Emerging Technologies

The American Red Cross maintains a centralized scientific laboratory of which our aim is to provide operational support and conduct applied studies focused primarily on infectious disease testing. This laboratory acts as the investigational branch of major blood screening assay developers, performing preclinical assay validations for investigational new drug (IND) applications and blood license applications (BLAs). These efforts contribute to the mission of ensuring a safe and effective blood supply.

Our work involves collaboration within the American Red Cross, with our vendors, federal agencies, and national and international colleagues.

Specifically, we work towards understanding and developing improved methods to reduce the risk of existing and emerging infectious disease agents. This includes working with our vendor partners towards development and validation of interventions to protect recipients from infection through transfusion, which includes testing (improved or new assays and assay platforms) or pathogen inactivation methods. We also assist our medical and counseling staff in providing donors accurate infectious disease test messages and investigating the likelihood of suspected transfusion-transmitted infections when reported to the Red Cross as part of our hemovigilance program. Our work has also included understanding the epidemiology of infected blood donors and associated residual risks (see Donor/Recipient Health & Epidemiology) and transmissibility of blood components from infected donors. Our work is not limited to infectious disease agents but also may involve the development and introduction of methods to improve donor and recipient safety and drive policy.

Contact Us

Paula Saa, PhD
Senior Director, Operational Research

Laura Tonnetti, PhD
Scientist IV

Current Projects

Pathogen inactivation (PI) technologies are a valuable resource in mitigating the risk of transfusion-transmitted infections from recognized pathogens, as well as emerging infectious agents for which immediate testing may not be available. Several studies performed in collaboration with the providers of different PI systems, have explored the effectiveness of PI on multiple parasites such as B. microti, Leishmania donovani and Trypanosoma cruzi.

Babesia microti in hamster’s red blood cells (acridine orange stain)

Transfusion-Transmitted Babesia and Malaria

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.

COVID-19 Antibody Study (Characterization of SARS-CoV-2 sero-reactive blood donors)

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.

Grifols Plasmodium (Malaria) Research Testing

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.

Recent Publications

Shields K, Cumming M, Rios J, Wong MT, Zwicker JI, Stramer SL, Alonso CD. Transfusion-associated Anaplasma phagocytophilum infection in a pregnant patient with thalassemia trait: a case report. Transfusion 2014;55:719-25.
Dodd RY, Foster GA, Stramer SL. Keeping blood transfusion safe from West Nile virus: American Red Cross experience, 2003-2012. Transfusion Medicine Reviews 2015;29:153-61.
Moorman AC, Stramer SL, Schaefer MK, Collier MG, Suryaprasad A, Kuehnert MJ, Moore Z, Rowan E, Habicht K, Bradley K, Fucci MC, Hopkins C, Xu F. Incident hepatitis among repeat blood donors: a sentinel event signaling possible health care-associated infection and need for reporting to public health authorities. Transfusion 2015;55:2531-3.
Tonnetti L, Thorp AM, Reddy HL, Keil SD, Doane SK, Goodrich RP, Leiby DA. Reduction of Leishmania donovani infectivity in whole blood using riboflavin and ultraviolet light. Transfusion 2015;55:326-9.
Chiu CY, Bres V,Yu G, Krysztof D, Naccache SN, Lee D, Pfelll J, Linnen JM, Stramer SL. Genomic assays for identification of chikungunya virus in blood donors, Puerto Rico, 2014. Emerg Inf Dis 2015; 21:1409-13.
Matos D, Tomashek KM, Perez-Padilla J, Muñoz-Jordán J, Hunsperger E, Horiuchi K, Noyd D, Winton C, Foster GA, Lanteri MC, Linnen JM, Stramer SL. Probable and possible transfusion-transmitted dengue associated with NS1-antigen negative but RNA-confirmed-positive red blood cells. Transfusion 2015;56:215-22.
Stramer SL, Moritz ED, Foster GA, Ong E, Linnen JM, Hogeman BM, Mak MY, Chia CP, Dodd RY. Hepatitis E virus: seroprevalence and frequency of viral RNA detection among U.S. blood donors. Transfusion 2015;56:481-8.
Thorp AM, Tonnetti L. Distribution and survival of Borrelia miyamotoi in human blood components. Transfusion 2016;56:705-11.
Stramer SL, Yu G, Herron R, Espinoza N, Foster, GA, Naccache SN, Brodsky JP, Ong E, Linnen JM, Dyer, N, Styer LM, Parker MM, Chiu, CY. Two human immunodeficiency virus Type 2 cases in US blood donors including serologic, molecular, and genomic characterization of an epidemiologically unusual case. Transfusion 2016;56:1560-68.
Garcia MN, Woc-Colburn L, Rossmann SN, Townsend RL, Stramer SL, Bravo M, Kamel H, Beddard R, Townsend M, Oldham R, Bottazzi ME, Hotez PJ, Murray KO. Trypanosoma cruzi screening in Texas blood donors, 2008-2012. Epidemiol. Infect. 2016;144:1010-3.

Brennan MB, Herwaldt BL, Kazmierczak JJ, Wiess JW, Klein CL, Leith CP, He R, Oberley MJ, Tonnetti L, Wilkins PP, Gauthier GM. Transmission of Babesia microti parasite by solid organ transplantation. Emerg Infect Dis 2016;11:1869-76.

Moritz ED, Winton CS, Tonnetti L, Townsend R, Berardi VP, Hewins ME, Weeks KE, Dodd RY, Stramer SL. Screening for Babesia microti in the US blood supply. New Engl J Med 2016;375:2236-45.

Betsem E, Kaidarova Z, Stramer SL, Shaz B, Sayers M, LeParc G, et al. Correlation of West Nile virus incidence in donated blood with West Nile neuroinvasive disease rates, United States, 2010–2012. Emerg Infect Dis. 2017;23:212-9.

Groves JA, Shafi H, Nomura JH, Herron RM, Baez D, Dodd RY, Stramer SL. A probable case of West Nile virus transfusion transmission. Transfusion 2017;57:850-6.

Bardina SV, Bunduc P, Tripathi S, Duehr J, Frere JJ, Brown JA, Nachbagauer R, Foster GA, Krysztof D, Tortorella D, Stramer SL, Garcia-Sastre A, Krammer F, Lim JK. Enhancement of Zika virus pathogenesis by preexisting antiflavivirus immunity. Science 2017;356:175-80.

Leiby DA, Nguyen ML, Proctor MC, Townsend RL, Stramer SL. Frequency of Trypanosoma cruzi parasitemia among infected blood donors with a potential association between parasite lineage and transfusion transmission. Transfusion 2017;57:1426-32.

Moritz ED, Hewins ME, Berardi VP, Dodd RY, Stramer SL. Description of 15 DNA-positive and antibody-negative “window-period” blood donations identified during prospective screening for Babesia microti. Transfusion 2017;57:1781-86.

LeBell DP, Moritiz ED, O’Brien J, Lazarchick J, Tormos LM, Duong A, Fontaine MJ, Squires JE, Stramer SL. Cases of transfusion-transmitted babesiosis occurring in nonendemic areas: a diagnostic dilemma. Transfusion 2017;57:2348-54.

Meissner EG, McGillicuddy JW, Squires J, Skipper D, Self S, Wray D, Moritz ED, Stramer SL, Nadig S. Across state lines: fulminant Babesia microti infection in a liver transplant recipient. Transpl Infect Dis. 2017;19:e12741.

Tonnetti L, Laughhunn A, Thorp AM, Vasilyeva I, Dupuis K, Stassinopoulos A, Stramer SL. Inactivation of Babesia microti in red blood cells and platelet concentrates. Transfusion 2017;57:2404-12.

Stramer SL, Townsend RL, Foster GA, Johnson R, Weixlmann B, Dodd RY. Discordant human T-lymphotropic virus screening with Western blot confirmation: evaluation of the dual-test algorithm for US blood donations. Transfusion 2018;58:638-40.

Linden JV, Pruskinski MA, Crowder LA, Tonnetti L, Stramer SL, Kessler DA, White J, Shaz B, Olkowsa D. Transfusion-transmitted and community-acquired babesiosis in New York, 2004 to 2015. Transfusion 2018;58:660-8.

Zafrullah M, Zhang X, Tran C, Nguyen M, Kamili S, Purdy MA, Stramer SL. Disparities in detection of antibodies against hepatitis E virus in US blood donor samples using commercial assays. Transfusion 2018;58:1254-63.

Saá P, Proctor M, Foster G, Krysztof D, Winton C, Linnen JM, Gao K, Brodsky JP, Limberger RJ, Dodd RY, Stramer SL. Investigational testing for Zika virus among U.S. blood donors. N Engl J Med 2018;378:1778-88.
Anand A, Mace KE, Townsend RL, Madison-Antenucci S, Grimm KE, Espina N, Losco P, Lucchi NW, Rivera H, Breen K, Tan KR, Arguin PM, White JL, Stramer SL. Investigation of a case of suspected transfusion-transmitted malaria. Transfusion 2018;58:2115-2121.
Dodd RY, Nguyen ML, Krysztof DE, Notari EP, Stramer SL. Blood donor testing for hepatitis B virus in the United States: is there a case for continuation of hepatitis B surface antigen detection? Transfusion 2018;58:2166-70.
Klevens RM, Cumming MA, Caten E, Stramer SL, Townsend RL, Tonnetti L, Rios J, Young CT, Soliva S, DeMaria A Jr. Transfusion-transmitted babesiosis: one state’s experience. Transfusion 2018; 58:2611-16.
Tejada-Strop A, Zafrullah M, Kamili S, Stramer SL, Purdy MA. Distribution of hepatitis A antibodies in US blood donors. Transfusion 2018;59;2761-5.
Pouch SM, Katugaha SB, Shieh WJ, Annambhotla P, Walker WL, Basavaraju SV, Jones J, Huynh T, Reagan-Steiner S, Bhatnagar J, Grimm K, Stramer SL, et al. Eastern equine encephalitis virus transplant transmission investigation team. Clin Infect Dis 2018; doi:10.1093/cid/ciy923.
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 2019; doi: 10.7326/M18-2238.
Tonnetti L, Townsend RL, Deisting BM, Haynes JM, Dodd RY, Stramer SL. The impact of Babesia microti blood donation screening. Transfusion 2019;59:593-600.
Ramachandran S, Groves JA, Xia G, Saa P, Notari EP, Drobeniuc J, Poe A, Khudyakov N, Schillie SF, Murphy TV, Kamili S, Teo CG, Dodd RY, Khudyakov YE, Stramer SL. Recent and occult hepatitis B virus infections among blood donors in the United States. Transfusion 2019;59:601-11.
Dodd RY, Groves JA, Townsend RL, Notari EP, Foster GA, Custer B, Busch MP, Stramer SL. Impact of one-time testing of Trypanosma cruzi antibodies among blood donors in the United States. Transfusion 2019;1016-23.
Stramer SL, Stanley J, Nguyen ML, Bertuzis R, Huynh N, Duncan JR, Albrecht P, Pate LL, Galel SA. Duplex nucleic acid test for the detection of chikungunya and dengue RNA viruses in blood donations. Transfusion 2019; 59:1283-90.
Faddy HM, Rooks KM, Irwin PJ, Viennet E, Paparini A, Seed CR, Stramer SL, Harley RJ, Chan HT, Dennington PM, Flower RLP. No evidence for widespread Babesia microti transmission in Australia. Transfusion 2019; doi:10.1111/trf.15336.
Tonnetti L, Townsend RL, Dodd RY, Stramer SL. Characteristics of transfusion-transmitted Babesia microti: American Red Cross 2010-2017. Transfusion 2019; doi: 10.1111/trf.15425.
Saa P, Chiu C, Grimm K, Yu G, Benjamin RJ, Corash L, Stramer SL. Acute Zika virus infection in an asymptomatic blood donor at the onset of the Puerto Rico epidemic. Transfusion 2019;59: 3164-70.
Delage G, Fearon M, Gregoire BM, Custer B, Scalia V, Hawes G, Bernier F, Nguyen ML, Stramer SL. Hepatitis E virus infection in blood donors and risk to patients in the United States. Transfusion Medicine Reviews 2019;33:139-145.
Straily A, Stuck S, Singleton J, Brennan S, Marcum S, Condit M, Lee C, Kato C, Tonnetti L, Stramer SL, Paddock CD. Antibody titers reactive with Rickettsia rickettsii in blood donors and implications for surveillance of spotted fever rickettsiosis in the United States. J Infect Dis 2019 (July 2 early view).
Tonnetti L, O'Brien SF, Grégoire Y, Proctor MC, Drews SJ, Delage G, Fearon MA, Brès V, Linnen JM, Stramer SL. Prevalence of Babesia in Canadian blood donors: June-October 2018. Transfusion 2019;59:3171-3176.
Bloch EM, Mrango Z, Kasubi M, Weaver J, Mihailovic A, Munoz B, Weimer A, Levin A, Tonnetti L, Linnen JM, Brès V, Norris DE, Carpi G, West SK. The Babesia observational antibody (BAOBAB) study: a cross-sectional evaluation of Babesia in two communities in Kilosa district, Tanzania. PLoS Negl Trp Dis. 2019;13:1869-76
Tonnetti L, Young C, Kessler DA, Williamson PC, Reik R, Proctor MC, Brès V, Deisting B, Bakkour S, Schneider W, Diner S, Busch MP, Stramer SL, Linnen JM. Transcription-mediated amplification blood donation screening for Babesia. Transfusion 2019 (early view).