ELISA LYME TESTS
Received Jan 7, 2015
Report MW5040163 · MDR key 4412325
Device
Generic name
Elisa Lyme Tests
Product problems
- Material Integrity Problem
Patient
Not reported
- Misdiagnosis
Narrative
Description of Event or Problem
I WAS MISDIAGNOSED AS NOT HAVING LYME USING THE CURRENT ELISA AND WESTERN BLOT TESTS. THEN, YEARS LATER, THOSE SAME TESTS DEMONSTRATED I WAS POSITIVE FOR LYME. NOW, USING THOSE SAME TESTS, I STILL TEST POSITIVE FOR LYME, AND I TEST POSITIVE USING THE NEW C6 PEPTIDE TEST MANY ARE ENDORSING TO REPLACE THE ELISA, AND YET I AM TOLD THOSE TESTS CANNOT BE CORRECT - THAT I CANNOT POSSIBLY STILL HAVE LYME. SO THE VERY INDIVIDUALS THAT PROMOTE ALL THREE OF THOSE TESTS TELL ME THEY CANNOT BE TRUSTED BECAUSE THEY THINK I CANNOT STILL HAVE LYME. WHAT DOES THAT SAY ABOUT THE EFFICACY OF THOSE TESTS? WHAT DOES IT SAY ABOUT THE DOGMA OF THEIR PROMOTERS AS WELL? I WAS DENIED TREATMENT FOR LYME ENCEPHALOPATHY FOR MANY YEARS BECAUSE OF THE UNRELIABILITY OF CURRENT CDC ENDORSED 2T TESTING. WE NEED NEW TESTS THAT WORK, AND I FEAR THE CURRENT CROP OF DIAGNOSTIC MANUFACTURERS IS LESS THAN INCENTIVIZED TO ALTER A STATUS QUO THAT IS GENERATING FOR THEM HALF A BILLION IN REVENUE EACH YEAR.