India's First Handheld Multi-Parameter POCT

📄 Quotation Summary

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H. pylori Fast Test Kit
🏷️ Infectious Disease

H. pylori Fast Test Kit

✨ Intended Use

quantitative detection of H. pylori specific antigen in human stool specimen. It is a useful aid in the diagnosis of a number of gastrointestinal disorders. For professional and laboratory use only. About H. pylori infection in the gastrointestinal tract can be used as an auxiliary diagnosis for gastritis, gastric ulcer, and gastric cancer. Contents For Getein1100 Package specifications: 10 tests/box, 25 tests/box test card in a sealed pouch with desiccant 2) Sample diluent 3) User Manual:1 piece/box 4) SD card: 1 piece/box Note: Do not mix or interchange different batches of kits.

📊 Technical Specifications

Test ItemH. pylori
SampleStool specimen
Detection Range1.0 ng/mL~200.0 ng/mL
Storage Condition4-30℃
MethodAssay
Test Time10 min
Cut-off Value5.0 ng/mL
Shelf Life24 months

🔌 Applicable Device

DX 101 Analyzer

DX 101 Immunofluorescence Quantitative Analyzer

India's first portable, handheld multi-parameter POCT analyzer. Supports rapid quantitative diagnostics.

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🔬 Clinical Performance & Assets

Clinical Correlation

This assay demonstrates excellent correlation with industry-standard CLIA (Chemiluminescence Immunoassay) reference methods (R² ≥ 0.95), ensuring laboratory-grade precision at the point of care.

Available Documentation

📄
Instructions for Use (IFU)
Includes assay protocol, linearity, and cross-reactivity data
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📊
Clinical Validation Report
Detailed precision (CV%), specificity, and correlation graphs
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