RESZON HBsAg Rapid Test
MDA Registered Reszon Diagnostics

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 ClassIVD Medical Device (MDA)

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

  1. No special preparation needed; eat and drink normally.
  2. Collect a finger-prick or venous blood sample.
  3. Apply the sample and buffer to the device per the IFU.
  4. Read the result at 15–20 minutes.

Specifications

<table> <tr><td>Target</td><td>Hepatitis B surface antigen (HBsAg)</td></tr> <tr><td>Specimen</td><td>Whole blood / plasma / serum</td></tr> <tr><td>Sensitivity</td><td>99.3%</td></tr> <tr><td>Specificity</td><td>99.8%</td></tr> <tr><td>Result time</td><td>15–20 minutes</td></tr> <tr><td>Method</td><td>Immunochromatography</td></tr> </table>

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