inforMED
MalfunctionLSR

ELISA TEST FOR LYME

Received Nov 17, 2014

Report MW5039182 · MDR key 4270723

Device

Generic name

Elisa Test For Lyme

Product problems

  • False Negative Result

Patient

30 YR

  • Misdiagnosis
  • Disability

Narrative

Description of Event or Problem

I WAS GIVEN THE ELISA TEST FOR LYME DISEASE IN 2006 AFTER A SERIES OF HEALTH PROBLEMS AND TESTED NEGATIVE FOR LYME. I WENT ON TO BELIEVE I WAS DEALING WITH SOMETHING OTHER THAN LYME DISEASE AND GOT SICKER AND SICKER TO THE POINT OF BEING HOUSEBOUND AND SO ILL I COULD NOT FUNCTION. I WENT ON TO BE TOLD BY DOCTORS THAT I HAD CHRONIC FATIGUE SYNDROME AND FIBROMYALGIA, UNTIL SOMEONE FINALLY THOUGHT TO RUN A MORE SENSITIVE TEST CALLED THE WESTERN BLOT IN 2014. I WAS POSITIVE FOR LYME DISEASE AND WENT ON TO BE TREATED PROPERLY. I NEVER SHOULD HAVE HAD TO LOSE SO MUCH OF MY LIFE, BECOME DISABLED, AND LOSE A CAREER BECAUSE OF A FAULTY TEST. THE ELISA MISSES ALMOST 50% OF ALL LYME DISEASE. WHY WOULD YOU MAKE THAT THE STANDARD TEST FOR DOCTORS TO RUN, BY SUPPORTING THE USE OF THIS TEST, YOU ARE SUPPORTING DOCTORS TO TELL PEOPLE THEY ARE LYME FREE AND GIVE THEM FALSE DIAGNOSIS FOR OTHER DISEASES THAT HAVE SIMILAR SYMPTOMS.