Description of Event or Problem · 1
AN ABNORMALLY HIGH REACTIVITY RATE FOR HLA CLASS I AND CLASS II ANTIBODIES IN VOLUNTEER BLOOD DONORS PROMPTED AN INVESTIGATION OF THE PRECISION OF THE LIFE-CODES DONOR SCREEN HLA CLASS I AND CLASS II ANTIBODY DETECTION ASSAY (B)(4) ON THE QUICKSTEP PLATFORM. A PRECISION STUDY WAS PERFORMED USING THE STATISTICAL FORMULAE RECOMMENDED IN CLSI EP 15-A2 TO ANALYZE THE QUANTITIVE OD AND THE RESULTS INDICATE THAT THE TEST DOES NOT APPEAR TO BE PERFORMING WITHIN THE PARAMETERS DEFINED IN THE PACKAGE INSERT, SPECIFICALLY THE REPRODUCIBILITY AS EVIDENCED BY THE STANDARD DEVIATION BETWEEN DAY TO DAY RUNS. INTRA-VARIABILITY IS BETTER, BUT STILL DEMONSTRATES GREATER IMPRECISION AT SOME LEVELS THAN EXPECTED PER PACKAGE INSERT. ALTHOUGH THIS IS A QUALITATIVE ASSAY, THE TARGET PRECISION ACCEPTABILITY VALUES WERE BASED ON THE QUALITATIVE OD VALUES PRESENT IN THE LIFECODES MANUFACTURER'S DIRECTION INSERT. IT WAS ALSO OBSERVED THAT THE QUALITY CONTROL DATA GENERATED ON THE QUICKSTEP DOES NOT ASSUME A GAUSSIAN DISTRIBUTION. THE LABORATORY WHERE TESTING IS PERFORMED IS TEMPERATURE CONTROLLED AND MONITORED. MANUFACTURER'S DIRECTION INSERTS ARE STRICTLY FOLLOWED TO ENSURE REAGENTS ARE UTILIZED APPROPRIATELY.