ORIGINAL ARTICLE Laboratory evaluation of rapid test kits to detect hepatitis C antibody for use in predonation screening in emergency settings Robert J. O’Connell, Robert G. Gates, Christian T. Bautista, Michelle Imbach, John C. Eggleston, Stephen G. Beardsley, Mark M. Manak, Richard Gonzales, Francisco J. Rentas, Victor W. Macdonald, Lisa J. Cardo, David T. Reiber, Susan L. Stramer, Nelson L. Michael, and Sheila A. Peel BACKGROUND: Emergency whole blood transfusion is a lifesaving procedure employed on modern battlefields. Rapid device tests (RDTs) are frequently used to miti- gate transfusion-transmitted infection risks. STUDY DESIGN AND METHODS: A limited evaluation of the RDT formerly used on battlefields was performed using 50 donor plasma samples and commercially available panels. Five hepatitis C virus (HCV) RDTs with sufficient stated sensitivity and thermostability were assessed using 335 HCV-positive and 339 HCV- negative donor plasma samples, 54 seroconversion panel plasma samples, and 84 HCV-positive and 84 HCV-negative spiked whole blood under normal, hot, and cold storage conditions and normal and hot test conditions, plus an ease-of-use survey. RESULTS: BioRapid HCV test sensitivity on donor plasma was 84% (95% confidence interval [CI], 70.9%- 92.8%). Using all positive plasma samples, OraQuick HCV sensitivity exceeded all comparators (99.4%, 95% CI, 98.0%-99.9%, p < 0.05). Specificity was consis- tently high, led by OraQuick HCV at 99.7% (95% CI, 98.6%-100%), statistically superior only to Axiom HCV (p < 0.05). Using seroconversion panels, only OraQuick HCV showed equivalent or earlier HCV detection com- pared to the gold standard. Using spiked whole blood, specificity was consistently high, and sensitivity ranged significantly from 34.5% (95% CI, 25.0%-45.1%) for CORE HCV to 98.8% (95% CI, 94.3%-99.9%) for OraQuick HCV. All comparator RDTs were significantly less sensitive than OraQuick HCV at one or more stress condition. CONCLUSION: This HCV RDT comparison identified significant sensitivity differences, particularly using whole blood under extreme storage and testing condi- tions. These data support OraQuick HCV superiority and illustrate the value of RDT evaluation under simu- lated field conditions. T ransfusion therapy is widely used for various indications in well-resourced developed set- tings, where safety is maximized through intensive and multifaceted research, regulation, and quality assurance vigilance. 1 In the United States, due to rigorous US Food and Drug Administration (FDA)-mandated and -regulated donor screening and testing programs, the risk of viral transfusion-transmitted infections (TTIs) due to hepatitis C virus (HCV), hepa- titis B virus, and human immunodeficiency virus (HIV) ABBREVIATIONS: LR(s) = likelihood ratio(s); RDT(s) = rapid device test(s); S/CO = signal to cutoff; TTI(s) = transfusion- transmitted infection(s). From the Walter Reed Army Institute of Research, Silver Spring, Maryland; the US Military HIV Research Program, Fort Gordon, Georgia; the US Army Blood Program, Falls Church, Virginia; the US Army Medical Department Center and School, Fort Sam Houston, San Antonio, Texas; the US Armed Services Blood Program, Falls Church, Virginia; the Department of Blood Research, Robertson Blood Center, Fort Hood, Texas; and the American Red Cross, Gaithersburg, Maryland. Address correspondence to: Robert J. O’Connell, MD, FACP, Walter Reed Army Institute of Research, Military HIV Research Program, 6720-A Rockledge Drive, Suite 400, Bethesda, MD 20817; e-mail: roconnell@hivresearch.org. The views expressed herein are those of the authors and do not necessarily reflect those of the Department of Defense or the Department of the Army. Trade names are used for identifi- cation purposes only and do not imply endorsement. This work was supported in part by funding from the US Army Blood Program and by Cooperative Agreement W81XWH- 07-2-0067 between the Henry Jackson Foundation for the Advancement of Military Medicine in collaboration and the US Army. Received for publication December 18, 2011; revision received April 30, 2012, and accepted April 30, 2012. doi: 10.1111/j.1537-2995.2012.03770.x TRANSFUSION **;**:**-**. Volume **, ** ** TRANSFUSION 1