Abstract:
A device system, and method of use thereof, for collecting, transporting, and processing a biological sample is provided.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority benefit from U.S. Provisional Application Ser. No. 62/278,494, filed on Jan. 14, 2016, which is incorporated herein by reference in its entirely. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to sample collection, transportation, and processing. 
       BACKGROUND OF THE INVENTION 
       [0003]    Swabs provide an economical and non-invasive method for collection and transportation of biological samples from buccal, fecal, sweat, semen, whole blood samples and other bodily fluids. The swab samples can be collected at multiple sites then have to be transported to a processing location for molecular biological applications. Receiving locations running a large amount of samples for analysis can implement liquid handlers and magnetic processors to help aid in the processing of the samples. These instruments require that the samples be in 24, 96 or 384 well formats with 96-well formats being the most common. The receiving locations must take the received swab samples from the individual packaging then place them into a 96-well plate and correctly catalog the correct location of the swab well. The process of placing the samples in a 96-well format is manual and leads to possible sample switching in either placing the sample in the wrong well or documentation of the sample location within the well. 
         [0004]    Swabs must be lysed to analyze the DNA, RNA or proteins from the cells contained on the swab. This generally requires the swabs to be placed in a lysis buffer that may require heating, mechanical, or enzymatic treatments. After lysis, the swabs must be removed from the liquid to obtain the desired DNA, RNA or proteins. Alternatives to swabs on the market such as whole blood can be invasive in their collection method while saliva collection devices exist on the market such as DNA Genotek Oragene collection devices but these require the donor to provide a large amount of saliva which can be difficult for children or animals. These existing collection devices then transfer the biological material to a stabilization solution which may be incompatible with the processing laboratories chemistry for DNA, RNA or protein extraction. The Promega SlicPrep 96 device allows the customer to raise and lower the swabs into a lysis buffer but cannot identify the location in which the swabs have been inserted and requires the laboratory to manually identify the locations. 
       SUMMARY OF THE INVENTION 
       [0005]    The invention provides a device system, and method of use thereof, for collection, transportation, identification and processing biological samples. In certain embodiments, the invention device system is used for collecting biological samples using with buccal swabs and/or any other tools suitable for collecting biological samples, now known or later developed in the art. The invention further provides a method to allow for sample collection, transportation, and processing by the laboratory without the need to manually transfer the biological sample into another sample collection tube which will then be placed in a well position of a 96-well microtiter plate. 
         [0006]    In certain embodiments, the invention provides a device system for collecting, transporting, and processing a biological sample, comprising: a) a detachable sample collection assembly; b) collection and/or extraction basket; c) place holder; and 4) hinged holder. In certain embodiments, the invention provides that a detachable portion of the invention device can be attached to corresponding paperwork, and the position in which it is inserted into the 96-well microtiter plate can be read by a barcode reader and/or any other readers, now known or later developed in the art for identification or label purposes. In certain embodiments, the invention provides how the swabs biological material can be transferred into the liquid and then further processed with liquid handling instruments or magnetic processors. 
         [0007]    The biological samples as used herein refer to any bodily fluid, tissue, organ, and/or cells including, but not limited to, buccal mucosa or cheek tissue, whole blood, plasma, urine, feces, skin, hair, and organ tissue. 
         [0008]    The invention also provides that the invention device system is used for processing the biological samples for nucleic acid (e.g., DNA and/or RNA) and/or protein extractions, and/or for any laboratory analytic analysis. 
         [0009]    Other features and advantages of the invention become apparent to those skilled in the art upon review of the following detailed description, claims and drawings in which like numerals are used to designate like features. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]    This patent application file contains at least one drawing executed in color. Copies of this patent application with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. 
           [0011]      FIG. 1 . The sample collection piece. The device has a swab portion which can be cotton, polyester, other material used to collect the donor sample by brushing against the donor. The swab portion is attached to a thin wooden or plastic cylindrical shaft which attaches a circular disc. The disc is a cap to the collection/extraction basket and can attach via screwing into the basket or snapping in. On the other side of the shaft in the middle of the disc, a 2-D barcode is printed or sticker placed on the disc. A different thin cylindrical shaft is attached to the disc from the opposite side of the other cylindrical shaft protruding from the same side as the 2-D barcode. The second shaft is offset to the side of the disc. The second cylindrical shaft attaches to a flat rectangular portion which a barcode may be attached via sticker or printing. 
           [0012]      FIG. 2 : The basket/collection piece. The piece has a flat circular disc bottom which includes 2×2 grid pattern. The holes are on the outside segments of the grid pattern and are not bigger than 1×1 mm. Cyclinder walls attach to the disc to create the basket shape with an opening at the top. On the cylinder walls a barcode may be printed. The cylinder walls also include a small opening to allow air flow. The basket collection piece has an outer plastic lip around the top of the device. 
           [0013]      FIG. 3 . The Holder piece (top view). A flat rectangular piece with holes that are slightly larger than the basket collection piece, arranged in a 12×8 pattern. Two square holes are on the outer edges of the piece on the short side. The square holes are slightly larger than the notches present on the hinged holder piece. On the short sides of the rectangular holder piece, flat pieces extend slightly vertically and are not higher than 3 mm or longer than 5 mm. 
           [0014]      FIG. 4 . Hinged Holder Piece (side view). A flat rectangular piece with holes, that are the slightly larger than the basket collection piece, arranged in a 12×8 pattern. Two hinged pieces extend off the short side of the rectangular, hinged holder piece which are the same width dimensions as the rectangular, hinged holder piece. On the end of the hinged piece is a rectangular piece protruding that is approximately 0.5×0.5×0.5 mm. This protruding piece when the hinged pieces are placed vertically aligns with the holder piece&#39;s two square holes and can be inserted into them. 
           [0015]      FIG. 5 . Assembled collection/extraction basket and swab portion. The top cylinder shaft has been removed and sample collection piece inserted into the basket/collection piece. 
           [0016]      FIG. 6 . Top view of baskets and swab inserted. The Holder piece and hinged holder piece are laying on top of a 96-well deep well plate in the raised position. 96 basket/collection pieces have been inserted into the pieces. 
           [0017]      FIG. 7 . Side View, Fully Assembled, Adaptors Raised with liquid. The Holder piece and hinged holder piece are laying on top of a 96-well deep well plate in the raised position. 96 basket/collection pieces have been inserted into the pieces. In the raised position the swab can be raised above the liquid level. 
           [0018]      FIG. 8 . Side View, Fully Assembled, Adaptors Raised without liquid. The Holder piece and hinged holder piece are laying on top of a 96-well deep well plate in the raised position. Ninety-six (96) basket/collection pieces have been inserted into the pieces. 
           [0019]      FIG. 9 . Side View, Fully Assembled, Adaptors lowered with liquid. The Holder piece and hinged holder piece are laying on top of a 96-well deep well plate in the raised position. 96 basket/collection pieces have been inserted into the pieces. 
           [0020]      FIG. 10 . Side View, Fully Assembled, Adaptors lowered without liquid. The Holder piece and hinged holder piece are laying on top of a 96-well deep well plate in the lowered position. Ninety-six (96) basket/collection pieces have been inserted into the pieces. 
       
    
    
       [0021]    Before the embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced or being carried out in various ways. Also, it is understood that the phraseology and terminology used herein are for the purpose of description and should not be regarded as limiting. 
       DETAILED DESCRIPTION OF THE INVENTION 
       [0022]    The invention provides a device system for collecting, transporting, and processing a biological sample, comprising: a) a sample collection assembly; b) a collection extraction basket; c) a place holder; and 4) a hinged holder. 
         [0023]    In certain embodiments, the sample collection assembly comprises a) a swab, b) a cap, and c) a handle comprising an area for a barcode or sample identification. In certain embodiments, the swab, the cap, and the handle, each can be detachable from each other. 
         [0024]    As illustrated in  FIG. 1 , the swab ( 1 ) with or without removing the handle can be inserted into the collection extraction basket ( 2 ) and the cap provides a lid for the collection and/or extraction basket ( 2 ). In certain embodiments, the cap or lid contains a sticker or imprinted sample identification via barcode which matches removable sample identifier. In certain embodiments, the handle contains a removable sample identifier, including but not limited to, sticker or printing, which can be removed by either removal of the sticker or breaking off. 
         [0025]    In certain embodiments, the swab is a buccal swab which can be used for collection of any cheek tissue samples, whole blood, faces, urine, skin, hair, including forensic samples. 
         [0026]    In certain embodiments, the collection extraction basket also comprises a barcode and/or any other readable identifier which matches the sample identifier labeled on either the cap or the handle of the detachable sample collection assembly. In certain embodiments, the collection extraction basket comprising tubes having small holes at the bottom that allow for liquid to enter the collection and/or extraction basket without remove the swab. 
         [0027]    In certain embodiments, the collection extraction basket ( 2 ) with the detachable sample collection assembly ( 1 ) can be placed for centrifugation where the biological sample on the swab is in contact with a sample processing solution. After the centrifugation, the biological sample remains in the sample processing solution while the swab can be discharged. In certain embodiments, the remaining sample processing solution comprising the biological sample can be removed from the collection extraction basket during the centrifugation if the collection extraction basket is above liquid level. 
         [0028]    In certain embodiments, the collection extraction basket ( 2 ) with the detachable sample collection assembly ( 1 ) is used as a transport chamber for transporting and/or shipping samples collected without additional transferring steps. 
         [0029]    In certain embodiments, the place holder ( 3 ) of the invention device system is for alignment and support between the detachable sample collection assembly ( 1 ) and the collection extraction basket ( 2 ). In certain embodiments, the place holder is made of polypropylene or other suitable polymers, glass, and/or plastic materials. In certain embodiments, the place holder is a plastic cover comprising 96 wells corresponding and/or suitable to be laid on top of a 96-deep well microtiter plate. The invention encompasses other type of plastic and/or polymer holders comprising different numbers of wells (e.g., 24 wells, 48 wells, etc.) which corresponding to and/or suitable to be laid on top of a microtiter plate with the same number of wells. 
         [0030]    In certain embodiments, the invention device system further comprises a hinged holder ( 4 ) also comprising 96 spaces corresponding to a 96-well microtiter plate. The hinged holder allows for the detachable sample collection assembly ( 1 ) and the collection extraction basket ( 2 ) to be inserted into the spaces but limit the top of the detachable sample collection assembly ( 1 ) and the collection extraction basket ( 2 ) from fully passing through hinged holder piece ( 4 ). Once detachable sample collection assembly ( 1 ) and the collection extraction basket ( 2 ) are inserted into the place holder ( 3 ) and the hinged holder ( 4 ), the barcodes on each individual sample can be read with a 2-D barcode reader thus identifying the position of the well containing each sample. 
         [0031]    In certain embodiments, the hinged holder ( 4 ) has two positions. When hinges are horizontal to the microtiter plate, it is in the lowered position which lowers the detachable sample collection assembly ( 1 ) and the collection extraction basket ( 2 ) containing the biological material to be in contact and/or merged with the sample processing solution pre-placed in each well of the 96-deep well microtiter plate. When hinges are extended vertically and lock into the place holder ( 3 ), it is in a raised position where the detachable sample collection assembly ( 1 ) and the collection extraction basket ( 2 ) are at the level above the sample processing solution. The device with this raised position can then be placed into a centrifuge to separate and remove the component containing the nucleic acids (e.g., DNA and/or RNA) or protein from the swab, and for further sample processing, such as DNA, RNA, or protein extraction, isolation, purification, and analysis. 
         [0032]    The present invention  1 s also described and demonstrated by way of the following examples. However, the use of these and other examples anywhere in the specification is illustrative only and in no way limits the scope and meaning of the invention or of any exemplified term. Likewise, the invention is not limited to any particular preferred embodiments described here. Indeed, many modifications and variations of the invention may be apparent to those skilled in the art upon reading this specification, and such variations can be made without departing from the invention in spirit or in scope. The invention is therefore to be limited only by the terms of the appended claims along with the full scope of equivalents to which those claims are entitled. 
       Examples 
       [0033]    Using this device, the medical staff or donor will swab the donor then place the swab portion of the device in the collection basket. The identification portion from the swab is placed on the paperwork accompanying the donor&#39;s sample. The swab/basket and paperwork is then shipped to the molecular biology laboratory for testing. At receiving, the laboratory can fill a 96-deepwell plate with lysis buffer and then place the swab/basket into a detachable collection assembly without the need for identifying the well which the sample is placed into. Once fully assembled, a barcode scanner/reader can take an image of the assembled detachable collection device thus identifying the location of each sample and the corresponding well location. The detachable assembly can then be lowered into the lysis buffer to release the DNA from the cells contained on the swab. The detachable assembly can then be raised above the liquid level and then centrifuged to remove any remaining liquid absorbed by the swab. The detachable assembly can then be discarded which contains the swab sample. The DNA, RNA or protein has been transferred to the lysis buffer in the 96-well deep well plate where it can be further processed by liquid handlers or magnetic processors. 
         [0034]    The present invention is not to be limited in scope by the specific embodiments described herein. Indeed, various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are intended to fall within the scope of the appended claims. 
         [0035]    All patents, applications, publications, test methods, literature, and other materials cited herein are hereby incorporated by reference in their entirety as if physically present in this specification. 
         [0036]    Various features of the invention are set forth in the following claims.