Evaluation of Seeplex® STD6 ACE Detection kit for the diagnosis of six bacterial sexually transmitted infections

Traditionally, the diagnosis of bacterial sexually transmitted infection (STI) has been dependent on the isolation ofthe causative pathogens by culturing endocervical or urethral swab specimens on selective media. While such procedurestypically provide excellent diagnostic accuracy, they are often time-consuming and expensive. A multiplex polymerase chainreaction (PCR) assay, based on a semi-automated detection system, was evaluated for the detection of six STI causativeorganisms. The Seeplex® STD6 ACE (auto-capillary electrophoresis) Detection assay employed six pairs of dual primingoligonucleotide (DPO™) primers specifically targeted to unique genes of Chlamydia trachomatis, Neisseria gonorrhoeae,Mycoplasma genitalium, Ureaplasma urealyticum, Mycoplasma hominis, and Trichomonas vaginalis. A total of 739 specimens (304cervical swabs and 435 urine samples) collected for 4 months were tested, and results were compared to those obtained with acombined monoplex PCR. The concordance between the multiplex PCR and monoplex PCR assay was 100% for both sensitivity andspecificity. We also tested for the presence of two pathogenic bacteria (C. trachomatis and N. gonorrhoeae) and compared theresults obtained with the multiplex PCR and BD ProbeTec duplex strand displacement amplification (SDA). The results of themultiplex PCR and duplex SDA were 99.7% concordant for C. trachomatis and 100% concordant for N. gonorrhoeae. The multiplexPCR assay using the Seeplex® STD6 ACE Detection kit proved to be a novel cost-effective and fast diagnostic tool withhigh sensitivity and specificity for the simultaneous detection of six STI pathogens.