BACKGROUND: Babesia microti, a transfusion-transmissible intraerythrocytic parasite, is increasing in frequency in the United States with no available FDA-licensed donor screening assay. We utilized investigational arrayed fluorescence immunoassay (AFIA) and polymerase chain reaction (PCR) to detect B. microti antibodies and DNA in blood donors. STUDY DESIGN AND METHODS: AFIA and real-time PCR were performed on frozen paired EDTA plasma (AFIA) and EDTA whole blood (PCR) samples collected from May to September 2010 to 2011 in nonendemic (Arizona [AZ] and Oklahoma [OK]), moderately endemic (Minnesota [MN] and Wisconsin [WI]), and highly endemic (Connecticut [CT] and Massachusetts [MA]) areas of the United States. AFIA utilized B. microti piroplasm as an antigen substrate; PCR primers and probes targeted the B. microti 18S ribosomal RNA gene. Data from AZ and OK were used to calculate specificity. All AFIA- or PCR-positive or -inconclusive donors were deferred, notified, and invited to participate in a follow-up study involving repeat testing and a demographic and risk-factor questionnaire. Recipient tracing was performed for any cellular component transfused at index, at subsequent donation, or within the prior 12 months. RESULTS: Testing of 13,269 paired samples included 4022 from AZ and OK, 4167 from MN and WI, and 5080 from CT and MA. B. microti antibody and/or DNA prevalences were 0.025% (95% confidence interval [CI], 0.00%-0.14%), 0.12% (95% CI, 0.04%-0.28%), and 0.75% (95% CI, 0.53%-1.03%) in the nonendemic, mid-endemic, and high-endemic regions, respectively. Specificities were 99.95% (95% CI, 99.82%-99.99%) at a 1-in-64 AFIA cutoff and 99.98% (95% CI, 99.86%-100.00%) at a 1-in-128 cutoff. CONCLUSIONS: B. microti prevalence followed expected geographical patterns. Screening was feasible with a performance comparable or superior to other infectious disease blood donor screening assays.
BACKGROUND:Babesia microti, a transfusion-transmissible intraerythrocytic parasite, is increasing in frequency in the United States with no available FDA-licensed donor screening assay. We utilized investigational arrayed fluorescence immunoassay (AFIA) and polymerase chain reaction (PCR) to detect B. microti antibodies and DNA in blood donors. STUDY DESIGN AND METHODS: AFIA and real-time PCR were performed on frozen paired EDTA plasma (AFIA) and EDTA whole blood (PCR) samples collected from May to September 2010 to 2011 in nonendemic (Arizona [AZ] and Oklahoma [OK]), moderately endemic (Minnesota [MN] and Wisconsin [WI]), and highly endemic (Connecticut [CT] and Massachusetts [MA]) areas of the United States. AFIA utilized B. microti piroplasm as an antigen substrate; PCR primers and probes targeted the B. microti 18S ribosomal RNA gene. Data from AZ and OK were used to calculate specificity. All AFIA- or PCR-positive or -inconclusive donors were deferred, notified, and invited to participate in a follow-up study involving repeat testing and a demographic and risk-factor questionnaire. Recipient tracing was performed for any cellular component transfused at index, at subsequent donation, or within the prior 12 months. RESULTS: Testing of 13,269 paired samples included 4022 from AZ and OK, 4167 from MN and WI, and 5080 from CT and MA. B. microti antibody and/or DNA prevalences were 0.025% (95% confidence interval [CI], 0.00%-0.14%), 0.12% (95% CI, 0.04%-0.28%), and 0.75% (95% CI, 0.53%-1.03%) in the nonendemic, mid-endemic, and high-endemic regions, respectively. Specificities were 99.95% (95% CI, 99.82%-99.99%) at a 1-in-64 AFIA cutoff and 99.98% (95% CI, 99.86%-100.00%) at a 1-in-128 cutoff. CONCLUSIONS:B. microti prevalence followed expected geographical patterns. Screening was feasible with a performance comparable or superior to other infectious disease blood donor screening assays.
Authors: Jose Thekkiniath; Sara Mootien; Lauren Lawres; Benjamin A Perrin; Meital Gewirtz; Peter J Krause; Scott Williams; J Stone Doggett; Michel Ledizet; Choukri Ben Mamoun Journal: J Clin Microbiol Date: 2018-09-25 Impact factor: 5.948
Authors: Sanjeev Gumber; Fernanda S Nascimento; Kenneth A Rogers; Henry S Bishop; Hilda N Rivera; Maniphet V Xayavong; Sushil G Devare; Gerald Schochetman; Praveen K Amancha; Yvonne Qvarnstrom; Patricia P Wilkins; François Villinger Journal: Transfusion Date: 2016-02-19 Impact factor: 3.157
Authors: Evan M Bloch; Andrew E Levin; Phillip C Williamson; Sherri Cyrus; Beth H Shaz; Debra Kessler; Jed Gorlin; Roberta Bruhn; Tzong-Hae Lee; Leilani Montalvo; Hany Kamel; Michael P Busch Journal: Transfusion Date: 2016-05-17 Impact factor: 3.157
Authors: Mikhail Menis; Richard A Forshee; Sanjai Kumar; Stephen McKean; Rob Warnock; Hector S Izurieta; Rahul Gondalia; Chris Johnson; Paul D Mintz; Mark O Walderhaug; Christopher M Worrall; Jeffrey A Kelman; Steven A Anderson Journal: PLoS One Date: 2015-10-15 Impact factor: 3.240
Authors: Kevin Cheng; Kelly E Coller; Christopher C Marohnic; Zachary A Pfeiffer; James R Fino; Randee R Elsing; Janet Bergsma; Marilee A Marcinkus; Alak K Kar; Orlando H Gumbs; Kathy S Otis; Jeffrey Fishpaugh; Phillip W Schultz; Mark R Pope; Alfredo R Narvaez; Susan J Wong; Susan Madison-Antenucci; Thomas P Leary; George J Dawson Journal: J Clin Microbiol Date: 2018-07-26 Impact factor: 5.948
Authors: Andrew E Levin; Phillip C Williamson; Evan M Bloch; Joan Clifford; Sherri Cyrus; Beth H Shaz; Debra Kessler; Jed Gorlin; James L Erwin; Neil X Krueger; Greg V Williams; Oksana Penezina; Sam R Telford; John A Branda; Peter J Krause; Gary P Wormser; Anna M Schotthoefer; Thomas R Fritsche; Michael P Busch Journal: Transfusion Date: 2016-05-25 Impact factor: 3.157