Evaluation of the Siemens VERSANT® CT/GC DNA 1.0 Assay (kPCR) for detection of Chlamydia trachomatis and Neisseria gonorrhoeae

• Published in: Journal of microbiological methods Vol. 87; no. 2; pp. 139 - 142
• Main Authors: Bongaerts, Maarten, van de Bovenkamp, Jeroen H.B., Morré, Servaas A., Manders, Monique E.L.M., Heddema, Edou R.
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 01.11.2011; Elsevier
• Subjects: Bacteriological methods and techniques used in bacteriology; Bacteriology; Biological and medical sciences; Chlamydia Infections - diagnosis; Chlamydia Infections - microbiology; Chlamydia trachomatis; Chlamydia trachomatis - genetics; Chlamydia trachomatis - isolation & purification; Cobas Amplicor; DNA; Female; Fundamental and applied biological sciences. Psychology; Gonorrhea - diagnosis; Gonorrhea - microbiology; Humans; kPCR; Male; Microbiology; Neisseria gonorrhoeae; Neisseria gonorrhoeae - genetics; Neisseria gonorrhoeae - isolation & purification; Probetec; quantitative polymerase chain reaction; Reagent Kits, Diagnostic; Real-Time Polymerase Chain Reaction - methods; urine; VERSANT; Probetec; CT; Neisseria gonorrhoeae; PT; kPCR; VERSANT; Cobas Amplicor; Chlamydia trachomatis; GC; CA; Chlamydiaceae; Neisseriaceae; Chlamydiales; Bacteria; Micrococcales; Detection
• ISSN: 0167-7012; 1872-8359
• DOI: 10.1016/j.mimet.2011.09.001

The Siemens VERSANT kPCR system is an automated system which combines extraction of nucleic acids from 96 samples with subsequent real-time PCR. The VERSANT CT/GC DNA 1.0 (kPCR) assay detects Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) in a multiplex real-time PCR on this system. We compared this assay with the BD ProbeTe™ ET System (PT) and the Roche Cobas Amplicor (CA). Three different sets of samples were tested in the kPCR: PT pre-treated samples, prospectively collected urine samples during routine CT/GC testing and urine samples obtained in a blinded fashion by an external lab facility. Agreement of kPCR with the comparator tests was >0.99 for sample set I and complete agreement was observed for sample set II and III. The kPCR assay demonstrated to be an easy to use robust diagnostic platform. A few modifications to the manufacturer's instructions are recommended to intercept false positivity. We advise to retest samples with Cq values above 35cycles at least one time and we suggest checking the amplification curves. ► We evaluated the VERSANT CT/GC DNA 1.0 (kPCR) assay. ► The assay detects Chlamydia trachomatis and Neisseria gonorrhoeae. ► The assay was compared with BD Probetec and Roche Cobas Amplicor. ► Almost complete agreement was observed. ► The assay demonstrated to be an easy to use robust diagnostic platform. ► We suggest a few modifications to the manufacturer's instructions to intercept false positivity.