Comparison of HR HPV Positive Rates Using the HC2 Versus the Cervista Test in Women 30 Years of Age or Older with NILM Cytology Results and Clinical Follow-Up
Christina Duckworth, Michael Hoskins, Krisztina Z Hanley. Emory University, Atlanta, GA
Background: The FDA approved Cervista HPV HR test similarly to the Hybrid Capture 2 (HC2), is used as a triage test for women with ASC-US cytology and as an adjunctive screening test in women 30 years or older. Advantages of the Cervista compared to the HC2 are smaller sample requirement and an internal DNA control. Studies showed that HPV HR positivity rates in women 30 or older with NILM cytology results are similar with the two methods. While there was concern about the performance of Cervista in the older women, studies have shown similar HPV HR positive rates as age increases with both tests. The goal of study was to compare HPV HR positive rates with HC2 and Cervista in women 30 or older with NILM cytology results.
Design: We retrospectively reviewed cervical cytology and HPV test results using the HC2 method from March 2008 to February 2009 from women 30 years of age or older with NILM cytology and positive HPV results. Similar selection criteria were used for the period of May 2009 to April 2010, with the difference that HPV testing was done by the Cervista test. Clinicopathologic follow-up data was reviewed in both groups.
Results: For the HC2 group 2311 women met our criteria. There were 138/2311 (5.97%) women with NILM Pap and HPV HR positive results. In the Cervista group 2213 women were included, and 135/2213 (6.1%) had NILM cytology and positive HPV HR results. Clinical follow-up was available in 23 (17%) of patients from the HC2 and 22 (16.2%) from the Cervista group.
Follow-up in the HC2 group (23): NILM, HPV – (11); NILM, HPV+ (4); ASC-US, HPV+ (4); CIN II (2); CIN III (1).
Follow-up in the Cervista group (22): NILM, HPV – (15); NILM, HPV+ (3); ASC-US, HPV+ (1); CIN I (1), CIN II (1); CIN III (1).
Conclusions: HR HPV positivity rates in women 30 or older with NILM cytology are comparable with two methods (5.97% vs. 6.1%).
While follow-up data was available for only a small number of patients, majority had negative (NILM, HPV-) follow up results, regardless of which HPV test was used.
Importantly both tests identified a small subset of women with clinically significant lesions, reflecting comparable sensitivity of the two tests.
Per ASCCP guidelines women 30 or older with NILM cytology and positive HR HPV test results should undergo repeat testing (Pap and HPV) at 12 months. Our data suggest that these recommendations are not strictly followed. While some women undergo repeat testing or further work-up sooner than 12 months, majority of patients had no follow-up.
Tuesday, March 20, 2012 9:30 AM
Poster Session III # 41, Tuesday Morning