Self-collected Vaginal Samples Research Articles

S14.2 A study of African American and Latina women and human papillomavirus: lessons learnt

BackgroundAfrican American and Latina women in the United States suffer from sexually transmitted infections at higher rates than white women. It is particularly important to prevent HPV in these groups...

Low‐level persistence of human papillomavirus 16 DNA in a cohort of closely followed adolescent women

Most human papillomavirus (HPV) infections in young women become undetectable by standard assays after a few months. It is possible that many HPV infections do not actually clear, but persist at very low levels for years, becoming detected again later in life. The purpose of this study is to describe HPV 16 clearance, reappearance, and low-level persistence in a cohort of adolescent women. Adolescent women (N = 66), not vaccinated against HPV, were recruited from 1998 to 2008 into a longitudinal study. Self-collected vaginal samples were obtained quarterly and tested for HPV by Linear Array HPV Genotyping Test (LA-HPV). To explore low-level persistence, a type-specific nested PCR for HPV 16 (TSN-PCR-16) was developed. Women with HPV 16 detected by LA-HPV had their negative swabs retested with TSN-PCR-16. Forty-two participants with HPV 16, followed for a mean of 6.3 years, were analyzed. Using LA-HPV, the median duration of HPV 16 detection was 428 days (SD 852.5 days). TSN-PCR-16 detected HPV 16 during periods of LA-HPV non-detection in samples from many women. Using a combination of LA-HPV and TSN-PCR-16 results, the median duration of HPV 16 detection was 1,022.5 days (SD 943.7 days). The durations of detection differed significantly between the two methods (P = 0.0042) with a mean difference of 434.5 days. In adolescent females, duration of HPV 16 detection was significantly longer when TSN-PCR-16 was combined with LA-HPV. Some apparently cleared HPV 16 could be shown to persist at low levels using nested PCR.

Influence of sexual intercourse on genital tract microbiota in infertile couples

Several studies have suggested the association of disturbed genital tract microbiota with infertility. Our aim was to clarify the influence of sexual intercourse on partner’s genital tract microbiota in infertile couples. Seventeen couples were studied, and in 5 men inflammatory prostatitis (IP) was diagnosed. Semen samples were collected during menstruation of the female counterpart, two self-collected vaginal samples were taken 3–5 days later – before intercourse and 8–12 h after intercourse. Ureaplasma parvum was found in 59% of women, its prevalence was higher in women whose partner had IP, as well as in half of their male partners. Sexual intercourse caused significant shifts in vaginal microbiota – increase of Nugent score and shifts in cultured microbiota (emergence and disappearance of several species). These changes were less expressed in the presence of normal vaginal microbiota but more prominent in the partners of IP men. These changes may interfere with fertilization.

5. Risk for Trichomonas Vaginalis Infections in Internet-Recruited Females Who Submit Self-Collected Vaginal Swabs

Submission of self-collected vaginal samples (SCVS) at home could remove barriers that adolescents face in getting tested for sexually transmitted infections (STIs). Internet recruitment of such specimens has been shown to be highly acceptable to women for testing of chlamydia and gonorrhea. The purpose of this study was to add trichomonas testing to the menu of available tests and to ascertain risk factors associated with trichomoniasis.

The Microbial Ecology of Bacterial Vaginosis: A Fine Scale Resolution Metagenomic Analysis

AbstractThe vaginal microbiota play an important protective role in maintaining the health of women. Disruption of the mutualistic relationship that exists between bacterial communities in the vagina and their hosts can lead to bacterial vaginosis (BV), a condition in which lactic acid producing bacteria are supplanted by a diverse array of strictly anaerobic bacteria. BV has been shown to be an independent risk factor for adverse outcomes including preterm delivery and low infant birth weight, acquisition of sexually transmitted infections and HIV, and development of pelvic inflammatory disease. National surveys indicate the prevalence of BV among U.S. women is 29.2%, and yet, despite considerable effort, the etiology of BV remains unknown. Moreover, there are no broadly effective therapies for the treatment of BV, and reoccurrence is common. In the proposed research we will test the overarching hypothesis that vaginal microbial community dynamics and activities are indicators of risk to BV. To do this, we propose to conduct a high resolution prospective study in which samples collected daily from 200 reproductive-age women over two menstrual cycles are used to capture molecular events that take place before, during, and after the spontaneous remission of BV episodes. We will use modern genomic technologies to obtain the data needed to correlate shifts in vaginal microbial community composition and function, metabolomes, and epidemiological and behavioral metadata with the occurrence of BV to better define the syndrome itself and identify patterns that are predictive of BV. The three specific aims of the research are: (1) Evaluate the association between the dynamics of vaginal microbial communities and risk to BV by characterizing the community composition of vaginal specimens archived from a vaginal douching cessation study in which 33 women self-collected vaginal swabs twice-weekly for 16 weeks; (2) Enroll 135 women in a prospective study in which self-collected vaginal swab samples and secretions are collected daily along with data on the occurrence of BV, vaginal pH, and information on time varying habits and practices; (3) Apply model-based statistical clustering and classification approaches to associate the microbial community composition and function, with metadata and clinical diagnoses of BV. The large body of information generated will facilitate understanding vaginal microbial community dynamics, the etiology of BV, and drive the development of better diagnostic tools for BV. Furthermore, the information will enable a more personalized and effective treatment of BV and ultimately help prevent adverse sequelae associated with this highly prevalent disruption of the vaginal microbiome.

Can human papillomavirus DNA testing of self-collected vaginal samples compare with physician-collected cervical samples and cytology for cervical cancer screening in developing countries?

Background: To determine human papillomavirus (HPV) types by polymerase chain reaction (PCR)-reverse line blot assay and examine the concordance between HPV by Hybrid Capture 2 (HC2) and PCR on self-collected vaginal and physician-collected cervical samples and cytology. Methods: This was a cross-sectional study of 546 sexually active women aged ≥30 years with persistent vaginal discharge, intermenstrual or postcoital bleeding or an unhealthy cervix. Participants self-collected vaginal samples (HPV-S) and physicians collected cervical samples for conventional Pap smear and HPV DNA (HPV-P) testing and performed colposcopy, with directed biopsy, if indicated. HPV testing and genotyping was done by HC2 and PCR reverse line blot assay. Concordance between HC2 and PCR results of self- and physician-collected samples was determined using a Kappa statistic ( κ) and Chi-square test. Results: Complete data were available for 512 sets with 98% of women providing a satisfactory self-sample. PCR detected oncogenic HPV in 12.3% of self- and 13.0% of physician-collected samples. Overall, there was 93.8% agreement between physician-collected and self-samples ( κ = 76.31%, 95% confidence interval [CI]: 64.97–82.29%, p = 0.04)—complete concordance in 473 cases (57 positive, 416 negative), partial concordance in seven pairs and discordance in 32 pairs. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of self-sampling for detection of cervical intraepithelial neoplasia (CIN)2+ disease were 82.5%, 93.6%, 52.4% and 98.4%, respectively; for physician-sampling they were 87.5%, 93.2%, 52.2% and 98.9%, respectively; and for cytology they were 77.5%, 87.3%, 34.1% and 97.9%, respectively. Concordance between HC2 and PCR was 90.9% for self-samples ( κ = 63.7%, 95% CI: 55.2–72.2%) and 95.3% for physician-collected samples ( κ = 80.4%, 95% CI: 71.8–89.0%). Conclusions: Self-HPV sampling compares favourably with physician-sampling and cytology. A rapid, affordable, HPV self-test kit can be used as the primary method of cervical cancer screening in low-resource situations.

Suitability of Self-Collected Vaginal Samples for Cervical Cancer Screening in Periurban Villages in Andhra Pradesh, India

Our aim was to determine if (1) Hybrid Capture 2 and a PCR-based method were comparable for detection of high-risk human papillomavirus (HPV) clinician-collected and self-collected samples were equally efficient to detect HPV and cervical cancer precursor lesions, and (3) if participation rates improved with home-based versus clinic-based self collection. Samples were selected from women participating in a cervical cancer screening study according to HPV, visual inspection with acetic acid, or Pap smear screening results. From 432 of 892 selected women, split sample aliquots were tested for HPV DNA using both the Hybrid Capture 2 assay and the Roche prototype line blot assay. Women from a subset of villages were recruited at two separate time points for clinic-based self-collection and home-based self-collection, and participation rates were compared. Pairwise agreement between self- and clinician-collected samples was high by both Hybrid Capture 2 (90.8% agreement, kappa = 0.7) and PCR (92.6% agreement, kappa = 0.8), with significantly increased high-risk HPV detection in clinician-collected specimens (McNemar's P < 0.01). Ability to detect precursor lesions was highest by PCR testing of clinician-collected samples and lowest by Hybrid Capture 2 testing of self-collected samples (11 of 11 and 9 of 11 cases of cervical intraepithelial neoplasia grade 2/3 and cancer detected, respectively). Participation in home-based screening was significantly higher than clinic-based screening (71.5% and 53.8%, respectively; P < 0.001) among women ages 30 to 45 years. The combination of improved screening coverage and a high single test sensitivity afforded by HPV DNA testing of home-based self-collected swabs may have a greater programmatic effect on cervical cancer mortality reduction compared with programs requiring a pelvic exam.

Commentary on “Validation of COBAS Taqman CT for the detection of Chlamydia trachomatis in vulvo-vaginal swabs”

We would like to congratulate Skidmore et al 1 for providing data to validate self-collected samples (SCS) for the detection of chlamydia. No doubt their study was undertaken within a...

The effect of vaginal douching cessation on bacterial vaginosis: a pilot study

The objective of the study was to evaluate the risk for bacterial vaginosis (BV) in a douching cessation trial. Thirty-nine reproductive-age women who reported use of douche products were enrolled into a 20-week study consisting of a 4 week douching observation (phase I) followed by 12-weeks of douching cessation (phase II). In phase III, participants then chose to resume douching or continue cessation for the remaining 4 weeks. Self-collected vaginal samples were obtained twice weekly in the first 16 weeks, and 1 sample was collected during week 20 (1107 samples total). BV was diagnosed by Nugent score of 7 or greater. Conditional logistic regression was used to evaluate douching cessation on the risk of BV. The adjusted odds ratio (aOR) for BV in the douching cessation phase, as compared with the douching-observation phase was 0.76 (95% confidence interval [CI], 0.33 to 1.76). Among women who reported their primary reason for douching was to cleanse after menstruation, BV was significantly reduced in douching cessation (aOR:0.23; 95% CI, 0.12 to 0.44). Vaginal douching cessation may reduce the risk for BV in a subset of women.

Baseline assessment of prevalence and geographical distribution of HPV types in Chile using self-collected vaginal samples

BackgroundChile has broad variations in weather, economics and population from the far desert north (Region 1) to the cold, icy south (Region 12). A home-based self-collected vaginal sampling was nested in the 2003 Chilean population-based health survey in order to explore the possibility of a type-specific geographical variation for human papillomavirusMethodsThe population was a national probability sample of people 17 years of age and over. Consenting women provided self-collected cervicovaginal swabs in universal collection media (UCM). DNA was extracted and typed to 37 HPV genotypes using PGMY consensus PCR and line blot assay. Weighted prevalence rates and adjusted OR were calculated.ResultsOf the 1,883 women participating in the health survey, 1,219 (64.7%) provided a cervicovaginal sample and in 1,110 (56.2% of participants and 66.5% of those eligible) the samples were adequate for analysis. Refusal rate was 16.9%. HPV prevalence was 29.2% (15.1% high-risk HPV and 14.1% low-risk HPV). Predominant high-risk types were HPV 16, 52, 51, 56 and 58. Predominant low-risk HPVs were HPV 84, CP6108, 62, 53 and 61. High-risk and low-risk HPV rates were inversely correlated between the regions. High-risk HPV prevalence was highest among the youngest women, whereas low-risk HPV increased slightly with age.ConclusionSelf-obtained vaginal sampling is adequate for monitoring HPV in the community, for identifying high-risk areas, and for surveying the long term impact of interventions.

Detection of Human Papillomavirus From Self-Collected Vaginal Samples of Women in Chiang Mai, Thailand

Detection of Human Papillomavirus From Self-Collected Vaginal Samples of Women in Chiang Mai, Thailand

Evaluation of HPV 16 PCR Detection in Self-compared With Clinician-collected Samples in Women Referred for Colposcopy

Abstract Objectives. A clinical prospective evaluation study was conducted to evaluate PCR detection of high-risk human papillomavirus (HPV) type 16 in self-sampled vaginal compared with clinician-collected cervical specimens. Methods. Paired vaginal and cervical specimens were collected from 137 consecutive women referred for colposcopy because of abnormal cervical cytology. In-house and a commercial PCR method for HPV type 16 were used. Self-sampled vaginal HPV 16 detection was compared to histology and physician-collected cervical specimens. Results. Of the 137 patients, 98 had proven abnormal histology and were included in the analysis. Overall, using the cervix HPV detection as reference method, the self-sampled vaginal sample showed sensitivity 91.8%, specificity 96.1% and agreement kappa (κ) 0.881. Using the histology as reference, all 11 cervical cancer cases were HPV-16-positive in both cervical and vaginal samples, and in 43 high-grade lesions, detection sensitivity in cervix was 72.1% (κ 0.588) and vagina 67.4% (κ 0.516). HPV 16 detection did not differ (P = 0.27) between clinician-collected cervical and self-sampled vaginal specimens. Conclusions. The self-collected vaginal sample is highly concordant with the physician-collected cervical sample in HPV 16 detection.

Accuracy of HPV testing of vaginal smear obtained with a novel self‐sampling device

Most of women diagnosed as having cervical cancer have not participated in organized cytological screening. Aim. A study was conducted to evaluate the accuracy of human papilloma virus testing by self-collected vaginal samples in comparison to regular cytological screening. The agreement of hybrid capture 2 assay and polymerase chain reaction assay for detection of human papilloma virus DNA in self-collected vaginal samples and clinician-obtained cervical smears was investigated. Forty-three women aged 23-58 years admitted for further examination due to previous positive cytology in the organized screening participated in self-collecting of vaginal samples with a novel self-sampling device. During the visit a clinician also collected a cervical smear using a cytobrush. The vaginal samples collected with the self-sampling device were analyzed for high-risk human papilloma virus with the hybrid capture 2 assay technique and the cervical smears were Pap-stained, examined cytologically and after that reanalyzed for human papilloma virus DNA using a polymerase chain reaction assay. The vaginal samples were positive for high-risk human papilloma virus in 37% of the cases using hybrid capture 2 assay. Twelve of the 43 Pap smears showed positive cytology (ASCUS-CIN 3), of which 4 showed CIN 2-3. When polymerase chain reaction assay was performed, human papilloma virus DNA was detected in 40% of the glass slides. The agreement between cytology and the two human papilloma virus testing techniques was 67-74% (kappa 0.27-0.45) and the agreement between the two human papilloma virus tests was 70% (kappa 0.36). Testing for high-risk human papilloma virus can identify more women at risk of developing cervical cancer than cytology irrespective of the sampling method. Furthermore, offering a self-sampling device for collection of vaginal smear seems to be a useful screening tool for cervical cancer among women not responding to an invitation for smear sampling.

Effect of Replens Gel Used with a Diaphragm on Tests for Human Papillomavirus and Other Lower Genital Tract Infections

Little is known about effects of vaginal lubricants with barrier contraceptives on detection of sexually transmissible infections. We hypothesized that Replens gel used with a diaphragm would neither inhibit human papillomavirus (HPV) detection in cervical samples and chlamydia (CT) and gonorrhea (GC) detection in urine samples, nor affect cervical cytology quality. After a clinician-collected cervical sample and a self-collected vaginal sample for HPV detection ("pregel" specimens), women placed a diaphragm containing Replens gel into the vagina. Participants (n = 77) removed the diaphragm after 6 hours and performed vaginal HPV self-sampling at several time points thereafter. Clinicians performed cervical cytology sampling and HPV testing ("postgel" specimens) 24 hours after diaphragm removal. Pregel and postgel specimens were analyzed with and without added SiHa cells (source of defined numbers of HPV16 genomes). HPV was detected by polymerase chain reaction using MY09/11 primers. Urine samples were obtained for CT and GC testing. Proportions of samples testing positive were compared using relative risk (RR) regression models. Proportions with detectable HPV in the clinician-collected cervical pregel and postgel samples were not statistically different for samples with added SiHa cells (88.3% vs 93.2%, RR = 1.06, 95% confidence interval = 0.96-1.14) or for native HPV infection (32.9% vs 28.2%, RR = 0.87, 95% confidence interval = 0.71-1.06). In self-collected vaginal postgel samples, there was no trend for decreased HPV detection after gel exposure. Gel affected neither urine tests for CT and GC nor cytological quality. Recent Replens gel use with a diaphragm does not inhibit cervical HPV testing, urine testing for CT and GC, or cervical cytology quality.

Evaluation of HPV 16 PCR detection in self- compared with clinician-collected samples in women referred for colposcopy

Objectives. A clinical prospective evaluation study was conducted to evaluate PCR detection of high-risk human papillomavirus (HPV) type 16 in self-sampled vaginal compared with clinician-collected cervical specimens. Methods. Paired vaginal and cervical specimens were collected from 137 consecutive women referred for colposcopy because of abnormal cervical cytology. In-house and a commercial PCR method for HPV type 16 were used. Self-sampled vaginal HPV 16 detection was compared to histology and physician-collected cervical specimens. Results. Of the 137 patients, 98 had proven abnormal histology and were included in the analysis. Overall, using the cervix HPV detection as reference method, the self-sampled vaginal sample showed sensitivity 91.8%, specificity 96.1% and agreement kappa ( κ) 0.881. Using the histology as reference, all 11 cervical cancer cases were HPV-16-positive in both cervical and vaginal samples, and in 43 high-grade lesions, detection sensitivity in cervix was 72.1% ( κ 0.588) and vagina 67.4% ( κ 0.516). HPV 16 detection did not differ ( P = 0.27) between clinician-collected cervical and self-sampled vaginal specimens. Conclusions. The self-collected vaginal sample is highly concordant with the physician-collected cervical sample in HPV 16 detection.

Good correlation of HPV DNA test between self-collected vaginal and clinician-collected cervical samples by the oligonucleotide microarray

Objectives. To evaluate the efficacy of self-collected vaginal samples for high-risk HPV detection by the HPV oligonucleotide microarray method (HPVDNAChip™). Methods. One hundred and eighteen patients with abnormal Pap smears were included. Self-collected vaginal and clinician-collected cervical samples for HPV testing were obtained. The result of the HPV DNA test was compared with the histopathological diagnosis or colposcopic finding. Results. Of the 118 patients, 42 (35.6%) had ≥ cervical intraepithelial neoplasia (CIN) III lesions. Using the HPVDNAChip™, high-risk types of HPV were detected in 38 of these 42 patients (90.5%) with the self-collected vaginal samples and in 37 of 42 (88.1%) with the clinician-collected cervical samples. The agreement of HPVDNAchip™ results between self- and clinician-collected samples was very good ( κ = 0.81) with a 93.2% concordance rate. Multiple HPV infections were found in 17 of 88 (19.3%) HPV-positive clinician-collected cervical samples. The rate of multiple HPV infection tended to decrease as the degree of pathologic classification increased. Conclusion. Using the HPVDNAchip™ to assay for HPV infection, results from self-collected vaginal samples were compatible with those from clinician-collected cervical samples.

Self-Sampling Is Associated with Increased Detection of Human Papillomavirus DNA in the Genital Tract of HIV-Seropositive Women

Analysis of self-collected swab samples from the genital tract could improve accrual and retention of women in studies of human papillomavirus (HPV) infection and precancerous cervical lesions. Self-collected vaginal swab specimens and physician-collected cervical swab specimens were compared for detection and typing of HPV DNA in 158 HIV-seropositive women. Paired samples were collected for 157 participants. Beta-globin was not detected in 6 (3.3%) physician-collected specimens and 8 (4.3%) self-obtained specimens collected from 11 women, leaving 146 paired samples suitable for PCR analysis. HPV DNA was amplified with the HPV primers PGMY09 and PGMY11 and typed using the line blot assay. HPV DNA was detected more frequently in self-collected samples (95 [65.1%] of 146), compared with physician-collected samples (78 [53.4%] of 146) (P = .04). Self-collected samples contained a greater number of types (mean +/- SD, 1.60 +/- 1.80 types; 95% confidence interval [CI], 1.31-1.90), compared with physician-collected samples (mean +/- SD, 1.25 +/- 1.66 types; 95% CI, 0.98-1.52) (P = .04). A good agreement between sampling methods was achieved for detection of any HPV DNA (kappa = 0.73; 95% CI, 0.58-0.89), high-risk types (kappa = 0.84; 95% CI, 0.68-0.99), and low-risk types (kappa = 0.71; 95% CI, 0.67-0.75). Agreement between sampling methods for detection of HPV DNA was found for 24 (88.8%) of 27 follow-up samples collected from a total of 20 women. A comparison of samples collected at consecutive visits revealed agreements for detection of any HPV DNA, detection of high-risk HPV, and HPV typing results between visits of 88.9% (24 of 27 samples), 81.5% (22 of 27), and 55.5% (15 of 27), respectively, for physician-collected samples, and 96.3% (26 of 27 samples), 92.6% (25 of 27), and 55.5% (15 of 27), respectively, for self-collected samples. Analysis of self-collected vaginal swab samples improved the detection rate of HPV, suggesting that such samples might be of greater value than physician-obtained samples in studies of HPV transmission.

Home STI testing: The adolescent female’s opinion

Purpose To assess sexually active adolescent females’ attitudes of home tests for sexually transmitted infections. Methods This study represents a follow-up to a study on adolescent attitudes toward different sampling methods for STI testing. In the initial study participants completed a pre-examination health survey, provided first void urine (FVU) and self-collected vaginal swab samples followed by a pelvic examination with STI screening by endocervical swabs. Participants’ attitudes about the three collection techniques were assessed at the end of the visit. For the current study, this same group of ethnically diverse adolescents (13–20-years-old) was contacted by telephone 9 months after their initial clinic visit to re-assess their attitudes about the three specimen collection techniques and to evaluate their attitudes regarding the use of home STI testing. Friedman tests of mean ranks evaluated teens’ rankings of STI sampling methods and multivariate regression analysis was used to identify predictors of home test preference. Results Home urine testing was the first choice for STI screening followed by the FVU, self-obtained vaginal swab and endocervical swab collected in a clinical setting. FVU was preferred to self-collected vaginal swabs ( p = .01). Adolescents who worried about having an STI were more likely to favor home urine testing (OR 5.5, p = .01). Only 22% would seek any STI screening if asymptomatic. Conclusions Because young women preferred home STI testing, this may be an additional option, as the foundation for such testing kits has progressed. Adolescent preferences may be heavily influenced by the pelvic examination experience. Because of the largely asymptomatic nature of CT infections, multiple screening options (clinical and home-based) need to be available to increase access to care.

Home STI testing: The adolescent femaleʼs opinion

<h2>Abstract</h2><h3>Purpose</h3> To assess sexually active adolescent females' attitudes of home tests for sexually transmitted infections. <h3>Methods</h3> This study represents a follow-up to a study on adolescent attitudes toward different sampling methods for STI testing. In the initial study participants completed a pre-examination health survey, provided first void urine (FVU) and self-collected vaginal swab samples followed by a pelvic examination with STI screening by endocervical swabs. Participants' attitudes about the three collection techniques were assessed at the end of the visit. For the current study, this same group of ethnically diverse adolescents (13–20-years-old) was contacted by telephone 9 months after their initial clinic visit to re-assess their attitudes about the three specimen collection techniques and to evaluate their attitudes regarding the use of home STI testing. Friedman tests of mean ranks evaluated teens' rankings of STI sampling methods and multivariate regression analysis was used to identify predictors of home test preference. <h3>Results</h3> Home urine testing was the first choice for STI screening followed by the FVU, self-obtained vaginal swab and endocervical swab collected in a clinical setting. FVU was preferred to self-collected vaginal swabs (<i>p</i> = .01). Adolescents who worried about having an STI were more likely to favor home urine testing (OR 5.5, <i>p</i> = .01). Only 22% would seek any STI screening if asymptomatic. <h3>Conclusions</h3> Because young women preferred home STI testing, this may be an additional option, as the foundation for such testing kits has progressed. Adolescent preferences may be heavily influenced by the pelvic examination experience. Because of the largely asymptomatic nature of CT infections, multiple screening options (clinical and home-based) need to be available to increase access to care.

Comparison of self-collected vaginal samples and clinician-collected cervicovaginal samples for HPV DNA

Comparison of self-collected vaginal samples and clinician-collected cervicovaginal samples for HPV DNA