title: Multiplex PCR testing for nine different sexually transmitted infections.
abstract: Current sexually transmitted infection (STI) testing is not optimal due to delays in reporting or missed diagnoses due to a lack of comprehensive testing. The FilmArray® (BioFire Diagnostics, LLC, Salt Lake City, Utah) is a user-friendly, fully automated, multiplex PCR system that is being developed for rapid point-of-care use. A research-use-only STI panel including multiple PCR primer sets for each organism was designed to detect Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum, Trichomonas vaginalis, Mycoplasma genitalium, Ureaplasma urealyticum, Haemophilus ducreyi, and herpes simplex virus (HSV) types 1 and 2. Standard clinical testing included Gram stain, nucleic acid amplification, wet mount examination, herpes simplex virus culture, and syphilis IgG. Standard clinical tests were not available for all the organisms tested by the FilmArray STI panel. Two hundred and ninety-five clinical specimens from 190 subjects were directly compared to standard testing. Urine (n = 146), urethral/cervical swabs (31), oral swabs (60), rectal swabs (43), and ulcer swabs (15) were tested. Among the tested samples, FilmArray detected C. trachomatis in 39 (13%), N. gonorrhoeae in 20 (7%), T. vaginalis in nine (3%), HSV 1 in five (2%), HSV 2 in five (2%), U. urealyticum in 36 (12%), M. genitalium in eight (3%), and T. pallidum in 11 (4%). Concordance between the FilmArray STI panel and standard nucleic acid amplification testing for C. trachomatis was 98% and for N. gonorrhoeae was 97%. Multiplex PCR STI testing has the potential to improve public health by providing rapid, sensitive, and reliable results within the clinic or nearby laboratory.
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, University of Utah, USA John.Kriesel@hsc.utah.edu.
authors.forename: John D
authors.initials: JD
authors.lastname: Kriesel
authors.affiliation: Division of Infectious Diseases, Department of Internal Medicine, University of Utah, USA.
authors.forename: Amiteshwar S
authors.initials: AS
authors.lastname: Bhatia
authors.affiliation: Salt Lake Valley Health Department, USA.
authors.forename: Cammie
authors.initials: C
authors.lastname: Barrus
authors.affiliation: BioFire Diagnostics, LLC, USA.
authors.forename: Mike
authors.initials: M
authors.lastname: Vaughn
authors.affiliation: BioFire Defense, LLC, USA.
authors.forename: Jordan
authors.initials: J
authors.lastname: Gardner
authors.affiliation: BioFire Diagnostics, LLC, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Crisp
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001419:Bacteria / Q000235:genetics / Q000302:isolation & purification*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012749:Sexually Transmitted Diseases / Q000175:diagnosis* / Q000453:epidemiology / Q000209:etiology; D014556:Urine / Q000382:microbiology / Q000469:parasitology; D055815:Young Adult
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: FilmArray; STI; diagnostic test performance; multiplex PCR; sexually transmitted diseases; sexually transmitted infections