Protein Chips for HPV Detection

Abstract

Embodiments of the invention provide methods, assays, and kits for detecting HPV infection, including infection by various HPV genotypes, early and / or late HPV-associated or HPV-specific proteins or antibodies. Detection of HPV DNAs, genomes, and / or oncoproteins by protein chips immunological assays can be used in early clinical screening for HPV infection and general diagnosis for cervical cancer and can be advantageous performed in a multiplexed test. Comparative detection of altered levels of HPV proteins and host proteins can performed in one or more assays. 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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This instant application is a continuation of U.S. patent application Ser. No. 12 / 082,740 filed on Apr. 14, 2008 and entitled “Protein Chips for HPV Detection” that claims benefit of U.S. Provisional Patent App. Ser. No. 60 / 911,802 filed on Apr. 13, 2007 and entitled “Protein Chips for Human Pappilomavirus (HPV) Detection”. U.S. patent application Ser. No. 12 / 082,740 filed Apr. 14, 2008 is a continuation-in-part of co-pending U.S. patent application Ser. No. 12 / 009,398 filed on Jan. 19, 2008 and entitled “Detection Method for Human Pappilomavirus (HPV) and Its Application in Cervical Cancer”, and U.S. Pat. No. 7,732,166 filed on Nov. 13, 2006 and entitled “Detection Method for Human Pappilomavirus (HPV) and Its Application in Cervical Cancer” that claims benefit of U.S. Provisional Patent App. Ser. No. 60 / 737,152 filed on Nov. 15, 2005 and entitled “Immunological Methods Detect Oncogenic Proteins or Serologic Responses to Hgh-Risk Groups ...

AI Technical Summary

Benefits of technology

This approach provides a sensitive, specific, and cost-effective method for HPV detection, suitable for routine clinical use, allowing for early diagnosis and screening of cervical cancer.

Problems solved by technology

The presence of these lesions, preferentially observed in women aged 35-40 yrs, is at high risk of progression toward invasive cancer.

However, the development of cervical cancer is a multiple step process that cannot be explained simply by infection with specific types of HPV.

It is found that younger age group women are often infected with HPV; however, clinical information reveals that most latent or asymptomatic infections with high risk HPV types as well as early dysplastic lesions (CIN 1) are usually self-limited and regress spontaneously.

However, due to subjective test criteria, drawbacks of pap smear tests include difficulty in obtaining samples, poor inter- and intra-observer agreement, a high rate of false negatives (up to 20%) and false positive, the requirements for specialized labs staffed with highly trained personnel, and inability to identify a large proportion of HPV-infected persons.

Nucleic acid methods, such as “DNA Hybrid Capture”, have been developed, but are not ideal primarily due to their high cost, assay operation procedures, and the requirements for facility, equipment, and highly trained personnel.

Attempts to detect the presence of HPV related antibodies in a human subject by ELISA (enzyme linked immunosorbent assays) generally lead to extremely low assay sensitivity and thus can not be developed into a commercially suitable diagnostic test.

Thus, there has not been successful ELISA assays available as a diagnostic tool for clinical samples.

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