Evaluation of clinical performance of a novel urine-based HPV detection assay among women attending a colposcopy clinic

Abstract

Background Human papillomavirus (HPV) testing in urine offers a convenient approach for cervical cancer screening but has previously suffered from limited clinical sensitivity. Objectives We evaluated clinical performance of the prototype Trovagene HPV test, a novel polymerase chain reaction assay that targets the E1 region of the HPV genome and detects and amplifies short fragments of cell-free HPV DNA in urine. Study design We conducted a pilot study among seventy two women referred to colposcopy following abnormal screening. Participants provided a urine sample prior to clinician-collected cervical sampling and colposcopically-directed punch biopsy. Trovagene HPV test results on urine samples were compared with cervical and urine testing by Linear Array HPV Genotyping Test (LA-HPV) for detection of histologically-confirmed cervical precancerous lesions. Results There was high concordance between urine samples tested by the Trovagene HPV test and corresponding cervical (87.5%) and urine (81.9%) samples tested by LA-HPV. The Trovagene HPV test had high sensitivity (92.3% for detecting CIN2/3, and 100% for CIN3), comparable to LA-HPV testing on cervical samples (96.0% and 100%, respectively), and higher than LA-HPV testing on urine samples (80.8% and 90.0%, respectively). In this referral population, the specificity of the Trovagene urine HPV test was non-significantly lower (29% f CIN2/3 and 25% for CIN3) than corresponding estimates of LA-HPV testing on cervical (36% and 28%, respectively) and urine (42% and 38%, respectively) samples. Conclusions This pilot study suggests that the Trovagene HPV test has high sensitivity for urine-based detection of cervical precancer and merits evaluation in larger studies.

Comparison between Urine and Cervical Samples for HPV DNA Detection and Typing in Young Women in Colombia

“…In addition to a higher HPV prevalence in urine, the absolute number of HPV genotypes that were detected in urine samples was higher (up to 9) than the number of genotypes identified in cervical samples. The higher prevalence and higher amount of identified genotypes may be explained by the fact that in urine samples there is presence of exfoliated cells containing HPV DNA or free virions that are continuously being shed not only from cervical epithelium but also from urethral and vulvar epithelium, which are also tissues susceptible to HPV infection (42).…”

Evaluation of the performance of Human Papillomavirus testing in paired urine and clinician-collected cervical samples among women aged over 30 years in Bhutan

“…Indeed, urine sampling offers a less invasive solution than cervical sampling to obtaining information from a representative sample of young women reluctant to accept a gynaecological examination. Other urine testing protocols are being used to monitor HPV vaccine impact in females [8, 9] and males [10] in high-income settings, and are also being evaluated as alternatives to cervical sampling for cervical cancer screening [5, 11–13]. …”

Molecular Triage of Premalignant Lesions in Liquid-Based Cervical Cytology and Circulating Cell-Free DNA from Urine, Using a Panel of Methylated Human Papilloma Virus and Host Genes

“…These fragments are known as transrenal DNA (TrDNA) (47)(48)(49). Recently, a capillary electrophoresis TrDNA test that targets the E1 region of the HPV genome for the detection of hrHPV demonstrated high sensitivity and modest specificity for urine-based detection of cervical precancerous lesions (50).…”