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Evaluation of the new AmpliSens multiplex real-time PCR assay for simultaneous detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis.
APMIS 2015; 123(10):879-86A

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+Show Affiliations

Department of Molecular Diagnostics, Central Research Institute for Epidemiology, Moscow, Russia.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.Department of Dermatovenereology, Örebro University Hospital, Örebro, Sweden.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.Department of Dermatovenereology, Örebro University Hospital, Örebro, Sweden.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.Public Health Laboratory, Amsterdam Health Centre, Amsterdam, the Netherlands. Department of Medical Microbiology, OLVG, Amsterdam, the Netherlands.Department of Molecular Diagnostics, Central Research Institute for Epidemiology, Moscow, Russia.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.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26299582

Citation

Rumyantseva, Tatiana, et al. "Evaluation of the New AmpliSens Multiplex Real-time PCR Assay for Simultaneous Detection of Neisseria Gonorrhoeae, Chlamydia Trachomatis, Mycoplasma Genitalium, and Trichomonas Vaginalis." APMIS : Acta Pathologica, Microbiologica, Et Immunologica Scandinavica, vol. 123, no. 10, 2015, pp. 879-86.
Rumyantseva T, Golparian D, Nilsson CS, et al. Evaluation of the new AmpliSens multiplex real-time PCR assay for simultaneous detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis. APMIS. 2015;123(10):879-86.
Rumyantseva, T., Golparian, D., Nilsson, C. S., Johansson, E., Falk, M., Fredlund, H., ... Unemo, M. (2015). Evaluation of the new AmpliSens multiplex real-time PCR assay for simultaneous detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis. APMIS : Acta Pathologica, Microbiologica, Et Immunologica Scandinavica, 123(10), pp. 879-86. doi:10.1111/apm.12430.
Rumyantseva T, et al. Evaluation of the New AmpliSens Multiplex Real-time PCR Assay for Simultaneous Detection of Neisseria Gonorrhoeae, Chlamydia Trachomatis, Mycoplasma Genitalium, and Trichomonas Vaginalis. APMIS. 2015;123(10):879-86. PubMed PMID: 26299582.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of the new AmpliSens multiplex real-time PCR assay for simultaneous detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis. AU - Rumyantseva,Tatiana, AU - Golparian,Daniel, AU - Nilsson,Christian S, AU - Johansson,Emma, AU - Falk,My, AU - Fredlund,Hans, AU - Van Dam,Alje, AU - Guschin,Alexander, AU - Unemo,Magnus, Y1 - 2015/08/24/ PY - 2015/04/02/received PY - 2015/07/08/accepted PY - 2015/8/25/entrez PY - 2015/8/25/pubmed PY - 2016/1/30/medline KW - APTIMA COMBO 2 assay KW - APTIMA Mycoplasma genitalium assay KW - APTIMA Trichomonas vaginalis assay KW - AmpliSens KW - Sexually transmitted infections SP - 879 EP - 86 JF - APMIS : acta pathologica, microbiologica, et immunologica Scandinavica JO - APMIS VL - 123 IS - 10 N2 - 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. SN - 1600-0463 UR - https://www.unboundmedicine.com/medline/citation/26299582/Evaluation_of_the_new_AmpliSens_multiplex_real_time_PCR_assay_for_simultaneous_detection_of_Neisseria_gonorrhoeae_Chlamydia_trachomatis_Mycoplasma_genitalium_and_Trichomonas_vaginalis_ L2 - https://doi.org/10.1111/apm.12430 DB - PRIME DP - Unbound Medicine ER -