The ELISA test is unreliable, and misses 35% of culture proven Lyme (only 65% sensitivity!) and is unacceptable as the first step of a two step screening protocol. (By definition a screening test should have 95% sensitivity.)
Of patients with acute culture proven Lyme disease, 20-30% remain seronegative on serial Western Blot sampling. Antibody titers also appear to decline over time; thus, the IgG Western Blot is even less sensitive in detecting chronic Lyme infection yet the IgM Western Blot may work. For "epidemiological purposes" the CDC eliminated from the Western Blot analysis the reading of bands 31 and 34. These bands are so specific to Borrelia burgdorferi that they have been chosen for vaccine development. However, for patients not vaccinated for Lyme, a positive 31 or 34 band is highly indicative of Borrelia burgdorferi exposure.
When used as a part of a diagnostic evaluation for Lyme disease, the Western Blot should be performed by a laboratory that reads and reports on all 16 bands as part of their routine comprehensive analysis. Laboratories (such as SmithKline) that use FDA approved kits (for instance, Mardex's Marblot) are restricted from reporting all of the bands, as they must abide by the rules of the manufacturer. These rules are set up in accordance with the CDCs surveillance criteria. and increase the risk of false negative results. These kits may be OK for surveillance purposes, but offer too scanty of an analysis to be useful in patient management.
PCR assay and detection of pieces of the spirochete through antigen assays both give stronger indication of the presence of the Lyme pathogen; but currently these tests don???t conclusively prove that live Bb spirochete are present and causing active illness. PCR tests are now available, and although they are very specific, sensitivity remains poor, possibly less than 30%. This is because Bb causes a deep tissue infection and is only transiently found in body humors. Therefore, just as in routine blood culturing, multiple specimens must be collected to increase yield; a negative result does not rule out infection, but a positive one is significant.
5. Bowen "Rapid Identification of Borrelia burgdorferi" (RIBb). The Bb antigen is identified by the presence of fluorescing structures upon microscopy. At Bowen Research & Training Institute, Inc., located in Palm Harbor , Florida , ongoing research is being conducted using the Bowen Q-RIBb (Quantitative Rapid Identification of Borrelia burgdorferi) test developed by Dr. JoAnne Whitaker. Originally a CLIA approved lab until April of 2003, the institute, lacking in vital grant funding, changed its status from that of a clinical lab to a research facility under the State of Florida Health Department. Since its inception, the main focus at the institute has been the development of an accurate test for the Borrelia burgdorferi (Bb) antigen, the causative agent of Lyme disease. The Bowen Q-RIBb test just recently received its preliminary US Patent approval. Although the Bowen Q-RiBb Test is not presently approved by the FDA for Lyme disease; an application for FDA approval is now pending.
If you have lead poisoning than when you are detoxed you should feel a lot better! The lead has probably caused all of your problems. That sux. Glad they finally found it. Maniclion, you are right on the same track as I am!! Good luck to you oaktown!
