Markus Schmitt1, Christophe Depuydt2, Michel Stalpaert2, Michael Pawlita3. 1. German Cancer Research Center (DKFZ), Research Program Infection and Cancer, Im Neuenheimer Feld 242, 69120 Heidelberg, Germany. 2. Laboratory of Molecular and Clinical Pathology (RIATOL), AML, Sonic Healthcare Benelux, Emiel Vloorsstraat 9, 2020 Antwerp, Belgium. 3. German Cancer Research Center (DKFZ), Research Program Infection and Cancer, Im Neuenheimer Feld 242, 69120 Heidelberg, Germany. Electronic address: m.pawlita@dkfz.de.
Abstract
OBJECTIVES: Sexually transmitted infections are a significant cause of genital disease, infertility and hospital admissions. The economic impact is high. An accurate diagnosis is often difficult and time consuming. We report the development and validation of a novel bead-based multiplex sexually transmitted infection profiling (STIP) assay that detects 18 sexually transmitted infections using a multiplex PCR followed by Luminex bead-based hybridisation. METHODS: STIP was validated using urogenital samples pretested by commercially available quantitative PCR, microscopy or by culturing methods. RESULTS: STIP specifically detects Chlamydia trachomatis, Herpes simplex virus 1 and 2, Treponema pallidum, Trichomonas vaginalis, Neisseria gonorrhoeae, Mycoplasma (M.) genitalium, M. hominis, M. pneumonia, M. spermatophilum, Ureaplasma urealyticum and U. parvum, and quantifies bacterial vaginosis-associated Atopobium vaginae and Gardnerella vaginalis as well as three Candida species and normal genital flora-associated Lactobacillus species. STIP reached an overall concordance of 95-100% with commercially available quantitative PCR tests. Compared to Nugent score, STIP reached a sensitivity of 95% and a specificity of 86% for bacterial vaginosis detection. Candida specimens, pretested by direct culturing, were identified with a sensitivity of 97% and a specificity of 99%. CONCLUSIONS: STIP is a powerful high-throughput tool in assessing a broad spectrum of urogenital infections.
OBJECTIVES: Sexually transmitted infections are a significant cause of genital disease, infertility and hospital admissions. The economic impact is high. An accurate diagnosis is often difficult and time consuming. We report the development and validation of a novel bead-based multiplex sexually transmitted infection profiling (STIP) assay that detects 18 sexually transmitted infections using a multiplex PCR followed by Luminex bead-based hybridisation. METHODS: STIP was validated using urogenital samples pretested by commercially available quantitative PCR, microscopy or by culturing methods. RESULTS: STIP specifically detects Chlamydia trachomatis, Herpes simplex virus 1 and 2, Treponema pallidum, Trichomonas vaginalis, Neisseria gonorrhoeae, Mycoplasma (M.) genitalium, M. hominis, M. pneumonia, M. spermatophilum, Ureaplasma urealyticum and U. parvum, and quantifies bacterial vaginosis-associated Atopobium vaginae and Gardnerella vaginalis as well as three Candida species and normal genital flora-associated Lactobacillus species. STIP reached an overall concordance of 95-100% with commercially available quantitative PCR tests. Compared to Nugent score, STIP reached a sensitivity of 95% and a specificity of 86% for bacterial vaginosis detection. Candida specimens, pretested by direct culturing, were identified with a sensitivity of 97% and a specificity of 99%. CONCLUSIONS: STIP is a powerful high-throughput tool in assessing a broad spectrum of urogenital infections.
Authors: Stefanie Castell; G Krause; M Schmitt; M Pawlita; Y Deleré; N Obi; D Flesch-Janys; Y Kemmling; A M Kaufmann Journal: Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz Date: 2014-11 Impact factor: 1.513
Authors: Katrin Hufnagel; Smiths Lueong; Martina Willhauck-Fleckenstein; Agnes Hotz-Wagenblatt; Beiping Miao; Andrea Bauer; Angelika Michel; Julia Butt; Michael Pawlita; Jörg D Hoheisel; Tim Waterboer Journal: Sci Rep Date: 2018-05-14 Impact factor: 4.379