Concerns Regarding a New Culture Method for Borrelia burgdorferi Not Approved for the Diagnosis of Lyme Disease

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Personal Author:
  Nelson, Christina ; Hojvat, Sally ; Johnson, Barbara ; Petersen, Jeannine ; Schriefer, Marty ; Ben Beard, C. ; Petersen, Lyle ; Mead, Paul
• Description:
  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.
• Subjects:
  Borrelia Burgdorferi Culture Techniques Diagnostic Test Approval Humans Lyme Disease Reproducibility Of Results
• Source:
  MMWR Morbidity Mortal Weekly Rep. 2014; 63(15):333.
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Pubmed ID:
  24739342
• Pubmed Central ID:
  PMC5779394
• Document Type:
  Journal Article
• Name as Subject:
  Centers for Disease Control and Prevention (U.S.) ; United States. Food and Drug Administration.
• Place as Subject:
  United States
• Pages in Document:
  1 pdf page
• Volume:
  63
• Issue:
  15
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:e56625395859325e613a730f02b14a916a54abd4625b8267189e9757100dfe561bfed6d0b9a03a2cfd36ef8a6f9d0b22633013743f8dfa7ef2991aa55c207649
• Download URL:
  https://stacks.cdc.gov/view/cdc/53301/cdc_53301_DS1.pdf
• File Type:
  [PDF - 89.89 KB ]