Abstract

Nowadays, several screening strategies are available to prevent cervical cancer, but inadequate resources, sociocultural barriers, and sampling issues impede their success in low-income countries. To overcome these issues, this study aimed to evaluate the performance of human papillomavirus (HPV) testing from dried urine spots (DUS). Eighty-eight urine samples (including 56 HPV DNA positive specimens) were spotted on filter paper, dried, and stored in paper-bags. HPV DNA was detected from the DUS after 1 week and 4 weeks of storage using a polymerase chain reaction (PCR) assay. The sensitivity, specificity, and concordance of the DUS-based HPV test were evaluated by comparing the results with those of HPV testing on fresh urine samples as the gold standard. The sensitivity of the test was 98.21% (95% CI: 90.56–99.68) for DUS stored for 1 week and 96.42% (95% CI: 87.88–99.01) for DUS stored for 4 weeks. The specificity was 100% (95% CI: 89.28–100) at both time points. The concordance between DUS and fresh urine HPV testing was “almost perfect” using the κ statistic. These preliminary data suggest that a DUS-based assay could bypass sociocultural barriers and sampling issues and therefore could be a suitable, effective tool for epidemiological surveillance and screening programs, especially in low-income countries.

Highlights

  • Cervical cancer is a relevant public health problem for women worldwide, being the third most frequent cancer and the fourth most common cause of death from cancer in women [1, 2]

  • Urine samples were obtained from 88 immigrant women (median age: 34 years; interquartile range (IQR): 28–43 years) who attended NAGA Onlus in Milan, Italy, between June 2012 and December 2013 and were included in a large epidemiological study on human papillomavirus (HPV) and Chlamydia trachomatis infections [20]

  • DNA was successfully extracted from all of the dried urine spots (DUS) samples stored at room temperature (RT) for either 1 week or 4 weeks

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Summary

Introduction

Cervical cancer is a relevant public health problem for women worldwide, being the third most frequent cancer and the fourth most common cause of death from cancer in women [1, 2]. The World Health Organization (WHO) estimates that there are 530,000 new cases of cervical cancer each year and more than 270,000 deaths, with 85% of deaths occurring in low- and middle-income countries [3]. All cervical cancers can be attributable to a sexually transmitted infection (STI) that is caused by the human papillomavirus (HPV). HPVs are DNA viruses that are grouped into cutaneous and mucosal types according to their infection site and further subdivided into high-risk (HR) and low-risk (LR) types, depending on their association with disease malignancy. The International Agency for Research on Cancer (IARC) has included 25 types of HPV in the high-risk clade (HR-clade) by subdividing them into three groups [4]. HPV16 and HPV18 are the two most common HR types in cervical cancer, causing approximately 70% of all cases worldwide [4]

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