SYSTEMS, DEVICES, AND METHODS FOR DEPLOYING ONBOARD REAGENTS IN A DIAGNOSTIC DEVICE
Disclosed herein are systems, devices, and methods for detecting the presence of a pathogen in a biological host, such as in a point of care setting. In certain aspects, materials and methods improve point of care devices by providing pre-loaded, preferably dried, agents for performing one or more of sample lysis and signal enhancement inside the device.
1 . A chamber located within a point of care device, wherein the chamber includes at least one agent in dry form.
2 . The chamber of claim 1 , wherein the chamber is a lysis chamber disposed between an inlet port of the device and a probe positioned within the device, the lysis chamber having at least one chemical lysing agent disposed therein.
3 . The chamber of claim 2 , wherein the at least one chemical lysing agent is in dry form.
4 . The chamber of claim 2 , wherein the at least one chemical lysing agent is dried to an interior surface of the lysis chamber.
5 . The chamber of any claim 1 , wherein the lysis chamber includes first and second chambers and a flow line disposed between the first and second chambers and through which fluid flows from the first to the second chamber.
6 . The chamber of claim 5 , wherein the first chamber includes a chemical lysing agent and the second chamber includes a neutralizing agent.
7 . The chamber of claim 6 , wherein the chemical lysing agent is a base and the neutralizing agent is an acid.
8 . The chamber of claim 6 , wherein the chemical lysing agent is an acid and the neutralizing agent is a base.
9 . The chamber of claim 6 or 7 , wherein the base is NaOH.
10 . The chamber of claim 5 , wherein a base is dried to an interior surface of the first chamber and an acid is dried to an interior wall of the second chamber.
11 . The chamber of claim 7 , wherein a fluid sample includes cells containing genetic material and, upon the fluid sample's contacting the base in the first chamber, the fluid sample forms a lysate comprising lysed cells and fragments of the genetic material, the lysate having a basic pH.
12 . The chamber of claim 11 , wherein the fragments of the genetic material are partial fragments of the genetic material.
13 . The chamber of claim 11 , wherein the lysate flows out of the second chamber having a pH that is less basic than the pH of the lysate that exits the first chamber.
14 . The chamber of claim 13 , wherein the lysate flowing out of the second chamber has a neutral pH.
15 . The chamber of claim 2 , wherein the chemical lysing agent is mixed with a detergent.
16 . The chamber of claim 1 , comprising a catalytic agent dried to an interior surface of the chamber.
17 . A point of care device having:
an inlet port through which a fluid sample flows,
a probe chamber, and;
a chamber according to any of the preceding claims.
18 . The point of care device of claim 17 , wherein the chamber is a lysis chamber.
19 . The point of care device of claim 17 , wherein the chamber is a catalytic agent chamber and contains one or more electrochemical agents configured to amplify an electrochemical signal arising from the device.
20 . The device of claim 19 , wherein the electrochemical agents include at least Ru(NH 3 ) 6 3+ or Fe(CN) 6 3− .
21 . A method of preparing a biological sample for analysis of its nucleic acid material, comprising the steps of:
(i) combining the biological sample in a buffer to form a first solution at a first pH,
(ii) flowing the first solution into contact with a first chemical agent that changes the pH of the first solution, forming a second solution at a second pH, and;
(iii) flowing the second solution into contact with a second chemical agent that changes the pH to a level that is less basic or less acidic than the second pH.