Evaluation of a multiplex Real-time PCR kit for simultaneous diagnosis of Ureaplasma urealyticum and Ureaplasma parvum

Abstract

Abstract Background: The aim of the study was to evaluate the clinical performance of the newly commercial PCR Kit (RepoDx) for Ureaplasma urealyticum (UU) and Ureaplasma parvum (UP) detection. Methods: A total of 572 genital tract swabs were tested. The kit performance for UU and UP detection was compared to that of Sanger sequencing, targeting specific regions within the UUR10_0680 and UP063 genes. Results: The RepoDx PCR kit showed an overall agreement (accuracy) of 96.31% (95%CI = 0.9441-0.9770, kappa = 0.940) for UU/UP with sequencing, offering over 93% positive percent agreement (PPA) and negative percent agreement (NPA) for detecting UU and UP. However, NPA dropped significantly with Mycoplasma hominis (MH) co-infection [NPA (UU-, UP-, MH-) vs. NPA (UU-, UP-, MH+): 93.86% vs. 65.22%], suggesting MH might interfere with Repodx PCR kit, meriting further investigation due to the significantly lower prevalence of MH than Ureaplasma in this study. Conclusions: Multiplex real-time PCR kit is a convenient method for the simultaneous detection of UU and UP. The overall agreement of the RepoDx PCR kit was comparable to that of the sequencing method.