Rapid immunochromatographic test for Hepatitis B surface antigen (HBsAg) in whole blood, plasma or serum. Sensitivity 99.3%, specificity 99.8%; result in 15–20 min.
MDA Reg. No. IVDD4340025-214346
| Regulatory Class | IVD Medical Device (MDA) |
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Product Overview
The RESZON® HBsAg Rapid Test qualitatively detects Hepatitis B surface antigen (HBsAg) in human whole blood, plasma or serum, helping identify current HBV infection. Result in 15–20 minutes; ideal for clinical and community screening programmes.
Unique Selling Points
- High accuracy — sensitivity 99.3%, specificity 99.8%
- Result in 15–20 minutes
- Only a finger-prick or small blood draw required
- Supports community hepatitis-screening programmes
- Part of Reszon's complete Hepatitis B & C range
Directions for Use
- No special preparation needed; eat and drink normally.
- Collect a finger-prick or venous blood sample.
- Apply the sample and buffer to the device per the IFU.
- Read the result at 15–20 minutes.
Specifications
| Target | Hepatitis B surface antigen (HBsAg) |
| Specimen | Whole blood / plasma / serum |
| Sensitivity | 99.3% |
| Specificity | 99.8% |
| Result time | 15–20 minutes |
| Method | Immunochromatography |
