inforMED

ELISA TEST

Received Aug 26, 2014 · Event occurred Apr 18, 2006

Report MW5037966 · MDR key 4048405

Device

Generic name

Lyme Test

Product problems

  • Incorrect Or Inadequate Test Results

Patient

52 YR

  • Misdiagnosis

Narrative

Description of Event or Problem

I AM WRITING TO REPORT TWO TEST FAILURES: THE FIRST IS THE FAILURE OF THE ELISA TEST; IT DID NOT DETECT MY LYME DISEASE, IT CAME BACK NEGATIVE. AS THE FIRST STEP OF A TWO-TIER TESTING SYSTEM, I WOULD HAVE BEEN DENIED THE OPPORTUNITY TO DO A WESTERN BLOT TEST. HOWEVER, IN MY CASE, I DID THE WESTERN BLOT FIRST, WHICH WAS 4-BAND POSITIVE, WHICH WAS GOOD ENOUGH TO DETECT LYME-POSITIVE ANTIBODY BANDS, BUT, ONCE AGAIN, NOT GOOD ENOUGH FOR CDC 5-BAND REPORTING. WHICH MEANS TWO THINGS: ONE, SINCE I HAVE LYME DISEASE CONTRACTED FROM A KNOWN TICK BITE IN MY FOOT, THE ELISA SCREENING TEST NEEDS TO BE STOPPED, AS IT MISSES TOO MANY PEOPLE, IN COMPARISON TO THE AIDS SCREENING TEST WHICH CATCHES 95-99%, DEPENDING ON WHO YOU TALK TO. AND SECOND, THE 5-BAND POSITIVE CDC RULE NEEDS TO END. EVEN ONE POSITIVE LYME-SPECIFIC BAND IS ENOUGH TO DIAGNOSE LYME.