Emerging Technologies

The ARC work on infectious risks of transfusion has focused primarily on vector-borne diseases, especially parasitic diseases including malaria and babesiosis. Of particular interest is the relationship between human mobility (such as travel and migration) and risk for transfusion-transmissible infections, and how these relationships and the attendant risk-mitigation alternatives might differ markedly by infectious agent.

• Transfusion-transmitted parasitic infections in the United States are almost exclusively due to Babesia microti, the tick-borne intraerythrocytic protozoan agent of babesiosis, naturally transmitted to humans through the bite of infected deer tick. Hospital-reported transfusion-transmitted babesiosis (TTB) are investigated by the American Red Cross’s Hemovigilance program.
• The ARC has been screening blood collected in endemic areas for B. microti under investigational protocols since 2010, performing clinical trials that lead to the Food and Drugs Administration (FDA) licensure of multiple screening tests. Babesia screening in 14 endemic states plus Washington DC is in the process of been implemented, as recommended by the FDA guidance released in May 2019. The screening will be performed with the Procleix Babesia assay, a nucleic acid amplification test for the detection of RNA from Babesia species from Grifols, and currently the only available FDA licensed Babesia test in the U.S.
  
• In the absence of an FDA licensed babesia confirmatory test, a research indirect immunefluorescent assay (IFA) for the detection of antibody against B. microti is performed in our laboratory.
• During a collaboration between the ARC and Canadian blood centers, the Procleix Babesia assay and B. microti IFA were used to assess the risk of Babesia infection in blood donors resident in geographic areas of Canada bordering the Northeastern and Upper Midwest United States, where B. microti is endemic.  

On June 15, 2020 the American Red Cross initiated screening all allogeneic blood donations for antibodies to the SARS coronavirus-2 (SARS-CoV-2); this is the virus that causes COVID-19. Reactive donations will be tested by a second COVID-19 antibody test using a different genetic target to confirm reactivity. In order to see how long the antibodies are present, the Scientific Support Office (SSO) will be contacting donors who test reactive by the two assays to ask them to give follow-up samples. The follow-up samples will be tested for antibodies to COVID-19 until a negative (nonreactive) result is obtained. The initial follow-up sample will be collected about a month after the reactive index donation, and then every three months. Once negative, the donor will no longer be followed. Results of this additional testing will be provided to the donors by letter.

Additionally, these donors will receive a link to a survey that asks questions about any COVID-19 symptoms they may have experienced prior to their last reactive index donation, if they have been previously tested, their motivation for donation and knowledge about testing. This research survey, along with the testing, will help provide the American Red Cross with additional information regarding the value of coronavirus antibody testing, and the duration of the antibody response following exposure to SARS-CoV-2.

Currently, there are no Food and Drug Administration (FDA) or Health Canada approved tests for screening donated blood for Plasmodium, the agent that causes malaria. Donor screening in the U.S. and Canada occurs by questionnaire. In the U.S., the estimated incidence of Transfusion-Transmitted Malaria is less than one per million units of collected blood, but yearly about 72,000 donors are deferred due to malaria risks. 

The American Red Cross Scientific Support Office (SSO) in collaboration with New York Blood Center, Héma-Québec and Grifols Diagnostics, Inc., is conducting a research study on testing for Plasmodium ribonucleic acid (RNA) in blood donors. This research is being conducted to evaluate a new research assay and learn more about the prevalence of Plasmodium infection in donors deferred for malaria risk. What we learn will help us know how many deferred donors are actually infected with the malaria parasite. Implementation of universal donation screening for malaria would aid in reducing the number of deferred donors for malaria risks.