Transcription of Laboratory Diagnostic Testing for Borrelia …
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4 Laboratory Diagnostic Testing for Borrelia burgdorferi Infection1 Barbara Johnson Introduction Serology is the only standardized type of Laboratory Testing available to support the clinical diagnosis of Lyme borreliosis (Lyme disease) in the USA. It is also the only type of Diagnostic Testing approved by the US Food and Drug Administration (FDA). Of the 77 devices cleared by the FDA for in vitro Diagnostic use for Lyme disease, all are designed to detect immune responses to antigens of Borrelia burgdorferi sensu stricto, particularly IgM and IgG (FDA, 2010).
Laboratory Diagnostic Testing for Borrelia burgdorferi Infection 75 controls and is specifi c to each test. Further information is needed from a second test in
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