Description of Event or Problem · 1
IN 2005, BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A MESSAGE FROM A CUSTOMER. CUSTOMER STATED THAT THEY HAD A PATIENT THAT WAS INITIALLY REACTIVE (IR) AND REPEATEDLY REACTIVE (RR) ON THE GENETIC SYSTEM HIV-1/HIV-2 PLUS O EIA KIT AS TESTED IN THE LAB IN 2005. ACCORDING TO CUSTOMER, THESE RESULTS WERE STRONGLY POSITIVE, WITH RESULTS AT THE UPPER END OF THE MICROPLATE READER RANGE. THIS SAMPLE WAS THEN SENT TO AN OUTSIDE REFERENCE LABORATORY FOR HIV-1 WESTERN BLOT SUPPLEMENTAL TESTING, AND RPTR INDICATES THAT THE RESULT OF THE TEST WAS POSITIVE, WITH "ALL BANDS PRESENT." AT THE PHYSICIAN'S REQUEST THE PATIENT RETURNED ON TWO LATER OCCASIONS FOR REDRAWS AND RETESTING. ON THE FIRST REDRAW, CUSTOMER, SENT THE PATIENT SAMPLE TO AN OUTSIDE REFERENCE LABORATORY FOR HIV-1 TESTING USING ANOTHER MANUFACTURER'S HIV-1 EIA TEST KIT. THIS SAMPLE WAS REPORTED BACK TO CUSTOMER AS NON-REACTIVE BY THE OUTSIDE REFERENCE LABORATORY. A SECOND REDRAW WAS TESTED BY CUSTOMER IN 2005 USING THE GENETIC SYSTEMS HIV-1/HIV-2 PLUS O EIA KIT, AND A NON-REACTIVE RESULT WAS OBTAINED. AFTER THE THIRD TESTING CUSTOMER CONTACTED BIO-RAD LABORATORIES TO DISCUSS THE DISCREPANCY. ACCORDING TO CUSTOMER, A TOTAL OF 79 PATIENT SAMPLES WERE BEING TESTED FOR HIV DURING THE INITIAL 2005 TESTING IN WHICH THE PATIENT WAS REPORTED AS IR AND RR. HOWEVER, BECAUSE SUBSEQUENT HIV TESTING OF TWO REDRAWS FROM THIS PATIENT HAS PRODUCED NON-REACTIVE RESULTS THERE IS A POTENTIAL THAT THE ORIGINAL SAMPLE WAS ERRONEOUSLY REPORTED AS POSITIVE, AND AS A RESULT ONE OF THE OTHER PATIENTS ASSAYED AT THE SAME TIME WAS REPORTED AS FALSELY NEGATIVE. CUSTOMER STATES THAT ALL 79 SAMPLES TESTED IN 2005 CAME FROM THE SAME SITE. BIO-RAD HAS RECOMMENDED TO CUSTOMER THAT ALL 79 PATIENTS ASSOCIATED WITH THIS 2005 TESTING EVENT BE REDRAWN AND RETESTED, AS IT IS POSSIBLE THAT A SAMPLE MIX-UP MAY HAVE OCCURRED EITHER AT THE ORIGINAL COLLECTION SITE OR AT CUSTOMER'S LOCATION.