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Test of cure for anogenital gonorrhoea using modern RNA-based and DNA-based nucleic acid amplification tests: a prospective cohort study
STI Outpatient Clinic, Department of Infectious Diseases Public Health Service Amsterdam, Amsterdam, The Netherlands; Department of Dermatology Academic Medical Center, University of Amsterdam, The Netherlands.
Department of Infectious Diseases Public Health Service Amsterdam, Amsterdam, The Netherlands; 4Center for Infection and Immunity Amsterdam, Academic Medical Center, University of Amsterdam, The Netherlands; 4Center for Infection and Immunity Amsterdam, Academic Medical Center, University of Amsterdam, The Netherlands.
Örebro University, School of Health Sciences. WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for Pathogenic Neisseria, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health.
Department of Medical Microbiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
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2016 (English)In: Clinical Infectious Diseases, ISSN 1058-4838, E-ISSN 1537-6591, Vol. 62, no 11, 1348-1355 p.Article in journal (Refereed) Published
Abstract [en]

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 STI 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 analysed using an RNA-based NAAT (Aptima Combo 2) and a DNA-based NAAT (Cobas 4800). Clearance was defined as three consecutive negative results, and blips as isolated positive results following clearance.

Results: We included 77 patients; five self-cleared gonorrhoea before treatment and ten were lost to follow-up. Clearance rate of the remaining 62 patients was 100%. Median time to clearance was two 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 1.4%, respectively. One patient had a reinfection.

Conclusions: If indicated, we recommend to perform a TOC 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.

Place, publisher, year, edition, pages
Cary, United Kingdom: Oxford University Press, 2016. Vol. 62, no 11, 1348-1355 p.
Keyword [en]
Neisseria gonorrhoeae, nucleic acid amplification test, Aptima, Cobas 4800, test of cure
National Category
Infectious Medicine Immunology in the medical area
Research subject
Infectious Diseases; Immunology
Identifiers
URN: urn:nbn:se:oru:diva-49334DOI: 10.1093/cid/ciw141ISI: 000378433400009PubMedID: 26962074Scopus ID: 2-s2.0-84971577910OAI: oai:DiVA.org:oru-49334DiVA: diva2:912700
Note

Funding Agency:

Public Health Service Amsterdam

Available from: 2016-03-17 Created: 2016-03-15 Last updated: 2017-10-17Bibliographically approved

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CiteExportLink to record
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