ELISA
Received Nov 17, 2014 · Event occurred Jan 12, 2012
Report MW5039181 · MDR key 4270709
Device
Generic name
Elisa
Product problems
- False Negative Result
Patient
12 YR
- Misdiagnosis
Narrative
Description of Event or Problem
(B)(4)/FDA APPROVED 2 TIER TESTING FAILED TO ACCURATELY DIAGNOSE LYME DISEASE IN OUR SON. QUEST ELISA TEST SHOWED A FALSE NEGATIVE. WESTERN BLOT THROUGH QUEST ONLY SHOWED A SINGLE IGG AND SINGLE IGM BAND. WESTERN BLOT THROUGH LABCORP SHOWED ZERO POSITIVE BANDS. SUBSEQUENT WESTERN BLOT THROUGH IGENEX SHOWED A TOTAL OF 7 POSITIVE BANDS PLUS ADDITIONAL IND BANDS. OUR SON CLINICALLY RESPONDED TO TREATMENT FOR LYME AND CO-INFECTIONS. (B)(4)/FDA APPROVED TESTS THAT WERE DESIGNED TO DETECT A SINGLE STRAIN OF THE LYME BACTERIA ARE FAILING TO ACCURATELY DETECT LYME DISEASE, LEADING TO DELAYS IN DIAGNOSIS AND HARDER TO TREAT, DISSEMINATED INFECTIONS.