A CUSTOMER IN (B)(6) CONTACTED BIOM?RIEUX TO REPORT THE OCCURRENCE OF A FALSE POSITIVE RESULT FOR A NEQAS SURVEY SAMPLE ((B)(6)) IN ASSOCIATION WITH THE VIDAS? 3 MEASLES IGG ASSAY. THE EXPECTED RESULT WAS NEGATIVE. THE VIDAS RAW RESULT WAS 0.79, JUST ABOVE EQUIVOCAL. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE NEQAS SURVEY SAMPLE. AN INTERNAL BIOM?RIEUX INVESTIGATION WILL BE INITIATED.
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Patient 1
A CUSTOMER IN (B)(6) CONTACTED BIOM?RIEUX TO REPORT THE OCCURRENCE OF A FALSE POSITIVE RESULT FOR A (B)(6) IN ASSOCIATION WITH THE VIDAS? 3 MEASLES IGG ASSAY. AN INTERNAL BIOM?RIEUX INVESTIGATION WAS PERFORMED. SPECIMEN (B)(6) MEASLES AND MUMPS IGG SEROLOGY DISTRIBUTION (B)(6) GAVE AN UNEXPECTED POSITIVE RESULT FOR SOME LABORATORIES WITH VIDAS? MEASLES IGG. ON THE (B)(6) REPORT, IT IS MENTIONED THAT : THE SPECIMEN (B)(6) WAS EXPECTED TO BE NEGATIVE FOR MSG (TESTED NEGATIVE WITH SIEMENS ENZYGNOST 1 MIU/ML). ONE HUNDRED THIRTY SIX PARTICIPANTS, GAVE THE EXPECTED RESULT NEGATIVE. TWENTY FIVE PARTICIPANTS GAVE AN EQUIVOCAL RESULT (24 PARTICIPANTS USING VIDAS MSG). EIGHTEEN PARTICIPANTS GAVE A POSITIVE RESULT (15 PARTICIPANTS USING VIDAS MSG). IN PRE-DISTRIBUTION TESTING, THE MEASLES IGG RESULTS WERE NEGATIVE WITH TRINITY BIOTECH, CAPTIA, SIEMENS ENZYGNOST, DIASORIN LIAISON ASSAYS WHILE IT WAS EQUIVOCAL WITH BIOM?RIEUX VIDAS?. THE BIOM?RIEUX LAB TESTED SPECIMEN (B)(6) AND FOUND AN EQUIVOCAL RESULT WITH BATCH 1004566030 / 161110-0 AND A POSITIVE RESULT WITH BATCH 1004457540 / 160929-0. ADDITIONAL TESTING WAS DONE ON FOUR (4) INTERNAL SERA (2 NEGATIVE AND 2 POSITIVE) ON THE RETAINS KIT VIDAS? MSG 1004457540 / 160929-0 AND 1004566030 / 161110-0 : THE RESULTS DID NOT CHANGE IN TERM OF SEROLOGICAL INTERPRETATION SINCE THE ACTIVITY RESULTS OBTAINED BY THE QUALITY CONTROL LABORATORY BEFORE BATCH RELEASE. THE DIFFERENCE OF RESULTS INSIDE VIDAS? GROUP COULD BE EXPLAINED BY A MATRIX EFFECT DUE TO THIS SPECIFIC SPECIMEN. IN THE PACKAGE INSERT, IT IS MENTIONED : "INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S HISTORY." INFORMATION FROM (B)(6) RELATED TO THE DIFFERENT BATCHES USED BY THE CUSTOMERS DURING THIS CAMPAIGN OR REGARDING SPECIMEN (B)(6) AND PRE-TESTING RESULTS WAS NOT RECEIVED DESPITE SEVERAL REMINDERS. WITHOUT THIS DATA, FURTHER INVESTIGATION IS NOT POSSIBLE. NO ANOMALY INVOLVING PERFORMANCES WAS IDENTIFIED ON VIDAS? MSG ASSAY.