Samples For Human Papillomavirus DNA Testing Research Articles

Self-obtained vaginal samples for HPV DNA testing to detect HPV-related cervical disease.

To investigate if a self-obtained vaginal sample (SOVAS) contains sufficient DNA for a human papillomavirus (HPV) test and if the results are comparable to those obtained via cervical samples (CS) collected by a physician. One hundred and fifty-one women who had abnormal cervical smears or who were HPV-positive were enrolled. Self-sampling was done after reading instructions and watching a 2-min-long video, whereas CS was obtained with a cervical cytobrush during a gynecologic examination. A multiplex real-time polymerase chain reaction-based assay detected the prevalence of any type of HPV to be 67.5% in the SOVAS and 57.4% in the CS, and that of high-risk (HR-) HPV to be 58.7% in the SOVAS and 48.6% in the CS. The sensitivity of detection of HR-HPV in the SOVAS was 100% (95% confidence interval [CI] -0.09 to 0.32) for high-grade squamous intraepithelial lesion, 78% (95% CI -0.09 to 0.13) for atypical squamous cells of undetermined significance or worse, and 95% (95% CI -0.01 to 0.25) for low-grade squamous intraepithelial lesion or worse, which was statistically within the non-inferiority margin compared with that of CS. Our study shows that the collection of a SOVAS is feasible and it is comparable to a CS for HPV DNA testing. Future studies are required to investigate the feasibility and cost-effectiveness of a mail-delivered SOVAS for cervical cancer screening.

Comparison of DRY and WET vaginal swabs with cervical specimens in Roche Cobas 4800 HPV and Abbott RealTime High Risk HPV tests

BackgroundSelf-collected vaginal swab samples have been proposed as an alternative specimen collection method for human papillomavirus (HPV) DNA detection. ObjectivesTwo vaginal swabs (a cone-shaped flocked swab (DRY) and a L-shape FLOQSwab with 2mL eNAT transport medium (WET)) were compared to standard cervical samples for HPV DNA testing. Additionally, they were also compared by using Roche Cobas 4800 HPV (Roche_HPV) and Abbott Real-time High Risk HPV (Abbott_HPV) tests. Study designNinety-six women were prospectively enrolled from the National Cancer Center in Korea between June and August 2015. WET and DRY vaginal swabs and cervical specimens were collected. Roche_HPV and Abbott_HPV tests were performed. The Roche_HPV test on cervical specimens was used as reference. ResultsThe observed agreements (kappa) of Roche_HPV and Abbott_HPV between WET and DRY swabs were 89.6% (0.790, 95% confidence interval (95% CI): 0.667–0.913) and 91.7% (0.833, 95%CI: 0.723–0.943), respectively. No statistical difference was observed between WET and DRY swabs (p>0.05 for all comparisons). For HPV16/18, the sensitivity/specificity of Roche_HPV on the DRY and WET samples presented 93.8%/96.3% and 87.5%/97.5%, respectively. For other High Risk HPV (hrHPV), the sensitivity/specificity of Roche_HPV on the DRY and WET swabs presented 91.9%/91.5% and 97.3%/98.3, respectively. The sensitivity/specificity of the Abbott_HPV on the DRY and WET swabs were 93.8%/98.8%, 87.5%/98.8% for HPV16/18, and 91.9%/93.2%, 100.0%/93.2% for other hrHPV, respectively. ConclusionsHPV tests performed similarly when using vaginal DRY and WET swab samples. Using DRY and WET swabs to collect vaginal specimens could be an alternative to collecting cervical samples for HPV DNA testing.

HPV Prevalence in Multiple Anatomical Sites among Men Who Have Sex with Men in Peru.

BackgroundHuman Papilloma Virus (HPV) infection is the most common sexually transmitted viral infection worldwide. HPV is highly prevalent in sexually active men who have sex with men (MSM) and has been associated with anal cancer, penile cancer, and oropharyngeal cancer.MethodsFrom March to September 2011, we conducted a cross-sectional study of HPV prevalence among MSM above age 18 years. Participants were recruited using respondent driven sampling at Clinica Cayetano Heredia. All participants provided anal, genital, and oral samples for HPV DNA testing, and blood for HIV and HPV antibody testing.ResultsA total of 200 MSM were recruited in the study. The mean age was 34 years (range 18–59 years, SD = 9.4) and101 participants were HIV negative (99 HIV positive). HPV 6/11/16/18 or quadrivalent HPV vaccine (HPV4) genotype seroprevalence among HIV negative and positive MSM was 64.3% (55%-75.9%) and 93.8% (87.6%-99.2%) respectively (p<0.001). HIV positivity was associated with a higher prevalence of HPV4 and HPV 16/18 DNA at external genital sites and the anal canal. HPV4 DNA prevalence at external genital sites among HIV negative and positive MSM was 14.9% and 28.7% (p = 0.02) respectively, at anal canal was 50.9% and 79.0% (p = 0.001), and at the oral cavity was 9.9% and 8.5% (p = 0.6).ConclusionsHPV4 seroprevalence was high in our study among both HIV positives and negatives, with HPV DNA prevalence much lower, and the anal canal being the anatomical site with the highest HPV DNA prevalence. HPV prevention interventions are needed among MSM at high-risk for HIV infection.

A pilot study to compare dry cervical sample collection with standard practice of wet cervical samples for human papillomavirus testing

BackgroundFor human papillomavirus (HPV) DNA detection, specimen collection and transportation using a dry swab without transport medium has advantages, in various situations, over liquid media. ObjectiveIn this pilot study we evaluated whether a dry cervical sample taken with a flocked swab (dry sample) is a valid alternative for HPV DNA testing compared with the standard practice of a wet sample taken with a cyto-broom placed directly into liquid media (wet sample). Study designWomen attending the dysplasia clinic at the Royal Women’s Hospital, Melbourne Australia between November 2013 and February 2014 were enrolled. During colposcopic examination, a practitioner collected wet and dry cervical samples, with the order of collection randomised. In the laboratory both samples were left for a week before being tested for 14 high-risk HPV types using the Roche Cobas 4800 test. ResultsOverall, 209 had valid HPV results from both samples. The observed agreement for HPV detection between wet and dry samples was 92.8% and kappa was 0.85 (95% confidence interval (95% CI): 0.78–0.92). There was no statistical difference in the percent HPV positive for each sample (p = 0.30). HPV testing of the dry sample had an 88.5% (95% CI: 79.9–94.3%) sensitivity for HPV detected using the wet specimen. For the HPV results categorized hierarchically, there was 92.8% overall agreement and a kappa of 0.87 (95% CI = 0.80–0.93) for the paired results. ConclusionUsing dry flocked swabs to collect cervical cells is a valid alternative to collecting wet samples for HPV DNA testing using a PCR based test.

P235 Prevalence and risk factors associated with oral HPV among sti clinic attendees

Background Oral human papillomavirus (HPV) infection increases the risk of a sub-set of head and neck cancers. The epidemiology of oral HPV infection is not well understood. Aim To describe the prevalence and risk factors for oral HPV infection amongst STI clinic attendees. Methods Participants were recruited from a STI clinic, completed a risk factor questionnaire and provided oral samples for HPV DNA testing by a highly sensitive PCR using the SPF-10 broad spectrum primers. Overall positivity (prevalence) for any HPV was calculated. Chi-square test was used to determine the association between risk factors and oral HPV-positivity. Results Ninety-eight participants (50 men and 48 women) with a median age of 29 (range 20–52 years) were recruited. Overall, 67.4% (66 of 98) participants were positive. All participants reported a history of oral sex. Participants from a non-White ethnic group were more likely to be oral HPV-positive than Whites (63.1% vs. 92.9%, p = 0.03) and those who engaged in open mouth/deep kissing in the last 24 h were also more likely to be oral HPV-positive than those who did not (86.2% vs. 59.7%, p = 0.01). No statistically significant associations were found with recent history of oral sex, smoking, alcohol and cannabis use, or lifetime number of sexual partners. Conclusion Oral HPV infection is common among STI clinic attendees. It is unclear whether these are transient oral HPV infections or true persistent infections with oncogenic potential. Our limited data suggest that recent open mouth/deep kissing behaviour is associated with transmission of oral HPV.

Human papillomavirus type‐specific persistence and recurrence after treatment for cervical dysplasia

Human papillomavirus (HPV) infection is a necessary factor in the cervical cancer development. Also after treatment for cervical dysplasia, HPV can be present and promote the recurrence of cervical disease. In the present study, the aim was to perform a long-term follow-up on the ability of HPV testing with genotyping, as compared with cytology, to predict recurrence of high-grade cervical intraepithelial neoplasia and to evaluate the effectiveness of treatment with loop electrosurgical excision procedure (LEEP) conization. Cervical samples for HPV DNA testing and cytological analysis were obtained from 178 women with abnormal smears referred for treatment with LEEP conization. These women were scheduled for HPV DNA testing and Pap smears before and 3, 6, 12, 24, and 36 months after treatment. Three years after treatment 3.1% (N = 4) of women were still persistently HPV-positive with the same type as had been detected at treatment. Recurrent or residual cervical intraepithelial neoplasia II+ in histopathology was found among 9 (5.1%) women during follow-up. All of these women had type-specific HPV-persistence (sensitivity 100% [95% CI 63-100%] and specificity 94.7% [89.8-97.4%]), but only 7/9 had abnormal cytology (sensitivity 77.8% [40.2-96.1%] and specificity 94.7% [89.8-97.4%]). No recurrent or residual disease was found among women with any other patterns of HPV positivity (e.g., type change or fluctuating positivity) (sensitivity 0% [95% CI 0-37.1%] and specificity 80.5% [73.5-86.0%]). In conclusion, only type-specific HPV persistence predicted recurrent or residual disease, and HPV genotyping appears useful to improve the specificity when using HPV testing in post-treatment follow-up.

Differences in patterns of high-risk human papillomavirus infection between urban and rural low-resource settings: cross-sectional findings from Mali

BackgroundThe burden of cervical cancer is disproportionately high in low-resource settings. With limited implementation of human papillomavirus (HPV) vaccines on the horizon in the developing world, reliable data on the epidemiology of high-risk HPV (HR-HPV) infection in distinct geographic populations is essential to planners of vaccination programs. The purpose of this study was to determine whether urban patterns of HR-HPV occurrence can be generalized to rural areas of the same developing country, using data from Mali, West Africa, as an example.MethodsUrban and rural women in Mali participated in a structured interview and clinician exam, with collection of cervical samples for HPV DNA testing, to determine HR-HPV prevalence and correlates of infection. Correlates were assessed using bivariate analysis and logistic regression.ResultsA total of 414 women (n=202 urban women; n=212 rural women) were recruited across both settings. The prevalence of HR-HPV infection in rural women was nearly twice that observed in urban women (23% v. 12%). Earlier age of sexual debut and fewer pregnancies were associated with HR-HPV infection among urban women, but not rural women. Twenty-six percent of urban women who had sexual intercourse by age 14 had an HR-HPV infection, compared to only 9% of those who had later sexual debut (p<0.01). Overall, age, income, and polygamy did not appear to have a relationship with HR-HPV infection.ConclusionsCompared to urban women, rural women were significantly more likely to be infected with high-risk HPV. The patterns and risk factors of HR-HPV infection may be different between geographic areas, even within the same developing country. The high prevalence in both groups suggests that nearly all rural women and most urban women in Mali will be infected with HR-HPV during their lifetime, so the effects of risk factors may not be statistically apparent. To control HPV and cervical cancer in West Africa and the rest of the developing world, planners should prioritize vaccination in high-burden areas.

Evaluation of dry and wet transport of at-home self-collected vaginal swabs for human papillomavirus testing

Our objective was to compare human papillomavirus (HPV) detection in paired self-collected vaginal samples transported by overnight mail in liquid specimen transport medium (STM) (wet) or in dry tubes (dry). Women aged 18-24 years were recruited online to self-collect vaginal swab samples at home for HPV testing and 159 women returned paired wet and dry samples. Dry samples were rehydrated with STM upon arrival at the laboratory. HPV was detected by the Roche Linear Array HPV genotyping test (37 genotypes) and Kappa and McNemar statistics were used to compare wet versus dry samples for detecting HPV. Of the subjects tested in this study, 51 % were HPV-positive (in either sample) and 40 % were positive for high-risk HPV. A total of 216 type-specific infections were detected among the 80 HPV-positive women. Almost perfect agreement was observed between paired samples for detecting any HPV (subject-level positive agreement: 91.9 %, κ: 0.85) or type-specific HPV (positive agreement across types: 90.1 %, κ: 0.90). Similar agreement between sample types was seen when testing for high-risk types and 81.9 % of all type-specific infections were detected in both samples. Among discordant pairs, wet samples were 3.3 times more likely to be positive for type-specific HPV than dry samples (P = 0.02). However, in 63.6 % of wet-positive/dry-negative discordant pairs analysed for viral load, type-specific HPV was either undetectable or detected at a low level (<100 copies) in the wet samples, suggesting that the majority of infections missed by using dry samples are less likely to be clinically relevant. Our results indicate that dry transport is a feasible option for transporting at-home self-collected vaginal samples for HPV DNA testing.

Self-Collected Samples for Testing of Oncogenic Human Papillomavirus: A Systematic Review

BackgroundTo investigate the role of self-sampling for human papillomavirus (HPV) testing as an alternative to cervical cancer screening by clinicians (i.e., Papanicolaou [Pap] test). MethodsA systematic search of MEDLINE, EMBASE, Cochrane Library, and other sources for evidence related to the efficacy and feasibility of HPV DNA self-collection. ResultsA total of 25 studies were identified. In 22 comparisons across 19 studies, the concordance between samples collected by patients and those obtained by clinicians was reasonably high in the majority of cases. Women in many countries across wide age ranges were successful in collecting samples for HPV DNA testing. In four studies, the quality of the cytology from patient samples was as good as clinician samples, with more than 95% of samples yielding HPV DNA results. The studies that examined acceptability found that women were generally very positive about collecting their own samples, although some concerns were noted. No study evaluated the effect of HPV DNA self-sampling on screening participation rates, early detection, survival, or quality of life. ConclusionsSelf-sampling for HPV DNA testing is a viable screening option, but there is insufficient evidence to conclude that self-sampling for HPV DNA testing is an alternative to the Pap test. Although HPV DNA testing using self-collected samples holds promise for use in under-resourced areas or for women who are reluctant to participate in Pap testing programs, the evidence supporting it is limited. Further definitive research is needed to provide a solid evidence base to inform the use of self-sampling for HPV DNA testing for the purpose of increasing screening rates, especially in women who are never or seldom screened.

Concordance of Self-Collected and Clinician-Collected Swab Samples for Detecting Human Papillomavirus DNA in Women 18 to 32 Years of Age

The objective of this study was to determine whether self- and clinician-collected samples are comparable for human papillomavirus (HPV) detection. Three hundred seventy-four women aged 23 to 32 (population 1) and 211 women aged 18 to 25 (population 2) contributed self-collected vaginal and clinician-collected cervical and vulvovaginal samples for HPV DNA testing. Eighty-six women mailed in self-collected samples. Agreement between self-collected vaginal and clinician-collected combined cervical/vulvovaginal samples was excellent (population 1:92.0%, kappa = 0.81; population 2: 96.4%, kappa = 0.88), but self-collected samples were more concordant with clinician-collected cervical samples in population 2 (kappa = 0.84) than population 1 (kappa = 0.65) (P = 0.01). Age-adjusted HPV prevalence was slightly lower in mailed-in (21.5%) than in-clinic self-collected samples (26.8%). The combined clinician-collected cervical/vulvovaginal sample is most sensitive for detecting all female genital tract HPV infections. HPV concordance between cervical and vaginal samples may be better for newer infections. Larger studies are needed to determine whether mailed-in self-samples are as effective as those collected in a clinical setting.

Condom Use and the Risk of Genital Human Papillomavirus Infection in Young Women

To evaluate whether the use of male condoms reduces the risk of male-to-female transmission of human papillomavirus (HPV) infection, longitudinal studies explicitly designed to evaluate the temporal relationship between condom use and HPV infection are needed. We followed 82 female university students who reported their first intercourse with a male partner either during the study period or within two weeks before enrollment. Cervical and vulvovaginal samples for HPV DNA testing and Papanicolaou testing were collected at gynecologic examinations every four months. Every two weeks, women used electronic diaries to record information about their daily sexual behavior. Cox proportional-hazards models were used to evaluate risk factors for HPV infection. The incidence of genital HPV infection was 37.8 per 100 patient-years at risk among women whose partners used condoms for all instances of intercourse during the eight months before testing, as compared with 89.3 per 100 patient-years at risk in women whose partners used condoms less than 5 percent of the time (adjusted hazard ratio, 0.3; 95 percent confidence interval, 0.1 to 0.6, adjusted for the number of new partners and the number of previous partners of the male partner). Similar associations were observed when the analysis was restricted to high-risk and low-risk types of HPV and HPV types 6, 11, 16, and 18. In women reporting 100 percent condom use by their partners, no cervical squamous intraepithelial lesions were detected in 32 patient-years at risk, whereas 14 incident lesions were detected during 97 patient-years at risk among women whose partners did not use condoms or used them less consistently. Among newly sexually active women, consistent condom use by their partners appears to reduce the risk of cervical and vulvovaginal HPV infection.