T/CITS 485-2025 Active Group standards

T/CITS 485-2025 Helicobacter pylori detection test strip

Publish Date: 2025-07-01 Implement Date: 2025-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CITS 485-2025

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Laboratory medicine

Publish Date: 2025-07-01

Implement Date: 2025-07-01

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.