2 TIER ELISA TEST
Received Jul 28, 2015
Report MW5045005 · MDR key 4960372
Device
Generic name
2 Tier Elisa Test
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
30 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
MANY FALSE NEGATIVE TESTS FROM THE ELISA THE ENZYME-LINKED IMMUNOSORBENT SERUM ASSAY IS THE SIMPLEST, LEAST EXPENSIVE, EASIEST TO PERFORM, AND MOST COMMON LYME TEST ORDERED. IT IS A TEST BASED ON DETECTING THE ANTIBODIES THAT OUR BODIES MAKE IN RESPONSE TO BEING EXPOSED TO LYME DISEASE, AKA BORRELIA BURGDORFERI. IT IS A PREFERRED TEST BY LABORATORIES, NOT BECAUSE IT IS MORE ACCURATE THAN OTHER LYME TESTS, BUT BECAUSE IT IS AUTOMATED. IT IS FAST TEST, IN OTHER WORDS, LABS CAN TURN OVER A QUICK PROFIT WITH THIS TEST. THIS TEST IS REPORTED TO ONLY BE 55% ACCURATE. WOULD YOU TEST YOUR FAMILY MEMBER FOR CANCER OR ANY OTHER DISEASE IF IT WAS ONLY A 55% OF GETTING IT RIGHT? HOW ELISA TEST WORKS IS THAT IT CAN BE PRIMED TO BE VERY SPECIFIC FOR SOME OF THE SPIROCHETES ANTIBODIES. THIS IS DONE BY TAKING A LAB SAMPLE OF THE BACTERIA AND BREAKING THE SAMPLE DOWN INTO FRAGMENTS. THESE FRAGMENTS, OR KNOW AS ANTIGENS, ARE THEN EMBEDDED ON THE SIDE OF A REAGENT VESSEL LIKE A TEST TUBE. THEN THE PATIENT'S SERUM IS ADDED, AND ANY FREE ANTIBODIES SPECIFIC FOR THE TEST STRAIN WILL THEN BIND TO THE ANTIGENS, WHICH ARE LINKED TO SPECIAL ENZYMES THAT WILL CHANGE COLOR WHEN ANTIBODIES ARE PRESENT. THE SAMPLE IS CONTINUALLY DILUTED UNTIL THE REACTION NO LONGER OCCURS AND NO COLOR CHANGE CAN BE DETECTED. THE SAMPLE IS THEN REPORTED AS A DILUTION RATIO, SUCH AS ONE PART SERUM TO 256 PARTS WATER, OR 1:256. THE ELISA TEST SEEMS SIMPLE, BUT IT HAS SOME MAJOR FLAWS. BORRELIA SPECIES ARE POLYMORPHIC. THAT IS, BORRELIA SPECIES CAN SIGNIFICANTLY CHANGE ITS SURFACE PROTEINS ENOUGH DURING CELL DIVISION AS TO EVADE OUR IMMUNE SYSTEM, WHICH MAY DIFFER FROM LABORATORY STRAINS ENOUGH TO RESULT IN A FALSE NEGATIVE, EVEN IF ANTIB ANTIBODIES ARE PRESENT. SO UNTIL WE CAN TEST FOR EVERY STRAIN THESE TESTS ARE PRETTY MUCH USELESS. NOTE: THERE HAVE BEEN NUMEROUS NEW STRAINS FOUND IN THE LAST COUPLE YEARS. (IN MORE THEN ONE COUNTRY) THE TEST CANNOT TEST FOR THESE.