CONGRESS has forced the FDA to do their jobs and assure Lyme testing meets FDA Validation criteria. The result is that now you can report your CDC, Dearborn, Two-Tiered Testing Criteria Adverse Event to MedWatch. Now, lets be clear: the only VALIDATED testing for Lyme according to the FDAs Rules on a Validation of an Analytical Method is the Yale Flagellin Method: actionlyme.org/CRYMEDISEASE_CHP1.htm HERE IS THE QUOTE FROM THE NEW JULY 31 FDA DOCUMENT ON WHAT THOSE CRITERIA ARE (Page 8): Under the FD&C Act, the FDA assures both the analytical validity (e.g., analytical specificity and sensitivity, accuracy and precision) and clinical validity of diagnostic tests through its premarket clearance or approval process. In addition to premarket review, FDA requirements provide other controls to ensure appropriate design, manufacture, and safety and effectiveness of the device. fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm407409.pdf ========================== THIS IS A VALIDATION PER THE FDA RULES: Here is the original 1991 Fikrig/Flavell report that goes with the USPTO.gov # 5,618,533 patent: The earliest humoral response in patients infected with Borrelia burgdorferi, the agent of Lyme disease, is directed against the spirochetes 41-kDa flagellar antigen. In order to map the epitopes recognized on this antigen, 11 overlapping fragments spanning the flagellin gene were cloned by polymerase chain reaction and inserted into an Escherichia coli expression vector which directed their expression as fusion proteins containing glutathione S-transferase at the N terminus and a flagellin fragment at the C terminus. Affinity-purified fusion proteins were assayed for reactivity on Western blots (immunoblots) with sera from patients with late-stage Lyme disease. The same immunodominant domain was bound by sera from 17 of 18 patients. This domain (comprising amino acids 197 to 241) does not share significant homology with other bacterial flagellins and therefore may be useful in serological testing for Lyme disease. ncbi.nlm.nih.gov/pubmed/1894359
Posted on: Fri, 29 Aug 2014 01:15:49 +0000
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