Published Paper Details:

Background: Blood transfusion is a vital therapy in modern health care, but the risk of transfusion-transmitted infections (TTIs) is still a huge challenge despite substantial improvements in donor screening. Conventional serological assays can be negative in early infections, and human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and other emerging pathogens continue to pose a threat to blood safety during the diagnostic window period. Therefore, the use of highly sensitive diagnostic technologies for better transfusion safety has become an objective of global importance. Objective: This review aims at critically discussing the principles, diagnostic performance, advantages and disadvantages, application and implementation of enzyme-linked immunosorbent assay (ELISA) and nucleic acid testing (NAT) in blood donor screening with a focus on the advantages, limitations, and clinical applications of these tests. Key findings: ELISA is the main method of routine blood donor screening due to its high specificity, low cost, scalability, and compatibility with automated laboratory systems. However, NAT allows for a direct detection of viral DNA or RNA, thus significantly shortening the window period for HIV, HBV and HCV and minimizing the potential of transmission of viral infections. Based on comparative analysis, both NAT and ELISA have their distinct merits and drawbacks, with NAT being more sensitive in terms of being able to detect pathogens earlier and perform analysis, and ELISA being more cost-effective and accessible, particularly in low-resource areas. These assays are recommended for simultaneous use, as this combination seems to be most effective for increasing blood safety (currently there is evidence supporting that). Implementation challenges in LMICs are also discussed and some emerging technologies such as artificial intelligence, CRISPR diagnostics, microfluidic platforms, next-generation sequencing and digital blood management systems are highlighted. Conclusion: A combined molecular and serological screening will increase transfusion safety, early detection of pathogens, and public trust in blood transfusion services. Advances in multiplex molecular diagnostics, automation, digital health technologies and global standardization of blood screening practices will continue to shatter the infection transmission risk associated with transfusion and enhance equitable access to safe blood supplies across the world, in the years ahead.