title: Evaluation of the new AmpliSens multiplex real-time PCR assay for simultaneous detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis.
abstract: In this study, we performed an evaluation of the new CE-marked multiplex real-time AmpliSens N.gonorrhoeae/C.trachomatis/M.genitalium/T.vaginalis-MULTIPRIME-FRT PCR assay compared to APTIMA tests, i.e., APTIMA COMBO 2 assay, APTIMA Trichomonas vaginalis assay (FDA-approved), and two different APTIMA Mycoplasma genitalium assays (research use only; one of them only used for discrepancy analysis). Vaginal swabs (n = 209) and first-void urine (FVU) specimens from females (n = 498) and males (n = 554), consecutive attendees (n = 1261) at a dermatovenerological clinic in Sweden, were examined. The sensitivity of the AmpliSens PCR assay for detection of C. trachomatis (6.3% prevalence), M. genitalium (5.7% prevalence), N. gonorrhoeae (0.3% prevalence), and T. vaginalis (0.08% prevalence) was 97.5% (95% confidence interval (CI): 91.2-99.6%), 81.9% (95% CI: 70.7-89.7%), 100% (95% CI: 40.2-100%) and 100% (95% CI: 16.5-100%), respectively. The specificity of the AmpliSens PCR assay was 100% (95% CI: 99.6-100%) for all agents. The analytical sensitivity and specificity for N. gonorrhoeae detection was excellent, i.e., 55 international gonococcal strains detected and 135 isolates of 13 non-gonococcal Neisseria species were negative. In conclusion, the multiplex real-time AmpliSens N.gonorrhoeae/C.trachomatis/M.genitalium/T.vaginalis-MULTIPRIME-FRT PCR assay demonstrated high sensitivity and excellent specificity for the detection of C. trachomatis, N. gonorrhoeae, and T. vaginalis, and excellent specificity but suboptimal sensitivity for M. genitalium detection.
authors: Department of Molecular Diagnostics, Central Research Institute for Epidemiology, Moscow, Russia.
authors: Tatiana
authors: T
authors: Rumyantseva
authors: WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for Pathogenic Neisseria, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
authors: Daniel
authors: D
authors: Golparian
authors: Department of Dermatovenereology, Örebro University Hospital, Örebro, Sweden.
authors: Christian S
authors: CS
authors: Nilsson
authors: WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for Pathogenic Neisseria, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
authors: Emma
authors: E
authors: Johansson
authors: Department of Dermatovenereology, Örebro University Hospital, Örebro, Sweden.
authors: My
authors: M
authors: Falk
authors: WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for Pathogenic Neisseria, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
authors: Hans
authors: H
authors: Fredlund
authors: Public Health Laboratory, Amsterdam Health Centre, Amsterdam, the Netherlands.|Department of Medical Microbiology, OLVG, Amsterdam, the Netherlands.
authors: Alje
authors: A
authors: Van Dam
authors: Department of Molecular Diagnostics, Central Research Institute for Epidemiology, Moscow, Russia.
authors: Alexander
authors: A
authors: Guschin
authors: WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for Pathogenic Neisseria, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
authors: Magnus
authors: M
authors: Unemo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002690:Chlamydia Infections / Q000175:diagnosis*; D002692:Chlamydia trachomatis / Q000235:genetics; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D009175:Mycoplasma Infections / Q000175:diagnosis*; D045704:Mycoplasma genitalium / Q000235:genetics; D009344:Neisseria gonorrhoeae / Q000235:genetics; D012680:Sensitivity and Specificity; D014247:Trichomonas Vaginitis / Q000175:diagnosis*; D014246:Trichomonas vaginalis / Q000235:genetics; D055815:Young Adult
keywords: APTIMA COMBO 2 assay; APTIMA Mycoplasma genitalium assay; APTIMA Trichomonas vaginalis assay; AmpliSens; Sexually transmitted infections