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DONOR INFECTIOUS DISEASE TESTING
Laboratory evaluation of rapid test kits to detect hepatitis C antibody for use in predonation screening in emergency settings
Article first published online: 23 JUL 2012
© 2012 American Association of Blood Banks
Volume 53, Issue 3, pages 505–517, March 2013
How to Cite
O'Connell, R. J., Gates, R. G., Bautista, C. T., Imbach, M., Eggleston, J. C., Beardsley, S. G., Manak, M. M., Gonzales, R., Rentas, F. J., Macdonald, V. W., Cardo, L. J., Reiber, D. T., Stramer, S. L., Michael, N. L. and Peel, S. A. (2013), Laboratory evaluation of rapid test kits to detect hepatitis C antibody for use in predonation screening in emergency settings. Transfusion, 53: 505–517. doi: 10.1111/j.1537-2995.2012.03770.x
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.
- Issue published online: 8 MAR 2013
- Article first published online: 23 JUL 2012
- Received for publication December 18, 2011; revision received April 30, 2012, and accepted April 30, 2012.
BACKGROUND: Emergency whole blood transfusion is a lifesaving procedure employed on modern battlefields. Rapid device tests (RDTs) are frequently used to mitigate 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 consistently 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 compared 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 conditions. These data support OraQuick HCV superiority and illustrate the value of RDT evaluation under simulated field conditions.