Alton

Researchers are evaluating investigational tests designed to detect a specific gene mutation, called gyrA 91F, that predicts resistance to the antibiotic ciprofloxacin in Neisseria gonorrhoeae infections. The study focuses on clinical specimens that have tested positive for N. gonorrhoeae using FDA-cleared molecular assays. It aims to compare the accuracy of these investigational reflex tests with the standard genetic sequencing method (Sanger sequencing) for identifying the gene mutation. The study uses multiple investigational reflex tests, named Investigational Reflex Test 1, Test 2, and Test 3, to analyze urine, vaginal swab, and pharyngeal swab specimens collected during routine clinical care. Each specimen will be tested by Sanger sequencing and one of the investigational reflex tests. The target sample sizes for each test are 311 urine samples, 496 vaginal swab samples, and 469 pharyngeal swab samples. This cross-sectional, multi-center study evaluates the diagnostic accuracy of these tests in detecting the mutant allele associated with ciprofloxacin resistance. Participants provide specimens collected as part of their routine care that test positive for N. gonorrhoeae. The study compares the results of the investigational reflex tests to genetic sequencing results from the same specimens. The main outcomes measure how well each test identifies the gyrA 91F mutation in urine, vaginal, and pharyngeal samples within one day. Specimens must be properly handled and stored and linked to basic information like age and sex to be included. The study helps assess new diagnostic methods for detecting antibiotic resistance in gonorrhea infections.