that can be used to connect additional devices to apparatus  70 .  
         [0051]     By replacing swab  75  with the plunging/scoop mechanism  4  described in  FIG. 1 , this particular configuration could be used to replace the existing stool collection containers. For example, a patient would fill the upper chamber  73  with a specimen. The plunging scoop mechanism described in  FIG. 1 , would fill cavity  77 . The entire specimen container could then be sent to the physician&#39;s office. The physician or technician would need only rotate plug  76  transferring the specimen to the open-ended section  78  providing access for further testing.  
         [0052]     U.S. Pat. No. 5,266,266 to Mason and U.S. Pat. No. 5,879,635 to Mason are hereby incorporated by reference as if fully set forth herein.  
         [0053]     There are numerous configurations that could be incorporated into an alternative device. The upper section could be used for receiving a solution or storing a reagent and the lower section could be used to obtain a sample specimen by means of a swab or applicator. By interchanging components in either the top section or lower section, along with various types of plugs, the apparatus could be used for numerous applications.  
         [0054]     Additionally, the invention described in  FIG. 1 , could be adapted to fit onto existing stool collection containers. By incorporating the plug/port and cavity feature/mechanism into a closure along with a plunging mechanism, a typical stool collection container could be utilized to take advantage of the invention described in  FIG. 1 .  
         [0055]      FIG. 8A  discloses another embodiment in accordance with the present invention. In this Figure, a diagnostics swab/applicator holder is shown. A unique feature of the diagnostics swab/applicator  80  is that the applicator includes a dropper tip dispenser  84 . Applicator  80  may also include a moldable filter  81  and swab connector  82  (where a typical swab  83  may be frictionally fit). Closure  85  hermetically seals the entire contents of the swab (with or without a specimen) and the test tube (or device) that it is adapted to. One of the unique benefits of this swab/applicator design is that the diagnostic swab/applicator could be incorporated onto a closed-end test tube.  
         [0056]     The diagnostic swab/applicator holder and dispenser described in  FIG. 8A  could be incorporated and/or adapted to the described invention in  FIG. 1 . Additionally, the apparatus shown in  FIG. 7  could include the “diagnostic swab/applicator  80  onto the lower section and/or the upper section of the device.  
         [0057]      FIG. 8B  is an alternative embodiment of a dispenser tip and closure (one piece system) with a swab/applicator holder and a molded filter. The unique feature of this dispenser/closure is that it includes a molded filter  86  and  87  that extends inward towards the center of the dispensing tip gradually getting smaller. This filter communicates with an applicator (if one is used) to control the diameter of the dispensing exit port. It also holds and aligns the applicator (or diagnostics swab). If an applicator is inserted into the molded filters diameter, the filter gives way to frictionally hold it in place. Depending on the size of the applicator the filter will have to give way more, with respect to a larger applicator. The larger the filter gives the larger the particles may pass through. At the lower section  87 , of the molded filter there is a taper to help align the applicator during insertion. The minimum size filtered exit port would be if no applicator was used and then the further the filter was distorted the larger the opening.  
         [0058]     The prior art applicators or swab holders do not have the ability to also dispense the specimen. For example, as previously mentioned in U.S. Pat. No. 5,879,635 which describes a “reagent dispenser and related test kit for biological specimens” the applicator or swab holder does not incorporate means to dispense the specimen and reagent mix. In order to dispense the specimen mix there is a dropper tip at the opposite end of an open ended tube. The alternative concept described in  FIG. 8 , would provide the means to dispense the specimen/reagent mix through the applicator holder and could be adapted to closed-ended test tubes that are commonly used today, or the concept could be adapted to the apparatus described in this invention.  
         [0059]      FIGS. 9, 10 ,  11 ,  12  are perspective front views of and alternative application of the apparatus described in  FIG. 1 , where the apparatus is used as a blood vacuum tube. Typical blood vacuum tubes are used to drawl the blood out of the person&#39;s veins. Once the blood is drawn, the blood serum is typically separated from the blood cells by using a centrifuge. One of the problems is that the serum does not stay separated from the blood cells for long periods of time. There are density barriers that are added into typical blood tubes, although these are not permanent either. By incorporating the plug described in  FIGS. 9, 10 ,  11  and  12  the upper section  91  of the blood vacuum tube apparatus could be closed off from the lower section  96  after the blood serum is separated from the whole blood. Plug  93  shown in  FIGS. 9 and 10  are designed to be pushed horizontally and plug  94  described in  FIGS. 11 and 12  are designed to be rotated.  
         [0060]     Another added advantage of incorporating a movable plug feature into vacuum tube containers, is that there are numerous analytical analyzers/equipment that could automatically access the upper section of the container. By incorporating a small cavity  98  into plug  93  along with bypass  99 , an extraction needle can enter into the upper section of the vacuum tube and retrieve a specified amount of specimen to be tested. Additionally, by incorporating a plug and transfer mechanism for use with vacuum tubes there would be no need to pour off the serum specimen into alternative tubes and it would be less likely to mix up or lose the specimen containers. Also, by incorporating a movable plug  94  with either a bypass and/or cavity into the vacuum tube, the original sample is always available when needed and there is no need to pour off serum samples into additional containers. This could provide a cost savings and a logistical advantage in handling specimens.  
         [0061]     Referring to  FIGS. 9 and 10 , a specimen container or blood vacuum tube is shown where the red blood cells  95  are separated from the serum  92 . At the lower end, there is an expandable closure  97  that may be manually pushed inward forcing the serum through the open bypass in plug  93  and into the upper section  91 . Once the serum is in the upper section of the container, the plug may be moved horizontally to shut off the upper section from the lower section. In  FIGS. 11 and 12  plug  94 , also includes cavity  98  (which can also be used to close the upper section from the lower section) and open bypass  99 .  
         [0062]     Referring to  FIG. 12 a  blood collection tube with plug  94  is shown that could be used to replace a typical vacuum tube. For example; after a technician extracts a blood sample from a patient the tube is placed into a centrifuge where the blood serum  92  is separated from the blood cells  95 . It is common to put a density barrier  101  into typical blood collection tubes, although the serum and blood cells will eventually re-constitute or combine overtime. By incorporating plug  94 , the test tube can be tilted horizontally to allow some of the serum to enter into the upper chamber  92 . Once serum is in the upper chamber  92 , the plug can be shut thus, isolating the upper chamber with the serum from the lower chamber. If more serum is required in the future plug  94  can be reopened to add additional serum to the upper chamber. It is also common for analytical equipment to utilize a small needle or pipette to obtain a sample from a small micro tube. By incorporating cavity  98  into plug  93 , the serum will remain in the cavity allowing the needle to retrieve the small samples that are available for testing. This replaces the need for commonly used micropipettes-inserts used in the chromatography containers for analytical testing equipment.  
         [0063]     Although this invention has been described and illustrated by reference to specific embodiments, it will be apparent to those skilled in the art that various changes and modifications may be made which clearly fall within the scope of this invention. The present invention is intended to be protected broadly within the spirit and scope of the appended claims.