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

ABSTRACT

Trichomonas vaginalis is one of the most common curable sexually transmitted pathogens infecting both men and women worldwide. Unlike traditional methods such as microscopy and culture, nucleic acid amplification tests rapidly detect this agent, assisting in treatment. Conventional polymerase chain reaction (PCR), the loop-mediated isothermal amplification (LAMP), and the Xpert TV assay were evaluated using 28 microscopy positive T. vaginalis samples and 125 microscopy negative samples from symptomatic females of reproductive age. The sensitivity of all tests was 100% and the specificity was 100%, 100%, and 99·2% for PCR, Xpert TV, and LAMP, respectively. The inter-rater reliability was excellent for PCR Xpert TV (kappa-coefficient = 1) and good for LAMP assay Xpert TV/PCR (kappa-coefficient = 0·98) and conventional PCR LAMP (kappa-coefficient = 0·98). The study highlights the importance of PCR for screening T. vaginalis in women, particularly in laboratories where the Xpert-TV assay is not available or not affordable. The LAMP assay showed a lower positive predictive value which merits further evaluation. SIGNIFICANCE AND IMPACT OF THE STUDY Trichomonas vaginalis is a common sexually transmitted pathogen associated with considerable morbidity and risk of complications. Due to the limitations of traditional diagnostic modalities, three molecular assays were compared conventional polymerase chain reaction (PCR), Xpert TV assay, and loop mediated isothermal amplification (LAMP) assay for detecting T. vaginalis in symptomatic females. All tests had a sensitivity of 100% and the inter-rater reliability was excellent for PCR Xpert TV, and good for LAMP assay Xpert TV/PCR. The translational impact of this study lies in the possible use of conventional PCR and LAMP in laboratories where the Xpert TV assay is not available or not affordable.