title: Rapid Diagnosis of Trichomonas vaginalis by Testing Vaginal Swabs in an Isothermal Helicase-Dependent AmpliVue Assay.
abstract: The AmpliVue Trichomonas Assay (Quidel) is a new Federal Drug Administration-cleared rapid test for qualitative detection of Trichomonas vaginalis (TV) DNA in female vaginal specimens. The assay is based on BioHelix's helicase-dependent amplification isothermal technology in conjunction with a disposable lateral-flow detection device, with a total turnaround time of approximately 45 minutes.
  
  
  
  The objective of this study was to compare the performance of this new assay to wet preparation and culture as well as to another Federal Drug Administration-cleared nucleic acid amplification assay.
  
  
  
  Four clinician collected vaginal swabs were obtained from women attending sexually transmitted disease, family planning, and OB/GYN clinics and tested by AmpliVue Trichomonas Assay and comparator tests: saline microscopy, TV culture (InPouch), and Aptima TV. AmpliVue Trichomonas Assay results were compared with a composite positive comparator (CPC) as determined by the results from culture and/or wet mount microscopic examination. At least one of either the wet preparation or culture reference test results was required to be positive to establish CPC.
  
  
  
  A total of 992 patients, 342 symptomatic and 650 asymptomatic patients, were included in the study. Results for AmpliVue for all women combined compared with saline microscopy and culture as a CPC yielded a sensitivity of 100%. Specificity for all women was 98.2%. Overall percent agreement versus Aptima TV was 97.8%. Sensitivity for AmpliVue compared with Aptima was 90.7% %, whereas specificity was 98.9%.
  
  
  
  The rapid AmpliVue Trichomonas Assay performed as well as microscopy and culture, and had comparable sensitivity and specificity to another nucleic acid amplification test for the detection of TV. This study provided evidence of new diagnostic options and indicated very good performance of amplified testing for detection of TV in symptomatic and asymptomatic women.
authors.affiliation: From the *Division of Infectious Diseases, The Johns Hopkins University, Baltimore, MD; †Division of Infectious Diseases, University of North Carolina, Chapel Hill, NC; ‡Division of Infectious Diseases, University of Washington, Seattle, WA; §Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL; and ¶Division of Infectious Diseases, St. Joseph's Healthcare/McMaster University, Hamilton, Ontario, Canada.
authors.forename: Charlotte A
authors.initials: CA
authors.lastname: Gaydos
authors.forename: Marcia
authors.initials: M
authors.lastname: Hobbs
authors.forename: Jeanne
authors.initials: J
authors.lastname: Marrazzo
authors.forename: Jane
authors.initials: J
authors.lastname: Schwebke
authors.forename: Jenell S
authors.initials: JS
authors.lastname: Coleman
authors.forename: Billie
authors.initials: B
authors.lastname: Masek
authors.forename: Laura
authors.initials: L
authors.lastname: Dize
authors.forename: Dan
authors.initials: D
authors.lastname: Jang
authors.forename: Jenny
authors.initials: J
authors.lastname: Li
authors.forename: Max
authors.initials: M
authors.lastname: Chernesky
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D008853:Microscopy; D021141:Nucleic Acid Amplification Techniques / Q000295:instrumentation / Q000379:methods; D012680:Sensitivity and Specificity; D012749:Sexually Transmitted Diseases / Q000175:diagnosis* / Q000382:microbiology; D014247:Trichomonas Vaginitis / Q000175:diagnosis* / Q000382:microbiology; D014246:Trichomonas vaginalis / Q000235:genetics / Q000302:isolation & purification*; D014621:Vagina / Q000382:microbiology; D055815:Young Adult