Description of Event or Problem · 1
RPTR'S E-MAIL DATED 2002 REPORTS ON A POTENTIAL PROBLEM WITH DIRECTOGEN A AND B TEST KITS (RAPID ANTIGEN TEST FOR INFLUENZA). THE PROBLEM WAS REPORTED TO DEPT OF HEALTH AT THE LAB. THE PROBLEM REPORTED IS THAT 4 SPECIMENS TESTED NEGATIVE FOR INFLUENZA, WERE SUBSEQUENTLY CULTURED AND IDENTIFIED AS POSITIVE. THEY CALLED TO GET THE DETAILS. THEY INDICATED THAT THEY WERE NOT INTERESTED IN MAKING A COMPLAINT AT THIS TIME, BUT FELT THE PROBLEM REQUIRED SURVEILLANCE. THEY INDICATED THAT 18 SPECIMENS WERE COLLECTED AT A NURSING HOME (BOTH NASOPHARYNGEAL AND THROAT). ALL TESTING CAME BACK NEGATIVE USING DIRECTOGEN A AND B TEST KIT LOT 1288951. 4 OF THE 18 WERE EVENTUALLY POSITIVE BY CULTURE. THEY REPORTED THEY WERE RELUCTANT TO REPORT THIS AS A COMPLAINT BECAUSE: THE ELDERLY TEND TO HAVE FEWER CELLS, IT IS VERY DIFFICULT TO GET THE SWABS FROM ELDERLY PTS, AND SOME HEALTH CARE PRACTITIONERS ARE BETTER AT OBTAINING THE SWABS THAN OTHERS. THEY FEEL IT IS POSSIBLE THAT AN INEFFECTIVE SWABBING COMBINED WITH FEWER CELLS IN THE ELDERLY POPULATION, MAY HAVE RESULTED IN THE FALSE NEGATIVES. THEY INDICATED SINCE THIS IS THE BEGINNING OF FLU SEASON, THEY WILL HAVE A BETTER HANDLE ON THE RELIABILITY OF THE TEST KITS IN A FEW WEEKS. THIS INFO WAS RELAYED BACK TO RPTR AT THE DEPT OF HEALTH, WHO REQUESTED WE INVESTIGATE THIS MATTER REGARDLESS OF THEIR COMMENTS. T/C WITH BECTON DICKSON, DIR OF QUALITY MGMT & REGULATORY COMPLIANCE. HE WAS AWARE OF THE COMPLAINT AND SAID THEY WERE INVESTIGATING. THEY REPORTED THAT THE LAB PLACED THE SWABS IN M4 MEDIUM AND CENTRIFUGED. HE SAID DFU STATE "DO NOT CENTRIFUGE". THIS COULD IMPACT ON THE RELIABILITY OF THE RESULTS. HE ALSO INDICATED THIS LOT WAS PART OF RECALL IN 12/01 REQUIRING THE REPLACEMENT OF THE REAGENT. (THE RECALL WAS NOT RELATED TO FALSE NEGATIVE RESULTS). HE SAID THE LAB WAS USING THE REPLACED REAGENT.