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Urine high-risk human papillomavirus testing as an alternative to routine cervical screening: A comparative diagnostic accuracy study of two urine collection devices using a randomised study design trial.
Davies, Jennifer C; Sargent, Alexandra; Pinggera, Elisabeth; Carter, Suzanne; Gilham, Clare; Sasieni, Peter; Crosbie, Emma J.
Afiliación
  • Davies JC; Gynaecological Oncology Research Group, Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
  • Sargent A; Department of Obstetrics and Gynaecology, Manchester Academic Health Science Centre, St Mary's Hospital, Manchester University NHS Foundation Trust, Manchester, UK.
  • Pinggera E; Cytology Department, Clinical Sciences Centre, Manchester Academic Health Science Centre, Manchester University NHS Foundation Trust, Manchester, UK.
  • Carter S; Gynaecological Oncology Research Group, Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
  • Gilham C; Gynaecological Oncology Research Group, Division of Cancer Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.
  • Sasieni P; Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK.
  • Crosbie EJ; Centre for Cancer Prevention, Wolfson Institute of Population Health, Queen Mary University of London, London, UK.
BJOG ; 131(11): 1456-1464, 2024 Oct.
Article en En | MEDLINE | ID: mdl-38660737
ABSTRACT

OBJECTIVE:

To evaluate the sensitivity of human papillomavirus (HPV) tested urine to detect high-grade cervical precancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) using two urine collection devices.

DESIGN:

Randomised controlled trial.

SETTING:

St Mary's Hospital, Manchester, UK. POPULATION Colposcopy attendees with abnormal cervical screening; a total of 480 participants were randomised. Matched urine and cervical samples were available for 235 and 230 participants using a first-void urine (FVU)-collection device and standard pot, respectively.

METHODS:

Urine was self-collected and mixed with preservative - randomised 11 to FVU-collection device (Novosanis Colli-pee® 10 mL with urine conservation medium [UCM]) or standard pot. Matched clinician-collected cervical samples were taken before colposcopy. HPV testing used Roche cobas® 8800. A questionnaire evaluated urine self-sampling acceptability. MAIN OUTCOME

MEASURES:

The primary outcome measured sensitivity of HPV-tested urine (FVU-collection device and standard pot) for CIN2+ detection. Secondary outcomes compared HPV-tested cervical and urine samples for CIN2+ and evaluated the acceptability of urine self-sampling.

RESULTS:

Urine HPV test sensitivity for CIN2+ was higher with the FVU-collection device (90.3%, 95% CI 83.7%-94.9%, 112/124) than the standard pot (73.4%, 95% CI 64.7%-80.9%, 91/124, p = 0.0005). The relative sensitivity of FVU-device-collected urine was 0.92 (95% CI 0.87-0.97, pMcN = 0.004) compared with cervical, considering that all women were referred after a positive cervical HPV test. Urine-based sampling was acceptable to colposcopy attendees.

CONCLUSIONS:

Testing of FVU-device-collected urine for HPV was superior to standard-pot-collected urine in colposcopy attendees and has promising sensitivity for CIN2+ detection. General population HPV testing of FVU-device-collected urine will establish its clinical performance and acceptability as an alternative to routine cervical screening.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Displasia del Cuello del Útero / Neoplasias del Cuello Uterino / Sensibilidad y Especificidad / Colposcopía / Infecciones por Papillomavirus / Detección Precoz del Cáncer / Toma de Muestras de Orina Límite: Adult / Female / Humans / Middle aged Idioma: En Revista: BJOG Asunto de la revista: GINECOLOGIA / OBSTETRICIA Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Displasia del Cuello del Útero / Neoplasias del Cuello Uterino / Sensibilidad y Especificidad / Colposcopía / Infecciones por Papillomavirus / Detección Precoz del Cáncer / Toma de Muestras de Orina Límite: Adult / Female / Humans / Middle aged Idioma: En Revista: BJOG Asunto de la revista: GINECOLOGIA / OBSTETRICIA Año: 2024 Tipo del documento: Article Pais de publicación: Reino Unido