Grifols SA, Sant Cugat del Valles, Spain, Catalonia, Spain
Background/Case Studies: Blood donors with malarial risk factors are currently deferred through a donor questionnaire, which primarily relies on self-reported information. This study assessed the economic impact of implementing Plasmodium nucleic acid testing (NAT) as a universal screening strategy in the US.
Study
Design/Methods: A budget impact analysis was developed. Two scenarios without testing (base case) and with universal Plasmodium NAT screening (test case) were compared. The test scenario included the following assumptions: removal of question (Q) 29 of malaria risk from the donor questionnaire (which aims to identify recent travelers and former residents of malaria endemic countries outside US and Canada), with NAT performed on mini pools (MPs) of 16 donations of individual red cell lysates, using a NAT assay with a 95% limit of detection of 8.46-11.89 18S-rRNA copies/mL and 2.10–6.82 infected red cells/mL, followed by resolution testing of individual samples comprising reactive MPs. Clinical, epidemiological, and cost data included in the model were sourced through a targeted literature review. The analysis was conducted from the perspective of blood suppliers. A 1- to-3-year projection and a one-way sensitivity analysis were performed to assess result uncertainty.
Results/Findings: Plasmodium NAT universal screening is estimated to impact US blood suppliers by -13,628,616 USD (negative values indicating cost savings). Specific costs considered in the calculation are displayed in Table 1. Implementation of plasmodium screening using NAT technology through pools of 16 followed by individual donor testing of positive pools would lead to an additional cost of 4,443,286 USD. This additional cost would be counterbalanced by: 1) additional blood donations being gathered from donors that before screening implementation were identified as malaria risk donors through Q29 and deferred from the system (266,438 additional blood products, leading to -15,037,737 USD additional income), 2) labor cost savings due to the removal of Q29, which is known to be time consuming, labor intensive and error prone (3,034,165 USD). Assuming an annual mean increase of 2.4% in the number of useable blood donations, the projected budget impact is -13,865,670 USD and -14,108,893 USD for years 2 and 3, respectively.
Conclusions: The implementation of Plasmodium NAT universally can potentially increase the availability and safety of blood products in the US, while reducing the cost of labor and lost collections.
