Brenda Y Hernandez1, Aileen C Tareg2, Martina Reichhardt3, Angelica Agapito4, Xuemei Zhu1, Angela Sy5, Arnice Yuji6, Jeffrey Killeen7, Owen Chan1, Lee E Buenconsejo-Lum5. 1. University of Hawaii Cancer Center, Honolulu, Hawaii, USA. 2. Public Health, Colonia, Yap, Micronesia (the Federated States of). 3. Yap State Department of Health Services, Colonia, Yap, Micronesia (Federated States of). 4. Waab Community Health Center, Colonia, Yap, Micronesia (the Federated States of). 5. John A. Burns School of Medicine, Honolulu, Hawaii, USA. 6. John A. Burns School of Medicine, Pacific Programs, Honolulu, Hawaii, USA. 7. Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, USA.
Abstract
BACKGROUND: Non-invasive, self-collection sampling methods for human papillomavirus (HPV) DNA detection have the potential to address logistical and cultural barriers to Pap screening, particularly in under resourced settings such as Yap state in the Federated States of Micronesia - a population with low levels of screening and high incidence of cervical cancer. METHODS: A randomized controlled trial was conducted among adult women in Yap to compare cervical HPV DNA in self-collected urine and clinician-collected liquid cytology. Adult women aged 21-65 (n=217) were randomized by the order of sample collection. Concordance of HPV DNA, evaluated by the Roche Linear Array, was compared in paired self-collected urine and clinician-collected liquid cytology samples. The sensitivity and specificity of urine HPV DNA for prediction of cervical HPV and abnormal cytology was also evaluated. p16 in urine cytology samples was additionally assessed. RESULTS: Overall, HPV DNA detection was significantly lower in urine than cervical samples for any HPV (27.8% and 38.3%, respectively) and high-risk HPV (15.1% and 23.8%, respectively). For paired samples, there was moderate agreement for the overall study population (Kappa=0.54, 95% confidence interval CI=0.40-0.68) and substantial agreement for women >40 years (Kappa=0.65, 95% CI=0.46-0.85). The sensitivity and specificity of urine for the detection of cervical high-risk HPV was 51.0% and 96.2%, respectively. The sensitivities of HPV DNA in urine and liquid cytology for prediction of abnormal cytology (ASCUS/LSIL/HSIL) were 47.4% (95% CI=31.0-64.2) and 57.9% (95% CI=40.8-73.7), respectively; specificities were 92.0% (95% CI=86.9%-95.5%) and 83.5% (95% CI=77.2-88.7). Urine p16 was poorly correlated with urine HPV DNA positivity. CONCLUSIONS: Urine is less sensitive but more specific than directed cervical sampling for detection of cytologic abnormalities and may have utility for screening in older populations within low-resource communities when clinically-collected samples cannot be obtained.
BACKGROUND: Non-invasive, self-collection sampling methods for human papillomavirus (HPV) DNA detection have the potential to address logistical and cultural barriers to Pap screening, particularly in under resourced settings such as Yap state in the Federated States of Micronesia - a population with low levels of screening and high incidence of cervical cancer. METHODS: A randomized controlled trial was conducted among adult women in Yap to compare cervical HPV DNA in self-collected urine and clinician-collected liquid cytology. Adult women aged 21-65 (n=217) were randomized by the order of sample collection. Concordance of HPV DNA, evaluated by the Roche Linear Array, was compared in paired self-collected urine and clinician-collected liquid cytology samples. The sensitivity and specificity of urine HPV DNA for prediction of cervical HPV and abnormal cytology was also evaluated. p16 in urine cytology samples was additionally assessed. RESULTS: Overall, HPV DNA detection was significantly lower in urine than cervical samples for any HPV (27.8% and 38.3%, respectively) and high-risk HPV (15.1% and 23.8%, respectively). For paired samples, there was moderate agreement for the overall study population (Kappa=0.54, 95% confidence interval CI=0.40-0.68) and substantial agreement for women >40 years (Kappa=0.65, 95% CI=0.46-0.85). The sensitivity and specificity of urine for the detection of cervical high-risk HPV was 51.0% and 96.2%, respectively. The sensitivities of HPV DNA in urine and liquid cytology for prediction of abnormal cytology (ASCUS/LSIL/HSIL) were 47.4% (95% CI=31.0-64.2) and 57.9% (95% CI=40.8-73.7), respectively; specificities were 92.0% (95% CI=86.9%-95.5%) and 83.5% (95% CI=77.2-88.7). Urine p16 was poorly correlated with urine HPV DNA positivity. CONCLUSIONS: Urine is less sensitive but more specific than directed cervical sampling for detection of cytologic abnormalities and may have utility for screening in older populations within low-resource communities when clinically-collected samples cannot be obtained.
Authors: L Stewart Massad; Mark H Einstein; Warner K Huh; Hormuzd A Katki; Walter K Kinney; Mark Schiffman; Diane Solomon; Nicolas Wentzensen; Herschel W Lawson Journal: J Low Genit Tract Dis Date: 2013-04 Impact factor: 1.925
Authors: Angela U Sy; Brenda Y Hernandez; Aileen Tareg; Martina Reichhardt; Lee Buenconsejo-Lum Journal: Cancer Epidemiol Date: 2017-10 Impact factor: 2.984
Authors: Salvatore Vaccarella; Silvia Franceschi; Rolando Herrero; Nubia Muñoz; Peter J F Snijders; Gary M Clifford; Jennifer S Smith; Eduardo Lazcano-Ponce; Sukhon Sukvirach; Hai-Rim Shin; Silvia de Sanjosé; Monica Molano; Elena Matos; Catterina Ferreccio; Pham Thi Hoang Anh; Jaiye O Thomas; Chris J L M Meijer Journal: Cancer Epidemiol Biomarkers Prev Date: 2006-02 Impact factor: 4.254
Authors: Patti E Gravitt; Mark Schiffman; Diane Solomon; Cosette M Wheeler; Philip E Castle Journal: Cancer Epidemiol Biomarkers Prev Date: 2008-05 Impact factor: 4.254
Authors: Philip E Castle; Mark Sadorra; Tiffany Lau; Carrie Aldrich; Francisco A R Garcia; Janet Kornegay Journal: J Clin Microbiol Date: 2009-08-12 Impact factor: 5.948
Authors: Philip E Castle; Ana C Rodriguez; Carolina Porras; Rolando Herrero; Mark Schiffman; Paula Gonzalez; Allan Hildesheim; Robert D Burk Journal: Sex Transm Dis Date: 2007-11 Impact factor: 2.830
Authors: Marc Steben; Jose Jeronimo; Scott Wittet; D Scott Lamontagne; Gina Ogilvie; Christina Jensen; Jennifer Smith; Silvia Franceschi Journal: Vaccine Date: 2012-11-20 Impact factor: 3.641
Authors: Brenda Y Hernandez; Lynne R Wilkens; Xuemei Zhu; Pamela Thompson; Katharine McDuffie; Yurii B Shvetsov; Lori E Kamemoto; Jeffrey Killeen; Lily Ning; Marc T Goodman Journal: Emerg Infect Dis Date: 2008-06 Impact factor: 6.883
Authors: Rubí Hernández-López; Luis Hermosillo; Leith León-Maldonado; Rafael Velázquez-Cruz; Leticia Torres-Ibarra; Eduardo Lazcano-Ponce; Attila Lörincz; Cosette M Wheeler; F Xavier Bosch; Jack Cuzick; Berenice Rivera-Paredez; Belinda Nedjai; Jorge Salmerón Journal: PLoS One Date: 2021-07-21 Impact factor: 3.240
Authors: Michelle B Shin; Gui Liu; Nelly Mugo; Patricia J Garcia; Darcy W Rao; Cara J Bayer; Linda O Eckert; Leeya F Pinder; Judith N Wasserheit; Ruanne V Barnabas Journal: Front Public Health Date: 2021-07-01