B-226 Clinical Evaluation of ElsiQ™ STI-12 Detection Kit 3/4 for Detection of Human Sexual Transmitted Infection Pathogens in Human Vaginal Swab and/or Urine Specimens

Abstract

Abstract Background Nucleic acid amplification tests are a highly sensitive method for detecting sexual transmitted infection (STI) pathogens, and multiplex molecular assays are even more advantageous in screening and diagnosing multiple STI pathogens simultaneously. The ElsiQ™ STI-12 Detection Kit 3/4 (ElsiQ) is in vitro diagnostic marked multiplex real-time PCR assay that targets 6 STI pathogens, including human herpes simplex virus 1 (HSV1), human herpes simplex virus 2 (HSV2), Gardnerella vaginalis (GV), Treponema pallidum (TP), Candida albicans (CA), and Ureaplasma parvum (UP) in human vaginal swab and/or urine specimens. Methods In this retrospective study, 575 clinical specimens suspected of having STI pathogen were enrolled; 280 genital swabs and 295 urine samples from April to July 2021. The comparison tests were performed using both the ElsiQ and PANA RealTyper™ STD Kit (PANA). Clinical sensitivity and clinical specificity were evaluated by comparing the patient’s clinical features. Results The comparison results between ElsiQ and PANA were all consistency in 5 strains (HSV1, HSV2, GV, TP, UP), and 96.4% positive percent agreement value with 0.97 kappa value in CA. (Table 1). The clinical sensitivity and clinical specificity showed 100% in 5 strains (HSV1, HSV2, GV, TP, UP). Only CA has 97.0% sensitivity, and 100% specificity. Conclusion The ElsiQ assay demonstrated excellent analytical performance for detecting six STD pathogens, with high sensitivity and specificity. The results of this study support the use of the ElsiQ assay as a reliable and efficient tool for the simultaneous diagnosis of multiple STIs.