Clinical evaluation of a sensitive fluorescent PCR assay for trichomonas vaginalis

Trichomoniasis, caused by Trichomonas vaginalis (T. vaginalis), is a common sexually transmitted disease (STD) that primarily affects the genital and urinary tracts. Trichomoniasis has a worldwide distribution and is also widely endemic in China. In recent years, due to the continuous increase in the proportion of recurrent or persistent vaginal trichomoniasis, the related clinical diagnosis and treatments are facing new challenges. Currently, clinical diagnosis relies on clinical features and laboratory tests. Microscopic examination of vaginal secretions is a commonly used diagnostic method in which active T. vaginalis can be observed under a microscope in vaginal secretions. Although microscopic examination has a high specificity, the sensitivity is only 50 %-60 %. Therefore, the development of more sensitive and accurate clinical diagnostic methods are urgently needed for trichomoniasis. In this study, a clinical diagnosis of T. vaginalis infection was conducted at the Maternal and Child Health Hospital of Hubei province, Xiangyang No.1 People's Hospital, The First Hospital of Hunan University of Chinese Medicine, and Jingzhou Central Hospital. Different methods-fluorescent PCR (F-PCR), microscopic examination, sequencing and culture-were employed to diagnose T. vaginalis. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), negative likelihood ratio (NLR), and accuracy of F-PCR are 100 % (98-100 %), 98 % (96 %-99 %), 97 % (93 %-98 %), 100 % (99 %-100 %), 0.00, and 99 % (97 %-100 %), respectively. Compared with traditional methods such as microscopic examination, F-PCR offers superior sensitivity and accuracy. Additionally, F-PCR has a lower probability of false negatives compared with sequencing and culture-based approaches. Compared with methods such as microscopic examination, sequencing, and culture, it significantly reduces the probability of false negatives; and is more sensitive and accurate, making it a powerful diagnostic method for clinical diagnoses.