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Stability of PreservCyt for Hybrid Capture (HC II) HPV test
J Sailors1, R Gander, M H Saboorian
1Department of Pathology, University of Texas Southwestern Medical Center, Dallas, 75390, USA.
Diagnostic Cytopathology
|April 15, 2005
Summary
The Hybrid Capture II assay can reliably detect high-risk human papillomavirus (HPV) DNA in cervical samples stored for over three months. This finding extends the utility of HPV testing beyond the initial 21-day FDA approval period.
Area of Science:
- Clinical Diagnostics
- Molecular Virology
- Gynecologic Oncology
Background:
- The FDA-approved Hybrid Capture II (HC II) assay detects high-risk human papillomavirus (HPV) DNA in PreservCyt-fixed specimens for up to 21 days.
- Limited data exists on the HC II assay's performance with patient samples stored for extended periods beyond 21 days.
Purpose of the Study:
- To evaluate the reliability of the HC II assay for detecting high-risk HPV DNA in cervical specimens stored for longer than the FDA-approved 21-day limit.
- To determine if extended storage impacts the accuracy of HPV DNA detection.
Main Methods:
- A total of 207 patient cervical specimens, previously tested for HPV DNA using the HC II assay, were retested after storage.
- Specimen storage duration ranged from approximately 2.5 to 13.5 months.
- Results from the primary HC II test were compared with results from the retest after extended storage.
Main Results:
- The results of the primary HPV DNA test and the retest showed agreement in 86% of the cases.
- This high agreement rate indicates consistent performance of the HC II assay despite prolonged storage.
Conclusions:
- The HC II assay can accurately detect high-risk HPV DNA in cervical cytology specimens preserved in PreservCyt for at least three months.
- These findings suggest that the 21-day storage limitation for HPV testing may be extended, offering greater flexibility in clinical practice.