Negative: If only bands 41 kDa and 83-93 kDa are present. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.īased on internal validation studies, IGeneX established the following criteria: Positive If two or more of the following bands are present:Ģ3-25, 31, 34, 39, 41 and 83-93 kDa.

The test is used for clinical purposes and should not be regarded as investigational or for research. The FDA has determined that such approval is not necessary. It has not been cleared or approved by the FDA. If only one of the following bands: 23, 31, 34, 39 and 93kDa is present or if one or more of these bands are indeterminate on the ImmunoBlot, testing with another method or retesting after 6-8 weeks is recommended.ĭisclaimer: This test was developed and its performance characteristics determined by IGeneX, Inc. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. A positive result suggests exposure to B. Viral antibodies cross react with the 93kDa antigen.

Limitation: Positive ImmunoBlot result with 31 and/or 34kDa may be present after Lyme vaccination in uninfected persons.

The most negative ifa odus