title: Cost-effectiveness of Babesia microti antibody and nucleic acid blood donation screening using results from prospective investigational studies.
abstract: BACKGROUND
  Babesia microti causes transfusion-transmitted babesiosis (TTB); currently, blood donor screening assays are unlicensed but used investigationally.
  
  
  METHODS
  We developed a decision tree model assessing the comparative- and cost-effectiveness of B. microti blood donation screening strategies in endemic areas compared to the status quo (question regarding a history of babesiosis), including testing by: (1) universal antibody (Ab), (2) universal polymerase chain reaction (PCR), (3) universal Ab/PCR, and (4) recipient risk-targeted Ab/PCR. The model predicted the number of TTB cases, complicated TTB cases, cases averted, and quality-adjusted life years (QALYs). Economic outcomes included each strategy's per-donation cost, waste (number of infection-free units incorrectly discarded), and waste index (number wasted units/number true positives). Sensitivity analyses examined uncertainty in transmission probabilities, prevalence rates, and other key model inputs.
  
  
  RESULTS
  Universal PCR in four endemic states would prevent 24 to 31 TTB cases/100,000 units transfused (pht) at an incremental cost-effectiveness ratio (ICER) of $26,000 to $44,000/QALY (transmission probability dependent) and waste index of zero. Universal Ab/PCR would prevent 33 to 42 TTB cases pht at an ICER of $54,000 to $83,000/QALY and waste index of 0.05. The questionnaire is most wasteful (99.62 units wasted pht; 208.62 waste index), followed by the risk-targeted strategy (76.27 units wasted pht; 0.68 waste index). The model predicted zero cases of TTB or complicated TTB with universal Ab/PCR (versus [33, 42] and [13, 18] pht, respectively [no screening]). Results are highly sensitive to transmission probabilities.
  
  
  CONCLUSIONS
  Universal PCR in endemic states is an effective blood donation screening strategy at a threshold of $50,000/QALY. Using a higher cost-effectiveness ratio, universal Ab/PCR is the most effective strategy.
authors.affiliation: Grado Department of Industrial and Systems Engineering, Virginia Polytechnic Institute and State University, Blacksburg, Virginia.
authors.forename: Ebru K
authors.initials: EK
authors.lastname: Bish
authors.affiliation: Scientific Support Office, American Red Cross, Gaithersburg, Maryland.
authors.forename: Erin D
authors.initials: ED
authors.lastname: Moritz
authors.affiliation: Grado Department of Industrial and Systems Engineering, Virginia Polytechnic Institute and State University, Blacksburg, Virginia.
authors.forename: Hadi
authors.initials: H
authors.lastname: El-Amine
authors.affiliation: Grado Department of Industrial and Systems Engineering, Virginia Polytechnic Institute and State University, Blacksburg, Virginia.
authors.forename: Douglas R
authors.initials: DR
authors.lastname: Bish
authors.affiliation: Scientific Support Office, American Red Cross, Gaithersburg, Maryland.
authors.forename: Susan L
authors.initials: SL
authors.lastname: Stramer
mesh_terms: D000913:Antibodies, Protozoan / Q000097:blood*; D041001:Babesia microti; D001404:Babesiosis / Q000097:blood / Q000191:economics; D001782:Blood Donors; D016054:DNA, Protozoan / Q000097:blood*; D046148:Donor Selection / Q000191:economics / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008954:Models, Biological; D018803:Models, Economic; D016133:Polymerase Chain Reaction / Q000379:methods*; D016053:RNA, Protozoan / Q000097:blood*
chemical_list: D000913:Antibodies, Protozoan; D016054:DNA, Protozoan; D016053:RNA, Protozoan