Systems, Methods, and Devices for Sample Collection, Stabilization and Preservation

Abstract

Herein, systems and methods are disclosed including a sample acquisition component (SAC) for user-friendly sample collection, a separation component for optional separation of plasma, and one or more stabilization components for stabilizing analytes. In a particular embodiment, the system and methods are directed towards sample collection and stabilization with optional sample separation. Other embodiments can perform any combination of collection, separation, stabilization or detection.

1 . A method comprising:
 obtaining a device comprising:
 (a) one or more piercing elements configured to penetrate skin of a subject to expose blood; 
 (b) a plunger configured to drive the one or more piercing elements into the skin of the subject; and 
 (c) a collection chamber for collecting the blood; 
   applying the device to the skin of the subject;   actuating the plunger to cause the one or more piercing elements to pierce the skin of the subject;   creating a vacuum upon withdrawal of the one or more piercing elements from the skin; and   collecting greater than 100 μL of the blood in the collection chamber to provide collected blood.   
     
     
         2 . The method of  claim 1 , further comprising contacting the collected blood with a stabilizing reagent that preserves the blood for transport or storage. 
     
     
         3 . The method of  claim 1 , further comprising contacting the blood with silica. 
     
     
         4 . The method of  claim 1 , further comprising contacting the blood with one or more salts. 
     
     
         5 . The method of  claim 1 , further comprising contacting the collected blood with one or more chelating agents. 
     
     
         6 . The method of  claim 5 , wherein the one or more chelating agents comprise ethylenediaminotetraacetic acid (EDTA). 
     
     
         7 . The method of  claim 1 , further comprising contacting the collected blood with a polymer. 
     
     
         8 . The method of  claim 1 , wherein the one or more piercing elements comprise a microneedle. 
     
     
         9 . The method of  claim 1 , wherein the one or more piercing elements are configured to minimize physical pain to the subject. 
     
     
         10 . The method of  claim 1 , wherein the one or more piercing elements are configured to allow for shallow penetration of the skin. 
     
     
         11 . The method of  claim 1 , wherein the collecting comprises collecting less than 1 mL of the blood. 
     
     
         12 . The method of  claim 1 , wherein the collecting comprises collecting less than 500 μL of the blood. 
     
     
         13 . The method of  claim 1 , wherein the collecting comprises collecting less than 200 μL of the blood. 
     
     
         14 . The method of  claim 1 , wherein the device comprises a body comprising a base comprising at least one aperture. 
     
     
         15 . The method of  claim 14 , wherein the one or more piercing elements are configured to pass through the at least one aperture in the base when the plunger is actuated. 
     
     
         16 . The method of  claim 1 , wherein the device comprises identifying information. 
     
     
         17 . The method of  claim 1 , wherein the device comprises a barcode. 
     
     
         18 . The method of  claim 1 , wherein the device comprises a color label. 
     
     
         19 . The method of  claim 1 , wherein the collected blood comprises one or more analytes, and wherein the one or more analytes comprise nucleic acid. 
     
     
         20 . The method of  claim 19 , wherein the nucleic acid comprises RNA or DNA. 
     
     
         21 . The method of  claim 1 , wherein the collected blood comprises one or more analytes. 
     
     
         22 . The method of  claim 21 , wherein the one or more analytes comprise protein. 
     
     
         23 . The method of  claim 21 , wherein the one or more analytes comprise nucleic acid. 
     
     
         24 . The method of  claim 21 , further comprising performing an assay for the one or more analytes. 
     
     
         25 . The method of  claim 24 , wherein the performing an assay is at a location remote from a site of the collecting. 
     
     
         26 . The method of  claim 1 , further comprising sequencing a nucleic acid from the collected blood or amplified product thereof. 
     
     
         27 . The method of  claim 1 , further comprising removing a component from the device following the collecting. 
     
     
         28 . The method of  claim 1 , further comprising using the collected blood for a diagnostic test. 
     
     
         29 . The method of  claim 1 , further comprising using the collected blood for a panel. 
     
     
         30 . The method of  claim 28 , wherein the diagnostic test is for a genetic disease. 
     
     
         31 . The method of  claim 28 , wherein the diagnostic test comprises pre-natal screening.