Immunological methodology for discerning human papillomavirus contemplating peptides from the E7 early coding region of HPV 16

Abstract

The invention provides peptides designed to be highly reactive with antibodies from patients infected with oncogenic HPV. Also disclosed is a method for their use in an immunoassay to detect HPV infection and HPV associated epithelial cell abnormalities, most notably those associated with premalignant and malignant epithelial cell lesions. The peptides and the disclosed method are particularly useful for diagnosing carcinomas of the uterine cervix, or pre-stages thereof, or those at risk of development of carcinoma. The detection can be effected on blood samples, or other bodily fluid or tissue, by ascertaining the presence of IgA or IgG antibodies against HPV 16 and/or 18.

Description

RELATED APPLICATIONS [0001] This application claims the benefit of co-pending U.S. patent application Ser. No. 09 / 828,645, filed Apr. 5, 2001, and entitled “IMMUNOLOGICAL METHODOLOGY FOR DISCERNING HUMAN PAPILLOMAVIRUS,” which claims the benefit of U.S. provisional patent application Ser. No. 60 / 194,796, filed Apr. 5, 2000, and entitled “IMMUNOLOGICAL METHODOLOGY FOR DISCERNING HUMAN PAPILLOMAVIRUS,” which are hereby incorporated herein by reference.BACKGROUND [0002] 1. Field of the Invention [0003] The present invention relates generally to the field of peptides reactive with antibodies directed against HPV. Some have termed this type of peptide as antigenic or immunoreactive. More particularly, the invention relates to peptides derived from the early coding region of the E2, E6, and E7 oncoproteins of human papillomavirus [HPV] and a method for their use for the diagnosis of HPV associated epithelial cell abnormalities via an immunoassay. [0004] 2. The Background Art [0005] The hu...

AI Technical Summary

Benefits of technology

[0010] Indeed, the E6 and E7 oncoproteins appear natural targets for antibody production due to their consistent expression in cervical cancer cells. The response against the E7 one in earlier studies had only been moderately disease specific, but E7 IgG and IgA have now been verified as strongly disease associated. Antibodies against the E6 and E7 oncoproteins are at high levels in sera from cervical cancer patients compared against non-cancer controls. Moreover, such antibodies seem detectable by immunological means even when present in lesser amounts. Sensitivity for identifying HPV infections and possible cancers increases with a combination of serological tests of multiple virus proteins. Hence, using both oncoproteins yields positive immunological results with samples from cervical cancer patients.

[0011] The main method for public health screening for cervical cancer has been the Papanicolaou smear. For a variety of reasons, the Papanicolaou smear is less than an ideal screening test. Drawbacks include difficulty of obtaining sampl

Problems solved by technology

The virus infects cervical and other cells that can support virus propagation, where it causes abnormal cellular changes that can lead to life threatening malignancies.

Drawbacks include difficulty of obtaining samples, high rate of false negatives (up to 20%), and requ

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