Reagent mixture for rapid detection of Helicobacter pylori bacteria, lyophilized preparation, kit containing this reagent mixture and procedure for in vitro detection of Helicobacter pylori bacteria.

Abstract

The invention proposes a reagent mixture for the rapid detection of Helicobacter pylori (H. pylori), a freeze-dried preparation containing this reagent mixture, a kit, and a procedure for the in vitro detection of H. pylori. The reagent mixture consists of urea, phenol red indicator, and a phosphate buffer system of potassium dihydrogen phosphate (KH₂PO4) and disodium hydrogen phosphate (Na2HPO4), formulated at an appropriate pH to detect the urease enzyme activity of H. pylori through a color change of the reagent. In one respect, the reagent mixture is mixed with a stabilizing additive and prepared in freeze-dried form to limit the self-degradation of the active components, increase the stability of the indicator system, and improve shelf life. The invention also proposes a kit including a freeze-dried reagent substrate, sterile water for reconstitution, and a sample transfer device for testing. The procedure for detecting H. pylori bacteria...The proposed in vitro H. pylori detection process involves steps such as reagent reconstitution, bringing the biological sample into contact with the reagent, and observing color changes to determine the presence of H. pylori bacteria. The solution under this invention allows for rapid detection of H. pylori urease activity, enhances reagent stability, and overcomes the drawbacks of traditional liquid or gel reagents, such as urea self-hydrolysis and discoloration during storage. Thanks to freeze-drying technology, the product can be stored and transported at room temperature for at least four months without requiring strict cold chain maintenance, contributing to reduced transportation costs and suitability for hot and humid tropical climates. The detection process offers high sensitivity and specificity, allowing for the identification of even weakly positive samples, thus improving the reliability of test results.Reagent mixtures and kits can be produced using materials and technologies suitable for domestic conditions, reducing dependence on imported products and increasing self-reliance in the supply of testing materials. The application of these kits for rapid detection of H. pylori from culture or gastric biopsy samples contributes to early diagnosis and effective treatment of diseases related to H. pylori infection.