Advantages of Syndromic Diagnostics: Detection of the Pathogens Causing Urethritis/Cervicitis with the STI CNM Real-Time PCR Kit from Vitro S.A.

Abstract

The STI CNM Real-Time PCR Kit from Vitro S.A. (Spain) demonstrates high sensitivity and specificity, is cost-effective, and can detect the three main etiological agents of urethritis/cervicitis in a single multiplex PCR. Sexually transmitted infections (STIs) are a significant public health problem and a significant burden of morbidity and mortality in hospitals. The World Health Organization (WHO) estimates the number of daily infections to be 1 million. Currently, the number of infections and antimicrobial-resistant strains is rising. A rapid and accurate etiologic diagnosis is critical to solving this problem. In this study, we compared the STI CNM Real-Time PCR Kit using the Xpert^® CT/NG technique (Cepheid^®, USA) as Gold Standard for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae and EasyNAT^® MG (Ustar Biotechnologies (Hangzhou) Ltd., China) as Gold Standard for the diagnosis of Mycoplasma genitalium infection. Regarding C. trachomatis and N. gonorrhoeae, out of 200 samples, there was a match in 199 cases, with only one positive sample not being detected by the STI CNM Real-Time PCR Kit. This results in a sensitivity of 96% and a specificity of 100% for this kit. Diagnosing M. genitalium infection, out of 200 samples, the STI CNM Real-Time PCR Kit correctly detected all negative and positive samples, with 100% agreement compared to the reference technique. In summary, the STI assay has a very high sensitivity and specificity, comparable to other commercial diagnostic kits. Furthermore, it has the advantage of bundling the detection of the three main bacterial agents of urethritis/cervicitis, resulting in better cost efficiency.