Abstract
Nowadays, it is of utmost importance to use fully validated assays for molecular-based diagnosis. In the field of sexually transmitted disease (STD), Roche and Hologic provide assays for diagnosing Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), and Trichomonas vaginalis (TV). A total of 212 clinical samples were tested. Aptima® Combo 2 (detecting CT and NG), Aptima® M. genitalium and the Aptima® T. vaginalis on the Panther® system were compared to CoBAS® CT/NG and CoBAS® TV/MG running on the CoBAS® 6800 system. To solve the discrepancies, Allplex™ STI Essential assay (Seegene®) and/or Sanger DNA sequencing were used. The diagnostic performance was calculated by mean of the sensitivity and specificity parameters. Aptima® (sensitivity: 98.90%, specificity: 100%), CoBAS® (sensitivity 100%, specificity: 96.67%). The CoBAS® combo (CT/NG) failed detecting NG from an anal/rectum specimen, which is not included into the validated specimens of the assay. Aptima® combo 2 produced two false positives (CT and NG), not detected by the third tests. All the assays showed an optimal diagnostic capacity, meeting the requirements for IVD DNA–based assays. All products work optimally on automatic platforms, minimizing time and risk of contamination during handling.
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Acknowledgments
The results published here are part of the thesis’s work of the PhD candidate Adolfo de Salazar, in the Biomedicine Doctoral Program of the University of Granada.
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Collection and storage of clinical specimens: A.F-L, E. S-C, B.E., A.dS.; validation: A.dS., A.B-D, A.F-L, N.C.; writing—original draft preparation: A.B-D., A.dS.; writing—review and editing: A.B-D, F.G.; project administration: M.A-E.; F.G.; funding acquisition: F.G.
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The study was designed and conducted according to the principles expressed in the Declaration of Helsinki and, was approved by the local Ethics Committee of Hospital Universitario Clínico San Cecilio (Granada).
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Barrientos-Durán, A., de Salazar, A., Fuentes-López, A. et al. Comparison between Aptima® assays (Hologic) and the CoBAS® 6800 system (Roche) for the diagnosis of sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium. Eur J Clin Microbiol Infect Dis 40, 1337–1342 (2021). https://doi.org/10.1007/s10096-020-04143-9
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DOI: https://doi.org/10.1007/s10096-020-04143-9