Comparison of GMT presto assay and Roche cobas® 4800 CT/NG assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in dry swabs.
Urogenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most prevalent bacterial STIs worldwide. Molecular tests are the standard for the detection of CT and NG, as these are difficult to culture. The recently introduced CE-IVD marked GMT Presto assay promises to be a valuable addition in CT and NG diagnostics. The advantage of the Presto assay is that it works on many PCR systems and the DNA can be isolated by any system.We compared the Presto assay to the widely used Roche cobas® 4800 CT/NG test for the detection of CT and NG in 612 vaginal and rectal dry collected swabs. Discrepant samples were tested by the TIB MOLBIOL Lightmix Kit 480 HT CT/NG assay. The alloyed gold standard was defined as two concurring Presto and cobas® 4800 results, or, with discrepant Presto and cobas® results, two concurring results of either test together with the Lightmix Kit 480 HT CT/NG assay. For the Presto assay,we observed 77 CT positive (13%) and 22 NG positive (3,6%) vaginal samples, and 41 CT positive (6,7%) and 11 NG positive (1,8%) rectal samples. For the cobas® 4800 assay,we observed 77 CT positive (13%) and 21NG positive (3,4%) vaginal samples, and 39 CT positive (6,4%) and 11 NG positive (1,8%) rectal samples. Ten CT samples were discrepant between Presto and cobas® 4800 CT/NG assays, while two NG samples were discrepant. CT sensitivity in both assays was 100% compared to the alloyed gold standard. The sensitivity was 100% for both vaginal and rectal dry swabs, underlining the suitability of these sample types for detection of CT and NG. The Presto assay is therefore valuable for molecular detection of CT and NG in dry vaginal and rectal swabs.
VU University Medical Centre, Department of Medical Microbiology & Infection Control, Laboratory of Immunogenetics, Amsterdam, The Netherlands; Institute for Public Health Genomics (IPHG), Department of Genetics and Cell Biology, Research School GROW (School for Oncology & Developmental Biology), Faculty of Health, Medicine & Life Sciences, University of Maastricht, Maastricht, The Netherlands.
Dewi J
DJ
de Waaij
VU University Medical Centre, Department of Medical Microbiology & Infection Control, Laboratory of Immunogenetics, Amsterdam, The Netherlands; Institute for Public Health Genomics (IPHG), Department of Genetics and Cell Biology, Research School GROW (School for Oncology & Developmental Biology), Faculty of Health, Medicine & Life Sciences, University of Maastricht, Maastricht, The Netherlands.
Jan Henk
JH
Dubbink
Anova Health Institute, Johannesburg and Tzaneen, South Africa; Department of Medical Microbiology, University of Maastricht, Maastricht, The Netherlands.
Remco P H
RP
Peters
VU University Medical Centre, Department of Medical Microbiology & Infection Control, Laboratory of Immunogenetics, Amsterdam, The Netherlands. Electronic address: s.ouburg@vumc.nl.
Sander
S
Ouburg
VU University Medical Centre, Department of Medical Microbiology & Infection Control, Laboratory of Immunogenetics, Amsterdam, The Netherlands; Institute for Public Health Genomics (IPHG), Department of Genetics and Cell Biology, Research School GROW (School for Oncology & Developmental Biology), Faculty of Health, Medicine & Life Sciences, University of Maastricht, Maastricht, The Netherlands.
Servaas A
SA
Morré
D000328:Adult; D001431:Bacteriological Techniques / Q000379:methods*; D002692:Chlamydia trachomatis / Q000235:genetics / Q000302:isolation & purification*; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis* / Q000382:microbiology; D006801:Humans; D008219:Lymphogranuloma Venereum / Q000175:diagnosis* / Q000382:microbiology; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009344:Neisseria gonorrhoeae / Q000235:genetics / Q000302:isolation & purification*; D012007:Rectum / Q000382:microbiology; D012680:Sensitivity and Specificity; D014621:Vagina / Q000382:microbiology; D055815:Young Adult
Chlamydia trachomatis; GMT presto assay; Neisseria gonorrhoeae; Real-time PCR; Roche cobas 4800 CT/NG test