Test of Cure for Anogenital Gonorrhoea Using Modern RNA-Based and DNA-Based Nucleic Acid Amplification Tests: A Prospective Cohort Study

Clin Infect Dis. 2016 Jun 1;62(11):1348-1355. doi: 10.1093/cid/ciw141. Epub 2016 Mar 8.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Aptima; Cobas 4800; Neisseria gonorrhoeae; nucleic acid amplification test; test of cure.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anal Canal / microbiology
  • Anti-Bacterial Agents / therapeutic use
  • Bacterial Load / genetics
  • DNA, Bacterial / analysis*
  • DNA, Bacterial / genetics*
  • Female
  • Gonorrhea / drug therapy*
  • Gonorrhea / microbiology*
  • Humans
  • Male
  • Neisseria gonorrhoeae / genetics*
  • Neisseria gonorrhoeae / isolation & purification
  • Nucleic Acid Amplification Techniques
  • Prospective Studies
  • RNA, Bacterial / analysis
  • RNA, Bacterial / genetics
  • Urine / microbiology
  • Vagina / microbiology
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • DNA, Bacterial
  • RNA, Bacterial