HPV self-sampling and urine HPV testing have the potential to increase cervical cancer screening completion among under- and never-screened women. Cytology and high-risk (hr) HPV testing currently rely on cervical specimens collected by medical personnel during a pelvic examination. Self-sampling of specimens could provide a simple and scalable alternative to physician collection, through non-invasive screening methods that may be more acceptable to women. Screening by self-samples or urine samples could also reduce the need and expense for trained medical personnel to complete primary screening via pelvic exam, with referral of only hrHPV self-test positive women to confirmation and/or treatment.
Self-collected specimens and physician-collected specimens have similar HPV detection results overall. However, a systematic review found that the pooled sensitivity of HPV in self-collected samples was somewhat lower than in physician-collected samples (0·88; 95% CI: 0·85-0·91) for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+), with a slightly lower specificity of self-collection (0·96; 0·95-0·97) vs physician HPV testing. Similar sensitivity for self-collection was observed in studies utilizing a PCR-based HPV test (1).
Urine testing has been shown to compare favorably to physician-collected cervical sampling for detection of HPV infection, but to have less than optimal clinical sensitivity for the detection of high-grade cervical lesions by cytology or histology. Promising data were found among colposcopy patients in Oklahoma using first-void urine samples with the Trovagene test, with a high sensitivity for detecting 26 cases of CIN2+ (96%). In North Carolina (NC), we conducted a pilot study of colposcopy patients, finding testing of initial stream urine samples with Trovagene assay to be highly sensitive for detection of 11 CIN2+ cases (88%). In another NC pilot study, we found high sensitivity (90.9%) of the Onclarity assay in initial stream urine samples for the detection of 11 CIN2+ cases. While this preliminary research is highly promising, sample sizes restrict statistical power and have been limited to colposcopy patients. It is necessary to evaluate HPV urine testing with a greater number of CIN2+ cases in the screening population.
For primary screening (opportunities for all), there is substantial potential for the use of both HPV self-sampling and urine sampling to conduct large-scale screening of populations. For women found to be HPV-positive on either the self-sampling or urine sampling tests (selective screening), further research is ongoing to identify biomarkers to optimally triage strategies.
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[1. Arbyn M et al. Lancet Oncol. 2014;15:172-83.]