ELISA
Received Oct 26, 2014 · Event occurred Oct 1, 2008
Report MW5038857 · MDR key 4216962
Device
Generic name
Elisa
Product problems
- False Negative Result
Patient
38 YR
- Complaint, Ill-Defined
- Disability
Narrative
Description of Event or Problem
IN 2008, THE TWO TIERED TESTING OF LYME DISEASE WITH STANDARD ELISA AND WESTERN BLOT WERE USED ON ME. THEY SHOWED FALSE NEGATIVES WHILE I CONTINUED TO SUFFER MANIFEST SYMPTOMS OF LYME DISEASE. AFTER SUFFERING FOR 2 YEARS, I FINALLY WAS TESTED USING (B)(4) LABS. THIS ALLOWED TREATMENT AND GREAT IMPROVEMENT FROM MY SYMPTOMS. FAST FORWARD TO 2013. I WAS BIT AGAIN AND TESTED FOR LYME AND CO-INFECTIONS WITH (B)(4) LABS. I CAME OUT POSITIVE, HOWEVER, A GP MD REFUSED TO ACKNOWLEDGE THIS. NOW, I'VE BECOME TOO ILL TO FUNCTION. IT IS BECAUSE OF THE MISCONCEPTION SEEDED BY THE (B)(4) THAT CUTTING EDGE TESTS LIKE THOSE FROM (B)(4) ARE ACTUALLY INACCURATE THAT PEOPLE BECOME DISABLED. DO NOT ALLOW THE FDA TO BAN CUTTING EDGE LYME DISEASE LABS LIKE (B)(4). MORE PEOPLE WILL FALL THROUGH THE CRACKS AND BECOME VERY ILL. MANUFACTURER NAME, CITY AND STATE: (B)(4).