Blood screening by nucleic acid amplification technology: current issues, future challenges

Area of Science:

• Transfusion Medicine
• Virology
• Public Health

Background:

• Current antibody-based assays for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) may miss infections before seroconversion.
• Nucleic acid amplification technology (NAT) is being evaluated for blood donor screening to detect viral RNA.
• The risk of transfusion-transmitted HIV and HCV, though low, necessitates improved detection methods.

Purpose of the Study:

• To evaluate the safety and efficacy of mini-pool NAT testing for HIV and HCV RNA in US blood donors.
• To compare the performance of NAT with existing enzyme immunoassay technologies.
• To discuss the benefits of NAT in reducing transfusion-transmitted infections.

Main Methods:

• Description of amplification technologies employed in NAT-based blood screening.
• Review of key issues and considerations surrounding NAT implementation.
• Comparative analysis of NAT and enzyme immunoassay performance characteristics.

Main Results:

• US clinical trials successfully identified infectious blood units using mini-pool NAT testing prior to seroconversion.
• NAT screening systems, though semiautomated, represent a significant innovation in the regulated blood industry.
• NAT demonstrates superior sensitivity in detecting preseroconversion infectious units compared to antibody assays.

Conclusions:

• Mini-pool NAT testing for HIV and HCV RNA is effective in identifying infectious blood donations.
• NAT-based screening is poised to become a standard in transfusion medicine due to its enhanced safety profile.
• Despite cost considerations, public perception favors NAT screening for a safer blood supply.