Comparative Analysis of NAT, TRFIA, and ELISA for Screening Blood-Borne Pathogens in Preoperative and Pre-Transfusion...

This retrospective single-center study compared nucleic acid testing (NAT), time-resolved fluorescence immunoassay (TRFIA), and enzyme-linked immunosorbent assay (ELISA) for screening hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and Treponema pallidum (TP) among 1243 preoperative and pre-transfusion patients. Specimens were detected by pathogen-targeted NAT, serological TRFIA and routine ELISA panels, respectively. HBV positive rates were 2.17% (NAT), 2.09% (TRFIA) and 1.53% (ELISA); HCV positive rates were 0.08%, 0.24% and 0.08%, without statistical intergroup differences (all p > 0.05). TRFIA yielded a significantly higher TP positive rate than ELISA (0.88% versus 0.40%, p < 0.05), while no HIV-positive specimens were identified in this cohort. Kappa tests showed moderate-to-good consistency for HBV (0.711-0.842) and perfect concordance between NAT and ELISA for HCV (Kappa = 1.000). Twenty-three discordant samples were found, including eight NAT-only HBV positives suggestive of potential window-period infections and six TRFIA-only TP positives. Limited by an obstetric-female-dominated cohort, scarce HCV cases, and zero HIV positives, standard diagnostic accuracy metrics could not be comprehensively evaluated. NAT and TRFIA exhibit complementary screening values, yet their combined application may increase false-positive risks and lacks systematic cost-effectiveness evidence to support large-scale clinical implementation.