ELECSYS CMV IGM IMMUNOASSAY

Additional Manufacturer Narrative

THE CUSTOMER'S RESULTS COULD BE CONFIRMED. THE SAMPLE WAS DETERMINED TO BE NON-REACTIVE IN THE ELECSYS CMV IGM ASSAY. ADDITIONAL ANALYSES SHOWED THAT THE SAMPLES CONTAINED CMV-SPECIFIC IGG ANTIBODIES OF HIGH AVIDITY, SUGGESTING THAT OTHER METHODS MIGHT DETECT PERSISTING OR RECURRING CMV IGM ANTIBODIES IN THE SAMPLE. THE OBTAINED RESULTS ARE NOT INDICATIVE OF AN EARLY PHASE OF INFECTION WITH CMV. THE INVESTIGATION DETERMINED THE ELECSYS CMV IGM ASSAY PERFORMED AS INTENDED. THE OBSERVED REACTIVITY PATTERN WAS CONSISTENT WITH THE POSSIBLE DETECTION OF PERSISTENT IGM IN COMPETITOR ASSAYS.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE E601 ANALYZER IS (B)(6). THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. H3 OTHER TEXT : NA.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS CMV IGM IMMUNOASSAY ON A COBAS 6000 E601 MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CMV IGM VALUE OF 0.161 COI (NON-REACTIVE) WHEN TESTED WITH THE ROCHE ASSAY. THE PATIENT HAS PREVIOUSLY HAD POSITIVE CMV IGG, IGM, AND AVIDITY RESULTS. THE SAMPLE WAS THEN SENT TO ANOTHER LABORATORY WHERE IT WAS TESTED USING THE BIORAD MULTIPLEX LUMINEX ASSAY, RESULTING IN A CMV IGM VALUE OF 2.1 COI (POSITIVE).