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Current methods of testing for human papillomavirus
P Davies1, J Kornegay, T Iftner
1BMI Health Services, The Advanced Diagnostic Centre, Cumberland House, Victoria Road, London, NW10 6RF, UK.
Best Practice & Research. Clinical Obstetrics & Gynaecology
|September 21, 2001
Summary
Standardized human papillomavirus (HPV) DNA testing is crucial for clinical labs. Commercially available, quality-controlled HPV tests are needed for reliable results alongside cervical cytology.
Area of Science:
- Molecular diagnostics
- Gynecologic oncology
- Virology
Background:
- Human papillomavirus (HPV) DNA testing is increasingly accepted but often uses research-based protocols unsuitable for clinical settings.
- Widespread clinical HPV DNA testing is anticipated as an adjunct to cervical cytology, necessitating adaptation for cytology laboratories.
- Implementation requires tests manageable by technicians without specialized virology or molecular biology training, ensuring consistent, reliable results.
Purpose of the Study:
- To review the technological basis and performance data of commercially available and research-based HPV DNA testing assays.
- To evaluate the clinical utility of HPV DNA tests for integration into routine cervical cancer screening programs.
Main Methods:
- Review of existing literature on HPV DNA testing technologies.
- Analysis of performance data from various HPV DNA assays.
- Evaluation of clinical utility based on published studies.
Main Results:
- Currently, only one standardized, quality-controlled commercial HPV DNA assay is available for clinical use.
- Several research-based assays show potential for future commercial development.
- The performance and clinical utility of these assays vary, requiring careful selection for laboratory implementation.
Conclusions:
- Standardized, quality-controlled commercial HPV DNA tests are essential for reliable implementation in clinical cytology laboratories.
- Further development and validation of commercial HPV assays are needed to support large-scale clinical use.
- The integration of HPV DNA testing into cervical cancer screening requires careful consideration of assay technology, performance, and laboratory workflow.