Description of Event or Problem · 1
(B)(6) LABORATORIES HAS OBSERVED INCONSISTENT RESULTS WHEN USING TRINITY BIOTECH CAPTIA SYPHILIS IGG EIA ASSAY. A PT'S SERUM SAMPLE TESTED POSITIVE ON LOT #058 AND TESTED NEGATIVE ON LOTS #055 AND #056. IN ADDITION, INCONSISTENCIES HAVE BEEN OBSERVED WITH PT SAMPLES FROM WELL TO WELL, MEANING THAT A PT SAMPLE TESTED ON THE SAME TEST RUN IN WELL E1 AND WELL F1 MIGHT TEST POSITIVE ON WELL E1 AND NEGATIVE ON WELL F1. THIS ISSUE HAS BEEN OBSERVED FOR LOTS #055, 056, AND 058. THESE LOTS HAVE BEEN IN USE AT (B)(6) LABORATORIES FROM 07/2010 UP TO THE PRESENT. (B)(6) LABORATORIES HAVE BEEN IN CONTACT WITH TRINITY BIOTECH NUMEROUS TIMES, AND TRINITY HAS NOT AS YET ACCEPTED BLAME FOR THIS ISSUE.(B)(6) LABORATORIES HAS EXHAUSTED EVERY OTHER SOURCE OF ERROR FOR GENERATING THESE INCONSISTENT RESULTS, INCLUDING INTERNAL [POTENTIAL EQUIPMENT MALFUNCTIONS AND ANALYST ERROR], AND HAVE DETERMINED THE CAPTIA TEST KIT IS THE SOURCE OF THE ERRORS, MOST LIKELY A PROBLEM WITH THE ANTIGEN COATING ON THE MICROWELLS. TRINITY BIOTECH SENT OUT AN ASSAY SPECIALIST TO TROUBLE SHOOT THE ASSAY ON (B)(6) 2010, AND HE EXPERIENCED THE SAME PROBLEMS AS THE (B)(6) LABORATORY STAFF. TRINITY BIOTECH CLAIMS THAT OTHER (B)(6) LABORATORIES ARE USING THE VERY SAME ASSAY WITH THE VERY SAME ALGORITHM, INCLUDING (B)(6) AND THAT THEY HAVE REPORTED NO ADVERSE RESULTS, BUT IT IS THOUGHT BY (B)(6) LABORATORIES THAT IF THOSE OTHER PHLS ARE RUNNING THE ASSAY WITH AN AUTOMATED SYSTEM AND A VERY HIGH SAMPLE VOLUME, THEY WOULD POSSIBLY NOT BE MONITORING INDIVIDUAL RESULTS AS CLOSELY AS (B)(6) LABORATORIES IS. (B)(6) LABORATORIES FEELS THAT THERE IS A POSSIBILITY THAT THE NEGATIVE RESULTS THEY HAVE REPORTED OUT USING THIS TEST COULD BE FALSE POSITIVES.