Direct reading detection kits for surface contamination by antineoplastic drugs

Abstract

Methods, kits and devices for detecting antineoplastic drug contamination of a surface are provided according to aspects of the present invention. According to aspects of the invention, methods for detecting antineoplastic drug contamination of a surface include providing a wetting solution compatible with the antineoplastic drug and formulated to promote release of the drug from the surface to be assayed; providing a solid matrix for reversible absorption of the antineoplastic drug; contacting the solid matrix with the wetting solution, generating an assay matrix; contacting the assay matrix and the surface, generating a surface sample; contacting the surface sample with a volume of wetting solution, generating a fluid test sample; and quantifying the antineoplastic drug in the fluid test sample by lateral flow assay to produce an assay result, thereby detecting antineoplastic drug contamination of the surface.

1 - 28 . (canceled) 
     
     
         29 . A competitive lateral flow assay device comprising:
 a conjugate pad, a solid or semi-solid porous support adjacent the conjugate pad, a test zone present on the support and a control zone present on the support, wherein the conjugate pad comprises a diffusibly bound detectably labeled anti-antineoplastic drug antibody to which the antineoplastic drug binds, wherein the test zone comprises a non-diffusibly bound antineoplastic drug which binds to the anti-antineoplastic drug antibody and the control zone comprises a non-diffusibly bound control reagent that binds specifically to the anti-antineoplastic drug antibody, wherein the solid or semi-solid porous support is adjacent a wicking pad that promotes the capillary flow of a fluid test sample along a flow path including the conjugate pad and the solid or semi-solid porous support, and   a fluid test sample disposed in the competitive lateral flow assay device, said fluid test sample comprising 0.01-10% v/v of a non-ionic surfactant, wherein the fluid test sample was prepared by:
 providing a solid matrix for reversible absorption of the antineoplastic drug from a surface; 
 contacting the solid matrix with a wetting solution comprising 0.01-10% v/v of the non-ionic surfactant, generating an assay matrix; 
 contacting the assay matrix and the surface, generating a surface sample; 
 contacting the surface sample with a volume of the wetting solution, generating the fluid test sample. 
   
     
     
         30 . The device of  claim 29 , wherein the wetting solution further comprise a buffer and 0.01-10% v/v of an organic solvent. 
     
     
         31 . The device of  claim 30 , wherein the organic solvent is an organic polar protic solvent. 
     
     
         32 . The device of  claim 29 , wherein the control reagent is an antibody which binds specifically to the anti-antineoplastic drug antibody. 
     
     
         33 . The device of  claim 29 , further comprising a housing at least partially enclosing the conjugate pad, the solid or semi-solid porous support, and/or the wicking pad. 
     
     
         34 . The device of  claim 29 , wherein the antineoplastic drug is selected from the group consisting of: doxorubicin, paclitaxel and 5-fluorouracil. 
     
     
         35 . A system for assaying for antineoplastic drug contamination of a surface comprising:
 the competitive lateral flow assay device of  claim 29 , and   an electronic reader for detecting an assay result of the lateral flow assay device, the electronic reader comprising:
 an optical detection device and 
 hardware and software components for computer implemented analysis of detected lateral flow assay results. 
   
     
     
         36 . A method of analyzing the line intensities of a competitive lateral flow assay device, the method comprising:
 obtaining a sample line intensity measurement from a competitive lateral flow assay device using an electronic reader;   determining the amount of antineoplastic drug present in the sample by fitting the sample line intensity measurement to a calibration curve, wherein the calibration curve is prepared by:
 calculating % B/Bo, wherein B is a test line intensity at given mass and Bo is a test line intensity at 0 mass; 
 plotting % B/Bo against spiked mass of an antineoplastic drug for spiked controls; 
 fitting % B/Bo for the spiked controls against log of spiked mass to produce the calibration curve.