A retrospective evaluation of the Euroarray STI-11 multiplex system for the detection of eight STI causing agents

Abstract With an incidence of more than > 1,000,000/day, sexually transmitted diseases remain a major challenge for health care systems worldwide. To reduce disease burden, complications, and spread, rapid diagnosis permitting early therapy is pivotal. The range of pathogens is wide and co-infect...

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Main Authors: Karl Dichtl, Andreas Osterman, Johannes Forster, Lena Jakob, Sebastian Suerbaum, Michael J. Flaig, Sören Schubert, Johannes Wagener
Format: Article
Language:English
Published: Nature Portfolio 2023-07-01
Series:Scientific Reports
Online Access:https://doi.org/10.1038/s41598-023-38121-w
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author Karl Dichtl
Andreas Osterman
Johannes Forster
Lena Jakob
Sebastian Suerbaum
Michael J. Flaig
Sören Schubert
Johannes Wagener
author_facet Karl Dichtl
Andreas Osterman
Johannes Forster
Lena Jakob
Sebastian Suerbaum
Michael J. Flaig
Sören Schubert
Johannes Wagener
author_sort Karl Dichtl
collection DOAJ
description Abstract With an incidence of more than > 1,000,000/day, sexually transmitted diseases remain a major challenge for health care systems worldwide. To reduce disease burden, complications, and spread, rapid diagnosis permitting early therapy is pivotal. The range of pathogens is wide and co-infections are common. This complicates pre-analytics, which are based on different laboratory techniques with potentially long turnaround times, e.g., cultivation and multistep serologies. Multiplex PCR provides the opportunity to overcome these limitations. In this study, we evaluated a novel assay, the Euroarray STI-11 microarray (EA; Euroimmun Medizinische Labordiagnostika), for the detection of eight obligate or facultative pathogens. Three-hundred-thirteen clinical specimens, which had been tested and pre-characterized for STI causing agents as part of routine diagnostics, were used as cases and controls in this retrospective study. The EA detected 34/44 Chlamydia trachomatis, 48/50 HSV-1, 50/50 HSV-2, 48/48 Mycoplasma hominis, 45/47 Neisseria gonorrhoeae, 9/11 Treponema pallidum, 46/46 Ureaplasma parvum, and 49/49 Ureaplasma urealyticum infections, respectively. 293 samples were EA positive, with polymicrobial infections (positive for two to six microbial or viral agents) detected in 130/293 cases. Specificities were 100% in the respective control groups (n = 18–48 depending on targeted pathogen) except for N. gonorrhoeae (25/26) and U. urealyticum (44/45). The broad spectrum of obligate and facultative pathogens targeted by the EA makes it a valuable tool in the setting of STI diagnostics and surveillance. The test has the potential to diagnose diseases neglected or overlooked in routine clinical practice. Besides a low sensitivity for C. trachomatis, the EA demonstrated high performance for all analyzed parameters. Further studies are warranted in order to capture a larger variety of the tested pathogens.
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spelling doaj.art-7039c6dc5c284fbf840d385c20a371ed2023-07-16T11:14:34ZengNature PortfolioScientific Reports2045-23222023-07-011311710.1038/s41598-023-38121-wA retrospective evaluation of the Euroarray STI-11 multiplex system for the detection of eight STI causing agentsKarl Dichtl0Andreas Osterman1Johannes Forster2Lena Jakob3Sebastian Suerbaum4Michael J. Flaig5Sören Schubert6Johannes Wagener7Lehrstuhl für Medizinische Mikrobiologie und Krankenhaushygiene, Max von Pettenkofer-Institut, Medizinische Fakultät, LMU MünchenLehrstuhl für Virologie, Max von Pettenkofer-Institut, LMU MünchenInstitut für Hygiene und Mikrobiologie, Julius-Maximilians-Universität WürzburgKlinik und Poliklinik für Dermatologie und Allergologie, Klinikum der Universität München, LMU MünchenLehrstuhl für Medizinische Mikrobiologie und Krankenhaushygiene, Max von Pettenkofer-Institut, Medizinische Fakultät, LMU MünchenKlinik und Poliklinik für Dermatologie und Allergologie, Klinikum der Universität München, LMU MünchenLehrstuhl für Medizinische Mikrobiologie und Krankenhaushygiene, Max von Pettenkofer-Institut, Medizinische Fakultät, LMU MünchenLehrstuhl für Medizinische Mikrobiologie und Krankenhaushygiene, Max von Pettenkofer-Institut, Medizinische Fakultät, LMU MünchenAbstract With an incidence of more than > 1,000,000/day, sexually transmitted diseases remain a major challenge for health care systems worldwide. To reduce disease burden, complications, and spread, rapid diagnosis permitting early therapy is pivotal. The range of pathogens is wide and co-infections are common. This complicates pre-analytics, which are based on different laboratory techniques with potentially long turnaround times, e.g., cultivation and multistep serologies. Multiplex PCR provides the opportunity to overcome these limitations. In this study, we evaluated a novel assay, the Euroarray STI-11 microarray (EA; Euroimmun Medizinische Labordiagnostika), for the detection of eight obligate or facultative pathogens. Three-hundred-thirteen clinical specimens, which had been tested and pre-characterized for STI causing agents as part of routine diagnostics, were used as cases and controls in this retrospective study. The EA detected 34/44 Chlamydia trachomatis, 48/50 HSV-1, 50/50 HSV-2, 48/48 Mycoplasma hominis, 45/47 Neisseria gonorrhoeae, 9/11 Treponema pallidum, 46/46 Ureaplasma parvum, and 49/49 Ureaplasma urealyticum infections, respectively. 293 samples were EA positive, with polymicrobial infections (positive for two to six microbial or viral agents) detected in 130/293 cases. Specificities were 100% in the respective control groups (n = 18–48 depending on targeted pathogen) except for N. gonorrhoeae (25/26) and U. urealyticum (44/45). The broad spectrum of obligate and facultative pathogens targeted by the EA makes it a valuable tool in the setting of STI diagnostics and surveillance. The test has the potential to diagnose diseases neglected or overlooked in routine clinical practice. Besides a low sensitivity for C. trachomatis, the EA demonstrated high performance for all analyzed parameters. Further studies are warranted in order to capture a larger variety of the tested pathogens.https://doi.org/10.1038/s41598-023-38121-w
spellingShingle Karl Dichtl
Andreas Osterman
Johannes Forster
Lena Jakob
Sebastian Suerbaum
Michael J. Flaig
Sören Schubert
Johannes Wagener
A retrospective evaluation of the Euroarray STI-11 multiplex system for the detection of eight STI causing agents
Scientific Reports
title A retrospective evaluation of the Euroarray STI-11 multiplex system for the detection of eight STI causing agents
title_full A retrospective evaluation of the Euroarray STI-11 multiplex system for the detection of eight STI causing agents
title_fullStr A retrospective evaluation of the Euroarray STI-11 multiplex system for the detection of eight STI causing agents
title_full_unstemmed A retrospective evaluation of the Euroarray STI-11 multiplex system for the detection of eight STI causing agents
title_short A retrospective evaluation of the Euroarray STI-11 multiplex system for the detection of eight STI causing agents
title_sort retrospective evaluation of the euroarray sti 11 multiplex system for the detection of eight sti causing agents
url https://doi.org/10.1038/s41598-023-38121-w
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