Browsing by Author "Gaydos, Charlotte A."

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    Clinical Performance of the BD CTGCTV2 Assay for the BD MAX System for Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Infections
    (Wolters Kluwer, 2021) Van Der Pol, Barbara; Torres-Chavolla, Edith; Kodsi, Salma; Cooper, Charles K.; Davis, Thomas E.; Fife, Kenneth H.; Taylor, Stephanie N.; Augenbraun, Michael H.; Gaydos, Charlotte A.; Medicine, School of Medicine
    Background: Diagnostic options to combat the increasing rates of sexually transmitted infections recorded throughout the world increasingly include multiplex assays. Here we describe the estimated sensitivity and specificity of a triplex molecular assay that simultaneously detects Chlamydia trachomatis (CT), Neisseria gonorrhoeae (or gonococci [GC]), and Trichomonas vaginalis (TV). Methods: Participants (2547 women and 1159 men) were recruited from 12 clinics in the United States. BD CTGCTV2 for BD MAX System assay (CTGCTV2) results were obtained from vaginal and endocervical swabs, endocervical samples in cytology medium, and female and male urine. Results were compared with infection standards that were sample type and pathogen dependent. Results: Female specimen sensitivity estimates ranged from 92.7% to 98.4%, 92.9% to 100%, and 86.6% to 100% for CT, GC and TV, respectively. Male urine sensitivity estimates were 96.7%, 99.2%, and 97.9% for CT, GC, and TV, respectively. Specificity estimates were >98.7% for all sample types. Conclusions: BD CTGCTV2 performed well using a variety of sample types. As a true triplex assay, performed using a benchtop instrument, BD CTGCTV2 may be useful in settings where no testing is currently performed and in settings, such as reference laboratories, where testing turnaround time may be several days. Use of this assay at local laboratories may result in greater access to testing and a shorter time to result, which are important steps for improving our ability to combat sexually transmitted infections.
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    Evaluation of the Performance of a Point-of-Care Test for Chlamydia and Gonorrhea
    (JAMA Network, 2020-05) Van Der Pol, Barbara; Taylor, Stephanie N.; Mena, Leandro; Lebed, Joel; McNeil, Candice Joy; Crane, LaShonda; Ermel, Aaron; Sukhija-Cohen, Adam; Gaydos, Charlotte A.; Medicine, School of Medicine
    Importance: Rates of chlamydial and gonococcal infection continue to increase in the United States, as do the associated costs of untreated infections. Improved diagnostic technologies that support testing and treating in 1 clinical visit are critical to advancing efforts to control the rates of chlamydial and gonococcal infection. Objective: To evaluate the clinical performance of a point-of-care (POC) molecular diagnostic assay for the detection of chlamydia and gonorrhea. Design, setting, and participants: A noninterventional, cross-sectional clinical study was conducted from September 18, 2018, through March 13, 2019, at sexually transmitted infection (STI), HIV, family planning, and obstetrics and gynecology clinics where STI screening is routine, using a convenience sample and comparing commercially available assays with a new 30-minute POC assay. Patients included were those eligible for STI screening or diagnostic testing who had not taken antibiotics effective against chlamydia or gonorrhea within the previous 28 days. Four vaginal swab samples were collected from women and a first-catch urine sample was obtained from men. Main outcomes and measures: A composite infection status was used to classify participants as infected if 2 or more comparator results were positive, as not infected if 2 or more comparator samples were negative, and as unevaluable if 1 result was invalid and the other 2 results did not agree with each other. Results: Swab samples from 1523 women (median age, 27 years [interquartile range, 17-37 years]), 817 (53.6%) of whom presented with symptoms, and 922 men (median age, 29 years [interquartile range, 17-41 years]), 308 (33.4%) of whom were symptomatic, were tested. For chlamydia, sensitivity of the new POC assay was 96.1% (95% CI, 91.2%-98.3%) for women and 92.5% (95% CI, 86.4%-96.0%) for men. For gonorrhea, sensitivity estimates were 100.0% (95% CI, 92.1%-100.0%) for women and 97.3% (95% CI, 90.7%-99.3%) for men. For chlamydia, specificity of the new POC assay was 99.1% (95% CI, 98.4%-99.5%) for women and 99.3% (95% CI, 98.4%-99.7%) for men. For gonorrhea, specificity estimates were 99.9% (95% CI, 99.5%-100%) for women and 100% (95% CI, 95.5%-100%) for men. Non-laboratory-trained personnel performed 94.8% of all tests (2318 of 2445) during the study. Conclusions and relevance: This study suggests that self-obtained vaginal swab samples were associated with performance equivalent to laboratory-based molecular diagnostics, which can support use of this POC assay in many settings. The availability of an easy-to-use, rapid (30-minute) molecular test for accurate detection of chlamydia and gonorrhea has the power to facilitate testing and treatment in a single patient visit for these STIs.
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    Weekly variations in feelings of trust predict incident STI within a prospective cohort of adolescent women from a US city FREE
    (BMJ, 2018) Matson, Pamela A.; Fortenberry, J. Dennis; Chung, Shang-en; Gaydos, Charlotte A.; Ellen, Jonathan M.; Pediatrics, School of Medicine
    Objectives Feelings of intimacy, perceptions of partner concurrency (PPC) and perceptions of risk for an STD (PRSTD) are meaningful and dynamic attributes of adolescent sexual relationships. Our objective was to examine whether variations in these STI-associated feelings and perceptions predicted incident Chlamydia trachomatis and/or Neisseriagonorrhoeae infection within a prospective cohort of urban adolescent women. Methods A cohort of clinic-recruited women aged 16–19 completed daily surveys on feelings and risk perceptions about each current sex partner on a smartphone continuously for up to 18 months. Urine was tested for C. trachomatis and N. gonorrhoeae every 3 months. Daily responses were averaged across the week. As overall means for trust, closeness and commitment were high, data were coded to indicate any decrease in feelings from the previous week. PRSTD and PPC were reverse coded to indicate any increase from the previous week. An index was created to examine the cumulative effect of variation in these feelings and perceptions. Generalised linear models were used to account for correlation among repeated measures within relationships. Results For each week that there was a decrease in trust, there was a 45% increase in the risk of being infected with an STI at follow-up (relative risk (RR) 1.45, 95% CI 1.18 to 1.78, P=0.004). Neither a decrease in closeness or commitment, nor an increase in PRSTD or PPC was associated with an STI outcome. Cumulatively, the index measure indicated that a change in an additional feeling or perception over the week increased the odds of an STI by 14% (RR 1.14, 95% CI 1.02 to 1.29, P=0.026). Conclusions A decrease in feelings of trust towards a main partner may be a more sensitive indicator of STI risk than PRSTD, PPC or commitment. The next generation of behavioural interventions for youth will need strategies to address feelings of intimacy within adolescent romantic relationships.