Abstract
Trichomonas vaginalis is the most common curable sexually transmitted infection (STI) worldwide. Although predominately asymptomatic, the disease spectrum of trichomoniasis in women is characterized primarily by signs and symptoms of vaginitis, including purulent discharge and localized vulvar pruritus and erythema. Several FDA-cleared nucleic acid amplification tests (NAATs) are available for the diagnosis of T. vaginalis infections, but laboratory developed tests (LDTs) are widely utilized and cost-effective solutions in both the research and clinical diagnostic settings. LDT diagnosis of T. vaginalis is particularly appealing since it can be performed using remnant specimens collected for other STI testing. Using a LDT implemented as part of this study, T. vaginalis was detected in 7% of participating Louisiana women (14/199). The mean T. vaginalis organism burden was 1.0x106 ± 4.5x105 organisms per mL of ThinPrep PreservCyt. Using DNA eluates obtained after HPV testing on the cobas 4800 system, the T. vaginalis LDT was characterized by excellent intra- and interassay reproducibility (coefficient of variation values all <3.5%). Compared with two commercially available NAATs from TIB MOLBIOL, the sensitivity and specificity of the LDT was 92.9 and 99.5%, respectively. Collectively, this study details the diagnostic and quantitative utility of a LDT for T. vaginalis. When applied in the clinical research setting, we confirmed the high prevalence of T. vaginalis, but also observed extraordinarily high organism burdens in the cervix. These findings highlight the unique host-pathogen relationship of T. vaginalis with lower reproductive tract tissues, and substantiate the need for continued investigation of this highly prevalent STI.
Highlights
Trichomonas vaginalis is the most common curable sexually transmitted infection (STI) worldwide [1]
When the laboratory developed tests (LDTs) is run as a quantitative test as described which includes running a standard curve of pre-quantified plasmid dilutions in duplicate, the maximum number of patient results per run (96-well plate format) is 84 (5 plasmid dilutions run in duplicate, 1 no template control, and one positive control are included in each run)
The quantitative capacity of the test is primarily applicable for clinical research as we continue to investigate the pathobiology of T. vaginalis infections
Summary
Trichomonas vaginalis is the most common curable sexually transmitted infection (STI) worldwide [1]. In the USA, T. vaginalis is more common than Chlamydia trachomatis and Neisseria gonorrhoeae in nationally representative studies [2, 3], no programmatic recommendations currently exist for routine screening in the general population [4]. Timely identification of trichomoniasis is further complicated by the fact that up to 85% of infections in women are asymptomatic [5], despite being associated with inflammatory lower urogenital tract syndromes including vaginitis and cervicitis. Trichomoniasis is most commonly associated with signs and symptoms of vaginitis including purulent vaginal discharge, and localized vulvar pruritus and erythema. Oral metronidazole or tinidazole are highly effective therapies [10], timely diagnosis of T. vaginalis remains sub-par as we most commonly rely upon insensitive in-clinic techniques, and direct our diagnostic testing towards patients with overt signs of vaginitis
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