Test of cure for anogenital gonorrhoea using modern RNA-based and DNA-based nucleic acid amplification tests : a prospective cohort study

• 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.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Infektionsmedicin (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Infectious Medicine (hsv//eng)

MEDICIN OCH HÄLSOVETENSKAP  -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)

MEDICAL AND HEALTH SCIENCES  -- Basic Medicine -- Immunology in the medical area (hsv//eng)

Keyword

Neisseria gonorrhoeae

nucleic acid amplification test

Aptima

Cobas 4800

test of cure

Infektionssjukdomar

Infectious Diseases

Immunologi

Immunology

Publication and Content Type

ref (subject category)

art (subject category)