W. Alton Russell, MS; Susan L. Stramer, PhD; Michael P. Busch, MD, PhD; Brian Custer, PhD
Presented in part at the 35th International Congress of the International Society of Blood Transfusion, Toronto, Ontario, Canada, 2–6 June 2018 (Mr. Russell); at the American Association of Blood Banks Annual Meeting, Boston, Massachusetts, 13–16 October 2018 (Dr. Custer); and at the 40th Annual North American Meeting of the Society for Medical Decision Making, Montreal, Quebec, Canada, 13–17 October 2018 (Mr. Russell).
Acknowledgment: The authors thank Prof. Margaret Brandeau for her feedback and the team at The Ottawa Hospital (Dr. Kumanan Wilson, Dr. Malia Murphy, and JoAnn Colas), who provided unpublished data on the proportion of transfusion recipients who are pregnant women not yet arrived at the hospital for delivery. The authors also thank Roche and Grifols for providing data from their Investigational New Drug Applications, which were used to estimate the rate of ZIKV-positive donations for Puerto Rico and the 50 states.
Financial Support: Mr. Russell was funded as an intern and contractor by Vitalant Research Institute. No external funding was received.
Disclosures: Mr. Russell reports personal fees from Terumo BCT outside the submitted work. Dr. Stramer reports laboratory support from Grifols, Roche Diagnostics, and Abbott Laboratories and speaker fees from Roche Diagnostics and Cerus outside the submitted work. Dr. Busch reports research grants related to ZIKV from Grifols, funding to his laboratory at Vitalant Research Institute from Grifols and Roche to perform confirmatory testing for ZIKV supporting the Zika testing investigational new drugs, and funding to his laboratory from Cerus for a study of ZIKV inactivation red blood cell transfusions, all outside the submitted work. Dr. Custer reports grants from Grifols Diagnostic Solutions, Terumo BCT, Macopharma, and Cerus and personal fees from Terumo BCT outside the submitted work. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-2238.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Proctor & Gamble, Pfizer, and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Not applicable. Statistical code: Available from Mr. Russell (e-mail, email@example.com). Data set: Model parameters were determined via secondary analysis of existing or published data. The primary data set used to sample recipient baseline characteristics is part of the Scandinavian Donations and Transfusions (SCANDAT) project (www.scandat.se) and is not publicly available.
Corresponding Author: W. Alton Russell, MS, Management Science and Engineering, Huang Engineering Center, Stanford University, 475 Via Ortega, Stanford, CA 94305; e-mail, firstname.lastname@example.org.
Current Author Addresses: Mr. Russell: Management Science and Engineering, Huang Engineering Center, Stanford University, 475 Via Ortega, Stanford, CA 94305.
Dr. Stramer: Scientific Affairs, American Red Cross, 9315 Gaither Road, Gaithersburg, MD 20877.
Drs. Busch and Custer: Vitalant Research Institute, 270 Masonic Avenue, San Francisco, CA 94118.
Author Contributions: Conception and design: W.A. Russell, B. Custer.
Analysis and interpretation of the data: W.A. Russell, S.L. Stramer, M.P. Busch, B. Custer.
Drafting of the article: W.A. Russell.
Critical revision of the article for important intellectual content: W.A. Russell, S.L. Stramer, M.P. Busch, B. Custer.
Final approval of the article: W.A. Russell, S.L. Stramer, M.P. Busch, B. Custer.
Statistical expertise: W.A. Russell.
Obtaining of funding: B. Custer.
Collection and assembly of data: W.A. Russell, S.L. Stramer, B. Custer.
In 2016, universal individual donation nucleic acid testing (ID-NAT) of donated blood for Zika virus began in U.S. states and territories.
To assess the cost-effectiveness of universal ID-NAT in the first year of screening compared with alternatives for the 50 states and separately for Puerto Rico.
Microsimulation that captured Zika-related harms to transfusion recipients, sexual partners, and their infants.
National testing results compiled by AABB and costs, utilities, and outcome probabilities estimated from the literature.
Universal ID-NAT, universal mini-pool NAT (MP-NAT), and ID-NAT exclusively for components transfused to women of childbearing age. Seasonally targeted strategies in Puerto Rico and geographically targeted strategies in the 50 states were also considered.
Costs, quality-adjusted life-years (QALYs), and outcomes.
In Puerto Rico, MP-NAT exclusively during high mosquito season was cost-effective at $81 123 per QALY (95% CI, −$49 138 to $978 242 per QALY). No screening policy was cost-effective in the 50 states. Universal ID-NAT cost $341 million per QALY (CI, $125 million to $2.90 billion per QALY) compared with no screening in the 50 states.
In Puerto Rico, MP-NAT only during the season of high mosquito activity was most cost-effective in 64% of probabilistic sensitivity analysis iterations. In the 50 states, no intervention was cost-effective in 99.99% of iterations. Cost-effectiveness was highly dependent on the rate of assumed infectious donations.
Data were limited on the component-specific transmissibility of Zika and long-term sequelae of infection.
Screening was cost-effective only in the high mosquito season in Puerto Rico, and no evaluated screening policy was cost-effective in the 50 states. During periods with lower rates of Zika-infectious donations, the cost-effectiveness of screening will be even less favorable.
Russell WA, Stramer SL, Busch MP, Custer B. Screening the Blood Supply for Zika Virus in the 50 U.S. States and Puerto Rico: A Cost-Effectiveness Analysis. Ann Intern Med. [Epub ahead of print ]:. doi: 10.7326/M18-2238
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Published: Ann Intern Med. 2019.
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