Methods for Detecting Papillomavirus DNA in Blood Plasma and Serum

Abstract

This invention relates to the detection of extracellular papillomavirus DNA in blood plasma or serum from a human or animal. In particular, the invention relates to the detection, identification, evaluation, or monitoring of neoplastic, premalignant or malignant disease associated with a papillomavirus. The invention thereby provides methods for the identification of individuals at risk for, or having, cervical dysplasia, cervical intraepithelial neoplasia, or cervical cancer.

1 . A kit for detecting human papillomavirus DNA from plasma or serum from a human, wherein the kit comprises at least one reagent for extracting human papillomavirus DNA from plasma or serum or at least one or a plurality of primers or probes that specifically hybridize to human papillomavirus DNA extracted from plasma or serum, or both at least one extracting reagent and at least one specifically-hybridizing primer or probe. 
     
     
         2 . A kit according to  claim 1  comprising at least one or a plurality of primers or probes that specifically hybridize to human papillomavirus DNA extracted from plasma or serum and further comprising at least one or a plurality of deoxynucleotide triphosphates. 
     
     
         3 . A kit according to  claim 3 , further comprising a thermostable polymerase. 
     
     
         4 . A kit according to  claims 1 ,  2  or  3 , wherein the human papillomavirus DNA is a human papillomavirus subtype associated with cervical cancer. 
     
     
         5 . A kit for detecting human papillomavirus RNA from plasma or serum from a human, wherein the kit comprises at least one reagent for extracting human papillomavirus RNA from plasma or serum or at least one or a plurality of primers or probes that specifically hybridize to human papillomavirus RNA extracted from plasma or serum or cDNA derived therefrom, or both at least one extracting reagent and at least one specifically-hybridizing primer or probe. 
     
     
         6 . A kit according to  claim 5  comprising at least one or a plurality of primers or probes that specifically hybridize to human papillomavirus RNA extracted from plasma or serum or cDNA derived therefrom, and further comprising a reverse transcriptase. 
     
     
         7 . A kit according to  claim 5  comprising at least one or a plurality of primers or probes that specifically hybridize to cDNA derived from human papillomavirus RNA extracted from plasma or serum and further comprising a thermostable polymerase. 
     
     
         8 . A kit according to  claim 6  comprising at least one or a plurality of primers or probes that specifically hybridize to cDNA derived from human papillomavirus RNA extracted from plasma or serum and further comprising a thermostable polymerase. 
     
     
         9 . A kit according to  claims 5 ,  6 ,  7  or  8 , wherein the human papillomavirus RNA is from a human papillomavirus subtype associated with cervical cancer.