Darrel A Cook1, Laurie W Smith2, Jennifer Law3, Wendy Mei3, Dirk J van Niekerk4, Kathy Ceballos4, Lovedeep Gondara2, Eduardo L Franco5, Andrew J Coldman6, Gina S Ogilvie7, Dan Jang8, Max Chernesky8, Mel Krajden9. 1. BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada; BC Centre for Disease Control, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada. 2. BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada. 3. Lower Mainland Laboratories, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada. 4. BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada; Lower Mainland Laboratories, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada; University of British Columbia, Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada. 5. McGill University, Division of Cancer Epidemiology, 546 Pine Ave W, Montreal, QC, H2W 1S6, Canada. 6. BC Cancer Agency, 675 West 10th Ave, Vancouver, BC, V5Z 1L3, Canada; University of British Columbia, Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada. 7. BC Centre for Disease Control, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada; University of British Columbia, Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada. 8. McMaster University/St. Joseph's Healthcare, 50 Charlton Ave E, Hamilton, ON, L8N 4A6, Canada. 9. BC Centre for Disease Control, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada; Lower Mainland Laboratories, 655 West 12th Ave, Vancouver, BC, V5Z 4R4, Canada; University of British Columbia, Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada. Electronic address: mel.krajden@bccdc.ca.
Abstract
BACKGROUND: Cervical cancer screening programs are switching from Pap screening to high-risk HPV testing. OBJECTIVES: To compare the Aptima HPV Assay (AHPV) with the Hybrid Capture®2 High-Risk HPV DNA Test® (HC2) for primary cervical screening. STUDY DESIGN: HPV FOCAL is a randomized trial comparing HC2 to liquid-based cytology (LBC) for screening women aged 25-65. AHPV and HC2 were compared at the baseline screen (n=3473). Genotyping was by the Aptima HPV 16 18/45 Genotype Assay. We assessed HPV genotyping and reflex LBC for colposcopy triage. RESULTS:AHPV/HC2 agreement was 96.5% (kappa 0.76); positive agreement was 77.4%. The AHPV positive rate was 7.2% vs. 8.4% for HC2 (p=0.06). Based on HC2 screening, round 1 CIN2 and CIN3+ rates were 9.2/1000 and 5.2/1000 respectively. Using HC2 as the comparator test, AHPV CIN2+ and CIN3+ relative sensitivities were 0.96 and 1.00 (p=1.00) respectively. High-grade reflex LBC and HPV 16 infection were significantly associated with CIN3+. AHPV specificity was 0.94 vs. 0.93 (p=0.05) for HC2. Compared with triage of HC2+ with abnormal cytology or HPV persistence for 12 months, colposcopy referral would be significantly reduced (38.3/1000 vs. 60.8/1000; p<0.001) if AHPV+ women with abnormal LBC and HPV 16/18/45 were referred at baseline. CIN2+ and CIN3+ detection rates were not significantly different for the two strategies. CONCLUSIONS:AHPV vs. HC2 screening had equivalent CIN2+ and CIN3+ detection. Triage of AHPV+ by abnormal reflex LBC and the presence of HPV 16/18/45 would result in a significantly lower colposcopy referral rate with similar CIN2+ and CIN3+ detection rates as the overall HC2+ referral algorithm.
RCT Entities:
BACKGROUND: Cervical cancer screening programs are switching from Pap screening to high-risk HPV testing. OBJECTIVES: To compare the Aptima HPV Assay (AHPV) with the Hybrid Capture® 2 High-Risk HPV DNA Test® (HC2) for primary cervical screening. STUDY DESIGN: HPV FOCAL is a randomized trial comparing HC2 to liquid-based cytology (LBC) for screening women aged 25-65. AHPV and HC2 were compared at the baseline screen (n=3473). Genotyping was by the Aptima HPV 16 18/45 Genotype Assay. We assessed HPV genotyping and reflex LBC for colposcopy triage. RESULTS: AHPV/HC2 agreement was 96.5% (kappa 0.76); positive agreement was 77.4%. The AHPV positive rate was 7.2% vs. 8.4% for HC2 (p=0.06). Based on HC2 screening, round 1 CIN2 and CIN3+ rates were 9.2/1000 and 5.2/1000 respectively. Using HC2 as the comparator test, AHPV CIN2+ and CIN3+ relative sensitivities were 0.96 and 1.00 (p=1.00) respectively. High-grade reflex LBC and HPV 16infection were significantly associated with CIN3+. AHPV specificity was 0.94 vs. 0.93 (p=0.05) for HC2. Compared with triage of HC2+ with abnormal cytology or HPV persistence for 12 months, colposcopy referral would be significantly reduced (38.3/1000 vs. 60.8/1000; p<0.001) if AHPV+ women with abnormal LBC and HPV 16/18/45 were referred at baseline. CIN2+ and CIN3+ detection rates were not significantly different for the two strategies. CONCLUSIONS: AHPV vs. HC2 screening had equivalent CIN2+ and CIN3+ detection. Triage of AHPV+ by abnormal reflex LBC and the presence of HPV 16/18/45 would result in a significantly lower colposcopy referral rate with similar CIN2+ and CIN3+ detection rates as the overall HC2+ referral algorithm.
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