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Human papillomavirus testing using hybrid capture II with SurePath collection: initial evaluation and longitudinal
Vincent Ko1, Rosemary H Tambouret, Diane L Kuebler
1Division of Cytopathology, Department of Pathology, Massachusetts General Hospital, Boston, MA 02114, USA. vko@partners.org
Cancer
|November 9, 2006
Summary
Clinical validation of Hybrid Capture II (HC II) HPV testing with SurePath (SP) sample collection demonstrates its effectiveness in managing cervical cytology. This method shows strong similarity to FDA-validated tests, confirming its clinical validity for patient care.
Area of Science:
- Gynecologic Oncology
- Molecular Diagnostics
- Public Health
Background:
- Human papillomavirus (HPV) testing is crucial for managing equivocal cervical cytology.
- Clinical validation of non-FDA-approved HPV tests is essential due to high test volumes and potential for missed high-grade lesions.
Purpose of the Study:
- To clinically validate the Hybrid Capture II (HC II) HPV detection method with SurePath (SP) sample collection.
- To compare the performance of HC II with SP to established FDA-validated HPV testing methods.
Main Methods:
- Analysis of a preinitiation study and 17 months of follow-up data.
- Comparison of HPV test results with abnormal cytology and follow-up biopsy results.
- Determination of HPV-positive rates for LSIL and HSIL, and CIN follow-up rates for ASC-US cases.
Main Results:
- The HC II with SP method demonstrated 100% sensitivity for LSIL and HSIL detection.
- In ASC-US cases, CIN III+ rates were 7.8% (HPV+) vs. 1.4% (HPV-), and CIN II+ rates were 17.5% vs. 4.3%.
- Positive predictive value (PPV) and negative predictive value (NPV) for CIN II+ were 17.5% and 95.7%, respectively.
Conclusions:
- The HC II with SP method's performance closely mirrors published data from FDA-validated HPV tests.
- The study indicates strong clinical validity for utilizing HC II with SP in cervical cytology triage.
- This validates the use of HC II with SP for reliable HPV detection and patient management.
