Self-collected Vaginal Samples Research Articles

Effectiveness of bivalent HPV vaccination against genital HPV DNA-positivity of a catch-up campaign at age 13–16 years compared to routine vaccination at age 12 years: a biennial repeated cross-sectional study

BackgroundThe Netherlands is one of few countries worldwide which has used the bivalent HPV vaccine for girls-only for over a decade. This allows assessment of vaccine effectiveness (VE) against female genital HPV DNA-positivity of this vaccine in an observational post-licencing real-world setting. Additionally, it is unclear whether catch-up vaccination campaigns result in similar VE as routine vaccination. Therefore, type-specific and grouped VE were assessed and compared for women who had been eligible for catch-up vaccination at 13–16 years with those who had been eligible for routine vaccination at 12 years.MethodsPASSYON is a Dutch biennial repeated cross-sectional (2011–2021) study among sexual health clinic clients aged 16–24 years old. Women provided self-collected vaginal samples, questionnaires on demographics and sexual behaviour were administered, and women self-reported HPV vaccination status. Samples were analysed using a PCR-based assay (SPF10-LiPA25). Type-specific and grouped VE estimates, adjusted with propensity score stratification, were assessed against genital positivity for 14 HPV types. VE for targeted and non-targeted genotypes were compared between women who had been eligible for the catch-up and those who had been eligible for routine vaccination.ResultsThe study included 4488 female participants who had been eligible for HPV vaccination and provided genital swabs (1561 eligible for catch-up, 2927 for routine vaccination). Very high VE against genital HPV-16 and HPV-18 was observed (resp. 93.5% and 89.5%) and significant cross-protection against six other genotypes (HPV-31/33/35/45/52/58), varying from 18.0% (HPV-52) to 79.6% (HPV-45). VE estimates were comparable between women who had been eligible for the catch-up campaign and those eligible for routine vaccination: VE HPV-16/HPV-18: 92.2% (95%CI: 87.9–94.9) vs. 91.8% (95%CI: 86.0–95.2).ConclusionsIn real-world settings, the VE of bivalent vaccine is high against targeted genotypes, with cross-protection against 6 other genotypes. Catch-up campaigns up to age 16 years can be as effective as routine vaccination at age 12, although it is recommendable to provide HPV vaccination at an age at which most are likely not sexually active yet. This may inform countries considering catch-up campaigns when introducing or extending the use of HPV vaccination within their national immunisation programmes.

A comparative study of self-collected versus clinician-collected specimens in detecting high-risk HPV infection: a prospective cross-sectional study.

The primary objective of this study was to compare the detection rate of high-risk human papillomavirus (HPV) infection between self-sampling to collect vaginal specimens and clinician sampling to collect cervical specimens, as well as the correlation between the two techniques. The secondary objective was to assess satisfaction with self-sampling for HPV testing. From October 2021 to September 2022, women positive for HPV 16/18 and other 12 high-risk HPV genotypes and cytological ASCUS were enrolled. All participants were instructed on the method for self-collection of HPV samples. Self-collected vaginal samples and clinician-collected cervical samples were subjected to HPV DNA typing. Paired self- and clinician-collected specimens were obtained from 104 women with positive HPV-positive results. The detection rate of high-risk HPV infection was comparable between the two techniques: 79/98 (80.6%) vs. 81/98 (82.7%) for the self-sampling and clinician-sampling techniques, respectively (McNemar's test; P=0.774). The agreement in detecting HPV infection was substantial, with a kappa coefficient of 0.75. More than 90% of the participants rated self-collection as satisfactory to very satisfactory because of its convenience and safety. Regarding methods of further follow-up, 51% of the participants chose self-sampling, whereas the remaining participants preferred collection by clinicians. No intervention-related complications were observed. The self-sampling technique for HPV testing was as effective as the clinician-sampling technique, and both techniques were substantially correlated in detecting high-risk HPV infection. The self-sampling method appears to be highly satisfactory and may provide better compliance for the detection of cervical HPV infection.

The Utility of an Human Papillomavirus Genotype Assay for Cancer Screening in Self-Collected Urine and Vaginal Samples from Japanese Women

Objectives: The high incidence of invasive cervical cancer among those who have not undergone cancer screening is a serious problem. This study aimed to investigate the utility of human papillomavirus (HPV) test results from self-collected urine and vaginal samples as screening tools. Design: The study was conducted in two steps. First, the appropriate storage container, temperature, and time until urine HPV assay performance were verified. Second, the results of spot urine testing under those conditions and of gynecologist-collected cervical and self-collected vaginal samples were compared to verify the feasibility of using the BD Onclarity® HPV assay for individuals with abnormal cervical cytology. Participants/Materials, Setting, Methods: The participants were 121 women with abnormal cervical cytology. Self-collected urine and vaginal samples, along with gynecologist-collected cervical samples, were tested for HPV using the BD Onclarity® HPV assay. The optimal conditions for urine sample storage were identified by comparing the HPV detection rates under various conditions. Results: Urine stored in a BD Probe Tec™ (QxUPT) for less than 72 h at room temperature was found to have the highest HPV positivity rate. Under these conditions, the detection rates of HPV in urine, cervical, and vaginal samples were examined. HPV type 16 was detected in 41.7% of the cervical samples, type 18 in 10%, and types 31 and 52 in 12.6% each. The concordance rate for HPV testing between clinician-collected cervical and urine samples was 63.9% (kappa: 0.34; 95% CI: 0.21–0.47), and that between clinician-collected cervical and self-collected vaginal samples was 77.8% (kappa: 0.68; 95% CI: 0.53–0.83), indicating good concordance. In a population with an HPV-related lesion/tumor prevalence of approximately 70%, the sensitivity of HPV testing was 82.7% for the cervix, 46.4% for urine, and 75.7% for vaginal samples. Limitations: The primary limitation is the lower detection rate of HPV in spot urine samples than in other sample types, indicating room for methodological improvement. The study’s findings are based on a specific population, which may limit generalizability. Conclusions: We investigated the optimal self-collected urine-to-testing time and temperature. Self-collected vaginal and urine HPV tests show moderate-high concordance with clinician-collected cervical HPV tests, suggesting their potential utility for women who do not undergo regular cancer screening. However, the sensitivity was not high in spot urine. Therefore, further large-scale studies are needed to verify these findings and optimize testing methods to encourage broader participation in cancer screening programs.

A Metagenomics Pipeline to Characterize Self-Collected Vaginal Microbiome Samples.

Vaginitis is a widespread issue for women worldwide, yet current diagnostic tools are lacking. Bacterial vaginosis (BV) is the most prevalent type of vaginitis, found in 10-50% of reproductive-aged women. Current diagnostic methods for BV rely on clinical criteria, microscopy, or the detection of a few microbes by qPCR. However, many vaginal infections lack a single etiological agent and are characterized by changes in the vaginal microbiome community structure (e.g., BV is defined as a loss of protective lactobacilli resulting in an overgrowth of anaerobic bacteria). Shotgun metagenomic sequencing provides a comprehensive view of all the organisms present in the vaginal microbiome (VMB), allowing for a better understanding of all potential etiologies. Here, we describe a robust VMB metagenomics sequencing test with a sensitivity of 93.1%, a specificity of 90%, a negative predictive value of 93.4%, and a positive predictive value of 89.6% certified by Clinical Laboratory Improvement Amendments (CLIA), the College of American Pathologist (CAP), and the Clinical Laboratory Evaluation Program (CLEP). We sequenced over 7000 human vaginal samples with this pipeline and described general findings and comparisons to US census data.

Evaluation of two alternative non-alcohol-based media for the suspension of self-collected vaginal swabs for HPV testing in cervical cancer screening

The introduction of Human Papillomavirus (HPV) testing in cervical cancer screening enhanced the opportunity to introduce self-collection as an innovative approach to improve coverage rates. Validation and standardization of the pre-analytical and analytical procedures are crucial for the quality assurance of HPV tests on self-collected samples.This study evaluated the analytical performance and the stability of self-collected vaginal samples resuspended in 5 mL of two non-alcohol-based media, eNat® and MSwab® compared to a professionally collected cervical sample, resuspended in 20 mL ThinPrep®, for the detection of high-risk HPV (hrHPV). The impact of the suspension volumes on analytical performance was also evaluated (2 and 5 ml).A good analytical concordance in hrHPV detection in cervical and vaginal self-collected swabs suspended in 5 ml of both non-alcohol-based media was demonstrated (eNat®: 91.2 %, k = 0.821; MSwab®: 91.4 %; k = 0.798). A similar analytical performance was found for samples resuspended in 2 mL (eNat®: 92.9 %, k = 0.811; MSwab®: 92.9 %, k = 0.811) compared to cervical samples.Good nucleic acid stability was demonstrated for vaginal samples stored at 20-25 °C and 37 °C for up to 4 weeks.Results of this preliminary study support the introduction of these media for vaginal self-sampling-based prevention programs. Nevertheless, further research is necessary to evaluate clinical accuracy in larger settings.

Acceptability of self-collected vaginal samples for human papillomavirus testing for primary cervical cancer screening: comparison of face-to-face and online recruitment modes

BackgroundThis study aimed to assess the acceptability and attitudes of women towards human papillomavirus (HPV) self-sampling and compare the effectiveness of two delivery modes utilising face-to-face and online website for cervical cancer screening in Hong Kong.MethodsWomen aged 30–65 years were invited to participate by distributing the study information pamphlets at the specialist clinics of a regional acute hospital. Those who were interested in participating were given the option to join directly face-to-face or through an online website. All participants provided informed consent and received self-sampling kits and acceptability questionnaires either immediately (face-to-face) or through the post after registering at the website (online). All participants were requested to collect their own vaginal samples using a swab which was then brushed on a DNA sample storage card and returned to the hospital either in person or by post. The self-collected samples were tested for high-risk HPV using the Sentis™ HPV assay, a validated isothermal nucleic acid amplification real-time fluorescent detection assay. The primary outcome was the uptake rate of HPV self-sampling.ResultsOf the 1998 women recruited (1200 face-to-face, 798 online), 1377 returned their samples, giving an overall uptake rate of 68.9%. The uptake rate was significantly greater in the face-to-face mode than in the online mode (74.6% vs. 60.4%, p < 0.001). The median age of the participants was 49 years, 43.7% were never or under-screened, and 7.1% had high-risk HPV detected. Overall, 82.1% of the participants reported self-sampling convenient, and 79.3% were not embarrassed when collecting self-samples. However, only 49.8% were confident that they had collected the self-samples correctly. Most (91.1%) of the participants expressed willingness to perform self-sampling again, mostly because it was simple (79.2%) and quick (56.3%).ConclusionsHPV self-sampling can serve as an alternative primary screening method for cervical cancer in Hong Kong, especially for individuals who have not been adequately screened in the past. Both face-to-face and online website recruitment were associated with high acceptability, emphasising the potential benefits of utilising different platforms and strategies for reaching diverse populations.

Evaluation of Pre-Analytical Variables for Human Papillomavirus Primary Screening from Self-Collected Vaginal Swabs

HPV primary screening is an effective approach to assessing cervical cancer risk. Self-collected vaginal swabs have shown promise to expand testing access, but there are limited data defining analytical performance criteria necessary for adoption of self-collected specimens, especially for those occurring outside the clinic where the swab remains dry during transport. Here, we evaluated the performance of self-collected vaginal swabs for HPV detection using the Roche Cobas 6800. There was insignificant variability between swabs self-collected by the same individual (n=15 participants collecting 5 swabs/participant), measured by amplification of HPV and human β-globin control DNA. Comparison of self-collected vaginal swab and provider-collected cervical samples (n=144 paired collections) proved highly concordant for HPV detection (total agreement=90.3%;PPA=84.2%). There was no relationship between the number of dry storage days and amplification of HPV (n=68, range 4-41days). Exposure of self-collected dry swabs to extreme summer and winter temperatures did not affect testing outcomes. We assessed a second internal control (RNAseP) in a subset and demonstrate that lack of amplification for β-globin from self-collected specimens was consistent with poor, but not absent, cellularity. These data suggest that self-collected vaginal samples enable accurate clinical HPV testing, and that extended ambient dry storage or exposure to extreme temperatures do not influence HPV detection. Further, lack of β-globin amplification in HPV negative samples accurately identified participants that required recollection.

Experiences of women participating in a human papillomavirus-based screen-triage-and treat strategy for cervical cancer prevention in Malawi.

To explore the experiences of Malawian women who underwent a human papillomavirus (HPV)-based screen-triage-treat algorithm for cervical cancer (CxCa) prevention. This algorithm included GeneXpert® HPV testing of self-collected vaginal samples, visual inspection with acetic acid (VIA) and colposcopy for HPV-positive women, and thermal ablation of ablation-eligible women. In-depth interviews were conducted with participants of a trial that evaluated the feasibility of a HPV-based screen-triage-treat algorithm among women living with HIV and HIV negative women in Lilongwe, Malawi. Participants were recruited from 3 groups: 1) HPV-negative; 2) HPV-positive/VIA-negative; 3) HPV-positive/VIA-positive and received thermal ablation. Interviews explored baseline knowledge of CxCa and screening, attitudes towards self-collection, and understanding of test results. Content analysis was conducted using NVIVO v12. Thematic saturation was reached at 25 interviews. Advantages of HPV self-collection to participants were convenience of sampling, same-day HPV results and availability of same-day treatment. There was confusion surrounding HPV-positive/VIA-negative results, as some participants still felt treatment was needed. Counseling, and in particular anticipatory guidance, was key in helping participants understand complex screening procedures and results. Overall, participants expressed confidence in the HPV screen-triage-treat strategy. HPV testing through self-collected samples is a promising tool to increase CxCa screening coverage. A multi-step screening algorithm utilizing HPV self-testing, VIA triage and thermal ablation treatment requires proper counseling and anticipatory guidance to improve patient understanding. Incorporating thorough counseling in CxCa screening programs can change women's perspectives about screening, build trust in healthcare systems, and influence healthcare seeking behavior towards routine screening and prevention.

Association between the Mode of Delivery and Vertical Transmission of Human Papillomavirus.

Human papillomavirus (HPV) can be vertically transmitted. Our objective was to measure the association between the mode of delivery and the detection of HPV in infants. We used data collected from pregnant women during the HERITAGE study. Self-collected vaginal samples from the first and third trimester were obtained for HPV testing. Specimens from oral, pharyngeal, conjunctival and anogenital mucosa were collected from infants 36-48 h after delivery and at 3 months of age. All samples were tested for HPV DNA by the Linear Array assay. Adjusted odd ratios (aOR) and 95% confidence interval (CI) were estimated using multivariate logistic regressions. From the 282 women revealed to be HPV-positive in both the first and third trimesters, 25 infants were born HPV-positive. The overall probability of transmission was 8.9% (25/282); 3.7% (3/81) in participants with a caesarean section and 10.9% (22/201) for those who delivered vaginally. Vaginal delivery increased the risk of HPV in infants compared to caesarean (aOR: 3.63, 95%CI: 1.03-12.82). Infants born after a caesarean with ruptured membranes were not at increased risk of HPV compared to infants born after an elective caesarean section with intact membranes (aOR: 1.31, 95%CI: 0.10-17.76). Our results support the hypothesis that transmission occurs mostly during the passage in the vaginal canal.

Feasibility and Acceptability of Self-sampling for Human Papillomavirus DNA Testing Among Asymptomatic Women in Rural Delta State, Nigeria

Background: Self-sampling and human papillomavirus (HPV) DNA testing can be vital tools in cervical cancer screening for hard-to-reach women with limited access to health care in sub-Saharan Africa. This study explored the feasibility and acceptability of self-sampling for HPV testing among asymptomatic women in Orhuwhorun community in Delta State. Methods: This was a cross-sectional study of 230 women aged between 30 - 65years, enrolled by a multi-stage sampling method. Recruited women were asked to provide self-collected vaginal samples between May and June, 2021. HPV detection and genotyping was done using 21 HPV Geno-Array Diagnostic kit. Participants were asked to complete questionnaires after self-sampling to point out their experiences and acceptability of HPV self-sampling. Results: An excellent feasibility of self-sampling (95.2%) was observed. The acceptability rate of self-sampling was 93.0%, and 99.6% (229/230) of the participants were confident that they used the device correctly. The quality of self-sampling was satisfactory in 100% of the samples; 21.1% (48/228) of the samples were positive for HPV, including 12.3% (28/228) with high-risk HPV types,2.6% (6/228) with probable high risk HPV types and 1.8% (4/228)with low-risk HPV types. Multiple HPV infection occurred in 10 cases (4.4%). Conclusion: This study indicates that self-sampling is a feasible and acceptable approach for cervical cancer screening among women in rural Delta State. Thus, the government should consider self-sampling as a valuable strategy in implementing national cancer screening programme.

Performance of BD Onclarity HPV assay on FLOQSwabs vaginal self-samples.

Human papillomavirus (HPV) testing on self-collected vaginal samples has been shown to improve women's participation to cervical cancer screening programs, particularly in regions with limited access to health care. Nevertheless, the introduction of self-sampling in cervical cancer screening programs requires prior clinical validation of the HPV assay in combination with a self-sample collection device, including also the laboratory workflow and automation required for high-throughput testing in screening. In this study, the performance of BD Onclarity HPV on FLOQSwab-collected vaginal self-samples has been compared to clinician-taken liquid-based cytology samples, to detect high-grade cervical intraepithelial neoplasia using two high-throughput platforms, BD Viper LT and BD COR. The study findings have shown a similar performance of BD Onclarity on testing self-collected samples, confirming the validation of the proposed pre-analytical and analytical protocols for their use in cervical cancer screening programs based on self-collected vaginal samples.

Community Screening for High-Risk Human Papilloma Virus Infection using Self-Sampling and 'Point-Of-Care' Test.

HR-HPV types 16 and 18 are responsible for pre-invasive and invasive lesions of the cervix, accounting for 70-80% of the total subtypes. The aim of this study was to investigate the prevalence of high-risk HPV subtypes 16 and 18 in self-collected vaginal samples using real-time micro-PCR and to study the acceptability of self-sampling. Eligible women (30-65 years) were screened from a semi-urban area of Uttarakhand (India) using self-sampling. High-risk HPV genotypes (16/31 and 18/45) were tested using real-time micro-PCR technique with results available in one hour. The positive results were validated by standard RT-PCR for high-risk HPV 16, 18, separately and for 12 other high-risk genotypes, combined. Ease of the procedure, level of comfort, and recommendation to other women were studied and the acceptability of self-sampling was analyzed using the Likert scale. Of 975 eligible women screened, 45 participants tested positive for HR-HPV (16/31,18/45) using real-time micro-PCR with a prevalence of 4.6%. Positive samples were further tested through routine RT-PCR and 60% were found to be HR-HPV 16 and 18 positive. For self-sampling, 96.72% (n=943) participants were 'very satisfied' and 94.15% (n=918) found self-sampling to be 'very comfortable' and 88.51% (n=863) stated that they will strongly recommend this test to other eligible women in the community. We conclude that HR-HPV testing with limited genotyping showed a prevalence of 4.6%, 60% of these were HPV 16/18 positive. Point of care testing was feasible in the community and self-sampling was acceptable.

Design of the HPV-automated visual evaluation (PAVE) study: Validating a novel cervical screening strategy

Background:The HPV-automated visual evaluation (PAVE) Study is an extensive, multinational initiative designed to advance cervical cancer prevention in resource-constrained regions. Cervical cancer disproportionally affects regions with limited access to preventive measures. PAVE aims to assess a novel screening-triage-treatment strategy integrating self-sampled HPV testing, deep-learning-based automated visual evaluation (AVE), and targeted therapies.Methods:Phase 1 efficacy involves screening up to 100,000 women aged 25–49 across nine countries, using self-collected vaginal samples for hierarchical HPV evaluation: HPV16, else HPV18/45, else HPV31/33/35/52/58, else HPV39/51/56/59/68 else negative. HPV-positive individuals undergo further evaluation, including pelvic exams, cervical imaging, and biopsies. AVE algorithms analyze images, assigning risk scores for precancer, validated against histologic high-grade precancer. Phase 1, however, does not integrate AVE results into patient management, contrasting them with local standard care.Phase 2 effectiveness focuses on deploying AVE software and HPV genotype data in real-time clinical decision-making, evaluating feasibility, acceptability, cost-effectiveness, and health communication of the PAVE strategy in practice.Results:Currently, sites have commenced fieldwork, and conclusive results are pending.Conclusions:The study aspires to validate a screen-triage-treat protocol utilizing innovative biomarkers to deliver an accurate, feasible, and cost-effective strategy for cervical cancer prevention in resource-limited areas. Should the study validate PAVE, its broader implementation could be recommended, potentially expanding cervical cancer prevention worldwide.Funding:The consortial sites are responsible for their own study costs. Research equipment and supplies, and the NCI-affiliated staff are funded by the National Cancer Institute Intramural Research Program including supplemental funding from the Cancer Cures Moonshot Initiative. No commercial support was obtained. Brian Befano was supported by NCI/ NIH under Grant T32CA09168.

Design of the HPV-automated visual evaluation (PAVE) study: Validating a novel cervical screening strategy.

The HPV-automated visual evaluation (PAVE) Study is an extensive, multinational initiative designed to advance cervical cancer prevention in resource-constrained regions. Cervical cancer disproportionally affects regions with limited access to preventive measures. PAVE aims to assess a novel screening-triage-treatment strategy integrating self-sampled HPV testing, deep-learning-based automated visual evaluation (AVE), and targeted therapies. Phase 1 efficacy involves screening up to 100,000 women aged 25-49 across nine countries, using self-collected vaginal samples for hierarchical HPV evaluation: HPV16, else HPV18/45, else HPV31/33/35/52/58, else HPV39/51/56/59/68 else negative. HPV-positive individuals undergo further evaluation, including pelvic exams, cervical imaging, and biopsies. AVE algorithms analyze images, assigning risk scores for precancer, validated against histologic high-grade precancer. Phase 1, however, does not integrate AVE results into patient management, contrasting them with local standard care.Phase 2 effectiveness focuses on deploying AVE software and HPV genotype data in real-time clinical decision-making, evaluating feasibility, acceptability, cost-effectiveness, and health communication of the PAVE strategy in practice. Currently, sites have commenced fieldwork, and conclusive results are pending. The study aspires to validate a screen-triage-treat protocol utilizing innovative biomarkers to deliver an accurate, feasible, and cost-effective strategy for cervical cancer prevention in resource-limited areas. Should the study validate PAVE, its broader implementation could be recommended, potentially expanding cervical cancer prevention worldwide. The consortial sites are responsible for their own study costs. Research equipment and supplies, and the NCI-affiliated staff are funded by the National Cancer Institute Intramural Research Program including supplemental funding from the Cancer Cures Moonshot Initiative. No commercial support was obtained. Brian Befano was supported by NCI/ NIH under Grant T32CA09168.

Effects of variation in sample storage conditions and swab order on 16S vaginal microbiome analyses.

The composition of the human vaginal microbiome has been linked to a variety of medical conditions including yeast infection, bacterial vaginosis, and sexually transmitted infection. The vaginal microbiome is becoming increasingly acknowledged as a key factor in personal health, and it is essential to establish methods to collect and process accurate samples with self-collection techniques to allow large, population-based studies. In this study, we investigate if using AssayAssure Genelock, a nucleic acid preservative, introduces microbial biases in self-collected vaginal samples. To our knowledge, we also contribute some of the first evidence regarding the impacts of multiple swabs taken at one time point. Vaginal samples have relatively low biomass, so the ability to collect multiple swabs from a unique participant at a single time would greatly improve the replicability and data available for future studies. This will hopefully lay the groundwork to gain a more complete and accurate understanding of the vaginal microbiome.

Human papillomavirus testing using HPV APTIMA® assay and an external cellularity control in self-collected samples.

In cervical cancer screening programs, the detection of high-risk human papillomavirus (HR-HPV)is now widely implemented on physician-collected samples and has expanded to include self-collected samples. The use of a cellularity control (CC)is needed to reduce false-negative HPV results. An external mRNA CC forthe HPV APTIMA®assay was assessed for its analytical performance and the results were compared with both cervix cytobrush samples taken by physicians and self-collected vaginal samples from 148 women. The performance of the CC was adjusted to control for the presence of cellular mRNA in the ThinPrep® and Multitest® transport media. This CC is user-friendly but implies to perform two independent assays on PANTHER®automate. Self-collected vaginal sampling gives a lower median CC results (13.2 vs. 16.9 min) but a higher risk of negative CC results (3.3 vs. 0%). The usefulness of the CC for the HR-HPVassay may be optimized by the definition of a threshold for a minimum cell number to be tested to increase confidence in HPV-negative results. The systematic use of an RNA CC increases confidence for HPV RNA assays on self-collected vaginal samples.

Evaluation of an Isothermal Amplification HPV Assay on Self-Collected Vaginal Samples as Compared to Clinician-Collected Cervical Samples.

This study aimed to evaluate the concordance of HPV results between the SentisTM HPV assay (Sentis) (BGI Group, Shenzhen, China), an isothermal amplification-based HPV assay, on self-collected and clinician-collected samples and the agreement of Sentis on self-collected samples with the BD OnclarityTM HPV assay (Onclarity) (Becton, Dickinson, and Company, Franklin Lakes, New Jersey, USA), a PCR-based HPV assay, on clinician-collected samples. This was a prospective study of 104 women attending the colposcopy clinic for abnormal smears. After informed consent, participants self-collected vaginal samples before having clinician-collected cervical samples. Self-collected samples underwent HPV testing with Sentis (Self-Sentis HPV) and clinician-collected samples were tested with Sentis (Clinician-Sentis HPV) and Onclarity (Clinician-Onclarity), which was used as a reference standard. The concordance was assessed using Cohen's kappa. The prevalence of HPV and the acceptability of self-sampling were also evaluated. The concordance rate between Self-Sentis HPV and Clinician-Sentis HPV was 89.8% with a kappa of 0.769. The concordance rate between Self-Sentis HPV and Clinician-Onclarity was 84.4% with a kappa of 0.643. The prevalence of HPV was 26.0% on Clinician-Onclarity, 29.3% on Clinician-Sentis HPV, and 35.6% on Self-Sentis HPV. Overall, 65% of participants would undergo self-sampling again. This was attributed to mainly not feeling embarrassed (68%) and being convenient (58%). Our study showed a substantial agreement between Self-Sentis HPV with Clinician-Sentis HPV and Clinician-Onclarity. Self-sampling was also shown to be a generally well-accepted method of screening.

Relationships between the vaginal microbiota and genitourinary syndrome of menopause symptoms in postmenopausal women: the Study of Women's Health Across the Nation.

To describe vaginal microbiota classified by community state types (CST) in a diverse cohort of postmenopausal women and evaluate relationships among genitourinary syndrome of menopause (GSM) symptoms (vaginal dryness, vulvovaginal irritation, sexual pain, dysuria, urinary urgency), CSTs, estrogen, vaginal maturation index (VMI), and vaginal pH. In the Study of Women's Health Across the Nation, 1,320 women aged 60.4 to 72.5 years self-collected (2015-2017) vaginal samples analyzed for microbiota composition and structure (CSTs) using 16S rRNA gene amplicon sequencing, VMI, and pH. GSM symptoms were collected with self-administered questionnaires; interviewers elicited estrogen use and measured body mass index. Serum E2 and E1 were measured using high-performance liquid chromatography. We analyzed data using Pearson χ2 tests, analysis of variance, Kruskal-Wallis tests, and binomial logistic regression. The most frequently occurring CST was low Lactobacillus species IV-C (49.8%); 36.4% of women had CSTs dominated by Lactobacillus species. More than half of the women with vaginal atrophy biomarkers (VMI <50 and pH >5) had CST IV-C0, whereas women using estrogen or with higher E1 and E2 levels had a higher prevalence of Lactobacillus crispatus-dominated CST I (P values < 0.001). Sexual pain was associated with atrophy biomarkers and independently associated with Streptococcus species-dominated CST IV-C1 (odds ratio, 2.26; 95% confidence intervals, 1.20-4.23). For all other GSM symptoms, we found no consistent associations with E1 or E2 levels, atrophy biomarkers, or any CST. Although close relationships exist among estrogen, CSTs, VMI, and pH, sexual pain was the only GSM symptom associated with the structure of vaginal microbiota and atrophy biomarkers.

Accuracy of Human Papillomavirus (HPV) Testing on Urine and Vaginal Self-Samples Compared to Clinician-Collected Cervical Sample in Women Referred to Colposcopy.

In the context of cervical cancer prevention, where human papillomavirus (HPV) infection is pivotal, HPV testing is replacing Pap Smear in primary screening. This transition offers an opportunity for integrating self-sampling to enhance coverage. We evaluated the accuracy of HPV testing using self-collected urine and vaginal samples, comparing them to physician-collected cervical swabs. From a cohort of 245 women with abnormal cytology, we collected self-sampled vaginal, urine, and clinician-administered cervical specimens. Employing Anyplex™II HPV28 assay, outcomes revealed HPV positivity rates of 75.1% (cervical), 78.4% (vaginal), and 77.1% (urine). Significant, hr-HPV detection concordance was observed between self-taken cervical samples and clinical counterparts (k = 0.898 for vaginal; k = 0.715 for urine). This study extends beyond accuracy, highlighting self-collected sample efficacy in detecting high-grade cervical lesions. The insight underscores self-sampling's role in bolstering participation and aligns with WHO's goal to eliminate cervical cancer by 2030.

Can HPV Test on Random Urine Replace Self-HPV Test on Vaginal Self-Samples or Clinician-Collected Cervical Samples?

This study investigated whether random urine (RU) samples can be used to accurately identify human papillomavirus (HPV) and whether these samples can replace self-collected vaginal samples in HPV tests. A total of 167 patients with abnormal Pap smears were recruited. The patients provided self-collected vaginal and RU samples for HPV testing. Clinicians obtained cervical samples from the patients. Colposcopy examination and cervical biopsy were performed. Hybrid Capture II (HC II) and Cervista tests were used to detect HPV in the RU samples. The results of tests on clinician-collected cervical samples were used as the benchmark. The sensitivities of the Cervista tests on vaginal samples and the HC II and Cervista tests on RU samples were 75.00%, 49.07%, and 44.44%, respectively. After we adjusted the HPV detection cutoff value for urine samples based on values in the receiver operating characteristic curve, the sensitivities of the HC II and Cervista tests increased to 63.89% and 58.33%, respectively. In 167 patients, 59 had cervix biopsies showing CIN2 or worse (CIN2+). For CIN2+, the sensitivity was 47.5% and 50.8% in the HC II and Cervista tests on RU samples, respectively. HPV tests on RU samples had approximately 60% sensitivity to HPV tests on clinician-collected cervical samples after the cutoff values were adjusted. For CIN2+, the sensitivity was only approximately 50%. Further studies and improvements in urine-based HPV testing are needed to establish it as a more convenient and accessible method for detecting HPV and cervical dysplasia in patients.