# US 2010/0167269 A1 · Detection method for human pappilomavirus (HPV) and its application in cervical Cancer > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2010/0167269 A1 - Document ID: US20100167269A1 - Status: Published application - Kind: A1 - Application number: 12/589,692 - Filed: 2009-10-26 - Published: 2010-07-01 - Earliest claimed: 2005-11-15 - Inventors: Shuling Cheng - Web page: https://patentgrep.com/patent/US20100167269A1 ## CPC - C12Q 1/708: {for papilloma} - C07K 14/005: from viruses - C12N 2710/20022: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes - C12N 2710/20051: Methods of production or purification of viral material - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) ## Abstract Embodiments of the invention provide methods, assays, and kits for detecting HPV infection and HPV associated epithelial cell abnormalities, most notably those associated with pre-malignant and malignant epithelial cell lesions. Detection of HPV DNAs, genomes, and/or oncoproteins by nucleic acid hybridization assays and immunological assays can be used in early clinical screening for HPV infection and diagnosis for cervical cancer. The polypeptides, recombinant proteins, antibodies, nucleic acids, and various detection methods thereof are particularly useful for diagnosing carcinomas of the uterine cervix and those at risk of developing cervical cancer. ## Claims ### Claim 1 A method of screening a human subject infected with a human papillomavirus, comprising: obtaining a clinical sample from the human subject; conducting a nucleic acid hybridization assay on the clinical sample; detecting the presence of a papillomavirus genome in the clinical sample from the human subject; conducting one or more immunological assays on the clinical sample; detecting the presence of an antibody to an early papillomavirus viral protein or the presence of the early papillomavirus viral protein in the clinical sample using a first recombinant protein of the early papillomavirus viral protein; and detecting the presence of an antibody to a late papillomavirus viral protein or the presence of the papillomavirus late viral protein in the clinical sample using a second recombinant protein of the late papillomavirus viral protein. ### Claim 2 (depends on 1) The method of claim 1, further comprising performing a cytological papanicolaou smear assay on the clinical sample and comparing the results of the cytological papanicolaou smear assay with the results for the presence of the papillomavirus genome and the results of the one or more immunological assays. ### Claim 3 (depends on 1) The method of claim 1, wherein the nucleic acid hybridization assay is selected from the group consisting of polymerase chain reactions, nucleic acid hybridization assays, DNA chip assays, radioactive nucleic acid hybridization and detection assays, and non-radioactive nucleic acid hybridization and detection assays. ### Claim 4 (depends on 1) The method of claim 1, wherein the presence of the papillomavirus genome is detected using a nucleic acid probe with sequence homology to conservative DNA sequences from a gene selected from the group consisting of papillomavirus late genes, L1 genes, L2 genes, papillomavirus early genes, E2 genes, E6 genes, E7 genes, and combinations thereof. ### Claim 5 (depends on 1) The method of claim 1, wherein the human papillomavirus is selected from the group consisting of high risk HPV types, low risk HPV types, HPV-16, HPV-18, HPV-31, HPV-33, HPV-35, HPV-39, HPV-45, HPV-51, HPV-52, HPV-56, HPV-58, HPV-59, and HPV-68, HPV-6, HPV-11, HPV-42, HPV-43, HPV-44, HPV-53, HPV-54, HPV-55, and HPV-56, and combinations thereof. ### Claim 6 (depends on 1) The method of claim 1, wherein the one or more immunological assays are selected from the group consisting of ELISA, antigen assays for papillomavirus proteins, antibody assays for antibodies against papillomavirus proteins, assays for papillomavirus immunocomplexes, protein chip assays, radioimmunopercipitation assays, rapid membrane immunochromatographic assays, rapid stick immunochromatographic assays. ### Claim 7 (depends on 1) The method of claim 1, wherein the early papillomavirus viral protein is selected from the group consisting of HPV-16 E6 proteins, HPV-16 E7 proteins, HPV-18 E6 proteins, HPV-18 E7 proteins, and combinations thereof. ### Claim 8 (depends on 1) The method of claim 1, wherein the late papillomavirus viral protein is selected from the group consisting of HPV-16 L1 proteins, HPV-18 L1 proteins, and combinations thereof. ### Claim 9 (depends on 1) The method of claim 1, wherein the clinical sample is selected from the group consisting of cervical cells, cervical tissues, cervical swabs, body fluids, serum, blood, tumors, and combination thereof. ### Claim 10 A method of screening a human subject of high risk human papillomavirus infection, comprising: obtaining a clinical sample from the human subject; obtaining a first recombinant protein purified from a first protein expression system with a first expression vector having a portion of nucleic acid sequence corresponding to the full length nucleic acid sequence of an early papillomavirus gene; obtaining a second recombinant protein purified from a second protein expression system with a second expression vector having a portion of nucleic acid sequence corresponding to the full length nucleic acid sequence of a late papillomavirus gene; conducting one or more immunological assays on the clinical sample; detecting the presence of an antibody to a viral oncoprotein or the presence of the viral oncoprotein in the clinical sample using the first recombinant protein; and detecting the presence of an antibody to a viral capsid protein or the presence of the viral capsid protein in the clinical sample using the second recombinant protein. ### Claim 11 (depends on 10) The method of claim 10, wherein the first recombinant protein is selected from the group consisting of recombinant HPV-16 E6 proteins, recombinant HPV-16 E7 proteins, recombinant HPV-18 E6 proteins, recombinant HPV-18 E7 proteins, and combinations thereof. ### Claim 12 (depends on 10) The method of claim 10, wherein the second recombinant protein is selected from the group consisting of recombinant HPV-16 L1 proteins, recombinant HPV-18 L1 proteins, and combinations thereof. ### Claim 13 (depends on 10) The method of claim 10, wherein the clinical sample is selected from the group consisting of cervical cells, cervical tissues, cervical swabs, body fluids, serum, blood, tumors, and combination thereof. ### Claim 14 (depends on 10) The method of claim 10, further comprising performing a cytological papanicolaou smear assay on the clinical sample and comparing the results of the cytological papanicolaou smear assay with the results of the one or more immunological assays. ### Claim 15 (depends on 10) The method of claim 10, wherein the early papillomavirus gene is selected from the group consisting of papillomavirus E6 genes, papillomavirus E7 genes, and combinations thereof. ### Claim 16 (depends on 10) The method of claim 10, wherein the late papillomavirus gene is selected from the group consisting of papillomavirus L1 genes, papillomavirus L2 genes, and combinations thereof. ### Claim 17 (depends on 10) The method of claim 10, wherein the one or more immunological assays are selected from the group consisting of ELISA, antigen assays for papillomavirus proteins, antibody assays for antibodies against papillomavirus proteins, assays for papillomavirus immunocomplexes, protein chip assays, radioimmunopercipitation assays, rapid membrane immunochromatographic assays, rapid stick immunochromatographic assays. ### Claim 18 (depends on 10) The method of claim 10, wherein the high risk human papillomavirus is selected from the group consisting of HPV-16 and HPV-18.