Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay

Andrew E. Levin, Phillip C. Williamson, Evan 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

Research output: Contribution to journalArticle

Abstract

BACKGROUND: The tick-borne pathogen Babesia microti has become recognized as the leading infectious risk associated with blood transfusion in the United States, yet no Food and Drug Administration–licensed screening tests are currently available to mitigate this risk. The aim of this study was to evaluate the performance of an investigational enzyme immunoassay (EIA) for B. microti as a screening test applied to endemic and nonendemic blood donor populations. STUDY DESIGN AND METHODS: The study aimed to test 20,000 blood donors from areas of the United States considered endemic for B. microti and 10,000 donors from a nonendemic area with the investigational B. microti EIA. Repeat-reactive samples were retested by polymerase chain reaction (PCR), blood smear, immunofluorescent assay (IFA), and immunoblot assay. In parallel, serum samples from symptomatic patients with confirmed babesiosis were tested by EIA, IFA, and immunoblot assays. RESULTS: A total of 38 of 13,757 (0.28%) of the donors from New York, 7 of 4583 (0.15%) from Minnesota, and 11 of 8363 (0.13%) from New Mexico were found repeat reactive by EIA. Nine of the 56 EIA repeat-reactive donors (eight from New York and one from Minnesota) were positive by PCR. The specificity of the assay in a nonendemic population was 99.93%. Among IFA-positive clinical babesiosis patients, the sensitivity of the assay was 91.1%. CONCLUSION: The B. microti EIA detected PCR-positive, potentially infectious blood donors in an endemic population and exhibited high specificity among uninfected and unexposed individuals. The EIA promises to provide an effective tool for blood donor screening for B. microti in a format amenable to high-throughput and cost-effective screening.

Original languageEnglish (US)
Pages (from-to)1866-1874
Number of pages9
JournalTransfusion
Volume56
Issue number7
DOIs
StatePublished - Jul 1 2016

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Babesia microti
Blood Donors
Immunoenzyme Techniques
Babesiosis
Tissue Donors
Polymerase Chain Reaction
Population
Donor Selection
Preclinical Drug Evaluations
Ticks
Blood Transfusion
Costs and Cost Analysis
Food

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Hematology

Cite this

Levin, A. E., Williamson, P. C., Bloch, E., Clifford, J., Cyrus, S., Shaz, B. H., ... Busch, M. P. (2016). Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay. Transfusion, 56(7), 1866-1874. https://doi.org/10.1111/trf.13618

Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay. / Levin, Andrew E.; Williamson, Phillip C.; Bloch, Evan; Clifford, Joan; Cyrus, Sherri; Shaz, Beth H.; Kessler, Debra; Gorlin, Jed; Erwin, James L.; Krueger, Neil X.; Williams, Greg V.; Penezina, Oksana; Telford, Sam R.; Branda, John A.; Krause, Peter J.; Wormser, Gary P.; Schotthoefer, Anna M.; Fritsche, Thomas R.; Busch, Michael P.

In: Transfusion, Vol. 56, No. 7, 01.07.2016, p. 1866-1874.

Research output: Contribution to journalArticle

Levin, AE, Williamson, PC, Bloch, E, Clifford, J, Cyrus, S, Shaz, BH, Kessler, D, Gorlin, J, Erwin, JL, Krueger, NX, Williams, GV, Penezina, O, Telford, SR, Branda, JA, Krause, PJ, Wormser, GP, Schotthoefer, AM, Fritsche, TR & Busch, MP 2016, 'Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay', Transfusion, vol. 56, no. 7, pp. 1866-1874. https://doi.org/10.1111/trf.13618
Levin, Andrew E. ; Williamson, Phillip C. ; Bloch, Evan ; Clifford, Joan ; Cyrus, Sherri ; Shaz, Beth H. ; Kessler, Debra ; Gorlin, Jed ; Erwin, James L. ; Krueger, Neil X. ; Williams, Greg V. ; Penezina, Oksana ; Telford, Sam R. ; Branda, John A. ; Krause, Peter J. ; Wormser, Gary P. ; Schotthoefer, Anna M. ; Fritsche, Thomas R. ; Busch, Michael P. / Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay. In: Transfusion. 2016 ; Vol. 56, No. 7. pp. 1866-1874.
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abstract = "BACKGROUND: The tick-borne pathogen Babesia microti has become recognized as the leading infectious risk associated with blood transfusion in the United States, yet no Food and Drug Administration–licensed screening tests are currently available to mitigate this risk. The aim of this study was to evaluate the performance of an investigational enzyme immunoassay (EIA) for B. microti as a screening test applied to endemic and nonendemic blood donor populations. STUDY DESIGN AND METHODS: The study aimed to test 20,000 blood donors from areas of the United States considered endemic for B. microti and 10,000 donors from a nonendemic area with the investigational B. microti EIA. Repeat-reactive samples were retested by polymerase chain reaction (PCR), blood smear, immunofluorescent assay (IFA), and immunoblot assay. In parallel, serum samples from symptomatic patients with confirmed babesiosis were tested by EIA, IFA, and immunoblot assays. RESULTS: A total of 38 of 13,757 (0.28{\%}) of the donors from New York, 7 of 4583 (0.15{\%}) from Minnesota, and 11 of 8363 (0.13{\%}) from New Mexico were found repeat reactive by EIA. Nine of the 56 EIA repeat-reactive donors (eight from New York and one from Minnesota) were positive by PCR. The specificity of the assay in a nonendemic population was 99.93{\%}. Among IFA-positive clinical babesiosis patients, the sensitivity of the assay was 91.1{\%}. CONCLUSION: The B. microti EIA detected PCR-positive, potentially infectious blood donors in an endemic population and exhibited high specificity among uninfected and unexposed individuals. The EIA promises to provide an effective tool for blood donor screening for B. microti in a format amenable to high-throughput and cost-effective screening.",
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AU - Levin, Andrew E.

AU - Williamson, Phillip C.

AU - Bloch, Evan

AU - Clifford, Joan

AU - Cyrus, Sherri

AU - Shaz, Beth H.

AU - Kessler, Debra

AU - Gorlin, Jed

AU - Erwin, James L.

AU - Krueger, Neil X.

AU - Williams, Greg V.

AU - Penezina, Oksana

AU - Telford, Sam R.

AU - Branda, John A.

AU - Krause, Peter J.

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AU - Busch, Michael P.

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N2 - BACKGROUND: The tick-borne pathogen Babesia microti has become recognized as the leading infectious risk associated with blood transfusion in the United States, yet no Food and Drug Administration–licensed screening tests are currently available to mitigate this risk. The aim of this study was to evaluate the performance of an investigational enzyme immunoassay (EIA) for B. microti as a screening test applied to endemic and nonendemic blood donor populations. STUDY DESIGN AND METHODS: The study aimed to test 20,000 blood donors from areas of the United States considered endemic for B. microti and 10,000 donors from a nonendemic area with the investigational B. microti EIA. Repeat-reactive samples were retested by polymerase chain reaction (PCR), blood smear, immunofluorescent assay (IFA), and immunoblot assay. In parallel, serum samples from symptomatic patients with confirmed babesiosis were tested by EIA, IFA, and immunoblot assays. RESULTS: A total of 38 of 13,757 (0.28%) of the donors from New York, 7 of 4583 (0.15%) from Minnesota, and 11 of 8363 (0.13%) from New Mexico were found repeat reactive by EIA. Nine of the 56 EIA repeat-reactive donors (eight from New York and one from Minnesota) were positive by PCR. The specificity of the assay in a nonendemic population was 99.93%. Among IFA-positive clinical babesiosis patients, the sensitivity of the assay was 91.1%. CONCLUSION: The B. microti EIA detected PCR-positive, potentially infectious blood donors in an endemic population and exhibited high specificity among uninfected and unexposed individuals. The EIA promises to provide an effective tool for blood donor screening for B. microti in a format amenable to high-throughput and cost-effective screening.

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