Abstract:
The present invention discloses a biological sample collection kit which can be utilized to collect samples of biological origin for use in any recovery and identification method.  
     The biological sample collection kit comprises a sterile device for collecting a sample, a device for depositing and holding the sample, a means for transferring the sample, and means for storing the storing the sample to be tested. There may also be means for identifying the sample and for diluting the sample. The biological sample collection kit preferably contains an outer bag which holds, in a sterile environment, all of the items used in the testing procedures. Additionally, a container of collection fluid is preferably included in the sample collection kit.

Description:
[0001]    The following application is a continuation-in-part of 09/160,153 filed Sep. 25, 2000.  
     
    
     
       BACKGROUND OF THE INVENTION  
         [0002]    1. Field of the Invention  
           [0003]    The present invention discloses a biological sample collection kit allowing for the collection and safe storing of samples.  
           [0004]    2. Description of the Prior Art  
           [0005]    Collection of microscopic biological samples has been random. For example, when a technician wants to test a surface for biological or chemical agents, he or she frequently has to search for a sterile cotton swab or cloth, wet it down if the surface is dry, and then wipe the surface. From there, a means must be found to transfer the absorbed material from the collection device (i.e., the cotton swab or cloth), to a storage place or an assay.  
           [0006]    By not having all of the materials in one package which are necessary for collecting and testing the sample in one package, the risk of contamination of the sample and getting erroneous results is increased. Additionally, a great deal of time is wasted when the technician has to look around to find all of the collection and storage devices needed to safely collect and store a sample.  
           [0007]    In the field, outside of the laboratory, it is even more necessary to have an efficient, light weight means of collecting and storing samples for testing in order to obtain more accurate results in a short period of time. A collection kit in the field must be self-contained as in the field, there is no lab supply cabinets or supply companies upon which to rely.  
         SUMMARY OF THE INVENTION  
         [0008]    The present invention discloses a biological sample collection kit which can be utilized to collect samples of biological origin for use in any recovery and identification method. The identification method may be PCR, luminescence, immunological, flow cytometry, etc.  
           [0009]    The biological sample collection kit comprises a sterile means for collecting a sample, a means for depositing and holding the sample, a means for transferring the sample, and means for storing the storing the sample to be tested. There may also be means for identifying the sample and for diluting the sample. The biological sample collection kit preferably contains an outer bag which holds, in a sterile environment, all of the items used in the testing procedures. Additionally, a container of collection fluid is preferably included in the sample collection kit.  
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]    [0010]FIG. 1 is a perspective view of the storage bag;  
         [0011]    [0011]FIG. 2 is a perspective view of a collection fluid container;  
         [0012]    [0012]FIG. 3 is a perspective view of a sample collection container;  
         [0013]    [0013]FIG. 4 is a perspective view of a sterile pipette;  
         [0014]    [0014]FIG. 5 is a perspective view of a filtered bag;  
         [0015]    [0015]FIG. 6 is a perspective view of a sponge;  
         [0016]    [0016]FIG. 7 is a perspective view of a swab;  
         [0017]    [0017]FIG. 8 is a perspective view of a cotton swab;  
         [0018]    [0018]FIG. 9 is a perspective view of a syringe;  
         [0019]    [0019]FIG. 10 is a perspective view of a sterile syringe filter;  
         [0020]    [0020]FIG. 11 is a perspective view of a slide lock bag;  
         [0021]    [0021]FIG. 12 is a perspective view of a collection tube;  
         [0022]    [0022]FIG. 13 is a perspective view of a bio-hazard bag;  
         [0023]    [0023]FIG. 14 is a perspective view of a sterile collection bag;  
         [0024]    [0024]FIG. 15 is a perspective view of a forceps;  
         [0025]    [0025]FIG. 16 is a perspective view of a spatula; and  
         [0026]    [0026]FIG. 17 is a perspective view of a sterile glove.  
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0027]    Referring to FIGS.  1 - 16 , the sample collection kit preferably contains a sponge  2 , a filtered bag  3 , a buffer solution  4 , a pipette  5 , and a specimen collection vile  6 . In a preferred embodiment of the invention, these items are kept in a collection kit bag  7 . The collection kit bag  7  is preferably a sealed bag, which is preferably hermetically sealed, and sterile inside the bag. The bag may be made out of a metal foil, or a plastic.  
         [0028]    The sponge  2  is preferably sterile, and kept in a bag  12 , preferably a stomacher bag The sponge  2  will be removed from the bag  12  just prior to use. The sterile sponge  2  is used to wipe surfaces to be tested for bacteria, chemicals or other foreign matter from a surface area. If the area to be tested is dry, the sponge  2  may be first hydrated with the buffer solution or asceptic collection fluid  4 . The buffer solution may be a carbonate, phosphate, or any other appropriate buffer. The buffer may also be a sterile water, a sterile saline solution or some other like sterile solution.  
         [0029]    In another embodiment of the invention, a sterile swab  20  is used in place of the sponge. Similarly, a sterile cotton ball  21  may be used, or any other absorbent material.  
         [0030]    The filtered bag  3  is preferably a stomacher bag  3 , with the bag having a filter  8  within said bag. This filter  8  may be a porous plastic or a paper filter, adhered to the walls  9  of the bag  3 , with an opening  10  at the top of the bag, and preferably cylindrical in shape. The filter  8  preferably runs the length of the bag, with the filter  8  being attached to the front and back of the bag.  
         [0031]    In place of the bag, any sterile receptacle may be used. However, a plastic sterile bag, with a filter and a stomacher bag, is preferred.  
         [0032]    After the sponge  2  is used to wipe down a surface area to be tested, it is placed in a general part of the filtered bag  3 . After the sponge is placed in the filter bag  3 , it is squeezed through the filter bag  3 . That is, the user squeezes the filter bag  3  with the sponge  2  inside the filter bag  3 . If so desired, additional buffer solution  4  may be added to the general part of the filtered bag  3 . It is best that the filtered bag be gently shaken to mix the contents.  
         [0033]    A pipette  5  or syringe, preferably a sterile transfer pipette contained in a sealed container  12  until use, is inserted into the opening of the filter compartment  11 . The filter serves the purpose of keeping out any large, extraneous material from the fluid to be tested, but which the sponge  2  may have picked up from the testing area, including paint chips, dust, wood chips, etc.  
         [0034]    The sample is drawn up into the pipette  5 . From there, the sample may be placed in a collection tube  13 , or the sample may be directly assayed. Labels  1  included in the kit may be attached to the collection tube properly identify the sample.  
         [0035]    In another embodiment of the invention, the collection kit includes, instead of a pipette, at least one syringe  40 , along with at least one sterile syringe filter  41 , at least one bag  42 , and preferably a slide lock bag, at least one collection receptacle  43 , preferably a collection tube, and at least one bottle of aseptic collection fluid  4 . The aseptic collection fluid may be sterile water or a sterile saline solution. The sterile collection tubes may have labels  1  attached, or may have labels included to be attached to the sterile collection tubes. It is preferred that there be at least two syringes  40 , two collection tubes  43 , and two syringe collection filters  41 . After the aseptic fluid  4  has been dispersed on the surface to be tested, a sample may be drawn up through a syringe  40 , and then, after the syringe filter  41  has been attached, the fluid may be expelled through the syringe  40 , and syringe filter  41 , and into the collection tubes  43 . The collection tube  43  or receptacle is then sealed, identified, and placed in the slide lock bag  42 . The used filters, and syringes, may also be placed in the bag, if desired.  
         [0036]    If the sample to be tested is a liquid, the aseptic collection fluid may be added to the collection tubes after the sample has been collected. All of the items are kept in a sealed bio-hazard bag  46  until ready for use.  
         [0037]    The syringes are also encased in a sterile wrapper  47 . A Bio-hazard bag  48  is also included in the kit.  
         [0038]    In another preferred embodiment of the invention, a liquid sample collection kit comprises a sterile whirl-pak collection bag  50 , which has a wire seal  51  at the top  52  of the bag  50  running along the perimeter of the opening of the bag with extended tabs for gripping and twisting the bag closed. The collection kit also includes a slide lock bag  42 , and at least one sterile syringe. The liquid sample collection kit is sealed bag  7 . To use the liquid sample collection kit, the sealed bag  7  is opened, the contents are removed, and the slide lock bag is marked. The sample is collected using the syringes as necessary. The syringes with the sample are placed into the collection bag, which is then closed. The collection bag is then placed into a slide lock bag, and the slide is closed.  
         [0039]    A collection kit for the collection of an air sample is also envisioned by this kit. Filters are normally set up on roof tops to collect air samples. In other open field situations, where rapid testing of air samples is desired, particularly in the military arena, filters are fitted in conjunction with air pumps, which can filter several liters of air in a short time period. The collection kit for the collection of an air sample comprises a sterile collection tube  43 , an aseptical collection fluid  4 , a slide lock bag  42 , and forceps  60 . To use this kit, the sealed bag  7  is opened, and the contents are removed. The sample, which is usually a filter of some sort, is transferred to the collection tube, by means of the forceps  60 , which are sterile and packaged  61 .. Aseptical solution may be added. The collection tube is closed, and placed into a slide lock bag. The slide is then closed.  
         [0040]    A collection kit may also be used to collect a powder or to collect a sample from a small surface. The collection kit for collecting a powder sample or a small surface sample comprises at least one, and preferably two sterile swab(s)  20 , at least one sterile spatula  70 , in a sterile wrapper  72 , at least one sterile collection tube  43 , with a label  1  attached, aseptisol (aseptic) collection fluid  4 , and at least one slide lock bag. All of these items are stored in a sealed bag  7  . To collect and store the sample, the pouch is opened, and the contents are removed. The sample is collected by using either a swab  20  moistened with aseptisol or with the sample is collected with the plastic spatula, particularly if it is a powder. The swab  20  or contents of the spatula  70  are deposited in the collection tube, and aseptisol is added if needed. The collection tube  43  is secured, and placed into the slide lock bag, which is then closed. The collection tube in this and in the other kits may include a label for marking the sample.  
         [0041]    A large surface sample collection kit comprises in a pouch, at least one sterile sponge  2 , in a sterile sealed whirl-pak bag  50 , aseptic collection fluid  4 , and at least one slide lock bag  50 . It is also preferred that a sterile glove  80 , preferably made out of latex and in a sterile package  81 , be included in the kit.  
         [0042]    To test a large surface for contaminants, the sealed bag  7  should be opened and the contents removed. The whirl-pak bag should be opened, and the collection fluid should be poured in, such that the sponge becomes saturated. If included, the package containing the glove should be opened, the glove removed, and worn. The sponge should be removed from the bag, and the designated sample area should be wiped. The sponge should then be returned to the bag containing the collection fluid, and the bag should be closed. This bag should then be placed into the slide lock bag, and the slide lock should be secured.  
         [0043]    Many modifications and variations of the present invention are possible in light of the above teachings. It is, therefore, to be understood within the scope of the appended claims the invention may be protected otherwise than as specifically described.