Deputy Director, Division of Vector-Borne Diseases
Centers for Disease Control and Prevention (CDC)
U.S. Department of Health and Human Services
Associate Editor, Emerging Infectious Diseases
Dr. Beard earned a B.S. in 1980 at Auburn University, a M.S. in 1983 at the Louisiana State University School of Medicine, and a Ph.D. in 1987 at the University of Florida. He was a post-doctoral fellow and associate research scientist at the Yale University School of Medicine from 1987 to 1991.
In 1991, he joined CDC’s Division of Parasitic Diseases, where he served as Chief of the Vector Genetics Section from 1999 to 2003. In 2003, he moved to CDC’s Division of Vector-Borne Diseases in Fort Collins, CO to become Chief of the Bacterial Diseases Branch.
In this capacity, he coordinated CDC’s programs on Lyme borreliosis, tick-borne relapsing fever, Bartonella, plague, and tularemia.
During his tenure at CDC, Dr. Beard has worked in the prevention of vector-borne diseases, both in the domestic and global arenas. In addition to his work as Chief of the Bacterial Diseases Branch, in 2011 Dr. Beard was appointed as the Associate Director for Climate Change in CDC’s National Center for Emerging and Zoonotic Infectious Diseases, where he coordinated CDC’s efforts to mitigate the potential impact of climate variability and disruption on infectious diseases in humans.
In 2017, he was appointed as the Acting Deputy Director of CDC’s Division of Vector-Borne Diseases. He has published over 125 scientific papers, books, and book chapters collectively, and has served on a variety of committees and panels both inside and outside of CDC, including working groups or advisory panels for the World Health Organization, the Bill & Melinda Gates Foundation, and the American Meteorological Society.
He is an Associate Editor for Emerging Infectious Diseases and past president of the Society for Vector Ecology and served as Deputy Incident Manager for CDC’s Zika virus outbreak response.
Source
https://www.hhs.gov/ash/advisory-committees/tickbornedisease/members/index.html
https://sites.google.com/view/marylandlyme/chronic-lyme/how-wrong-can-they-be
Last Updated- March 2020
Lucy Barnes
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From CDC website- March 4, 2020
When assessing a patient for Lyme disease, health care providers should consider:
CDC currently recommends a two-step testing process for Lyme disease. Both steps are required and can be done using the same blood sample. If this first step is negative, no further testing is recommended. If the first step is positive or indeterminate (sometimes called “equivocal”), the second step should be performed. The overall result is positive only when the first test is positive (or equivocal) and the second test is positive (or for some tests equivocal).
New tests may be developed as alternatives to one or both steps of the two-step process. Before CDC will recommend new tests, they must be cleared by the Food and Drug Administration (FDA). For more details, see: Recommendations for Test Performance and Interpretation from the Second National Conference on Serologic Diagnosis of Lyme Disease.
NEW! Updated CDC Recommendation for Serologic Diagnosis of Lyme Disease
Page last reviewed: November 20, 2019
Content source: Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Vector-Borne Diseases (DVBD)
https://www.cdc.gov/lyme/diagnosistesting/index.html
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Morbidity and Mortality Weekly Report (MMWR)
Weekly / August 16, 2019 / 68(32);703
Paul Mead, MD1; Jeannine Petersen, PhD1; Alison Hinckley, PhD1 (View author affiliations)
What is already known about this topic?
Serologic testing is the principal means of laboratory diagnosis of Lyme disease. Current recommendations include using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay, followed by a western immunoblot assay for specimens yielding positive or equivocal results.
What is added by this report?
On July 29, 2019, the Food and Drug Administration (FDA) cleared several Lyme disease serologic assays with new indications for use, allowing for an EIA rather than western immunoblot assay as the second test in a Lyme disease testing algorithm.
What are the indications for public health practice?
When cleared by FDA for this purpose, serologic assays that utilize a second EIA in place of western immunoblot assay are acceptable alternatives for the serologic diagnosis of Lyme disease.
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Lyme disease is a tickborne zoonosis for which serologic testing is the principal means of laboratory diagnosis. In 1994, the Association of State and Territorial Public Health Laboratory Directors, CDC, the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Council of State and Territorial Epidemiologists, and the National Committee for Clinical Laboratory Standards convened the Second National Conference on Serologic Diagnosis of Lyme Disease (1).
The conference proceedings recommended a two-test methodology using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay as a first test, followed by a western immunoblot assay for specimens yielding positive or equivocal results (1,2). Regarding the development of future tests, the report advised that evaluation of new serologic assays include blind testing against a comprehensive challenge panel, and that new assays should only be recommended if their specificity, sensitivity, and precision equaled or surpassed the performance of tests used in the recommended two-test procedure. To assist serologic test developers, CDC has made available, with support from NIH, a comprehensive panel of sera from patients with various stages of Lyme disease and other conditions, as well as healthy persons (3).
On July 29, 2019, FDA cleared several Lyme disease serologic assays with new indications for use based on a modified two-test methodology (4). The modified methodology uses a second EIA in place of a western immunoblot assay. Clearance by FDA of the new Lyme disease assays indicates that test performance has been evaluated and is “substantially equivalent to or better than” a legally marketed predicate test.
When cleared by FDA for this purpose, serologic assays that utilize EIA rather than western immunoblot assay in a two-test format are acceptable alternatives for the laboratory diagnosis of Lyme disease. Based on the criteria established at the 1994 Second National Conference on Serologic Diagnosis of Lyme Disease, clinicians and laboratories should consider serologic tests cleared by FDA as CDC-recommended procedures for Lyme disease serodiagnosis.
Corresponding author: Paul Mead, pmead@cdc.gov, 970-221-6474.
1Division of Vector-borne Diseases, National Center for Emerging and Zoonotic Infectious Diseases, CDC.
All authors have completed and submitted the ICMJE form for disclosure of potential conflicts of interest. No potential conflicts of interest were disclosed.
Suggested citation for this article: Mead P, Petersen J, Hinckley A. Updated CDC Recommendation for Serologic Diagnosis of Lyme Disease. MMWR Morb Mortal Wkly Rep 2019;68:703. DOI: http://dx.doi.org/10.15585/mmwr.mm6832a4external icon.
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Page last reviewed: August 15, 2019
Content source: Centers for Disease Control and Prevention
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