Abstract
BackgroundUrine sampling may offer a less invasive solution than cervical sampling to test for human papillomavirus (HPV) for HPV vaccine impact monitoring.MethodsPaired samples of urine and exfoliated cervical cells were obtained for 89 women with history of high-risk (HR) HPV-positive normal cytology in Bhutan. Urine sampling protocol included self-collection of first-void urine immediately into a conservation medium and procedures to optimize DNA yield. Colposcopical abnormalities were biopsied. Two HPV assays were used: a multiplex type-specific PCR (E7-MPG) and a less analytically sensitive GP5+/6+ PCR followed by reverse line blot.ResultsHPV positivity for 21 types common to both assays was similar in urine and cells by E7-MPG (62.9% and 57.3%, respectively, p = 0.32) but lower in urine by GP5+/6+ (30.3% and 40.4%, p = 0.05). HPV6/11/16/18 positivity did not significantly differ between urine and cells by either assay. Sensitivity of urine (using cells as gold standard) to detect 21 HPV types was 80% and 58% for E7-MPG and GP5+/6+, respectively, with specificity 61% and 89%. HPV type distribution in urine and cells was similar, regardless of assay. The 5 detected CIN3+ were HR-HPV positive in cells by both assays, compared to 4 and 3 by E7-MPG and GP5+/6+, respectively, in urine samples.ConclusionFor the monitoring of vaccine impact, we demonstrate validity of a urine sampling protocol to obtain HPV prevalence data that are broadly comparable to that from cervical cells. However, detection of HPV in urine varies according to assay sensitivity, presumably because low level infections are frequent.
Highlights
Urine sampling may offer a less invasive solution than cervical sampling to test for human papillomavirus (HPV) for HPV vaccine impact monitoring
Using a device for self-collection of first-void urine and implementation of optimized procedures for urine sample management, we have recently reported good acceptability and performance of a protocol of HPV testing from urine to monitor HPV vaccine impact in young women in Bhutan and Rwanda [7]
HPV positivity for 21 types common to both assays is shown in Table 1, and was similar in urine (62.9%) and cells (57.3%) by the E7 polymerase chain reaction (PCR) bead-based multiplex genotyping assay (E7-MPG) assay, whereas it was lower in urine (30.3%) than in cells (40.4%) by the GP5+/6+ test (PR = 0.75, p = 0.05)
Summary
Urine sampling may offer a less invasive solution than cervical sampling to test for human papillomavirus (HPV) for HPV vaccine impact monitoring. Confidence in the use of urine samples for the detection of human papillomavirus (HPV) has been increasing in recent years. Using a device for self-collection of first-void urine and implementation of optimized procedures for urine sample management, we have recently reported good acceptability and performance of a protocol of HPV testing from urine to monitor HPV vaccine impact in young women in Bhutan and Rwanda [7]. Urine sampling offers a less invasive solution than cervical sampling to obtaining information from a representative sample of young women reluctant to accept a gynaecological examination. Other urine testing protocols are being used to monitor HPV vaccine impact in females [8, 9] and males [10] in high-income settings, and are being evaluated as alternatives to cervical sampling for cervical cancer screening [5, 11,12,13].
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