Trichomonas vaginalis Detection in Urogenital Specimens from Symptomatic and Asymptomatic Men and Women by Use of the cobas TV/MG Test

Abstract

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.

The prevalence of Mycoplasma genitalium (MG) and Trichomonas vaginalis (TV) at testing centers in Belgium, Germany, Spain, and the UK using the cobas TV/MG molecular assay

“…Specimens were tested with the cobas TV/MG assay for use on the cobas 6800/8800 Systems (Roche Molecular Systems, Branchburg, NJ, USA), following the manufacturer's recommended Instructions for Use (IFU). The performance of the cobas TV/MG assay for use on the cobas 6800/8800 Systems has been described previously and can reliably detect TV [24] and MG [25]. Sample testing was performed from December 2018 to April 2019.…”

Establishment and application of a CRISPR-Cas12a-based RPA-LFS and fluorescence for the detection of Trichomonas vaginalis

“…Meanwhile, T. vaginalis infection can increase the risk of HIV infection [ 8 ], cervical intraepithelial neoplasia [ 9 ] and posthysterectomy infection [ 10 ]. In some women, trichomoniasis can lead to symptoms such as vaginal erythema, production of gray-green or yellow-green secretions and difficulty in urination [ 11 ], but most infected individuals, especially men, are asymptomatic [ 12 ]. Therefore, accurate diagnosis is crucial for the proper treatment and prevention of trichomoniasis and to avoid recurrence [ 13 ].…”

“…The current diagnostic methods of T. vaginalis are mainly microscopic observation [ 12 ]. Although these tests have a high specificity, they have a low sensitivity of 40% to 70% [ 14 ].…”

Prevalence of Trichomonas vaginalis infection among Sudanese patients with different genders in Khartoum state, Sudan

“…T.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 [16].…”