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Fiction and Fact about the ELISA

Chemotherapy. 2006 Feb 22;52(2):53-59

Fiction: The Lyme enzyme-linked immunosorbent assay (ELISA) is the 'preferred method' to diagnose Lyme disease due to its 'sensitivity, adaptability to automation and ease of '.

Fact: The Lyme ELISA consistently misses at least 50% of Lyme disease cases due to the insensitivity of the assay and variability with antibiotic treatment [5, 6, 29,36] .

It follows that the 'two-tiered' testing system endorsed by the Centers for Disease Control and Prevention (CDC), which includes an ELISA screening test followed by a confirmatory Western blot, will also miss 50% of Lyme disease cases because a positive ELISA result is required to proceed to the 'confirmatory' Western blot test [29, 30] .

Parenthetically, the CDC criteria were developed for surveillance of Lyme disease, not for diagnostic purposes. This is an important distinction because it is inappropriate to apply surveillance criteria to symptomatic patients whose clinical picture already suggests the presence of Lyme disease. In fact, the clinical case rate for Lyme disease may be as much as 40 times greater than the CDC surveillance case rate [37] . Thus, in contrast to standardized blood testing for human immunodeficiency virus, there is currently no sanctioned, standardized, consistent serologic test for Lyme disease in the United States [5, 6, 29, 30] .

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