Concerns Regarding a New Culture Method for Borrelia burgdorferi Not Approved for the Diagnosis of Lyme Disease
Some tests for Lyme disease are not
adequately validated and can be misleading to patients and health care
providers.
Recently,
CDC has received inquiries regarding a test that uses a novel culture method to
identify Borrelia
burgdorferi, the spirochete that causes Lyme disease. Published
methods and results for this test were reviewed by CDC. The review raised
serious concerns about false-positive results caused by laboratory contamination
and the potential for misdiagnosis and improper treatment of patients. This
situation highlights the importance of FDA clearance/approval of diagnostic
tests, which provides assurance that the test itself has adequate analytical
and clinical validation and is safe and effective. CDC recommends that
laboratory tests cleared by FDA be used to aid in the routine diagnosis of Lyme
disease.
0 comments :
Post a Comment