MalfunctionLJN
MONOLERT
Received Jan 4, 1995
Report MW1004647 · MDR key 18708
Device
Generic name
Mononucleosis Test Elisa
Manufacturer
Meridian Diagnostics, Inc.Product problems
- False Positive Result
Patient
*
Narrative
Description of Event or Problem
ACCORDING TO AN ARTICLE PUBLISHED BY RPTR, 38 CHILDREN (AGES 18 MONTHS TO 17 YEARS) WHO WERE DIAGNOSED WITH ACUTE IM USING THE TEST DURING THE PERIOD 10/92 TO 8/93. EIGHTY-THREE PERCENT OF THESE CHILDREN HAD NO EVIDENCE OF EPSTEIN-BARR VIRUS INFECTION ON SUBSEQUENT INVESTIGATION. THE FALSE POSITIVE RESULTS OF THE TEST COULD NOT BE EXPLAINED ON THE BASIS OF ELEVATED ANTIBODY TITERS TO EITHER CYTOMEGALOVIRUS OR BORRELIA BURGDORFERI. CONCLUSION BY THE RPTR IS THAT THIS IS A POOR SCREENING TEST AND IS OF LITTLE APPARENT VALUE AS A DIAGNOSTIC TEST FOR ACUTE EPSTEIN-BARR VIRUS INFECTION IN PEDIATRIC PTS. (*)