False‐negative testing errors in routine viral marker screening of blood donors

Abstract

False-negative testing results occur infrequently during routine infectious-disease donor screening. Although most false-negative results occurred with borderline-reactive HTLV-II samples and/or early-generation HCV EIAs, frank technical errors (e.g., sample mixup or failure to add sample to EIA well) also occur at a low rate (0.05%; 95% CI, 0-1.5%). Process enhancements designed to reduce errors (e.g., enhanced automation of data management and testing systems and process controls for EIAs) are warranted to detect and prevent false-negative results.