Sample preparation device

Abstract

A manually actuated chromatography device comprising a chamber for receiving a liquid sample, a pump with a metering valve, and a chromatography element, wherein the pump moves a predetermined volume of liquid from the sample chamber to the chromatography element.

1 . A method for performing an isothermal nucleic acid amplification comprising:
 providing a raw liquid sample;   processing the raw liquid sample to remove nucleic acid amplification inhibiting agents and/or fluorescent agents;   performing an isothermal nucleic acid amplification on the processed sample; and
 monitoring for amplified nucleic acid. 
   
     
     
         2 . The method according to  claim 1  wherein the processing step comprises using size exclusion chromatography. 
     
     
         3 . The method according to  claim 1  further comprising contacting the raw liquid sample to a lytic agent prior to processing the raw liquid sample. 
     
     
         4 . The method according to  claim 1  further comprising buffering the raw liquid sample. 
     
     
         5 . The method according to  claim 1  wherein the raw liquid sample is selected from the group consisting of urine, blood, plasma, serum, saliva, cerebrospinal fluid, and tear fluid. 
     
     
         6 . The method according to  claim 1  wherein the raw liquid sample is an elute from a vaginal, nasal, throat, penile, anal, or skin swab. 
     
     
         7 . The method of  claim 1  further comprising buffering the raw liquid sample during processing the raw liquid sample. 
     
     
         8 . The method according to  claim 1  wherein processing the raw liquid sample comprises providing a manually actuated chromatography device comprising a chamber for receiving a liquid sample, a pump with a metering valve, and a chromatography element. 
     
     
         9 . The method of  claim 8  wherein the manually actuated chromatography device comprises a first part and a separate second part receivable in the first part. 
     
     
         10 . The method of  claim 9  further comprising receiving, in the first part, the second part. 
     
     
         11 . The method of  claim 10  comprising actuating the pump by the second part of the manually actuated chromatography device operably engaging the first part of manually actuated chromatography device. 
     
     
         12 . The method of  claim 8 , wherein the pump moves a predetermined volume of liquid from the chamber to the chromatography element. 
     
     
         13 . The method of  claim 8 , wherein the manually actuated chromatography device is a single-use device. 
     
     
         14 . The method of  claim 8 , wherein the device is actuatable by a single movement. 
     
     
         15 . The method of  claim 14 , wherein said single movement is a push or rotation. 
     
     
         16 . The method of  claim 1 , wherein processing the raw liquid sample is completed in less than 10 minutes. 
     
     
         17 . The method of  claim 1 , wherein processing the raw liquid sample is completed in less than 3 minutes. 
     
     
         18 . The method of  claim 12 , wherein said predetermined volume of liquid is 0.5 to 1.0 milliliters. 
     
     
         19 . The method of  claim 1 , wherein said isothermal nucleic acid amplification is a recombinase polymerase amplification (RPA) or nicking and extension amplification reaction (NEAR). 
     
     
         20 . The method of  claim 1 , wherein the method is performed at the point of care.