How does a UTI test work?

A UTI test uses a urine dipstick with reagent pads to detect chemical changes in urine, comparing them to a reference chart. It checks for Leukocytes and Nitrite in urine. These two parameters are clinically relevant indicators to diagnose a UTI.

What is the clinical significance of leukocytes and nitrite in urine?

Leukocytes: The detection of the white blood cells in urine suggests inflammation and/or active immune response, which may be a sign of UTI.

Nitrite: Screening for possible asymptomatic infections caused by nitrate-reducing bacteria.

What factors can cause false readings on urine test strips?

False readings on urine test strips can result from various factors, including old urine, certain medications, improper usage, non-sterile containers, and substances affecting urine color. Refer to the package insert for more details.

Why is the individual wrapping of the test important?

Individual wrapping of the Urinox test strips maintains freshness, ensures test reliability, and extends shelf life to 24 months, reducing waste and enhancing portability and storage.

Is this test FDA-cleared and what does it mean to have FDA clearance?

Yes, the Urinox-UTI test is FDA-OTC cleared. FDA clearance signifies rigorous testing and evaluation, ensuring clinical accuracy and safe at-home use. It's a meticulous process involving thorough data review by investigators for FDA 510(k) clearance.