Prospective evaluation study on the benefit of the simultaneous detection of seven sexually transmitted pathogens for the clinical management of patients suffering from sexually transmitted diseases

Abstract

Background: Sexually transmitted infections (STIs) represent a growing relevant public health problem. Early and accurate STI diagnosis is capable of preventing the spread and severe complications of curable STIs through pathogen adapted antibiotic treatment regimens. Limitations of current STI diagnostic tools are the lack of simultaneous pathogen detection and result quantification. Methods: A prospective analysis of clinical specimens (n = 100, from 82 symptomatic patients) from different sites of infections was performed. All samples were processed with multiplex real-time polymerase chain reaction (PCR) assay Anyplex™ II STI-7, using thermal cycler CFX96™. The Anyplex™ II STI-7 detection assay covers Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), Mycoplasma hominis (MH), Ureaplasma parvum (UP), Ureaplasma urealyticum (UU) and Trichomonas vaginalis (TV). STI-7 results were compared to standard methods and transferred to the attending physician for treatment adjustment. Results: Compared to performed standard method results the assay achieved sensitivities ranging from 90.9% to 100%, respectively, and specificities of 100%, with negative predictive values (NPV) ranging from 98.5% to 100%, respectively, and positive predictive values (PPV) of 100%. The Anyplex™ II STI-7 detection assay measured a Cohen's kappa of 1.00 for UU/UP, MH, and MG and a Cohen's κ agreement of 0.95 and 0.96 for NG and CT, respectively. Conclusions: The Anyplex™ II STI-7 assay can easily be introduced into the microbiological laboratory work flow due to its short hands-on-time and PCR mutiplexity. The simultaneous detection of seven STI pathogens provides a comprehensive profile for each patient, enabling clinicians to decide on best treatment options, decreasing antibiotic misuse and infection spreading risk. The semiquantitative results enables clinicians to gain a complete package of diagnostic information including disease diagnosis, disease degree severity and treatment monitoring, although. Further clinical studies on this topic are needed.