TWO-TIERED LYME DISEASE TESTING ELISA
Received Oct 29, 2014 · Event occurred Jul 10, 2014
Report MW5038946 · MDR key 4231603
Device
Generic name
Lyme Test
Product problems
- Incorrect Or Inadequate Test Results
Patient
29 YR
- Chest Pain
- Fatigue
- Fever
- Inflammation
- Pain
- Misdiagnosis
- Chills
- Sweating
- Cognitive Changes
Narrative
Description of Event or Problem
DUE TO THE TWO TIERED LYME TESTING PROTOCOL, I DIDN'T RECEIVED ADEQUATE TREATMENT EVEN THOUGH I HAD A KNOWN TICK BITE THAT WAS RED AND INFLAMED FOR OVER A MONTH. I HAD SEVERE FATIGUE, PAIN IN MY SPLEEN AND CHEST, INTERMITTENT JOINT PAIN, LOW GRADE FEVERS, CHILLS, NIGHT SWEATS, BRAIN FOG, COGNITIVE IMPAIRMENT. THE STANDARD ELISA TEST FOR LYME HAS BEEN PROVEN TO MISS 50-85% OF PTS WHO ACTUALLY HAVE LYME. IF THIS IS THE FIRST TEST AND YOU HAVE TO TEST POSITIVE IN ORDER TO RECEIVE TREATMENT THAN 50-85% OF LYME PTS ARE LEFT TO SUFFER DUE TO THIS INADEQUATE TESTING. THE CURRENT INSENSITIVE TEST SYSTEM GUARANTEES THAT OVER HALF OF LYME DISEASE CASES GO UNDIAGNOSED AND UNTREATED. SEROLOGICAL (BLOOD) TESTING OF BB IS CHALLENGING DUE TO COMPLEX ANTIGENIC COMPOSITION OF BB, TEMPORAL APPEARANCE OF ANTIBODIES TO DIFFERENT ANTIGENS AT SUCCESSIVE TIME INTERVALS AFTER INFECTION AND FALSE POSITIVE RESULTS REPORTED ESPECIALLY WITH OTHER SPIROCHETAL INFECTIONS (EBV, (B)(6)) SEROLOGICAL TESTING OF LYME IS NOT RECOMMENDED IN THE EARLY STAGE OF INFECTION BECAUSE THE RESULTS ARE USUALLY NEGATIVE. SENSITIVITY IN PTS TESTED AT LEAST 4-6 WEEKS AFTER INFECTION IS ONLY 44% TO 56%, WHICH IS INADEQUATE FOR DIAGNOSTIC TESTING. DUE TO THE NATURE OF LYME DISEASE, DIAGNOSIS SHOULD BE MADE BASED ON A CLINICAL DIAGNOSIS SUPPORTED BY A POSITIVE SEROLOGICAL TEST. CLINICAL DIAGNOSTIC CRITERIA FOR LYME DISEASE ARE TOO STRINGENT, WITH ONLY OBJECTIVE SIGNS OF THE DISEASE SUCH AS AN ERYTHEMA MIGRANS RASH, ARTHRITIS, MENINGITIS, OR CARDITIS, CONSIDERED RELEVANT ? PTS WITH LATE LYME DISEASE MAY ONLY DISPLAY SUBJECTIVE SYMPTOMS OF THE DISEASE. THERE ARE TWO OUTER SURFACE PROTEINS (OSPA AND OSPB) EXPRESSED BY BB THAT ARE HIGHLY SPECIFIC TO LYME DISEASE. THE CDC HAS NEGLECTED TO INCLUDE THEM IN LYME DISEASE TESTING INTERPRETATION, THOUGH THESE ANTIGENS WERE USED FOR THE VACCINES AND THEREFORE, ANTIBODIES TO THESE ANTIGENS MUST BE OF IMPORTANCE. CURRENT CLINICALLY AVAILABLE TESTING CANNOT PROVE THAT THE INFECTION HAS BEEN ERADICATED.