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.
This is a prospective, multi-center, cross-sectional study using consecutive clinical specimens that are collected for routine clinical care and test positive for N. gonorrhoeae using an FDA-cleared molecular assay. The study evaluates the diagnostic accuracy of multiple investigational reflex tests to detect the mutant allele gyrA 91F that predicts ciprofloxacin resistance in N. gonorrhoeae, as compared to a reference standard of Sanger sequencing of the gyrA codon 91. Specimens will be tested via a reference standard of Sanger sequencing and one investigational reflex test. The target sample size is 311 urine specimens, 496 vaginal swab specimens, and 469 pharyngeal specimens, for each investigational reflex test.
Study Type
OBSERVATIONAL
Enrollment
3,291
Investigational Reflex Test 1
Investigational Reflex Test 2
Investigational Reflex Test 3
San Francisco Public Health Laboratory
San Francisco, California, United States
RECRUITINGIndiana University School of Medicine
Indianapolis, Indiana, United States
RECRUITINGMississippi State Department of Public Health
Jackson, Mississippi, United States
RECRUITINGCorewell Health
Royal Oak, Missouri, United States
RECRUITINGLabCorp
Durham, North Carolina, United States
RECRUITINGARUP Laboratories
Salt Lake City, Utah, United States
RECRUITINGUniversity of Virginia School of Medicine
Charlottesville, Virginia, United States
RECRUITINGMolecular Testing Labs
Vancouver, Washington, United States
RECRUITINGNumber of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in urine
Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Time frame: One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in vaginal swabs
Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Time frame: One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 1 relative to the sequenced results in pharyngeal swabs
Investigational Reflex Test 1 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Time frame: One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in urine
Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Time frame: One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in vaginal swabs
Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Time frame: One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 2 relative to the sequenced results in pharyngeal swabs
Investigational Reflex Test 2 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Time frame: One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in urine
Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Time frame: One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in vaginal swabs
Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Time frame: One day
Number of participants with gyrA 91F identified by Investigational Reflex Test 3 relative to the sequenced results in pharyngeal swabs
Investigational Reflex Test 3 results include gyrA 91F, gyrA 91S, invalid, and missing. Sanger Sequencing reference results include gyrA 91F, gyrA 91S, invalid, and missing.
Time frame: One day
Number of invalid results for Investigational Reflex Test 1 in urine
Time frame: One day
Number of invalid results for Investigational Reflex Test 1 in vaginal swabs
Time frame: One day
Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs
Time frame: One day
Number of invalid results for Investigational Reflex Test 2 in urine
Time frame: One day
Number of invalid results for Investigational Reflex Test 2 in vaginal swabs
Time frame: One day
Number of invalid results for Investigational Reflex Test 2 in pharyngeal swabs
Time frame: One day
Number of invalid results for Investigational Reflex Test 3 in urine
Time frame: One day
Number of invalid results for Investigational Reflex Test 3 in vaginal swabs
Time frame: One day
Number of invalid results for Investigational Reflex Test 3 in pharyngeal swabs
Time frame: One day
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