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Title: Evaluation of clinical performance of a novel urine-based HPV detection assay among women attending a colposcopy clinic.
Authors: 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
Journal: J Clin Virol
Date: 2014 Aug
Branches: CGB, EBP, HREB
PubMed ID: 24881489
PMC ID: PMC4146457
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 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.