Improved Safety of Nucleic Acid Amplification Technology Combined With Serological Tests for Screening Blood Donors: A Systematic Review and Meta‐Analysis

TL;DR

Combining nucleic acid amplification tests with serological tests improves blood donor screening safety for Hepatitis C, HIV, and Hepatitis B.

Contribution

Demonstrates the added safety of combining NAT with serological tests for blood donor screening through a systematic review and meta-analysis.

Findings

HBV infection was most common among donors with positive NAT results.

Positive NAT results after negative serology showed significant pooled frequencies for HBV and HCV but not for HIV.

Molecular testing significantly improves detection of bloodborne infections during the diagnostic window period.

Abstract

No laboratory test performed to date provides an absolute guarantee for detecting infectious agents. Nucleic acid amplification techniques/tests (NAT) associated with serological tests can increase safety and provide greater diagnostic accuracy for patients. We investigated the added safety of NAT technology combined with serological tests for screening blood donors for Hepatitis C virus (HCV), human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Data were obtained from a systematic search conducted up until march 30, 2024 in five electronic databases: PubMed, Web of Science, Scopus, Embase, and the Cochrane library. Twenty‐nine studies, published between 1998 and 2023, were included in the review. Notably, HBV infection was predominant among donors with positive NAT results, with 425 cases, including 373 with positive serology and 52 with negative serology. Data from the diagnostic window period (WP) indicated the highest number of HBV infection cases, with 154 reported. Of the 29 included studies, 10 reported cases of occult HBV infection and diagnostic WP infection. Thirteen studies identified donors during the occult HBV infection period, and 17 identified WP cases. Meta‐analyses of positive NAT results following negative serological screening for HBV, HCV, and HIV revealed a significantly pooled frequency (p < 0.001). Positive NAT results retrieved from donors with negative serological HBV and HCV showed a significantly combined frequency (p < 0.001), while for HIV occurs the opposite (p = 0.085). For HBV, HBC and HIV serological tests and NAT‐positive results, the pooled frequency was significantly (p < 0.001). The findings demonstrate the positive relationship and safety of molecular technology in screening blood donors for HBV, HCV, and HIV using serological tests. Molecular testing remains a valuable tool for detecting and elucidating bloodborne infections.

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