![]() Test result does not meet either positive or indeterminate criteria.ĬDC/NYS Criteria: The Lyme IgG Western Blot is considered positive if 5 of the following 10 bands are present: 18, 23-25, 28, 30, 39, and 41, 45, 58, 66 and 83-93kDa. Thus, the following confirmation test of an Indeterminate Western Blot IgG result is recommended: Test # 489 31 kDa Epitope Test IgG. Therefore, when there a positive signal at position 31 kDa band, there is 50% chance (based on our internal review of patient data collected over years) that the positive signal is due to presence of Lyme specific antibody in patient serum. It is also present in some viruses and other spirochetes. One (Osp A) is a very specific marker of Lyme disease whereas the second antigen is a house keeping gene that can also present in some viruses and bacteria, including other spirochetes. Note: There are two Borrelia antigens present at 31kDa position on the Western blot strip. Two or more of the following bands are present: 23-25, 31, 34, 39, 41 and 83-93 kDa. 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.īased on internal validation studies, IGeneX established the following criteria: Positive If: For diagnostic purposes, Western blot 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 Lyme Western blot result with 31 and/or 34kDa may be present after Lyme vaccination in uninfected persons. The Lyme IgM Western Blot is considered positive if:Ģ of the following 3 bands are present: 23-25, 39, and 41kDa. Only bands 41 and 83-93kDa from the positive criteria are present OR if test result does not meet either positive or indeterminate criteria. Thus, the following confirmation test of an Indeterminate Western Blot IgM result is recommended: Test # 488 31kDa Epitope Test IgM. Only bands 31 and 41kDa OR only bands 31 and 83-93kDa are present. 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. Limitation: Positive ImmunoBlot result with 31 and/or 34kDa may be present after Lyme vaccination in uninfected persons.
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