Factors that influence confirmation of Neisseria gonorrhoeae positivity by molecular methods

Kate Cuschieri, Jill Shepherd, Catriona Graham, Daniel Guerendiain, Kate E Templeton

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

Several Neisseria gonorrhoeae (NG) nucleic acid amplification tests (NAATs) exist with high sensitivity. However, specificity of NG NAAT testing may be suboptimal, particularly in extra-genital biospecimens. Consequently, confirmation with a second NAAT is common, although represents a burden on resources. Furthermore, the rationale for confirmation is contentious.The objective of this work was to assess NG confirmation in over 13,000 NG screen-positive samples representing various biospecimens and three separate screening assays: the Abbott Real Abbott RealTime CT/NG (Abbott Molecular Inc., Des Plaines, IL), the Cobas CT/NG test (Roche Diagnostics, Indianapolis, IN) and the BD ProbeTec ET CT/GC Amplified DNA assay (Becton Dickinson and Company, Sparks, MD). Factors predictive of confirmation were determined via logistic regression involving: sex, year, whether the samples was formally validated and sample site.Level of confirmation varied according to screening assay (96.2%, 86.0% and 73.9%) for the Abbott, Roche and BD test respectively in sample types formally included according to manufacturers instructions (i.e.-validated). Sex did not affect confirmation for 2/3 assays and the likelihood of confirmation of samples not formally included in manufacturer instructions (ie non validated) was 89.1%, 82.1% and 59.2% for the Abbott Roche and BD test respectively. Rectal swabs, which are non validated samples, confirmed in 91.5%, 90.1% and 87.4% of samples initially tested with the respective assaysThe requirement to confirm NG in validated samples is not required for all NAATs although initial, assay-specific evaluation is justified given observed variability. Rectal samples represent robust biospecimens for NG NAAT testing and do not require confirmation when screened with the assays described.

Original languageEnglish
JournalJournal of Clinical Microbiology
Early online date24 May 2019
Publication statusE-pub ahead of print - 24 May 2019


Dive into the research topics of 'Factors that influence confirmation of Neisseria gonorrhoeae positivity by molecular methods'. Together they form a unique fingerprint.

Cite this