Concerns Regarding a New Culture Method for Borrelia burgdorferi Not Approved for the Diagnosis of Lyme Disease
In 2005, CDC and the Food and Drug Administration (FDA) issued a warning regarding the use of Lyme disease tests whose accuracy and clinical usefulness have not been adequately established. Often these are laboratory-developed tests (also known as "home brew" tests) that are manufactured and used within a single laboratory and have not been cleared or approved by FDA. Recently, CDC has received inquiries regarding a laboratory-developed test that uses a novel culture method to identify Borrelia burgdorferi, the spirochete that causes Lyme disease. Patient specimens reportedly are incubated using a two-step pre-enrichment process, followed by immunostaining with or without polymerase chain reaction (PCR) analysis. Specimens that test positive by immunostaining or PCR are deemed "culture positive". Published methods and results for this laboratory-developed test have been reviewed by CDC. The review raised serious concerns about false-positive results caused by laboratory contamination and the potential for misdiagnosis.
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ABSTRACT: Lyme disease has become a global public health problem and a prototype of an emerging infection. Both treatment-refractory infection and symptoms that are related to Borrelia burgdorferi infection remain subject to controversy. Because of the absence of solid evidence on prevalence, causes, diagnostic criteria, tools and treatment options, the role of autoimmunity to residual or persisting antigens, and the role of a toxin or other bacterial-associated products that are responsible for the symptoms and signs, chronic Lyme disease (CLD) remains a relatively poorly understood chronic disease construct. The role and performance of family medicine in the detection, integrative treatment, and follow-up of CLD are not well studied either. The purpose of this paper is to describe insights into the complexity of CLD as a multidimensional chronic disease construct and its relevance to family medicine by means of a systematic literature review.
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ABSTRACT: Diagnostic testing for Lyme disease in the clinical setting primarily relies on assessment of serologic responses to infection, with the exception of the early localized phase of disease, in which the diagnosis must be made clinically, due to the recognized insensitivity of serologic testing at this phase of disease. For the diagnosis of early disseminated and late disease, the Centers for Disease Control and Prevention (CDC) recommends a two-tiered approach to testing consisting of initial IgM and IgG quantitative enzyme-linked immunosorbent assay (ELISA), followed by confirmation of all indeterminate or positive ELISA tests with separate IgG and IgM Western blots. This critical analysis addresses the sensitivity, specificity, and predictive value of serologic testing for Lyme disease in early localized, early disseminated, and late disease. Other testing modalities currently under evaluation are also discussed, including IgG vlsE C6 peptide ELISA, other two-tiered testing strategies, rapid diagnostics, and PCR. An understanding of the strengths and limitations of currently available testing for Lyme disease is critical for appropriate diagnosis.