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Analysis of sample‐to‐cutoff ratios on chemiluminescent immunoassays used for blood donor screening highlights the need for serologic confirmatory testing

BACKGROUND: High sample‐to‐cutoff (s/co) ratios on hepatitis C virus antibody (anti‐HCV) screening immunoassays (IAs) are indicative of confirmed‐positive results and, according to some reports, can be used to determine anti‐HCV status without the need for confirmatory testing. The purpose of this study was to determine whether s/co ratios on hepatitis B surface antigen (HBsAg), antibody to human immunodeficiency virus Types 1 and 2 (anti‐HIV‐1/2), anti‐HCV, and antibody to human T‐lymphotropic virus Types I and II (anti‐HTLV‐I/II) chemiluminescent immunoassays (ChLIAs) can be used to discriminate between biologic false‐reactive (BFR) and confirmed‐positive results.