title: Usefulness of a novel multiplex real-time PCR assay for the diagnosis of sexually-transmitted infections.
abstract: BACKGROUND
  Sexually transmitted infections (STI) are currently on the increase worldwide. New molecular tools have been developed in the past few years in order to improve their diagnosis. An evaluation was carried out using a new commercially available real-time PCR assay, Anyplex™ II STI-7 (Seegene, Seoul, Korea), which detects seven major pathogens in a single reaction - Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum, and Ureaplasma parvum - and compared with conventional methods performed in our laboratory.
  
  
  METHODS
  Two different populations were included, and 267 specimens from different sites of infection (urines, endocervical swabs, rectal swabs, vaginal swabs, urethral swabs and one inguinal adenopathy) were processed for both methods.
  
  
  RESULTS
  The parameters of clinical performance were calculated for C. trachomatis, N. gonorrhoeae, and T. vaginalis, and the assay achieved sensitivities (SE) from 93.94% to 100%, and specificities (SP) from 96.55% to 100%, with negative predictive values (NPV) from 93.33% to 98.85%, and positive predictive values (PPV) from 96.88% to 100%, with a very good agreement (kappa index from 0.88 to 1).
  
  
  CONCLUSIONS
  Anyplex™ II STI-7 is a good tool for the reliable diagnosis of STI. Its ease of use and processing allows it to be incorporated into the day to day laboratory work.
authors.affiliation: Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain. Electronic address: gemafrivas@gmail.com.
authors.forename: Gema
authors.initials: G
authors.lastname: Fernández
authors.affiliation: Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain; CIBER de Epidemiología y Salud Pública (CIBERESP) , Madrid, Spain.
authors.forename: Elisa
authors.initials: E
authors.lastname: Martró
authors.affiliation: CIBER de Epidemiología y Salud Pública (CIBERESP) , Madrid, Spain; Centre d'Estudis Epidemiològics sobre les ITS/sida de Catalunya, Agència de Salut Pública de Catalunya (ASPC), Generalitat de Catalunya, Badalona, Spain.
authors.forename: Victoria
authors.initials: V
authors.lastname: González
authors.affiliation: Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain; CIBER de Epidemiología y Salud Pública (CIBERESP) , Madrid, Spain.
authors.forename: Verónica
authors.initials: V
authors.lastname: Saludes
authors.affiliation: Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain.
authors.forename: Elisabet
authors.initials: E
authors.lastname: Bascuñana
authors.affiliation: Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain.
authors.forename: Clara
authors.initials: C
authors.lastname: Marcó
authors.affiliation: Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Rivaya
authors.affiliation: Centre d'Estudis Epidemiològics sobre les ITS/sida de Catalunya, Agència de Salut Pública de Catalunya (ASPC), Generalitat de Catalunya, Badalona, Spain.
authors.forename: Evelin
authors.initials: E
authors.lastname: López
authors.affiliation: IrsiCaixa Hospital Universitari Germans Trias i Pujol, Badalona, Spain; BCN Checkpoint, Barcelona, Spain.
authors.forename: Pep
authors.initials: P
authors.lastname: Coll
authors.affiliation: Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain; CIBER de Epidemiología y Salud Pública (CIBERESP) , Madrid, Spain.
authors.forename: Lurdes
authors.initials: L
authors.lastname: Matas
authors.affiliation: Servicio de Microbiología, Hospital Universitari Germans Trias i Pujol, Departamento de Genética y Microbiología, Universidad Autónoma de Barcelona, Badalona, Spain; CIBER de Enfermedades Respiratorias (CIBERES), Madrid, Spain.
authors.forename: Vicente
authors.initials: V
authors.lastname: Ausina
mesh_terms: D002692:Chlamydia trachomatis / Q000302:isolation & purification; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D045704:Mycoplasma genitalium / Q000302:isolation & purification; D019535:Mycoplasma hominis / Q000302:isolation & purification; D009344:Neisseria gonorrhoeae / Q000302:isolation & purification; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D012749:Sexually Transmitted Diseases / Q000175:diagnosis* / Q000382:microbiology; D014246:Trichomonas vaginalis / Q000302:isolation & purification; D014509:Ureaplasma / Q000302:isolation & purification; D016990:Ureaplasma urealyticum / Q000302:isolation & purification
keywords: Chlamydia trachomatis; Infecciones de transmisión sexual; Multiplex PCR; Neisseria gonorrhoeae; PCR multiplex; Real-time PCR; Sexually transmitted diseases; Trichomonas vaginalis