title: Bead-based multiplex sexually transmitted infection profiling.
abstract: OBJECTIVE
  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.affiliation: German Cancer Research Center (DKFZ), Research Program Infection and Cancer, Im Neuenheimer Feld 242, 69120 Heidelberg, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Schmitt
authors.affiliation: Laboratory of Molecular and Clinical Pathology (RIATOL), AML, Sonic Healthcare Benelux, Emiel Vloorsstraat 9, 2020 Antwerp, Belgium.
authors.forename: Christophe
authors.initials: C
authors.lastname: Depuydt
authors.affiliation: Laboratory of Molecular and Clinical Pathology (RIATOL), AML, Sonic Healthcare Benelux, Emiel Vloorsstraat 9, 2020 Antwerp, Belgium.
authors.forename: Michel
authors.initials: M
authors.lastname: Stalpaert
authors.affiliation: German Cancer Research Center (DKFZ), Research Program Infection and Cancer, Im Neuenheimer Feld 242, 69120 Heidelberg, Germany. Electronic address: m.pawlita@dkfz.de.
authors.forename: Michael
authors.initials: M
authors.lastname: Pawlita
mesh_terms: D002584:Cervix Uteri / Q000382:microbiology / Q000821:virology; D003584:Cytological Techniques; D004269:DNA, Bacterial / Q000302:isolation & purification; D004271:DNA, Fungal / Q000302:isolation & purification; D004279:DNA, Viral / Q000302:isolation & purification; D005260:Female; D006801:Humans; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D012749:Sexually Transmitted Diseases / Q000175:diagnosis* / Q000382:microbiology* / Q000821:virology*; D013048:Specimen Handling; D014621:Vagina / Q000382:microbiology / Q000821:virology
chemical_list: D004269:DNA, Bacterial; D004271:DNA, Fungal; D004279:DNA, Viral
keywords: Bacterial vaginosis; Luminex; PCR; Screening; Sexually transmitted infection (STI); Sexually transmitted infection profiling (STIP)