Vikrant V Sahasrabuddhe1, Patti E Gravitt2, S Terence Dunn3, David Robbins4, David Brown5, Richard A Allen6, Yolanda J Eby7, Katie M Smith8, Rosemary E Zuna9, Roy R Zhang10, Michael A Gold11, Mark Schiffman12, Joan L Walker13, Philip E Castle14, Nicolas Wentzensen15. 1. Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, United States; Vanderbilt University, Nashville, TN, United States. Electronic address: vikrant.sahasrabuddhe@nih.gov. 2. Johns Hopkins School of Public Health, Baltimore, MD, United States. Electronic address: pgravitt@jhsph.edu. 3. University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: terry-dunn@ouhsc.edu. 4. UTC Labs, New Orleans, LA, United States. Electronic address: drobbins@renrx.com. 5. University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: david-brown@ouhsc.edu. 6. University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: richard-allen@ouhsc.edu. 7. Johns Hopkins School of Public Health, Baltimore, MD, United States. Electronic address: yeby@jhsph.edu. 8. University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: katie-smith@ouhsc.edu. 9. University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: rosemary-zuna@ouhsc.edu. 10. University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: roy-zhang@ouhsc.edu. 11. Tulsa Cancer Institute and the University of Oklahoma School of Community Medicine, Tulsa, OK, United States. Electronic address: michael.gold@tciok.org. 12. Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, United States. Electronic address: schiffmm@exchange.nih.gov. 13. University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States. Electronic address: joan-walker@ouhsc.edu. 14. Global Cancer Initiative, Chestertown, MD, United States. Electronic address: castle.philip@gmail.com. 15. Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Bethesda, MD, United States. Electronic address: wentzenn@mail.nih.gov.
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. Published by Elsevier B.V.
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.
Entities:
Keywords:
Cervical cancer; Human papillomavirus; Screening; Urine
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