Devices and Methods for Biological Assay Sample Preparation and Delivery

Abstract

Devices and methods for preparing and delivering biological assay samples are provided herein. Components of such devices include a sample receiving module within which a biological assay sample can be prepared and a cap, which when operatively coupled with the sample receiving module, pressurizes the module. These devices can be employed for subsequently delivering a biological assay sample.

1 . A biological assay sample preparation device, the device comprising:
 a. a sample receiving module comprising an outer body forming a first chamber, an inner body forming a second chamber, a preparation solution, and a first attachment element; and   b. a cap removably coupleable to the sample receiving module and comprising:   i. a pressurizing component; and   ii. a second attachment element operatively coupleable with the first attachment element,   wherein the pressurizing component extends into and pressurizes the sample receiving module upon operative coupling of the first attachment element to the second attachment element   wherein the outer body comprises a piercing member, wherein the inner body comprises a breakable seal and is movable within the outer body, and   wherein operatively coupling the first attachment element to the second attachment element comprises moving the inner body within the outer body to break the breakable seal and place the first and second chambers in fluidic communication.   
     
     
         2 . The device according to  claim 1 , wherein the fluid container is adapted to receive one or more portions of a sample. 
     
     
         3 . The device according to  claim 1 , wherein the preparation solution is a nucleic acid amplification preparation solution. 
     
     
         4 . The device according to  claim 1 , wherein the cap comprises a receptacle configured to receive an end of the sample receiving module therein when the cap is coupled to the sample receiving module. 
     
     
         5 . The device according to  claim 4 , wherein the pressurizing component is disposed within the receptacle or integral with the cap. 
     
     
         6 . (canceled) 
     
     
         7 . The device according to  claim 1 , wherein the device is a hand-held device. 
     
     
         8 . The device according to  claim 1 , wherein the fluid container has a volume of 50 cm 3  or less. 
     
     
         9 . The device according to  claim 1 , wherein the sample collector comprises a swab. 
     
     
         10 . The device according to  claim 1 , wherein the first attachment element comprises a thread and the second attachment element comprises a reciprocating groove for slidably receiving the thread therein. 
     
     
         11 . The device according to  claim 1 , wherein the pressurizing component pressurizes the sample receiving module to a peak pressure ranging from 10000 Pa to 30000 Pa. 
     
     
         12 . The device according to  claim 1 , wherein the pressurizing element extends from an interior surface of the cap. 
     
     
         13 . The device according to  claim 1 , wherein the pressurizing element is cylindrical. 
     
     
         14 - 16 . (canceled) 
     
     
         17 . The device according to  claim 1 , wherein the sample receiving module comprises an actuable valve configured to discharge fluid from the fluid container therethrough when actuated. 
     
     
         18 . The device according to  claim 17 , wherein the first attachment element is at a first end of the sample receiving module and the valve is at a second end of the sample receiving module opposite the first end. 
     
     
         19 - 20 . (canceled) 
     
     
         21 . The device according to  claim 17 , wherein the device further comprises a filter configured to filter a sample fluid prior to discharging the sample fluid through the valve. 
     
     
         22 - 25 . (canceled) 
     
     
         26 . The device according to  claim 1 , wherein the outer body comprises a staging reagent. 
     
     
         27 . The device according to  claim 26 , wherein the staging reagent is a lyophilized lysing reagent. 
     
     
         28 - 29 . (canceled) 
     
     
         30 . A method of delivering a biological assay sample, the method comprising:
 a. collecting a biological sample with a sample collector;   b. inserting the sample collector into a sample receiving module of a sample preparation device, wherein inserting the sample collector comprises exposing the biological sample to a preparation solution to produce a prepared biological assay sample;   c. operatively coupling a cap of the sample preparation device to the sample receiving module and thereby pressurizing the sample receiving module; and   d. delivering the prepared biological assay sample by depressurizing the sample receiving module by flowing at least a portion of the prepared biological assay sample out of the sample receiving module.   
     
     
         31 - 52 . (canceled) 
     
     
         53 . A biological assay sample preparation device, the device comprising:
 a. a cap comprising a first chamber, a plunger comprising a piercing member, and a seal; and   b. a sample receiving module which is operatively coupleable to the cap and comprises a second chamber,   wherein when the sample receiving module is operatively coupled to the cap, advancing the plunger pierces the seal with the piercing member and places the first chamber in fluidic communication with the second chamber.   
     
     
         54 . (canceled) 
     
     
         55 . A method of preparing a biological assay sample, the method comprising:
 a. operatively coupling a cap and a sample receiving module of a biological assay sample preparation device, wherein the cap comprises a seal and a plunger comprising a piercing member; and   b. advancing the plunger to pierce the seal with the piercing member and thereby placing the first chamber in fluidic communication with the second chamber and preparing the biological assay sample.   
     
     
         56 - 60 . (canceled)