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Combining nucleic acid testing with serology enhances blood donor screening by detecting early and previously undetected viral infections more effectively.
Safe blood transfusion remains a major clinical priority, as no single test can eliminate infectious risk. Serological screening may fail to detect infections during early or asymptomatic stages, particularly for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). To address this limitation, researchers aimed to evaluate whether integrating nucleic acid amplification techniques/tests (NAT) with routine serology improves detection rates and enhances blood donor screening safety.
This systematic review and meta-analysis were performed using data from PubMed, Web of Science, Scopus, Embase, and the Cochrane Library. A total of 29 studies were included. The analysis focused on identifying HBV, HCV, and HIV infections using combined NAT and serological testing. Pooled estimates were calculated to evaluate NAT-positive cases, particularly among seronegative donors, including those in the window period (WP) and with occult infections.
The diagnostic WP—a critical phase when infections may evade detection by standard serology—illustrated the highest burden for HBV, with 154 cases identified. Across the included studies:
Meta-analysis revealed a significant pooled frequency (p < 0.001) of NAT-positive results among donors who initially tested negative on serological screening for HBV, HCV, and HIV. When analyzed separately:
Additionally, pooled frequencies of NAT-positive results among serology-positive cases for HBV, HCV, and HIV were also significant (p < 0.001). Thus, NAT reduces the likelihood of transfusion-transmitted infections by identifying cases during early infection and occult phases—particularly for HBV. This dual-testing strategy strengthens blood safety protocols and enhances early detection, which is critical for preventing disease transmission.
Reviews in Medical Virology
Improved Safety of Nucleic Acid Amplification Technology Combined With Serological Tests for Screening Blood Donors: A Systematic Review and Meta-Analysis
Heloise Skiavine Madeira et al.
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