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Background: The objective was to compare commercial assays on clinical specimens for Mycoplasma genitalium (MG) detection and macrolide resistance mutation (MRM) frequency. Methods: Three self-collected vaginal swabs (VS) and a first-void urine (FVU) from 300 consented women were tested by Aptima MG (AMG), ResistancePlus MG (RPMG) and Seeplex STD6 ACE (STD6) for detection of MG. Aptima MG and STD6 MG positives were tested for MRM using MG 23S rRNA polymerase chain reaction with Sanger sequencing (23SMGSS) compared with MRM determination in the RPMG assay. Unique AMG positives were tested with confirmatory Aptima assays. Results: M. genitalium prevalence ranged from 7.1% to 19.7%, influenced by the assay used and the specimen tested. Overall agreements for MG detection were 96.3% (κ = 0.91) for VS and 93.3% (κ = 0.72) for FVU between AMG and RPMG with lower agreements with STD6. Using a rotating reference standard, sensitivities on VS and FVU were 100% and 100% for AMG, 100% and 83.3% for RPMG, and 54.2% and 48.4% for STD6. Specificities were high for RPMG and STD6 and AMG detected extra positives, most of which were confirmed. Macrolide resistance mutation frequency rates testing VS and FVU were 50% (24/48) and 58.1% (18/31) by RPMG compared with 52.5% (31/59) and 23.5% (12/51) by 23SMGSS. MRM overall agreements between RPMG and 23SMGSS were 73.2% (κ = 0.41) for VS and 76.0% (κ = 0.52) for FVU. Conclusions: Aptima MG detected more cases of MG infections. ResistancePlus MG detection was more effective on VS than on FVU. Seeplex STD6 ACE performance was inferior. The MRM detection component of RPMG agreed with results from 23SMGSS most of the time.

A survey of clinical laboratories in the United States was conducted to compare 2013 Chlamydia trachomatis/Neisseria gonorrhoeae testing practices (before the release of the 2014 Centers for Disease Control and Prevention testing recommendations) with 2015 C. trachomatis/N. gonorrhoeae testing practices. Supplemental digital content is available in the text., Background Adherence to recommended laboratory testing practices is crucial for sexually transmitted infection prevention and control. The objective of this article is to compare Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing practices of US clinical laboratories in 2013 before the updated 2014 Centers for Disease Control and Prevention recommendations and in 2015 after the updated recommendations. Methods A total of 236 clinical laboratories participated in surveys about their 2013 and 2015 CT and NG testing practices, including questions on specimen types collected and assays used. Results There was an increase of 5 laboratories offering CT nucleic acid amplification testing (NAAT) from 2013 to 2015 and an increase of 5 laboratories offering NG NAAT. There was a net increase of 3 laboratories accepting urine for CT and NG NAAT, the preferred specimen type for male individuals. There was not a net increase in the total number of laboratories accepting vaginal swabs for CT NAAT (n = 89 in 2013 and 2015), the preferred specimen type for female individuals, but there was an increase of 3 laboratories accepting vaginal swabs for NG NAAT. The number of laboratories performing NG susceptibility testing decreased from 100 in 2013 to 89 in 2015 (χ2 = 1.07, P > 0.10). Conclusions There were no major changes in testing practices in the 2-year period from 2013 to 2015. However, there were some small shifts, including increases in the use of NAATs, acceptance of Centers for Disease Control and Prevention–preferred specimen types for CT/NG, and changes in usage of assays by manufacturer.

Self-obtained vaginal swabs, first-void urine and pooled specimens were collected at home and in a clinic. Percent prevalence and collection site concordance was 30.3 and 100 for Mycoplasma genitalium (74.4% azithromycin resistant) 15.1 and 96.7 for Chlamydia trachomatis and 6.6 and 100 for Neisseria gonorrhoeae (27% ciprofloxacin-resistant).

BACKGROUND: Few studies have evaluated the acceptability of self-collected vaginal swabs among young women in sub-Saharan Africa, including in school settings. We evaluated the acceptability of 2 conditions for the self-collection of swabs in secondary schools in Entebbe, Uganda. METHODS: Assenting girls with parental consent from 3 secondary schools were provided instructions for sampling, and randomly allocated to self-collection of vaginal swabs with or without nurse assistance to help with correct placement of the swab. Swabs were tested for bacterial vaginosis by Gram stain. Participants were followed up after 1 to 2 days and 1 to 2 weeks and invited for a qualitative interview. RESULTS: Overall 96 girls were enrolled (median age, 16 years; interquartile range, 15-17 years). At the first follow-up visit, participants in both arms reported that instructions for sample collection were easy to understand, and they felt comfortable with self-collection. Girls in the nurse assistance arm reported feeling less relaxed (27% vs. 50%, P = 0.02) than those in the arm without nurse assistance, but more confident that they collected the sample correctly (96% vs. 83%, P = 0.04). About half (47%) of participants agreed that self-sampling was painful, but almost all (94%) would participate in a similar study again. Qualitative data showed that participants preferred self-collection without nurse assistance to preserve privacy. Bacterial vaginosis prevalence was 14% (95% confidence interval, 8-22). CONCLUSIONS: In this setting, self-collection of vaginal swabs in secondary schools was acceptable and feasible, and girls preferred self-collection without nurse assistance. Self-collection of swabs is an important tool for the detection, treatment and control of reproductive tract infections in girls and young women.

To evaluate the relationship between douching and bacterial vaginosis (BV) among women with and without prior abnormal vaginal flora.1193 women had vaginal swabs obtained for Gram stain for BV, culture for vaginal microflora, and DNA amplification for Neisseria gonorrhoeae and Chlamydia trachomatis at baseline and 6, 12, 24, and 36 months. Self-reported douching was queried every 6 months.In cross-sectional analyses, douching at least once per month was associated with BV among women who had BV at the immediately preceding visit but not among women with normal or intermediate flora. In prospective analyses, douching increased the risk of acquisition for BV among women with intermediate flora (adj. HR 1.5, 95% CI 1.1-2.4) but not among women with normal flora.Douching appeared to be associated with BV among women with already imbalanced flora but not among women with normal flora.

Background Objective biomarkers of product use and protocol compliance are urgently needed. We compared the sensitivity and specificity of DNA and protein-based biomarkers, obtained from used vaginal gel applicators, to visual inspection of those applicators under ambient light (visual inspection of returned applicator [VIRA]) and ultraviolet light (UVL). Methods Forty women inserted hydroxyethylcellulose placebo gel vaginal applicators under direct observation. Applicators were evaluated by VIRA, UVL, and DNA/protein-based methods at 2 time points: within 7 days of the visit and after storing applicators for approximately 30 days. Semen biomarkers were assayed from vaginal swabs and returned applicators. Results The overall sensitivity and specificity of DNA and protein-based biomarkers in determining vaginal insertion versus sham handling of returned applicators were 98.3% and 100%, respectively, at both 7- and 30-day evaluations. The overall sensitivity and specificity of VIRA at 7 and 30 days after collection were significantly lower than those of DNA and protein-based biomarkers. Ultraviolet light inspection also had significantly lower overall sensitivity and overall specificity compared with DNA and protein biomarkers. The sensitivity of DNA and protein-based biomarkers for detecting insertion of wiped applicators was 95%, whereas the sensitivity of VIRA (range of 24%-28%) and UVL inspection (range, 38%-84%) was low for this subset. It was feasible to obtain semen biomarkers from vaginal swabs and returned used applicators. Conclusions DNA and protein-based biomarkers offer significantly higher sensitivity and specificity compared with VIRA and UVL assessment. The accuracy of these objective biomarkers is maintained despite storage of returned products for approximately 30 days and under conditions potentially modeling field use.

BACKGROUND Testing for Chlamydia trachomatis by nucleic acid amplification tests (NAATs) using self-collected vaginal swabs (VS) is acceptable and accurate. The objectives were to implement an educational Internet-based program for women to facilitate home screening, to determine whether women would request and use self-collected VS kits, to determine associated risk factors for infection, and to determine satisfaction with the process. METHODS The website, www.iwantthekit.org, was designed to encourage women > or =14 years to obtain home-sampling kits. Kits could be obtained in the community, requested by Internet/e-mail, or telephone. Users mailed the self-collected VS to the laboratory. Swabs were tested by 3 NAAT assays. Respondents called for results. RESULTS Forty-one of 400 (10.3%) women were chlamydia positive; 95.1% were treated. Questionnaires indicated 89.5% preferred self-collection, 93.5% rated collection easy/very easy, and 86.3% would use the Internet program again. Black race and age

Objectives: Cervicovaginal lavage (CVL) is often used for research and may be easier and more accurate than vaginal swabs as a specimen collection method. Goal: The goal of this study was to compare (CVL) with vaginal swabs for the detection of bacterial vaginosis (BV) and Trichomonas vaginalis (TV). Study: CVL and vaginal swabs were collected from 216 HIV-infected women. Clinical assessments were made using wet mount for TV and Amsel's criteria for BV through CVL and swab collection methods. Laboratory gold standards used were Nugent's criteria for BV and InPouch (Biomed Diagnostics, San Jose, CA) culture for TV collected by swab. Results: The prevalence by gold standards for BV was 49.3% and for TV was 25.2%. Sensitivities for direct microscopy versus culture for TV were 72.2 for CVL and 52.8 for vaginal swab (P

Background and Objectives: The development and introduction of nucleic acid amplification (NAA) tests by commercial sources has improved our ability to diagnose chlamydial infections and other sexually transmitted diseases (STDs). A review of approaches to diagnosing STDs can provide a clearer picture of the present needs. Goals: To review the advantage and disadvantages of current and future diagnostic approaches. Study Design: Survey the literature and define current and future needs in developed and developing country settings. Results: The increase in analytical sensitivity afforded by NAA has enabled the use of noninvasive specimens, such as first-void urine (FVU) and self-obtained vaginal swabs, for diagnostic testing and screening asymptomatic low-prevalence populations and hard-to-access populations. This technology allows multiplexing in which targets from multiple agents responsible for a particular syndrome can be amplified and detected. Although NAA tests have been designed to minimize contamination, there is some reluctance to replace less sensitive tests with this new technology. The concerns involve potential false positive and false negative results caused by the presence of inhibitors, even though the rates of false results are low. Other concerns are cost, through-put, hands-on time, and time necessary for results. Conclusions: Nucleic acid amplification tests are a great improvement and additional tests are needed for the diagnosis of STDs at the point of first encounter, with minimal delay between diagnosis and treatment. Affordable tests, which are rapid, sensitive, and specific are needed for use in resource-limited settings where most STDs are seen; this has been a major undertaking for the Sexually Transmitted Diseases Diagnostics Initiative.

Performance characteristics of the Cobas 4800 CT/NG assay were estimated for vaginal swab samples from more than 4000 women. Vaginal samples identified 92.9% and 98.5% of Chlamydia and Gonorrhea infections, respectively, which was more than any other single specimen type (endocervical swabs or urine) regardless of collection method (clinician collected or self-obtained).

Repeat infection with Chlamydia trachomatis following treatment is common and increases the risk of sequelae. Despite clinical guidelines recommending rescreening within 3 months of treatment, rescreening rates remain low. We undertook a systematic review to identify studies that compared rates of rescreening for repeat chlamydial infection between patients receiving and not receiving an intervention.We searched Medline, EMBASE, and conference Web sites from 2000 to September 2010 using variations of the terms "chlamydia" and "rescreening" and "intervention." We used meta-analysis to calculate the overall relative risk (RR) effect on rescreening rates by study design and strategy type.We identified 8 randomized controlled trials (RCTs) and 4 controlled observational studies, all conducted in the United States. Four RCTs assessed mailed screening kits ± reminders, with an average effect estimate of 1.30 (95% confidence interval [CI]: 1.01-1.50); 2 RCTs assessed motivational interviewing ± reminders with a summary effect of 2.15 (95% CI: 0.92-3.37); one RCT evaluated the effect of reminders with a RR of 9.67 (95% CI: 1.31-71.31), and another RCT assessed the effect of a $20 patient incentive with a RR of 1.16 (95% CI: 0.62-2.17). Three controlled observational studies assessed reminder strategies with RRs of 1.97 (95% CI: 1.76-2.21), 1.01 (95% CI: 0.66-1.55), and 1.88 (95% CI: 1.58-2.24)-a summary effect was not calculated due to significant heterogeneity; and one controlled observational study assessed the promotion of clinical guidelines with a RR of 1.35 (95% CI: 0.96-1.90).The review suggests that the use of mailed screening kits is an important strategy to increase rescreening, reminder systems are promising, and motivational interviewing is worth investigation.

BACKGROUND:: It has not been well established whether common indices of male condom failure are valid predictors of biologically meaningful exposure during condom use. METHODS:: To address this gap the authors compared self-reported condom malfunctions (i.e. breakage and slippage) and incorrect condom practices to 2 following objective measures of failure: prostate-specific antigen (PSA) detected in vaginal swabs collected after condom use and structural integrity of used condoms. The study conducted in 2000-2001 evaluated 635 male condoms used by 77 women attending an outpatient reproductive-health clinic in Birmingham AL. RESULTS:: Women reported breakage or slippage for 7.9% of condoms; 3.5% of postcoital swabs had moderate or high levels of PSA; and laboratory testing of used condoms revealed breaks (1.1%) and leaks (2.0%). Self-reported breakage and slippage was associated with moderate/high PSA concentrations in postcoital swabs only when the malfunctions were not accompanied by reports of corrective actions to reduce exposure (adjusted odds ratio [aOR] 6.9; 95% confidence interval [CI] 1.8-26.2). Defects observed in postcoital laboratory testing were related to PSA detection (aOR 8.0; 95% CI 1.5-42.6). Incorrect practices defined on the condom label were frequent but not all types were associated with semen exposure. Furthermore other practices not currently label-defined were associated with semen exposure: touching the tip of the penis with his hands (aOR 6.2; 95% CI 2.3-17.0) or with her hands (aOR 2.8; 95% CI 1.1-72) before donning the condom. CONCLUSIONS:: Used correctly male condoms afforded good protection based on objective measures of failure.

This study evaluates the performance of self-obtained vaginal swabs (SVS)/first-catch urine (FCU) combination samples in comparison to testing FCU or SVS alone. The Chlamydia trachomatis detection rate for the SVS, FCU, and SVS/FCU combination were 94%, 90%, and 94%, respectively. Self-obtained vaginal swabs are therefore the specimen of choice for Chlamydia trachomatis Nucleic Acid Amplification Tests in females.

Many sexually transmitted diseases (STDs) are prevalent among adolescents, yet compliance to undergo STD testing by this population is suboptimal. Efforts to enhance compliance with testing among at-risk youth are needed.To determine the feasibility and acceptability of self-collection of vaginal swabs for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis among high-school students attending a school health clinic.Enrolled in the study were 228 female students between the ages of 15 and 19 years. Each student self-collected a single vaginal swab that was tested for C trachomatis, N gonorrhoeae, and T vaginalis by polymerase chain reaction amplification. Acceptability of self-collection of vaginal swabs was assessed.The prevalence of any STD was 18%. Trichomoniasis, chlamydia, and gonorrhea were diagnosed in 10%, 8%, and 2% of students, respectively. Nearly 13% of females who had never previously had a gynecologic examination tested positive for an STD, and 51% of infected students would not have pursued testing by traditional gynecologic examination if self-collection was not offered. Self-collection of vaginal swabs was almost uniformly reported as easy to perform (99%) and preferable to a gynecologic examination (84%). Nearly all (97%) stated that they would undergo testing at frequent intervals if self-testing were available.Self-collected vaginal swabs for STD testing can be easily implemented in a high-school setting with high acceptability among students, enabling the detection of many STDs that would otherwise remain undetected and untreated.