T/CITS 485-2025 Helicobacter pylori detection test strip
T/CITS 485-2025 Helicobacter pylori detection test strip
Basic Information
Scope
Scope: This document specifies the technical requirements, test methods, inspection rules, labels and user manuals, packaging, transportation, and storage for Helicobacter pylori detection test strips. This document applies to the quality control of test strips that use immunoassay as the principle to qualitatively detect Helicobacter pylori antigens in human feces, as well as test strips that use dry chemistry as the principle to qualitatively detect Helicobacter pylori urease in human dental plaque. Main technical content: This document specifies the technical requirements, test methods, inspection rules, labels and user manuals, packaging, transportation, and storage for Helicobacter pylori detection test strips. This document applies to the quality control of test strips that use immunoassay as the principle to qualitatively detect Helicobacter pylori antigens in human feces, as well as test strips that use dry chemistry as the principle to qualitatively detect Helicobacter pylori urease in human dental plaque.