インドにおける核酸増幅検査（NAT）の血液バンクにおける付加価値：15年間の後ろ向き研究

Background Viral transfusion-transmissible infections (TTIs), hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency virus (HIV) pose a major risk to blood safety in India, where most blood banks rely on serology alone for TTI screening. Our blood bank at Max Healthcare, New Delhi, India, has used nucleic acid testing (NAT) alongside serology for TTI screening since 2010. Objectives The aim of this study was to evaluate 15 years of real-world blood bank data to evaluate the impact of NAT alongside serology in improving TTI detection and transfusion safety. Methods This single-centre retrospective observational study analysed blood donor, serology, and NAT data from 211,555 donations between January 2010 and December 2024. All donations underwent chemiluminescence immunoassay (CLIA)-based serology for TTI detection. All seronegative samples were subject to NAT on the Cobas MPX polymerase chain reaction (PCR)-based minipool NAT (Roche, Basel, Switzerland). Seropositive donations and NAT-reactive donations were discarded. Results A total of 2,04,609 (96.72%) were replacement donations. A total of 3,333 (1.58%) donations were seropositive for viral TTIs, and most of these were from replacement donors (N=3,289; 98.68%). Seropositivity was highest for HBV (N=1,460; 43.78%), followed by HCV (N=1,213; 36.39%) and HIV (N=660; 19.8%). NAT detected 205 additional TTI cases missed by serology; most (N=164; 79.76%) were HBV NAT yields, followed by HCV (N=35; 16.83%) and HIV (N=7; 3.41%). There was one case of HBV-HCV co-infection. The overall NAT yield rate was 1:1005, and the HBV NAT yield rate was 1:1262. Conclusion NAT enhances blood safety by detecting infections missed by serology, supporting the need for mandatory nationwide implementation despite cost and infrastructure challenges.