title: Concerns regarding a new culture method for Borrelia burgdorferi not approved for the diagnosis of Lyme disease.
abstract: 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.
authors.forename: Christina
authors.initials: C
authors.lastname: Nelson
authors.forename: Sally
authors.initials: S
authors.lastname: Hojvat
authors.forename: Barbara
authors.initials: B
authors.lastname: Johnson
authors.forename: Jeannine
authors.initials: J
authors.lastname: Petersen
authors.forename: Marty
authors.initials: M
authors.lastname: Schriefer
authors.forename: C Ben
authors.initials: CB
authors.lastname: Beard
authors.forename: Lyle
authors.initials: L
authors.lastname: Petersen
authors.forename: Paul
authors.initials: P
authors.lastname: Mead
mesh_terms: D025065:Borrelia burgdorferi / Q000302:isolation & purification*; D002487:Centers for Disease Control and Prevention, U.S.; D046508:Culture Techniques / Q000379:methods; D057069:Diagnostic Test Approval / Q000592:standards*; D006801:Humans; D008193:Lyme Disease / Q000175:diagnosis*; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration
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