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


Autoři: Adolfo de Salazar aff001;  Beatriz Espadafor aff002;  Ana Fuentes-López aff001;  Antonio Barrientos-Durán aff001;  Luis Salvador aff002;  Marta Álvarez aff001;  Federico García aff001
Působiště autorů: Hospital Universitario San Cecilio, Servicio de Microbiología, Instituto de Investigación Ibs, Granada, Spain aff001;  Hospital Universitario Virgen de las Nieves, Servicio de Dermatología, Centro de ETS, Granada, Spain aff002
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: https://doi.org/10.1371/journal.pone.0222439

Souhrn

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.

Klíčová slova:

Biology and life sciences – Microbiology – Medical microbiology – Microbial pathogens – Bacterial pathogens – Organisms – Bacteria – Chlamydia – Neisseria – Eukaryota – Protists – Trichomonas – Trichomonas vaginalis – Anatomy – Body fluids – Physiology – Molecular biology – Molecular biology techniques – Artificial gene amplification and extension – Polymerase chain reaction – Reverse transcriptase-polymerase chain reaction – Biochemistry – Nucleic acids – Medicine and health sciences – Pathology and laboratory medicine – Pathogens – Chlamydia trachomatis – Neisseria gonorrhoeae – Urine – Infectious diseases – Sexually transmitted diseases – Chlamydia infection – Research and analysis methods


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