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Context:
In 2002, the American Society for Colposcopy and Cervical Pathology (ASCCP) introduced follow-up guidelines recommending High Risk (HR) Human Papilloma Virus (HPV) testing for patients with liquid-based Pap tests interpreted as Atypical Squamous Cells of Undetermined Significance (ASC-US).
Objective:
To determine if SurePath™ (SP) liquid-based Pap testing with Digene Hybrid Capture® 2 (HCII) HR HPV testing increases agreement between ASC-US Pap tests and follow-up cervical biopsies over conventional Papanicolaou (Pap) smears alone.
Methods:
In June 2003, our laboratory completed 100% conversion from conventional Pap smears to SP Pap testing, adding HCII HR HPV testing for Pap tests interpreted as ASC-US. Prior to conversion, all patients with ASC-US Pap smears were referred for cervical biopsy.
Follow-up biopsy diagnoses from SP ASC-US Pap tests with positive HR HCII HPV results collected from June through December 2003 were compared to biopsy diagnoses from conventional Pap smears collected from June through December 2002. From 26,975 SP Pap tests collected in 2003, 458 had ASC-US interpretations with positive HR HPV results; 278 biopsies were collected. In 2002, 30,724 conventional Pap smears were collected. 814 were interpreted as ASC-US with 479 biopsies collected.
A retrospective review performed in our department compared the percentages of patients referred for cervical biopsy, cervical intraepithelial neoplasm (CIN) detected on cervical biopsy, and cervical biopsies diagnosed as No Evidence of Dysplasia (NED).
Results:
Patients referred for colposcopic biopsy decreased by 25.92% from 2002 to 2003 with a 17.28% increase in CIN detection and a 21.31% reduction of biopsies diagnosed as NED.
Conclusions:
SurePath™ liquid-based Pap testing with Digene HCII testing for HR HPV has increased CIN detection on biopsy while decreasing the percentages of patients referred for colposcopy and biopsies diagnosed as NED. This change provides a more effective method of screening patients for cervical disease than conventional Pap smears alone.
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See more of The 2005 Institute for Quality in Laboratory Medicine Conference