🏷️ Infectious Disease
HBsAg Fast Test Kit
✨ Intended Use
quantitative determination of hepatitis B surface antigen (HBsAg) in human serum and plasma samples. The test is used clinically as suitable for blood supply screening and clinical diagnosis of hepatitis B virus infection. For professional and laboratory use only.
📊 Technical Specifications
| Test Item | HBsAg |
| Sample | Serum/Plasma |
| Detection Range | 1~100 IU/mL |
| Storage Condition | 4-30℃ |
| Method | Assay |
| Test Time | 15 min |
| Cut-off Value | <1.00 IU/mL |
| Shelf Life | 24 months |
🔌 Applicable Device
DX 101 Immunofluorescence Quantitative Analyzer
India's first portable, handheld multi-parameter POCT analyzer. Supports rapid quantitative diagnostics.
View Device Details →🔬 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
📄
Request PDF
Instructions for Use (IFU)
Includes assay protocol, linearity, and cross-reactivity data
📊
Request Data
Clinical Validation Report
Detailed precision (CV%), specificity, and correlation graphs
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