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Evaluation of the new AmpliSens multiplex real-time PCR assay for simultaneous detection of Neisseriagonorrhoeae, Chlamydiatrachomatis, Mycoplasmagenitalium, and Trichomonasvaginalis
Department of Molecular Diagnostics, Central Research Institute for Epidemiology, Moscow, Russian Federation.
WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for Pathogenic Neisseria, Örebro University, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro, Sweden.
Department of Dermatovenereology, Örebro University Hospital, Örebro, Sweden.
Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. WHO Collaborating Ctr Gonorrhoea & Other STIs, Natl Reference Lab Pathogen Neisseria, Dept Lab Med, Microbiol.
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2015 (English)In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), ISSN 0903-4641, E-ISSN 1600-0463, Vol. 123, no 10, 879-886 p.Article in journal (Refereed) Published
Abstract [en]

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 2assay, APTIMA Trichomonasvaginalis assay (FDA-approved), and two different APTIMA Mycoplasmagenitalium 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.

Place, publisher, year, edition, pages
Wiley-Blackwell, 2015. Vol. 123, no 10, 879-886 p.
Keyword [en]
Sexually transmitted infections, AmpliSens, APTIMA COMBO 2 assay, APTIMA Trichomonasvaginalis assay, APTIMA Mycoplasmagenitalium assay
National Category
Immunology in the medical area
Research subject
Immunology
Identifiers
URN: urn:nbn:se:oru:diva-46285DOI: 10.1111/apm.12430ISI: 000362127600009PubMedID: 26299582Scopus ID: 2-s2.0-84942371426OAI: oai:DiVA.org:oru-46285DiVA: diva2:862691
Note

Funding Agencies:

Örebro County Council Research Committee

Foundation for Medical Research at Orebro University Hospital, Sweden

Available from: 2015-10-23 Created: 2015-10-23 Last updated: 2017-10-18Bibliographically approved

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Golparian, DanielJohansson, EmmaFredlund, HansUnemo, Magnus
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