Stability of a Urea Solution for the Diagnosis of Helicobacter pylori

Abstract

Introduction: The rapid urease test is the method of choice for the initial diagnosis of Helicobacter pylori, as it qualitatively detects urease activity in gastric mucosal biopsies, providing rapid and specific results in clinical gastroenterology.

Objective: To evaluate the physicochemical and biological stability of a urea solution formulated for the diagnosis of Helicobacter pylori.

Methods: A stability study was conducted in accordance with the standards of the National Center for the Control of Medicines, Equipment, and Medical Devices. Key physicochemical and microbiological properties were monitored. Stability was evaluated in real time (use, transport, and shelf life) and under accelerated thermal stress. Samples were analyzed at 1, 2, 3, 6, 9, and 12 months, applying statistical validation protocols.

Results: Real-time monitoring confirmed the absence of changes in organoleptic properties, sterility, and volume. No precipitation, discoloration, or microbial contamination was observed. The pH remained stable within the expected range (7.0±2) and the substrate concentration remained within permissible limits (6.4 mmol/L). Accelerated testing projected a shelf life of 242 days at 4°C and 2.07 years at -20°C, thereby meeting international diagnostic standards.

Conclusions: The developed urea solution demonstrates robust long-term stability. Its validated performance in storage, transport, and clinical use ensures sustained diagnostic reliability, supporting its routine laboratory application without compromising analytical accuracy or patient safety.