Abstract:
A specimen collection device capable of maintaining chain of custody and automated specimen manipulation is provided. The specimen collection device of the present invention maintains secure association with a specimen and specimen identifying information, and provides compatibility with automated specimen handling and analysis equipment capable of transferring and/or extracting a collected specimen from clinical or environmental samples without human intervention.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    This application relates to and claims the priority of U.S. Provisional Application Ser. No. 62/081,772, which was filed on Nov. 19, 2014 and is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present disclosure relates to a specimen collection device capable of automated specimen manipulation and of maintaining chain of custody of a specimen collected thereon. The device is securely associated with the specimen collection absorbent and subject identifying information to preserve chain of custody. The device is also compatible with automated specimen handling and analysis equipment and allows for transferring and/or extracting a specimen collected on the specimen collection absorbent from clinical or environmental samples without human intervention. 
       BACKGROUND OF THE INVENTION 
       [0003]    Increasingly in law enforcement it is necessary to collect biological samples as evidence of a crime or for use as identifying information of a particular human as is the case of DNA collection from suspects. In the collection of biological specimens, it is necessary to associate information about the subject with the specimen and the subject associated with the specimen at the time of collection as there is no manner for identifying a biological specimen by simple inspection. Therefore, a useful form of evidence collection device for use with biological specimens will contain, at least, a means for specimen identification. Such specimen identification means may further comprise suspect information portion for recording subject information data thereon. 
         [0004]    The use of biological specimens as evidence further requires that the biological specimen be securely associated with the identifying information so as to assure that after collection of the specimen, the collection paper or absorbent cannot be intentionally or inadvertently switched to a different collection paper. At a minimum, a proper evidence collection device or holder should easily and clearly show that tampering was attempted either by damage to delicate indicia on the device or by overt damage to a strongly secured device. 
         [0005]    The foregoing issues relate, generally, to a process referred to as evidence “chain of custody.” “Chain of custody” encompasses the procedures and documentation used to maintain and demonstrate the chronological history of the evidence. In biological samples, the principles of evidence or sample identification involved in maintaining proper “chain of custody” are especially critical as a fluid or cellular biological sample, once collected onto an absorbent presents no distinguishing characteristics. This lack of visual characteristics foils any attempt to properly identify such a biological fluid or cellular sample once it has become separated from its identifying information. 
         [0006]    Another problem or issue presented in the analysis of biological specimens is the need to extract or transfer the collected sample from the original collection absorbent and onto an alternate medium to permit analysis or testing of the specimen using the analysis equipment that is available in the selected laboratory. Using existing systems and methods, human intervention is necessary to extract or transfer the collected sample from the original collection absorbent. Manual transfer or extraction of the collected specimen from the original collection absorbent introduces the possibility of sample contamination as well as operator exposure to sample, reagents, and process waste. In addition, it is often necessary to separate the collection absorbent from its originally obtained identifying information that is directly associated with the original collection absorbent for further sample processing. This separation of specimen from identifying information can lead to mistakes in associating the specimen with the correct subject or suspect or can lead to the “chain of custody” being open to question in court and a failure of proof of a crime. Sample misidentification is a major source of error both in laboratory analysis and in substantiating criminal evidence. 
         [0007]    Accordingly, a need exists for a specimen collection device that is securely associated with the specimen collection absorbent and specimen identifying information, while providing compatibility with automated specimen handling and analysis equipment capable of transferring and/or extracting a collected specimen from clinical or environmental samples (or from environmental samples collected manually) without human intervention. Further, it would be beneficial if such device was tamper proof or tamper evident. 
       SUMMARY OF THE INVENTION 
       [0008]    A specimen collection device capable of maintaining chain of custody and automated specimen manipulation is provided. The instant specimen collection device maintains secure association with the specimen and specimen identifying information, and provides compatibility with automated specimen handling and analysis equipment capable of transferring and/or extracting a collected specimen from clinical or environmental samples without human intervention. 
         [0009]    In some embodiments, the specimen collection device comprises a collector holder tube for insertion into a receiver void of a test block, and a specimen collector for insertion within the collector tube holder. The specimen collector comprises a closure having an insert portion and a cap portion, and a shaft having a first end coupled to the insert portion of the closure and extending therefrom. The shaft terminates at a second end that has a collection swab coupled thereto. A co-axial tube contains at least a portion of the shaft. The co-axial tube may be coupled to the insert portion of the closure at one end. In some embodiments, the specimen collector additionally comprises a chamber within the cap portion of the closure configured to hold identification indicia known in the art, such as a bar code, radio-frequency identification (RFID) tags and the like, in order to maintain the chain of custody of a collected specimen. 
         [0010]    In some embodiments, the specimen collector device may also comprise a locking feature so that once the specimen collector is fixed within the holder tube by insertion of the closure, it is locked therein and the holder with specimen collector attached cannot be tampered with or opened without the damage being evident. At least one locking flange extends from the base of the cap portion and is configured to engage a locking receiver of the test block. 
         [0011]    Various objects and advantages of this device will become apparent from the following description taken in conjunction with the accompanying drawings wherein, by way of illustration, certain embodiments of this disclosure are set forth. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    Preferred embodiments of the invention, illustrative of the best modes in which the applicant has contemplated applying the principles, are set forth in the following description and are shown in the drawings and are particularly and distinctly pointed out and set forth in the appended claims. 
           [0013]      FIG. 1  is a cross-sectional front view of a first embodiment of a specimen collection device  16  inserted into a receiver void  12  of a test block  10 , the specimen collection device  16  having a closure  18  which comprises a chamber  42  in the cap portion  30  for securing an RFID tag  44 . 
           [0014]      FIG. 2  is a cross-sectional front view of an alternative embodiment of the specimen collection device  16  depicting a closure  18  having a solid cap portion  50 . 
           [0015]      FIG. 3  side perspective view of the closure  18  for the specimen collection device having the lid removed to depict the inner chamber  42  positioned within the cap portion to house an RFID tag, as well as locking flanges  54  for securement of the device to a test block. 
           [0016]      FIG. 4  is a top perspective view of an embodiment of the test block depicting a sliding lock engagement track  56  for attachment to the closure of the specimen collection device. 
           [0017]      FIG. 5  is a top perspective view of the lid  46  for use with an embodiment of the specimen collection device  16 . 
           [0018]      FIG. 6  is a cross-sectional perspective view of the collector holder tube  14 . 
       
    
    
     DETAILED DESCRIPTION 
       [0019]    The purpose of the present invention is to meet collection requirements that allow blood specimen collection or body fluid collection or DNA collection to qualify for secure evidence handling and for chain of custody proof requirements in law enforcement. In particular, the present invention is directed to a specimen collector device that maintains secure association with the specimen or sample and avoids the need for any transfer of the specimen or require the transfer of a bar code or other identifying material from the specimen collector onto the sample device holder. 
         [0020]    Referring now to  FIG. 1 , a first embodiment of a specimen collection device  16  is shown.  FIG. 1  illustrates a cross-sectional view of the specimen collection device  16  inserted into a receiver void  12  of a test block  10 , the specimen collection device comprising a specimen collector  22  and a collector holder tube  14 , the specimen collector depicted as being inserted into the collector holder tube. The specimen collector  22  is comprised of a closure  18  having a shaft  28  connected thereto and the shaft extending from one end of the closure having a collection swab  24  attached to a second end  26  of the shaft. A co-axial tube  20  is positioned around the shaft  28 . 
         [0021]    In the embodiment of  FIG. 1 , the closure  18  is comprised of a cap portion  30  and an insert portion  32  for insertion of the specimen collector  22  into the collector holder tube  14 . The insert portion  32  is provided with a gasket, such as an O-ring  34  so that it is sufficiently spaced from the open end  36  of the collector holder tube  14  to prevent the closure  18  from pivoting within the collector holder tube  14 . By biasing the closure  18  towards a non-pivoted alignment, the O-ring  34  keeps the swab  24  from being forced against either side of the collector holder tube  14 . The closure  18  is further provided with the cap portion  30  in order to seal the open end  36  of the collector holder tube  14 . The cap portion  30  is sufficiently wide to permit the cap portion to contact the test block so that locking flanges  38  extending from the cap portion  36  may be inserted into lock receivers  40  located within the test block  10 . The purpose of the locking flanges and the lock receivers is to allow the closure  18  to secure the specimen collection device  16  to the test block  10  so that, as internal pressure is developed within the collector holder tube, that pressure does not expel the closure from the device. 
         [0022]    The closure  18  of the embodiment of  FIG. 1  also is provided with a void or chamber  42  within the cap portion  30 . Identifying information, such as a radio frequency identification chip or tag  44  (RFID), may be inserted into the chamber within the cap portion  30  and enclosed therein by the attachment of a lid  46  onto the cap portion  30 . The RFID tag or chip could be a passive or active chip and would have a unique identification number associated therewith to provide a unique identifier to each individual specimen collector. It is preferred that the lid  46  be securely attached to the cap portion  30  such that only by the use destructive measures could the lid be removed. This secure attachment is intended to prevent unobserved tampering with the RFID tag  44  housed inside the cap portion. In the embodiment of  FIG. 1  a sonic weld  48  may be used to attach the lid  46  to the cap portion  30 . In some embodiments, the cap portion  30  is configured as a handle, but without being solid therein. 
         [0023]    Referring now to  FIG. 2 , an alternative embodiment of the specimen collection device  16  is presented. Specifically,  FIG. 2  depicts the closure of the device having a solid cap portion  50  rather than a void or chamber for holding identifying information, such as an RFID tag. The solid cap portion  50  is inserted into the open end  36  of the collector holder tube  14  such that the it operates as an handle for the specimen collector  22  extending from the end of the insert portion  30  of the closure. It may be seen in  FIG. 2  that the O-ring  34  is positioned on the insert portion  30  and that the co-axial tube  20  surrounds the shaft  28  of the specimen collector  22 . 
         [0024]    Referring now to  FIG. 3 , the closure  18  of  FIG. 1  is shown with the lid  46  having been removed to illustrate the chamber  42  in which the RFID tag may be housed. The O-ring has been removed and the groove  52  into which the O-ring is fitted is shown. Also in  FIG. 3 , an embodiment of a locking flange  54  is shown that may be fitted into a sliding track mechanism  56  of a test block  10 , as is shown in  FIG. 4 . It will be appreciated that the sliding lock engagement track  56  of  FIG. 4  can provide either a releasable lock or a non-releasable lock with respect to the attachment of the closure to the test block. 
         [0025]    Referring again to  FIG. 1  and  FIG. 3 , the locking flanges  54  of the embodiment of  FIG. 3  are shown to extend downwardly from the cap portion  30  of the closure so that they may engage with a lock receiver  40  on the test block  10 , as shown in  FIG. 1 . The lock receiver  40  of  FIG. 1  may be a void in which the flange of  FIG. 3  is captured by frictional fit or the lock receiver  40  may be of a mechanical engagement type as is shown in  FIG. 4 . 
         [0026]    Referring now to  FIG. 5 , the lid  46  for attachment to the cap portion  30  illustrated in  FIG. 1  is shown. The lid  46  sealingly engages the cap portion adjacent the chamber. The seal may be reversible or permanent and may be by any means known in the art, including adhesive, sonic weld  48 , or mechanical means, such as a locking flange and lock receiver coupling. In a preferred embodiment, the lid is permanently sealed to the cap portion  30  in order to prevent unauthorized access to or tampering with the RFID tag  44  housed within the chamber  42  of the cap portion. 
         [0027]      FIG. 6  shows a cross-sectional view of the collector holder tube  14  of the specimen collection device. It will be appreciated that the narrow channel wherein the collector swab  24  is disposed (as is shown in  FIG. 1 ) is provided to limit the area in which reagents are able to flow as the reagents are injected into the test block and forced upwardly into the collector swab to dissolve any biological specimen that is on the swab. It will be appreciated that when the collector holder tube  14  is being used apart from the test block  10  that a bottom end cover or cap may be provided to close the narrow end of the collector holder tube  14  near the swab to avoid contamination of the swab and any specimen collected thereon. 
         [0028]    One skilled in the art would readily appreciate that the devices described herein are representative of exemplary embodiments, and not intended as limitations on the scope of the disclosure. It will be readily apparent to one skilled in the art that varying substitutions and modifications may be made to the present disclosure disclosed herein without departing from the scope and spirit of the disclosure. The present disclosure illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations that are not specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the present disclosure claimed. Thus, it should be understood that although the present disclosure has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this disclosure as defined by the appended claims.