HPV Testing Using Self-Collected vs Clinician-Collected Samples for the Detection of Cervical Intraepithelial Neoplasia
In a Dutch study (IMPROVE) reported in The Lancet Oncology, Polman et al found that human papillomavirus (HPV) testing with a clinically validated polymerase chain reaction (PCR)–based assay had similar accuracy using self-collected vs clinician-collected samples in detecting cervical intraepithelial neoplasia (CIN)2+ or CIN3+ lesions.
Study Details
In the noninferiority trial, women aged 29 to 61 years were invited to participate as part of regular screening invitation in the Netherlands. Eligible women were randomly allocated to a self-sampling group, in which women were requested to collect their own cervicovaginal sample using an Evalyn Brush (Rovers Medical Devices BV), or a clinician-based sampling group, in which samples were collected by a general practitioner with a Cervex-Brush (Rovers Medical Devices BV). All samples were tested for HPV using the clinically validated GP5+/6+ PCR enzyme immunoassay (Labo Biomedical Products BV). Women found to be HPV-positive in both groups were retested with the other collection method and triaged by cytology and repeat cytology in accordance with screening guidelines.
Primary endpoints were detection of CIN2+ and CIN3+. Noninferiority testing for self-collected vs clinician-collected samples used a margin of 90% for the relative sensitivity and 98% for relative specificity.
Testing Accuracy
Among 187,473 women invited to participate, 8,212 were randomly allocated to the self-sampling group and 8,198 to the clinician-based sampling group. After exclusion of ineligible women and those who did not return their sample, 7,643 women were included in the self-sampling group and 6,282 in the clinician-based sampling group.
Overall, 569 (7.4%) self-collected samples and 451 (7.2%) clinician-collected samples tested positive for HPV (relative risk = 1.04, 95% confidence interval = 0.92–1.17). Median follow-up for HPV-positive women was 20 months. No difference in HPV testing for CIN2+ in sensitivity or specificity was observed between self-sampling vs clinician-based sampling (relative sensitivity = 0.96, 95% CI = 0.90–1.03; relative specificity = 1.00, 95% CI = 0.99–1.01). Similarly, no difference in testing for CIN3+ was observed (relative sensitivity = 0.99, 95% CI = 0.91–1.08; relative specificity = 1.00, 95% CI = 0.99–1.01).
The investigators concluded, “HPV testing done with a clinically validated PCR-based assay had similar accuracy on self-collected and clinician-collected samples in terms of the detection of CIN2+ or CIN3+ lesions. These findings suggest that HPV self-sampling could be used as a primary screening method in routine screening.”
Johannes Berkhof, PhD, of Amsterdam UMC, Vrije Universiteit Amsterdam, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by the Ministry of Health, Welfare, and Sport (Netherlands) and the European Commission. The study authors' full disclosures can be found at thelancet.com.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
