Comparison between Aptima Assays

Sexually transmitted infections (STIs) remain a worldwide problem and a severe threat to public health. The purpose of this study was to compare Aptima.sup.® Assays (Hologic.sup.®) and the Allplex.sup.[TM] STI Essential Assay (Seegene.sup.®) for the simultaneous detection of Chlamydia trachomatis, N...

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Bibliographic Details
Published in:PloS one 2019-09, Vol.14 (9), p.e0222439
Main Authors: de Salazar, Adolfo, Espadafor, Beatriz, Fuentes-López, Ana, Barrientos-Durán, Antonio, Salvador, Luis, Álvarez, Marta, García, Federico
Format: Article
Language:English
Subjects:
Chlamydia
Chlamydia trachomatis
Control
Diagnosis
Disease transmission
Microorganisms
Pathogenic microorganisms
Public health
Risk factors
Sexually transmitted diseases
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Summary:Sexually transmitted infections (STIs) remain a worldwide problem and a severe threat to public health. The purpose of this study was to compare Aptima.sup.® Assays (Hologic.sup.®) and the Allplex.sup.[TM] STI Essential Assay (Seegene.sup.®) for the simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium in clinical practice. The Aptima.sup.® assays (Hologic.sup.®) are based on a transcription-mediated amplification (TMA) method. The Allplex.sup.[TM] STI Essential assay (Seegene.sup.®) 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.sup.® 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.sup.[TM] . 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.sup.® 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 ([kappa] = 0.80). In conclusion, the Aptima.sup.® assays show a higher sensitivity on a wide range of sample types compared to the Allplex.sup.[TM] assay.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0222439