title: Test of Cure for Anogenital Gonorrhoea Using Modern RNA-Based and DNA-Based Nucleic Acid Amplification Tests: A Prospective Cohort Study.
abstract: The use of nucleic acid amplification tests (NAATs) to diagnose Neisseria gonorrhoeae infections complicates the performance of a test of cure (TOC) to monitor treatment failure, if this is indicated. As evidence for the timing of TOC using modern NAATs is limited, we performed a prospective cohort study to assess time to clearance when using modern RNA- and DNA-based NAATs.
  
  
  
  We included patients with anogenital gonorrhoea visiting the Sexually Transmitted Infection Clinic Amsterdam from March through October 2014. After treatment with ceftriaxone mono- or dual therapy (with azithromycin or doxycycline), anal, vaginal, or urine samples were self-collected during 28 consecutive days, and analyzed using an RNA-based NAAT (Aptima Combo 2) and a DNA-based NAAT (Cobas 4800). Clearance was defined as 3 consecutive negative results, and blips as isolated positive results following clearance.
  
  
  
  We included 77 patients; 5 self-cleared gonorrhoea before treatment and 10 were lost to follow-up. Clearance rate of the remaining 62 patients was 100%. Median time to clearance was 2 days, with a range of 1-7 days for RNA-based NAAT and 1-15 days for DNA-based NAAT. The risk of finding a blip after clearance was 0.8% and 1.5%, respectively. One patient had a reinfection.
  
  
  
  If indicated, we recommend that TOC be performed for anogenital gonorrhoea at least 7 or 14 days after administering therapy, when using modern RNA- or DNA-based NAATs, respectively. When interpreting TOC results for possible treatment failure, both the occurrence of blips and a possible reinfection need to be taken into account.
authors.affiliation: STI Outpatient Clinic, Department of Infectious Diseases, Public Health Service Amsterdam.|Department of Dermatology, Academic Medical Center, University of Amsterdam.
authors.forename: Carolien M
authors.initials: CM
authors.lastname: Wind
authors.affiliation: Department of Infectious Diseases, Public Health Service Amsterdam.|Center for Infection and Immunity Amsterdam, Academic Medical Center, University of Amsterdam, The Netherlands.
authors.forename: Maarten F
authors.initials: MF
authors.lastname: Schim van der Loeff
authors.affiliation: World Health Organization Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Pathogenic Neisseria, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Sweden.
authors.forename: Magnus
authors.initials: M
authors.lastname: Unemo
authors.affiliation: Department of Medical Microbiology, University Medical Centre Utrecht.
authors.forename: Rob
authors.initials: R
authors.lastname: Schuurman
authors.affiliation: Public Health Laboratory, Public Health Service Amsterdam.|Department of Medical Microbiology, Onze Lieve Vrouwe Gasthuis General Hospital, Amsterdam, The Netherlands.
authors.forename: Alje P
authors.initials: AP
authors.lastname: van Dam
authors.affiliation: STI Outpatient Clinic, Department of Infectious Diseases, Public Health Service Amsterdam.|Department of Dermatology, Academic Medical Center, University of Amsterdam.|Center for Infection and Immunity Amsterdam, Academic Medical Center, University of Amsterdam, The Netherlands.
authors.forename: Henry J C
authors.initials: HJC
authors.lastname: de Vries
mesh_terms: D000328:Adult; D001003:Anal Canal / Q000382:microbiology; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D058491:Bacterial Load / Q000235:genetics; D004269:DNA, Bacterial / Q000032:analysis* / Q000235:genetics*; D005260:Female; D006069:Gonorrhea / Q000188:drug therapy* / Q000382:microbiology*; D006801:Humans; D008297:Male; D009344:Neisseria gonorrhoeae / Q000235:genetics* / Q000302:isolation & purification; D021141:Nucleic Acid Amplification Techniques; D011446:Prospective Studies; D012329:RNA, Bacterial / Q000032:analysis / Q000235:genetics; D014556:Urine / Q000382:microbiology; D014621:Vagina / Q000382:microbiology; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D004269:DNA, Bacterial; D012329:RNA, Bacterial
keywords: Aptima; Cobas 4800; Neisseria gonorrhoeae; nucleic acid amplification test; test of cure