Evaluation of the ResistancePlus GC (beta) assay: a commercial diagnostic test for the direct detection of ciprofloxacin susceptibility or resistance in Neisseria gonorrhoeae
Year: 2019
Type: article
Abstract: OBJECTIVES: To evaluate the performance of the ResistancePlus GC (beta) assay for the simultaneous detection of Neisseria gonorrhoeae and gyrA S91 markers of resistance (S91F) and susceptibility (WT) to ciprofloxacin, from both clinical specimens and isolates. METHODS: Performance was assessed on several sample banks, including N. gonorrhoeae isolates (n = 822), non-gonococcal isolates (n = 110), N. gonorrhoeae-positive clinical specimens (n = 402) and N. gonorrhoeae-negative specimens (n = 290). Results were compared with previous testing data, including S91 genotyping and phenotypic resistance profiles. RESULTS: Overall, the assay demonstrated 100% sensitivity for N. gonorrhoeae detection in clinical isolates. For gyrA S91 mutation detection in clinical isolates, the assay showed 100% sensitivity/specificity compared with the genotype, and >99%/>97% sensitivity/specificity when compared with phenotype. For positive clinical specimens, the assay demonstrated >96% sensitivity for N. gonorrhoeae detection and 100% sensitivity/specificity for gyrA S91 mutation detection. The assay demonstrated >99% specificity for N. gonorrhoeae detection against non-gonococcal isolates and 100% specificity for negative clinical specimens. CONCLUSIONS: The ResistancePlus GC (beta) assay is suitable for the detection of N. gonorrhoeae and gyrA markers associated with resistance/susceptibility to ciprofloxacin directly in clinical samples. This assay could be implemented for the individualized treatment of gonorrhoea infections as well as to enhance current antimicrobial resistance surveillance methods.
DOI: 10.1093/jac/dkz108
Authors: Samantha Ebeyan, Madeline Windsor, Amanda Bordin, Lebogang Mhango, Simon Erskine, Ella Trembizki, Elisa Mokany, Lit Yeen Tan, David Whiley, GRAND2 Study Investigators, Rebecca Guy, Handan Wand, Basil Donovan, Stephen Bell, John Kaldor, Marlene Kong, Damian Conway, Lise Lafferty, James Ward, Monica Lahra, Marcus Chen, Nathan Ryder, David Lewis, David Paterson, Ella Trembizki, Robert Baird, Christopher Fairley, Manoji Gunathilake, Ben Howden, Jeff Klausner, Graeme Nimmo, Darren Russell, Arun Menon, Cheryn Palmer, Anna McNulty, David Templeton, Philip Cunningham, Sebastian van Hal, Rodney Givney
Institution: The University of Queensland
Language: English
Subfield: Microbiology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: green
Award: G7509887860
OpenAlex ID: W2922981891