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

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.

Loop mediated isothermal amplification assay for detection of Trichomonas vaginalis in vaginal swabs among symptomatic women from North India

“…In a recent study by Schwebke et al (2018); the sensitivity and specificity of Xpert TV were reported to be 96Á4% and 99Á6%, respectively, in vaginal samples. The slightly lower sensitivity could be because they had included 'patient collected' vaginal specimens which may have affected the quality of the sample, in contrast to our study where only vaginal swabs collected by a clinician or trained healthcare professional were used.…”

“…Although the current paradigm is to treat STIs by a syndromic approach, since T. vaginalis infection is frequently asymptomatic, diagnostic testing followed by prompt treatment is essential to avoid serious consequences. Amongst the available formats for the molecular diagnosis of T. vaginalis, the Xpert TV assay (Cepheid, Sunnyvale, CA) has improved the diagnostic capability and is a US-FDA approved NAAT for use in both females and males (Schwebke et al 2018). Amongst laboratory tests, wet mount microscopy has been used traditionally.…”

“…The use of NAATs provides the opportunity to screen and simultaneously generate precise epidemiologic information regarding T. vaginalis infection in various populations. Amongst the available formats for the molecular diagnosis of T. vaginalis, the Xpert TV assay (Cepheid, Sunnyvale, CA) has improved the diagnostic capability and is a US-FDA approved NAAT for use in both females and males (Schwebke et al 2018). Polymerase chain reaction (PCR) targeting the 18S rRNA, beta-tubulin, and adhesin genes of T. vaginalis, has also shown promising results (Riley et al 1992;Madico et al 1998).…”

Comparison between DiaPlexQ™ STI6 and GeneFinder™ STD I/STD II multiplex Real‐time PCR Kits in the detection of six sexually transmitted disease pathogens

“…Some of these technologies will allow for rapid near‐patient testing at the point of care and others have potential for high‐throughput batch testing . Rapid testing using random‐access platforms such as the GeneXpert system (Cepheid, Sunnyvale, CA) may be suitable for in‐clinic testing handling of a low number of specimens, whereas high‐throughput batch testing including the DiaPlexQ assay is useful for laboratories performing a large number of assays …”

Point-of-Care Testing for Sexually Transmitted Infections: A Review of Recent Developments

“…The sensitivity ranges from 95% in patient-collected vaginal swabs to 100% in symptomatic endocervical swabs, with specificities of 99% or higher. 40 A benefit of this assay is that it can be used in settings already using the GeneXpert platform. Indeed, the assay was found to be feasible in antenatal care clinics in Papua New Guinea and among pregnant women living with HIV in South Africa.…”