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