Stability of PreservCyt® for Hybrid Capture® (HC II) HPV test

The Food and Drug Administration (FDA) has approved the Hybrid Capture® II (HC II) assay to test for the presence of high-risk types of human papilloma virus (HPV) DNA using specimens in PreservCyt® fixative for up to 21 days after collection. The ability of HC II to determine the presence of HPV DNA in actual patient samples after longer periods of storage has not been shown. To determine if specimens older than 21 days can yield useful results, 207 patient specimens that had been tested for HPV DNA by HC II (primary test) were tested again after a significant period of storage ranging from approximately 2.5 to 13.5 mo (retest). The results of the primary test and the retest agreed in 86% of the cases. The high level of agreement in the results suggests that the presence of high-risk types of HPV DNA can be determined from actual cervical cytology material in PreservCyt® with the HC II assay for at least 3 mo after specimen collection.