KEMRI Hep-cell II hepatitis B surface antigen screening kit

Area of Science:

• Virology
• Immunology
• Medical Diagnostics

Background:

• Kenya faces a high burden of Hepatitis B Virus (HBV) infection.
• Ensuring blood transfusion safety is critical for preventing HBV transmission.
• High cost and limited availability of imported screening kits hinder widespread testing in Kenya.

Purpose of the Study:

• To develop a locally produced Hepatitis B surface antigen (HBsAg) screening kit.
• To enable comprehensive screening of donated and patient blood samples across Kenya.

Main Methods:

• Production of anti-Hepatitis B (anti-HBs) antibody in guinea pigs using purified HBsAg.
• Sensitization of sheep red blood cells (SRBC) with anti-HBs antibody.
• Lyophilization of the final product and comparison of its sensitivity and specificity with commercial kits.

Main Results:

• The KEMRI Hep-cell II kit demonstrated 98% sensitivity and 99% specificity.
• The kit exhibited stability and potency for one year at various temperatures (4°C, 37°C, and room temperature).

Conclusions:

• Successful local production of the KEMRI Hep-cell II HBsAg screening kit.
• The kit's performance is comparable to commercial alternatives.
• The diagnostic tool is stable, affordable, and suitable for use anywhere in Kenya due to its simple apparatus requirement.