ELISA BLOOD TEST
Received Aug 27, 2014 · Event occurred Aug 26, 2011
Report MW5038014 · MDR key 4059157
Device
Generic name
Lyme Test
Product problems
- False Negative Result
Patient
57 YR
- Fatigue
- Memory Loss/Impairment
- Pain
- Anxiety
- Disability
- Joint Disorder
- Inadequate Pain Relief
- Neck Pain
- Sleep Dysfunction
- Ambulation or Postural Difficulties
Narrative
Description of Event or Problem
I HAD EXPERIENCED SEVERE CHRONIC PAIN FOR 6 MONTHS, BEGINNING IN (B)(6) 2011, WITH SEVERE INSOMNIA, ANXIETY, LOSS OF ENERGY, NERVE PAIN IN BOTH FEET, PANIC ATTACKS, TIGHT PAINFUL NECK AND BACK AND MANY OTHER SYMPTOMS. THESE INCLUDED OVERALL PAIN AFFECTING PRIMARILY MY SHOULDERS, NECK, BACK, HAMSTRINGS, AND SI ATTACHMENT SITES, DEBILITATING INSOMNIA, ANXIETY, PANIC ATTACKS, LOSS OF ENERGY, BRAIN FOG, LACK OF CONCENTRATION, INABILITY TO FOCUS MY ATTENTION, SHORT-TERM MEMORY, INABILITY TO FUNCTION BY MYSELF, INABILITY TO COOK OR LIFT ANYTHING BEYOND A SPOON TO FEED MYSELF, INABILITY TO WASH MY OWN HAIR, MANY OF THE DAILY FUNCTIONS OF LIFE I COULD NOT PERFORM AND MY HUSBAND WAS AND CONTINUES TO BE MY CAREGIVER SINCE 2011. I EXPERIENCED SEVERE INFLAMMATION THROUGHOUT MY BODY WITH PAINFUL JOINTS SO SEVERE I COULDN'T SIT, STAND, OR LIE DOWN WITHOUT GREAT PAIN. MY BLOOD PRESSURE, WHICH HAD BEEN NORMAL, BECAME UNCONTROLLABLE EVEN WITH MEDICATION. I HAD NUMEROUS DOCTOR APPOINTMENTS WITH NUMEROUS SPECIALISTS WHO ALL SAID THERE WAS NOTHING WRONG WITH ME. I WAS SENT TO A PAIN DOCTOR M.D. WHO PERFORMED A TEST FOR RA AND AN ELISA TEST FOR LYME AS WELL AS BLOOD WORK. THE ELISA LYME TEST CAME BACK NEGATIVE. I NEVER CONSIDERED THE POSSIBILITY OF HAVING CHRONIC LYME SINCE I HAD NEVER NOTICED A TICK BITE NOR ANY BULLS EYE RASH. I LIKEWISE DID NOT HAVE THE SPECIFIC MARKERS FOR RA OR FIBROMYALGIA AND THESE TESTS CAME BACK NEGATIVE AS WELL. A VISIT TO AN RA SPECIALIST ALSO RULED OUT RA AND FIBROMYALGIA. THE PAIN WAS SO SEVERE I WENT TO THE ER FOUR TIMES WITH SHOTS EACH TIME THAT GAVE NO RELIEF FOR PAIN OR INSOMNIA. THE 4TH TIME, I WAS ADMITTED FOR PAIN AND WAS IN THE HOSPITAL TWO DAYS AND TWO NIGHTS. I WAS GIVEN MORPHINE, OXYCODONE, ADDITIONAL MEDICATION TO HELP SLEEP, AND THEY PERFORMED AN MRI OF MY NECK AND X RAYS OF MY BACK AND NECK. THIS HELPED THE INSOMNIA FOR ABOUT ONE WEEK. ALL MY SYMPTOMS CONTINUED TO GET WORSE. I HAVE SPENT APPROXIMATELY (B)(6) IF NOT MORE OUT OF MY OWN POCKET SEEKING RELIEF FROM EVERY FORM OF ALTERNATIVE TREATMENT AVAILABLE AND EVERY FORM OF STANDARD TREATMENT. I BOUGHT A SPECIAL BED FRAME AND MATTRESS TO ENABLE ME TO LIE DOWN WITH LESS PAIN. I HAVE BEEN FOLLOWING AN ORGANIC DIET .AND TAKING MANY NUTRITIONAL SUPPLEMENTS AS PRESCRIBED BY VARIOUS HOLISTIC PRACTITIONERS TO NO AVAIL. THIS HAS ADDED INCREASED THOUSANDS OF DOLLARS SPENT. ULTIMATELY A FRIEND RECOMMENDED A FORMER (B)(6) PHYSICIAN WHO ALSO PRACTICED ALTERNATIVE TREATMENTS IN A DIFFERENT STATE. IN (B)(6) 2013 I HAD MY FIRST APPOINTMENT WITH HIM TO REVIEW MY MEDICATIONS, SUPPLEMENTS, AND ANY RECOMMENDATIONS HE MIGHT HAVE FOR REDUCING THE INFLAMMATION AND INSOMNIA I WAS EXPERIENCING. HE IMMEDIATELY RECOGNIZED ALL MY SYMPTOMS AS BEING RELATED TO CHRONIC LYME DISEASE. HE WAS AWARE OF THE HIGH FAILURE RATE OF THE ELISA TEST SO HE PERFORMED A CD57 BLOOD TEST TO CHECK THE NK CELLS FOR VARIOUS MARKERS. SINCE THE RESULTS WERE VERY INDICATIVE OF CHRONIC LYME COMBINED WITH HAVING SIGNIFICANT LYME SYMPTOMS, HE ORDERED A WB TEST WITH (B)(6) LABS, WHICH I HAD TO PAY FOR OUT OF MY POCKET. THE TEST CAME BACK POSITIVE FOR LYME AND I BEGAN ANTIBIOTIC TREATMENT. IT HAS BEEN ONE YEAR OF TREATMENT NOW, WHICH IS EXTREMELY EXPENSIVE. I HAVE SEEN GREAT IMPROVEMENT THUS FAR AND AM VERY POSITIVE AND RELIEVED TO KNOW WHAT IS WRONG WITH ME AND TO BE RECEIVING APPROPRIATE TREATMENT. SO MUCH PAIN AND SUFFERING COULD HAVE BEEN AVOIDED HAD MY ORIGINAL, LOCAL PAIN DOCTOR OR ANY OF THE NUMEROUS DOCTORS I HAD SEEN, WAS FAMILIAR WITH CHRONIC LYME AND THE NEED FOR A CD57 BLOOD TEST TO THEN POINT TO THE WB TEST. THE 2 TIER APPROACH OF REQUIRING A POSITIVE ELISA TEST THAT HAS AN 85% FAILURE RATE IS UNACCEPTABLE. A CD57 TEST IS INEXPENSIVE AND (B)(6) IS A SPECIALITY LAB THAT HAS DEVELOPED AN EXCELLENT TEST FOR IDENTIFYING LYME.