HPV / DNA testing: technical and programmatic issues for cervical cancer prevention in low-resource settings.

Abstract

Several technologies exist for the molecular detection of HPV infection. Most of these technologies while sensitive and specific are too costly and cumbersome to incorporate into large-scale screening programs. Recently molecular diagnostic kits have been tested in developed and developing countries through several large research projects incorporating HPV screening into cervical dysplasia detection programs. Currently two commercially available molecular diagnostic kits have been approved by the United States Food and Drug Administration (US FDA) and field-tested in the developing world. Both kits the Hybrid Capture Tube test and the Hybrid Capture II test (HC II) are produced by the Digene Corporation (Gaithersburg Maryland). Molecular-based HPV diagnostics remain largely untested in broad screening programs however. Research and pilot projects are under way in several countries to clarify the diagnostic clinical and programmatic implications of HPV screening for cervical cancer prevention. This document provides a summary of HPV as it relates to cervical cancer and examines the molecular technologies currently available for detecting HPV. Particular emphasis is placed on assessing the suitability of these diagnostic tests for use in cervical cancer prevention programs in developing countries. (excerpt)