Establishing Baseline Sysmex UF-5000 Flow Cytometer Results in Healthy Men

Study Summary

Acute urethritis (inflammation of the male urethra) affects millions of men in the United States each year. Effective management of STIs is complicated by asymptomatic infections, as men often delay seeking care until symptoms become severe. Yet, even men without symptoms can show measurable evidence of urethritis. Therefore, a cheap, simple, and non-invasive point-of-care (POC) test, providing results within 30 minutes, could significantly enhance STI management by facilitating early diagnosis and treatment. A new diagnostic method, urine flow cytometry, has shown potential in hospital settings for accurately detecting inflammation by counting white blood cells (infection-fighting cells) in urine samples. The Sysmex UF-5000 flow cytometer, a state-of-the-art device, may offer a non-invasive, cost-effective, and accurate method to diagnose urethritis compared to traditional Gram stains and urinalysis, potentially extending its use beyond specialized clinics. This study aims to determine the efficacy and precision of the Sysmex UF-5000 analyzer in diagnosing urethritis using first-catch urine samples. Additionally, the study seeks to evaluate whether urine collected using the 10 mL Colli-Pee device provides greater accuracy and precision compared to the standard urine cup (30-60 mL) when used with urine flow cytometry and LE urinalysis.

Primary Outcome

Urinary white blood cell (WBC) counts (cells/µL) will be measured using a Sysmex UF-5000 urine flow cytometer. Each participant will provide urine samples on three separate days during each of two weeks, with samples collected using both a standard urine cup and a Colli-Pee device. WBC counts will be summarized using the median (and interquartile range) and compared between collection methods.

Interventions

• DIAGNOSTIC_TEST Urinalysis
• DEVICE Colli-Pee
• DEVICE standard of care 60 mL urine cup
• DIAGNOSTIC_TEST Sysmex UP-5000