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Sexually transmitted infections (STIs) remain a worldwide problem and a severe threat to public health. The purpose of this study was to compare Aptima ®  Assays (Hologic ® ) and the Allplex ™  STI Essential Assay (Seegene ® ) for the simultaneous detection of  Chlamydia trachomatis ,  Neisseria gonorrhoeae ,  Trichomonas vaginalis  and  Mycoplasma genitalium  in clinical practice. The Aptima ®  assays (Hologic ® ) are based on a transcription-mediated amplification (TMA) method. The Allplex ™  STI Essential assay (Seegene ® ) is based on a multiplex Real-Time PCR (RT-PCR) method. A total of 622 clinical samples from different anatomical sites were tested using both methods. A total of 88 (14.1%) and 66 (10.6%) positive samples were found for any of the TMA assays used and for the RT-PCR assay, respectively. Aptima ®  assays showed a slightly higher rate of positive results for all pathogens except for  T .  vaginalis , the results of which were similar to those obtained with Allplex ™ . The most commonly detected pathogen was  C .  trachomatis  (37 samples; 5.9% using TMA assays) and the anatomical site with the highest prevalence of microorganisms was a non-urogenital site, the pharynx (27 positive samples; 4.3%). Using the Aptima ®  assays as reference method, the comparison showed that the average specificity of multiplex RT-PCR was 100.0% for the four pathogens. However an average sensitivity of 74.5% was observed, showing 95.2% (CI95%; 93.6–96.9) of overall concordance ( κ  = 0.80). In conclusion, the Aptima ®  assays show a higher sensitivity on a wide range of sample types compared to the Allplex ™  assay.

Comparison between Aptima Assays (Hologic) and the Allplex STI Essential Assay (Seegene) for the diagnosis of Sexually transmitted infections