Direct Diagnostic Tests for Lyme Disease

Steven E Schutzer¹, Barbara A Body², Jeff Boyle³, Bernard M Branson⁴, Raymond J Dattwyler⁵, Erol Fikrig⁶, Noel J Gerald⁷, Maria Gomes-Solecki⁸, Martin Kintrup⁹, Michel Ledizet¹⁰, Andrew E Levin¹¹, Michael Lewinski¹², Lance A Liotta¹³, Adriana Marques¹⁴, Paul S Mead¹⁵, Emmanuel F Mongodin¹⁶, Segaran Pillai¹⁷, Prasad Rao⁷, William H Robinson¹⁸, Kristian M Roth⁷, Martin E Schriefer¹⁵, Thomas Slezak¹⁹, Jessica L Snyder²⁰, Allen C Steere²¹, Jan Witkowski²², Susan J Wong²³, John A Branda²⁴

Affiliations

¹ Department of Medicine, Rutgers New Jersey Medical School, Newark.
² Laboratory Corporation of America, Burlington, North Carolina.
³ Qiagen, Inc., Germantown, Maryland.
⁴ Scientific Affairs, LLC, Atlanta, Georgia.
⁵ Department of Microbiology/Immunology, New York Medical College, Valhalla.
⁶ Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
⁷ Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland.
⁸ Department of Microbiology, Immunology and Biochemistry, University of Tennessee Health Science Center, Memphis.
⁹ Viramed Biotech AG, Planegg, Germany.
¹⁰ L2 Diagnostics, LLC, New Haven, Connecticut.
¹¹ Kephera Diagnostics, Wellesley, Massachusetts.
¹² Roche Diagnostics, Pleasanton, California.
¹³ Center for Applied Proteomics and Molecular Medicine, College of Science, George Mason University, Manassas, Virginia.
¹⁴ Clinical Studies Unit, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
¹⁵ Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado.
¹⁶ Department of Microbiology and Immunology, University of Maryland School of Medicine, Baltimore.
¹⁷ Office of Laboratory Science and Safety, US Food and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland.
¹⁸ Department of Medicine, Stanford University School of Medicine, California.
¹⁹ Lawrence Livermore National Laboratory, California.
²⁰ T2 Biosystems, Inc., Lexington, Massachusetts.
²¹ Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston.
²² Cold Spring Harbor Laboratory, New York.
²³ Wadsworth Center, New York State Department of Health, Albany.
²⁴ Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston.

PMID: 30307486
PMCID: PMC6399434
DOI: 10.1093/cid/ciy614

Review

Direct Diagnostic Tests for Lyme Disease

Steven E Schutzer et al. Clin Infect Dis. 2019.

. 2019 Mar 5;68(6):1052-1057.

doi: 10.1093/cid/ciy614.

Authors

Affiliations

¹ Department of Medicine, Rutgers New Jersey Medical School, Newark.
² Laboratory Corporation of America, Burlington, North Carolina.
³ Qiagen, Inc., Germantown, Maryland.
⁴ Scientific Affairs, LLC, Atlanta, Georgia.
⁵ Department of Microbiology/Immunology, New York Medical College, Valhalla.
⁶ Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
⁷ Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland.
⁸ Department of Microbiology, Immunology and Biochemistry, University of Tennessee Health Science Center, Memphis.
⁹ Viramed Biotech AG, Planegg, Germany.
¹⁰ L2 Diagnostics, LLC, New Haven, Connecticut.
¹¹ Kephera Diagnostics, Wellesley, Massachusetts.
¹² Roche Diagnostics, Pleasanton, California.
¹³ Center for Applied Proteomics and Molecular Medicine, College of Science, George Mason University, Manassas, Virginia.
¹⁴ Clinical Studies Unit, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
¹⁵ Division of Vector-Borne Diseases, Centers for Disease Control and Prevention, Fort Collins, Colorado.
¹⁶ Department of Microbiology and Immunology, University of Maryland School of Medicine, Baltimore.
¹⁷ Office of Laboratory Science and Safety, US Food and Drug Administration, Department of Health and Human Services, Silver Spring, Maryland.
¹⁸ Department of Medicine, Stanford University School of Medicine, California.
¹⁹ Lawrence Livermore National Laboratory, California.
²⁰ T2 Biosystems, Inc., Lexington, Massachusetts.
²¹ Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston.
²² Cold Spring Harbor Laboratory, New York.
²³ Wadsworth Center, New York State Department of Health, Albany.
²⁴ Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston.

PMID: 30307486
PMCID: PMC6399434
DOI: 10.1093/cid/ciy614

Abstract

Borrelia burgdorferi was discovered to be the cause of Lyme disease in 1983, leading to seroassays. The 1994 serodiagnostic testing guidelines predated a full understanding of key B. burgdorferi antigens and have a number of shortcomings. These serologic tests cannot distinguish active infection, past infection, or reinfection. Reliable direct-detection methods for active B. burgdorferi infection have been lacking in the past but are needed and appear achievable. New approaches have effectively been applied to other emerging infections and show promise in direct detection of B. burgdorferi infections.

Keywords: Borrelia burgdorferi; Lyme disease; PCR; high-throughput sequencing; tests.

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References

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1. Steere AC, Sikand VK, Meurice F, et al. . Vaccination against Lyme disease with recombinant Borrelia burgdorferi outer-surface lipoprotein A with adjuvant. Lyme Disease Vaccine Study Group. N Engl J Med 1998; 339:209–15. - PubMed
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1. Branda JA, Body BA, Boyle J, et al. . Advances in serodiagnostic testing for Lyme disease are at hand. Clin Infect Dis 2017; 66:1133–39. - PMC - PubMed
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Direct Diagnostic Tests for Lyme Disease

Affiliations

Direct Diagnostic Tests for Lyme Disease

Authors

Affiliations

Abstract

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

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