Lateral flow assays for non-diagnostic analytes

Abstract

Methods of determining whether a non-diagnostic analyte is present in a non-diagnostic sample are provided. Aspects of the methods include applying a non-diagnostic sample to a sample receiving region of a lateral flow assay device and reading a detection region to determine whether a non-diagnostic analyte is present in the non-diagnostic sample. Also provided are kits that find use in practicing methods of the invention.

1 - 41 . (canceled) 
     
     
         42 . A lateral flow assay device, the device comprising:
 a sample receiving region configured to receive a non-diagnostic sample;   a detection region downstream from the sample receiving region, wherein the detection region comprises a capture binding member that specifically binds to the non-diagnostic analyte; and   a control region comprising an immobilized control agent.   
     
     
         43 . The device according to  claim 42 , wherein the non-diagnostic sample is selected from the group consisting of: a bacterial sample, a yeast sample, a viral sample, an insect cell sample, a mammalian cell sample, a lysate sample, an in vitro culture sample, a supernatant sample, a recombinant vector sample, an acellular biomolecule reaction mixture, and a column eluant. 
     
     
         44 . The device according to  claim 42 , wherein the non-diagnostic analyte is selected from the group consisting of: a recombinant vector, a protein or epitope tag thereof, a nucleic acid, and a laboratory or sample contaminant. 
     
     
         45 . The device according to  claim 42 , wherein the control region is downstream from the detection region. 
     
     
         46 . The device according to  claim 42 , wherein the lateral flow assay device further comprises a reporter binding member positioned upstream from the detection region, wherein the reporter binding member is non-stably associated with the lateral flow assay device. 
     
     
         47 . The device according to  claim 46 , wherein the reporter binding member is positioned in the sample receiving region or between the sample receiving region and the detection region. 
     
     
         48 . The device according to  claim 46 , wherein the reporter binding member binds to the analyte at a location that is different from the location to which the capture binding member binds. 
     
     
         49 . The device according to  claim 48 , wherein the reporter binding member comprises a fluorescent label, an enzymatic label, a colorimetric label, or a radiolabel. 
     
     
         50 . The device according to  claim 46 , wherein the immobilized control agent binds the reporter binding member. 
     
     
         51 . The device according to  claim 44 , wherein the non-diagnostic analyte is a recombinant vector that is a recombinant retrovirus. 
     
     
         52 . The device according to  claim 51 , wherein the recombinant retrovirus is a recombinant lentivirus. 
     
     
         53 . The device according to  claim 44 , wherein the non-diagnostic analyte is a lentiviral protein. 
     
     
         54 . The device according to  claim 53 , wherein the lentiviral protein is p24. 
     
     
         55 . The device according to  claim 42 , wherein the analyte is a nucleic acid analyte. 
     
     
         56 . The device according to  claim 55 , wherein the nucleic acid analyte is DNA or RNA. 
     
     
         57 . The device according to  claim 56 , wherein the nucleic acid is amplified. 
     
     
         58 . The device according to  claim 44 , wherein the non-diagnostic analyte is a recombinant viral vector and the lateral flow assay device comprises a volume of viral vector packaging supernatant in the sample receiving region. 
     
     
         59 . The device according to  claim 58 , wherein the volume ranges from 5 μl to 20 μl or 50 μl to 200 μl. 
     
     
         60 . The device according to  claim 44 , wherein the non-diagnostic analyte is a recombinant vector and the amount of capture binding member present in the detection region captures a sufficient quantity of analyte attached to the reporter binding member to produce a visible signal when a concentration of recombinant vector sufficient to transduce target cells is present in the sample. 
     
     
         61 . The device according to  claim 60 , wherein the recombinant vector is a recombinant lentivirus and the analyte is p24. 
     
     
         62 . The device according to  claim 61 , wherein the concentration is greater than 5×10 5  infectious units per milliliter. 
     
     
         63 . A kit comprising the lateral flow assay device of  claim 42 . 
     
     
         64 . The kit according to  claim 63 , wherein the kit further comprises at least a second identical lateral flow assay device. 
     
     
         65 . The kit according to  claim 63 , wherein the kit further comprises instructions directing a user to apply a volume of viral packaging supernatant to the sample receiving region. 
     
     
         66 . The kit according to  claim 65 , wherein the volume ranges from 5 μl to 20 μl or 50 μl to 200 μl. 
     
     
         67 . The kit according to  claim 65 , wherein the instructions further direct the user to visually inspect the detection region of the lateral flow assay device to determine whether the recombinant vector is present in the viral packaging supernatant. 
     
     
         68 . The kit according to  claim 65 , wherein the instructions are present in the kit as printed information on a suitable medium or substrate. 
     
     
         69 . The kit according to  claim 65 , wherein the instructions are provided via a website. 
     
     
         70 . The kit according to  claim 63 , wherein the kit comprises a separate control for the analyte.