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

AbstractNowadays, 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 diagnosingChlamydia trachomatis (CT),Neisseria gonorrhoeae (NG),Mycoplasma genitalium (MG), andTrichomonas 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 include d 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, mini mizing time and risk of contamination during handling.
Source: European Journal of Clinical Microbiology and Infectious Diseases - Category: Microbiology Source Type: research