Trichomonas vaginalis detection in urogenital specimens from symptomatic and asymptomatic men and women using the cobas TV/MG test

Trichomonas vaginalis is a prevalent sexually transmitted infection (STI). Diagnosis has historically relied on either microscopic analysis or culture, the latter being the previous gold standard. However, these tests are not readily available for male diagnosis, generally only perform well for symptomatic women, and are not as sensitive as nucleic acid amplification tests (NAATs). Men are largely asymptomatic but carry the organism and transmit to their sexual partners. This multicenter, prospective study evaluated the performance of the cobas® T. vaginalis /Myocoplasma genitalium (TV/MG) assay for detection of T. vaginalis DNA compared with patient infection status (PIS) defined by a combination of commercially available NAATs and culture using urogenital specimens. A total of 2,064 subjects (984 men and 1,080 women, 940 [45.5%] symptomatic, 1124 [54.5%] asymptomatic) were evaluable. In women, sensitivity ranged from 99.4% (95% confidence interval [CI] 96.8–99.9%) using vaginal samples to 94.7 (95% CI 90.2–97.2%) in PreservCyt samples. Specificity ranged from 98.9–96.8% (95% CI 95.4–97.8%). In men, the cobas TV/MG assay was 100% sensitive for the detection of T. vaginalis in both male urine samples and meatal swabs, with specificity of 98.4% in urine samples and 92.5% in meatal swabs. The cobas TV/MG is a suitable diagnostic test for the detection of T.vaginalis, which could support public health efforts towards infection control and complement existing STI programs.

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Clinical Evaluation of the Cepheid Xpert TV Assay for Detection of Trichomonas vaginalis with Prospectively Collected Specimens from Men and Women

Journal of Clinical Microbiology ◽

10.1128/jcm.01091-17 ◽

2017 ◽

Vol 56 (2) ◽

Cited By ~ 5

Author(s):

Jane R. Schwebke ◽

C. A. Gaydos ◽

T. Davis ◽

J. Marrazzo ◽

D. Furgerson ◽

...

Keyword(s):

Trichomonas Vaginalis ◽

Transmitted Disease ◽

The United States ◽

Nucleic Acid Amplification ◽

Urine Samples ◽

Broth Culture ◽

Men And Women ◽

Content Type ◽

Sexually Transmitted ◽

Diagnostic Sensitivity And Specificity

ABSTRACT Trichomoniasis is the most prevalent curable sexually transmitted disease (STD). It has been associated with preterm birth and the acquisition and transmission of HIV. Recently, nucleic acid amplification tests (NAAT) have been FDA cleared in the United States for detection of Trichomonas vaginalis in specimens from both women and men. This study reports the results of a multicenter study recently conducted using the Xpert TV (T. vaginalis) assay to test specimens from both men and women. On-demand results were available in as little as 40 min for positive specimens. A total of 1,867 women and 4,791 men were eligible for inclusion in the analysis. In women, the performance of the Xpert TV assay was compared to the patient infected status (PIS) derived from the results of InPouch TV broth culture and Aptima NAAT for T. vaginalis. The diagnostic sensitivities and specificities of the Xpert TV assay for the combined female specimens (urine samples, self-collected vaginal swabs, and endocervical swabs) ranged from 99.5 to 100% and 99.4 to 99.9%, respectively. For male urine samples, the diagnostic sensitivity and specificity were 97.2% and 99.9%, respectively, compared to PIS results derived from the results of broth culture for T. vaginalis and bidirectional gene sequencing of amplicons. Excellent performance characteristics were seen using both female and male specimens. The ease of using the Xpert TV assay should result in opportunities for enhanced screening for T. vaginalis in both men and women and, hopefully, improved control of this infection.

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Prenatal chlamydial, gonococcal, and trichomonal screening in the Democratic Republic of Congo for case detection and management

International Journal of STD & AIDS ◽

10.1177/0956462419888315 ◽

2020 ◽

Vol 31 (3) ◽

pp. 221-229

Author(s):

Adva Gadoth ◽

Chelsea L Shannon ◽

Nicole A Hoff ◽

Gisèle Mvumbi ◽

Kamy Musene ◽

...

Keyword(s):

Birth Outcomes ◽

Trichomonas Vaginalis ◽

Democratic Republic ◽

Democratic Republic Of Congo ◽

Nucleic Acid Amplification ◽

Case Detection ◽

Transmitted Infection ◽

Republic Of Congo ◽

Sexually Transmitted ◽

Screening Programs

Prenatal Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) infections are associated with adverse birth outcomes. As rapid diagnostic tests become available, it is important to evaluate prenatal sexually transmitted infection (STI) prevalence, as well as the acceptability and feasibility of prenatal screening programs. We recruited 371 pregnant women from four clinics in Kisantu Health Zone, Democratic Republic of Congo (DRC) from October 2016 to March 2017. Trained clinicians collected cervical swabs, and samples were tested by nucleic acid amplification for CT, NG, and TV using a GeneXpert® system. Those testing positive for an STI were treated and asked to return after 4–8 weeks for tests-of-cure. Screening for STIs was widely accepted (99%). STI prevalence at baseline was CT, 3.2%; NG, 1.5%; and TV, 14%; treatment completion was 97%. Symptoms were reported among 34% of STI-positive women at baseline, compared with 37% of STI-negative women. Upon first test-of-cure, 100% of returning women were cured of CT ( n = 10) and NG ( n = 5), but only 47% were cured of TV. This study demonstrates the feasibility of implementing diagnostic STI testing for case detection and treatment among expectant mothers in DRC, with implications for maternal and birth outcomes.

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Prevalence of Trichomonas Vaginalis and its Correlation with Socio-demographic Variables in Pregnant Women in Al-Diwaniya,Iraq

International Journal of Research in Pharmaceutical Sciences ◽

10.26452/ijrps.v9ispl1.1286 ◽

2018 ◽

Vol 9 (SPL1) ◽

Author(s):

Shiren Ali Al Hamzawi

Keyword(s):

Pregnant Women ◽

Rural Areas ◽

Trichomonas Vaginalis ◽

Cross Sectional Study ◽

Demographic Variables ◽

Transmitted Infection ◽

Cross Sectional ◽

Sexually Transmitted ◽

Vaginal Swabs ◽

Low Education

Estimates of Trichomonas vaginalis prevalence in pregnant women are variable with few studies in Iraq.T. vaginalis is a worldwide prevalent sexually transmitted infection,but fortunately,it is very treatable. Researchers believed that pregnancy is one of the effective factors for T. vaginalis infection in women.A cross-sectional study performed in Obstetrics and Gynecology Department at Maternity and Children Teaching Hospital in Al-Diwaniya city on two hundred female pregnant patients between the ages of 16-45 years. These females had no intercourse for 2–3 days,not using drugs (antibiotics,antiprotozoal or steroids) for the last 15 days. Vaginal discharges of any type with or without itching,burning sensation or both were their main complaints. Vaginal swabs were taken from all participating patients for direct wet mount microscopy and culture for the detection of Trichomonas vaginalis infection. The study showed that twelve out of two hundred examined pregnant women (6%) presented with T. vaginalis infection. The infection was more in those with mothers’ age (26-35) years,housewives,low education,higher parity,and of rural residents. Other maternal variables were not significantly associated with T. vaginalis infection. The study showed a prevalence of (6%) of T. vaginalis infection in pregnant female attendees. Infection was more in those with mothers ’age (26-35) years,housewives,low educational level,higher parity,and living in rural areas.

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Improved molecular laboratory productivity by consolidation of testing on the new random-access analyzer Alinity m

LaboratoriumsMedizin ◽

10.1515/labmed-2020-0102 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Martin Obermeier ◽

Monia Pacenti ◽

Robert Ehret ◽

Francesco Onelia ◽

Rory Gunson ◽

...

Keyword(s):

Trichomonas Vaginalis ◽

Random Access ◽

Mycoplasma Genitalium ◽

Transmitted Infection ◽

Sexually Transmitted ◽

B Virus ◽

Immunodeficiency Virus ◽

International Multicenter Study ◽

Laboratory Productivity ◽

Laboratory Workflow

AbstractObjectivesAutomated molecular analyzers have accelerated diagnosis, allowing earlier intervention and better patient follow-up. A recently developed completely automated molecular analyzer, Alinity™ m (Abbott), offers consolidated, continuous, and random-access testing that may improve molecular laboratory workflow.MethodsAn international, multicenter study compared laboratory workflow metrics across various routine analyzers and Alinity m utilizing assays for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), hepatitis B virus (HBV), high-risk human papillomavirus (HR HPV), and sexually transmitted infection (STI) (Chlamydia trachomatis [CT]/Neisseria gonorrhoeae [NG]/Trichomonas vaginalis [TV]/Mycoplasma genitalium [MG]). Three turnaround times (TATs) were assessed: total TAT (sample arrival to result), sample onboard TAT (sample loading and test starting to result), and processing TAT (sample aspiration to result).ResultsTotal TAT was reduced from days with routine analyzers to hours with Alinity m, independent of requested assays. Sample onboard TATs for standard workflow using routine analyzers ranged from 7 to 32.5 h compared to 2.75–6 h for Alinity m. The mean sample onboard TAT for STAT samples on Alinity m was 2.36 h (±0.19 h). Processing TATs for Alinity m were independent of the combination of assays, with 100% of results reported within 117 min.ConclusionsThe consolidated, continuous, random-access workflow of Alinity m reduces TATs across various assays and is expected to improve both laboratory operational efficiency and patient care.

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A Review on Diagnostic Methods for Trichomonas Vaginalis

Tabari Biomedical Student Research Journal ◽

10.18502/tbsrj.v3i3.6925 ◽

2021 ◽

Author(s):

Fatemeh Rahmani ◽

Yahya Ehteshaminia ◽

Hamid Mohammadi ◽

Seif Ali Mahdavi

Keyword(s):

Trichomonas Vaginalis ◽

Pap Smear ◽

High Sensitivity ◽

Protozoan Parasite ◽

Signs And Symptoms ◽

Diagnostic Methods ◽

Culture Methods ◽

Transmitted Infection ◽

Sexually Transmitted ◽

Asymptomatic Individuals

Introduction: Trichomoniasis is the most common non-viral sexually transmitted infection in the world, caused by the protozoan parasite Trichomonas vaginalis, which infects the urogenital tract of men and women. Approximately, 250 million new cases of Trichomonas vaginalis Infection are reported worldwide each year. Trichomoniasis is also considered an important HIV co-infection. The infection is often asymptomatic but can be accompanied by symptoms such as severe inflammation, itching and irritation, foamy discharge, and malodorous smell mucus, but the signs and symptoms of the disease are not sufficient for specific diagnosis. Material and Methods: In this study, the websites of PubMed, Google Scholar, SID, and Margiran were searched and related articles were reviewed. Results: Only screening and the use of highly sensitive and specific diagnostic methods can identify asymptomatic individuals. Today, the most common way to diagnose the infection is to use wet slide, Pap smear and culture methods that do not have high sensitivity and specificity. Also, due to the increase in infection and its complications, finding an efficient, rapid, and easy test to detect the parasite and differentiate Trichomoniasis vaginitis from other sexually transmitted diseases is considered important and necessary. Conclusion: Nowadays, there are several diagnostic methods that differentiate trichomoniasis infection from other sexually transmitted infections with high accuracy and sensitivity. Of course, existing diagnostic methods mostly use women's urine and vaginal samples for diagnosis, and methods that specifically diagnose the infection in men are more limited.

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Direct detection of microorganisms responsible for the sexually transmitted infection on the mobile real-time PCR device without treating in advance

10.1101/2021.03.02.21252726 ◽

2021 ◽

Author(s):

Masaaki Muraoka ◽

Kazunori Sohma ◽

Osamu Kawaguchi ◽

Mikio Mizukoshi

Keyword(s):

Real Time ◽

Real Time Pcr ◽

Limit Of Detection ◽

Direct Detection ◽

Treponema Pallidum ◽

Nucleic Acid Amplification ◽

Direct Pcr ◽

Transmitted Infection ◽

Sexually Transmitted ◽

Ct Value

ABSTRACTAs WHO reported, four curable STIs-chlamydia, gonorrhoea, syphilis and trichomoniasis occur more than 1 million per each day globally almond 2016. For this reason, it is important to control these STIs, one of which is “to detect”. The general methods in order to detect STIs are nucleic acid amplification tests (NAATs). One of the reasons why NAATs are utilized in many tests is that it is possibly to be more sensitive than other test. However, there needs to treat extraction of nucleic acids in advance and amplify specific regions by NAATs, and hence it must take much labour and much time. In this work, for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Treponema pallidum (TP) which is each etiological agent of chlamydia, gonorrhoea and syphilis, we evaluate and propose “quicker and simpler” NAATs. Specifically, utilizing mobile real-time PCR device “PCR1100” and PCR reagent kit “KAPA3G Plant PCR Kit”, it was considered whether real-time direct PCR could be performed or not without treating DNA extraction in advance so-called “direct”.As a result, firstly, we established that real-time direct PCR could be performed in all of CT, NG, and TP, and moreover, each Ct value correlated with the concentration of each organism similarly to detection of genome DNA (each correlation coefficient R2 > 0.95). Moreover, each assay demonstrated a limit of detection (LOD) of the follows; CT was 10^0.86 = 7.24 IFU/reaction, NG was 10^-0.19 = 0.65 CFU/reaction, and TP was 10^1.4 = 25.1 organisms/reaction. However, it appeared the sensitivity was a little low, especially for CT and TP.Secondly, we found that even as without treating sample in advance, the time of detection was required more less 15 minutes at any of case, which was very quick compared with other current methods for real-time PCR. Additionally, compared with other commercial devices, it was easier to operate the PCR1100 device, for example, start, analysis of Ct value.In conclusion, the present study has demonstrated that it is possible for real-time direct PCR to perform with combination of the PCR1100 device and the PCR reagent kit in 3 kinds of microorganisms-CT, NG and TP. Furthermore, we propose “quicker and simpler” methods for NAATs, which it would not take labour and time. Further studies are needed in order to contribute to control STIs.

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Comparison of Trichomoniasis Diagnosis by Microscopic Methods and Indirect ELISA Technique in a Sample of Iraqi Women

Iraqi Journal of Science ◽

10.24996/ijs.2020.61.4.5 ◽

2020 ◽

pp. 742-748

Author(s):

Nada H. Bedair ◽

Hayder Z. Ali

Keyword(s):

Trichomonas Vaginalis ◽

Vaginal Discharge ◽

Indirect Elisa ◽

Elisa Method ◽

Transmitted Infection ◽

Sexually Transmitted ◽

Wet Mount ◽

Urine Examination ◽

Iraqi Women ◽

Elisa Technique

Trichomonas vaginalis is an eukaryotic parasite that causes the most common non-viral sexually transmitted infection, trichomoniasis. This disease is responsible for many serious health problems such as preterm birth. More than half of the infected women do not develop symptoms, which makes it difficult to diagnose thedisease. In this study, a specific indirect ELISA method was developed to detect anti-Trichomonas vaginalis IgM and IgG immunoglobulins in the sera of infected females. The aim of this study was to investigate the sensitivity of a simple ELISA procedure in comparison to the classical urine examination and vaginal wet mount preparation for the diagnosis of T. vaginalis. The sensitivity of the indirect ELISA was compared with the classical vaginal discharge swab and urine microscopic examination, and the results showed sensitivities of 65.5% and 57.2%, respectively. Furthermore, the infection was measurable as acute or chronic with the refined test.

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Should we still be testing for asymptomatic non-specific urethritis in departments of genitourinary medicine?

International Journal of STD & AIDS ◽

10.1258/0956462053654311 ◽

2005 ◽

Vol 16 (4) ◽

pp. 273-277 ◽

Cited By ~ 2

Author(s):

P J Horner

Keyword(s):

Current Practice ◽

Cost Effective ◽

Review Article ◽

Nucleic Acid Amplification ◽

Sexually Transmitted ◽

Non Invasive ◽

Genitourinary Medicine ◽

The Cost ◽

Urine Specimens ◽

Asymptomatic Men

It has recently been advocated that non-invasive testing with first-catch urine specimens using nucleic acid amplification techniques, to detect Chlamydia trachomatis and Neisseria gonorrhoeae, should replace routine microscopy on asymptomatic men. Although it is assumed that this strategy will be cost effective, the available evidence suggests that this will result in fewer sexually transmitted infections being averted than continuing the current practice of screening for urethritis and testing for both microorganisms in asymptomatic men. This review article summarizes the available evidence and argues that research is urgently needed in order to properly evaluate the cost-effectiveness of detecting urethritis in asymptomatic men.

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Rapid electrostatic DNA enrichment for sensitive detection of Trichomonas vaginalis in clinical urinary samples

Analytical Methods ◽

10.1039/c9ay02478f ◽

2020 ◽

Vol 12 (8) ◽

pp. 1085-1093

Author(s):

Justin M. Rosenbohm ◽

James M. Robson ◽

Rishabh Singh ◽

Rose Lee ◽

Jane Y. Zhang ◽

...

Keyword(s):

Nucleic Acid ◽

Trichomonas Vaginalis ◽

Nucleic Acid Amplification ◽

Urine Samples ◽

Sensitive Detection ◽

Isothermal Nucleic Acid Amplification

Rapid electrostatic enrichment of DNA from urine samples for improved isothermal nucleic acid amplification-based detection of Trichomonas vaginalis.

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Partner notification and treatment outcomes among South African adolescents and young adults diagnosed with a sexually transmitted infection via laboratory-based screening

International Journal of STD & AIDS ◽

10.1177/0956462420915395 ◽

2020 ◽

Vol 31 (7) ◽

pp. 627-636 ◽

Cited By ~ 1

Author(s):

Pooja Chitneni ◽

Mags Beksinska ◽

Janan J Dietrich ◽

Manjeetha Jaggernath ◽

Kalysha Closson ◽

...

Keyword(s):

Young Adults ◽

Sexually Transmitted Infection ◽

Trichomonas Vaginalis ◽

Partner Notification ◽

Mycoplasma Genitalium ◽

Adolescents And Young Adults ◽

Transmitted Infection ◽

Sexually Transmitted ◽

Care Cascade ◽

Essential Components

Partner notification and treatment are essential components of sexually transmitted infection (STI) management, but little is known about such practices among adolescents and young adults. Using data from a prospective cohort study (AYAZAZI) of youth aged 16–24 years in Durban, South Africa, we assessed the STI care cascade across participant diagnosis, STI treatment, partner notification, and partner treatment; index recurrent STI and associated factors; and reasons for not notifying partner of STI. Participants completed laboratory-based STI screening ( Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, Trichomonas vaginalis) at enrollment and at 12 months. Of the 37/216 participants with STI (17%), 27/37 (73%) were women and 10/37 (27%) were men. Median age was 19 years (IQR: 18–20). Of the participants with STI, 23/37 (62%) completed a Treatment and Partner Tracing Survey within 6 months of diagnosis. All survey participants reported completing STI treatment (100%), 17/23 (74%) notified a partner, and 6/23 (35%) reported partner treatment. Overall, 4/23 (11%) participants had 12-month recurrent C. trachomatis infection, with no association with partner notification or treatment. Stigma and lack of STI knowledge were reasons for not notifying partner of STI. STI partner notification and treatment is a challenge among youth. Novel strategies are needed to overcome barriers along the STI care cascade.

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