ELISA FOR LYME DISEASE
Received Nov 17, 2014
Report MW5039185 · MDR key 4270729
Device
Generic name
Elisa For Lyme Disease
Product problems
- False Negative Result
Patient
54 YR
- Misdiagnosis
- Disability
Narrative
Description of Event or Problem
FOLLOWING TICK BITS IN (B)(6) I DEVELOPED A COMPLEX ARTHRALGIC, FIBROMYALGIC, CHRONIC FATIGUE SYNDROME LIKE ILLNESS WITH SEVERE NEUROLOGICAL COMPROMISE. MY DOCTOR CONSIDERED LYME AND TICK BORNE DISEASES AT THE TOP OF THE DIFFERENTIAL DIAGNOSTIC CAUSES. TRYING TO GIVE HISTORY, HE REASSURED HE WOULD DO THE TEST IE: ELISA FIRST AND W BLOT IF DIRECTED BY ELISA. TEST WAS NEGATIVE. SURVEILLANCE CRITERIA WERE APPLIED BY MY ILLNESS RESULTING IN 2-3 YEAR DELAY IN DIAGNOSIS, SUFFERING AND DISABILITY. LONG, LONG, LONG TERM RX HAS RESULTED IN RETURN TO QUALITY OF LIFE WITH CONTINUED TREATMENT. THIS COULD BE AVOIDED BY CORRECT INFORMATION TO PATIENTS THAT THE TEST WHEN NEGATIVE, A PATIENT CAN STILL HAVE LYME DISEASE. THEN GETTING MORE TESTING AT MY COST WOULD HAVE BEEN A DOOR OPENED, NOT CLOSED BY EXAGGERATED ACCURACY OF THE ELISA "SCREENING" TEST. A TEST WHICH QUALIFIES BY MEASURING ITSELF IN OTHER SAMPLES. GO FIGURE.