@article{36645be16d374dc4a1d125c7780682d6,
title = "Advances in Serodiagnostic Testing for Lyme Disease Are at Hand",
abstract = "The cause of Lyme disease, Borrelia burgdorferi, was discovered in 1983. A 2-tiered testing protocol was established for serodiagnosis in 1994, involving an enzyme immunoassay (EIA) or indirect fluorescence antibody, followed (if reactive) by immunoglobulin M and immunoglobulin G Western immunoblots. These assays were prepared from whole-cell cultured B. burgdorferi, lacking key in vivo expressed antigens and expressing antigens that can bind non-Borrelia antibodies. Additional drawbacks, particular to the Western immunoblot component, include low sensitivity in early infection, technical complexity, and subjective interpretation when scored by visual examination. Nevertheless, 2-tiered testing with immunoblotting remains the benchmark for evaluation of new methods or approaches. Next-generation serologic assays, prepared with recombinant proteins or synthetic peptides, and alternative testing protocols, can now overcome or circumvent many of these past drawbacks. This article describes next-generation serodiagnostic testing for Lyme disease, focusing on methods that are currently available or near-at-hand.",
keywords = "Borrelia burgdorferi, Diagnosis, Lyme disease, Serology, Tests",
author = "Branda, {John A.} and Body, {Barbara A.} and Jeff Boyle and Branson, {Bernard M.} and Dattwyler, {Raymond J.} and Erol Fikrig and Gerald, {Noel J.} and Maria Gomes-Solecki and Martin Kintrup and Michel Ledizet and Levin, {Andrew E.} and Michael Lewinski and Liotta, {Lance A.} and Adriana Marques and Mead, {Paul S.} and Mongodin, {Emmanuel F.} and Segaran Pillai and Prasad Rao and Robinson, {William H.} and Roth, {Kristian M.} and Schriefer, {Martin E.} and Thomas Slezak and Jessica Snyder and Steere, {Allen C.} and Jan Witkowski and Wong, {Susan J.} and Schutzer, {Steven E.}",
note = "Funding Information: Potential conflicts of interest. J. A. B. has received research funding from Immunetics, bioMerieux, Alere, DiaSorin, and the Bay Area Lyme Foundation; he is a consultant to T2 Biosystems. A. R. M. is a co-inventor on a US patent using the luciferase immunoprecipitation systems assay for profiling antibody responses to a panel of B. burgdorferi proteins. J. L. S. is an employee and shareholder of T2 Biosystems. B. A. B. was a Vice President and Director at Laboratory Corporation of America, from whom she received salary including stock as compensation. She served on advisory boards for Roche Diagnostics and Roche Molecular Systems. Funding Information: She retired in January 2017 and formed BAB Dx Solution Pathways, LLC. L. A. L. receives funding from the Commonwealth of Virginia, and the NIH, and is a shareholder in Ceres Nanosciences. M.K. is president and CEO of Viramed Biotech AG. B. M. B. reports consultancies with FHI 360, Gilead Sciences, and Siemens Healthcare Diagnostics. R. J. D. has an ownership stake in Biopeptides Corp. and has received research funding from BioRad. M. L. is employed by Roche Molecular Systems, Inc. T. S. is currently a board member of LexaGene, an early-stage PCR diagnostic instrumentation company. He was previously a consultant at 10X Genomics from 2014 to 2016. A. E. L. was an employee of Immunetics, Inc., which developed and markets the C6 ELISA test, and prior to October, 2016, held stock ownership in Immunetics. J. B. is employed by Qiagen. All other authors report no conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Funding Information: Disclaimer. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US government. This publication is not an official US Food and Drug Administration guidance or policy statement. The meeting referred to in the text was supported by Cold Spring Harbor Laboratory Banbury Center, with a meeting grant from the Global Lyme Alliance. Meeting sponsors had no participation in the content of the meeting, or in preparation of the manuscript. Funding Information: Financial support. Participants gratefully acknowledge that, throughout many years, research in this area was supported in part by the Intramural and Extramural Research Programs of the National Institutes of Health (NIH), NIAID. Publisher Copyright: {\textcopyright} The Author(s) 2017.",
year = "2018",
month = mar,
day = "19",
doi = "10.1093/cid/cix943",
language = "English (US)",
volume = "66",
pages = "1133--1139",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "7",
}