The goal of this study is to learn if a few investigational tests can correctly find the gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae. The main question the study aims to answer:
Can the investigational reflex test find the correct gene mutation (Neisseria gonorrhoeae gyrA 91F or gyrA 91S) as compared to the sequenced result?
Specimens that are collected for routine clinical care and harbor Neisseria gonorrhoeae will be evaluated in this study.
Be N. gonorrhoeae-positive on an FDA-cleared molecular assay
Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing
Undergo proper handling and storage conditions
The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site
The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source
Duke University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
SpeeDx Pty Ltd
Collaborator
Abbott
Collaborator
Seegene USA Inc
Collaborator