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

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

Author information

1
STI Outpatient Clinic, Department of Infectious Diseases, Public Health Service Amsterdam.
2
Department of Dermatology, Academic Medical Center, University of Amsterdam.
3
Department of Infectious Diseases, Public Health Service Amsterdam.
4
Center for Infection and Immunity Amsterdam, Academic Medical Center, University of Amsterdam, The Netherlands.
5
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.
6
Department of Medical Microbiology, University Medical Centre Utrecht.
7
Public Health Laboratory, Public Health Service Amsterdam.
8
Department of Medical Microbiology, Onze Lieve Vrouwe Gasthuis General Hospital, Amsterdam, The Netherlands.

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

PMID:
26962074
DOI:
10.1093/cid/ciw141
[Indexed for MEDLINE]

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