Comparison of Cytology and Urine HPV DNA Testing for Cervical Cancer Screening in Yap, Federated States of Micronesia

Authors:

Brenda Hernandez (Presenter)
University of Hawaii Cancer Center

Aileen Tareg, NCD Program, Public Health
Martina Reichhardt, Yap State Department of Health Services
Angelica Agapito, Waab Community Health Center
Angela Sy, University of Hawaii at Manoa
Lee Buenconsejo-Lum, University of Hawaii at Manoa

Public Health Statement: Non-invasive, self-collected sampling methods for HPV DNA detection in women, which are reliable, efficient, and acceptable have the potential to address current barriers to cervical cancer screening in underserved communities.

Purpose: The purpose of the project was to evaluate the detection of HPV DNA in self-collected urine compared to clinician-collected cervical cell samples overall and by cervical cytologic status.

Methods/Approach: A randomized controlled trial was conducted in the state of Yap in the Federated States of Micronesia. Adult women (ages 21–65) who had not had a hysterectomy, were not pregnant, who had not had cervical cancer screening or who had abnormal screening results within the past 3 years were recruited and consented. Study subjects were randomized into one of two groups:

1. Cervical sampling (liquid based cytology) collected by a clinician followed by self-collection of urine
2. Self-collected urine followed by cervical sampling.

Information on cervical cancer risk factors and screening history and acceptability of sample collection was collected. Cervical cytology was evaluated and Roche Linear Array HPV genotyping was conducted.

Results: A total of 217 women were enrolled. HPV DNA was detected in 38.3% of liquid cytology samples and 27.8% of urine samples. Overall, HPV DNA detection based on paired liquid cytology samples and urine samples from the same person had a percent agreement of 79.5% and Kappa value of 0.55 (95% CI 0.43–0.66). Genotype concordance (partial or complete) was 81.6% for HPV+ cytology/HPV+urine pairs. Agreement was superior when urine samples were collected first: percent agreement 82.0%; Kappa 0.60, 95% CI 0.43–0.76). Agreement was also better in women 50 years and older. When urine was compared to liquid cytology for the prediction of cervical cytology, for high-risk HPV, sensitivity was identical (66.7%) for urine and liquid cytology while specificity was higher in urine (91.4%) compared to liquid cytology (83%).

Conclusions/Implications: In low-resource settings, HPV DNA testing in self-collected urine may be an appropriate surrogate for cervical cytology and HPV DNA collected in the clinical setting.