Sanitary swab collection system, microfluidic assay device, and methods for diagnostic assays

Abstract

Biohazard specimen collection containers are provided with an external disposable skin, that is stripped away and discarded after the biohazardous specimen is collected, thus reducing or eliminating objectionable or dangerous residues on the outside surfaces of the container. Further, we teach that the sample collection container with external disposable skin may also serve as an integrated microfluidic biosample processing and analytical device, thereby providing a single entry, disposable assay unit, kit and system for “world-to-result” clinical diagnostic testing. These integrated assay devices are provided with synergic, multiple safe-handling features for protecting healthcare workers who handle them. The modified collection containers and analytical devices find application, for example, in PCR detection of infectious organisms or pathogenic markers collected on a swab.

1 . A sample collection device, the device comprising:
 a) a body having an external surface and an internal hollow volume;   b) a removable disposable external skin layer or shell covering a first portion of the external surface of the body and dividing the external surface into a covered area and an uncovered area, the uncovered area defining a swab receiving orifice for inserting a swab into the internal hollow volume, the swab receiving orifice compatible with a sealable closure that may be sealably closed over the swab receiving orifice; and,   wherein the removable disposable external skin layer or shell comprises a first gripping surface and the uncovered area comprises a second gripping surface, said first gripping surface having means for removing said external skin layer or shell from said body.   
     
     
         2 . The sample collection device of  claim 1 , wherein the external skin layer or shell is a decal having a pressure sensitive adhesive that can be removed without leaving a residue. 
     
     
         3 . The sample collection device of  claim 1 , wherein the external skin layer or shell comprises a first part and a second part. 
     
     
         4 . The sample collection device of  claim 3 , wherein the first part and the second part are joined by a tear strip. 
     
     
         5 . The sample collection device of  claim 1 , wherein the external skin layer or shell is a foam sheath shaped with a receptacle covering the first portion of the external surface of the body. 
     
     
         6 . The sample collection device of  claim 1 , wherein the external skin layer or shell is a foam block encasing the first portion of the external surface of the body. 
     
     
         7 . The sample collection device of  claim 6 , wherein the foam block is divided into a first member and a second member, wherein the first gripping surface is defined on the first member. 
     
     
         8 . The sample collection device of  claim 1 , wherein said second gripping surface comprises a cap adapted to hold the body with a clean hand while removing and discarding the external skin layer or shell. 
     
     
         9 . The sample collection device of  claim 1 , further comprising a swab, wherein the swab comprises a handle with frangible neck and an absorbent tip for collecting the sample. 
     
     
         10 . The sample collection device of  claim 1 , wherein the swab is a tampon. 
     
     
         11 . The sample collection device of  claim 1 , wherein the body comprises internal workings for processing the sample prior to performing an analysis on the sample. 
     
     
         12 . The sample collection device of  claim 1 , wherein the body comprises internal workings for analyzing the sample.