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
Clinical specimens from male and females that test positive for Neisseria gonorrhoeae
Other
Prospective
Investigational Reflex Test 1
Diagnostic testInvestigational Reflex Test 1
Investigational Reflex Test 2
Diagnostic testInvestigational Reflex Test 2
Investigational Reflex Test 3
Diagnostic testInvestigational Reflex Test 3
Number 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.
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.
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.
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.
Number of invalid results for Investigational Reflex Test 1 in urine
Number of invalid results for Investigational Reflex Test 1 in vaginal swabs
Number of invalid results for Investigational Reflex Test 1 in pharyngeal swabs
Number of invalid results for Investigational Reflex Test 2 in urine
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Duke University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
SpeeDx Pty Ltd
Collaborator
Abbott
Collaborator
Seegene USA Inc
Collaborator
