Will genome detection replace serology in blood screening for microbial agents?

Area of Science:

• Virology
• Public Health
• Blood Transfusion Safety

Background:

• The residual risk of transfusion-transmitted viral infections is minimal but zero risk is a public health goal.
• Genomic screening advances detection of Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), and Hepatitis B Virus (HBV).

Purpose of the Study:

• To evaluate the impact and necessity of genomic screening for transfusion-transmitted viruses.
• To assess the role of existing serological markers alongside new genomic assays.

Main Methods:

• Review of genomic screening strategies for HCV, HIV, and HBV in blood donations.
• Analysis of pooled versus individual donation testing, including multiplexing and automation needs.
• Comparison of genomic detection with serological markers (HBsAg, anti-HCV, anti-HIV, HIV-1 p24 antigen, anti-HTLV-I/II).

Main Results:

• Genomic screening effectively eliminates donations in the pre-seroconversion window period and detects viral variants.
• Pooled testing can yield false results; individual testing requires advanced technology and cost-effectiveness.
• Serological markers like HBsAg, anti-HCV, and anti-HIV are likely to remain essential due to persistent infectiousness in some recovered or serologically negative individuals.

Conclusions:

• Genomic screening is a significant improvement for blood safety, particularly for HCV, HIV, and HBV.
• Existing serological tests will likely complement genomic screening, especially for HBV and HCV.
• HIV-1 p24 antigen screening may become redundant with HIV RNA testing, while anti-HTLV-I/II remain superior to genomic methods for HTLV.