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

Sahasrabuddhe VV, Gravitt PE, Dunn ST, Robbins D, Brown D, Allen RA, Eby YJ, Smith KM, Zuna RE, Zhang RR, Gold MA, Schiffman M, Walker JL, Castle PE, Wentzensen N
J Clin Virol. 2014 60 (4): 414-7

PMID: 24881489 · PMCID: PMC4146457 · DOI:10.1016/j.jcv.2014.04.016

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 72 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% for 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.

Published by Elsevier B.V.

MeSH Terms (16)

Adult Cervical Intraepithelial Neoplasia Colposcopy DNA, Viral DNA Helicases Early Detection of Cancer Female Humans Mass Screening Oncogene Proteins, Viral Papillomaviridae Papillomavirus Infections Pilot Projects Precancerous Conditions Uterine Cervical Neoplasms Young Adult

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