Female Prisoners’ Preferences of Collection Methods for Testing for Chlamydia trachomatis and Neisseria gonorrhoeae Infection

Newman, Sara B.; Nelson, Michael B.; Gaydos, Charlotte A.; Friedman, H.

doi:10.1097/00007435-200304000-00006

Cited by 38 publications

(33 citation statements)

References 17 publications

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“…These data are similar to those for our STD clinic population and those of Miller et al and Wendel et al (18,30,31). Male urine and SOVS have been shown to be acceptable for the detection of T. vaginalis (9,10,16,20,23,31). In our study, these self-obtained samples demonstrated a very high initial sensitivity and specificity for TMA of 96.7% and 97.3%, respectively, and the TMA assay had excellent resolved sensitivity and specificity at 98.6% and 99.1%.…”

supporting

confidence: 90%

Comparison between the Gen-Probe Transcription-Mediated Amplification Trichomonas vaginalis Research Assay and Real-Time PCR for Trichomonas vaginalis Detection Using a Roche LightCycler Instrument with Female Self-Obtained Vaginal Swab Samples and Male Urine Samples

Hardick

Wood

et al. 2006

J Clin Microbiol

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This study compared two assays for Trichomonas vaginalis detection, Gen-Probe's transcription-mediated amplification (TMA) assay for Trichomonas vaginalis and BTUB FRET PCR, using self-obtained clinical samples from 611 patients. Infection status was defined as two positive results by two different tests. The initial TMA assay sensitivity was 96.7%; specificity was 97.5%. The TMA assay was comparable to BTUB FRET PCR.Trichomonas vaginalis is the cause of the most common parasitic sexually transmitted infection in the world and is estimated to 3 million infections in the United States annually (1, 21). T. vaginalis can cause vaginitis, cervicitis, preterm labor, urethritis, and prostatitis (3,32,33). T. vaginalis is cytopathic to vaginal cells and is associated with other sexually transmitted diseases (STDs), including transmission of human immunodeficiency virus (2,7,26,29).Conventional methods for diagnosing T. vaginalis are microscopic examination of wet-mount preparations and culturebased systems. Both methods rely on the collection of viable organisms and suffer from poor sensitivity (25). More sensitive research-based PCRs for the diagnosis of T. vaginalis have been described (9, 11-16, 22, 24).The development of a commercially available amplification assay for T. vaginalis using self-collected samples would be highly desirable from patient, clinical, and public-health perspectives (6). Other commercially available FDA-cleared STD tests, such as those for chlamydia and gonorrhea, could also be performed on the self-obtained samples (4,5,27,28).We report a comparison of a research transcription-mediated amplification (TMA) assay for T. vaginalis, now available as an analyte-specific reagent (Gen-Probe Inc., San Diego, CA), with BTUB FRET PCR (BTUB), a real-time research PCR (9).(Results from this analysis were presented in part at the International Society for Sexually Transmitted Diseases Research, Amsterdam, The Netherlands, 10 to 13 July 2005.)We screened 615 people attending two STD clinics; 611 had male urine samples (n ϭ 290) or duplicate female self-obtained vaginal swabs (SOVS) (n ϭ 321) collected. Institutional Review Board approval was obtained, and the study was funded in part by Gen-Probe. BTUB PCR. For females, two SOVS for BTUB and TMA testing were collected in random order. SOVS for BTUB testing were transported in a dry state and were rehydrated in 1 ml of Tris-EDTA buffer, 200 l of which was used for DNA robotic extraction. Similarly, 200 l of male urine was subjected to this automated DNA extraction (MagNA Pure LC instrument; Roche Diagnostics, Indianapolis, IN). The BTUB PCR assay design was based on fluorescent resonance energy transfer (FRET) probe chemistry (Roche Diagnostics). The use of positive and negative controls, the thermocycling protocol, data analysis, and specific sequences of primers and probes using the Roche LightCycler Instrument were previously published (9).TMA for T. vaginalis. The SOVS were placed in specimen transport medium (Gen-Probe), and male urine was pipetted i...

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supporting

confidence: 90%

Comparison between the Gen-Probe Transcription-Mediated Amplification Trichomonas vaginalis Research Assay and Real-Time PCR for Trichomonas vaginalis Detection Using a Roche LightCycler Instrument with Female Self-Obtained Vaginal Swab Samples and Male Urine Samples

Hardick

Wood

et al. 2006

J Clin Microbiol

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“…Collection was not uncomfortable for 84.3% of the women, and a subanalysis of the question according to age showed that 87.4% of women 25 years or older (n ϭ 480) and 78.8% of those Ͻ25 years of age (n ϭ 212) reported that the collection process was not uncomfortable (P ϭ 0.005). These observations are similar to other studies assessing self-collection of vaginal samples using swabs (3)(4)(5)(6). Other studies have reported that self-collection of vaginal samples was not preferred over collection by health care workers (7-10) but was acceptable.…”

supporting

confidence: 88%

Ease and Comfort of Cervical and Vaginal Sampling for Chlamydia trachomatis and Trichomonas vaginalis with a New Aptima Specimen Collection and Transportation Kit

et al. 2014

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bUse of a new collection kit for vaginal and cervical sampling was reported as easy by the majority of 692 women and not uncomfortable (by 87.4% of those >25 years old and 78.8% of those <25 years old). By Aptima testing, patient-and physician-collected samples agreed strongly for Chlamydia trachomatis (99.6% to 99.3%; ‫؍‬ 0.93 to 0.89) and T. vaginalis (99.6% to 98.9%; ‫؍‬ 0.97 to 0.78). Chlamydia trachomatis and Trichomonas vaginalis are common sexually transmitted infections (STI) of the lower genital tract. Control programs require screening to detect and treat asymptomatic infections to prevent upper tract complications due to C. trachomatis and persistent T. vaginalis infections and related sequelae.Detection of infections requires the collection of endocervical or vaginal samples during a pelvic examination or selfcollection of first-void urine or vaginal samples. If self-swabbing is to be used for screening, the procedure and collection device will be more acceptable if the device is easy to use and is not uncomfortable.A new specimen collection and transportation (SCT) kit (Hologic/Gen-Probe Incorporated) was developed for sampling the cervix and vagina for STIs and transporting the specimens to the laboratory to be tested by Aptima transcription-mediated amplification assays. The collection device is a tapered brush similar in appearance to collection brushes used for collecting cervical cells for human papillomavirus testing (1, 2). The objective was to determine the ease and comfort of using the SCT when women selfcollected a vaginal sample and to compare the new SCT kit for detection of C. trachomatis and T. vaginalis from self-collected vaginal SCT (S-VSCT) and physician-collected vaginal and cervical samples.A total of 708 women (580 attending a gynecology clinic and 128 attending a street youth health clinic) signed consent for the collection of 2 vaginal and 3 cervical samples as outlined in the consent form, which was approved by St. Joseph's Healthcare and Juravinski Hospital Research Ethics Boards in Hamilton, Ontario, Canada. Each patient self-collected a vaginal sample and then answered a questionnaire concerning ease and comfort of collection using the new SCT kit. The physician then collected a vaginal sample (P-VSCT) and, after insertion of a speculum, collected PreservCyt (PC) L-Pap, cervical SCT (CSCT), and SurePath (SP) L-Pap endocervical samples. The PC L-Pap sample was always collected first as the standard of care for cervical cytology. L-Pap samples were collected with a cervix broom placed into the manufacturer's medium. The PC L-Pap sample was processed for cytology, and the remainder of the sample was sent with the other samples to the Infections Research Laboratory (IRL) at St. Joseph's Healthcare, where they were tested within 72 h by Aptima Combo 2 (AC2) for C. trachomatis and Aptima T. vaginalis (ATV) for T. vaginalis on a TIGRIS DTS instrument (Hologic/Gen-Probe Incorporated).Each patient was asked to complete a 5-point Likert scale questionnaire indicating whether it w...

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“…Similarly higher sensitivities have been observed with vaginal swab specimens than with urine and/or cervical swab specimens for the detection of C. trachomatis in other studies (32,34,40) and for the detection of N. gonorrhoeae (32,34). Many studies have shown that self-collection of vaginal swab specimens is well accepted by women (12,15,28) and that the results obtained with such specimens are comparably sensitive to those obtained with clinician-obtained vaginal specimens, making them the specimen type of choice for laboratory testing (5,12,15,32,40). The use of self-obtained vaginal swabs also allows women to be screened in nontraditional clinical settings, such as at street clinics, community sites, and home, thereby increasing the number of patients who can be tested (11,31).…”

Section: Discussionmentioning

confidence: 53%

Comparison of Transcription-Mediated Amplification and PCR Assay Results for Various Genital Specimen Types for Detection of Mycoplasma genitalium

Wroblewski¹,

Manhart

Dickey³

et al. 2006

J Clin Microbiol

103

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Mycoplasma genitalium is now recognized as a possible cause of several idiopathic sexually transmitted disease (STD) syndromes. However, due to the difficulty of culture of this fastidious bacterium, nucleic acid amplification tests (NAATs) are necessary for its detection in patient specimens. In the current study we compared a newly developed research-only transcription-mediated amplification (TMA) assay (Gen-Probe Incorporated) to our in-house DNA-based PCR assay for detection of M. genitalium. The relative performance characteristics of these two NAATs were assessed with genital specimens from 284 women and 352 men reporting to an STD clinic in Seattle, WA. Among the women, M. genitalium was detected by the TMA and PCR assays in 36 (13%) and 39 (14%) vaginal swab specimens, respectively ( ‫؍‬ 0.923); 26 (9%) and 23 (8%) cervical swab specimens, respectively ( ‫؍‬ 0.843); and 25 (9%) and 28 (10%) urine specimens, respectively ( ‫؍‬ 0.687). Among the M. genitalium-positive women, the relative sensitivities of detection for the TMA and PCR assays were 84% and 91%, respectively, for vaginal swab specimens; 60% and 53%, respectively, for cervical swab specimens; and 58% and 65%, respectively, for urine specimens. By using an infected patient (a woman positive at any site by TMA assay and at any site by PCR) as a proxy for a "gold standard," the specificities of detection were >99.5% for both the TMA and the PCR assays. Among the men, M. genitalium was detected in 24 urine specimens (6.8%) by the TMA assay, 26 (7.4%) urine specimens by PCR assay, and 32 urine specimens (9%) by either test ( ‫؍‬ 0.791). We conclude that the M. genitalium TMA and PCR assays are highly specific and that vaginal swab specimens are the most sensitive specimen type for the detection of M. genitalium in women.Mycoplasma genitalium was first isolated from urethral exudates from two men with urethritis in 1981 (38), yet the isolation and culture of this fastidious organism are extremely difficult and time-consuming. Although culture techniques for M. genitalium have improved in the last two decades (20), efficient isolation and cultivation of this organism remain elusive (2,20), and thus, identification of infected individuals has relied on the use of PCR tests (16,36). The application of M. genitalium-specific PCR tests has allowed studies that assess reproductive tract disease in men and women, including urethritis, cervicitis, endometritis, and pelvic inflammatory disease (7,14,16,19,25,27,36,37), suggesting a disease spectrum similar to those caused by Chlamydia trachomatis and Neisseria gonorrhoeae. Detection of DNA from this organism by PCR in fallopian tube tissue from a woman with salpingitis (8) and the association of M. genitalium with tubal factor infertility by serologic tests (6) suggest an even broader range of disease associations and sequelae for this emerging pathogen. These results are particularly disconcerting, considering that M. genitalium has been detected in 1% of young adults in the U.S. general population, a preval...

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Female Prisoners’ Preferences of Collection Methods for Testing for Chlamydia trachomatis and Neisseria gonorrhoeae Infection

Abstract: The study population of female federal prisoners expressed no aversion to the self-collection of either vaginal swab or urine specimens for STD testing. A majority of participants expressed a preference for noninvasive techniques rather than a pelvic examination.

Cited by 38 publications

References 17 publications

Comparison between the Gen-Probe Transcription-Mediated Amplification Trichomonas vaginalis Research Assay and Real-Time PCR for Trichomonas vaginalis Detection Using a Roche LightCycler Instrument with Female Self-Obtained Vaginal Swab Samples and Male Urine Samples

Comparison between the Gen-Probe Transcription-Mediated Amplification Trichomonas vaginalis Research Assay and Real-Time PCR for Trichomonas vaginalis Detection Using a Roche LightCycler Instrument with Female Self-Obtained Vaginal Swab Samples and Male Urine Samples

Ease and Comfort of Cervical and Vaginal Sampling for Chlamydia trachomatis and Trichomonas vaginalis with a New Aptima Specimen Collection and Transportation Kit

Comparison of Transcription-Mediated Amplification and PCR Assay Results for Various Genital Specimen Types for Detection of Mycoplasma genitalium

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