scholarly journals High-volume workflow and performance comparisons for Chlamydia trachomatis and Neisseria gonorrhoeae testing using automated molecular platforms

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
André Frontzek ◽  
Gudrun Aretzweiler ◽  
Daniela Winkens ◽  
Dana Duncan ◽  
Elizabeth M. Marlowe
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
High Volume ◽  
Turnaround Time ◽  
Screening Programs ◽  
Percent Agreement ◽  
Significant Difference ◽  
Mcnemar’S Test ◽  
And Performance ◽  
Mcnemar's Test

Abstract Background The global burden of sexually transmitted infections (STIs) is high and there have been reports of increasing chlamydial and gonorrheal infections. High-volume screening programs for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are an important component of STI control. This study evaluated the high-volume workflow and performance of the cobas® CT/NG assay for use on the automated Roche cobas® 6800 system, with the cobas p 480 instrument for pre-analytics, compared with the Aptima Combo 2 assay on the Hologic Panther system. Methods High-volume workflow and performance were evaluated using paired female urine specimens. Workflow analysis (n = 376) included hands-on time (HoT), number of manual interventions, and time to first and last results. For performance assessment, paired results from the cobas CT/NG and Aptima Combo 2 assays, for both CT and NG, were compared and two-sided 95% confidence intervals calculated to provide estimates of positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (OPA) between the tests. McNemar’s test was used for significance testing. Results Pre-analytical preparations and system start-up on the cobas 6800 system required 00:27:38 (hr:min:sec) HoT whilst the Panther system required 00:30:43. The cobas 6800 system required eight interactions and 00:43:59 HoT to process 376 samples. The Panther system required six interactions and 00:39:10 HoT. Time to first results was 02:53:00 on the cobas c6800 system for 96 samples and 03:28:29 on the Panther system for five samples. The cobas 6800 system delivered all 376 results 3 h faster than the Panther system (07:45:26 and 10:47:30, respectively). The performance correlation between both assays was high (PPA, NPA and OPA > 99% for both CT and NG). McNemar’s test revealed no statistically significant difference between the assays. Conclusion For high-volume automated CT/NG testing, both the cobas 6800 system and Panther system provided accurate results. Although less manual intervention steps were needed for the Panther system, improved turnaround time was obtained with the cobas 6800 system with less risk for contamination. The additional testing capacity on the cobas 6800 system would allow a growing service to deliver more results in a single shift.

Ease, Comfort, and Performance of the HerSwab Vaginal Self-Sampling Device for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

2016 ◽  
Vol 43 (2) ◽  
pp. 125-129 ◽  
Author(s):  
Manuel Arias ◽  
Dan Jang ◽  
Jodi Gilchrist ◽  
Kathy Luinstra ◽  
Jenny Li ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Sampling Device ◽  
And Performance

Medication Adherence Reminder System for Virtual Home Assistants: Mixed Methods Evaluative Study (Preprint)

2021 ◽  
Author(s):  
Cynthia F. Corbett ◽  
Elizabeth M. Combs ◽  
Peyton S. Chandarana ◽  
Isabel Stringfellow ◽  
Karen Worthy ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Medication Adherence ◽  
Feasibility Study ◽  
Global Public Health ◽  
Constructive Feedback ◽  
The Past ◽  
Significant Difference ◽  
Mcnemar’S Test ◽  
Medication Reminder ◽  
Mcnemar's Test

BACKGROUND Medication non-adherence is a global public health challenge that results in sub-optimal health outcomes and increases healthcare costs. Forgetting to take medicines is one of the most common reasons for unintentional non-adherence. Research findings indicate that voice-activated virtual home assistants (VHAs), such as Amazon Echo and Google Home devices, may be useful in promoting medication adherence. OBJECTIVE Create a medication adherence app (skill) for Amazon Echo devices and measure the use, usability, and usefulness of that skill. METHODS A single-group mixed methods cohort feasibility study was conducted with females who took oral contraceptives (n=25). Participants were undergraduate students (mean age = 21.8, SD 6.2) at an urban university in the Southeast United States. Participants were given an Amazon Echo Dot with MedBuddy, a new medication reminder skill for Echo devices created by our team, attached to their study account, which they used for 60 days. Participants self-reported baseline and post-study medication adherence. MedBuddy use was objectively evaluated by tracking the participants’ interaction with MedBuddy through Amazon Alexa. The usability and usefulness of MedBuddy were evaluated through a post-study interview with participants responding to both quantitative and qualitative questions. RESULTS Participants’ interactions with MedBuddy, as tracked through Amazon Alexa, only occurred on half of the study days (mean of 50.97, SD 29.5). Compared to baseline, at study end participants reported missing their medication less in the past one and six months (χ 2 = .884 and .420 respectively, McNemar’s test p < .001 for both). However, there was no significant difference in participants’ reported adherence to consistently taking medication within the same two-hour time frame each day the past one or six months at the end of the study compared to baseline (χ 2 = 3.544 and 5.526 respectively, McNemar’s test p = .63 and p = .13 respectively). Overall feedback about usability was positive, and participants provided constructive feedback about features of the skill that could be improved. Participants’ evaluation of the usefulness of Medbuddy was overwhelmingly positive. Most participants (65.2%, n=15) said they would continue to use MedBuddy as a medication reminder in the future if provided the opportunity and the majority (91.3%, n=21) said they would recommend it to others. MedBuddy features that participants enjoyed were an external prompt separate from their phone, being able to hear the reminder prompt from a separate room, multiple reminders, and verbal responses as prompts. CONCLUSIONS The results of this feasibility study indicate the MedBuddy medication reminder skill may be useful in promoting medication adherence, but the skill could benefit from further usability enhancements.

Clinician education, advice and SMS/text reminders improve test of reinfection rates following diagnosis of Chlamydia trachomatis or Neisseria gonorrhoeae: before and after study in primary care

2019 ◽  
Vol 46 (1) ◽  
pp. 32-37
Author(s):  
Sally B Rose ◽  
Susan M Garrett ◽  
Deborah Hutchings ◽  
Kim Lund ◽  
Jane Kennedy ◽  
...  
Keyword(s):  
Primary Care ◽  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Systematic Approach ◽  
Control Period ◽  
Intervention Period ◽  
Clinician Education ◽  
Significant Difference ◽  
Time Periods

BackgroundEvidence-based guidelines for the management of Chlamydia trachomatis and Neisseria gonorrhoeae recommend testing for reinfection 3–6 months following treatment, but retesting rates are typically low.MethodsParticipants included six primary care clinics taking part in a pilot study of strategies designed to improve partner notification, follow-up and testing for reinfection. Rates of retesting between 6 weeks and 6 months of a positive chlamydia or gonorrhoea diagnosis were compared across two time periods: (1) a historical control period (no systematic approach to retesting) and (2) during an intervention period involving clinician education, patient advice about reinfection risk reduction and retesting, and short messaging service/text reminders sent 2–3 months post-treatment inviting return for retesting. Retesting was calculated for demographic subgroups (reported with 95% CI).ResultsOverall 25.4% (61 of 240, 95% CI 20.0 to 31.4) were retested during the control period and 47.9% (116 of 242, 95% CI 43.2 to 55.1) during the intervention period. Retesting rates increased across most demographic groups, with at least twofold increases observed for men, those aged 20–29 years old, and Māori and Pasifika ethnic groups. No significant difference was observed in repeat positivity rates for the two time periods, 18% (11 of 61) retested positive during the control and 16.4% (19 of 116) during the intervention period (p>0.05).ConclusionsClinician and patient information about retesting and a more systematic approach to follow-up resulted in significant increases in proportions tested for reinfection within 6 months. These simple strategies could readily be implemented into primary healthcare settings to address low rates of retesting for bacterial sexually transmitted infections.Trial registration numberACTRN12616000837426.

scholarly journals Prevalence estimates of genital Chlamydia trachomatis infection in Belgium: results from two cross-sectional studies

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Natalie Fischer ◽  
Ilse Peeters ◽  
Sofieke Klamer ◽  
Marion Montourcy ◽  
Vicky Cuylaerts ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Age Groups ◽  
Chlamydia Infection ◽  
Health Examination ◽  
Cross Sectional ◽  
Heterogeneous Distribution ◽  
Prevalence Studies ◽  
Screening Programs ◽  
Significant Difference ◽  
Belgian Population

Abstract Background Chlamydia trachomatis (chlamydia) is the most diagnosed sexually transmitted infection in Belgium. Screening programs focus on young women, due to the implications of chronic asymptomatic infections for reproductive health. Thereby, the frequency of infections in men and older adults is underestimated. This study aimed to estimate the point-prevalence of chlamydia in the broader Belgian population, to inform evidence-based prevention and control strategies. Methods We conducted two cross-sectional prevalence studies of chlamydia infection in the population of Belgium aged 16–59 years, 2018–2020. In the CT1 study 12,000 representative individuals were randomly selected from the national register and invited by letter to collect a urine sample at home. The CT2 study used urine samples collected through the Belgian Health Examination Survey. Molecular detection of chlamydia DNA was performed using Xpert® or Abbott Real-Time CT/NG assays. Weighted estimated prevalence and 95% confidence interval (CI) was calculated per gender and age groups of 16/18–29, 30–44 and 45–59 years, relative to the general Belgian population. Data collected on sociodemographic variables and sexual behavior were used to identify potential risk factors for chlamydia infection through calculation of the odds ratio (OR). Results The population-wide weighted estimated prevalence was 1.54% (95% CI 0.78–3) in CT1 and 1.76% (95% CI 0.63–4) in CT2. We observed no statistically significant difference between men and women or age groups. Civil relationship status (OR = 14.1 (95% CI 1.78–112), p < 0.01), sexual intercourse with a casual partner (OR = 6.31 (95% CI 1.66–24.1), p < 0.01) and > 3 sexual partners in the last 12 months (OR = 4.53 (95% CI 1.10–18.6), p = 0.02) were associated with higher relative risk for chlamydia infection. Conclusion Nationwide prevalence studies are relevant to assess the distribution of chlamydia and inform public health actions. The overall low prevalence and heterogeneous distribution of chlamydia in the general Belgian population needs to be considered for future strategies and potential harm of testing and treating asymptomatic individuals need to be taken into account. Effective case management should include appropriate treatment of symptomatic patients and partner notification, and prevention strategies should encourage behaviors such as condom use.

scholarly journals Simultaneous Evaluation of Diagnostic Assays for Pharyngeal and Rectal Neisseria gonorrhoeae and Chlamydia trachomatis Using a Master Protocol

2019 ◽  
Author(s):  
Sarah B Doernberg ◽  
Lauren Komarow ◽  
Thuy Tien T Tran ◽  
Zoe Sund ◽  
Mark W Pandori ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Reference Method ◽  
Likelihood Ratios ◽  
Anatomic Site ◽  
Transmitted Infection ◽  
Cross Sectional ◽  
Predictive Values ◽  
Sexually Transmitted ◽  
Percent Agreement

Abstract Background Pharyngeal and rectal Neisseria gonorrhoeae and Chlamydia trachomatis play important roles in infection and antibacterial resistance transmission, but no US Food and Drug Administration (FDA)–cleared assays for detection at these sites existed prior to this study. The objective was to estimate performance of assays to detect those infections in pharyngeal and rectal specimens to support regulatory submission. Methods We performed a cross-sectional, single-visit study of adults seeking sexually transmitted infection testing at 9 clinics in 7 states. We collected pharyngeal and rectal swabs from participants. The primary outcome was positive and negative percent agreement for detection of N. gonorrhoeae and C. trachomatis for 3 investigational assays compared to a composite reference. Secondary outcomes included positivity as well as positive and negative predictive values and likelihood ratios. Subgroup analyses included outcomes by symptom status and sex. Results A total of 2598 participants (79% male) underwent testing. We observed N. gonorrhoeae positivity of 8.1% in the pharynx and 7.9% in the rectum and C. trachomatis positivity of 2.0% in the pharynx and 8.7% in the rectum. Positive percent agreement ranged from 84.8% to 96.5% for different anatomic site infection combinations, whereas negative percent agreement was 98.8% to 99.6%. Conclusions This study utilized a Master Protocol to generate diagnostic performance data for multiple assays from different manufacturers in a single study population, which ultimately supported first-in-class FDA clearance for extragenital assays. We observed very good positive percent agreement when compared to a composite reference method for the detection of both pharyngeal and rectal N. gonorrhoeae and C. trachomatis. Clinical Trials Registration NCT02870101.

scholarly journals The efficacy of using computer-aided detection (CAD) for detection of breast cancer in mammography screening: a systematic review

2018 ◽  
Vol 60 (1) ◽  
pp. 13-18 ◽  
Author(s):  
Emilie L Henriksen ◽  
Jonathan F Carlsen ◽  
Ilse MM Vejborg ◽  
Michael B Nielsen ◽  
Carsten A Lauridsen
Keyword(s):  
Breast Cancer ◽  
Early Detection ◽  
High Volume ◽  
Population Based ◽  
Screening Mammography ◽  
Computer Aided Detection ◽  
Screening Programs ◽  
Significant Difference ◽  
Computer Aided ◽  
Screening Population

Background Early detection of breast cancer (BC) is crucial in lowering the mortality. Purpose To present an overview of studies concerning computer-aided detection (CAD) in screening mammography for early detection of BC and compare diagnostic accuracy and recall rates (RR) of single reading (SR) with SR + CAD and double reading (DR) with SR + CAD. Material and Methods PRISMA guidelines were used as a review protocol. Articles on clinical trials concerning CAD for detection of BC in a screening population were included. The literature search resulted in 1522 records. A total of 1491 records were excluded by abstract and 18 were excluded by full text reading. A total of 13 articles were included. Results All but two studies from the SR vs. SR + CAD group showed an increased sensitivity and/or cancer detection rate (CDR) when adding CAD. The DR vs. SR + CAD group showed no significant differences in sensitivity and CDR. Adding CAD to SR increased the RR and decreased the specificity in all but one study. For the DR vs. SR + CAD group only one study reported a significant difference in RR. Conclusion All but two studies showed an increase in RR, sensitivity and CDR when adding CAD to SR. Compared to DR no statistically significant differences in sensitivity or CDR were reported. Additional studies based on organized population-based screening programs, with longer follow-up time, high-volume readers, and digital mammography are needed to evaluate the efficacy of CAD.

scholarly journals Meta-analysis of the Cepheid Xpert® CT/NG assay for extragenital detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections

Sexual Health ◽  
2019 ◽  
Vol 16 (4) ◽  
pp. 314 ◽  
Author(s):  
Claire C. Bristow ◽  
Sheldon R. Morris ◽  
Susan J. Little ◽  
Sanjay R. Mehta ◽  
Jeffrey D. Klausner
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Bayesian Method ◽  
Day Treatment ◽  
Point Of Care ◽  
Meta Analysis ◽  
Turnaround Time ◽  
Nucleic Acid Amplification ◽  
Testing Performance ◽  
Amplification Assay

Background Most studies evaluating extragenital testing performance for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) detection by the Xpert® CT/NG show high per cent agreement with comparison assays; however, the precision around positive per cent agreement is low and thus the values that have been reported are not highly informative. Therefore, a systematic review was conducted and data from five studies were combined to better assess positive per cent agreement. Methods: The literature indexed on PubMed.gov was searched. Included studies were those that were an evaluation of the Xpert CT/NG assay with rectal and/or pharyngeal specimen types compared with another nucleic acid amplification test (NAAT), the Aptima transcription mediated amplification assay. A full Bayesian method was used for bivariate fixed-effect meta-analysis of positive and negative per cent agreement and pooled estimates (and 95% confidence intervals (CI)) were presented for each. Results: The pooled positive and negative per cent agreement for detection of CT in rectal specimens was 89.72% (95% CI: 84.97%, 93.64%) and 99.23% (95% CI: 98.74%, 99.60%), and in pharyngeal specimens, they were 89.96% (95% CI: 66.38%, 99.72%) and 99.62% (95% CI: 98.95%, 99.95%) respectively. For NG detection in rectal specimens, the pooled positive and negative per cent agreement was 92.75% (95% CI: 87.91%, 96.46%) and 99.75% (95% CI: 99.46%, 99.93%), and in pharyngeal specimens, they were 92.51% (95% CI: 85.84%, 97.18%) and 98.56% (95% CI: 97.69%, 99.23%) respectively. Conclusions: It was found that the Xpert CT/NG assay performed similarly to the Aptima transcription mediated amplification assay for the detection of CT and NG in extragenital specimens. The Xpert assay has the benefit of providing faster results at the point-of-care, thus reducing the turnaround time for results, potentially enabling same-day treatment.

scholarly journals Clinical Performance of the Xpert® CT/NG Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae: A Multicenter Evaluation in Chinese Urban Hospitals

2022 ◽  
Vol 11 ◽  
Author(s):  
Yan Han ◽  
Mei-Qin Shi ◽  
Qing-Ping Jiang ◽  
Wen-Jing Le ◽  
Xiao-Lin Qin ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Sensitivity And Specificity ◽  
Clinical Performance ◽  
Point Of Care ◽  
High Sensitivity ◽  
Turnaround Time ◽  
Urine Samples ◽  
Urban Hospitals ◽  
Receive Treatment

BackgroundWe aimed to evaluate the clinical performance of the GeneXpert® (Xpert) CT/NG assay for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using urine and cervical swabs collected from patients in China.MethodsThis study was conducted from September 2016 to September 2018 in three Chinese urban hospitals. The results from the Xpert CT/NG test were compared to those from the Roche cobas® 4800 CT/NG test. Discordant results were confirmed by DNA sequence analysis.ResultsIn this study, 619 first void urine (FVU) specimens and 1,042 cervical swab specimens were included in the final dataset. There were no statistical differences between the results of the two tests for the detection of CT/NG in urine samples (p &gt; 0.05), while a statistical difference was found in cervical swabs (p &lt; 0.05). For CT detection, the sensitivity and specificity of the Xpert test were 100.0% (95%CI = 96.8–99.9) and 98.3% (95%CI = 96.6–99.2) for urine samples and 99.4% (95%CI = 96.5–100.0) and 98.6% (95%CI 97.5–99.2) for cervical swabs, respectively. For NG detection, the sensitivity and specificity of the Xpert test were 99.2% (95%CI = 94.9–100.0) and 100.0% (95%CI = 99.0–100.0) for urine and 100% (95%CI = 92.8–100.0) and 99.7% (95%CI = 99.0–99.9) for cervical swabs, respectively.ConclusionThe Xpert CT/NG test exhibited high sensitivity and specificity in the detection of CT and NG in both urine and cervical samples when compared to the reference results. The 90-min turnaround time for CT and NG detection at the point of care using Xpert may enable patients to receive treatment promptly.

The use and performance of oral–throat rinses to detect pharyngeal Neisseria gonorrhoeae and Chlamydia trachomatis infections

2007 ◽  
Vol 59 (3) ◽  
pp. 259-264 ◽  
Author(s):  
John R. Papp ◽  
Katherine Ahrens ◽  
Christi Phillips ◽  
Charlotte K. Kent ◽  
Susan Philip ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
And Performance

Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis among women with genitourinary infection and pregnancy-related complications in Tehran: A cross-sectional study

2020 ◽  
Vol 31 (8) ◽  
pp. 773-780
Author(s):  
Mohammadreza Rajabpour ◽  
Amir Darb Emamie ◽  
Mohammad Reza Pourmand ◽  
Narjes Noori Goodarzi ◽  
Firouzeh Akbari Asbagh ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Ectopic Pregnancy ◽  
Trichomonas Vaginalis ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Sexually Transmitted ◽  
Screening Programs ◽  
Patient Groups ◽  
Genitourinary Infection

The present study investigates the prevalence of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) among women with genitourinary infection and pregnancy-related complications in Tehran. It also evaluates the demographic information, symptoms, and sequelae. Endocervical samples were obtained over a period of eight months from 360 women including 180 symptomatic patients and 180 patients with pregnancy-related complications and infertility. CT, NG, and TV were detected in 10.8%, 6.9%, and 8.3% of all patients, respectively. The prevalence of CT, NG, and TV among women in the symptomatic group was 11.1%, 7.2%, and 13.3%, respectively, and among women with pregnancy-related complications and infertility was 10.6%, 6.7%, and 3.3%, respectively. Associations between chlamydia and ectopic pregnancy ( p =  0.001), and infertility ( p <  0.001) were observed. Abortion ( p =  0.008), infertility ( p =  0.005), and ectopic pregnancy ( p <  0.001) were associated with gonorrhea. Abnormal vaginal discharge ( p =  0.02) and vulvar itching ( p =  0.02) were associated with trichomoniasis. Overall, the prevalence rates of CT, NG, and TV were high in these patient groups. These high prevalences suggest that screening programs are required to reduce the burden of these sexually transmitted infections and their effects on genitourinary symptoms, pregnancy-related complications, and infertility.

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