Utilization of the Sysmex UF-5000 as a Novel Non-Invasive Diagnostic Assay to Diagnose Acute Urethritis Using First-Catch Urine in Men
Stephen Jordan
Primary Investigator
Brief description of study
What is the purpose of this study?
Acute urethritis (i.e., inflammation of the male urethra) affects millions of men within the United States annually. STI management has proven challenging due to the prevalence of asymptomatic infections and because men often fail to seek STI care until they experience pronounced symptoms. However, even without urethral symptoms, most men with a urethral STI have measurable evidence of urethritis. Thus, a cheap, simple, and non-invasive point of care (POC) test (i.e., results available within 30 minutes) that accurately detects urethritis could be a game changer in STI management as asymptomatic infections could be detected and treated, potentially decreasing the risk of spreading STIs to sexual partners.
Detailed description of study
Study Procedures
For Aim 1, we will identify 100 symptomatic males and 100 asymptomatic males who presented to BFC for evaluation.
- Once informed consent is signed, we will abstract clinical and demographic data from the Electronic Medical Record (EMR) and, in asymptomatic men, obtain a urethral Gram stain smear.
- Symptomatic men provide a urethral Gram stain, per BFC protocols.
- We will also record the results of stat BFC testing, including HIV and syphilis, and the urethral Gram stain.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acute urethritis
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Age: 18 years - 100 years
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Gender: Male
Inclusion Criteria
• Men aged 18 and older
• Reason for visiting Bell Flower Clinic is either (1) symptom evaluation or (2) asymptomatic screening and are being tested for GC/CT by urine NAAT
Exclusion Criteria
• Refused to provide a urine specimen or urethral swab for Gram stain.
• Transgender persons
• Recent antibiotic use (<30 days prior to enrollment)
• Non-English speaker, altered mental status, or suspected intoxication/drug use or psychiatric disorder.
• Prior urethral surgery, excluding circumcision
