BIOFIRE FILMARRAY V.1.7 RESPIRATORY PANEL

Description of Event or Problem

RSV. WE OBSERVED AN UNEXPECTED UPTICK IN RSV POSITIVES BEGINNING (B)(6) THIS YEAR USING THE FILMARRAY V.1.7 RESPIRATORY PANEL, POUCH LOT NUMBER 671519 (FROM BOX (B)(4)). WE TEMPORARILY STOPPED USING THAT LOT, THE UNEXPECTED RSV POSITIVES DID NOT CONTINUE, BUT NO FURTHER INVESTIGATION TOOK PLACE AT THAT TIME. IN (B)(6) THIS YEAR THE LOT IN QUESTION, 671519, WAS RETURNED TO CLINICAL USE. IN (B)(6) WE OBSERVED A SECOND UNEXPECTED SERIES OF RSV POSITIVES IN SIX SPECIMENS FROM PATIENTS (B)(6). AFTER A LOOKBACK, THREE ADDITIONAL RSV POSITIVES WERE FOUND IN PATIENTS (B)(6) FROM LATE (B)(6) PATIENT (B)(6) SPECIMENS WERE RETESTED USING POUCH LOT 940119 AND WERE RSV NEGATIVE. TO RESOLVE THE DISCREPANCY, THE SIX SPECIMENS FROM PATIENTS (B)(6) WERE TESTED A THIRD TIME WITH LUMINEX ARIES FLU A/B & RSV ASSAY AND WERE NEGATIVE. THE THREE SPECIMENS FROM PATIENTS (B)(6) WERE NOT AVAILABLE FOR ADDITIONAL TESTING. THE LIMIT OF DETECTION (LOD) WAS COMPARED BETWEEN THE FILMARRAY LOT 671519, LOT 940119, AND LUMINEX. STOCK OF CELL CULTURE GROWN RSV OBTAINED FROM AN (B)(6) RESEARCH LABORATORY AND USED FOR SERIAL DILUTIONS ABOVE AND BELOW LIMIT OF DETECTION (LOD) STATED BY BIOFIRE (2 TCID50/ML). WE TESTED 10-FOLD SERIAL DILUTIONS BETWEEN 0.01X LOD AND 1000X LOD. THE LAB QUANTIFIED THE RSV QUANTITY BY A TAQMAN ASSAY USING DNA PLASMIDS AND GENERATING A STANDARD CURVE. AN ABERRANT RSV POSITIVE WAS DETECTED AT 0.01 X LOD FOR LOT 671519 CONFIRMING TO US THAT THE LOT IS DEFECTIVE AND RESULTING IN FALSE POSITIVE RSV. INSTRUMENT: BIOFIRE DIAGNOSTICS, LLC (B)(4). (B)(4).