Evaluation of Self-Collected Vaginal Swab, First Void Urine, and Endocervical Swab Specimens for the Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Adolescent Females

doi:10.1016/j.jpag.2008.03.010

Journal of Pediatric and Adolescent Gynecology

Volume 21, Issue 6, December 2008, Pages 355-360

https://doi.org/10.1016/j.jpag.2008.03.010 Get rights and content

Abstract

Objective

To assess the concordance of self-obtained vaginal swabs (SVS), first void urine samples (FVU) and provider-collected endocervical swabs (PES) for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) in adolescents.

Methods

A total of 342 adolescent women and 1080 baseline and semi-annual visits were analyzed. FVU, SVS and PES were collected at each biannual visit. All specimens were tested by BDProbeTec ET^™ Amplified DNA Assay. Sensitivity, specificity, positive predictive value (PPV) negative predictive value (NPV) and kappa coefficient were calculated to evaluate the ability to identify possible infected cases using samples from three anatomic sites and the test agreement between any two of these three specimen types. Positive results from at least two of the three specimens collected from same subject at the same study visit was considered true positive.

Results

The positivity rates for CT and NG were 26.6 and 11.7 per 100 women respectively. The sensitivities of SVS, FVU and PES for detecting CT were 97.3%, 89.2% and 90.1% respectively. For the detection of NG, the sensitivities of the three sampling methods were 100%, 88.6% and 95.5% respectively. The specificities were between 94.7% and 99.7% for both CT and NG. Kappa coefficients of CT test results were 0.89, 0.88 and 0.83 for specimen pairs SVS vs PES, SVS vs FVU and PES vs FVU respectively. For the detection of NG, kappa coefficients were 0.91, 0.87 and 0.91 for these three pairs (all P < 0.0001). Kappa > 0.75 is considered excellent agreement between specimens.

Conclusion

There were strong agreements among SVS, PES and FVU specimens on the detection of CT and NG infections in adolescent females using nucleic acid amplification test. SVS represented as high as or more sensitive an approach for detecting both CT and NG compared to PES. Although FVU was the least sensitive sampling method, it is also the least invasive method. Thus SVS and FVU may provide a reliable alternative to endocervical specimens for CT and NG screening.

Introduction

Adolescent females have the highest rates of chlamydia trachomatis (CT) and neisseria gonorrhea (NG) among all age groups in America (CDC Sexually Transmitted Diseases Surveillance 2005). Since most of the infected adolescent women are asymptomatic, successful detection of CT and NG infections relies on effective, convenient, non-invasive, and low cost diagnostic methods for broad screening. Several previous studies demonstrated that non-invasive alternatives to the traditional endocervical swab, such as urine and vaginal samples to detect reproductive tract infections, are required and well accepted among adolescents.1, 2, 3

The nucleic acid amplification test (NAAT) became available in the last decade for use in clinical microbiology laboratories and has been considered the most sensitive and promising test in identifying CT and NG organisms. The ability to detect CT and NG using urine and vaginal specimens without a pelvic examination is a key advantage of nucleic acid amplification test, and this ability facilitates screening females in situations other than traditional venues. However, given the current limited FDA approval for self-collected vaginal swabs (SVS) to health care settings only, it is necessary to demonstrate the equivalent performance of SVS to other specimen types in order to support the expanded CT and NG screening using SVS. This is especially important when screening a high prevalence population.

In this study, we used BDProbeTec ET^™ Amplified DNA Assay (BD Biosciences, Sparks, MD) in detecting CT and NG infections. Although BDProbeTec ET^™ has proved its performance both in men and women, most studies have been limited to adults or mixed age groups. The suitability of tests may vary by the population examined because of acceptability of testing, ability to properly obtain specimens, prevalence of infections and potential endogenous biological variables. The objective of this study was to assess the concordance of two self-collected sampling methods (urine sample and vaginal swab) and conventional provider-collected endocervical sampling (PES) for the detection of CT and NG in adolescent females using BDProbeTec ET^™.

Section snippets

Study Population

Over a period of 5 years from 2001 to 2006, as part of a longitudinal study on hormonal contraceptive use, ectopy, and sexually transmitted infection acquisition, a total of 350 adolescent females were recruited and followed up for the study. This study was carried out at an urban Adolescent Clinic in an academic institution. Healthy female adolescents were eligible to participate if they were 12–18 years old, sexually active, and not currently pregnant or pregnant in the last 3 months. After

Results

Among 350 adolescent females enrolled in the study, 96% were African American, whose median age was 16 (range 12–18) years at their study entry visits. On average, the study participants initiated their sexual activity at 14 (range 10–18) years and had four sexual partners (Table 1).

Of 350 adolescent female subjects in the study, 342 participants and 1080 baseline and semi-annual visits had BDProbeTec ET^™ test results (including indeterminate results) available for CT and 1079 visits for NG

Discussion

The increased sensitivities and specificities of nucleic acid amplification techniques have led to the evaluation of less invasive specimen collection procedures for screening gonococcal and chlamydial urogenital infections. Despite their advantages, there are limitations of NAATs. Of note, the strand displacement amplification test system used by BDProbeTec ET^™ can be inhibited resulting in false negative results. False positive result could also be possible due to specimen contamination.

Acknowledgments

The authors acknowledge the funding by The National Institute of Child Health and Human Development (NICHD RO1 HD37785-04) for the study. The authors thank Drs. Jonathan Zenilman and Denise Jacobson for their consultation in setting up the protocol for collecting specimens and Dr. Judith Lovchik for processing specimens and providing assistance in technical details for the laboratory methods of this article. The authors also thank Dr. Raida Harik-Khan and Ms. Karen Schlumpf for their review and

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The U.S. has seen a rise in sexually transmitted infections; the need to increase access to screening is essential to reverse this trend, especially for vulnerable populations such as lesbian, gay, bisexual, and transgender/transsexual plus individuals, people of color, or those at a low SES. This study's primary objective is to assess preferences among people who were assigned female at birth for at-home self-collection for gonorrhea and chlamydia screening. This study aims to provide insight into the need for clinicians to adopt at-home self-collection of urine or vaginal samples to improve access to sexually transmitted infection screening.
A recruitment mailer was distributed in September–October 2021. Inclusion criteria included established patients (seen within the last 3 years for clinical services either in person or through telemedicine) at a local urban federally qualified health center in the state of Wisconsin, assigned female at birth, aged 18–24 years, and speaking English language. Participants completed an anonymous online survey regarding their preferences, experiences, and likelihood of self-collecting either urine or vaginal samples for gonorrhea and chlamydia screening at home.
Among the total participants (N=88), 69% (n=61) overall preferred home collection for screening with no significance based on age; lesbian, gay, bisexual, and transgender/transsexual plus status; and race and/or ethnicity. However, patients were less likely to prefer at-home self-collection screening if they had lower educational attainment (OR=0.25; 95% CI=0.08, 0.77; p<0.05), lacked insurance (OR=0.19; 95% CI=0.06, 0.67; p<0.05), or were unemployed (OR=0.28; 95% CI=0.08, 0.95; p<0.05).
There is overall acceptability for at-home self-collection sexually transmitted infections screening (61 of 88=0.69; 95% CI=0.59, 0.79). Primary care clinics can expand needed screening by integrating such methods into workflows for established patients. Although this study showed that patients who are employed, attained a higher education level, and have their own insurance may prefer at-home self-collection, there is a need to focus on social determinants of health to decrease rising sexually transmitted infection rates in the U.S.
Identifying a consensus sample type to test for Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Trichomonas vaginalis and human papillomavirus
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Sexually transmitted infections (STIs) are a global cause of acute illness. Early detection plays a crucial role in interrupting transmission and preventing complications. However, the accessibility of STI testing is curbed by the lack of an overall preferred sample type. By means of a prospective study in female sex workers (FSW), we compared the sensitivity of samples from different anatomical sites in detecting Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Mycoplasma genitalium and human papillomavirus. Besides, we documented the prevalence of each STI in this high-risk population.
We selected 303 FSW and tested them for each STI by nucleic acid amplification testing on two vaginal and cervical swabs from different manufacturers, cervical smear and first-void urine. The sensitivity of each sample type was compared for each infectious agent in order to identify a consensus sample type.
Vaginal swabs were superior to all other sample types, with an overall sensitivity of 86%. The sensitivity was the lowest for first-void urine, detecting only 63% of positive cases. The prevalence was 3.3% (10/299) for Neisseria gonorrhoeae; 9.0% (27/299) for Chlamydia trachomatis; 7.4% (22/298) for Trichomonas vaginalis; 10.8% (32/296) for Mycoplasma genitalium and 55.6% (158/284) for human papillomavirus.
When testing for STIs, vaginal swabs are the sample of choice and first-void urine should be avoided. Designating (self-sampled) vaginal swabs as a consensus sample type enables harmonization of STI testing and extension of testing to large numbers of unscreened females.
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Thirdly, our questions did not ask about different collection techniques. Previous studies have found that different collection methods can produce different results in detection capability (Fang et al., 2008) and that men and women do have different preferences when it comes to how specimens for STDs are collected (Schacter et al., 2005; Shoveller et al., 2010). However, the questions used for our analyses of young adults were framed using the phrase “like a pregnancy test” which implies a urine sample.
Chlamydia trachomatis (CT) and Neisseria gonorrhea (GC) are the most frequently reported notifiable diseases in the United States and costs for diagnosis and treatment of these two infections are approximately $700 million per year. A proposed new method for screening for these two infections is self-tests; similar to at-home pregnancy and HIV tests which do not include sending collected specimens to a laboratory for diagnosis. However, no such self-tests for sexually transmitted diseases (STD) have been approved by the Food and Drug Administration (FDA). To determine the acceptability of such a test, we used three surveys, conducted in 2017, including the American Men's Internet Survey, the SummerStyles survey, and the DocStyles survey to ask potential users about their interest in this type of test and how they might use it. Among our sampled population of men who have sex with men, 79.5% said they would prefer to take this type of test at home and 73.9% said they would be willing to pay at least $20 for the test. Among young adults (18–29 years), 54.1% indicated that they would like to take this test at home and 64.5% were willing to pay more than $10 for such a test. Among sampled physicians, 85.1% were “likely” or “very likely” to use an FDA-approved STD self-test in their office to screen for CT or GC. Self-tests for STDs are on our horizon and we need to be prepared to integrate these tests into our healthcare systems.
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Additionally, clinicians could be reluctant to offer IUDs to nulliparous women, whom they believe experience more pain with IUD insertion [3,4]. Because cervical cytology for cancer screening is now deferred until the age of 21 years in the USA [5], and urine testing is often used for sexually transmitted infection screening [6], few young nulliparous women have undergone a pelvic examination. Fear of discomfort associated with such an examination could compound the fear of pain from IUD insertion.
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These results indicate that good performance can be achieved when self-collected vaginal swabs are used for testing of CT and NG, indicating that self-collected swabs are acceptable for screening using NAATs. This finding is in consistency with previous studies (Fang et al., 2008; Gaydos et al., 2010; Schachter et al., 2003; Shafer et al., 2003). The prevalence of CT and NG using rectal swabs (13.8 and 5.4%, respectively) was higher than those obtained for self-collected vaginal swabs (10.4 and 0.6% respectively).
A prospective, multicenter trial was designed to compare the performance characteristics of the cobas® 4800 (Roche Diagnostics, Indianapolis, IN, USA) and m2000 real-time™ (Abbott Molecular Inc., Des Plaines, IL, USA) assays for detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in rectal and self-collected vaginal swabs. Rectal (n = 234) or self-collected vaginal swabs (n = 687) were obtained from consenting individuals visiting their general practitioners, dermatologists, gynecologists, sexually transmitted disease clinics, or family planning centers from May 2010 to February 2011. High concordance rates (≥96%) were observed between the cobas® 4800 and m2000 real-time™ assays for CT/NG detection in both rectal and self-collected vaginal swabs. The performance profiles confirm the usefulness of both kinds of swab types for CT and NG detection using described nucleic acid amplification tests assays. Based on this study, rectal and self-collected vaginal swabs offer a noninvasive alternative, which may improve screening for CT and NG infections.
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: Funded by NICHD RO1 HD37785-04.

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Original StudiesEvaluation of Self-Collected Vaginal Swab, First Void Urine, and Endocervical Swab Specimens for the Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Adolescent Females

Abstract

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Study Population

Results

Discussion

Acknowledgments

Obstet Gynecol

J Mol Diagn

What sexually transmitted disease screening method does the adolescent prefer? Adolescents' attitudes toward first-void urine, self-collected vaginal swab, and pelvic examination

Arch Pediatr Adolesc Med

Self-obtained vaginal swabs for diagnosis of treatable sexually transmitted diseases in adolescent girls

Arch Pediatr Adolesc Med

Self-collection of vaginal swabs for the detection of Chlamydia, gonorrhea, and trichomoniasis: opportunity to encourage sexually transmitted disease testing among adolescents

Sex Transm Dis

The measurement of observer agreement for categorical data

Biometrics

Evaluation of self-collected samples in contrast to practitioner-collected samples for detection of Chlamydia trachomatis, Neisseria gonorrhea, and Trichomonas vaginalis by polymerase chain reaction among women living in remote areas

Sex Transm Dis

Original Studies
Evaluation of Self-Collected Vaginal Swab, First Void Urine, and Endocervical Swab Specimens for the Detection of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Adolescent Females