Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay

Andrew E. Levin, Phillip C. Williamson, James L. Erwin, Sherri Cyrus, Evan Bloch, Beth H. Shaz, Debra Kessler, Sam R. Telford, Peter J. Krause, Gary P. Wormser, Xiaoyan Ni, Haihong Wang, Neil X. Krueger, Sally Caglioti, Michael P. Busch

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Transfusion-transmitted babesiosis caused by Babesia microti has emerged as a significant risk to the US blood supply. This study estimated the prevalence of B. microti antibodies in blood donors using an investigational enzyme immunoassay (EIA). STUDY DESIGN AND METHODS: A peptide-based EIA that detects both immunoglobulin (Ig)G and IgM antibodies to B. microti was developed and validated. Donor samples randomly selected from areas defined as high-risk endemic, lower-risk endemic, and nonendemic for B. microti were deidentified and tested using the investigational EIA. Samples that were EIA repeat reactive were further tested by B. microti immunofluorescent assay (IFA), polymerase chain reaction (PCR) on red blood cell lysates, and peripheral blood smear examination. A random subset of 1272 samples from high-risk endemic areas was tested by IFA, PCR, and peripheral blood smear in parallel with EIA. RESULTS: Among 15,000 donations tested with the investigational B. microti EIA, EIA repeat-reactive rates were 1.08% (54/5000) in a high-risk endemic area, 0.74% (37/5000) in a lower-risk area, and 0.40% (20/ 5000) in a nonendemic area. After application of a revised cutoff, these values were reduced to 0.92%, (46/5000), 0.54% (27/5000), and 0.16% (8/5000). Overall concordance between EIA and IFA among donor samples was 99.34%. One seropositive sample was positive by PCR. CONCLUSION: The seroprevalence of B. microti in blood donors in a high-risk area measured by an investigational EIA was approximately 1%. The EIA shows promise as an efficient high-throughput blood donor screening assay for B. microti.

Original languageEnglish (US)
Pages (from-to)2237-2244
Number of pages8
JournalTransfusion
Volume54
Issue number9
DOIs
StatePublished - 2014
Externally publishedYes

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Babesia microti
Seroepidemiologic Studies
Blood Donors
Immunoenzyme Techniques
Population
Polymerase Chain Reaction
Tissue Donors
Babesiosis
Donor Selection
Antibodies
Immunoglobulin M

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Hematology

Cite this

Levin, A. E., Williamson, P. C., Erwin, J. L., Cyrus, S., Bloch, E., Shaz, B. H., ... Busch, M. P. (2014). Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay. Transfusion, 54(9), 2237-2244. https://doi.org/10.1111/trf.12763

Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay. / Levin, Andrew E.; Williamson, Phillip C.; Erwin, James L.; Cyrus, Sherri; Bloch, Evan; Shaz, Beth H.; Kessler, Debra; Telford, Sam R.; Krause, Peter J.; Wormser, Gary P.; Ni, Xiaoyan; Wang, Haihong; Krueger, Neil X.; Caglioti, Sally; Busch, Michael P.

In: Transfusion, Vol. 54, No. 9, 2014, p. 2237-2244.

Research output: Contribution to journalArticle

Levin, AE, Williamson, PC, Erwin, JL, Cyrus, S, Bloch, E, Shaz, BH, Kessler, D, Telford, SR, Krause, PJ, Wormser, GP, Ni, X, Wang, H, Krueger, NX, Caglioti, S & Busch, MP 2014, 'Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay', Transfusion, vol. 54, no. 9, pp. 2237-2244. https://doi.org/10.1111/trf.12763
Levin, Andrew E. ; Williamson, Phillip C. ; Erwin, James L. ; Cyrus, Sherri ; Bloch, Evan ; Shaz, Beth H. ; Kessler, Debra ; Telford, Sam R. ; Krause, Peter J. ; Wormser, Gary P. ; Ni, Xiaoyan ; Wang, Haihong ; Krueger, Neil X. ; Caglioti, Sally ; Busch, Michael P. / Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay. In: Transfusion. 2014 ; Vol. 54, No. 9. pp. 2237-2244.
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abstract = "BACKGROUND: Transfusion-transmitted babesiosis caused by Babesia microti has emerged as a significant risk to the US blood supply. This study estimated the prevalence of B. microti antibodies in blood donors using an investigational enzyme immunoassay (EIA). STUDY DESIGN AND METHODS: A peptide-based EIA that detects both immunoglobulin (Ig)G and IgM antibodies to B. microti was developed and validated. Donor samples randomly selected from areas defined as high-risk endemic, lower-risk endemic, and nonendemic for B. microti were deidentified and tested using the investigational EIA. Samples that were EIA repeat reactive were further tested by B. microti immunofluorescent assay (IFA), polymerase chain reaction (PCR) on red blood cell lysates, and peripheral blood smear examination. A random subset of 1272 samples from high-risk endemic areas was tested by IFA, PCR, and peripheral blood smear in parallel with EIA. RESULTS: Among 15,000 donations tested with the investigational B. microti EIA, EIA repeat-reactive rates were 1.08{\%} (54/5000) in a high-risk endemic area, 0.74{\%} (37/5000) in a lower-risk area, and 0.40{\%} (20/ 5000) in a nonendemic area. After application of a revised cutoff, these values were reduced to 0.92{\%}, (46/5000), 0.54{\%} (27/5000), and 0.16{\%} (8/5000). Overall concordance between EIA and IFA among donor samples was 99.34{\%}. One seropositive sample was positive by PCR. CONCLUSION: The seroprevalence of B. microti in blood donors in a high-risk area measured by an investigational EIA was approximately 1{\%}. The EIA shows promise as an efficient high-throughput blood donor screening assay for B. microti.",
author = "Levin, {Andrew E.} and Williamson, {Phillip C.} and Erwin, {James L.} and Sherri Cyrus and Evan Bloch and Shaz, {Beth H.} and Debra Kessler and Telford, {Sam R.} and Krause, {Peter J.} and Wormser, {Gary P.} and Xiaoyan Ni and Haihong Wang and Krueger, {Neil X.} and Sally Caglioti and Busch, {Michael P.}",
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T1 - Determination of Babesia microti seroprevalence in blood donor populations using an investigational enzyme immunoassay

AU - Levin, Andrew E.

AU - Williamson, Phillip C.

AU - Erwin, James L.

AU - Cyrus, Sherri

AU - Bloch, Evan

AU - Shaz, Beth H.

AU - Kessler, Debra

AU - Telford, Sam R.

AU - Krause, Peter J.

AU - Wormser, Gary P.

AU - Ni, Xiaoyan

AU - Wang, Haihong

AU - Krueger, Neil X.

AU - Caglioti, Sally

AU - Busch, Michael P.

PY - 2014

Y1 - 2014

N2 - BACKGROUND: Transfusion-transmitted babesiosis caused by Babesia microti has emerged as a significant risk to the US blood supply. This study estimated the prevalence of B. microti antibodies in blood donors using an investigational enzyme immunoassay (EIA). STUDY DESIGN AND METHODS: A peptide-based EIA that detects both immunoglobulin (Ig)G and IgM antibodies to B. microti was developed and validated. Donor samples randomly selected from areas defined as high-risk endemic, lower-risk endemic, and nonendemic for B. microti were deidentified and tested using the investigational EIA. Samples that were EIA repeat reactive were further tested by B. microti immunofluorescent assay (IFA), polymerase chain reaction (PCR) on red blood cell lysates, and peripheral blood smear examination. A random subset of 1272 samples from high-risk endemic areas was tested by IFA, PCR, and peripheral blood smear in parallel with EIA. RESULTS: Among 15,000 donations tested with the investigational B. microti EIA, EIA repeat-reactive rates were 1.08% (54/5000) in a high-risk endemic area, 0.74% (37/5000) in a lower-risk area, and 0.40% (20/ 5000) in a nonendemic area. After application of a revised cutoff, these values were reduced to 0.92%, (46/5000), 0.54% (27/5000), and 0.16% (8/5000). Overall concordance between EIA and IFA among donor samples was 99.34%. One seropositive sample was positive by PCR. CONCLUSION: The seroprevalence of B. microti in blood donors in a high-risk area measured by an investigational EIA was approximately 1%. The EIA shows promise as an efficient high-throughput blood donor screening assay for B. microti.

AB - BACKGROUND: Transfusion-transmitted babesiosis caused by Babesia microti has emerged as a significant risk to the US blood supply. This study estimated the prevalence of B. microti antibodies in blood donors using an investigational enzyme immunoassay (EIA). STUDY DESIGN AND METHODS: A peptide-based EIA that detects both immunoglobulin (Ig)G and IgM antibodies to B. microti was developed and validated. Donor samples randomly selected from areas defined as high-risk endemic, lower-risk endemic, and nonendemic for B. microti were deidentified and tested using the investigational EIA. Samples that were EIA repeat reactive were further tested by B. microti immunofluorescent assay (IFA), polymerase chain reaction (PCR) on red blood cell lysates, and peripheral blood smear examination. A random subset of 1272 samples from high-risk endemic areas was tested by IFA, PCR, and peripheral blood smear in parallel with EIA. RESULTS: Among 15,000 donations tested with the investigational B. microti EIA, EIA repeat-reactive rates were 1.08% (54/5000) in a high-risk endemic area, 0.74% (37/5000) in a lower-risk area, and 0.40% (20/ 5000) in a nonendemic area. After application of a revised cutoff, these values were reduced to 0.92%, (46/5000), 0.54% (27/5000), and 0.16% (8/5000). Overall concordance between EIA and IFA among donor samples was 99.34%. One seropositive sample was positive by PCR. CONCLUSION: The seroprevalence of B. microti in blood donors in a high-risk area measured by an investigational EIA was approximately 1%. The EIA shows promise as an efficient high-throughput blood donor screening assay for B. microti.

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