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

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

doi:10.1111/trf.13618

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

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

School of Medicine

Research output: Contribution to journal › Article › peer-review

19 Scopus citations

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 language	English (US)
Pages (from-to)	1866-1874
Number of pages	9
Journal	Transfusion
Volume	56
Issue number	7
DOIs	https://doi.org/10.1111/trf.13618
State	Published - Jul 1 2016

ASJC Scopus subject areas

Immunology and Allergy
Immunology
Hematology

Access to Document

10.1111/trf.13618

Cite this

Levin, A. E., Williamson, P. C., Bloch, E. M., Clifford, J., Cyrus, S., Shaz, B. H., Kessler, D., Gorlin, J., Erwin, J. L., Krueger, N. X., Williams, G. V., Penezina, O., Telford, S. R., Branda, J. A., Krause, P. J., Wormser, G. P., Schotthoefer, A. M., Fritsche, T. R., & 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

Levin, AE, Williamson, PC, Bloch, EM, 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

@article{4f5b0a3ac575462bb5759a2905fa7d4f,

title = "Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay",

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.",

author = "Levin, {Andrew E.} and Williamson, {Phillip C.} and Bloch, {Evan M.} and Joan Clifford and Sherri Cyrus and Shaz, {Beth H.} and Debra Kessler and Jed Gorlin and Erwin, {James L.} and Krueger, {Neil X.} and Williams, {Greg V.} and Oksana Penezina and Telford, {Sam R.} and Branda, {John A.} and Krause, {Peter J.} and Wormser, {Gary P.} and Schotthoefer, {Anna M.} and Fritsche, {Thomas R.} and Busch, {Michael P.}",

note = "Publisher Copyright: {\textcopyright} 2016 The Authors Transfusion published by Wiley Periodicals, Inc. on behalf of AABB",

year = "2016",

month = jul,

day = "1",

doi = "10.1111/trf.13618",

language = "English (US)",

volume = "56",

pages = "1866--1874",

journal = "Transfusion",

issn = "0041-1132",

publisher = "Wiley-Blackwell",

number = "7",

}

TY - JOUR

T1 - Serologic screening of United States blood donors for Babesia microti using an investigational enzyme immunoassay

AU - Levin, Andrew E.

AU - Williamson, Phillip C.

AU - Bloch, Evan M.

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.

AU - Wormser, Gary P.

AU - Schotthoefer, Anna M.

AU - Fritsche, Thomas R.

AU - Busch, Michael P.

PY - 2016/7/1

Y1 - 2016/7/1

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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84977618216&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84977618216&partnerID=8YFLogxK

U2 - 10.1111/trf.13618

DO - 10.1111/trf.13618

M3 - Article

C2 - 27224258

AN - SCOPUS:84977618216

SN - 0041-1132

VL - 56

SP - 1866

EP - 1874

JO - Transfusion

JF - Transfusion

IS - 7

ER -

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

Abstract

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this