See Acknowledgments for members of the International NAT Study Group.
Prevalence of human immunodeficiency virus RNA and antibody in first-time, lapsed, and repeat blood donations across five international regions and relative efficacy of alternative screening scenarios
Version of Record online: 19 JUN 2013
© 2013 American Association of Blood Banks
Special Issue: Thirty Years of Progress since Recognition of Transfusion-Associated AIDS
Volume 53, Issue 10pt2, pages 2399–2412, October 2013
How to Cite
Bruhn, R., Lelie, N., Custer, B., Busch, M., Kleinman, S. and International NAT Study Group (2013), Prevalence of human immunodeficiency virus RNA and antibody in first-time, lapsed, and repeat blood donations across five international regions and relative efficacy of alternative screening scenarios. Transfusion, 53: 2399–2412. doi: 10.1111/trf.12299
Research support provided by Novartis Vaccines and Diagnostics, Inc.
- Issue online: 4 OCT 2013
- Version of Record online: 19 JUN 2013
- Manuscript Revised: 17 APR 2013
- Manuscript Accepted: 17 APR 2013
- Manuscript Received: 21 JAN 2013
- Novartis Vaccines and Diagnostics, Inc.
Twenty-one blood organizations from five geographical regions provided HIV individual donation (ID)-NAT and serology data on 11,787,610 donations. Infections were classified as anti-HIV-/RNA+ window period (WP), anti-HIV+/RNA+ concordant positive (CP) or anti-HIV+/RNA- elite controller (EC). Residual risk and efficacy of several screening scenarios were estimated for first time, lapsed and repeat donations.
WP residual risk estimates assumed a 50% infectious dose of 3.16 virions and a 50% detection limit of 2.7 HIV RNA copies/mL for ID-NAT and 10,000 copies/mL for p24Ag. Infectivity for CP (100%) and EC (2.2%) donations was estimated based on viral load distributions and 100-fold reduced infectivity by antibody neutralization as reported elsewhere. Efficacy was calculated as proportion of transmission risk removed from baseline (i.e. in absence of any screening).
There was no significant difference in transmission risk between lapsed and repeat donations in any region. Risk was 3.8-fold higher in first time than combined lapsed/repeat donations in South Africa but not in other regions. Screening strategies were most efficacious at interdicting infectious transfusions in first time (98.7-99.8%) followed by lapsed (97.6-99.7%) and repeat (86.8-97.7%) donations in all regions combined. In each donor category the efficacy of ID-NAT alone (97.7-99.8%) was superior to that of minipool (MP)-NAT/anti-HIV (95.0-99.6%) and p24 Ag/anti-HIV (89.8-99.1%).
Efficacy patterns were similar by donor/donation status in each region despite large differences in HIV prevalence and transmission risk. As similar data become available for HBV and HCV, this modeling may be useful in cost effectiveness analyses of alternative testing scenarios.